One Heart Magazine, 2012

ONE HEART MAGAZINE Global Cardiovascular Alliance

A UNITED FRONT

TEAMING UP TO FIGHT CVD AROUND THE WORLD One Hear t Global Cardiovascular Alliance

charitable support for

quality care A mission to save more than a thousand lives Ever since BIOTRONIK developed the very first Germanengineered pacemaker almost 50 years ago, our focus has been to provide safe, innovative solutions for unmet clinical needs. We work closely together with patients and practitioners to identify and solve these needs, further innovation by collaborating with universities, and fund selected health and education programs on an ongoing basis.

As many as three million people each year suffer needlessly because they cannot afford a life-saving pacemaker or implantable cardioverter-defibrillator (ICD). In our commitment to tackle this inequality in cardiovascular care, BIOTRONIK has formed a strong, strategic alliance with Heartbeat International Foundation (HBI).

„

Quality prevails throughout BIOTRONIK‘s company culture. It also means living up to our own high standards and remembering the people we help. We therefore believe that it is our corporate responsibility to provide access to high quality care for everyone in need of it – especially those who are most vulnerable because they cannot afford it.

„

– Christoph Böhmer, Managing Director, BIOTRONIK

Saving and improving lives by providing access to care BIOTRONIK actively supports HBI by donating devices free of charge and helps to set up new heart centers and education programs around the globe. To date, the HBI network of volunteer doctors and hospitals are saving lives in 14 countries.

Heart centers using BIOTRONIK donated devices.

www.biotronik.com

ONE MORE

A leader in providing the tools physicians need to treat peripheral vascular disease

Bard Peripheral Vascular, Inc.

1 800 321 4254 www.bardpv.com 1625 W. 3rd Street Tempe, AZ 85281 Bard is a trademarks and/or registered trademarks of C. R. Bard, Inc. Copyright Š 2012, C. R. Bard, Inc. All Rights Reserved.

G70464 REV 0

#1 Selling Peripheral CTO Device* ONE MORE walk on the beach

#1 Selling Peripheral PTA Portfolio* ONE MORE walk for a cure

#1 Selling SFA Stent*

ONE MORE walk with your daughter Bard Peripheral Vascular, Inc. 1 800 321 4254 • www.bardpv.com • 1625 W. 3rd Street Tempe, AZ 85281 *Dollar market share based on Q4 2011 IMS Data, US Only Please consult labels and IFU for indications, contraindications, hazards, warnings, cautions, and information for use.

Warning: Do not exceed RBP as balloon rupture may occur. To prevent over pressurization, use of a pressure monitoring device is recommended.

Bard, Crosser, LifeStent, Solo and VascuTrak are trademarks and/or registared trademarks of C. R. Bard, Inc. or an affiliate. Copyright © 2012, C. R. Bard, Inc. All Rights Reserved.

G70512 Rev 0

Scan with a Smart Phone and your local Bard Rep will contact you

FACT

For 30% of those who have a myocardial infarction, their first symptom is death.

Get the facts. it just may save your life.

Recent studies also show that 50% of those who have a heart attack or stroke have “normal” cholesterol levels. This suggests that many individuals at risk are presumed low-risk because they have normal cholesterol levels. Thus, routine cholesterol tests are failing to identify people at risk for heart attack and stroke. With a focus on prevention and wellness, Cleveland HeartLab, Inc. designed the CVD Inflammation Profile™ to more accurately estimate cardiovascular risk for patients who may warrant more aggressive and comprehensive therapy. In particular, this profile is focused on managing and reducing inflammation. We also offer an array of standard and advanced tests that physicians can choose from.

Please read our feature on the “Clinical Utility of Inflammation Testing” in this issue of One Heart Magazine.

Contact Cleveland HeartLab today at 866.358.9828 or www.clevelandheartlab.com.

Cleveland HeartLab, Inc. | 866.358.9828 www.clevelandheartlab.com

TABLE OF CONTENTS

16

A United Front Against CVD

HBI’s Global Cardiovascular Alliance brings together governments, industry, charities

29

46

Fighting Heart Disease in China

Beyond Its Borders American Heart Association doesn’t confine efforts to just the U.S.

