One Heart Magazine, 2011

ONE HEART MAGAZINE A global cardiovascular alliance project

Aligning Industry, Government, and Philanthropy

A mission to save over a thousand lives BIOTRONIK has a strong tradition of giving to philanthropy, and is actively engaged in local, national and international charity. Not only does BIOTRONIK consider giving to communities and patients in-need a corporate responsibility as a member of the global community, but a sincere and compassionate reflection of ‘excellence for life’.

The current highlight of BIOTRONIK’s philanthropic activity is a mission to save over a thousand lives via a strong strategic alliance with Heartbeat International Foundation (HBI), a global charity dedicated to providing much-needed heart devices to patients in need. There are one million – and possibly as many as three million – people who die each year because they cannot afford a pacemaker or ICD. The partnership between HBI and BIOTRONIK is committed to bringing those numbers down.

HBI has been in the business of saving lives in the poorest corners of the world since its founding 25 years ago. Patients in some of the most impoverished areas of Pakistan, Honduras, Benin, Venezuela, Kenya, Guatemala, Trinidad, the Dominican Republic, Colombia, Ecuador, Philippines, Thailand, India and China have benefited from their valiant efforts. BIOTRONIK believes that HBI is a profoundly effective and passionate organization, and is honored to be a part of their efforts worldwide.

quality

protection

With a mission to save lives, quality is our obsession.

www.biotronik.com

CARDIAC RHYTHM MANAGEMENT

What inspired our hybrid OR solutions? Keeping things simple.

Why simple? Because a hybrid OR is complicated enough. That’s why Philips hybrid OR solutions integrate all the equipment needed by interdisciplinary teams, including high-quality imaging systems. You can count on solutions that help you manage even the most challenging cases quickly and efficiently. To see a virtual tour of our hybrid OR solutions, please visit www.philips.com/hybridOR

*Because our innovations are inspired by you

TABLE OF CONTENTS The World Health Organization Interview with Dr. Shanthi Mendis

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Heartbeat International

A history of making peace through pacemakers

Biotronik bringing ICDs to Trinidad and World Tobago

58 Heart Federation

By Dr. Sid Smith

www.heartbeatsaveslives.org

Global Cardiovascular Alliance Teaming up to fight CVDs around the globe

By Dr. Benedict S. Maniscalco

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TINY HEARTS INSPIRED HYBRID LABS wITH ACCESS FOR BIG TEAMS. Fixing a heart from birth through adulthood takes big teams working together. So we examined the needs of leading clinicians when designing our hybrid solutions.

The result: our Infinix -i with 5-axis positioners and low profile detectors, stays out of the way, but right where needed, providing the best possible access to patients.

To lead, you must first listen.

TM

medical.toshiba.com

2010 Top 20 Best In KLAS Awards: Medical Equipment

Ranked #1: XarioTM Ultrasound-General Imaging, AquilionTM CT-64 Slice +, Vantage MRI 1.5T. Category Leader: Infinix-i Angio in CV/IR x-ray, Aquilion 32 in CT-Under 64 Slice.

2010

www.KLASresearch.com Š2010 KLAS Enterprises, LLC. All rights reserved.

TABLE OF CONTENTS Arrythmia Alliance

By Trudie Lobban

70 76 82 92 96 100 108 112

American College of Cardiology By Dr. David R. Holmes, Jr. Johns Hopkins Cardiology

By Dr. W. Lowell Maughan

Solidarity Bridge

By Christin Kirschenbaum

Project Pacer International

By Dr. Thomas Piemonte

Cardiostart International The Challenges of Emerging Economies

By Dr. Aubyn Marath

International Academy of Cardiovascular Sciences

By Ivan Berkowitz

Boston Scientific Closing the Gap

By Annete Ruzicka www.heartbeatsaveslives.org

ONE HEART MAGAZINE

Memorial Hermann Improves Patient Care Through Radial Intervention Using Toshiba’s Infinix -i Five-Axis C-arm Cath Labs TM

As one of the world’s largest providers of cardiovascular care, Memorial Hermann Heart and Vascular Institute – Texas Medical Center performs thousands of interventional cases annually. In 2009, as part of its commitment to provide the best imaging technology to its patients, Memorial Hermann Heart and Vascular Institute – TMC installed five Infinix-i vascular X-ray systems from Toshiba America Medical Systems, Inc., including two Infinix VF-i bi-planes, two Infinix CF-i single planes and one Infinix VF-i single plane.

After working with the Infinix-i systems, two leading interventional cardiologists at the Memorial Hermann Heart and Vascular Institute - TMC, Dr. Colin Barker, assistant professor at The University of Texas Health Science Center at Houston (UTHealth), and Dr. Richard Smalling, professor and director of Interventional Cardiovascular Medicine at UT Health, embarked on a quality initiative to elevate the organization’s already excellent patient care to an even higher level by instituting the transradial approach for interventional procedures.

Femoral Versus Radial Access Intervention When it comes to percutaneous coronary intervention (PCI), most healthcare providers in the U.S. rely on femoral access despite its inherent risk of complications. Most U.S. fellows are taught PCI using the femoral artery, an artery accessed through the patient’s groin, which offers a wide pathway to the heart.

Despite the potential technical challenges, research shows radial intervention significantly reduces bleeding complications during angioplasty and stenting, cutting by nearly 60 percent the risk of bleeding complications following PCI, while maintaining a high procedural success rate 1. In addition to being safer for the patient, it is also more comfortable. After radial intervention, patients experience rapid ambulation. The lower risk of complication coupled with faster ambulation results in speedier recovery, better patient comfort and reduced length of stay. By reducing the complications and improving recovery time, patients are discharged from the hospital faster to help lower overall healthcare costs.

Infinix-i’s Role in Radial Access Relying on their Infinix-i vascular labs, the interventional team at Memorial Hermann Heart and Vascular Institute – TMC transitioned into performing more transradial procedures. The design of Toshiba’s Infinix-i systems with the flexible five-axis C-arm movement facilitates the radial approach with ease, as it allows clinicians to access the patient from either side, move the C-arm seamlessly and situate the monitors and control panel to meet the needs of the interventional team.

1Cath Lab Digest article, Source: Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, August 2008.

Dr. Barker is now using the radial approach in 80 percent of the interventional cases he handles, including both low risk and high risk cases, such as diagnostics, type A lesions with a single blockage, ST-Segment Elevation Myocardial Infarction (STEMI), PCI, chronic occlusion, and stenting in patients with weak hearts. He only relies on femoral access when radial access is not a viable option due to the patient’s situation, such as patients who are very small, have limited blood supply in their arms, or have swelling or dialysis in the arm.

“Toshiba’s Infinix-i vascular lab is ideal for radial interventions as it allows equal access to the right and left radial arteries,” explained Dr. Barker. “The design of the system enables us to move the monitors and change the positioning of the C-arm, without having to pivot the table to reposition the patient, so we can operate from either side. This creates an ergonomically comfortable environment for the interventional team and the patient.”

Improved Collaboration: Using the Radial Approach Moving Forward After a nine-month period of bringing the team up to speed on radial intervention using the Infinix-i systems, Memorial Hermann Heart and Vascular Institute – TMC is now performing between 200 – 300 transradial cases annually. The excellent range of motion offered by the Infinix-i five-axis C-arm and the system’s overall ergonomics have helped improve workflow and collaboration between cardiologists, interventional cardiologists, anesthesiologists and clinical staff during exams, making it an ideal system to support radial intervention.

medical.toshiba.com

ONE HEART MAGAZINE A global cardiovascular alliance project

one heart mAGAzIne A global cardiovascular alliance project

Aligning Industry, Government, and Philanthropy

Chairman Heartbeat International Foundation Dr. Benedict S. Maniscalco Executive Vice President Heartbeat International Foundation Laura Maniscalco DeLise Vice President of Business Development Johnathan Hartmand Accounting Leanne Ragano Charles Stevens Advertising Associates Jason Easton Penn Mills Gage Pierce Creative Director Bryan Clapper Editorial Director Kevin Anderson Sales Support Staff Michelle Santiago Alfredo Escandion Contributing Writers Dr. Shanthi Mendis Dr. Sid Smith Dr. David Holmes Dr. Benedict S. Mansicalco Dr. Lowell Maughan Dr. Thomas Piemonte Dr. Aubyn Marath Christin Kirschenbaum Ivan Berkowitz Trudie Lobban

www.heartbeatsaveslives.org

Corporate Headquarters 4302 Henderson Blvd., Ste 102 Tampa, Florida 33629, USA Tel. (813) 261-2127

Publishers Adam Longaker Edward Suyak Chad Fernandez

Are you in it?

Non-Profit Liaison Laura Maniscalco DeLise Heartbeat International Support Staff Georgina Cronin Christine Conley Michael Maniscalco Production Associate Michael Johns Legal Counsel Albert Salem, Esquire Special Thanks Biotronik American College of Cardiology World Heart Federation World Health Organization Heartbeat International Foundation Johns Hopkins Project Pacer International Arrhythmia Alliance Solidarity Bridge Cardiostart Boston Scientific

Intelligence for leaders in medicine, philanthropy, business and government

ŠCopyright 2011 The Publishing Firm, Inc. All rights reserved. Reproduction of editorial content in whole or in part without written permission is prohibited.

The Publishing Firm, Inc. does not assume responsibility for the advertisements, nor any representation made therein, nor the quality or deliverability of the products themselves.

Reproduction of articles and photographs, in whole or in part, contained herein is prohibited without expressed written consent of the publisher, with the exception of reprinting for news media use. Printed in the United States of America.

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Antibacterial Envelope & Antibacterial Flat Sheet The AIGISRx速 Antibacterial Envelope is a polypropylene mesh device that securely holds a pacemaker or implantable cardioverter-defibrillator (ICD), creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotic agents rifampin and minocycline, which elute over a 7 to 10 day period. This antibiotic combination has been shown to reduce infections associated with medical devices in multiple randomized controlled trials.1,2,3,4,5

Help Prevent CIED Infection

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AIGISRx Envelope Shows Low Infection Rate & High Implantation Success For CIED Procedures

TYRX, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852 Customer Service: 866-908-8979 www.TYRX.com 1. Hanna et al. Journal of Clinical Oncology; 2004; 22(15): 3163-3171 2. Leon et al. Intensive Care Medicine; 2004; 30(10): 1891-1899 3. Zabramski et al. Journal of Neurosurgery; 2003; 98(4): 725-730 4. Chatzinikolaou et al. American Journal of Medicine; 2003; 115(5): 352-357 5. Raad et al. Annals of Internal Medicine; 1997; 127(4): 267-274 6. Bloom et al. Pacing Clinical Electrophysiol; 2011; 34(2):133-142 CAUTION: Federal law limits the device to sale by, or on the order of, a licensed practitioner. For full prescribing information, including indications, warnings, cautions and contraindications, see instructions for use.

MKT-23-091 Rev 2

Welcome

ABOUT DR. BENEDICT S. MANISCALCO

CARDIOVASCULAR DISEASE IS THE MOST SEVERE PANDEMIC THE WORLD HAS EVER FACED.

Dr. Benedict

No longer confined to wealthy countries, cardiovascular disease has become the leading cause of death and disability throughout the world. Left unchecked, it will undermine the health of exponentially more people as the world’s population increasingly urbanizes and adopts lifestyle and nutritional habits that contribute to cardiovascular disease. Not only can cardiovascular disease prove ruinous to an individual’s health and a family’s financial security, but given its ubiquity, also has the potential to thwart an entire country’s economic development.

co, chairman

During the past several decades, as billions of dollars were allocated to combat the spread of major infectious diseases, the prevalence of cardiovascular disease has been on an ever-upward trajectory. The money that went to support research, clinical trials for new drug therapies, programs of widespread immunization, and acute and chronic care have done wonders for our fight against infectious disease and our progress there has been remarkable.

But we must now embark on an even more robust campaign against noncommunicable diseases, especially cardiovascular diseases, the burdens and costs of which are projected to dwarf those associated with infectious diseases.

The majority of the people of the developing world are at risk. The governments of these nations are ill prepared and lack the resources to combat the scourge of cardiovascular diseases.

in cardiovas-

In this inaugural issue of ONE HEART magazine, a Global Alliance project, you will find a discussion of the breadth and depth of the problem discussed by the leader of the cardiovascular division of the World Health Organization (WHO). You will learn of the recommended steps to be taken by all countries and the resources that are needed if the fight against cardiovascular diseases is to be successful. You will learn how medical societies and organizations, academic and research organizations, and governmental and non-governmental organizations are approaching the issues and challenges to be faced and what others are presently doing, or preparing to do, in the campaign against this epidemic.

that have directly influenced healthcare

Heartbeat International has called for a “boots on the ground” Global Cardiovascular Alliance, to be composed of governmental and nongovernmental organizations strategically aligned to bring their core competencies to bear on the populations of the developing nations and to carry out specific missions in education, prevention, research, and the provision of lifesaving cardiovascular solutions. Others will concentrate on the geographic, political, and economic policy to be addressed for a successful campaign.

Join us in this quest by becoming informed and volunteering of your time, talent, and treasury!

S. Maniscaland CEO of Heartbeat International, has been a private practitioner specializing cular diseases since 1976. In addition to his work in preventive and consultative cardiology, he serves as medical advisor to multiple companies involved in medically related business. Well regarded as an innovator and educator in cardiovascular medicine, Dr. Maniscalco has been engaged with the American College of Cardiology at the local, state, and national levels, serving in leadership roles practices and policy.

After graduating from the Duke University School of Medicine, Dr. Maniscalco interned at Grady Memorial Hospital in Atlanta and did his junior and senior residencies at Emory University and its affiliated hospitals, and followed that with a fellowship in cardiovascular diseases from 1973–1975. He served on the faculty at the University of South Florida School of Medicine before leaving to found the St. Joseph’s Heart Institution in Tampa, Florida. He is a member of the American Medical Association, American Heart Association and a Fellow of the American Heart Association, the American College of Cardiology, the American College of Physicians, the American College of Chest Physicians, and the Society for Cardiac Angioplasty.

Benedict www.heartbeatsaveslives.org

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THE

Dear Reader,

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search Heart Magazine’. Re ne ‘O ad re to e tim the rbing ty-five minutes abso Thank you for taking en tw d en sp ill w er e age read the value of your tim e shows that the aver iz gn co re e W n. tio om publica the content of a cust investment of it. and appreciate your magazine will be is th in ad ge pa llthe average fu u could If you do the math, nds. But what if yo co se ve el tw of l ta to for a ients es of your target cl viewed by the reader fic of d an es m ho e n into th ld you say to them? ou w place your organizatio t ha W ? es ut in m twenty-five or donors for a full ering producing a id ns co n he w lf se ur estion to ask yo tal real This is the key qu aders’ time and men re ur yo to ss ce ac read. o gain custom publication. T ative and compelling rm fo in an ith w em to ovide th it is also important estate, you need to pr g, in ish bl pu to in n ventures hure.

As your organizatio ine, not a sales broc az ag m a g in uc od pr e remember that you ar ritten note of the content w ke ta it, ad re u yo md while iovascular Medical Co Enjoy One Heart, an rd Ca e th in s er ak m d policy by global leaders an munity. how your organin ar le to d lle pe m co Heart, you feel ed at no cost, email uc od pr If after reading One n tio ica bl pu -quality custom n. zation can have a high dule your consultatio he sc to m .co m fir ng connect@thepublishi .. ing One Heart, Thank you for read

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Rotar y Interna tion joins H BI’s effo al Clubs rts and pacem expand ake s 25 worl r banks to dwide.

Sixten pacem aker ba establis nks he South A d and operati ng in merica , the C and As arribea ia. n

HBIWW s doctors tarts program from pa to bring cemake around r banks the wo rld to a continu nnual ing edu cation worksh op.

Oct. 18 , 1984 :H Interna tional W eartbeat orld W and op id erates at the W e starts in Lake atson C land, F linic lorida.

‘PACEMAKERS CAN BE PEACEMAKERS’ Since 1984, Heartbeat International has provided more than 11,000 pacemakers to those in need around the world

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The fam ily banks g of HBI pacem rows to a 34 in 2 ker countrie 3 s with th e newe Argenti st bank na and s in Kenya.

Sept. 1 5, 199 2: and M aniscalc Drs. Mcintosh o agre and op e to mo era ve Heart In te HBI to St. Joseph stitute in ’s Tampa, Florida .

Off-sho re establis storage facilit y he Jamaic d in Montego a to ho Bay, use needed at a pa pacemakers u cemake n r bank. til Nov. 3 0, Florida 1993: HBI be comes corpora a tion.

HBI mo ves to n ew fac ilities.

Arnold Zohn P acema in Chen ker B gd training u, China ope ank n center to train s HBI from th physicia e Sichu an pro ns vince.

continues on page 20

Sixten pacem aker ba establis nks he South A d and operati ng in merica , the C and As arribea ia. n

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n the early 1970s, Dr. Federico Alfaro completed his medical residency and cardiology fellowship at Baylor University in Houston, Texas. Young, idealistic, he returned to his native Guatemala eager to practice and treat cardiology patients in his homeland. Then a patient came to him, a seriously ill 17-year-old boy with “heart block”—a condition in which the heartbeat continually slows until eventually it simply stops beating altogether. Despite Alfaro’s best efforts to secure financial assistance for the family, the boy died because they could not afford the pacemaker he needed. Dr. Alfaro soon realized that this was not an isolated case; many of his poor patients were dying for lack of access to modern medical technology, particularly pacemakers. He vowed to do something about it.

When Dr. Alfaro later became president of his local Rotary organization, the Club Rotario Guatemala de le Asunción, he made good on that vow. Gathering together a board of directors as well as a number of other cardiologists and surgeons, in 1977 he started a pacemaker bank that “loaned” pacemakers to indigent patients; when the pacemakers were no longer required, which was generally after the patient’s death, the units were returned to the bank for evaluation and, when possible, refurbishment for re-use. Member surgeons donated their time to perform the implants. Starting with an inventory of about 50 of the donated devices, the pacemaker bank was soon helping patients not only in Guatemala but also in other Caribbean and Central American countries, including Nicaragua, Costa Rica, El Salvador, Honduras, and the Dominican Republic.

The program was small but effective.

In 1983, a friend and former teacher of Dr. Alfaro came to visit and was impressed by the idea of a pacemaker bank and its medical and humanitarian potential. Dr. Henry Deane McIntosh, a former Chairman of Medicine at Baylor College of Medicine as well as one of the founders of the first Florida chapter of the American College of Cardiology, was eager to expand the concept of a pacemaker bank on a much grander scale. A former OSS commando and resistance fighter during WWII, Dr. Macintosh envisioned the program as not only way to save lives and help underserved populations gain access to vital cardiac care but also as a way to encourage international cooperation and, in doing so, promote world peace. He was fond of saying that pacemakers could be peacemakers.

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Over 11,000 lives saved Heartbeat International Christine Bocus Cardiovascular Disease is the number one cause of death globally; the World Health Organization has confirmed that Non-Communicable Diseases have surpassed communicable diseases as the number one health problem of developing nations.

Cardiovascular Disease accounts for approximately 80% of the Non-Communicable Diseases.

Heartbeat International’s mission is to save lives globally by providing cardiovascular implantable devices and follow up care to the needy people of the world. Our mission is accomplished with the support of individuals, corporations, non-governmental organizations, civic organizations, institutions, industry and healthcare professionals.

Heartbeat International is a public 501c3 nonprofit organization. Since our founding in 1984 Heartbeat International has saved over 11,000 lives; lives that would have otherwise perished. Working with our partners to restore the lives of those in need around the world is why Heartbeat International exists.

Christine is a 19-year-old student at the University of the West Indies, where she is studying Accounting.

After being diagnosed with a heart condition, she received a pacemaker in 2006. For several years she lived a healthy life until she once again felt weak and listless.

Doctors explained that because of her active lifestyle, the first pacemaker’s battery was dying, and she needed a new cardiac device. Christine’s family was unable to afford the device and the government health program did not cover it.

CHRISTINE BOCUS, TRINIDAD & TOBAGO

Then Christine received what seemed like miraculous news. “We were called in and told that BIOTRONIK from Germany had donated pacemakers to Heartbeat International of Trinidad & Tobago, and I would get one,” she recalls. On February 4, 2011, doctors implanted the device in Christine’s chest. “The second implant has restored my normal life,” she says. “I am overjoyed and grateful. I have been given a new lease on life.”

Christine is now able to continue her studies at University, preparing her to give back to those who have given to her. She says Heartbeat International and BIOTRONIK have saved her life and answered her prayers.

We need your help!

We need you to fulfill our mission and save lives. Please donate, volunteer or take part in our Henry D. McIntosh Fellowship program. For more information visit us at www.HeartbeatSavesLives.com.

HEARTBEAT INTERNATIONAL FOUNDATION 4302 Henderson Blvd, Suite 102 / Tampa, FL 33629 Phone ( 813 ) 259 - 1213 Fax ( 813 ) 259 - 1215 www.HeartBeatSavesLives.com

One Heart. One World. www.heartbeatsaveslives.com

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Benedic t S. Ma niscalc FACC, o, MD, becom es Hea Interna rtbeat tional C hairma Chief E n and xecutiv e Offic er.

HBI imp lants its 6,000th pacem aker.

HBI cele brates its 5,00 pacem 0th aker im plant a pacem nd gro aker ba ws nks to 4 countrie 1 in 27 s aroun d the w orld.

HBI sta rts Fellows Henr y D. Mcin hip Soc tosh ie sustain able fin ty to establish a a n founda tion an cial future for d hono the r its fou nder.

Dr. McIntosh realized that there would be substantial hurdles in the form of liability issues, FDA regulations, bureaucratic red tape, and customs complications, so he set to work developing a plan that would allow the program to operate without obstruction. He hit upon the key—gifting—when Dr. Alfaro traveled to the United States for a cardiology conference and Dr. McIntosh presented him with six used pacemakers— along with a letter stating that the pacemakers were gifts intended to save lives and to further peace and understanding between countries.

Fortuitously, when Dr. Alfaro presented the pacemakers and the letters at a Rotary Club meeting there in Guatemala in 1984, sitting in the audience was a Rotarian from Houston, Eddie Carrette. Carrette was so impressed by the program that he contacted an old college classmate who Dr. Benedict S. Maniscalco, right, has been HBI’s chairman and chief executive officer since worked for a pacemaker manufacturer; 2003.

Allen Webb convinced his company, Intermedics, Inc., to donate 486 new doctors from the pacemaker banks around the world to pulse generators and endocardial an annual workshop devoted to continuing education and pacing electrodes to the program, and made arrangements training in electrical problems of the heart and other current with Dr. McIntosh. Around the same time, the president of state of the art topics in cardiovascular disease.

Rotary International, Dr. Carlos Canseco, pledged support On June 18, 1986, Heartbeat International Worldwide, for the program and helped secure a US$250,000 grant from along with 99 other organizations nationwide, was that organization’s Health, Hunger, and Humanity Program. recognized

by President Reagan in the Rose Garden at the Heartbeat International Worldwide was born on October White House with a presidential citation, a part a federal 18, 1984, at the Watson Clinic in Lakeland, Florida, where program to stimulate private sector initiatives. Soon after, Dr. McIntosh practiced. Heartbeat International is the Dr. McIntosh retired from the Watson clinic, and moved cooperative effort of many individuals and entities: the the Heartbeat International’s base of operations to Tampa, Watson Clinic, the Rotary International service organization Florida, at the St. Joseph’s Heart Institute. In 2007, Heartbeat (1.22 million members worldwide in 33,976 clubs in International Worldwide earned its 501(c)(3) tax-exempt 200 countries and regions), representatives from the U.S. status from the U.S. Internal Revenue Service and created pacemaker manufacturing industry (past and present the Heartbeat International Foundation, which helped companies include BIOTRONIK, Intermedics, Medtronics, the organization navigate the complex regulatory maze CPI, and Telectronics), and consultative support from involved in accepting donations of new pacemakers as the American College of Cardiology. By 1985, Heartbeat well as securing, maintaining, refurbishing, donating, and International Worldwide had initiated a program to bring implanting previously used pacemakers to patients beyond

2003

2004 www.heartbeatsaveslives.org

the country’s borders. In 1997, Heartbeat International became a member of the Independent Charities of America (ICA), an umbrella organization that previews and approves nonprofit organizations as candidates for government employee and military personnel donations.

ABOUT DR. HENRY MCINTOSH A distinguished and much beloved physician and administrator, Dr. Henry D. McIntosh MD MACC served on numerous cardiology committees and boards, not the least of which was the Presidency of the American College of Cardiology (ACC) in 1974-5.

His professorial positions included Duke University School of Medicine (1962-70), University of Florida, School of Medicine (1977-2000), University of South Florida School of Medicine (1993-98), Kunming Medical College, Kunming, China (1996 onwards), West China University, Chengdu, China (1996 onwards) and in particular Professor and Chairman Department of Medicine, Baylor College of Medicine in Houston (1970-77).

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A humble man and forever a humanitarian and champion of the poor, Dr. McIntosh is best known internationally as founder of Heartbeat International, a charitable 501(c) (3) organization which through its strategic alliances with Rotary International and other civic organizations, pacemaker manufacturers and an army of medical and nonmedical volunteers which is responsible for providing and implanting cardiac implantable electronic devices in totally indigent and needy patients around the world.

2008

HBI cre ate directio s new strateg ic n with concep heartbe t of at glob al mov ement.

HBI esta bli banks in shes new pa cemake Hondu r ras, Be Cote d nin and ’Ivoire.

His creed “the service we give to our fellow man, is the rent we pay for the right to live on this earth” lives on.

HBI rec eiv saves it es $300,000 s 9,000 grant a nd th life.

As part of restr ucturing pacem , ake from 46 r banks are re duced to 32.

B indepe ndent o anks become rganiza tions.

HBI me ets with leaders the pac hip of emaker manufa compa cturing nies to seek ad support vice for futu re opera and tions.

Benedic tS Wil Mic . Maniscalco an k Colomb travel to Guate d ia, Cos mala, ta Rica Panam and a to res tructure HBI.

THE BEAT GOES ON The Heartbeat International network oversees the selection of patients who meet the medical and financial criteria to qualify as recipients of its devices and services, but the actual medical care and surgical implantation by people operating under the auspices of one of the 36 centers in 24 countries around the globe: Argentina, Barbados, West Africa, Cote D’Ivoire, Ghana, Bolivia, Chile, Dominican Republic, Ecuador, Egypt, Guatemala, Honduras, India, Mexico, Pakistan, Panama, Philippines, Romania, Suriname, and Trinidad. Local stakeholder participation and oversight enables the organization to work more cost-effectively and efficiently and to provide better medical care. In the early 2000s, operations were streamlined with a shift to fewer Pacemaker Banks but more implantation centers. This improvement in the group’s inner workings has allowed the growing philanthropic organization to save the lives of more than 11,000 cardiac patients who would have almost certainly have died without the free devices and services of the Heartbeat International Foundation.

The organization keeps itself intentionally lean and efficient, employing few paid staff members and continuing to work very closely with, and rely on, the volunteer services of Rotary International, the generosity of device manufacturers, and the donated services of dedicated doctors and other medical support staff in the recipient countries. As of 2009, an impressive 90 cents of every dollar donated could be applied directly to providing and implanting pacemakers and to patient follow-up care; just US$500 could save the life of one indigent heart patient, compared with the average cost of US$50,000 for similar services in the United States. This cost-efficiency is critical to the mission: according to the organization’s current chairman and CEO, Dr. Benedict S. Maniscalco, there are an estimated 1 to 3 million people worldwide currently in need of pacemakers, and many of them will be unable to afford the cost of the devices or the medical services without the assistance of Heartbeat International.