24 Cardiovascular Credentialing International

www.heartbeatsaveslives.org

ONE HEART MAGAZINE

7

ONE HEART MAGAZINE Global Cardiovascular Alliance

ONE HEART MAGAZINE Global Cardiovascular Alliance

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

A UNITED FRONT

Publishers Adam Longaker Edward Suyak

TEAMING UP TO FIGHT CVD AROUND THE WORLD

Advertisers

Name Pages

One Hear t Global Cardiovascular Alliance

Accumetrics 18 Atricure 49 Bard Peripheral Vascular 4-5 Berlin Heart

20

Biotronik 2-3, 40-41, 84 Boston Scientific

54

CardioComm Solutions 30 CardioTek 36 Cardiovascular Credentialing International 28 Cleveland Heart Lab Defy Medical

6 67

ECA Medical Instruments 37 Ecoventura 79 Eli Lilly

12-15

Foundation for Medical Education and Research

31

Old Bahama Bay

68

Pace Medical

78

Point Grace

34

Regent Palms

56-57

Shape 53 The Meridian Club

60

TYRX 10 Vasomedical

47, 73

Water Beach Club Hotel

25

Zoll 64

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 Stephanie Ricker Gordon F. Tomaselli, M.D. Marc S. Penn, M.D. Michelle Beidelschies, Ph.D. Dayi Hu Janet Wright, M.D. Nadeem Afridi, M.D., FACC Sidney Smith et al

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 Berlin Heart American Heart Association Cleveland Heart Lab Water Beach Club Hotel China Medical Association Million Hearts Initiative American College of Cardiology Biotronik Association of Pakistani-Descent Cardiologists of North America World Heart Federation World Health Organization ŠCopyright 2012 Heartbeat International Foundation. All rights reserved. Reproduction of editorial content in whole or in part without written permission is prohibited.

Heartbeat International Foundation 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.

TABLE OF CONTENTS

58

A Million Hearts

Galvanizing clinicians and communities to prevent U.S. heart attacks and strokes

38

Advances in Inflammatory Biomarker Testing to define cardiovascular risk

Making a global difference

80 Keeping pace

61

74

Fighting NCDs in Pakistan

with the world Biotronik travel guide gives patients ease of mind

65

A call to action

www.heartbeatsaveslives.org

21

Just the right size

ONE HEART MAGAZINE

9

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

More Protection Less Risk with AIGISRx速

Antibacterial Envelope

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

ABOUT DR. BENEDICT S. MANISCALCO

Welcome

T

he inaugural edition of ONE HEART was met with enthusiastic reviews and we are pleased and humbled by its acceptance from our readers. Thank you all for the comments and support for our efforts.

This second edition reports on initiatives of organizations which were featured in our first edition and content from others who have worked in the cardiovascular arena around the globe addressing the growing problems associated with cardiovascular disease.

Dr. Benedict S. Maniscalco, chairman and CEO of Heartbeat International, has been a private

ONE HEART MAGAZINE Global Cardiovascular Alliance

practitioner specializing in cardiovascular diseases since 1976. In addition to his work in preventive and consultative cardiology, he serves as medical advisor to multiple

In the inaugural issue Dr Mendes of the World Health Organization discussed the magnitude of the world wide problem of cardiovascular disease as well as the enormous burden of other chronic nonTEAMING UP TO FIGHT communicable diseases. The NonCVD AROUND THE WORLD Communicable Disease Alliance One Hear t Global (NCDA) was presented in great Cardiovascular Alliance detail and Heartbeat International Foundation announced the start of the One Heart Global Cardiovascular Alliance and called upon interested parties to join us in pursuit of opportunities and initiatives in the developing world. Many have done so and others are now in conversation with us and coming on board.

A UNITED FRONT

We are grateful to those companies, organizations, and individuals who have supported this project and the publication of ONE HEART. We particularly are grateful to all who have provided content and discussions of the missions of their organizations. We hope you will enjoy this second edition and learn about the dedication and initiatives in the fight against cardiovascular diseases around the globe. We encourage your comments and participation and would welcome learning about your organization and its missions around the world.