Given the state of the global economy and the rapid rise

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in demand for pacemakers and other cardiac interventions, NGO, and other participating organizations to form a trusted, it is unclear whether Heartbeat International will be able to expert, effective global resource for cardiac care for the rely strictly on donated devices to meet the needs of patients indigent. worldwide. At some point, Heartbeat International will in all Heartbeat International has received numerous awards, likelihood have to purchase some percentage of the units. accolades, and recommendations from organizations around Fortunately, its IRS status as a public foundation allows it to the world, including the American College of Cardiologists, receive funds from all manner of donors, as it seems likely the Heart Rhythm Society, the International Academy that the organization will have to increase substantially its of Cardiovascular Sciences, the International Cardiac monetary donations from various U.S. and international Pacing and Electrophysiology Society, and the Asociación government, charitable, philanthropic, and private Guatemalteca de Cardiologia. Dr. Guisela Castellanos Castillo endowment sources. of the latter association, One company that referring to the more has already increased than 900 Guatemalan “A hero is someone who has given its philanthropic patients who had been his or her life to something bigger involvement is a recipients of Heartbeat than oneself.” leading manufacturer International’s largesse, —Dr. Henry D. McIntosh of implantable cardiac noted that without FOUNDING CHAIRMAN HEARTBEAT INTERNATIONAL devices, BIOTRONIK, the organization’s which pledged in April intervention none of 2010 to provide over the patients would have 1,000 pacemakers over been able to afford the the next three years. device, operation, or “We are proud to be a part of HBI’s team and we intend after-care and would have died. “This effort is an example of to continue to support the foundation’s admirable efforts solidarity throughout the world that really promotes peace by aiming toward a goal of helping over a thousand needy and understanding between human beings,” she wrote in patients with BIOTRONIK devices within the next 3 years,” 2009. Speaking of the shared humanitarian vision of Dr. said Marlou Janssen, the global vice-president of Marketing Federico Alfaro and HBI founder Dr. Henry Deane McIntosh, and Sales for the Berlin-based company, in December 2010, she continued, “I think the mottos of Heartbeat International after the successful implantation of a pacemaker donated describe perfectly its mission—‘Making “Poor” Hearts Beat by the company saved the life of 7-year-old Yuleisy Daniela Better,’ and ‘Pacemakers as Peacemakers.’ ” Banos Peraldo of Ecuador.

The operation followed a mitral valve replacement by REFERENCES American College of Cardiology. (2009, April 24.) Endorsement letter.

Dr. Gerardo Davalos. Said Dr. Davalos after the girl returned Asociación Guatemalteca de Cardiologia. (2009, April 23). Endorsement home, “Without the cardiac device from BIOTRONIK, sweet letter. little Yuleisy would not have been able to live her life the Baman, T. S., Romero, A., Kirkpatrick, J. N., Romero, J., Lange, D. C., way a child should—with freedom, fun, fearlessness and Sison, E. O., et al. (2009). Safety and efficacy of pacemaker reuse in joy.” Thanks to Heartbeat International and others like underdeveloped nations: a case series. Journal of the American College of Cardiology, 54(16), 1557–1558. them who work cooperatively to provide lifesaving medical BIOTRONIK SE Co. & KG. (2010, December 20). BIOTRONIK and Heartbeat interventions, he continued, “Others like Yuleisy are given International collaborate to drive positive change. Retrieved from new hope for a healthy life and a future of possibilities.” http://www.biotronik.com/wps/wcm/connect/int_web/biotronik/right/

“

KEEPING PACE IN THE FUTURE While implanting pacemakers can save millions of lives, there are other ways that Heartbeat International hopes to be able to help ailing cardiac patients. In wealthy, developed countries such as the United States, hundreds of thousands of patients have access to such lifesaving interventions as heart valves, stents, drugs, and specialized procedures, all of which are beyond the means of most people in the countries where Heartbeat International has heart centers. They hope to expand their services to include additional devices, equipment, training, expertise, and personnel. Toward that end they have developed what they call the Global Cardiovascular Alliance, dedicated to combining its resources through strategic partnerships with industry, government,

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tradition/Philanthropy/#jump Conti, C. R. (2009). Henry Deane McIntosh. Transactions of the American Clinical and Climatological Association, 120, ci–ciii.

Heartbeat International Foundation. Online at heartbeatsaveslives.org Heart Rhythm Society. (2009, March 5.) Endorsement letter.

International Academy of Cardiovascular Sciences. (2009, May 1.)

Endorsement letter.

International Cardiac Pacing and Electrophysicology Society. (2009, February 17). Endorsement letter.

Maniscalco, B. S. (2010). Chairman’s vision. Heartbeat International Foundation, Inc. Retrieved from http://www.heartbeatintl.org/ chairman.htm McIntosh, H. D., Conti, C. R., Vlietstra, R. E., & Gonzales, J. L. (1987).

Heartbeat International: A cooperative program using cardiac pacemakers to foster goodwill and understanding. Transactions of the American Clinical and Climatological Association, 98, 187–196.

Mond, H. G., Mick, W., & Maniscalco, B. S. (2009). Heartbeat International: Making “poor” hearts beat better. Heart Rhythm, 6(10), 1538–1540.

www.heartbeatsaveslives.org

Effective angina relief –

Nitrolingual Pumpspray ®

(nitroglycerin lingual spray)

To request a sample,

call 1-866-516-4950 today!

Effective Pain Relief

Stability & Potency

Spray Form

Important Safety Information Nitrolingual Pumpspray is contraindicated in patients who are allergic to nitroglycerin or taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors).

Concomitant use may cause severe hypotension including amplification of vasodilatory effects.

Nitroglycerin should be used with caution in the early days after myocardial infarction and may aggravate the angina caused by hypertrophic cardiomyopathy. Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin and may result in paradoxical bradycardia and increased angina. It should be used with caution in patients who have volume depletion from diuretic therapy or who have low systolic blood pressure.

Not actual size

Fire extinguisher image does not depict actual product.

Indications and Usage Nitrolingual® Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

200 metered 60 metered sprays sprays

Tolerance to this drug and cross-tolerance to other nitrates and nitrites may occur.

Headache is the most reported side-effect and may be severe and persistent. Adverse events occurring at a frequency greater than 2% were headache, dizziness and paresthesia.

Please see full Prescribing Information on next page.

W W W. N I T R O L I N G U A L . C O M

© 2011 Arbor Pharmaceuticals, Inc. All rights reserved. The following trademarks are either registered trademarks or trademarks of Pohl-Boskamp in the United States and/or other countries:Pohl-Boskamp word mark; Pohl-Boskamp logo; Nitrolingual word mark; Peppermint flavor of nitroglycerin; Peppermint scent of nitroglycerin; Nitrolingual Pumpspray shapes; Nitrolingual Pumpspray colors; and the sound of Nitrolingual Pumpspray. Arbor Pharmaceuticals’ use of Nitrolingual is under license from G. Pohl-Boskamp GmbH & Co. KG. NL.035.002

@NitrolingualPS

(nitroglycerin lingual spray) 400 mcg per spray, 60 or 200 Metered Sprays DESCRIPTION: Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is:

CH2 —ONO2 CH —ONO2 CH2 —ONO2 Nitrolingual® Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil.

CLINICAL PHARMACOLOGY: The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle, producing a vasodilator effect on both peripheral arteries and veins with more prominent effects on the latter. Dilation of the post-capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure (pre-load). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (after-load).

The mechanism by which nitroglycerin relieves angina pectoris is not fully understood.

Myocardial oxygen consumption or demand (as measured by the pressure-rate product, tension-time index, and stroke-work index) is decreased by both the arterial and venous effects of nitroglycerin and presumably, a more favorable supply-demand ratio is achieved.

While the large epicardial coronary arteries are also dilated by nitroglycerin, the extent to which this action contributes to relief of exertional angina is unclear.

Nitroglycerin is rapidly metabolized in vivo, with a liver reductase enzyme having primary importance in the formation of glycerol nitrate metabolites and inorganic nitrate. Two active major metabolites, 1,2- and 1,3-dinitroglycerols, the products of hydrolysis, although less potent as vasodilators, have longer plasma half-lives than the parent compound. The dinitrates are further metabolized to mononitrates (considered biologically inactive with respect to cardiovascular effects) and ultimately glycerol and carbon dioxide.

Therapeutic doses of nitroglycerin may reduce systolic, diastolic and mean arterial blood pressure. Effective coronary perfusion pressure is usually maintained, but can be compromised if blood pressure falls excessively or increased heart rate decreases diastolic filling time.

Elevated central venous and pulmonary capillary wedge pressures, pulmonary vascular resistance and systemic vascular resistance are also reduced by nitroglycerin therapy. Heart rate is usually slightly increased, presumably a reflex response to the fall in blood pressure. Cardiac index may be increased, decreased, or unchanged. Patients with elevated left ventricular filling pressure and systemic vascular resistance values in conjunction with a depressed cardiac index are likely to experience an improvement in cardiac index. On the other hand, when filling pressures and cardiac index are normal, cardiac index may be slightly reduced.

In a pharmacokinetic study when a single 0.8 mg dose of Nitrolingual® Pumpspray was administered to healthy volunteers (n = 24), the mean Cmax and Tmax were 1,041pg/mL · min and 7.5 minutes, respectively. Additionally, in these subjects the mean area-under-thecurve (AUC) was 12,769 pg/mL · min.

In a randomized, double-blind single-dose, 5-period cross-over study in 51 patients with exertional angina pectoris significant dose-related increases in exercise tolerance, time to onset of angina and ST-segment depression were seen following doses of 0.2, 0.4, 0.8 and 1.6 mg of nitroglycerin delivered by metered pumpspray as compared to placebo.

Additionally the drug was well tolerated as evidenced by a profile of generally mild to moderate adverse events.

INDICATIONS AND USAGE: Nitrolingual® Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

CONTRAINDICATIONS: Allergic reactions to organic nitrates are rare. Nitroglycerin is contraindicated in patients who are allergic to it. Nitrolingual® Pumpspray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), as their concomitant use can cause severe hypotension. The time course and dose-dependency of this interaction are not known.

WARNINGS: Amplification of the vasodilatory effects of Nitrolingual® Pumpspray by certain drugs (phosphodiesterase inhibitors) used to treat erectile dysfunction can result in severe hypotension. The time course and dose dependence of this interaction have not been studied.

Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The use of any form of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status.

PRECAUTIONS: (General) Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. The drug, therefore, should be used with caution in subjects who may have volume depletion from diuretic therapy or in patients who have low systolic blood pressure (e.g., below 90 mm Hg). Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin-induced hypotension.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

Tolerance to this drug and cross-tolerance to other nitrates and nitrites may occur. Tolerance to the vascular and anti-anginal effects of nitrates has been demonstrated in clinical trials, experience through occupational exposure, and in isolated tissue experiments in the laboratory.

In industrial workers continuously exposed to nitroglycerin, tolerance clearly occurs. Moreover, physical dependence also occurs since chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitroglycerin from the workers. In various clinical trials in angina patients, there are reports of anginal attacks being more easily provoked and of rebound in the hemodynamic effects soon after nitrate withdrawal. The relative importance of these observations to the routine, clinical use of nitroglycerin is not known.

PRECAUTIONS: (INFORMATION FOR PATIENTS) Physicians should discuss with patients that Nitrolingual® Pumpspray should not be used with certain drugs taken for erectile dysfunction (phosphodiesterase inhibitors) because of the risk of lowering their blood pressure dangerously.

DRUG INTERACTIONS: Alcohol may enhance sensitivity to the hypotensive effects of nitrates. Nitroglycerin acts directly on vascular muscle. Therefore, any other agents that depend on vascular smooth muscle as the final common path can be expected to have decreased or increased effect depending upon the agent.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and oral controlled-release nitroglycerin were used in combination. Dose adjustments of either class of agents may be necessary.

Concomitant use of nitric oxide donors (like Nitrolingual® Pumpspray) and certain drugs for the treatment of erectile dysfunction (phosphodiesterase inhibitors) can amplify their vasodilatory effects, resulting in severe hypotension. The concomitant use of these drugs is contraindicated (see CONTRAINDICATIONS) and alternative therapies should be used to treat acute angina episodes.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Animal carcinogenesis studies with sublingual nitroglycerin have not been performed.

Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in both sexes were 52% vs.

0% in controls, and incidences of testicular tumors were 52% vs. 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.

Nitroglycerin was weakly mutagenic in Ames tests performed in two different laboratories.

Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, p.o., or in in vitro cytogenic tests in rat and dog tissues.

In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for six months prior to mating of the F0 generation with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males. In this three-generation study there was no clear evidence of teratogenicity.

PREGNANCY: Pregnancy Category C – Animal teratology studies have not been conducted with nitroglycerin-pumpspray. Teratology studies in rats and rabbits, however, were conducted with topically applied nitroglycerin ointment at doses up to 80 mg/kg/day and 240 mg/kg/day, respectively. No toxic effects on dams or fetuses were seen at any dose tested. There are no adequate and well-controlled studies in pregnant women. Nitroglycerin should be given to pregnant women only if clearly needed.

NURSING MOTHERS: It is not known whether nitroglycerin is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Nitrolingual® Pumpspray is administered to a nursing woman.

PEDIATRIC USE: Safety and effectiveness of nitroglycerin in pediatric patients have not been established.

ADVERSE REACTIONS: Adverse reactions to oral nitroglycerin dosage forms, particularly headache and hypotension, are generally dose-related. In clinical trials at various doses of nitroglycerin, the following adverse effects have been observed: Headache, which may be severe and persistent, is the most commonly reported side effect of nitroglycerin with an incidence on the order of about 50% in some studies. Cutaneous vasodilation with flushing may occur. Transient episodes of dizziness and weakness, as well as other signs of cerebral ischemia associated with postural hypotension, may occasionally develop. Occasionally, an individual may exhibit marked sensitivity to the hypotensive effects of nitrates and severe responses (nausea, vomiting, weakness, restlessness, pallor, perspiration and collapse) may occur even with therapeutic doses. Drug rash and/or exfoliative dermatitis have been reported in patients receiving nitrate therapy. Nausea and vomiting appear to be uncommon.

Nitrolingual® Pumpspray given to 51 chronic stable angina patients in single doses of 0.4, 0.8 and 1.6 mg as part of a double-blind, 5-period single-dose cross-over study exhibited an adverse event profile that was generally mild to moderate. Adverse events occurring at a frequency greater than 2% included: headache, dizziness, and paresthesia. Less frequently reported events in this trial included (≤2%): dyspnea, pharyngitis, rhinitis, vasodilation, peripheral edema, asthenia, and abdominal pain.

OVERDOSAGE: Signs and Symptoms: Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions, and possibly death due to circulatory collapse.

Methemoglobinemia: Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.

Treatment of Overdosage: Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Administer oxygen and artificial ventilation, if necessary.

If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required. If an excessive quantity of Nitrolingual® Pumpspray has been recently swallowed gastric lavage may be of use.

WARNING: Epinephrine is ineffective in reversing the severe hypotensive events associated with overdosage. It and related compounds are contraindicated in this situation.

DOSAGE AND ADMINISTRATION: At the onset of an attack, one or two metered sprays should be administered onto or under the tongue. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists, prompt medical attention is recommended. Nitrolingual® Pumpspray may be used prophylactically five to ten minutes prior to engaging in activities which might precipitate an acute attack.

Each metered spray of Nitrolingual® Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of 5 sprays. It will remain adequately primed for 6 weeks.

If the product is not used within 6 weeks it can be adequately reprimed with 1 spray. Longer storage periods without use may require up to 5 repriming sprays. There are 60 or 200 metered sprays per bottle. The total number of available doses is dependent, however, on the number of sprays per use (1 or 2 sprays), and the frequency of repriming.

The transparent container can be used for continuous monitoring of the consumption. The end of the pump should be covered by the fluid level. Once fluid falls below the level of the center tube, sprays will not be adequate and the container should be replaced. As with all other sprays, there is a residual volume of fluid at the bottom of the bottle which cannot be used.

During application the patient should rest, ideally in the sitting position. The container should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should preferably be sprayed onto the tongue by pressing the button firmly and the mouth should be closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. The medication should not be expectorated or the mouth rinsed for 5 to 10 minutes following administration. Patients should be instructed to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night.

HOW SUPPLIED: Each box of Nitrolingual® Pumpspray contains one glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 12 g (Net Content) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming.

Nitrolingual® Pumpspray is available as: • 60-dose (4.9 g) single bottle NDC 24338-300-65 • 200-dose (12 g) single bottle NDC 24338-300-20 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Note: Nitrolingual® Pumpspray contains 20% alcohol. Do not forcefully open or burn container after use. Do not spray toward flames. Rx Only.

Manufactured for Arbor Pharmaceuticals, Raleigh, North Carolina 27609

by G. Pohl-Boskamp GmbH & Co. KG, 25551 Hohenlockstedt, Germany

Rev. 09/10

A world

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www.heartbeatsaveslives.org

of difference Dr. Shanthi Mendis, senior advisor and coordinator of the global Cardiovascular Diseases Prevention and Management program for the World Health Organization, talks about the group’s role in fighting heart disease around the globe. story begins on page 30

www.heartbeatsaveslives.org

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Ad

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ONE HEART MAGAZINE

www.heartbeatsaveslives.org

Luxury getaway on the world’s best beach What do you need in a vacation? Comfort without fuss?

Warmth mixed with refreshing trade winds? Natural beauty?

Excellence in service performed at a relaxed pace with a certain charm? Then make some time for the Turks & Caicos Islands, where your pulse rate is sure to slow down.

Turks and Caicos is actually made up of over 40 islands and cays east south east of the Bahamas, spanning a distance of less than 100 miles from east to west and even fewer north to south. Just eight are inhabited, each reflecting distinct natural beauty, history and culture. Most visitors spend their time on Providenciales, the perfect place to unwind, but trips to the outer islands are highly recommended if you are looking to get a better impression of this small lively nation. Scheduled air flights and well organized excursions are readily available.

Providenciales’ Grace Bay Beach consistently receives accolades as the world’s best beach. It was named after Grace Hutchings, an early visitor in 1892, in honor of her beauty, style and of course grace. This pristine 12 mile beach seems to have that perfect combination of fine white powder sand, expansive vistas, constant breezes and yet no crowds. The sea colors will stay with you forever; shades of Tiffany blue, turquoise, cobalt and more; and the sunsets are not to be missed. Many of the country’s most luxurious resorts are here, making for easy movement between one world class refreshment experience to another. Of course there’s nothing like becoming a ‘local’ in your own luxury resort, and one that has received the World Travel Award for the Caribbean’s Leading Boutique Hotel from 2005 to 2010 is Point Grace, Luxury Resort & Spa. The resort is appropriately named as it sits on the ‘point’ half way along Grace Bay Beach where with it’s expanse of white sand and untamed beauty you feel like you are on your own desert island. The resort’s magnificent suites, restaurants and spa are all inspired by classic turn-of-thecentury British Colonial architecture creating a West Indian setting untouched by time.

The islands are a divers feast with close to shore wall drops of up to 8,000 feet. Humpback whales pass by during Spring whaling season. Nature can be found in many forms from turtles to osprey eagles. Fitness lovers will find quality gyms, classes and water-sports with expert tuition. Kite-boarding, triathlons, 5/10K runs, sea-swims are all pursuits to join in. Tennis, golf and horse-back riding are all catered for, again with experts on hand.

Fishing from bone fishing to deep sea fishing is world class. There is plenty to do if you are looking to be active.

World class chefs seek to impress you with their signature dishes creating a cosmopolitan fare, but Caribbean and nativestyle dishes abound with the fresh catch of the day and the country’s own Conch. Dining is everything from a simple to luxurious experience. You’ll find a huge selection of wines and drinks on offer too. Point Grace’s elegant gourmet restaurant, Grace’s Cottage, has specialized in pairing fine wines with inspired cuisine for many years now. Come, take time to enjoy cuisine at it’s best, in the best possible settings.

Your body and soul have already entered a new dimension, where you feel energized but utterly peaceful. The Point Grace Thalasso Spa is all you need to further the restoration process.

Treatments are European in style; Thalassotherapy using the islands natural resources and Thalgo products. The setting is truly West Indian; white washed exquisite cottages just set back from the natural beach dunes with inspiring sea views and breezes.

Turks and Caicos is very accessible with many international flights. It’s just over an hour from Miami and two and a half hours from New York amongst many routes. Your first vision of the islands from the plane will be awe inspiring. You’ll finally know you are on vacation. Getting through the soon to be expanded small airport terminal is fine but a discrete courteous fast track VIP Flyers service is available; Turks and Caicos will give you the luxury you desire at every step.

Those that live in the islands keep their history and culture close to their hearts, but they also move with the times and going-green, ecotourism and government-reform are all hot topics. There is certainly a pride in the islands that we do things our way, we don’t just follow others, and that gives the islands a spirit all to their own. If you chose to visit Turks and Caicos you’d very likely become one of our many return visitors, so we hope to see you very soon.

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D

r. Shanthi Mendis, whom the Physiological Society of Sri Lanka called “one of the most brilliant products of the Peradeniya Medical School (MBBS ’74, DM ’88),” completed her additional undergraduate and postgraduate training in England and postdoctoral training in the United States. Dr. Mendis, now a specialist in cardiology and public health, joined the Peradeniya Medical School faculty in 1991 as a professor, and became the head of its department of medicine in 1995.

A Fellow of the American College of Cardiology and a Fellow of the Royal College of Physicians of London, Dr. Mendis has extensive experience in policy development in developing countries, health systems research, and undergraduate and postgraduate training. She has received many honors and awards, including the Professor M. Viswanathan Gold Medal Oration 2010, and has published widely in scientific literature. In 1999 she joined the World Health Organization, where she currently serves as Senior Advisor and Coordinator of the Global Cardiovascular Diseases Prevention and Management program at the WHO headquarters in Geneva, Switzerland. In that capacity she oversees the three-pronged Global Strategy for Prevention and Control of NCDs, which involves surveillance (mapping the epidemic), prevention (reducing levels of exposure to risk factors) and management (strengthening the health system for people with disease), through a six-part action plan comprising key objectives in advocacy, policy development, primary prevention, research and partnership development, as well as monitoring and evaluation.

ONE HEART: What motivated you to join the WHO? DR. MENDIS: Before I joined the World Health Organization, I was able to help people on a small scale, one patient at a time, but although that was fulfilling, I wanted to be able to influence the development of health policies to improve health of people on a larger scale. Before I joined WHO, I worked in the UK and USA for 8 years and also many years in Sri Lanka and Southeast Asia, and I was alarmed at the scale of the gaps and inequities in health in general and cardiovascular diseases in particular. Over 80% of the deaths attributed to cardiovascular diseases occur in the developing world—that is, among those who don’t have the same access to lifesaving cardiovascular solutions as people in developed nations. Joining WHO gave me the opportunity to make a difference particularly in the field of non-communicable diseases on a global scale.

What is the scope of the problem of cardiovascular disease from both health and socioeconomic standpoints?

Non-communicable diseases (NCDs) as a whole are 30

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responsible for claiming over 36 million deaths a year worldwide—63% of the global mortality —and over 80% of those deaths occur in low- and middle-income countries.

About 9 million of those deaths are in people who are still in their productive years—under 60 years of age.

Cardiovascular diseases are the leading NCDs, contributing to a total of about 17 million deaths out of the 36 million, www.heartbeatsaveslives.org

The World Health Organization assembly meets to discuss ways to combat non-concommunicable diseases, such as heart disease, cancer and diabetes.

www.heartbeatsaveslives.org

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or almost half. Clearly cardiovascular disease is a major global health issue.

Diabetes is also on the rise, which contributes to the rise of cardiovascular diseases because these two are very closely linked. In the next 10 years, you would expect deaths from NCDs to increase by about 17% in developing countries. In some regions—Africa, for example—the increases are expected to be even higher; these are very alarming trends being predicted by WHO.

Dr. Shanthi Mendis

What disparities are there between the care received by people with CVDS in developed countries and developing nations?

There are disparities in all countries—even in the rich countries. Even in some developed countries you find that within the borders there are certain regions or socioeconomic groups that don’t receive equitable care.

But the disparity is most striking between high-income and lowincome countries, for many reasons.

One of the main reasons is lack of financial resources. Out-ofpocket expenditures in developing countries are very high, and there are no insurance plans or social protection schemes that cover the whole population, except in a few countries. This means that people have to spend for their healthcare, and considering that the vast majority of people in these developing countries are not very well-to-do, when they have other priorities—education, housing, food—they are going to delay accessing healthcare when they have to pay out of pocket. So, in general, diagnosis in such countries comes late, which leads to patients in more advanced stages of illness and with complications that are very costly, both on the family’s finances directly and on a larger scale in terms of people’s productivity. Of course, there are personal and emotional consequences as well. From an economic standpoint, however, CVDs and other NCDs can be devastating on households; a family member’s heart attack or stroke can push a household into poverty. If the family is poor, they become poorer still from the catastrophic expenditures continues on page 36

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www.heartbeatsaveslives.org

World Health Organization fact sheet on cardiovascular diseases » CVDs are the number one cause of death globally: more people die annually from CVDs than from any other cause. » An estimated 17.1 million people died from CVDs in 2004, representing 29%of all global deaths. Of these deaths, an estimated 7.2 million were due to coronary heart disease and 5.7 million were due to stroke. » Low- and middle-income countries are disproportionally affected: 82% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. » By 2030, almost 23.6 million people will die from CVDs, mainly from heart disease and stroke. These are projected to remain the single leading causes of death. The largest percentage increase will occur in the Eastern Mediterranean Region. The largest increase in number of deaths will occur in the South-East Asia Region.

Why are cardiovascular diseases a development issue in low- and middle-income countries? » Over 80% of the world’s deaths from CVDs occur in low- and middle-income countries. » People in low- and middle-income countries are more exposed to risk factors leading to CVDs and other noncommunicable diseases and are less exposed to prevention efforts than people in high-income countries. » People in low- and middle-income countries who suffer from CVDs and other noncommunicable diseases have less access to effective and equitable health care services which respond to their needs (including early detection services). » As a result, many people in low- and middle-income countries die younger from CVDs and other noncommunicable diseases, often in their most productive years. » The poorest people in low- and middle-income countries are affected most. At household level, sufficient evidence is emerging to prove that CVDs and other noncommunicable diseases contribute to poverty. For example, catastrophic health care expenditures for households with a family member with CVD can be 30 per cent or more of annual household spending. » At macro-economic level, CVDs place a heavy burden on the economies of low- and middle-income countries. Heart disease, stroke and diabetes are estimated to reduce GDP between 1 and 5% in low- and middle-income countries experiencing rapid economic growth, as many people die prematurely. For example, it is estimated that over the next 10 years (2006-2015), China will lose $558 billion in foregone national income due to the combination of heart disease, stroke and diabetes.

avoiding foods that are high in fat, sugar and salt, and maintaining a healthy body weight.

Comprehensive and integrated action is the means to prevent and control CVDs. » Comprehensive action requires combining approaches that seek to reduce the risks throughout the entire population with strategies that target individuals at high risk or with established disease. » Examples of population-wide interventions that can be implemented to reduce CVDs include: comprehensive tobacco control policies, taxation to reduce the intake of foods that are high in fat, sugar and salt, building walking and cycle ways to increase physical activity, providing healthy school meals to children. » Integrated approaches focus on the main common risk factors for a range of chronic diseases such as CVD, diabetes and cancer: unhealthy diet, physically inactivity and tobacco use.

There are several treatment options available. » Effective and inexpensive medication is available to treat nearly all CVDs. » Survivors of a heart attack or stroke are at high risk of recurrences and at high risk of dying from them. The risk of a recurrence or death can be substantially lowered with a combination of drugs – statins to lower cholesterol, drugs to lower blood pressure, and aspirin. » Operations used to treat CVDs include coronary artery bypass, balloon angioplasty (where a small balloon-like device is threaded through an artery to open the blockage), valve repair and replacement, heart transplantation, and artificial heart operations. » Medical devices are required to treat some CVDs. Such devices include pacemakers, prosthetic valves, and patches for closing holes in the heart.