Sincerely,

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 that have directly influenced healthcare 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

Benedict S. Maniscalco, M.D. Chairman, C.E.O. Heartbeat International Foundation, Inc.

Heart Association, the American College of Cardiology, the American College of Physicians, the American College of Chest Physicians, and the Society for Cardiac Angioplasty.

www.heartbeatsaveslives.org

ONE HEART MAGAZINE

11

YOURACS-PCI ACS-PCIPATIENT PATIENT ISISYOUR ATHIGH HIGHRISK RISKFOR FORFUTURE FUTURE AT THROMBOTICCV CVEVENTS? EVENTS? THROMBOTIC

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

Effient is available in 5-mg and 10-mg tablets.

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

Effient (prasugrel) can cause significant, sometimes fatal,fatal, bleeding.

Douse notEffient use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.

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

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

[MI])[MI]) where its effect appears to beto greater and its use considered.

Dostart not start Effient in patients to undergo urgent coronary artery bypass surgery (CABG).

When possible, discontinue Do not Effient in patients likelylikely to undergo urgent coronary artery bypass graftgraft surgery (CABG).

When possible, discontinue Effient at least 7 days any surgery.

Effient at least 7 days priorprior to anytosurgery.

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

If possible, manage bleeding without discontinuing Effient.

Discontinuing Effient, particularly thefew firstweeks few weeks If possible, manage bleeding without discontinuing Effient.

Discontinuing Effient, particularly in theinfirst afterafter acuteacute coronary syndrome, increases theofrisk of subsequent cardiovascular events. coronary syndrome, increases the risk subsequent cardiovascular events.

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

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

Effient should also be Patients who experience a stroke or TIA on Effient generally should havehave therapy discontinued.

Effient should also be discontinued for active bleeding and elective surgery discontinued for active bleeding and elective surgery Premature discontinuation of Effient increases risk of stent thrombosis, MI,death and death Premature discontinuation of Effient increases risk of stent thrombosis, MI, and Thrombotic thrombocytopenic purpura rareserious but serious condition thatbe can be fatal, has been reported with Effient, Thrombotic thrombocytopenic purpura (TTP),(TTP), a rarea but condition that can fatal, has been reported with Effient, sometimes a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis sometimes afterafter a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients a history Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with awith history of hypersensitivity reaction to other thienopyridines of hypersensitivity reaction to other thienopyridines

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

Please see Brief Summary of Prescribing Information, including Boxed Warning regarding Please see Brief Summary of Prescribing Information, including Boxed Warning regarding bleeding on subsequent pages. bleeding risk,risk, on subsequent pages.

MORE INFORMATION, CALL YOUR EFFIENT REPRESENTATIVE FORFOR MORE INFORMATION, CALL YOUR EFFIENT REPRESENTATIVE HCP.COM TODAY! VISIT EFFIENT HCP.COM TODAY! OR OR VISIT EFFIENT

*1

*1

include refill prescriptions. *Data*Data include refill prescriptions.

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

Effient®Effient and theand Effient logo are registered trademarks of Eli Lilly andLilly Company.

Copyright ©Daiichi 2012 Daiichi LillyLLC. USA,AllLLC. All Reserved.

Rights Reserved.

Copyright © 2012 Sankyo,Sankyo, Inc. andInc. Lillyand USA, Rights PG75240.

PGHCPISI03Oct2011.

USA. January PG75240.

PGHCPISI03Oct2011.

PrintedPrinted in USA.inJanuary 2012. 2012.

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)].

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)].

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)].

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)].

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 OPOo45 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 XBT driven predominantly by MI, with no difference on strokes and little difference on CV death [see Clinical Studies (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 not 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)]. Because the large majority of patients are managed without CABG, however, treatment can be considered before determining coronary anatomy if need for CABG is DPOTJEFSFE VOMJLFMZ 5IF BEWBOUBHFT PG FBSMJFS USFBUNFOU XJUI &GýFOU must then be balanced against the increased rate of bleeding in patients who do need to undergo urgent CABG. 2 DOSAGE AND ADMINISTRATION *OJUJBUF &GýFOU USFBUNFOU BT B TJOHMF NH PSBM MPBEJOH EPTF BOE 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)]. Effient may be administered with or without food [see Clinical Pharmacology (12.3) and Clinical Studies (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 TBGFUZ PG UIF NH EPTF 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)].