How can the burden of cardiovascular diseases be reduced?

Heart disease and stroke can be prevented through healthy diet, regular physical activity and avoiding tobacco smoke.

Individuals can reduce their risk of CVDs by engaging in regular physical activity, avoiding tobacco use and second-hand tobacco smoke, choosing a diet rich in fruit and vegetables and www.heartbeatsaveslives.org

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EECP Therapy: A Treatment for Heart Failure via Improvement in Endothelial Dysfunction Gregory W. Barsness, MD, Division of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.

Enhanced external counterpulsation (EECP) is a noninvasive outpatient therapy cleared for marketing by the US FDA for the treatment of chronic angina and heart failure. EECP treatment produces an acute hemodynamic effect similar to that produced by the invasive intra-aortic balloon pump.

Cuffs on the calves, the lower thighs, and upper thighs are sequentially inflated with compressed air during the diastolic phase of the cardiac cycle and are simultaneously deflated in early systole. This rapid inflation and deflation raises diastolic aortic pressure to increase coronary perfusion, provides afterload reduction and increases venous return, resulting in an increase in cardiac output. The safety and efficacy of EECP therapy for angina and heart failure have been well documented in several large international studies.

Several investigators have studied the mechanisms of action of EECP therapy, including the endothelial function effects of increased systemic blood flow velocity and beneficial shear stress forces. The observed endothelial function improvement is associated with an observed increase in the release of endothelial nitric oxide synthase (eNOs) and the vasodilator nitric oxide (NO), as well as suppression of the vasoconstrictor endothelin (ET-1). There are also published studies demonstrating that EECP therapy is effective in stimulating the endothelium to release vascular endothelial growth factor and, together with the mechanical pressure gradient generated during EECP, to potentially promote coronary collateral flow, coronary fractional flow reserve and increase microcirculatory density. In addition, EECP therapy decreases circulating levels of inflammatory cytokines and activates endothelial progenitor stem cells to replace and repair endothelium apoptosis, thereby enhancing endothelial function and slowing down the atherosclerotic process and the progression of cardiovascular disease.

The beneficial actions of EECP therapy to inhibit the progression of disease can be illustrated in its use as a treatment of heart failure with positive results from a randomized, controlled clinical trial entitled Prospective Evaluation of EECP in Congestive Heart Failure (PEECH™), in which 187 heart failure patients with NYHA II or III classification were randomized into either EECP + pharmacologic therapy (PT) or PT alone. The results of the PEECH™ trial showed a significant portion (35%) of EECP treated patients achieving a 60-second or more increase in exercise duration versus

25% in the PT control group at 6 months post treatment, with a 25 second increase in average exercise duration for the EECP group verses a 10 second decrease for the control group, 6 months post treatment. This trial demonstrated more significant improvements in favor of EECP therapy for the subgroup of patients 65 years or older, including improvements in exercise duration, peak volume of oxygen uptake, symptom status and quality of life. Patients in the trial who had an ischemic etiology (i.e. pre-existing coronary artery disease) demonstrated a greater response to EECP therapy than those who had an idiopathic (non-ischemic) etiology.

The confluence of these effects is manifest in endothelial dysfunction as a predictor of future major adverse cardiovascular events in patients suffering from heart failure, especially those patients with ischemic heart disease. Given the strong evidence that EECP is effective in improving endothelial dysfunction, the potential use and benefit of EECP in patients with heart failure is an attractive consideration.

Currently in the United States, EECP therapy is reimbursed as a covered benefit by the Centers for Medicare and Medicaid Service (CMS) and many private insurance companies for the treatment of patients with disabling angina. Many of these patients, however, present with concomitant symptoms of ischemic heart failure. The safety and efficacy of EECP in this patient subset has been confirmed among 8,000 patients enrolled in the International EECP Patient Registry™ (IEPR). University of Pittsburgh investigators found that approximately one-third of patients treated for angina with EECP also have a history of heart failure. Among this group, approximately 70% to 80% have demonstrated positive outcomes from EECP therapy.

EECP therapy remains an important therapeutic tool for the safe and effective outpatient treatment of a broad spectrum of symptomatic cardiovascular disorders. Investigation into likely therapeutic mechanisms, such as improved vascular endothelial function, along with exploration of benefit in new patient subgroups, such as those with heart failure, continues, while the application of this novel treatment modality remains ever increasing as the observed benefits become more apparent. 

Delegates attend a technical briefing on non-communicable diseases.

of having to pay for hospital stays and extended care. This has a major impact on the national economy because it affects the developing country’s GDP, the national growth and development. Recent studies done in developing countries clearly indicate that there are detrimental macroeconomic consequences that make healthcare a major national development issue for many nations. And that needs to be addressed; if not, the nation’s or region’s macroeconomic growth will be seriously affected and retarded.

When you add up the cost of the healthcare—the lost income and the affected nations’ loss of development—is there any idea what the total economic impact of CVDS is from a global standpoint?

We cannot accurately assess the global cost. For some countries we have adequate data on the macroeconomic impact of various healthcare costs, but for other countries we lack the kind of detailed data we need to calculate meaningful totals. For example, we can take data from the United States and determine what gets spent on cardiovascular care and what gets spent on prevention and treatment, but with data from many other countries the budget breakdowns are not as clear. The differences in the quantity and quality of data make it very difficult to quantify healthcare costs in terms of either budget or productivity loss. We have reports from some developing nations, but they do not provide enough information for us to work out a global number. This week a study conducted by the Harvard 36

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Medical School in collaboration with the World Economic Forum estimated the total economic lost to be 7 trillion over the period 2011-2025; a staggering cost.

What role do you see WHO playing in the fight against CVDS over the next twenty years?

WHO started putting in place very concrete steps way back in 1998, WHO had been mandated to develop a strategy for the prevention and control of noncommunicable diseases. I joined WHO at this time.

That strategy, which has provided a strong, sensible, and sound foundation was endorsed by all 193 member states, gives countries guidance on how to address the non-communicable disease epidemic, especially the cardiovascular disease epidemic. It focuses on the four major non-communicable diseases— cardiovascular disease, cancer, diabetes and chronic respiratory disease—and recognizes that these four NCDs share major risk factors: tobacco, unhealthy diet, physical inactivity, and harmful use of alcohol, and that there are social determinants that affect the growth of these risk factors. Countries cannot treat their way out of noncommunicable diseases; a comprehensive approach is needed. WHO recommends a combination of population wide prevention and strong healthcare systems that provide equitable care, together with systems to monitor what happens to the disease epidemic and the risk factors. That’s the real way of controlling the problem, making the risk factors www.heartbeatsaveslives.org

less prevalent in the population. The strategy gives a lot of attention to the primary healthcare approach as the best way to provide equitable healthcare for non-communicable diseases. This year we worked extensively on estimating costs and have now released the estimated global price tag for scaling up noncommunicable diseases in developing countries; USD 11.4 billion a year, for implementing a set of Best Buy interventions prioritized by WHO. These are high impact interventions that can be implemented even in the poorest countries in an incremental fashion.

Between 2000 and 2008 there were at least two major milestones spear headed by WHO. One was the Framework Convention on Tobacco Control, the first public health treaty endorsed by the World Health Assembly. WHO has taken some very important steps toward tobacco control, and that has led to quite a lot of progress in various countries, although there is much more to be done. In 2004, the member states unanimously endorsed another global strategy that

“

“(D)iagnosis in such countries comes late, which leads to patients in more advanced stages of illness and with complications that are very costly, both on the family’s finances directly and on a larger scale in terms of people’s productivity.”

”

—Dr. Shanthi Mendis

SENIOR ADVISOR AND COORDINATOR, GLOBAL CARDIOVASCULAR DISEASES PREVENTION AND MANAGEMENT WORLD HEALTH ORGANIZATION

focused on the promotion of healthy diet and physical activity. Last year we moved forward a Global Strategy aimed at taking steps to control harmful use of alcohol.

All Member States signed up to these Global Strategies.

This year, WHO has been particularly active, providing technical support to countries to prepare for the United Nations High Level Meeting on noncommunicable diseases, 20-21 September 2011. We’re looking ahead to the United Nations General Assembly High Level Meeting. We had a preparatory meeting in April, a ministerial meeting hosted by the Russian government on non-communicable diseases and there has been meetings in all WHO Regions. With the UN’s involvement there will be greater global commitment and global recognition for the CVD and NCD epidemics.

We hope that cardiovascular disease and NCDs will be placed on the development agenda of countries and that countries will be encouraged to monitor progress in these areas. The UN’s involvement will provide greater opportunities for these strategies and action plans that WHO has already laid down to be taken forward in a much more meaningful way.

WHO will continue to provide guidance through its vast experience and expertise. In the next decade or two, WHO will focus extensively on getting countries to develop prevention programs for the major risk factors: www.heartbeatsaveslives.org

tobacco, physical inactivity, unhealthy diet—including trans-fat reduction—and the harmful use of alcohol.

These efforts will require a great deal of international and multisectoral cooperation. Since it can be very difficult to make that happen, we are proposing that at the highest levels—at the heads of state level—there be committees or some overseeing body to coordinate the multisectoral cooperation that is needed among, say, ministries of transport, culture, health, education, etc.

That is an area where WHO will have to play a major role—coordinating the work of other UN agencies, civil society and academia and the private sector assisting countries to move forward.

The second area that WHO will concentrate on will be ensuring that NCDs and cardiovascular disease remain on the development agendas of countries and that development assistance continues to be available for prevention and control efforts. This will be a major challenge since there are many countries where the domestic resources overall are inadequate yet the country needs to invest more in healthcare and also use the available resources more efficiently and cost effectively.

What are your thoughts on the role of a global alliance of nonprofit organizations working together to approach the problems of developing nations in the field of cardiovascular disease prevention and treatment?

Nonprofit organizations certainly can play a role, especially given the general lack of capacity of some countries. This is particularly true with problems like the cardiovascular disease epidemic, with its complex etiologies and complex determinants.

However, while it’s very important that all stakeholders be able to play a role, there has got to be multilevel coordination and a coherent effort. Governments must put in place national non-communicable diseases prevention and control programs that include public health strategies and action plans for cardiovascular disease and other major NCDs. If you have an overarching framework of good public health policies, within that framework nonprofit organizations and the private sector can be empowered to contribute, and that can be productive. There are various issues—building capacity, resource mobilization, advocacy, promoting best practices in food and beverage industries— that can sometimes be better handled by nonprofit organizations than by government organizations, especially with governments that don’t have the capacity or have many other competing priorities such as dealing with ongoing HIV/AIDS problems, communicable diseases, and maternal and childhood health issues. When there are capacity problems on the national level, nonprofit organizations can play a role, but it has to be coordinated by the ministry of health under a well coordinated, sustainable, overarching national program.

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A UNITED FRONT Teaming up to fight CVD around the world

By Dr. Benedict S. Maniscalco

T

hroughout the last several decades, infectious and communicable diseases have dominated the world’s health problems and consumed the time, talent, and financial support of governmental and non-governmental agencies, and organizations, as well as the attention of foundations, charities, and philanthropists. Billions of dollars from all sources have been marshaled to fight the ravages of HIV- AIDS, tuberculosis, polio, and other such diseases. Although we have not eradicated these diseases, we have made great strides in controlling them by deploying those dollars in programs of education, prevention, and therapeutic solutions. In response to calls issued by the World Health Organization (WHO) and other leading international organizations concerned with the health of the world’s populations, a concentrated effort by governmental and non-governmental organizations to fight these diseases www.heartbeatsaveslives.org

remains under way. The challenges in the struggle against communicable diseases remain significant but the achievements we have made on that front have been substantial and confirm our belief that we can make similarly successful inroads against non-communicable diseases, now the leading cause of mortality and morbidity globally.

The new Goliath is cardiovascular disease, which is now the world’s most common noncommunicable disease and the leading cause of death worldwide. Our challenge is to harness resources, both tangible and intangible, to address the enormous burden that cardiovascular disease places on the people of all nations, particularly in developing countries with limited resources. This, of course, is a battle that many organizations have waged for years.

Most such organizations have focused their efforts on a particular aspect of cardiovascular care. The fine work and generous philanthropy of these organizations has been a blessing to countless people, but the scale of the challenge ONE HEART MAGAZINE

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is immense. Furthermore, the same organizations are forced to compete for the same scarce resources, a reality made more acute in today’s austere economic environment.

Having carefully considered our experiences and having discussed the issue with colleagues at many other philanthropic organizations, we at Heartbeat International Foundation have concluded that what is needed is an alliance: a Global Cardiovascular Alliance. A collaborative effort comprised of existing like-minded organizations, strategically aligned, to provide population-based planning, implementation, and delivery of a continuum of cardiovascular services worldwide, and in particular in the emerging and developing countries.

By presenting a single, united front, such an alliance will be better positioned to solicit, receive, and allocate larger grants and charitable contributions, and to receive government funding while preserving the missions and activities of individual organizations.

Delegating the formidable task of fundraising and disbursement to alliance representatives will free up individual organizations to deliver services rather than compete for capital, equipment, and other resources.

We believe that governments, charities, industry, foundations, and individual donors will support such an initiative because, as we have seen in the fight against communicable diseases, we will be able to affect large populations by providing a continuum of cardiovascular services, including education (professional and patient) and prevention, population screening, diagnosis and intervention, treatment solutions and transfers of intellectual property.

HEARTBEAT INTERNATIONAL FOUNDATION The first seeds for this global cardiovascular alliance were sown not only by the lessons learned in the positive outcomes and methods in the fight against communicable diseases, but also in the founding of the many charitable organizations now engaged in the battle against cardiovascular disease.

In the case of Heartbeat International Foundation, the tragic death of a young Guatemalan man unable to purchase a needed pacemaker over 25 years ago inspired Dr. Federico Alfaro, a Guatemalan cardiologist, to set up an innovative program, a Pacemaker Bank, that loaned previously implanted devices to indigent pacemakers.

Dr. Alfaro’s mentor at Baylor University, Dr. Henry Deane McIntosh, collaborated with Dr. Alfaro and expanded the creative program, establishing Heartbeat International Foundation (HBI). The program still provides implantable cardiac devices to poor patients who would otherwise perish or lead severely compromised lives. HBI operates in 25 countries from centers in 36 cities at any given time to provide these lifesaving devices. Physicians and hospitals, members of civic organizations, and volunteers operate our Pacemaker Bank and Heart Centers. Our generous industry partners include BIOTRONIK, Boston Scientific, Medtronic, and St. Jude Medical.

As of this writing, HBI has saved over 11,000 lives 42

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and touched the lives of thousands more. Yet, the need for pacing devices, estimated to be in excess of 1 to 3 million every year, already exceeds HBI’s current capacity to single-handedly meet the need for implantable devices, especially since the need is expected to increase exponentially in the coming decades.

But this number is small relative to the evergrowing burden of cardiovascular diseases worldwide.

Organizations dedicated to treating cardiovascular disease in developing nations must expand their missions by working together to deliver educational and preventative services while also providing a broader range of cardiovascular care, devices, and therapeutic solutions to the same population of patients to whom we www.heartbeatsaveslives.org

long-term clinical basis. They are the providers of cardiac care in their communities. We have recently begun the process of converting our pacemaker banks into Heart Centers with full-time staff and operations to implement the programs of HBIF. We intend for the Heart Centers to be the nerve centers of the Global Cardiovascular Alliance.

The planning and implementation of the population-based approach to combating cardiovascular diseases will be coordinated through these Heart Centers.

Working together, members of the Global Cardiovascular Alliance can ensure that entire populations, not just individuals, will benefit from its efforts. The cost savings are estimated to be enormous because most of the programs will be carried out by philanthropic organizations working with the professionals and citizens of the host country. These organizations do not require compensation, only support.

Healthcare policy, economics, and delivery systems cannot be molded in a vacuum. The Global Cardiovascular Alliance concept provides the opportunity for students, experts, and leaders in economics, public health, political science, and research to conduct their activities in conjunction with and through the members of the Global Cardiovascular Alliance and its infrastructure.

are now committed, the world’s indigent. Our board of directors has directed that HBI launch a global alliance of governmental and non-governmental agencies that will align itself behind the mandates of the World Health Organization and other leaders concerned with global issues in cardiovascular diseases. We have termed this initiative the Global Cardiovascular Alliance.

THE GLOBAL CARDIOVASCULAR ALLIANCE Over the last 25 years, Heartbeat International Foundation has built and sustained relationships with physicians, hospitals, civic organizations, and government agencies around the world. Our physician volunteers are available 24/7 to care for our patients on an acute and www.heartbeatsaveslives.org

HOW DOES IT WORK? The underlying precept of the Global Cardiovascular Alliance is that philanthropy is at the core of human activity. The very essence of philanthropy is a concern for humankind. Worldwide, thousands of individuals and organizations exist for this very reason, with activities pursued without consideration of economic reward: Doctors without Borders responds to worldwide disasters; the International Children’s Heart Fund promotes the international growth and quality of cardiac surgery, particularly in children and young adults; CardioStart provides cardiac surgical procedures on a worldwide basis; Partners in Health leads the fight in Haiti and other countries against tuberculosis and HIV/AIDS; Project Pacer International and Solidarity Bridge carry mission work into the developing countries of the world to minister to the poor with cardiovascular disease. And these are just a few. There are many.

The American College of Cardiology, the European College of Cardiology, and the American Heart Association and its sister organizations have led the way in education and research for both the lay public and the medical professionals. The Preventative Cardiovascular Nurses Association provides educational materials and programs for both professional and lay people. Similar organizations at the international, national, and regional levels deal with education, prevention, research, and clinical solutions in their respective countries. The Heart Rhythm Society and the European Society of Cardiac Pacing and Electrophysiology have long dealt with the disturbances of the electrical system of the heart. All of these organizations are concerned with bettering the human condition by alleviating the suffering caused by continues on page 48 ONE HEART MAGAZINE

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Effient (prasugrel) is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: [1] patients with unstable angina (UA) or non–ST-elevation myocardial infarction (NSTEMI); [2] patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI. The loading dose of Effient is 60 mg and the maintenance dose is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets. ®

EFFIENT IS INCLUDED IN THE GUIDELINES FOR UA/NSTEMI AND STEMI PATIENTS UNDERGOING PCI 2011 ACCF/AHA Update for UA/NSTEMI1,2 2009 ACC/AHA/SCAI Update for PCI3,4 2009 ACC/AHA Update for STEMI3,4

IMPORTANT SAFETY INFORMATION WARNING: BLEEDING RISK Effient® (prasugrel) can cause significant, sometimes fatal, bleeding.

Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.

In patients ≥75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered.

Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.

Additional risk factors for bleeding include: body weight <60 kg propensity to bleed concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs]) Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.

If possible, manage bleeding without discontinuing Effient. Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events.

References: 1. Wright RS, Anderson JL, Adams CD, et al. Circulation. 2011;123:2022-2060. 2. Wright RS, Anderson JL, Adams CD, et al.

J Am Coll Cardiol. 2011;57:1920-1959. 3. Kushner FG, Hand M, Smith SC Jr, et al. Circulation. 2009;120:2271-2306. 4. Kushner FG, Hand M, Smith SC Jr, et al. J Am Coll Cardiol. 2009;54:2205-2241.

Effient and the Effient logo are registered trademarks of Eli Lilly and Company.

Copyright © 2011 Daiichi Sankyo, Inc. and Lilly USA, LLC. All Rights Reserved.

PG71320. PGHCPISI10Dec2010. Printed in USA. June 2011. ®

CONTRAINDICATIONS Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product

WARNINGS AND PRECAUTIONS Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued.

Effient should also be discontinued for active bleeding and elective surgery Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis

ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Brief Summary of Prescribing Information on subsequent pages.

FOR MORE INFORMATION, PLEASE VISIT EFFIENTHCP.COM

BRIEF SUMMARY: Please see Full Prescribing Information for additional information about Effient.

WARNING: BLEEDING RISK Effient can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 and 5.2) and Adverse Reactions (6.1)] (6.1)].

Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke [see Contraindications (4.1 and 4.2)] 4.2)].

In patients â&#x2030;Ľ75 years of age, Effient is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in highrisk situations (patients with diabetes or a history of prior MI) where its effect appears to be greater and its use may be considered [see Use in Specific Populations (8.5)] (8.5)].

Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.

Additional risk factors for bleeding include: t CPEZ XFJHIU <60 kg t QSPQFOTJUZ UP CMFFE t DPODPNJUBOU VTF PG NFEJDBUJPOT UIBU JODSFBTF UIF SJTL PG bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal anti-inflammatory drugs [NSAIDs]) Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.

If possible, manage bleeding without discontinuing Effient.

Discontinuing Effient, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular events [see Warnings and Precautions (5.3)] (5.3)].

1 INDICATIONS AND USAGE 1.1 Acute Coronary Syndrome: EffientÂŽ is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: t 1BUJFOUT XJUI VOTUBCMF BOHJOB 6" PS OPO 45 FMFWBUJPO NZPDBSEJBM JOGBSDUJPO /45&.*

t 1BUJFOUT XJUI 45 FMFWBUJPO NZPDBSEJBM JOGBSDUJPO 45&.* XIFO managed with primary or delayed PCI. Effient has been shown to reduce the rate of a combined endpoint of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal TUSPLF DPNQBSFE UP DMPQJEPHSFM 5IF EJGGFSFODF CFUXFFO USFBUNFOUT was driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (14)] (14)].

It is generally recommended that antiplatelet therapy be administered promptly in the management of ACS because many cardiovascular events occur within hours of initial presentation. In the clinical trial that established the efficacy of Effient, Effient and the control drug were OPU BENJOJTUFSFE UP 6" /45&.* QBUJFOUT VOUJM DPSPOBSZ BOBUPNZ XBT established. For the small fraction of patients that required urgent CABG after treatment with Effient, the risk of significant bleeding was substantial [see Warnings and Precautions (5.2)] (5.2)]. Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for $"#( JT DPOTJEFSFE VOMJLFMZ 5IF BEWBOUBHFT PG FBSMJFS USFBUNFOU XJUI Effient must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG. 2 DOSAGE AND ADMINISTRATION Initiate Effient treatment as a single 60 mg oral loading dose and then continue at 10 mg orally once daily. Patients taking Effient should also take aspirin (75 mg to 325 mg) daily [see Drug Interactions (7) and Clinical Pharmacology (12.3)] (12.3)]. Effient may be administered with or without food [see Clinical Pharmacology (12.3) and Clinical Studies (14)] (14)].

Dosing in Low Weight Patients: Compared to patients weighing â&#x2030;Ľ60 kg, patients weighing <60 kg have an increased exposure to the active metabolite of prasugrel and an increased risk of bleeding on a 10 mg once daily maintenance dose. Consider lowering the maintenance dose to 5 mg in patients < LH 5IF FGGFDUJWFOFTT BOE safety of the 5 mg dose have not been prospectively studied.

4 CONTRAINDICATIONS 4.1 Active Bleeding: Effient is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)] (6.1)].

4.2 Prior Transient Ischemic Attack or Stroke: Effient is contraindicated in patients with a history of prior transient ischemic BUUBDL 5*" PS TUSPLF *O 53*50/ 5*.* 53ial 3*50/ 5*.* 53ial to Assess Improvement

in 5IFSBQFVUJD 0VUDPNFT CZ 0ptimizing 0ptimizing Platelet InhibitioN with 1SBTVHSFM QBUJFOUT XJUI B IJTUPSZ PG 5*" PS JTDIFNJD TUSPLF >3 months prior to enrollment) had a higher rate of stroke on Effient (6.5%; of which 4.2% were thrombotic stroke and 2.3% were intracranial hemorrhage [ICH]) than on clopidogrel (1.2%; all thrombotic). In patients without such a history, the incidence of stroke was 0.9% (0.2% ICH) and 1.0% (0.3% ICH) with Effient and clopidogrel, respectively. Patients with a history of ischemic stroke within 3 months of screening and patients with a history of IFNPSSIBHJD TUSPLF BU BOZ UJNF XFSF FYDMVEFE GSPN 53*50/ 5*.* 1BUJFOUT XIP FYQFSJFODF B TUSPLF PS 5*" XIJMF PO &GýFOU HFOFSBMMZ should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (14)] (14)].

4.3 Hypersensitivity: Effient is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product [see Adverse Reactions (6.2)] (6.2)].

5 WARNINGS AND PRECAUTIONS 5.1 General Risk of Bleeding: 5IJFOPQZSJEJOFT JODMVEJOH &GĂ˝FOU increase the risk of bleeding. With the dosing regimens used in 53*50/ 5*.* 5*.* 5ISPNCPMZTJT JO .ZPDBSEJBM *OGBSDUJPO .B 53*50/ 5*.* 5*.* 5ISPNCPMZTJT JO .ZPDBSEJBM *OGBSDUJPO .BKPS (clinically overt bleeding associated with a fall in hemoglobin â&#x2030;Ľ5 g/dL, PS JOUSBDSBOJBM IFNPSSIBHF BOE 5*.* .JOPS PWFSU CMFFEJOH BTTPDJBUFE with a fall in hemoglobin of â&#x2030;Ľ3 g/dL but <5 g/dL) bleeding events were more common on Effient than on clopidogrel [see Adverse Reactions (6.1)] 5IF CMFFEJOH SJTL JT IJHIFTU JOJUJBMMZ BT TIPXO JO 'JHVSF (6.1)] (events through 450 days; inset shows events through 7 days).

Figure 1: Non-CABG-Related TIMI Major or Minor Bleeding Events

EffientÂŽ (prasugrel) tablets Brief Summary of Prescribing Information

Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures even if the patient does not have overt signs of bleeding. %P OPU VTF &GýFOU JO QBUJFOUT XJUI BDUJWF CMFFEJOH QSJPS 5*" PS TUSPLF [see Contraindications (4.1 and 4.2)] 4.2)].

0UIFS SJTL GBDUPST GPS CMFFEJOH BSF t "HF â&#x2030;Ľ75 years. Because of the risk of bleeding (including fatal bleeding) and uncertain effectiveness in patients â&#x2030;Ľ75 years of age, use of Effient is generally not recommended in these patients, FYDFQU JO IJHI SJTL TJUVBUJPOT QBUJFOUT XJUI EJBCFUFT PS IJTUPSZ PG myocardial infarction) where its effect appears to be greater and its use may be considered [see Adverse Reactions (6.1), Use in Specific Populations (8.5), Clinical Pharmacology (12.3), and Clinical Trials (14)] (14)]. t $"#( PS PUIFS TVSHJDBM QSPDFEVSF [see Warnings and Precautions (5.2)] (5.2)]. t #PEZ XFJHIU LH $POTJEFS B MPXFS NH NBJOUFOBODF EPTF [see Dosage and Administration (2), Adverse Reactions (6.1), Use in Specific Populations (8.6)] (8.6)]. t 1SPQFOTJUZ UP CMFFE F H SFDFOU USBVNB SFDFOU TVSHFSZ SFDFOU PS recurrent gastrointestinal (GI) bleeding, active peptic ulcer disease, or severe hepatic impairment) [see Adverse Reactions (6.1) and Use in Specific Populations (8.8)] (8.8)]. t .FEJDBUJPOT UIBU JODSFBTF UIF SJTL PG CMFFEJOH e.g., oral BOUJDPBHVMBOUT DISPOJD VTF PG OPO TUFSPJEBM BOUJ JOĂžBNNBUPSZ drugs [NSAIDs], and fibrinolytic agents). Aspirin and heparin were DPNNPOMZ VTFE JO 53*50/ 5*.* [see Drug Interactions (7), Clinical Studies (14)] (14)].

5IJFOPQZSJEJOFT JOIJCJU QMBUFMFU BHHSFHBUJPO GPS UIF MJGFUJNF PG UIF QMBUFMFU EBZT TP XJUIIPMEJOH B EPTF XJMM OPU CF VTFGVM JO managing a bleeding event or the risk of bleeding associated with an JOWBTJWF QSPDFEVSF #FDBVTF UIF IBMG MJGF PG QSBTVHSFM T BDUJWF metabolite is short relative to the lifetime of the platelet, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding: 5IF risk of bleeding is increased in patients receiving Effient who undergo CABG. If possible, Effient should be discontinued at least 7 days prior to CABG. 0G UIF QBUJFOUT XIP VOEFSXFOU $"#( EVSJOH 53*50/ 5*.* UIF SBUFT PG $"#( SFMBUFE 5*.* .BKPS PS .JOPS CMFFEJOH XFSF JO UIF Effient group and 4.5% in the clopidogrel group [see Adverse Reactions (6.1)] (6.1)] 5IF IJHIFS SJTL GPS CMFFEJOH FWFOUT JO QBUJFOUT USFBUFE

with Effient persisted up to 7 days from the most recent dose of study drug. For patients receiving a thienopyridine within 3 days prior to $"#( UIF GSFRVFODJFT PG 5*.* .BKPS PS .JOPS CMFFEJOH XFSF (12 of 45 patients) in the Effient group, compared with 5.0% (3 of 60 patients) in the clopidogrel group. For patients who received their last dose of thienopyridine within 4 to 7 days prior to CABG, the frequencies EFDSFBTFE UP PG QBUJFOUT JO UIF QSBTVHSFM HSPVQ BOE PG QBUJFOUT JO UIF DMPQJEPHSFM HSPVQ %P OPU TUBSU &GýFOU JO QBUJFOUT MJLFMZ UP VOEFSHP VSHFOU $"#( $"#( related bleeding may be treated with transfusion of blood products, including packed red blood cells and platelets; however, platelet transfusions within 6 hours of the loading dose or 4 hours of the maintenance dose may be less effective.

5.3 Discontinuation of Effient: Discontinue thienopyridines, including &GýFOU GPS BDUJWF CMFFEJOH FMFDUJWF TVSHFSZ TUSPLF PS 5*" 5IF PQUJNBM duration of thienopyridine therapy is unknown. In patients who are managed with PCI and stent placement, premature discontinuation of any antiplatelet medication, including thienopyridines, conveys an increased risk of stent thrombosis, myocardial infarction, and death.

Patients who require premature discontinuation of a thienopyridine will be at increased risk for cardiac events. Lapses in therapy should be avoided, and if thienopyridines must be temporarily discontinued because of an adverse event(s), they should be restarted as soon as possible [see Contraindications (4.1 and 4.2) and Warnings and Precautions (5.1)] (5.1)].

5.4 Thrombotic Thrombocytopenic Purpura: 5ISPNCPUJD UISPNCPDZUPQFOJD QVSQVSB 551 IBT CFFO SFQPSUFE XJUI UIF VTF PG &GýFOU 551 DBO PDDVS BGUFS B CSJFG FYQPTVSF XFFLT 551 is a serious condition that can be fatal and requires urgent USFBUNFOU JODMVEJOH QMBTNBQIFSFTJT QMBTNB FYDIBOHF 551 JT characterized by thrombocytopenia, microangiopathic hemolytic anemia (schistocytes [fragment red blood cells] seen on peripheral smear), neurological findings, renal dysfunction, and fever [see Adverse Reactions (6.2)] (6.2)]..

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience: 5IF GPMMPXJOH TFSJPVT BEWFSTF reactions are also discussed elsewhere in the labeling: t #MFFEJOH [see Boxed Warning and Warnings and Precautions (5.1, 5.2)] t 5ISPNCPUJD UISPNCPDZUPQFOJD QVSQVSB [see Warnings and Precautions (5.4)] Safety in patients with ACS undergoing PCI was evaluated in a DMPQJEPHSFM DPOUSPMMFE TUVEZ 53*50/ 5*.* JO XIJDI QBUJFOUT were treated with Effient (60 mg loading dose and 10 mg once daily) GPS B NFEJBO PG NPOUIT QBUJFOUT XFSF USFBUFE GPS PWFS NPOUIT QBUJFOUT XFSF USFBUFE GPS NPSF UIBO ZFBS 5IF population treated with Effient was 27 to 96 years of age, 25% GFNBMF BOE $BVDBTJBO "MM QBUJFOUT JO UIF 53*50/ 5*.* T GFNBMF BOE $BVDBTJBO "MM QBUJFOUT JO UIF 53*50/ 5*.* TUVEZ XFSF UP SFDFJWF BTQJSJO 5IF EPTF PG DMPQJEPHSFM JO UIJT TUVEZ XBT B 300 mg loading dose and 75 mg once daily.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials cannot be directly compared with the rates observed in other clinical trials of another ESVH BOE NBZ OPU SFĂžFDU UIF SBUFT PCTFSWFE JO QSBDUJDF Drug Discontinuation 5IF SBUF PG TUVEZ ESVH EJTDPOUJOVBUJPO CFDBVTF Discontinuation of adverse reactions was 7.2% for Effient and 6.3% for clopidogrel. Bleeding was the most common adverse reaction leading to study drug discontinuation for both drugs (2.5% for Effient and 1.4% for clopidogrel).

Bleeding: Bleeding Unrelated to CABG Surgery Surgery *O 53*50/ 5*.* PWFSBMM SBUFT PG 5*.* .BKPS PS .JOPS CMFFEJOH BEWFSTF SFBDUJPOT unrelated to coronary artery bypass graft surgery (CABG) were TJHOJýDBOUMZ IJHIFS PO &GýFOU UIBO PO DMPQJEPHSFM BT TIPXO JO 5BCMF Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38) Effient (%) Clopidogrel (%) (N=6741) (N=6716) 5*.* .BKPS PS .JOPS CMFFEJOH 4.5 3.4 2.2 1.7 5*.* .BKPS CMFFEJOHb -JGF UISFBUFOJOH 1.3

Fatal 0.3 0.1 Symptomatic intracranial 0.3 0.3 hemorrhage (ICH) Requiring inotropes 0.3 0.1 Requiring surgical 0.3 0.3 intervention Requiring transfusion 0.7 0.5 (â&#x2030;Ľ44 units) 2.4 1.9 5*.* .JOPS CMFFEJOHb

p-value p=0.002 p=0.029 p=0.015

p=0.022

Patients may be counted in more than one row. b See 5.1 for definition.

'JHVSF EFNPOTUSBUFT OPO $"#( SFMBUFE 5*.* .BKPS PS .JOPS CMFFEJOH 5IF CMFFEJOH SBUF JT IJHIFTU JOJUJBMMZ BT TIPXO JO 'JHVSF (inset: Days 0 to 7) [see Warnings and Precautions (5.1)] (5.1)]. a

Bleeding rates in patients with the risk factors of age â&#x2030;Ľ75 years and weight < LH BSF TIPXO JO 5BCMF Table 2: Bleeding Rates for Non-CABG-Related Bleeding by Weight and Age (TRITON-TIMI 38) Major/Minor Fatal Effient Clopidogrel Effient Clopidogrel (%) (%) (%) (%) Weight < LH / Effient, N=356 clopidogrel) Weight â&#x2030;Ľ60kg (N=6373 Effient, N=6299 clopidogrel) Age < ZFBST / &GĂ˝FOU / DMPQJEPHSFM

Age â&#x2030;Ľ ZFBST / &GĂ˝FOU / DMPQJEPHSFM

10.1

6.5

0.0

0.3

4.2

3.3

0.3

0.1

2.9

0.2

0.1

9.0

6.9

1.0

0.1

Bleeding Related to CABG CABG *O 53*50/ 5*.* QBUJFOUT XIP received a thienopyridine underwent CABG during the course of the TUVEZ 5IF SBUF PG $"#( SFMBUFE 5*.* .BKPS PS .JOPS CMFFEJOH XB XBT GPS UIF &GýFOU HSPVQ BOE JO UIF DMPQJEPHSFM HSPVQ 5 GPS UIF &GýFOU HSPVQ BOE JO UIF DMPQJEPHSFM HSPVQ 5BCMF

5IF IJHIFS SJTL GPS CMFFEJOH BEWFSTF SFBDUJPOT JO QBUJFOUT USFB 5IF IJHIFS SJTL GPS CMFFEJOH BEWFSTF SFBDUJPOT JO QBUJFOUT USFBUFE XJUI Effient persisted up to 7 days from the most recent dose of study drug.

Table 3: CABG-Related Bleedinga (TRITON-TIMI 38) 5*.* .BKPS PS .JOPS CMFFEJOH 5*.* .BKPS CMFFEJOH Fatal Reoperation 5SBOTGVTJPO PG â&#x2030;Ľ5 units Intracranial hemorrhage 5*.* .JOPS CMFFEJOH

Effient (%) Clopidogrel (%) (N=213) (N=224) 14.1 4.5 11.3 3.6 0.9 0

0.5 6.6 2.2 0 0

0.9

a Patients may be counted in more than one row.

Bleeding Reported as Adverse Reactions Reactions )FNPSSIBHJD FWFOUT SFQPSUFE BT BEWFSTF SFBDUJPOT JO 53*50/ 5*.* XFSF GPS Effient and clopidogrel, respectively: epistaxis (6.2%, 3.3%), gastrointestinal hemorrhage (1.5%, 1.0%), hemoptysis (0.6%,

TVCDVUBOFPVT IFNBUPNB QPTU QSPDFEVSBM hemorrhage (0.5%, 0.2%), retroperitoneal hemorrhage (0.3%, 0.2%), pericardial effusion/hemorrhage/tamponade (0.3%, 0.2%), and retinal hemorrhage (0.0%, 0.1%).

Malignancies %VSJOH 53*50/ 5*.* OFXMZ EJBHOPTFE NBMJHOBODJFT Malignancies were reported in 1.6% and 1.2% of patients treated with prasugrel BOE DMPQJEPHSFM SFTQFDUJWFMZ 5IF TJUFT DPOUSJCVUJOH UP UIF EJGGFSFODFT were primarily colon and lung. It is unclear if these observations are DBVTBMMZ SFMBUFE PS BSF SBOEPN PDDVSSFODFT 0UIFS "EWFSTF &WFOUT *O 53*50/ 5*.* DPNNPO BOE PUIFS JNQPSUBOU 0UIFS "EWFSTF &WFOUT *O 53*50/ 5*.* DPNNPO BOE PUIFS JNQPS OPO IFNPSSIBHJD BEWFSTF FWFOUT XFSF GPS &GýFOU BOE DMPQJEPHSFM respectively: severe thrombocytopenia (0.06%, 0.04%), anemia (2.2%, 2.0%), abnormal hepatic function (0.22%, 0.27%), allergic reactions

BOE BOHJPFEFNB 5BCMF TVNNBSJ[FT the adverse events reported by at least 2.5% of patients.

Table 4: Non-Hemorrhagic Treatment Emergent Adverse Events Reported by at Least 2.5% of Patients in Either Group

Effient (%) Clopidogrel (%) (N=6741) (N=6716) Hypertension 7.5 7.1 Hypercholesterolemia/Hyperlipidemia 7.0 7.4 Headache 5.5 5.3 Back pain 5.0 4.5 Dyspnea 4.9 4.5 Nausea 4.6 4.3 Dizziness 4.1 4.6 Cough 3.9 4.1 Hypotension 3.9

Fatigue 3.7

/PO DBSEJBD DIFTU QBJO 3.1 3.5 Atrial fibrillation 2.9 3.1 Bradycardia 2.9 2.4

3.5 Leukopenia (<4 ( x 109 WBC/L) Rash

2.4 Pyrexia 2.7 2.2 Peripheral edema 2.7 3.0 Pain in extremity 2.6 2.6 Diarrhea 2.3 2.6

6.2 Postmarketing Experience: 5IF GPMMPXJOH BEWFSTF reactions have been identified during post approval use of Effient. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible

to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders â&#x20AC;&#x201D; 5ISPNCPDZUPQFOJB 5ISPNCPUJD UISPNCPDZUPQFOJD QVSQVSB 551 [see Warnings and Precautions (5.4) and Patient Counseling Information (17.3)] Immune system disorders â&#x20AC;&#x201D; Hypersensitivity reactions including anaphylaxis [see Contraindications (4.3)] 7 DRUG INTERACTIONS 7.1 Warfarin: Coadministration of Effient and warfarin increases the risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] (12.3)].

7.2 Non-Steroidal Anti-Inflammatory Drugs: Coadministration of Effient and NSAIDs (used chronically) may increase the risk of bleeding [see Warnings and Precautions (5.1)] (5.1)].

7.3 Other Concomitant Medications: Effient can be administered with drugs that are inducers or inhibitors of cytochrome P450 enzymes [see Clinical Pharmacology (12.3)] (12.3)].

Effient can be administered with aspirin (75 mg to 325 mg per day), heparin, GPIIb/IIIa inhibitors, statins, digoxin, and drugs that elevate gastric pH, including proton pump inhibitors and H2 blockers [see Clinical Pharmacology (12.3)] (12.3)].

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy: Pregnancy Category B 5IFSF BSF OP BEFRVBUF BOE B well controlled studies of Effient use in pregnant women. Reproductive and developmental toxicology studies in rats and rabbits at doses of up to 30 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite) revealed no evidence of fetal harm; however, animal studies are not always predictive of a human response. Effient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

In embryo fetal developmental toxicology studies, pregnant rats and rabbits received prasugrel at maternally toxic oral doses equivalent to more than 40 times the human exposure. A slight decrease in pup body weight was observed; but, there were no structural malformations in either species. In prenatal and postnatal rat studies, maternal treatment with prasugrel had no effect on the behavioral or reproductive development of the offspring at doses greater than 150 times the human exposure [see Nonclinical Toxicology (13.1)] (13.1)].

8.3 Nursing Mothers: It is not known whether Effient is excreted in human milk; however, metabolites of Effient were found in rat milk.

Because many drugs are excreted in human milk, prasugrel should be used during nursing only if the potential benefit to the mother justifies the potential risk to the nursing infant.

8.4 Pediatric Use: Safety and effectiveness in pediatric patients have not been established [see Clinical Pharmacology (12.3)] (12.3)].

8.5 Geriatric Use: *O 53*50/ 5*.* PG QBUJFOUT XFSF â&#x2030;Ľ65 years of age and 13.2% were â&#x2030;Ľ ZFBST PG BHF 5IF SJTL PG CMFFEJOH increased with advancing age in both treatment groups, although the relative risk of bleeding (Effient compared with clopidogrel) was similar across age groups.

Patients â&#x2030;Ľ75 years of age who received Effient had an increased risk of fatal bleeding events (1.0%) compared to patients who received clopidogrel (0.1%). In patients â&#x2030;Ľ75 years of age, symptomatic JOUSBDSBOJBM IFNPSSIBHF PDDVSSFE JO QBUJFOUT XIP SFDFJWFE Effient and in 3 patients (0.3%) who received clopidogrel. Because of the risk of bleeding, and because effectiveness is uncertain in patients â&#x2030;Ľ75 years of age [see Clinical Studies (14)] (14)], use of Effient is generally OPU SFDPNNFOEFE JO UIFTF QBUJFOUT FYDFQU JO IJHI SJTL TJUVBUJPOT (diabetes and past history of myocardial infarction) where its effect appears to be greater and its use may be considered [see Warnings and Precautions (5.1), Clinical Pharmacology (12.3), and Clinical Studies (14)] (14)].

8.6 Low Body Weight: *O 53*50/ 5*.* PG QBUJFOUT USFBUFE with Effient had body weight <60 kg. Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of prasugrel [see Dosage and Administration (2), Warnings and Precautions (5.1), and Clinical Pharmacology (12.3)] (12.3)]. $POTJEFS MPXFSJOH UIF NBJOUFOBODF EPTF UP NH JO QBUJFOUT LH 5IF FGGFDUJWFOFTT BOE TBGFUZ PG UIF NH EPTF IBWF OPU CFFO prospectively studied.

8.7 Renal Impairment: No dosage adjustment is necessary for QBUJFOUT XJUI SFOBM JNQBJSNFOU 5IFSF JT MJNJUFE FYQFSJFODF JO QBUJFOUT XJUI FOE TUBHF SFOBM EJTFBTF [see [see Clinical Pharmacology (12.3)] (12.3)].

8.8 Hepatic Impairment: No dosage adjustment is necessary in QBUJFOUT XJUI NJME UP NPEFSBUF IFQBUJD JNQBJSNFOU $IJME 1VHI $MBTT " BOE # 5IF QIBSNBDPLJOFUJDT BOE QIBSNBDPEZOBNJDT PG QSBTVHSFM in patients with severe hepatic disease have not been studied, but such patients are generally at higher risk of bleeding [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] (12.3)].

8.9 Metabolic Status: In healthy subjects, patients with stable atherosclerosis, and patients with ACS receiving prasugrel, there was

no relevant effect of genetic variation in CYP2B6, CYP2C9, CYP2C19, PS $:1 " PO UIF QIBSNBDPLJOFUJDT PG QSBTVHSFM T BDUJWF NFUBCPMJUF or its inhibition of platelet aggregation.

10 OVERDOSAGE 10.1 Signs and Symptoms: Platelet inhibition by prasugrel is rapid and irreversible, lasting for the life of the platelet, and is unlikely to be increased in the event of an overdose. In rats, lethality was observed after administration of 2000 mg/kg. Symptoms of acute toxicity in dogs included emesis, increased serum alkaline phosphatase, and hepatocellular atrophy. Symptoms of acute toxicity in rats included mydriasis, irregular respiration, decreased locomotor activity, ptosis, staggering gait, and lacrimation.

10.2 Recommendations about Specific Treatment: Platelet USBOTGVTJPO NBZ SFTUPSF DMPUUJOH BCJMJUZ 5IF QSBTVHSFM BDUJWF NFUBCPMJUF is not likely to be removed by dialysis.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis Carcinogenesis /P DPNQPVOE SFMBUFE UVNPST XFSF PCTFSWFE JO B ZFBS SBU TUVEZ XJUI QSBTVHSFM BU PSBM EPTFT VQ UP NH LH EBZ (>100 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human NFUBCPMJUF 5IFSF XBT BO JODSFBTFE JODJEFODF PG UVNPST (hepatocellular adenomas) in mice exposed for 2 years to high doses (>250 times the human metabolite exposure).

Mutagenesis Mutagenesis 1SBTVHSFM XBT OPU HFOPUPYJD JO UXP in vitro tests (Ames bacterial gene mutation test, clastogenicity assay in Chinese hamster fibroblasts) and in one in vivo test (micronucleus test by intraperitoneal route in mice).

Impairment of Fertility Fertility 1SBTVHSFM IBE OP FGGFDU PO GFSUJMJUZ PG NBMF BOE GFNBMF SBUT BU PSBM EPTFT VQ UP NH LH EBZ UJNFT UIF IVNBO major metabolite exposure at daily dose of 10 mg prasugrel).

17 PATIENT COUNSELING INFORMATION See Medication Guide 17.1 Benefits and Risks t 4VNNBSJ[F UIF FGGFDUJWFOFTT GFBUVSFT BOE QPUFOUJBM TJEF FGGFDUT of Effient. t 5FMM QBUJFOUT UP UBLF &GýFOU FYBDUMZ BT QSFTDSJCFE t 3FNJOE QBUJFOUT OPU UP EJTDPOUJOVF &GýFOU XJUIPVU ýSTU EJTDVTTJOH it with the physician who prescribed Effient. t 3FDPNNFOE UIBU QBUJFOUT SFBE UIF .FEJDBUJPO (VJEF 17.2 Bleeding: Inform patients that they: t XJMM CSVJTF BOE CMFFE NPSF FBTJMZ t XJMM UBLF MPOHFS UIBO VTVBM UP TUPQ CMFFEJOH t TIPVME SFQPSU BOZ VOBOUJDJQBUFE QSPMPOHFE PS FYDFTTJWF CMFFEJOH or blood in their stool or urine.

17.3 Other Signs and Symptoms Requiring Medical Attention t *OGPSN QBUJFOUT UIBU 551 JT B SBSF CVU TFSJPVT DPOEJUJPO UIBU has been reported with Effient. t *OTUSVDU QBUJFOUT UP HFU QSPNQU NFEJDBM BUUFOUJPO JG UIFZ FYQFSJFODF any of the following symptoms that cannot otherwise be explained: fever, weakness, extreme skin paleness, purple skin patches, yellowing of the skin or eyes, or neurological changes.

17.4 Invasive Procedures: Instruct patients to: t JOGPSN QIZTJDJBOT BOE EFOUJTUT UIBU UIFZ BSF UBLJOH &GýFOU CFGPSF any invasive procedure is scheduled. t UFMM UIF EPDUPS QFSGPSNJOH UIF JOWBTJWF QSPDFEVSF UP UBML UP UIF prescribing health care professional before stopping Effient.

17.5 Concomitant Medications: Ask patients to list all prescription NFEJDBUJPOT PWFS UIF DPVOUFS NFEJDBUJPOT PS EJFUBSZ TVQQMFNFOUT they are taking or plan to take so the physician knows about other treatments that may affect bleeding risk (e.g., warfarin and NSAIDs).

Literature revised: December 6, 2010 Manufactured by Eli Lilly and Company, Indianapolis, IN, 46285 Marketed by Daiichi Sankyo, Inc. and Eli Lilly and Company Copyright Š 2009, 2010, Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

1( 1()$1#4 %FD PV 7311 AMP 13*/5&% */ 64"

HBI Chairman Dr. Benedict S. Maniscalco, with Board of Directors Member Basha Mohammed, HBI staff Farouk Khan Hosein, Laura DeLise, and happy and healthy Trinidad and Tobago pacemaker recipients.

cardiovascular disease. From all of these sources come philanthropic volunteers.

Most of these organizations, however, do not have permanence in the field, especially in the developing nations. This is where HBI is different: we have people in placeâ&#x20AC;&#x201D;stethoscopes on the ground. It is our objective that each local HBI operation be operated through a Heart Center and become a resource for and portal through which other organizations can partner with us to deliver on the promise of the Global Cardiovascular Alliance.

Members of the Global Cardiovascular Alliance will be able to access the populations in question through the closest Heart Center. Members who deal with population screening for risk factors will do so while those who deal with heart surgery or diagnostics will carry out their 48

ONE HEART MAGAZINE

individual activities and missions, aided and supported by the Global Cardiovascular Alliance. Competition will ultimately be eliminated; economies of scale and portability will be possible.

What all of these organizations and the thousands of church-based or individually founded organizations have in common is philanthropy. From these organizations and from individuals within these organizations come the greatest philanthropists of the world. They come from all walks of life, from all countries and cultures, from all religious denominations, from all political persuasions, and from all economic sectors. They give of their time, talent, and treasury without reservation and without the expectation of reward. These organizations and individuals will be the members of the Global www.heartbeatsaveslives.org

Cardiovascular Alliance. They are anxious to do more but are limited by the availability of resources and the competition for those resources.

With the proper support and funding, the Global Cardiovascular Alliance will lead the way in the fight against the global cardiovascular pandemic.

The shared philanthropic missions will be carried out in all countries where HBI operates now and in the future. But to achieve efficiency and economies of scale will require coordination.

A CALL TO ACTION The compelling forces creating the Global Cardiovascular Alliance include the following: • The emergence of cardiovascular disease as the leading cause of death and disability in the world • An era of economic insecurity worldwide, making governments ill prepared to deal with the cost or the ability to handle the sheer number of patients with cardiovascular disease • The increasingly stringent regulatory requirements by government agencies on corporations whose products and services have been generously donated to charitable organizations • Competition for identical resources among the multitude of charitable agencies • Insufficient funding at all levels for personnel, equipment, facilities, and professionals The mission of the Global Cardiovascular Alliance will be to identify populations in need of all cardiovascular services involving education, prevention, diagnosis, and therapy.

Coordination of specific programs will be accomplished at the local level by a full-time staff at each Heart Center.

Educational materials and classes, diagnostic equipment, screening programs will be housed at the Heart Center and all members of the Global Cardiovascular Alliance will have access to and use of the facility. Individual volunteers and organized teams of healthcare professionals in the cardiovascular field will rotate year round through the Heart Centers to carry out their missions. Similarly, Heart Centers will conduct outreach programs to access populations outside the urban centers and better identify patients in need.

Currently, many of the developing countries do not www.heartbeatsaveslives.org

have the facilities, technology, or the trained personnel to provide a continuum of cardiovascular services. Those that do have the ability often lack the capacity: they are often overwhelmed by the number of patients in need; the only available professionals may not be able to provide needed services in a timely fashion; there are often long lists of patients—hundreds of patients!—waiting for medical evaluation, diagnostic studies, and/or therapy such as drugs to combat high blood pressure, pacemakers for rhythm disturbances of the heart, or heart surgery for blocked arteries or poorly functioning heart valves. As a result, many patients die.

The Global Cardiovascular Alliance will help combat these problems. These are its objectives: • Work together with the healthcare professionals in the designated city, country, or region • Implement education and prevention programs with outreach components • Identify patients at risk in the populations and begin therapy • Jointly perform needed diagnostic tests in conjunction with the professional and technical personnel of the country (with consequent transfer of intellectual knowledge) • Absorb the backlog of patients in need of care • Jointly perform needed therapeutic procedures such as heart catheterization, angioplasty, stents, bypass surgery, valve surgery, and electrophysiology procedures with the professional and technical personnel of the country • Ensure the ongoing care of these patients by local medical and support personnel Successful operating Heart Centers will coordinate the efforts of government, local health care professionals and organizations, and the many volunteer charitable organizations to provide population based services in the continuum of cardiovascular diseases while providing the opportunity for the transfer of knowledge and intellectual property to the resident professional and technical personnel.

In short, the Global Cardiovascular Alliance will capitalize on the philanthropic spirit of individuals and organizations to provide modern, high-quality cardiovascular care to large populations at risk in developing countries. There will be enormous cost savings for all governments and, more importantly, untold numbers of human lives spared and saved.

Many organizations have already committed to participation in the Global Cardiovascular Alliance and many more are being approached. You will read about some of these organizations in this publication, and about some of the unsung heroes who have toiled in the field and done a magnificent job in humanitarian service. Heartbeat International Foundation congratulates them and welcomes them to the Global Cardiovascular Alliance.

Your help is needed now. Your organization is needed now. Your talent is desired and appreciated.

Your contributions to this great cause will allow the Global Cardiovascular Alliance to carry out its mission in the fight against cardiovascular disease.

ONE HEART MAGAZINE

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2. Year-end 2009 data, total dollar volume and share of projected distributor unit sales of the Coagulation Reagents/Kits, POC 91994 by GHX Market Intelligence Data.

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www.coaguchek.com www.roche.com COAGUCHEK is a trademark of Roche. © 2011 Roche Diagnostics. All rights reserved. 573-50668-0511

Systematic Anticoagulation Management A better PT/INR testing solution for physicians and their patients Improved patient care. By improving consistency in results, SAM has been shown to increase patients’ average time in therapeutic range by as much as 97%2 and to significantly reduce thromboembolic and hemorrhagic events – as well as the costs associated with them.2,5,7,8 Better patient satisfaction and outcomes. Nine out of 10 warfarin patients prefer fingerstick testing at the doctor’s office over venous lab draws.

As the most critical component in determining patient compliance, improved satisfaction can lead to better outcomes.6

Managing patients on warfarin therapy in a cost-effective way can be a challenge for physicians because of a narrow therapeutic dosing range, inefficient office workflow models and other factors.