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 to Assess Improvement in 5IFSBQFVUJD 0VUDPNFT CZ 0ptimizing Platelet InhibitioN with Prasugrel),

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 IJTUPSZ PG IFNPSSIBHJD TUSPLF BU BOZ UJNF XFSF FYDMVEFE GSPN 53*50/ 5*.* 1BUJFOUT XIP FYQFSJFODF B TUSPLF PS 5*" XIJMF PO &GýFOU generally should have therapy discontinued [see Adverse Reactions (6.1) and Clinical Studies (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)].

5 WARNINGS AND PRECAUTIONS 5.1 General Risk of Bleeding: 5IJFOPQZSJEJOFT JODMVEJOH &GĂ˝FOU JODSFBTF UIF SJTL PG CMFFEJOH 8JUI UIF EPTJOH SFHJNFOT VTFE JO 53*50/ 5*.* 5*.* 5ISPNCPMZTJT JO .ZPDBSEJBM *OGBSDUJPO .BKPS DMJOJDBMMZ overt bleeding associated with a fall in hemoglobin â&#x2030;Ľ5 g/dL, or JOUSBDSBOJBM IFNPSSIBHF BOE 5*.* .JOPS PWFSU CMFFEJOH BTTPDJBUFE XJUI 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 FWFOUT UISPVHI 450 days; inset shows events through 7 days).

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

Non-CABG-Related TIMI Major or Minor Bleeding Events (%)

EffientÂŽ (prasugrel) tablets Brief Summary of Prescribing Information

Effient

5 4

Clopidogrel 3

3 2

2

1

1

0 0

0

Number at risk: Effient 6741 Clopidogrel 6716

90

6042 6023

0

1

2

3

4

5

6

7

180

270

360

450

5707 5764

4813 4883

4078 4138

2747 2792

Days from Randomization

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)].

5.4 Thrombotic Thrombocytopenic Purpura: 5ISPNCPUJD UISPNCPDZUPQFOJD QVSQVSB 551 IBT CFFO SFQPSUFE XJUI UIF VTF PG &GýFOU 551 DBO PDDVS BGUFS B CSJFG FYQPTVSF XFFLT 551 JT B serious condition that can be fatal and requires urgent treatment, JODMVEJOH QMBTNBQIFSFTJT QMBTNB FYDIBOHF 551 JT DIBSBDUFSJ[FE 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)].

5.5 Hypersensitivity Including Angioedema: Hypersensitivity including angioedema has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines [see Contraindications (4.3), Adverse Reactions (6.2)].

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience: 5IF GPMMPXJOH TFSJPVT BEWFSTF SFBDUJPOT 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 XFSF USFBUFE XJUI &GýFOU NH MPBEJOH EPTF BOE NH PODF EBJMZ

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% female, BOE $BVDBTJBO "MM QBUJFOUT JO UIF 53*50/ 5*.* TUVEZ XFSF UP SFDFJWF BTQJSJO 5IF EPTF PG DMPQJEPHSFM JO UIJT TUVEZ XBT B NH 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 drug BOE NBZ OPU SFĂžFDU UIF SBUFT PCTFSWFE JO QSBDUJDF Drug Discontinuation 5IF SBUF PG TUVEZ ESVH EJTDPOUJOVBUJPO because 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 *O 53*50/ 5*.* PWFSBMM SBUFT PG 5*.* .BKPS PS .JOPS CMFFEJOH BEWFSTF SFBDUJPOT VOSFMBUFE to coronary artery bypass graft surgery (CABG) were significantly higher PO &GýFOU UIBO PO DMPQJEPHSFM BT TIPXO JO 5BCMF Table 1: Non-CABG-Related Bleedinga (TRITON-TIMI 38)

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)].

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, except JO IJHI SJTL TJUVBUJPOT QBUJFOUT XJUI EJBCFUFT PS IJTUPSZ PG NZPDBSEJBM 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)]. t $"#( PS PUIFS TVSHJDBM QSPDFEVSF [see Warnings and Precautions (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)]. 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)]. 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)].