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Systematic anticoagulation management (SAM) is a patient-focused approach that utilizes PT/INR testing at the point of care rather than through an outside lab. Multiple studies have shown that this approach may increase the time patients are in range and reduce adverse events.1,2,3,4

Systematic Anticoagulation Management (SAM) can help personalize warfarin therapy – even for patients who self-monitor – by focusing on four specific areas. This systematic approach enables clinicians to make immediate therapy decisions for improved patient outcomes.2,4,5,6

COAGUCHEK is a trademark of Roche. © 2011 Roche Diagnostics. All rights reserved. 573-50658-0611

Improved office economics. In-office monitoring makes PT/INR testing a single-day process, which helps to improve the efficiency of the office workflow and frees up staff to spend more time with patients.2,4,6 Higher potential revenue. While costs and potential revenue are based on a number of variables, implementing SAM with computerized decision support and an optimized workflow at the point of care enabled one university-affiliated primary care clinic to capture additional revenue of more than $320 per patient per year.2 SAM provides a framework for PT/INR testing that allows physicians to offer patients timely monitoring and dosage adjustments for proactive therapy management at the point of care – all in one office visit. The benefits in quality of care, office economics and patient satisfaction can have a positive impact on both the practice and its patients.

More information about Systematic Anticoagulation Management and point-of-care PT/INR testing is available at www.medscape.com and www.poc. roche.com.

1 Jacobson A, Guilloteau F, Campbell P, Denham C. Comparison of point of care testing and standard reference laboratory testing for PT/INR measurements in patients receiving routine warfarin therapy: an engineering work process flow study.

Dis Manage Clin Outcomes. 2000;2.

2 Wurster M, Doran T. Anticoagulation management: A new approach. Disease Management. 2006;4:201-209.

Management 3 Jacobson AK. In: Ansell JE et al., eds. Managing Oral Anticoagulation Therapy. 2nd ed. St. Louis, Mo.: Facts and Comparisons; 2003:45:1-6.

4 Campbell P, Radensky P, Denham C. Economic analysis of systematic anticoagulation management vs. routine care for patients on oral warfarin therapy. Dis Manage Clin Outcomes. 2000;2:1-8.

5 Heneghan C, Alonso-Coello P, Garcia-Alamino JM, et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006;367:404-411.

6 Giles T and Roffidal L. Results of the prothrombin office-testing benefit evaluation (PROBE). Cardiovascular Reviews and Reports. 2002;23:27-33.

7 Finck KM, Doetkott C, Miller DR. Clinical impact of interlaboratory variation in international normalized ratio determinations. Am J Health Syst Pharm. 2001;58:684-688.

8 Gardiner C, Williams K, Mackle JJ, Machin SJ, Cohen H. Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. British Journal of Haematology. 2004;128:242-247.

One heart.

One country.

One life saved.

BRINGING LIFE-SAVING ICDs TO TRINIDAD AND TOBAGO

J

ennifer Ali is busy. And she’s tired. The 62-year-old is separated from her husband, and she must look after two children and three grandchildren. She helps kids in her community who are having trouble with their homework. And, she has a debilitating heart condition. She can’t

walk up a full flight of stairs without pausing to rest. She often has severe headaches, and sometimes faints without warning. Jennifer is not suffering from some mysterious disease without a cure. Her doctors know exactly what is wrong with her, and they know exactly how to fix it. But they can’t.

Jennifer, who lives on the island nation of Trinidad and Tobago, has been waiting four years to get a pacemaker. Doctors believe the device could save Jennifer’s life. While the procedure is common in places like the United States, it is prohibitively expensive in much of the developing world, and simply out of reach for Jennifer.

Until now.

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www.heartbeatsaveslives.org

“

”

“As a global medical device company, we feel it is our responsibility to save as many lives as possible, especially in those countries where cardiac devices are not readily available.”

T

his spring, a team of volunteer doctors and nurses implanted a BIOTRONIK pacemaker into Jennifer’s chest at the Eric Williams Medical Services Complex in Mount Hope. Jennifer is now recovering nicely, the fatigue, headaches and agony all a thing of the past. She’s not the only one. Nearly 100 other heart patients in Trinidad and Tobago who have long been waiting desperately for cardiac devices now have them, along with a new lease on life. “My hope in life was restored,” says Jennifer. “I feel that I will live a useful life once more.”

This remarkable turnaround was made possible by a life-saving collaboration between Heartbeat International Foundation – a Florida-based, global charity – and Berlin-based biomedical technology company BIOTRONIK. Last year, BIOTRONIK joined Heartbeat International’s threedecades-long fight to save lives in impoverished countries by making a commitment to donate hundreds of expensive cardiac devices to patients all over the world. This year, the collaboration continued with a significant donation to HBI’s Trinidad and Tobago project, and Johns Hopkins International is assisting Heartbeat International with the implants in the country.

The implants are done in a public hospital, which the government has made available free of charge.

Trinidad and Tobago’s government has also allowed the donated devices and supplies to enter the country free of duties and taxes.

Globally, between one and three million people die each year because they cannot afford a pacemaker or implantable cardiac defibrillator (ICD). In Trinidad and Tobago alone, as many as 150 people at one time have been on the waiting list for a cardiac device.

While the government health care system there pays for many medical expenses, it does not cover the costs for these cardiac devices. The price tag for the pacemaker implantation and device can be anywhere from $3,000 to $8,000 USD and up to $20,000 USD for www.heartbeatsaveslives.org

—Marlou Janssen

GLOBAL VICE PRESIDENT OF MARKETING AND SALES, BIOTRONIK

an implantable cardiac defibrillator, which is more than the per capita income for Trinidad and Tobago 2 – not to mention the 17 percent of people who live below the poverty line. 3 Without outside help, most people who need pacemakers or ICDs will live a seriously compromised life or may even die.

While the donation is substantial, the payoff comes with stories like that of Christine Bocus, who also lives in Trinidad and Tobago. Christine is a 19-year-old

First pediatric recipient through BIOTRONIK and Heartbeat International partnership, Yuleisy Daniela Baños.

student at the University of the West Indies, where she’s studying Accounting. After being diagnosed with a heart condition, she received a pacemaker in 2006. Life was good until about six months ago, when the weakness and listlessness from before the first implant returned.

Doctors explained that because of her active lifestyle, the first pacemaker’s battery was dying, and she needed a new cardiac device.

Like Jennifer, Christine’s family was unable to afford the device, the government health program didn’t cover it and even Heartbeat International did not have an adequate device available. Just a few months ago, they ONE HEART MAGAZINE

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Globally, between one and three million people die each year because they cannot afford a pacemaker or implantable cardiac defibrillator.

were ready to give up hope. It was also a frustrating — but not uncommon — situation for doctors and Heartbeat International officials. “It was difficult to know that some would die whilst waiting on us,” says Basha Mohammed, Heartbeat International Director for the Caribbean.

Then, Christine received what seemed like miraculous news. “We were called in and told that BIOTRONIK from Germany had donated pacemakers to Heartbeat International of Trinidad & Tobago, and I would get one,” she recalls. “I did not know whether to cry or laugh: Would this divine gift from BIOTRONIK in Germany save my life and answer my prayers?”

On February 4 of this year, doctors implanted the device in Christine’s chest. “The second implant has restored my normal life,” she says. “I am overjoyed and grateful. I have been given a new lease on life.”

As for Jennifer, now that her broken heart has been mended, she’s “elated” and ready to get back to the important work of caring for her children and grandchildren and helping out other kids in the community. She’s also got some other heartfelt ideas: “With the Grace of God and BIOTRONIK,” she says. “I may even be able to get married again.”

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“As a global medical device company, we feel it is our responsibility to save as many lives as possible, especially in those countries where cardiac devices are not readily available,” says Marlou Janssen, Global Vice President of Marketing and Sales at BIOTRONIK. “We are proud of our partnership with Heartbeat International, and the support we provide to help them achieve their mission.” “‘One heart, one country, one life saved’ represents our vision to save hundreds of thousands of lives affecting not only individuals but entire communities,” says Dr. Benedict S. Maniscalco, Chairman and CEO of Heartbeat International Foundation. “The key objective is to become a trusted and expert global resource with ‘boots on the ground’ in providing these services.”

References: 1 Mehra R., Global public health problem of sudden cardiac death. Journal of Electrocardiology. 2007 Nov-Dec; 40 (6 Suppl): S118-22; Saksena, S., Journal of Interventional Cardiac Electrophysiology, Volume 17, Number 3, 163-168; Mond, H., Irwin, M., Morillo, C., & Ector, H., The world survey of cardiac pacing and cardioverter defibrillators: calendar year, Pacing and Clinical Electrophysiology, 2004, 27 (7), 955–964, Jul.; Frost & Sullivan, Strategic analysis of world cardiac rhythm markets, 2004 2 http://www.state.gov/r/pa/ei/bgn/35638.htm 3 https://www.cia.gov/library/publications/the-world-factbook/ fields/2046.html www.heartbeatsaveslives.org

Protecting Patients from Sudden Cardiac Arrest in the Age of Evidence-Based Criteria

By Michael Mirro, MD Cardiac Electrophysiologist Fort Wayne Cardiology, Inc. Medical Director Parkview Health System Clinical Research Center, Fort Wayne, Indiana

“No one delights in he who brings bad news” – Sophocles, circa 442 BC. Since the publication of “Non-Evidence based ICD implantations in the United States” in the January 5, 2011 edition of Journal of the American Medical Association (JAMA) in which it was concluded that over 22% of Implantable Cardioverter Defibrillator (ICD) implantations are “non-evidence based”, the groundswell of commentary from the lay press and cardiovascular community has been nothing short of mountainous.

At the center of the debate is the analysis that data were derived from the National Cardiovascular Data Registry (NCDR), the Center for Medicare and Medicaid Services (CMS)-mandated data repository for ICD procedures that is managed by the American College of Cardiology and the Heart Rhythm Society. This study assessed clinical variables prior to ICD implant in over 110,000 patients. The findings of the study showed that the major reasons for nonadherence to implanting criteria was implantation during ICD waiting periods (greater than 40 days post-myocardial infarction or recently diagnosed congestive heart failure during medical therapy optimization). The predictable kneejerk reaction by the general media was quick to sensationalize the findings and arrive at the conclusion that ICD implantation was, obviously, rampant. Implanting physicians were implied to be greedy or, at a minimum, ignorant. Interestingly, and most concerning, the response from a majority of cardiologists took on an entirely different tone and invoked the Sophoclean adage of ignoring the message and attacking the messenger.

The first salvo of the initial reaction from cardiologists following the release of the study decried the implication that ICD implantation outside of recommended criteria was detrimental to patient care. The blogosphere erupted with claims that the implementation of this so called ‘cookbook medicine’ heralded the downfall of the medical profession and that medical judgment would soon be dead. The firing squad next turned their attention to the source of the analysis, the NCDR. Seemingly every aspect of how the data were collected, aggregated and calculated was impugned. And while analysis of registry databases do present challenges, the fact that institutional rates of ICD implantation that were outside of criteria ranged from zero to almost 60% was overlooked completely along with variations by physician specialty.

Additionally, from the patient perspective, the NCDRICD registry provides comfort in the fact that an outside group of experts are assessing institutional and physician performance to outline benchmarks for improvement and safety.

To add further fuel to the fire, the disclosure that the Department of Justice (DOJ) had launched an investigation of ICD implants involving â&#x20AC;&#x153;proper guidelines for clinical decision makingâ&#x20AC;? has reinforced that increased scrutiny is here, and will likely not abate anytime in the near future. While a cause and effect relationship between the publication of the JAMA study and the HRS statement acknowledging the ongoing DOJ investigation is unlikely, the possibility of being included in the same sentence as the DOJ is enough to spark the attention of any implanting cardiologist.

The message can no longer be ignored.

All eyes are focused on the ICD world and selectively supporting only the data that validates an individual preconceived notion of the world will only serve to deny the inevitable reality that is rapidly approaching. What then is the new reality of protecting patients from Sudden Cardiac Death? Part of the answer resides in the fact that ICD therapy provides sustained, long-term life-saving benefits as proven by randomized clinical trials that define the patient populations indicated for this therapy. Of equal importance to the issue of ICD implantation outside of criteria is the issue of not implanting devices in patients who are at risk for SCA and who qualify for an ICD. The other part of this new reality is that the current and future state of global healthcare does and will involve economic considerations, and practice criteria will serve as the roadmap in the appropriate application of medical care.

And while the storm of heated rhetoric, denial and blame continues to brew, patients continue to need protection from Sudden Cardiac Arrest. The strategy that blames the messenger is a losing one. The results of the JAMA study showed that the major source of ICD implantation outside of criteria occurred during the waiting period between an acute MI or new onset of CHF and ICD implantation (Primary SCA prevention). Careful attention to ICD implantation criteria is imperative for all cardiovascular specialists for several reasons. First, advancements in cardiovascular drug optimization combined with innovations in medical device technology, such as the wearable cardioverter defibrillator (WCD), have recently given cardiologists tools that serve to bridge the period between when a patientâ&#x20AC;&#x2122;s long-term SCA risk is being evaluated and when final decision to implant an ICD has been made. For example, in several leading health centers, patients identified as high risk for SCA (low LV ejection fraction) receive a period of optimal medical therapy (ranging from 40-90 days) while being protected from SCA by the WCD. Secondly, we must ensure that all patients who could benefit from an ICD receive one. The incorporation of an institution-wide systematic approach to screening all appropriate patients for SCA, protecting them with a WCD during the waiting period and, when appropriate, implanting an ICD, is the most effective way to protect patients at risk of SCA. Remember that the JAMA study demonstrated that, as a group, Electrophysiologists had a higher level of adherence to ICD implantation criteria compared to other groups of implanting physicians. Likewise, Electrophysiologists had a higher overall volume of implants, meaning that small improvements in adherence to criteria could have meaningful improvements to the quality and consistency of patient care being administered across the United States. As experts in SCA protection and ICD implantation, Electrophysiologists have an opportunity to serve as leaders among their peers and achieve the goals of ensuring that all high risk patients are screened for SCA, protected during medical therapy optimization (during the waiting periods) with a WCD, and, following criteria, implanted with an ICD when appropriate.

A global fight World Heart Federation unites efforts of 200 organizations in 100 countries to battle heart disease and strokes

By Sid Smith, MD

Heart Federation is now recognized by the World Health Organization as its leading NGO partner he World in CVD prevention and Heart control.

Federation As CVD is the is the world’s only leading cause of death global body dedicated in both men and to leading the fight women in all parts of against cardiovascular the globe except subdisease (CVD). We Saharan Africa—and do this via a united even there it is on the community of 200 rise—the philosophy member organizations guiding the World Heart that brings together Federation is to help the strength of medical developing countries societies and heart and economies in foundations from more transition adopt known than 100 countries. Our and effective solutions Above, the InterAmerican Heart Foundation, 2010. mission is to ensure in combating the Facing, the Portguese Society of Cardiology, 2010. that people all over growing burden of CVD. the world live a longer The WHO states that more than 17 million people die each and better life, free of heart disease and stroke, but with year from CVD, with 82 percent of the deaths occurring in a particular focus on low- and middle- income countries LMICs, and this figure is predicted to rise to 23.6 million by (LMICs).

2030; therefore, there is an urgent need to raise the priority The World Heart Federation was originally formed in of CVD on the global health and development agendas. The 1978 by a merger of the International Society of Cardiology World Heart Federation advocates with its members toward (ISC) and the International Cardiology Federation (ICF), achieving this common goal. Another important aim for which became the International Society and Federation of the organization, and one in which I have a great personal Cardiology (ISFC). In 1998, the ISFC changed its name to interest, is establishing guidelines and quality-improvement the World Heart Federation. The ISC was founded in 1946 programs with proven efficacy in developed countries, and as a professional scientific organization with a membership translate these into healthcare systems in LMICs. of national societies of cardiology. The ICF was set up in 1970, composed of heart foundations from around HOW THE WHF CARRIES OUT THESE AIMS the world, with the purpose of supporting international The World Heart Federation has six strategic goals: research, professional and public education, and community 1. Raise the priority of cardiovascular health on the programs. global health agenda The World Heart Federation is governed by a board 2. Improve care of heart disease and stroke whose members are leading cardiologists from around the 3. Promote heart-healthy diets and physical activity for all world and executives from major heart foundations. Thus, 4. Improve recognition and control of high blood the World Heart Federation represents a broad range of pressure globally people involved in cardiovascular health, united in their efforts in the fight the world’s number one killer. The World continues on page 62 President World Heart Federation

T

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www.heartbeatsaveslives.org

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Just because...

you can’t see it…

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“Health professionals exposed to low dose radiation,... with an average exposure of 4mSv/ yr, show a 2-fold increase of circulating lymphocytes of chromosome aberrations and/or micronuclei, which represent surrogate biomarkers of cancer risk and intermediate endpoints of carcinogenesis” Lucia Venneri, MD, PhD,a Francesco Rossi, et al.; “Cancer Risk from Professional Exposure in Staff Working in Cardiac Catheterization Laboratory: Insights from the Nation Council's Biological Effects of Ionizing Radiation VII Report”

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The Taiwan Heart Foundation, 2010

5. Advance a tobacco-free world 6. Eliminate rheumatic fever and minimize the burden of rheumatic heart disease To achieve these goals, the World Heart Federation brings together thought leaders in cardiovascular science and advocacy, and enables experts to become catalysts in the global fight against heart disease and stroke. As an umbrella organization, we unite our members (cardiac societies and heart foundations) to provide a global voice to shape public health agendas, and we are a unique point of connection for global cardiovascular communities to exchange ideas and best practices. We encourage the advancement of scientific knowledge and evidence, and provide a collective source of independent knowledge and authority in controlling the burgeoning CVD epidemic. Our work is organized into four program areas: • Raising awareness: Around the world, our members work to build awareness for the prevention and control of heart disease and stroke. Our stand-out campaigns, which include World Heart Day, educate those at risk and promote the importance and benefits of heart-healthy diets, physical activity, and tobacco-free lives.

• Advocacy: With our members and partners, we are advocating for policy changes in all areas linked to CVD, such as tobacco control and obesity. This includes lobbying 62

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for the accelerated implementation of the Framework Convention on Tobacco Control (FCTC), as well as pursuing strategies to reduce the consumption of salt, sugar, and saturated and trans fats.

• Applied research: We seek to measurably reduce heart disease and stroke risk factors via resource-appropriate applied research projects. We work with ministries of health, members, health practitioners, partners, and the WHO to establish best-practice models for cost-effective prevention and control. We also enable local capacity building, thus ensuring that projects are sustainable in the long term.

• Sharing science/building capacity: We do this through the World Congress of Cardiology (WCC) Scientific Sessions, the official congress of the World Heart Federation.

Held every two years, the WCC is our main platform for exchange of information, science, and innovation in CVD medicine. In addition to the congress—and the next one will take place April 18–21, 2012, in Dubai—we publish two peer-reviewed journals, and offer a variety of workshops and training courses and fellowships. Underpinning these efforts are leading scientific working groups focused on research, rheumatic heart disease, education, and training. continues on page 64 www.heartbeatsaveslives.org

Carlson Cod Liver Oil: a Norwegian Tradition

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Carlson award-winning Cod Liver Oil begins in Norway. In the clean arctic waters off the coast of Norway, cod fish are caught during winter and early spring when the liver oil content is at its highest. In Norway, the health benefits of Cod Liver Oil are so well recognized that it is the only food supplement recommended by the government for its citizens to take their entire life. Cod Liver Oil naturally provides the important omega-3 fatty acids EPA and DHA and is also a natural source of essential vitamins A and D. Trust your patients are getting the important omega-3’s they need with Carlson Norwegian Cod Liver Oil. 1 teaspoon provides: Omega-3 fatty acids . . . .1100 mg DHA . . . . . . . . . . . . . . . . 500 mg EPA . . . . . . . . . . . . . . . . . 400 mg ALA . . . . . . . . . . . . . . . . . 40 mg Vitamin A . . . . . . . . . . . . . . . . 850 IU Vitamin D . . . . . . . . . . . . . . . . 400 IU

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PREPARING FOR THE SUMMIT: THE WORLD HEART FEDERATION AND THE NCD ALLIANCE In 2009, the World Heart Federation joined with the International Diabetes Federation, the Union for International Cancer Control, and the International Union Against Tuberculosis and Lung Disease to form the NonCommunicable Disease (NCD) Alliance, with the aim of putting NCDs on the global agenda. We are a formal alliance representing the four main NCDs outlined in the WHO’s 2008–2013 Action Plan for NCDs: cardiovascular disease, diabetes, cancer, and chronic respiratory disease. These conditions share common risk factors (including tobacco use, physical inactivity, and unhealthy diets) and also share common solutions, which suggests the benefits of a mutual platform for collaboration and joint advocacy. By working together from the global to the local level in an alliance that has grown to represent nearly 900 national member

The next World Congress of Cardiology Scientific Session will take place in 2012 in Dubai, United Arab Emirates.

associations, we bring a united voice to the global campaign for NCDs. On May 13, 2010, the NCD Alliance celebrated its first great success when the United Nations voted unanimously for the passage of resolution 64/265, “Prevention and control of non-communicable diseases.” As the global burden of NCDs continues to grow, this resolution—calling for heads of state to address NCDs in a high-level summit convened in September 2011—serves as a major political statement that has the potential to make NCDs a priority among international leaders and secure multisectoral commitment for their prevention and control.

The four main NCDs currently cause over 60 percent of all deaths globally (35 million), with LMICs bearing 80 percent of the mortality burden of these diseases. Poverty plays a role both as a risk factor and as a consequence of NCDs: one-third of the poorest two quintiles in the developing world die prematurely from preventable NCDs, which affect everyone from children to the elderly and often hold them back from achieving their potential or fulfilling 64

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essential roles in their communities. Despite this, NCDs are perceived to primarily afflict the wealthy. This misconception has led to the virtual absence of vital investment. Failure to address NCDs will impede future development, derail efforts to reduce poverty, and reverse the worldwide development gains of the Millennium Development Goals (MDGs).

Achievement of the MDGs requires a global response that places chronic diseases at the center of health and development initiatives. This means giving prominence to disease prevention, recognition of the strong correlation between communicable and non-communicable diseases, and the acknowledging the need to strengthen existing health systems that encourage multisectoral government approaches to public health. Evidence and experience have demonstrated that by taking appropriate action, countries can reverse these negative trends.

The NCD community will have just one chance to dialogue with the world’s leaders and heads of state on NCDs. As a leading body in these advocacy efforts, the World Heart Federation has and continues to prepare arguments, evidence and solutions that will enable politicians and policy makers to grasp the sheer magnitude NCDs pose and to take action that will halt and reverse their economic, political and social consequences. Governments alone cannot solve an epidemic on this scale. The solution requires concerted action by governments, international agencies, NGOs, the private sector, health professionals, the research community and the general public themselves. As the world’s only global body dedicated to leading the fight against heart disease and stroke, the World Heart Federation is uniquely placed to mobilize its 200 member organizations in a civil society movement that will benefit the millions of people lacking access to affordable CVD and NCD treatment, address health systems struggling with dual burdens of infectious and noncommunicable disease, and begin to turn around the global NCD epidemic.

THE GLOBAL COST OF CARDIOVASCULAR DISEASE The total cost of CVD on a global level is very difficult to quantify, although the Institutes of Medicines (IOM) Report on Cardiovascular Disease in the Developing World released in 2010 has been able to give significant insight into how far and deep the epidemic reaches. Global CVD deaths have increased to 17.1 million, 82 percent of which take place in LMICs. Today, CVD is the largest single contributor to global mortality. Poverty plays a role both as a risk factor and as a consequence of CVD. The sheer magnitude of this disease and the far-reaching damage it inflicts on individuals, families, and communities threatens to reverse development (MDG) gains made worldwide. CVD increases global health inequalities and increases the strain on alreadyoverburdened families. The high cost of treatment can lead to lost employment opportunities as well as lost economic and social opportunities, especially for young adults and women.

CVD events can result in catastrophic health costs that force parents to reduce basic consumption. Often this translates into children being withdrawn from school to continues on page 66 www.heartbeatsaveslives.org

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assist in caregiving or to enter into the workforce. In China, out-of-pocket expenses from stroke pushed 37 percent of patients and their families below the poverty line; 62 percent without insurance slipped into poverty.

New scientific research on the “early origins of health” indicates that NCD risks have their origins in the fetal and postnatal periods, which shape the development and function of specific organs. Aspects of the developmental environment, such as the mother’s diet or body composition, have longterm consequences for both the mother and child’s predisposition to NCDs. Maternal malnutrition during pregnancy, including both over- and undernutrition, triggers an increased risk of developing chronic conditions such as cardiovascular diseases in adulthood. Preventing and detecting diseases at the earliest possible moment is a critical tool for minimizing human suffering and societal costs.

THE WHF’S ROLE IN THE NEXT 20 YEARS The primary goal of the World Heart Federation is to reduce cardiovascular disease worldwide. Moving forward, we will play a critical role in promoting environments that enable heart-healthy lifestyle choices and therefore help reduce the risk of CVD and NCDs more broadly.

Specifically, toward the NCD High Level Summit and beyond, the World Heart Federation will play a pivotal role in advocating that governments and private donors recognize that CVD and NCDs are key areas that require capacity-building and technical assistance. This will require a specific commitment to align with existing global health efforts and build on the public health infrastructure. Beyond leadership in the advocacy arena, the World Heart Federation will work with its over 200 members to suggest evidence-based and locally relevant solutions to address CVD. As we have two specific health communications campaigns, World Heart Day and Go Red for Women (kindly made available for international development by the American Heart Association), we do and will continue to encourage our members to advocate for guidelines that are accompanied by these campaigns and place significance on the same priorities: environments that enable healthy choices, making healthy choices for yourself and family, and, more broadly, placing significance on health equity worldwide.

For many countries there are policies, campaigns, and general efforts to address CVD already taking place; however, assessing what has and is working and disseminating this information will be key for us. To do this we are making sure that moving forward the evaluation and reporting of programs is incorporated in our biennial World Congress of Cardiology.

Here we will share evidence and best practices on successful interventions and enable an environment to discuss which interventions are the most feasible in certain settings. Although there are local considerations to take into account, there are many similarities that can provide excellent guidance. Finally, as our partnership with the NCD Alliance suggests, collaboration between various stakeholders is crucial. Working with the NCD Alliance, we have been pushing for strategies at the international level that will reduce the intake of salt, sugar, and saturated and trans fats. As the NCD High Level Summit approaches, our advocacy efforts will be vital in ensuring that our members are engaged in fruitful dialogue with their governments and are persuading heads of state to commit to international and national strategies to prevent and reduce the burden of CVD.

One of the World Heart Foundation’s awareness campaigns is “Go Red For Women,” which aims to improve women’s knowledge of heart disease and stroke. Each year more than 9.1 million women globally die of heart disease and stroke.

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Rapid Percutaneous and Portable Extracorporeal Life Support ECLS/ECMO has undergone resurgence in recent years due to successful attempts at salvage of H1N1 patients who would have otherwise died of refractory hypoxemia as well as some key improvements in technology. These early “Hail Mary” attempts at treating young adults with H1N1 were later justified by the results of the CESAR trial which randomized patients in the UK between conventional medical therapy (including “invasive” ventilation) and ECMO. There was a statistically significant increase in survival among the ECMO patients.

The recent introduction of LIFEBRIDGE, a small portable membrane oxygenation system for patients requiring cardiac or pulmonary support has led to a wide variety of applications. The LIFEBRIDGE portable ECMO unit has been described as a “plug and play” device and I believe this is an apt description. It is made of 3 modules of which the patient module is disposable. Housed within the modules are a polypropylene oxygenator, centrifugal pump, filter and 7 stage air eliminator system. It weighs approximately 40 lbs. and it’s connectors are compatible with 3/8” tubing. We refer to our portable ECMO program as the RED ARCC (Rapid ECMO Deployment for Acute Respiratory and Circulatory Collapse).