5IJFOPQZSJEJOFT JOIJCJU QMBUFMFU BHHSFHBUJPO GPS UIF MJGFUJNF PG UIF QMBUFMFU EBZT TP XJUIIPMEJOH B EPTF XJMM OPU CF VTFGVM JO NBOBHJOH B Effient (%) Clopidogrel (%) p-value bleeding event or the risk of bleeding associated with an invasive (N=6741) (N=6716) QSPDFEVSF #FDBVTF UIF IBMG MJGF PG QSBTVHSFM T BDUJWF NFUBCPMJUF JT TIPSU 3.4 p=0.002 relative to the lifetime of the platelet, it may be possible to restore 5*.* .BKPS PS .JOPS CMFFEJOH 4.5 2.2 1.7 p=0.029 hemostasis by administering exogenous platelets; however, platelet 5*.* .BKPS CMFFEJOHb transfusions within 6 hours of the loading dose or 4 hours of the -JGF UISFBUFOJOH 1.3

p=0.015 maintenance dose may be less effective.

Fatal 0.3 0.1 Symptomatic intracranial 0.3 5.2 Coronary Artery Bypass Graft Surgery-Related Bleeding: 5IF 0.3 hemorrhage (ICH) risk of bleeding is increased in patients receiving Effient who Requiring inotropes 0.3 0.1 undergo CABG. If possible, Effient should be discontinued at least 7 Requiring surgical days prior to CABG. 0.3 0.3 intervention 0G UIF QBUJFOUT XIP VOEFSXFOU $"#( EVSJOH 53*50/ 5*.* UIF Requiring transfusion 0.7 0.5 SBUFT PG $"#( SFMBUFE 5*.* .BKPS PS .JOPS CMFFEJOH XFSF JO UIF (â&#x2030;Ľ4 units) Effient group and 4.5% in the clopidogrel group [see Adverse Reactions 5*.* .JOPS CMFFEJOHb 2.4 1.9 p=0.022 (6.1)] 5IF IJHIFS SJTL GPS CMFFEJOH FWFOUT JO QBUJFOUT USFBUFE XJUI &GĂ˝FOU a persisted up to 7 days from the most recent dose of study drug. For b Patients may be counted in more than one row. patients receiving a thienopyridine within 3 days prior to CABG, the See 5.1 for definition.

GSFRVFODJFT PG 5*.* .BKPS PS .JOPS CMFFEJOH XFSF PG 'JHVSF EFNPOTUSBUFT OPO $"#( SFMBUFE 5*.* .BKPS PS .JOPS CMFFEJOH

5IF CMFFEJOH SBUF JT IJHIFTU JOJUJBMMZ BT TIPXO JO 'JHVSF JOTFU %BZT to 7) [see Warnings and Precautions (5.1)].

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;Ľ60 kg (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 *O 53*50/ 5*.* QBUJFOUT XIP SFDFJWFE B UIJFOPQZSJEJOF VOEFSXFOU $"#( EVSJOH UIF DPVSTF PG UIF TUVEZ 5IF SBUF PG $"#( SFMBUFE 5*.* .BKPS PS .JOPS CMFFEJOH XBT GPS UIF &GýFOU HSPVQ BOE JO UIF DMPQJEPHSFM HSPVQ 5BCMF 5IF IJHIFS SJTL GPS bleeding adverse reactions in patients treated with 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 )FNPSSIBHJD FWFOUT SFQPSUFE BT BEWFSTF SFBDUJPOT JO 53*50/ 5*.* XFSF GPS &GýFOU 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 were reported in 1.6% and 1.2% of patients treated with prasugrel and DMPQJEPHSFM SFTQFDUJWFMZ 5IF TJUFT DPOUSJCVUJOH UP UIF EJGGFSFODFT XFSF QSJNBSJMZ DPMPO BOE MVOH *U JT VODMFBS JG UIFTF PCTFSWBUJPOT BSF DBVTBMMZ related or are random occurrences.

0UIFS "EWFSTF &WFOUT *O 53*50/ 5*.* DPNNPO BOE PUIFS JNQPSUBOU 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 9

3.5 Leukopenia (<4 x 10 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

Reference: 1. Data on file: #EFF20110809a: DSI/Lilly.