The miniaturized Heart / Lung machine can be set up within minutes, and is easily implemented. Via femoral-femoral percutaneous cannulation connection, it stabilizes the patient’s circulation, secures gas exchange to all vital organs and helps prevent developing acidosis. Adding a portable heart-lung machine into clinical practice (not requiring constant supervision and operated by trained, but not specialised staff) allows to establish an immediate circulatory support or even fully replace the circulatory system at any location. In other words, practical applications for ECLS are now available “out of the surgical environment”. ECLS also allows “as a welcome side effect” the rapid and well controlled cooling of patients in severe myocardial infarction or in post resuscitation status as required by current clinical guidelines. In addition, the subsequent rewarming of the patient can easily be performed by ECLS in a controlled manner.

No additional cooling system and no often less powerful cooling device or cooling therapy is needed to establish hypothermia when ECLS therapy is provided.

References: 1. Mehlhorn U, Brieske M, Fischer UM et al.. LIFEBRIDGE: A Portable, Modular, Rapidly Available “Plug-and-Play” Mechanical Circulatory Support System. Ann Thorac Surg 2005; 80: 1887-1892.

2. Buz S, Jurmann M, Gutsch E, Jurmann B, Koster A, Hetzer R. Portable mechanical circulatory support: human experience with the Lifebridge system. Ann Thoracic Surg 2011; 91: 1591-5.)

The mainstream use of this technology is in support of acute heart failure situations

After European approval (one year before FDA 510k clearance) more than 400 cases have been performed for a broad spectrum of indications. The main indication up to now is associated with AMI as well as Cath Lab associated circulatory emergencies. Up to 9 – 12% of all acute myocardial infarct (AMI) patients run into cardiogenic shock (CS) before catheterization, during transport or revascularization (with an excessively high mortality rate of 50 – 70 %). Rapid reperfusion of the patient, not only the heart, especially in STEMI patients, is the goal of all cardiologists. Mortality / morbidity rates potentially can be significantly reduced if rapid cardiopulmonary support could be provided. LIFEBRIDGE enables earlier reperfusion, support before, during and post PCI while the heart is recovering. The same concept may be adopted in principle for other emergency situations enabling treatment while securing perfusion of the body or while transferring the patient to the place where next step of care can be offered.

References: • Ferrari M, Poerner TC, Brehm BR, Schlosser M, Krizanic F, Schmidt R, Figulla HR. First use of a novel plug-and-play percutaneous circulatory assist device for high-risk coronary angioplasty. Acute Card Care 2008; 10:111-115.

• Jung C, Schlosser M, Figulla HR, Ferrari M. Providing Macro and Microcirculatory Support with the LIFEBRIDGE System During High-risk PCI in Cardiogenic shock. Heart Lung Circulation2009; 18:296-8.

Methodist Hospital and Transfer Experience

At The Methodist Hospital (TMH) we have embraced this technology as well as the clinical strategy of lung rest and “rest” ventilator settings. Together with our colleagues of cardiac surgery and cardiology we “translated” the concept of “bringing cardiopulmonary bypass wherever needed” into our clinical pathways.

Our ECMO program has become an integral part of the thoracic transplant and ventricular assist device programs supporting patient as a bridge to lung and heart/lung transplant; patients with primary graft failure for heart, lung, and heart/lung transplant; and patients requiring left, right and biventricular support who develop refractory hypoxemia. In 2010 at TMH, we performed in excess of 100 lung transplants, 8 heart/lung transplants, approximately 20 heart transplants, 54 long-term LVAD’s and over 50 ECMO circuits.

Among the many new technologies we have utilized to support ECMO patients the one which has most transformed our program to date is the LIFEBRIDGE Technology. The LIFEBRIDGE portable ECMO unit has become the cornerstone of our portable ECMO program. Eight patients have been transported from outside hospitals, to date, all of them arriving at TMH

without incident. All of these patients were too unstable to transfer until placed on ECMO. The very first patient transported on the LIFEBRIDGE in the U.S. is a good illustration of the utility of the device.

Case report

F.R. is a 49 y/o woman who worked as a nurse at the facility where she was admitted for shortness of breath and altered mental status. CXR showed bibasilar infiltrates. The patient is a diabetic vasculopath with a history of aortofem and fem-fem bypasses. The patient was intubated and started on pressors. At the time a consult was placed for ECMO then patients’ O2 was in the 40’s with an FIO2 of 100% on bilevel ventilation.

The patient was also hypotensive despite having been placed on 18 mics of dopamine, 18 mics of Levophed and 0.2 unites of Vasopressin. Given the clinical scenario we decided to place the patient on veno-arterial ECMO. The patients right femoral vessels were explored at the bedside.

The patients previous vascular surgeries precluded placement of a femoral arterial cannula. A right femoral venous cannula was placed and a right axillary artery cutdown was also done. An 8mm Hemoshield graft was sewn end to side to the axillary artery and used as the arterial inflow. After systemic heparinization the patient was attached to the Lifebridge device and ECMO was initiated. The patient was then transported via ambulance to TMH (Fig. 1). After arrival to our CVICU the patients coagulopathy was corrected and her cannula sites re-explored.

Over then next 24 hours we were able to wean her off pressors. On ECMO day 4 the patient was converted to veno-venous ECMO with an Avalon cannula and the axillary and femoral cannuals were removed. (Fig. 2) On ECMO day 5 the patient was weaned off of ECMO. Five days later the patient was extubated and 1 week later the patient was discharged to home.

Moving forward we hope to increase our volume of patients by increasing the number of hospitals we support as well as widening the geography we will cover. There are opportunities for expanding our indications and improving our outcomes through clinical research and improving technologies. We now think of ECMO as the cardiac / pulmonary equivalent of renal replacement therapy, ie IV oxygen. There is a spectrum of increasing pulmonary support starting with noninvasive ventilation (BIPAP or CPAP) to invasive ventilation (intubation and mechanical ventilation) to PECLA (pumpless extracorporal lung assist-Novalung) to VV-ECMO (venovenous) to VA-ECMO (veno-arterial) to pulmonary replacement (lung

transplant or total artificial lung.) There are, however, no more patients requiring cardiac or pulmonary bypass that are “too sick” to support or to transfer.

This has also been demonstrated by European groups in cases of infield circulatory stabilisation, post-resuscitation instability (on-going study in Germany), cardiology interventions (imminent shock in AMI, high risk percutaneous coronary interventions (PCI), trans-catheter valve implantations), emergency medicine & intensive care (AMI, extended CPRs), as well as patient transport between hospitals comparable to the case presented here.

References: • Feindt P, Dalyanoglu H, Lichtenberg A. Re: Extracorporeal circulatory systems in the interhospital transfer of critically ill patients: experience of a single institution. Ann Saudi Med 2010; 30:169-170.

• Sonntag S, Ferrari M, Schlosser MH, Bruch L, Fritzel T, Kleber FX. Improved Survival of Cardiogenic Shock Patients After High-Risk Coronary Interventions under Portable Cardiopulmonary Bypass Support. ESC 2008.

EHJ 2009; S1:P2907.

Future horizons

• Remote cardiac surgery in emerging countries (80% of the world’s population has no access to cardiac medicine) • In-field stabilization of battlefield induced injuries i.e. blast injuries to the lung • Extended concepts of organ donor management (DCD / non heart beating donors).

Translating the concept of a simple, safe and quickly installed heartlung machine into the Cath Lab and ER settings or in referral hospital concepts or as part of emergency networks will have tremendous impact on cardio-thoracic and emergency medicine. It may offer the opportunity of a significant improvement of outcomes of patients with acute circulatory and/or lung failure.

Acknowledgements TMH Thoracic Transplant and Mechanical Circulatory Support Team TMH Perfusion Services Fondren Brown CVICU Nursing Respiratory Therapy and Physical Therapy

THE

RHYTHM OF

HOPE HER YOUNGEST DAUGHTER’S DIAGNOSIS WITH REFLEX ANOXIC SEIZURES STARTED TRUDIE LOBBAN’S 18-YEAR QUEST TO BRING AWARENESS TO ARRHYTHMIA

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By Trudie Lobban

A

rrhythmia Alliance (A-A), The Heart Rhythm Charity, is a coalition of patients, caregivers, patient groups, independent medical professionals, medical groups, charitable organizations, and industry members. While maintaining their independence, members work together under the A-A umbrella to promote the following: • Timely and effective diagnosis • Access to appropriate treatment for cardiac arrhythmias • Ongoing patient support • Improved quality of life for all those affected A-A is led by Trudie Lobban MBE, who is also the founder and CEO of Russell Brown raised awareness of the importance of people checking their pulse at an event the Atrial Fibrillation Association, in Parliament as part of World Heart Rhythm Week.

Syncope Trust And Reflex anoxic Seizures (STARS), and The Blackouts Trust. Lobban founded STARS in 1993, achievements since then are outlined below: following her youngest daughter’s diagnosis of Reflex Anoxic • In 2006, A-A organized the U.K.’s inaugural Heart Seizures.

Rhythm Congress, which is now an annual conference Following ten years of campaigning and mobilizing combining scientific sessions for medical professionals, experts to improve the management of syncope, Lobban with advocacy and educational sessions for patients and approached other organizations working to improve the carers. The 2010 conference saw over 3,000 delegates and care of patients with cardiac arrhythmias. In the autumn many international speakers—the largest exhibition to date. of 2003, a handful of arrhythmia patient groups in the Notably, HRC now hosts an international roundtable meeting United Kingdom began a grassroots campaign to persuade of representatives from existing and prospective member Parliament to establish guidelines for the treatment of countries to discuss best practices and future collaboration. arrhythmias. At that time, although 700,000 people had • In 2007 Lobban co-founded, with Professor A. John cardiac arrhythmias, and 100,000 people per year died of Camm, the Atrial Fibrillation Association (AFA), following sudden cardiac arrest, there were no government arrhythmia demand from patients and clinicians worldwide. AFA has guidelines, as well as a shortage of health professionals expanded rapidly, and membership has increased by 200% trained to diagnose and treat arrhythmias. Many people in the last year alone. with arrhythmias did not know where to turn to learn about • 2008 saw the launch of World Heart Rhythm Week, treatments, or for hope and encouragement that they could the international development of Arrhythmia Awareness achieve a good quality of life. The campaign succeeded Week, which calls on supporters across the globe to promote beyond all expectations, leading to a vital change in health our message. This event has grown considerably, and last policy that resulted in the inclusion of an additional chapter year drew support from over 200 organizations. in the National Service Framework for heart disease • 2009-2010 saw the rapid growth of the international specifically covering arrhythmias and sudden cardiac death. organization. Initially established in the United Kingdom The U.K.’s first Arrhythmia Awareness Week, held in but now developing internationally, the Arrhythmia Alliance June 2004, was a coordinated campaign to ensure that sources, collates and reflects views and data collected from the voices of patients would be heard whenever decisions members, bringing beneficial perspectives to the fore to were being made on the development and implementation ensure that change is led by the people for the people. To of arrhythmia care services. The Arrhythmia Alliance was extend the advantages of collaboration between patients and launched soon after, in 2005; some of its most considerable physicians, A-A has assisted in the establishment of multiple www.heartbeatsaveslives.org

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A-A National Partners across Asia, Australasia, Europe, North America, and South America, in over 20 individual countries. A-A National Partners has continued the work of A-A worldwide by establishing a patient support organization comprising healthcare professionals, patients, caregivers, and allied professionals.

Arrhythmia Alliance’s work in campaigning on behalf of patients with arrhythmias has seen great advances in not only raising awareness of heart rhythm disorders, but in ensuring that patients have access to appropriate diagnosis and treatment. The importance of joint efforts between specialist clinicians and patients within patient associations should not be underestimated. At a time when national governments are implementing austerity measures and

Mike Weatherley getting his pulse checked by a volunteer in order to raise awareness of the “Know Your Pulse” campaign for Arrhythmia Alliance.

cutting back on healthcare and its budgetary support, patient groups—along with specialist clinicians—can continue to work together in partnership to ensure that key messages are heard by policymakers and filtered down to all levels of the health system.

Through all this work, Trudie Lobban has become recognized as a world expert representing patients and their caregivers, as well as all those involved in the care and treatment of people affected by cardiac arrhythmias and sudden cardiac death. In 2009, Lobban was awarded an MBE for services to healthcare.

A-A offers support to patients, caregivers, and medical professionals through a variety of media. A-A provides support, information, and the understanding that is essential for those living with cardiac arrhythmias. Our core activities are some of our most important: helping and supporting patients and caregivers. We achieve this through a wide 72

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range of means, including patient information booklets, an annual newsletter, monthly e-bulletins, a comprehensive website, Cardiac Update Courses, Heart Rhythm Week, and our annual Heart Rhythm Congress.

A key to the successful impact of Arrhythmia Alliance has been the “patient’s voice,” which remains at the center of the coalition’s dialogue and activities. Now the case is stronger than ever that great things can be achieved through the power of an alliance, working together to improve the lives of those affected by heart rhythm disorders.

QUESTIONS & ANSWERS WITH TRUDIE LOBBAN What was your motivation for forming the Arrhythmia Alliance?

I first established the non-profit organization The Syncope Trust in 1993 when my daughter was diagnosed with a heart-rhythm disorder, reflex anoxic seizure, at the request of her consultant. The organization is known as STARS, for the Syncope Trust And Reflex anoxic Seizure, online at www.

STARS-international.org. In 2003, I invited other organizations to join forces to host an awareness week and to call upon the UK government to introduce recommendations for the diagnosis, treatment, and care for arrhythmias and sudden cardiac arrest (SCA).

This was a grassroots campaign run from my home.

Following the success and change in government policy on arrhythmias and SCA, I decided to form the Arrhythmia Alliance to continue the work and ensure the government and department of health followed through with their promises to ensure more rapid diagnosis, available treatment options, and improved quality of life for all those affected by arrhythmias and sudden cardiac arrest.

What benefits have you seen from working together as an alliance, such as economic scaling, sharing resources, larger impacts, etc.?

Working together has huge advantages. We have a louder voice, and a bigger, better message. Since we are all seeking the same outcome—an army of like-minded, focused people—it’s a win-win situation as we all engage together to reach the same goals. We can ensure that our resources are endorsed by recognized healthcare organizations and that all patients receive the same high standard of information through all those affiliated with the Arrhythmia Alliance. Funding can be easier to secure when you demonstrate that many groups and individuals will work together to ensure the project is a success and reach as many recipients as possible.

What challenges has the Arrhythmia Alliance faced that an individual organization does not?

Bringing together individuals and organizations and demonstrating that together we can make a difference— together we stand, divided we fall! However, it takes determination and a common goal. Trying to keep everyone focused is more difficult than it might be with a smaller www.heartbeatsaveslives.org

ARRHYTHMIA ALLIANCE HAS ASSISTED IN THE ESTABLISHMENT OF NATIONAL PARTNERS IN OVER 20 INDIVIDUAL COUNTRIES.

organization with fewer individuals. You need a strong, dedicated leader and board who remain focused and yet are willing to consider all options and proposals, and to listen to the patients; voices, above all. You must never lose sight of the patients and caregivers and their needs.

What objectives has the Arrhythmia Alliance been able to achieve that the individual organizations would not have been able to accomplish on their own?

The Arrhythmia Alliance has achieved a number of important things: 1. Changed government policy 2. Engaged with politicians—who, after all, must listen to the voters 3. Worked closely with departments of health to ensure that our objectives dovetail with theirs and to ensure that they—and we—are responding to the needs of patients and caregivers.

4. Worked with physicians to understand the problems they face—and to make sure that they appreciate the problems that their patients face 5. Acted as the voice of the patient—the end “customers” 6. Worked with industry to ensure that they understand the needs of the patients and educate them on living with heart rhythm disorders— to give the conditions and treatment options a human face so that they are more than just numbers in a sales target for an endof-quarter quota 7.

Worked with patients and caregivers, listening, reassuring, and supporting them 8. Educated clinicians, patients and caregivers, and the public, and empowering them all www.heartbeatsaveslives.org

to make a difference 9. Supported and informed all those involved in an affected by arrhythmias and sudden cardiac death, including patients, caregivers, clinicians, governments, and industry 10. Gathered case studies to share with the media to highlight the issues 11. Acted in a professional way at all times and ensuring that both the clinical and patient voices are heart at all times 12. Worked as a coalition—that is, cooperatively.

This is not a battle or a war. At the end of the day, everyone should be working for the same outcome, which is improved quality of life for all those affected by arrhythmias and sudden cardiac arrest I could go on, but those are the high points.

Understand that these are things that individuals and smaller organization can and often do accomplish, but as an alliance we have been able to do these things more efficiently, effectively, and on a larger scale.

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The ACC’s role in ‘interesting times’

By David R. Holmes, Jr., M.D.

President, American College of Cardiology

T

he wonderful phrase “May you live in interesting times” has been variously termed a curse or a blessing for wonderful opportunity; either way, it has great relevance in the modern era of cardiovascular “The ACC constantly strives to address cardiovascular disease. There are multiple disease globally with partnerships with international issues to be addressed by cardiovascular societies using NCDR registries, reducing door-to-balloon times, and the society as a whole and within development of chapters. ” the cardiovascular specialties —Dr. David R. Holmes PRESIDENT in particular, and the American AMERICAN COLLEGE OF CARDIOLOGY College of Cardiology (ACC) plays an essential role.

The American College of Cardiology is transforming cardiovascular care and improving heart health through continuous quality improvement, patientcentered care, payment innovation, and professionalism. A 40,000-member nonprofit medical society comprising physicians, surgeons, nurses, physician assistants, pharmacists, and practice managers, the ACC bestows credentials upon cardiovascular specialists who meet its stringent qualifications.

The College is a leader in the formulation of health policy, standards, and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care.

“

T

he mission of the American College of Cardiology is to advocate for quality cardiovascular care—through education, research promotion, development, and the application of standards and guidelines—and to influence healthcare policy. Healthcare policy has presented a central challenge. The ACC is ideally suited to help provide information that can be used in decision making related to societal and governmental policies. The ACC has developed a robust series 76 ONE HEART MAGAZINE

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of registries dealing with percutaneous coronary intervention (PCI), electrophysiology, pediatrics, and now outpatient medicine. These registries focus on collecting and collating scientific data on the practice of medicine in real-world settings.

This information has been invaluable and has been used to identify practice patterns, most recently of percutaneous coronary intervention and implantable cardioverter defibrillators. www.heartbeatsaveslives.org

The 2011 American College of Cardiology scientific sessions in New Orleans.

The National Registry of Diagnostic Cardiac Catheterization and PCI registry is the oldest and the most robust of the family of registries, containing standardized data collected from more than 100,000 U.S. sites, including detailed information on patient and hospital characteristics, coronary angiographic findings and percutaneous coronary intervention, and hospital outcomes.

Recently, data on 500,154 PCI procedures performed at 1,091 U.S. hospitals from July 1, 2009, to September 30, 2010, was used to evaluate the appropriateness of care with PCI. This methodology, 78

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based upon a modified Delphi approach, evaluated 198 distinct and mutually exclusive clinical indicators for the performance of both PCI and coronary bypass graft surgery. These settings were designed to represent a diverse range of clinical and angiographic patterns. An expert panel assembled the 198 different scenarios were subdivided into three major groups of indications. A grading system of indication was used. Grade 1â&#x20AC;&#x201C;3 procedures were deemed as inappropriate (i.e., coronary revascularization was unlikely to improve either patientâ&#x20AC;&#x2122;s health status or survival), grade 4-6 procedures were described www.heartbeatsaveslives.org

as uncertain, and grade 7–9 as appropriate (i.e., coronary revascularization would likely improve a patient’s health status or survival).

Using this NCDR database, patterns of care were identified; specifically, of patients with an acute episode of cardiovascular disease, 98.6 percent of PCI procedures were deemed appropriate, 0.3 percent as uncertain, and only 1.1 percent inappropriate. Of the entire group, 30 percent of patients had a nonacute indication, and within this group, the results were mixed: 50 percent were appropriate, 38 percent were uncertain, and the remainder of the procedures were deemed as inappropriate, but there was marked variability between centers. The source of this www.heartbeatsaveslives.org

variability is unknown but is the focus of subsequent research. By identifying practice patterns, as well as variability in these patterns, this registry provides the opportunity to develop more efficient and optimal strategies of care.

This registry has also been used to develop risk-adjusted models for bleeding hazard. Such models are currently in use to tailor approaches— device approaches, arterial access approaches, and adjunctive medical therapy—to minimize bleeding.

The most recent extensions of the registry to the outpatient setting with the PINNACLE registry will provide a very robust data set and facilitate study of optimal practice patterns and the development of new strategies of care. This tool will tool allow practices to monitor secondary prevention as well as monitor readmissions. As part of this process, the American College of Cardiology has developed and tested appropriate use criteria based on best practices and vetted by a number of societies and individuals within the medical profession. This information allows for evaluation of variability in practice. It is being piloted in Wisconsin as a statewide initiative to reduce costs of care by reducing inappropriate PCI use.

As healthcare reform proceeds, the ACC believes that medical professional engagement is an essential aspect of actually reforming the delivery and payment system encouraging meaningful use of health information technology and empowering patients. Patient-centered care is at the “heart” of the matter, and the ACC is leading this process. The ACC has worked in several areas to ensure appropriate imaging, prevent hospital readmissions, reduce geographic variations in care and, as previously mentioned, encourage adherence to guidelines. A crucial part of this initiative is patient education and patient empowerment so that the patient becomes part of the healthcare team.

Informing patients allows for more rational and appropriate decisions and recommendations.

The ACC developed the concept of “door-toballoon” time, which has radically changed the care of patients with acute myocardial infarction.

Currently, pilots under way include the American College of Cardiology “hospital-to-home” (H2H) initiative, which is committed to improving the transition across sites and sources of care for patients with cardiovascular disease: the aim is to reduce preventable 30-day readmissions for patients with heart disease by at least 20 percent by 2012. The American College of Cardiology is also focused on reducing the rate of imaging that is deemed to be inappropriate by at least 15 percent through the use of the appropriate use criteria.

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cost-effective, efficient, quality care, whether through bundling of patient-centered medical homes or the creation of virtual integrated systems.

Part of this process will be based upon increasing adherence to guidelines through the use of clinical decision support tools embedded in electronic health records, development of educational tools and programs and the creation of networks of hospitals and practices committed to quality improvement. In addition, the ACC continues to

disease and the burgeoning problems of obesity and diabetes. These trends, taken together, have the potential to drastically increase global morbidity and mortality. Strategies for addressing the issues of noncommunicable diseases will be developed in concert with the societies involved in this United Nations meeting.

The ACC constantly strives to address cardiovascular disease globally with partnerships with international cardiovascular societies using NCDR registries, reducing door-to-balloon times, and the development of chapters.

New educational initiatives harness the power and breadth of technology that will be used and highlighted at the upcoming 2012 meeting to deliver the latest science and evidencebased guidelines globally.

Long-distance learning will be the focus of a substantial number of initiatives in this area. The number of international chapters as well as the full complement of state chapters partnering with international societies to address cardiovascular issues and share best practices have the potential to globally elevate cardiovascular care worldwide.

S i g n i f i c a n t c h a l l e n g es lie ahead. We need to develop Medtronic exhibiting at the 60th Annual American College of Cardiology Scientific tools to educate a wide variety Sessions in New Orleans. of patient populations and to help encourage adherence to work on increasing adherence to primary and medications and lifestyle changes. There will be secondary prevention through the development of enormous economic issues relating to healthcare tools to monitor and encourage patient adherence reform in this country as well as globally. to lifestyle changes, adherence to medication Cardiovascular medications are expensive; regimens, and patientsâ&#x20AC;&#x2122; understanding of efforts are under way to decrease the costs and cardiovascular disease. make medication use more user-friendly with Other issues related to healthcare policy revolve the development of things such innovations as around payment. ACC has been involved in helping to the â&#x20AC;&#x153;poly-pillâ&#x20AC;? (a combination medication of guide implementation of innovations in e-prescribing multiple active ingredients). There will be issues payment adjustments. ACC is also working closely in terms of new technology and how it can be with the Food and Drug Administration and CMS distributed worldwide. Regulatory agencies and to help in the process of rational dispersion of new reimbursement agencies need to be in alignment technology. as much as possible throughout the world so that An important global role that the ACC plays all patient groups can have access to optimal is highlighted by our participation in the United medical care, thereby improving the quality as Nations high-level meeting on non-communicable well as the quantity of life and reducing the diseases, a huge issue worldwide. The ACC will be disparities worldwide. an integral part to the meeting, which will include The American College of Cardiology with the World Heart Federation, European Society its 40,000 members and its full complement of of Cardiology, the American Heart Association, dedicated staff is making the difference locally, and other professional organizations devoted to nationally, and globally in the fight against addressing the global epidemic of cardiovascular cardiovascular disease.

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www.jamesabelevents.com

+1 917.399.4552

inquiry@jamesabelevents.com New York, New York

A jump start for Trinidad and Tobago Johns Hopkins Cardiology partners to help public-sector cardiovascular services in the Caribbean island nation

By W. Lowell Maughan, MD, MBA Professor of Medicine and Biomedical Engineering Johns Hopkins University Medical Director, Trinidad and Tobago Health Sciences Cardiovascular Services Initiative

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he incidence and prevalence of cardiovascular diseases are high in Trinidad and Tobago, and public sector cardiovascular services are significantly underdeveloped. To address this need, the Government contracted with Johns Hopkins International to increase capacity and access to cardiovascular services through education and training. Over 70 faculty and staff from the Johns Hopkins University Cardiology Division are providing nearly continuous onsite training in Trinidad and Tobago. Physician training includes CME lectures, day-long basic instruction in the common diseases, quarterly conferences on best practices, and a fulltime 24-month Cardiology Fellowship. Ancillary staff training includes inpatient and outpatient cardiovascular nursing courses and a full-time 14-month echocardiogram sonography course, as well as cardiac catheterization and electrophysiology technologist training. The budget also provides funding for the equipment and cardiovascular management expertise necessary to implement new services. Johns Hopkins has partnered with Trinidad and Tobagoâ&#x20AC;&#x2122;s Ministries

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of Health and of Science, Technology and Tertiary Education; with the five Regional Health Authorities; with the University of the West Indies, the University of Trinidad and Tobago, and the College of Science, Technology and Applied Arts of Trinidad and Tobago; the Trinidad and Tobago Medical Association; and with Heartbeat International.

The partnership’s goal is to develop sustainable approaches to continued expansion and advancement of public sector cardiovascular care in Trinidad and Tobago. This seems to be an effective model to jumpstart development of needed specialty services in developing healthcare systems.

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rinidad and Tobago is a two-island nation with a population of about 1.3 million. Its stable government has provided

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leadership and fostered the development of natural resources that have allowed the country to advance its public services and infrastructure. A significant proportion of the population has a genetic predisposition toward diabetes and hypertension. This, combined with the average citizen’s penchant for a lifestyle more typical of developed countries, has led to a high incidence of cardiovascular diseases. This has resulted in an inordinate number of premature deaths and cases of serious longterm disability.

The population’s healthcare is served by a two-part system: the public health sector delivers 87% of health services, and the private health sector, which plays a vital role in providing services not readily available through the government program. Patients flow freely between these two sectors, with specific services at any given time determined largely by the ability to pay and timely access.

The Ministry of Health determines health policies and priorities and funds five Regional Health Authorities charged with implementing those policies and delivering care. Public healthcare

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is delivered at roughly 100 local community health centers, each staffed with physicians and ancillary personnel who deliver the majority of primary care. Most of the regions also have District Health Facilities, which are larger centers with accident and emergency departments and, depending on the facility, may have a variety of more specialized services such as pediatrics, obstetrics and gynecology, and lifestyle clinics that manage chronic disease such as hypertension, heart failure, and diabetes. In addition, each of the five regions has a regional hospital with inpatient beds. Most drugs are provided free to patients from a national formulary.