6.2 Postmarketing Experience: 5IF GPMMPXJOH BEWFSTF SFBDUJPOT 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)].

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)].

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)].

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)].

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy: Pregnancy Category B 5IFSF BSF OP BEFRVBUF BOE XFMM DPOUSPMMFE TUVEJFT PG &GýFOU VTF JO QSFHOBOU XPNFO 3FQSPEVDUJWF 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)].

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)].

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 intracranial IFNPSSIBHF PDDVSSFE JO QBUJFOUT XIP SFDFJWFE &GĂ˝FOU BOE JO 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)], use of Effient is generally not SFDPNNFOEFE JO UIFTF QBUJFOUT FYDFQU JO IJHI SJTL TJUVBUJPOT EJBCFUFT 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)].

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)]. $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 patients XJUI SFOBM JNQBJSNFOU 5IFSF JT MJNJUFE FYQFSJFODF JO QBUJFOUT XJUI FOE stage renal disease [see Clinical Pharmacology (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 JO

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)].

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, or $:1 " PO UIF QIBSNBDPLJOFUJDT PG QSBTVHSFM T BDUJWF NFUBCPMJUF PS JUT 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 /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 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 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 JU 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 PS 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 IBT 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. t *OGPSN QBUJFOUT UIBU UIFZ NBZ IBWF IZQFSTFOTJUJWJUZ SFBDUJPOT including rash, angioedema, anaphylaxis, or other manifestations.

Patients who have had hypersensitivity reactions to other thienopyridines may have hypersensitivity reactions to Effient.

17.4 Invasive Procedures: Instruct patients to: t JOGPSN QIZTJDJBOT BOE EFOUJTUT UIBU UIFZ BSF UBLJOH &GýFOU CFGPSF BOZ 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 UIFZ 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: September 27, 2011 EffientÂŽ is a registered trademark of Eli Lilly and Company.

Manufactured by Eli Lilly and Company, Indianapolis, IN 46285 Marketed by Daiichi Sankyo, Inc. and Lilly USA, LLC Copyright Š 2009, 2011 Daiichi Sankyo, Inc. and Eli Lilly and Company. All rights reserved.

1( 1()$1#4 0DU 17 ".1 13*/5&% */ 64"

AUnited FRONT H

eartbeat International has spent the last year deliberating, collaborating and developing, with its partners as described below, the One Heart Global Cardiovascular Alliance; a project aimed at bringing governments, Industry, Heartbeat International’s Heart Centers, and other charitable organizations together to deliver cardiovascular health services and needed equipment to larger populations in need throughout the developing world. We have reached out to the many organizations and societies working in the cardiovascular field securing their commitment to assist Heartbeat International in its vision and mission of saving lives globally.

As of publication of this One Heart magazine, Heartbeat International has secured the commitment of nine partners, with more than 15 others in the review process. Our committed partners have agreed to work with us in achieving the primary goals of the One Heart Global Cardiovascular Alliance: 1. Identify specific cardiovascular health needs of indigent populations in countries served by the GCA Partner or an HBI Heart Center or in other developing countries in which they may work together to establish new Heart Centers.

2. Design programs to address the needs identified above. Such program will be operated over a period of time sufficient to make a measurable and meaningful impact on the cardiovascular health of the targeted recipients and provide a meaningful opportunity for in-country medical personnel to acquire the knowledge, skills and experience that will allow them to continue to address the targeted medical need after a program has been completed.

3. Raise the financial resources needed to carry out selected programs.

4. Raise funds to acquire the equipment or devices, medical or otherwise, to carry out selected programs.

5. Identify and secure the participation or approval of any governmental organizations, charitable organizations, 16

business organizations or individuals that may be required to most effectively carry out intended programs.

6. Funds, devices, equipment or other assets associated with a program shalt by managed by the parties by mutual agreement in a manner that most effectively supports the relevant program.