To date, the public health sector has focused on primary care, and has been very effective at treating infectious diseases and the causes of early mortality that plague developing countries and health systems. This success has resulted in a shift of the disease profile to one that resembles that of developed countries, with a high prevalence of coronary artery disease and mortality related to circulatory disease and diabetes.

Trinidad and Tobago is a two-island nation of around 1.3 million residents, 87 percent of whom are served by its public healthcare system.

However, development of specialty services in the public sector has lagged far behind. This is illustrated by the situation with cardiovascular care. In 2008, there was only one fully trained public sector cardiologist and four internists with a cardiology focus to provide care to the 1.3 million population; in contrast, in most developed health systems that same population would be served by 60 to 80 cardiologists. Three of the five regional hospitals had no cardiology specialists, no coronary care units, no stress testing, no echocardiography, and no electrophysiology services. Furthermore, only one facility provided routine 84

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acute thrombolysis. There was no dedicated intensive coronary care facility, the accepted best practice for patients with acute myocardial infarction, the most common cause of mortality in the country.

TTHSI/CVSI: THE TRINIDAD AND TOBAGO CARDIOVASCULAR HEALTH SERVICES INITIATIVE Starting in 2006, the government of Trinidad and Tobago sought input and proposals from Johns Hopkins International to address areas of healthcare underdevelopment. Johns Hopkins International is a branch of Johns Hopkins Medicine and provides access for international clients that request help from the faculty and medical experts at Johns Hopkins University. One of the largest and most highly regarded academic institutions and health systems in the United States, for the past 20 years Johns Hopkins University has been consistently ranked as the nation’s best hospital by the U.S. News and World Report. In the early 20th century, Johns Hopkins served as the model for outstanding medical education, a model adopted by the U.S. government for all academic institutions in the country.

Discussions among Johns Hopkins, healthcare providers, and educators led to a number of proposals, three of which were funded by the Trinidad and Tobago government. These included the establishment of a master’s degree in healthcare administration, a program to improve care of diabetic patients, and the cardiovascular services initiative program that is the focus of this article. The goal of the proposed programs was to increase cardiology service capacity and access in the public sector through education.

The focus of the cardiovascular services initiative is the development and implementation of sustainable, long-term improvements in cardiovascular care, in partnership with the country’s public health sector personnel and infrastructure, academic institutions, and medical associations. To do this, the cardiology contract provides funding for three key program elements. The first element of program funding brings cardiology faculty and ancillary staff educators in a variety of subspecialty areas to teach in Trinidad and Tobago for 48 weeks a year for four years; this resource supported the establishment of a wide variety of comprehensive training program based primarily at the Eric Williams Medical Sciences Complex but encompassing all five regions.

The second element of program funding budgets for the equipment needed initially for training but eventually deployed to allow the newly trained personnel to deliver the services. The third key element of program funding covers the cardiovascular management expertise needed to assist the regional health authorities in coordinating staff training, equipment delivery, scheduling, information technology, and space to assure that all of the components needed to establish and sustain a service are available. This www.heartbeatsaveslives.org

three-program approach insured that all elements required to implement effective services could be coordinated in an efficient and timely fashion.

KEY STAKEHOLDERS AND PROGRAM PARTNERS Although training, equipment, and management expertise were essential elements, the key to effectiveness and sustainability is identifying key partners who desired and could benefit from additional resources to develop cardiovascular services. The Ministry of Health, in particular the Chief Medical Officer, has played a key role in advising and guiding the direction of the efforts and providing guidance on how best to work within the existing systems and infrastructure. The Ministry of Science, Technology, and Tertiary Education has also been essential as the funding agency for the project. The Regional Health Authorities have guided the identification of personnel and implementation of most of the training program. The University of Trinidad and Tobago is charged with administering the program from the Trinidad and Tobago side. The University of the West Indies in Trinidad is critical to sustaining post-graduate physician education and leading innovation. The College of Science, Technology and Applied Arts of Trinidad and Tobago (COSTAATT) is the key partner in providing longterm program to train allied health professionals, including nurses, technologists, and technicians to perform specialized cardiovascular laboratory and procedure studies.

Several non-government organizations are also key partners. The Trinidad and Tobago Medical Association is our partner in providing continuing medical education programs and credit for physicians as well as other educational

A product of

programs. Heartbeat International has been an important partner in working to develop the pacemaker and AICD device-implantation program. The Trinidad and Tobago Heart Foundation, as well as the Trinidad and Tobago Olympic Committee, are important partners in public education.

Since public sector healthcare delivery in Trinidad and Tobago is provided through the five Regional Health Authorities (RHAs), these were the central partners in directing both the volume and accessibility of cardiovascular services. Starting in January 2010, the physician and administrative leadership from each of the RHAs created a Regional Health Authority Executive Cardiovascular Services Implementation Committee, which reviewed the status of cardiovascular services in each region and, with representatives from the Hopkins Cardiology Division, recommended a national strategy for public sector distribution of cardiovascular services.

A NATIONAL PUBLIC HEALTH CARDIOVASCULAR SERVICES STRATEGY Efficiency, provider availability, and best practices dictated that access to highly specialized services such as coronary angioplasty, electrophysiologic procedures, cardiac surgery, advanced heart failure care, and pediatric cardiology services should be centralized but accessible to all. At the same time, the high prevalence of cardiovascular diseases and the need for early detection, aggressive prevention, and risk management dictated that basic cardiovascular services should be available at every health center. Given that cardiac care situations are time-critical, the district health facilities needed to be able to provide emergency

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cardiac services as well as provide frequently used diagnostic and management services at locations relatively close to where patients live. Having a national strategy also ensured a smooth and coordinated system for timely movement of patients and information among levels of service. The strategy recognized that building and sustaining effective cardiovascular care requires a commitment to education and development of a national academic referral center to provide advanced, comprehensive care. This center could not only train cardiologists and future academic leaders but would also serve to stimulate the innovation needed to develop and introduce advances in cardiovascular care. In January 2011, a National Cardiovascular Strategy Workshop was held with representatives from the Ministry of Health, the Ministry of Science, Technology and Tertiary Education, the Regional Health Authorities, the University of the West Indies, the College of Science Technology and Applied Arts of Trinidad and Tobago, and Johns Hopkins Cardiology. This group, in a vote, expressed virtually unanimous support for this approach.

As a result of these discussions, the TTHSI Cardiovascular Services Initiative has focused its training, equipment, and management resources on the areas illustrated in Figure 1. According to the initiative, each health centre would have specific staff training (physician, nursing, and allied health personnel) in outpatient cardiovascular care and all healthcare providers will be trained in either basic or advanced cardiac life support; each health centre should have the ability to perform and interpret electrocardiograms; and there should be a strategy for the health centers to provide ongoing continuing cardiovascular medical education.

It was agreed that the specific services that should be available at the District Health Facility level would include echocardiography; stress testing; a nurse-run, physician-supervised anticoagulation clinic; ambulatory ECG monitoring; the knowledge and resources to evaluate, stabilize, give thrombolytics to and transport patients with acute myocardial infarction; and all of the services available at the health centers.

Specific services suggested as appropriate for the major regional hospitals were more variable, and dependent on the circumstances of each region: • The North Central Region contains the Eric Williams Medical Sciences Complex, which includes the University of the West Indies St. Augustine Medical School Campus as well as a cardiology group that has grown during the initial two TTHSI program years to include four cardiology consultants, a cardiac catheterization laboratory, a small but excellent echocardiography program, the start of an electrophysiology program, and on-site cardiac surgery two weeks a month.

The complex was already regarded as the national cardiovascular referral center and it was recommended that this would logically continue as a comprehensive national academic referral center; with support from the University of the West Indies, it could offer Cardiology Fellowship training and lead innovation and training throughout the country.

• The South West Region serves almost half the population of Trinidad and Tobago. It was suggested that its

Figure 1: Suggested distribution of public sector cardiovascular services Regional Hospital Cardiologist Cardiology referral outpatient clinic Coronary Care Unit—Inpatient CV nurse training Emergency Department Emergent Cardiac Care (Thrombolysis) Echocardiography Stress Testing Ambulatory ECG monitoring Anticoagulation Clinic ECG accessible and interpreted BLS/ACLS training for all caregivers Outpatient Nursing Training Continuing Medical Education for Physicians Tertiary Referral Centers Cardiology training program Cardiac Catheterization Laboratory Electrophysiology Service Cardiac Surgery Cardiac CT District Health Facilities Emergency Department Emergent Cardiac Care (Thrombolysis) Monitored emergency transport to tertiary hospital Echocardiography Stress Testing Ambulatory ECG monitoring Anticoagulation Clinic ECG accessible and interpreted BLS/ACLS training for all caregivers Outpatient Nursing Training Continuing Medical Education for Physicians District Health Facilities ECG accessible and interpreted BLS/ACLS training for all caregivers Outpatient Nursing Training Continuing Medical Education for Physicians

major hospital, San Fernando General, should have a well developed cardiology program with several cardiologists and a coronary care unit, and that it should generally have the personnel and resources to provide most forms of comprehensive cardiovascular care.

• The North West Region includes the Port of Spain, the largest city in Trinidad and Tobago. The Port of Spain General Hospital currently has no in-house cardiovascular services, and uses the Eric Williams Medical Sciences Complex, about a 30-minute drive away, to provide public sector cardiovascular care. It was recommended that patients with cardiovascular disease who live in Port of Spain should have access to more fully developed public sector care, including cardiologists and equipment to provide routine and some specialized diagnostic and treatment services.

• The Eastern Region is smaller, and it was suggested

that while it was not practical or necessary to develop full comprehensive cardiology services there, it was important to have basic referral services available, as well as the ability to care for acute cardiac illnesses. Thus it was recommended that the Regionâ&#x20AC;&#x2122;s patients would benefit from the presence of a full-time cardiologist, a coronary care unit, and a referral clinic. In addition, basic testing such as echocardiography, stress testing, ambulatory monitoring, and anticoagulation clinic should be available for the diagnosis and management of common cardiovascular conditions. â&#x20AC;˘ Tobago, a separate island accessible quickly only by plane, deserves special attention. Although the population is relatively small compared with Trinidad, the islandâ&#x20AC;&#x2122;s geography requires a more comprehensive portfolio of cardiovascular services than would otherwise be provided. A new hospital with modern equipment serves this purpose very well. It was recommended that cardiology expertise and services at the hospital include the diagnosis and management of common conditions, risk factors, and presentations such as angina and atrial fibrillation, as well as the ability to care for acutely ill cardiac patients (e.g., administer thrombolytics) and provide a coronary care unit setting.

THE PROGRAM IMPACT As of this writing in mid-2011, the TTHSI Cardiology program is a little more than halfway through its anticipated implementation timeline. The start-up phase, which included identifying Trinidad and Tobago personnel for training and adjusting their schedules to allow for training, took slightly longer than anticipated, as did ordering the necessary cardiovascular equipment and supplies. This has led to an extension at no additional cost.

At the start of 2008, the services listed in Figure 1 were almost completely lacking in the 100 health centers, 10 District Health Facilities and five major regional hospitals.

By mid-2011 virtually all of the training programs needed for the services listed in Figure 1 had been developed, and training completed for stress testing and nurse-run, physician-supervised anticoagulation clinics. Training in most other areas was implemented and is ongoing, including a 24-month full-time cardiology fellowship that currently includes five fellows; nurse training in outpatient and inpatient cardiac care; echocardiography for sonographers; laboratory staff for cardiac catheterization and electrophysiology procedures; cardiac CT and ECG training 88

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Johns Hopkins International is a branch of Johns Hopkins Medicine and provides access for international clients that request help from the faculty and medical experts at Johns Hopkins University.

for physicians and support staff; BLS and ACLS training; and CME courses. Some training (e.g., ambulatory ECG analysis and physician echocardiography training) await delivery of key equipment.

We anticipate that unless unanticipated roadblocks appear, by February 2013 almost all of the services listed in Figure 1 will be implemented and available at all of the appropriate facilities. Considerable anecdotal evidence suggests that we are already seeing a significant improvement in patient care thanks to the training that has already occurred; however, without the delivery of needed equipment and the full implementation of the new services, it is too early to measure the full effects of the program.

We believe this five-year program represents a realistic transition from having no public sector location in which sufficient resources were available to deliver adequate cardiac care to one in which basic cardiac services are distributed throughout Trinidad and Tobago.

To sustain these services will require the implementation of continuous training to renew and advance the staff delivering these services, and we are optimistic that these training programs can be developed. Although it may take longer than anticipated to achieve all of these goals, we believe that this is an effective model to jumpstart, in a relatively short timeframe, the development of needed specialty services in developing health systems. www.heartbeatsaveslives.org

Small non-profi

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About the author Christin Kirschenbaum is the Director of Philanthropy for Solidarity Bridge.

Solidarity Bridge has provided more than $17 million in medical care to the poor in Bolivia and Paraguay

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s I write this, my little boy is like a small ninja in my belly, constantly stretching and kicking and dancing his way towards our world. I have a beautiful stepdaughter but this is the first time I will be birthing my child through my own body. It has transformed me beyond my wildest imaginings—and he’s not even in my arms yet.

Maybe that’s why I burst into tears today when I received Luis’s story from our social worker. For ten years I have been a fundraiser for Solidarity Bridge (www.

SolidarityBridge.org), a U.S.–based non-profit serving the poor of Bolivia and Paraguay, so I am no stranger to the plight of the poor. I have lived many years with them in my heart. I have held them as they cried, kissed their babies, and shared in their struggles and joys. But never before have I looked at a mere photo of a child and wept.

I see this little boy’s deep chocolate eyes looking out at me from the photo while I feel my own baby kicking. I know it would kill me to lose such a precious gift. My step-daughter was born with a multitude of medical problems, including a huge hole in her heart, but she was lucky enough to have been treated at one of the best hospitals in the world. She is thriving today. For little Luis, this is not an option. Without open-heart surgery, this beautiful boy will die. My own little boy will live because he will be born in a different country. Chance separates the two: One to die and one to live.

In Bolivia, an open-heart surgery costs roughly $15,000, much cheaper than in the United States, but still beyond the reach of all but the wealthiest Bolivians. Luis’s parents make about $250 a month. When the www.heartbeatsaveslives.org

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doctors told them what they needed to save their little boy’s life, they simply took him home to die. They had no other choice.

At Solidarity Bridge, we hear variations on this story over and over again. Sobbing parents hand us their listless child, telling us of how the cost of the needed surgery is beyond their wildest dreams, let alone their actual ability to pay. Teenagers who have dropped out of school to support their families beg us for help because their once-strong mother or father can no longer even get out of bed.

These stories are a daily heartache for our staff and volunteers. We work in Bolivia and Paraguay, the two most povertystricken nations in South America.

Daily living is a struggle for most— affording even the most basic medical care is often impossible, and paying for lifesaving surgery is just a dream.

We work in Bolivia not just because of its great need but also because of our love for the country and its resilient people. It is a land of great beauty with teeming jungles and the majestic Andes, with a rich traditional culture. Bolivia is the most indigenous nation in South America; 62 percent of the population descends from the ancient Guaraní, Quechua, and Aymara peoples. Sadly, these groups closely overlap with the 60 percent of Bolivians who live in deep poverty and who struggle with little or no access to medical resources. Bolivia endures such political turmoil that it has undergone nearly 200 coups in its 185 years of being a nation. It is the most destitute nation on the continent.

Bolivia’s neighbor, Paraguay, is the second-least developed country in South America. Nearly 50 percent of the population lives in extreme poverty, living on less than $2 a day. Ethnically, Paraguayans are 95 percent mestizo (mixed Spanish and Native American) and approximately 90 percent speak the indigenous Guaraní language. The country is still recovering from a 35-year military dictatorship that ended in 1989, and faces entrenched corruption and deficient infrastructure. In Paraguay, there is a tremendous gap between the rich and the poor: 90 percent of the people own just 25 percent of the land. In rural areas, where many of our patients live, only 15 percent have access to clean water and 42 percent have access to basic health care.

For many of the sick living in poverty in both Bolivia and Paraguay, the help we provide is their only chance for a productive life or even survival.

Solidarity Bridge has many programs, but our most farreaching and lifesaving is our Heart Program, which operates 92

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in both Bolivia and Paraguay. Every year we perform over 150 pacemaker surgeries and about 30 open-heart surgeries.

Our pacemaker program mostly serves those affected by Chagas disease, which kills over 50,000 people every year in Latin America alone and infects approximately 9 million.

In Paraguay it is one of the greatest health problems: an estimated 150,000 Paraguayans are infected annually, and over 3 million are at risk of infection, and some areas in Paraguay have infection rates as high as 38 percent. In Bolivia, the devastation of Chagas is even more dramatic. In one area where we work, the city of Tarija, over 70 percent of the population is infected, and Chagas accounts for 13 percent of all deaths in Bolivia—mostly of them among those who live in poverty or rural areas. Chagas, usually spread by an insect that infests mud or thatched houses, causes debilitating and often fatal heart-related problems that appear only after several years following infection.

The illness can cause patients pain and fatigue so severe that patients often can’t even get out of bed. A heart that damaged requires a pacemaker to stabilize the heart and prevent heart failure.

We are a small non-profit, but our focus is big. Our primary goal is not just to heal those living in poverty but to train and equip local medical personnel to better serve their fellow citizens.

Our Medical Program is a partnership between U.S. and Latin American surgical and medical colleagues. We have provided more than US$17 million worth of medical training, supplies, medicines and equipment; seen roughly

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Promoting better understanding, diagnosis, treatment and quality of life for individuals with cardiac arrhythmias

Medical Membership The Bene�its

♥ Access to educa�on and training to promote diversity and improved technology ♥ Free Department of Health endorsed publica�ons across all areas of heart rhythm management, for pa�ents and clinicians ♥ Extend your knowledge of heart rhythm disorders and promote successful models of prac�ce through regional cardiac update courses ♥ Opportunity to promote your research programme, survey, event, mee�ng or pa�ent support group ♥ Free materials for World Heart Rhythm Week For further information and to register as a member contact Arrhythmia Alliance

+44 (0) 1789 450 787 @ info@heartrhythmcharity.org.uk ➚ www.heartrhythmcharity.org.uk ➚ www.aa-interna�onal.org

www.afa-international.org

Registered Charity No: 1107496

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54,000 patients; and made possible more than 2,300 surgeries. In addition to our Heart Surgery Program, we have three other primary medical programs: our Direct Service Medical Trips bring U.S. surgeons and medical volunteers to Bolivia to heal those living in poverty and to advance the expertise of the Bolivian surgeons and medical community; our General Surgery Program provides general surgery for those in need of cancer, hernia, gallbladder, and colostomyreversal surgeries; and our Neurosurgery Program raises the standard of neurological surgery in Bolivia through training and medical equipment.

As our mission evolved, we recognized the need to not only heal the sick, but to go to the root of the problem of poverty. To answer this call we began our Fair Trade Program and its current partnerships with Dharma Trading, Solidarity Clothing, and Greenola.

With these relationships we provide a bridge between indigenous Bolivian sewing cooperatives and the United States, establishing a Fair Trade market for clothing produced by Bolivian workers. Fair Trade is an exchange of goods in which the workers directly participate in setting a fair price for their goods, which assures them a sustainable living wage.

Our organization faces difficulties similar to those

Every year, Solidarity Bridge provides more than 150 pacemaker surgeries and about 30 open heart surgeries.

of many other non-profits that aid the poor through pacemaker implants around the world. Solidarity Bridge and Heartbeat International have been discussing the idea of forming a Global Cardiovascular Alliance of like-minded non-profit organizations. Through the Global Cardiovascular Alliance we would come together through a central board of directors to provide a “united front” to the manufacturers. This Global Cardiovascular Alliance could address many of our shared issues. For example, implanting pacemakers requires the services of a local physician as well as a programming machine to be left in place for the critical patient follow-up care.

It would be a great service for the Global Cardiovascular Alliance to create ethical guidelines that include such provisions and therefore assure the pacemaker 94

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manufacturers that proper care is being provided.

A Global Cardiovascular Alliance could also set up a tracking system for all pacemakers implanted to verify for the manufacturers that donated pacemakers are indeed going to the proper recipients. A Global Cardiovascular Alliance, if well developed, could be an important development in getting the poor the help they desperately need.

Like all non-profits, Solidarity Bridge faces many challenges in the coming years—expansion headaches, fundraising struggles, dealing with unstable governments, and other obstacles. One of the most heartrending and soul-searching dilemmas is the delicate balance between serving the many while not losing sight of the few. When I first started working for Solidarity Bridge I met Maria, a teenage girl who needed a pacemaker. Our organization was brand new. I was deeply involved in starting our fledgling sponsorship program, and I wanted to include her story as a way to convince even more people of the critical need for donations. She was such a beautiful girl and I reasoned that her story could help us find money for many others, so I focused my energy on preparing the sponsorship materials. While I knew that getting the money for Maria’s surgery was critical, I thought we had plenty of time. As soon as the sponsorship materials were finished and ready, I made sure the money was sent and Maria’s surgery was scheduled. But I was too late. Maria died the morning of her surgery. I had unwittingly sacrificed the one for the many—a terrible lesson for me to learn, and one I deeply regret.

Another variation on this dilemma arises often within our Heart Surgery Program. Through the partnerships we have with local hospitals and the generous donations of medical companies like Medtronic, we can perform a pacemaker surgery for about $450. We can perform an open-heart surgery for $5,000 to $10,000. There is a moral dilemma in this disparity. Do we choose one over the other because of the cost? This choice becomes especially poignant because most of our pacemaker patients are adults, whereas many of our openheart surgery patients are children. Do we abandon little Luis because we can save so many other lives with the money it would cost for his one surgery?

As my own baby dances in my womb my heart immediately says, “Yes, save Luis! He is most precious.”

Then I think of the many people waiting for pacemakers who are sacrificed to save one little boy. Though older, they too are someone’s son or daughter. Many of them are the sole providers for their children. There is no easy answer. Our staff and board of directors wrestle with this ethical dilemma on a daily basis. We all face these kinds of tough choices: do we give our charitable donations to the non-profit working to stop global warming or promote world peace—issues that affect us all, the many—or to the non-profit begging us to help save the life of a single child whose face gazes up at us from a photograph?

How do you choose? www.heartbeatsaveslives.org

Translate Science into Patient-Centered Care with: •

16 new learning pathways, allowing the ACC to better address the needs of you, our learners

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A focus on science each morning and practical clinical applications each afternoon, helping you get the most out of ACC.12

New this year! ACC.12 officially kicks off on Saturday, March 24 at 8 a.m. with the ACC.12 Opening Session & Late-Breakers, and closes on Tuesday, March 27 at noon with the new ACC.12 Closing Session: Innovators in Cardiology. Early bird registration is now open!

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Go to www.accscientificsession.org to learn more!

©2011 American College of Cardiology A1291

pace

Keeping with world’s medical needs Project Pacer International has delivered $5 million in care to India, South America

I

n 1986, an unlikely collaboration between two physicians of different medical subspecialties and different cultural backgrounds—Dr. Thomas Piemonte and the late Dr. Verinder Saini—gave birth to a highly successful effort to deliver health care outside the borders of the United States. A cardiothoracic surgeon and interventional cardiologist who worked together in a community hospital decided to explore and better understand the medical needs of indigent people in developing countries. This collaboration led to a deep and abiding friendship, and to the founding of Project Pacer International, a non-profit 501(c)(3) organization dedicated to the delivery of cardiac care to indigent patients in developing countries.

Project Pacer International has completed 60 missions over the last 25 years and delivered approximately $5 million of healthcare to multiple countries. The effort started in India— Dr. Saini’s native land—and over the years grew to include programs in the cities of New Delhi, Chandigarh,

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Scientific Sessions 2012 | 18 – 21 April 2012 Dubai, United Arab Emirates

‫المؤتمر العالمي المراض القلب‬ 2012 - ‫الجلسات العلمية‬

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In the last 25 years, Project Pacer International has completed 60 missions and delivered approximately $5 million of healthcare to multiple countries.

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Puttaparthi, and Trivandrum. Later, through an association with Dr. Richard Carey, an internist who made frequent trips to the indigent populations in the Bolivian mountains, Project Pacer members met a remarkable Jesuit missionary, Robert Thomas.

Father Thomas in turn introduced the group to Dr. Oscar Ferrufino, a cardiologist in Cochabamba, Bolivia.

Since that time, Project Pacer has undertaken yearly missions to Bolivia, working from the Viedma Hospital in Cochabamba, in addition to its India trips. These highly successful missions have included invasive procedures such as mitral valvuloplasties, cardiac defibrillators, and pacemaker implantations.

An integral part of each mission is the examination of hundreds of patients in the Cardiac Clinic in the Viedma Hospital by a team of nurse practitioners, physician residents, attending physicians, nurses, and pacemaker representatives.

At present, Project Pacer International is lead by Dr. David Martin, an electrophysiologist at Lahey Clinic who serves as the president, and Dr. Thomas Piemonte, an interventional cardiologist who serves as its chairman. Robert Murray serves as treasurer. The PPI board oversees projects and budgets for upcoming trips, with operations funded largely through individual donors and industry grants.

The team at Project Pacer International has been working with members of Heartbeat International to form a Global Cardiovascular Alliance of non-profit, charitable organizations with the express purpose of expanding healthcare delivery in the developing world.

This collaborative effort between organizations is important and timely. The need for advanced healthcare among the less fortunate has never been greater and the fiscal challenge to organizations trying to deliver this care has never been more formidable.

Currently many organizations compete for identical resources, both human and financial, to fulfill strikingly similar missions. Invariably, volunteers use their own resources and approach the same donors again and again.

Corporate entities, both private and public, are deluged with donation requests, and the burden has become much greater and the business and regulatory constraints more formidable. The GCA offers a means to transform www.heartbeatsaveslives.org

competition into cooperation. This collaborative effort would approach donor sources as a single entity, greatly easing the challenges of fundraising and enhancing the ability to deliver more comprehensive services across the spectrum of cardiovascular diseases.

The GCA project, spearheaded by Dr. Benedict S. Maniscalco of Heartbeat International, will provide the necessary framework for efforts to expand the charitable work of several allied groups. Multiple organizations, each with its own specific humanitarian mission and particular core competencies, will combine to address the cardiovascular needs of under-served indigent populations. This Global Cardiovascular Alliance is an essential step along the road to improving efforts to deliver much-needed healthcare to the developing world.

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Responding to Challenges in Emerging Economies CardioStart faces issues in international CVD work head-on

By Janine Henson, Michelle Kaplinski, Jodi Gunther, & Aubyn Marath CardioStart International

The development of pediatric and congenital cardiac surgical options mostly evolved shortly after World War II. Irrespective of where it is carried out, five cardinal features of neonatal, pediatric and adult heart surgery contribute toward—but do not guarantee—a satisfactory result: • a high standard of cardiological investigation and work-up • timely surgical management • meticulous anesthesia and perfusion using intensive monitoring by dedicated specialists in pediatric and adult care • expertise in delivering Intensive Care for extended periods of time by a cohesive team using well-tried protocols • employing the most up-to date equipment These are rightly proclaimed as essentials for safe, modern practice in international meetings in cardiovascular surgery and form the platform upon which intra-hospital departmental morbidity/mortality discussions shape our quality assurance measures.

What happens, however, when one or more, or even most of these ingredients are missing or are less than optimal? In disadvantaged healthcare systems, which of the related diseases, or functional status, or extended morbidity from lack of timely medical consultation, or ordinary quality of life limitations will become critically important in determining a successful outcome? We already lament and debate the lack of uniformity in surgical performance among advanced centers, but how low should we go? Can surgery be undertaken without all the specialists 100

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present to make a cohesive unit? Is it essential that the team members know each other and have had a prior working relationship together? If advanced equipment is not fully available, what equipment can we safely do without? Which standard should be considered acceptable or too low and how do we measure that? What are the ethical, moral and legally culpable defining lines?

Both our experience and our common sense tell us that there is much to be concerned about. In contrast to the high standards provided by the established world centers of excellence are the very depressing statistics elsewhere; these represent the variable and, in some locations, almost complete failure of effective delivery of cardiology and cardiac surgery.

In many parts of the world there is nothing available for the general population. Patients with congenital and adult heart diseases are easily tracked in Europe and North America, but as population studies confirm, most of these patients live elsewhere. Children and many adults with cardiovascular disease (CVD) in disadvantaged locations simply die without even access to evaluation or treatment. CVD remains the number one cause of death worldwide.

According to the World Health Organization (WHO), an estimated 17.1 million people died globally from CVD in 2004; this represented a total of 29 percent of all deaths in the world (WHO fact sheet). Moreover, 80 percent of deaths from CVD occurred in low- and middle-income countries (LMIC), largely due to both a lack of preventative measures and an inability to access medical interventions when needed. Unfortunately, LMICs are affected by CVD by two separate mechanisms: • First, there is the development of stroke, heart disease, and diabetes in these countries due to natural genetic predisposition, increase in the automation of work, smoking, sedentary lifestyle and poor eating habits.

• Second, there is the continuation of many congenital and infectious disease processes that continue to plague these countries and lead to CVD. Although congenital heart condition rates are the same between higher and lower income countries, CVDs caused by infectious diseases are still substantially higher in LMICs. These include rheumatic heart disease, Chagas, and endomyocardial fibrosis. Most of the congenital and infectious disease causes of CVD are surgically correctable, but resources are very limited in LMICs. The yearly loss of life worldwide has different causation rates within each of the countries currently evaluated, and data is incomplete. The burden of dealing with correctable heart conditions is born by local teams with little support from their own health ministries owing to lack of funding or an overwhelming incidence of different and more immediate health problems. Practical assistance is often carried entirely by volunteer organizations from higher income countries.

THE ISSUES SEEN IN INTERNATIONAL CVD MISSION WORK Countries that CardioStart are currently assisting struggle to provide even the basic tools to support appropriate cardiological and surgical management: a) A chronic lack of appropriate investigative equipment Equipment such as a C-arm is unavailable, and there is 102 ONE HEART MAGAZINE

often no ongoing maintenance contract for any important radiological investigative equipment already possessed. An angio-catheter suite is usually well beyond financial reach; some locations struggle to evolve with an old (donated) 2-D echocardiological machine. Many centers suffer equipment loss from major power surges each year. b) Inadequacy of direct government support Despite their unique importance, education and healthcare are usually the ministries that receive the lowest budget support by governments in office, irrespective of what might be promised in election campaigns. Most governments even in advanced systems fail in this responsibility; those in struggling economies normally feed the military’s needs first, to ensure their own survival and protection. c) Grossly inadequate local health care budgets, making further growth impossible When CardioStart visited Nicaragua and set up a unit in Managua with two subsequent supporting visits and a very successful series of surgical accomplishments, the annual healthcare budget for the nation was US$560,000—for a 6.3 million population at the time. d) Personnel However hard local doctors may try to attract necessary staff to form a functioning specialist unit, educational advancement and salary lines continue to be the most challenging for any hospital administration.

Nurses who acquire any kind of training in intensive care become tempted to join private health care clinics.

Others leave the country to work in Europe, the United Kingdom, Canada and the United States. These countries are the major players and have a voracious appetite for absorbing newly trained staff, luring them with more tempting salaries than those given to the highest earners among doctors back home. Local medical directors are often selected from one of the hospital departments, and these directors know they are in a notoriously temporary position with all the tensions the position implies. They is either “under the thumb” of their respective health ministries’ requirements and expectations, and can anticipate regular scoldings; or they may do what is natural, and use the position while they have it as a onceonly chance to secure better support for their specialty as a priority while in office. e) Surgical skill Despite the best efforts of those building new programs, attracting talented specialist leaders costs money; well intentioned appointments may fail if the infrastructure is insufficient to sustain good outcomes. A blame game then follows: “Dr. X lost a patient not through technical imperfections, but because the doctors have been set up to fail and have been thoroughly unsupported by competent staff or equipment.” This trend is very destructive to units trying to evolve. If litigation does follow, it gives way to years of uncertainty and a fear of starting over in case of fresh criticism. www.heartbeatsaveslives.org

As part of its mission, CardioStart teaches pediatric care for cardiovascular disease patients to doctors and nurses around the world.

f) Procedures performed in circumstances with only basic standards of medical care The pioneering spirit in building a unit is necessary and courageous, but most â&#x20AC;&#x153;pioneersâ&#x20AC;? are left scarred from various battles to ensure consistent results. An audacious approach may have a very uncertain outcome. Local, regional, or national economic pressures may be the determining factor of survival and growth quite apart from the excellence of an individual; many good units have lost momentum or been forced to close through cutbacks, despite single-center excellence. g) Deficiencies in essential items such as valves and software disposables The corporate medical industry has been visibly and consistently generous over the decades, both directly and through volunteer organizations doing international work, but they continue to suffer from a lack of a realistic market opportunity in nations whose political position, as well as social and health infrastructure, are uncertain and weak.

CardioStart has achieved over 700 operative successes with the discarded disposables and valve donations given by U.S., Canadian and U.K. hospitals. h) Poor funding support for international assistance teams Most international teams struggle to mount missions and scrounge for essential items to perform their work www.heartbeatsaveslives.org

effectively. There is no infrastructure for an academic professorship in international healthcare in most universities and it is almost nonexistent in cardiology and cardiothoracic surgery. Individual or department goodwill and a sense of global medical awareness and responsibility may be limited by financial constraints, despite the wealth of some university endowments dedicated towards foundation support. i) International efforts mounted by individually inspired hospital groups Over 30 such compassionate care groups exist in advanced-center locations with a regular success record of performing safely conducted evaluation and surgical treatment year after year. These have great merit in fighting the immensely high waiting lists, but cannot effectively bring about program development for the local team unless there is a structured advancement program with daily lectures set in place, supported by regular visits. j) Only small numbers of patients are helped SuperďŹ cial evaluation of numbers of cases done on a mission may seem small, almost inconsequential to the massive numbers afflicted with CVD. The contribution by the cardiological/surgical visiting teams that provide daily evaluation of patients and screening programs needs recognition, greater emphasis, and more support to supply local teams with useful equipment and educational advancement.

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CardioStart works to improve intensive care unit documentation in emerging economies.

k) Quality assurance measures are neither defined nor policed Most international volunteer groups do not have the personnel available on the mission to address this concern, and most local hospitals assisted do not have the electronic hardware or software programs to do yearround data collection and analyses. Health ministries also do not have the resources available to address this, and long-term preventative programs tend to follow directives published by advanced-care systems, so they lag behind in terms of effective action. An example of this is the smoking habit, which directly contributes to the enormous burden of disease affecting cardiovascular, gastrointestinal, and cerebral systems. In contrast, while smoking is now strongly condemned in the West by health maintenance and disease prevention groups, the British-American Tobacco 104

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company reports substantial growth in yearly profits and the installation of new cigarette manufacturing plants in countries where smoking is a growing practice. l) Pediatric and congenital disease complicated by late presentation, acquired cardiac pathology, and distortion from hypertrophy In our experience, this is true and has frustrated efforts to effectively deal with some pediatric and adult cardiac presentations. A surprising finding has been the excellent outcomes of patients with rheumatic valve disease complicating congenital presentations. Data is currently being acquired to examine this further. m) Supporting educational material such as illustrative films and textbooks www.heartbeatsaveslives.org

The great expense of educational programs and practical constraints limit the development and maintenance of cardiac programs. We found few centers had up-to-date journals, a departmental library, or computer access available to trainees. One had modern educational material dedicated to postgraduate nurse training. Only five programs had weekly lecture training periods when first assisted by CardioStart.

The reasons why units fail may have little to do with surgical competence or the cardinal features that define a successful program, as listed above. People simply get discouraged and leave.

HOW TO MOVE FORWARD: OUR EXPERIENCED VIEW ON THE BEST STRATEGY FOR MAJOR CARDIOVASCULAR ASSISTANCE To provide focused and comprehensive help, CardioStart International has evolved the following initiatives in its global approach: 1. Provide free evaluation and operative correction of heart disease This is given to children and adults to assist any country seeking cardiovascular assistance, irrespective of political position or religious creed. We are not unique in this approach. All international compassionate cardiac surgery groups seem to have these two unifying features in their work. It illustrates the power and wholesomeness of unqualified compassion by healthcare professionals— arguably, more than any other professional group—in penetrating politically sensitive or “no-go” areas of the world, with no other agenda except to offer free medical assistance. Ours focuses on advanced specialist assistance to help hospitals grow or recover from disadvantage and personal training and education is a priority. Consistent with this, CardioStart has not refused any country seeking specialist cardiovascular assistance.

2. Being sensitive to local needs and issues unique to each country The countries assisted have both similar and uniquely different challenges and the progress by each developing www.heartbeatsaveslives.org

unit depends on personnel, equipment, in-hospital dynamics and on the support by regional healthcare authorities. Some nations have struggled with various calamities and intense deprivation and hardship has been endured. For example, Peru’s change of governments and varying emphasis on healthcare budget allocation has made continuity very difficult; Immense suffering and significant financial and human costs have been caused by large outbreaks of diseases such as HIV, tuberculosis, and Chagas, the largest cholera outbreak in South American history, civil unrest, conflict from home-grown terrorist cells and an earthquake in 2002. The last event cut off the entire electricity to the region, and did very serious damage to hospital equipment— especially the radiology department, which was reduced to a single portable radiographic machine for several months.

3. Effectively introducing a cardiac surgical discipline A concentrated effort is made to help form a routine that produces complete peri-operative surgical management, as well as assisting refinement of procedures. Working side-byside with local staff in every area involving cardiovascular management, including the operating room, visiting teams safely assure a fast-track learning initiative toward resolution of the many cardiological and cardiac surgical problems they see.

4. Working with unfamiliar teams On most occasions, no CardioStart volunteer team is the same; few of the members know each other, and all arrive with different training backgrounds and experience levels from advanced hospital units around the globe. When teams are assembled with no previous interaction, the dynamics are presumed to be dysfunctional and generally less efficient, although we found the opposite.

5. Helping develop the specialties essential to cardiology and cardiac surgery This includes specialist cardiac anesthesia in both pediatric and adult management, perfusion, OR nursing issues, chemical pathology, blood bank technologies and various aspects of intensive care management. Volunteer teams are drawn from related specialties, including respiratory therapy, laboratory, blood bank and biomedical technology, so that all the relevant local departments are developed at the same time. Respiratory therapy is given special emphasis (which is better developed in North America than elsewhere), because studies have clearly shown its inclusion does result in improved clinical outcomes and shorter ICU stays. In hospitals struggling to survive, this may have a critical bearing on a unit flourishing or floundering.

6. Offering in-servicing and checking of equipment donations and disposables Our original volunteer team launched the first mission to Egypt using suitcase donations, and it became very clear that local teams needed more equipment support to accomplish responsible program development. Regular 40-foot-container shipments go to the countries being assisted each year.

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7. Intense educational support All volunteer experts are required to provide instruction and education in their field of expertise to develop the local heart surgery programs and related specialties.

Our experience has underscored the vital need for a multidisciplinary approach in introducing cardiology and cardiac surgery to struggling units, so that good surgical results are not blighted by shortcomings in related specialties. In many locations it has been possible to hold a complete lecture series in English and the local language (currently available in Spanish and Vietnamese). Exchange programs are now being introduced. One example is that

9. Out-of-hospital program development—outreach Outreach clinics and local orphanages have been developed in several city and rural areas over the years.

Specific projects include rural clinic consultations, emergency medicine building and teaching, water sanitation, electrical re-wiring, plumbing and creative projects for children.

10. Data analysis This is a monumental task, as the clinical algorithms of general medical management are often incomplete. We have attempted to build an international database (collaborating with a university in the United States) to develop a medical scoring system for cardiovascular, neurocognitive, and quality-of-life outcomes with better applicability in emerging economies. It is now operational.

CONCLUSION The outcomes of international mission work have been positive, fascinating. and are currently being analyzed. Three international scientific studies are under way supported by CardioStart, with the following accomplishments to date:

CardioStart provides practical, hands-on ICU training.

developed by CardioStart nurses with the Peruvian university Universidad Catholica de Santa Maria, which led to the establishment of an Arequipan Critical Care Nurses group.

The American Association of Critical Care Nurses has since offered a free three-year online access to the AACN website and journals for this nursing society and the university.

8. CardioStart Integrated Emergency Resuscitation course—CIER In recent years, emphasis has been placed on applying the principles of ACLS, ATLS, and PALS—which local doctors usually cannot afford, as they amount to more than their salaries—with a course they can afford, which is CIER. Still being developed as a three-day course, this costs $30 and is certified by a CardioStart appointed committee. It is given to both hospital- and clinic-based doctors, nurses, and paramedic staff. A multiple-choice examination at the end of the course is given in the local language.

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• Surgical procedures can be safely modified and adapted from standard approaches when only basic supplies are available.

• Aprotonin is not a mandatory requirement, and although coagulopathies do occur, they are manageable.

• Medication usage internationally requires caution; many drugs are not uniform with those used by advanced healthcare systems.

• Free equipment donations are usually sufficient to permit safe surgery and subsequent care.

• Educational material using teaching programs from advanced centers does help accelerate evolution of the program and an efficient knowledge transfer.

• Substantial cost savings have a positive impact on later advancement of specialist center development.

• The term “gold standard” as commonly used to describe a center of excellence is not a directly applicable term nor necessarily transferable to CVD work done in those nations that endure significant material shortcomings, as well as both complex and late presentations of disease.

There is an even greater need now for both surgical and medical interventions for CVDs in LMICs. Success can be achieved in translating operative care in small numbers during two-week missions towards full program evolution. Better communication among www.heartbeatsaveslives.org

organizations with similar objectives for resource allocation needs nurturing to avoid duplication of effort.

The early quality-of-life and hemodynamic outcomes for pediatric surgical patients worldwide with early and latepresenting congenital heart disease are encouraging. Similar outcomes appear to be evident in adults submitted to such care. To date, CardioStart International has accomplished 52 missions to 21 countries.

RESOURCES & FURTHER READING

1. Carapetis, J. R., Steer, A. C., Mulholland, E. K., & Weber, M. (2005). The global burden of group A streptococcal diseases. Lancet Infectious Diseases, 5(5), 685–694.

2. Yusuf, S., Reddy, S., Ounpuu, S., et al. (2001). Global burden of cardiovascular disease: Part I: General considerations, the epidemiologic transition, risk factors and impact of urbanization. Circulation, 104, 2746–2753.

3. Yusuf, S., Reddy, S., Ounpuu, S., et al. (2001). Global burden of cardiovascular disease: Part II, Variation in cardiovascular disease by specific ethnic groups and geographic regions and prevention strategies. Circulation, 104, 2855–2864 4. Reddy, K. S. (2004). Cardiovascular disease in non-Western countries.

New England Journal of Medicine, 350, 2438–2440; Greenberg, H., Raymond, S. U., Leeder, S. R. (2005). Cardiovascular disease and global health: Threat and opportunity. Heart Disease. Available at: http://content.healthaffairs.org/cgi/ reprint/hlthaff.w5.31v1.pdf.

5. World Health Organization. (2003). Neglected global epidemics: 3 growing threats. In Shaping the future: The world health report (pp. 85–95).

Geneva: World Health Organization.

11. Cox, J. L. (2001). Presidential address: Changing boundaries. The Journal of Thoracic and Cardiovascular Surgery, 122, 413–418.

12. Unger, F. (1999). Worldwide survey on cardiac interventions, Cor Europaeum, 7, 128–146.

13. Giamberti, A., Mele, M., Di Terlizzi, M., Abella, R., Carminati, M., Cirri, S., & Frigiola, A. (2004). Association of Children with Heart Disease in the World: 10 year experience. Pediatric Cardiology, 25(5), 492–494.

14. Pezzella, T. (2006, September). Letters to the editor. The Journal of Thoracic and Cardiovascular Surgery.

15. Larrazabal, L.A., Jenkins, K. J., Gauvreau, K., Vida, V. L., Benavidez, O. J., Gaitán, G. A., Garcia, F., & Castañeda, A. R. (2007). Improvement in congenital heart surgery in a developing country: The Guatemalan experience.

Circulation, 107(116), 1882–1887.

16. Joshi, R., Jan, S., Wu, Y., & MacMahon, S. (2008). Global inequalities in access to cardiovascular health care: Our greatest challenge. The Journal of American College of Cardiology, 52(23), 1817–1825.

6. World Health Organization. Preventing chronic disease: a vital investment.

Available at http://www.who.int/chp/chronic_disease_report/en/

17. Yusuf, S., Vaz, M., Pais, P. (2004). Tackling the challenge of cardiovascular disease burden in developing countries. American Heart Journal, 148, 1–4.

7. Atlas of heart disease and stroke. (2004). Geneva: World Health Organization.

18. Yacoub, M. H. (2007). Establishing pediatric cardiovascular services in the developing world. Circulation, 116, 1876–1878.

8. World Health Organization. (2006). World health report 2006: Working together for health. Geneva: World Health Organization.

19. World Health Organization. (2007). Cardiovascular diseases: Fact sheet number 317. Retrieved from http://www.who.int/mediacentre/factsheets/fs317/ en/index.html

9. World Health Organization. (2001). Secondary prevention of noncommunicable diseases in low and middle income countries through communitybased and health service interventions. World Health Organization, Wellcome Trust Meeting Report, August 1–3. Geneva: World Health Organization.

10. Velebit, V., Montessuit, M., Bednarkiewicz, M., Khatchatourian, G., Mueller, X., & Neidhart, P. (2008). The development of cardiac surgery in an emerging country: A completed project. Texas Heart Institute Journal, 35(3), 301–306.

www.heartbeatsaveslives.org

* Executive Director, CardioStart International & Data Coordinator, International Database in collaboration with University of Minnesota, MN, USA ** Data Collator, University of California, San Francisco, CA, USA *** Education Director, CardioStart International, Illinois, USA **** President, CardioStart International; Faculty, pediatric & adult cardiothoracic surgery department, Oregon Health & Sciences University, Portland, Oregon, USA.

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Delegates to the International Academy of Cardiovascular Sciencesâ&#x20AC;&#x2122; fourth world congress in February 2011.

IACS aids networking, knowledge sharing International Academy of Cardiovascular Sciences believes spreading information the key to improving heart health around the world

W

innipeg, Manitoba, Canada is often described as the heart of the continent. The city is also becoming well known as a centre for excellence in the field of heart health, and that fact is illustrated by its choice as the Global Headquarters of the International Academy of Cardiac Sciences. The IACS has seven independent sections - South America, Japan, Europe, India, China, Russia and North America.

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The IACS was founded in 1996. It is led by its International Executive with President-Elect James Willerson, the cardiologist of exceptional standing from Dallas, Texas; IACS Founder and C E O, Dr. Naranjan S. Dhalla, world- renowned cardiovascular scientist from Winnipeg; and current President Sir Magdi Yacoub, regarded widely as the worldâ&#x20AC;&#x2122;s pre-eminent cardiac surgeon from Harefield UK. Two-hundred and thirtythree Fellows and 22 Fellow-Emeritus from over 40 countries who are exceptional leaders in cardiovascular health have been recognized. The Academy honours extraordinary achievement with its pre-eminent Medal of Merit which has been given to such incredible people including Nobel Prize winners Louis Ignarro, Sir John Vane, Edwin Krebs and Robert Furchgott; as well as Michael BeBakey; Eugene Braunwald; Sir George Radda; Richard Bing; Robert Lefkowitz; James Willerson; Sir www.heartbeatsaveslives.org

quality

protection

With a mission to save lives, quality is our obsession

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Magdi Yacoub; Victor Dzau; Robert Jennings; Sen. Wilbert Keon; Jutta Schaper; Sir Salvador Moncado; Howard Morgan; Wolfgang Schaperand; Nirmal Ganguly; Arnold Katz; Eric Olson; Laszlo Szerkes; and Erneston Carafoli. Numerous other awards have been presented for special contribution to heart health around the world.

Established by renowned cardiovascular scientists, surgeons and cardiologists, the academy provides the organizational structure for the worldwide sharing of research and education information in the field of heart health. Although great strides have been made in improving the death rate from heart disease, heart attacks and related problems are still the No. 1

The International Academy of Cardiovascular Sciences has 11 office locations worldwide.

killer. The Academy believes that research has found answers but the facts are too slow in moving beyond the laboratories to the bedside. The Academy, through world-wide representation, builds connectivity and encourages networking through traditional means of journals, texts and symposia, a quarterly official bulletin CV Network, as well as through an interactive website: www.heartacademy.org to provide more interactive and timely sharing of developments. As well, IACS has begun and will extend use of social networks to encourage sharing and exchanges within the IACS links of professionals, students and the public. IACS has achieved significant success in sharing online talks and discussions from international events which promises for further extending the impact of the Global Network participants. Investigation is underway to have IACS 110

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conferences entirely networked online in the manner of the highly successful, web-based series of conferences by the International Society of Holter and Non-invasive Electrocardiology (ISHNE). There also seems to be potential to facilitate distance learning courses led

by Academy Fellow David Brasil from Belo Horizonte, Brazil.

It aims to organize cardiovascular forums all over the world for the continued education nad networking of practicing physicians, surgeons and experimental cardiologists. The 4th IACS World Congress was held in 3 centres in India in February, 2011 The Congress was attended by over 100 eminent speakers, from 22 countries across the world. Overwhelming response was received from more than 2,000 participants.

A new initiative is the IACS Global Network To Fight Cardiovascular Diseases which is being formed to educate and train medical personnel around the world in research, treatment and prevention of cardiovascular disease.

The goal of the network is to stem the rising rate of CVD by transferring knowledge primarily in emerging nations.

The Academy is registered to give tax-deductible receipts in Canada (International Academy of Cardiovascular Sciences Inc.) as well as in the United States (Academy of Cardiovascular Sciences Foundation USA Inc.) Ivan Berkowitz, IACS Heart Health Scholar says “We seem to be facing a global pandemic of cardiovascular disease which shows all the signs of getting worse”. He says “some experts claim this is due to the urbanization of many populations, a move that often goes along with a change for the worse in diet and less emphasis on physical exercise. Fighting the disease depends on earlier detection, education and a cooperative, interactive approach to sharing knowledge and medical skills. People do need to take better care of themselves and we all have room for improvement,” Berkowitz has his own formula for staying well. His family has summered at a cottage on Trout Lake near Kenora, Ontario since the 1940s and he’s developed his own program of diet and exercise. “I call it the Trout Lake Diet rather than the Miami location diet,” he laughs. For further background, please visit http://factsaccordingtoivan.blogspot.com. www.heartbeatsaveslives.org

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Initiative addresses cardiovascular care for women and people of color

GAP

By Annette Ruzicka Boston Scientific Corporation/ Close the Gap

H

eart disease causes more deaths in Americans of both genders and all racial and ethnic groups than any other disease. Yet despite similar prevalence across racial/ethnic groups, women and people of color are treated at a lesser rate for cardiovascular disease than Caucasian men.

A study by the Kaiser Family Foundation called Racial/Ethnic Differences in Cardiac Care: The Weight of the Evidence triggered the inception of a unique initiative aimed at addressing the gap in cardiovascular care for women and people of color. In June 2006, a team of physicians and health care professionals from across the country came together to look at ways to address disparities in cardiovascular care for the underserved patient populations of women, black Americans, and Hispanic/Latino Americans. From these discussions, Close the Gap, an educational initiative sponsored by Boston Scientific, was launched. The Close the Gap initiative is led by a Steering Committee of physicians and healthcare professionals identifying opportunities and defining strategies to improve cardiovascular health outcomes for underserved patients.

The committee is actively involved in initiative efforts across the country.

Close the Gap focuses on three areas: community education, patient values and quality measures.

COMMUNITY EDUCATION The goal of our community education focus is to increase awareness of cardiovascular risk factors through a variety of community programs.

By increasing awareness of risk factors, we hope to identify and help more high-risk patients. Our efforts to achieve this goal include partnering with community institutions including faith-based organizations, collegiate and professional athletic organizations, and patient advocacy groups. Close the Gap sponsors a variety of community outreach 112

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events throughout the year, encouraging attendees to learn about the risk factors for developing heart disease and the actions needed to mitigate those risks. A calendar of upcoming Close the Gap events can be found at www.your-heart-health.com.

Close the Gap has attracted the support of several collegiate and professional coaches, former and current professional athletes and other professionals from the athletic world. Many of these Close the Gap champions have participated in a public service campaign designed to educate, equip and empower their fans to “take charge of your heart health.” Visit www.youtube.com/yourhearthealth to view video PSAs from Tony Dungy (NBC Sunday Night Football), Marvin Lewis (Head Coach, Cincinnati Bengals), Kellen Winslow (Pro Football Hall of Fame Member), Tubby Smith (Head Men’s Basketball Coach, University of Minnesota), Reggie Wayne (Pro Bowl Wide Receiver, Indianapolis Colts), Clark Kellogg (CBS Sports), Tara VanDerveer (Head Women’s www.heartbeatsaveslives.org

Basketball Coach, Stanford University) and many others.

Entertainers such as R&B singer Cupid and actor/comedian Flex Alexander have also supported Close the Gap through public service announcements.

PATIENT VALUES Partnering with health care institutions and medical professional organizations offers the opportunity to help health care providers at all levels learn about the cultural beliefs that can act as barriers to acceptance among underserved populations. When a barrier to acceptance is recognized and appropriately addressed, more patients will then understand and receive life extending and improving cardiovascular therapies. Close the Gap partners with physician associations such as the American College of Cardiology, the Association of Black Cardiologists and the Hispanicâ&#x20AC;Ś Educational events for local health care professionals, led

by Close the Gap Steering Committee physicians and healthcare professionals, take place at several locations across the country.

QUALITY MEASURES Close the Gap is working to help raise awareness of heart failure quality measures and is advocating the inclusion of ICD (implantable cardioverter defibrillator) therapy as recommended treatment for patients at risk of sudden cardiac arrest. Spotlighting the existing and growing cache of evidence based medicine can help medical guidelines be reviewed and enhanced to further www.heartbeatsaveslives.org

ensure that proven, effective cardiac therapies are offered to all patients who would benefit from them.

Since its inception in 2006 and public launch in early 2008, Close the Gap has reached hundreds of thousands of people with important heart health information. With events scheduled throughout the remainder of 2011 and into 2012, thousands more will be educated about how gender, ethnicity and race can affect their chance of developing heart disease. To learn more about Close the Gap, or to take our online heart health risk assessment, visit www.your-heart-health.com. We invite you to follow us at www.twitter.com/YourHeartHealth or friend us at www.facebook.com/ClosetheGap. ONE HEART MAGAZINE

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With a technology platform of over 35,000 implants, MediVed brings affordable cardiac rhythm management to developing nations.

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Who knew that space exploration would lead us closer to the human heart?

Š 2011 Medtronic, Inc. All Rights Reserved.

We did.

Weâ&#x20AC;&#x2122;re always exploring new ways to apply innovative technologies. By applying NASA technology we were able to leverage an innovative polymer originally designed to survive challenges in space. Its stability in extreme environments, corrosion-protective qualities and ability to work in very small places allowed us to reach the complex left side of the heart, which led to one giant leap in product design.

Weâ&#x20AC;&#x2122;re always reaching further, going farther. The story continues at medtronic.com/innovation.

Innovating for life.

Innovating for life.

At Medtronic, we’re changing what it means to live with chronic disease. We’re creating innovative therapies that help patients do things they never thought possible. Seeing our work improve lives is a powerful motivator. The more we do, the more we’re driven to push the boundaries of medical technology.

To learn more about Medtronic, visit medtronic.com.

© 2011 Medtronic, Inc. All Rights Reserved.