Inaugural Partners of the One Heart Global Cardiovascular Alliance: The American Heart Association states that the ultimate goal of its international activities is “to reduce the global burden of cardiovascular disease and stroke.” This mission “requires a multifaceted approach, including efforts aimed at young and old, healthy and at-risk, researchers, clinicians, academicians, healthcare administrators, and government agencies.” The American Heart Association knows that they alone can not achieve this lofty goal and have committed

ONE HEART MAGAZINE www.heartbeatsaveslives.org

AGAINST CVD

“The One Heart program and Global Cardiovascular Alliance are vibrant, compassionate and compelling programs to help the world’s poor and underserved achieve improved quality of life.

ECA Medical Instruments, a 33 year partner in the cardiovascular industry is pleased to support and be a member of this vital industry group.”

—James B. Schultz

EXECUTIVE VICE PRESIDENT ECA

www.heartbeatsaveslives.org

to “forging partnerships with like-minded organizations, healthcare entities and corporations around the world.”

(AHA Global Strategies Brochure) Heartbeat International is proud to call the American Heart Association one of our inaugural partners in the One Heart Global Cardiovascular Alliance.

Cardiovascular Credentialing International is a non profit corporation established for the purpose of administering credentialing examinations as an independent credentialing agency. CCI offers eight credentials which, when earned, demonstrate that the registrant holds fundamental knowledge in the particular cardiovascular specialty. With our partnership in CCI, the One Heart Global Cardiovascular Alliance will work to transfer the skills and experience to in-country medical personnel needed to address the cardiovascular challenges and aid in health systems strengthening initiatives in each location. CCI and the Alliance will work together to build capacity in cardiovascular care globally.

The Caribbean Cardiac Society is a non profit organization comprised of medical professionals, including physicians, surgeons, nurses and technologists, who are involved in the treatment of supporting services to cardiac patients in the Caribbean region. Their mission is to improve the health of the Caribbean people through the advancement of cardiovascular knowledge and practice. Past CCS President, Dr. Raymond Massey, expressed the support of the Alliance by stating: “Heartbeat International’s work has always been consistent with the mission of the CCS. We are certain that the launch and success of the One Heart Global Cardiovascular Alliance will greatly enhance this contribution.”

CardioStart International is a 501c3 charity using a global network of volunteer effort, and the collective skills of experts in healthcare to provide free heart surgery and associated medical care to children and adults living in underserved regions of the world. CardioStart and its worldwide volunteers conduct two-week missions in such countries as Peru, Haiti, Uganda and Vietnam. To date, CardioStart has completed 55 comprehensive missions in 27 countries. Through the One Heart Global Cardiovascular Alliance, CardioStart and Heartbeat International will expand services and training to both CardioStart and Heartbeat International global locations.

Christian Medical Ministry to Cambodia/Jeremiah’s Hope is a nondenominational, international, Christian mission dedicated to providing excellent medical care to the poor and quality medical education to the healthcare community ONE HEART MAGAZINE

17

AnTiplATeleT TheRApy BRand or GeneRic? Platelet Reactivity Testing Critical Information for Critical Patient Care Decisions

The RighT FiT for every paTienT

Studies show that up to 1 in 3 patients may not respond adequately to their anti-platelet medications. With more medication options available, itâ&#x20AC;&#x2122;s critical to assess your patient care strategy with the verifynow system.

System

To find out more, visit www.accumetrics.com/oneheart 1(858) 643-1600 Source: one Heart The accumetrics logo and verifynow are registered trademarks of accumetrics, inc., Š2012 accumetrics, inc. pn:148434.a

09/2012

The Joint Board for Heartbeat International Foundation and Heartbeat International Worldwide. From left to right, Joseph Messer, MD, Albert Salem, JD, Mo Kasti (Strategic Planning Facilitator, CTI), Peter Nagle (Carlton & Co.), Anthony Reece, JD, Jennifer Goodwin Schunemann, Federico Alfaro, MD, Basha Mohammed, Wit Ostrenko, Sandra Kreul, ARNP, Thomas Piemonte, MD, Andres Baffigo, Benedict Maniscalco, MD, Art Noriega

of Cambodia. The One Heart Global Cardiovascular Alliance will work to expand the services and training Jeremiah’s Hope can take to Cambodia.

ECA Medical Instruments manufactures a broad range of high-quality, robust precision torque wrenches and elegant custom instrument solutions which have become the gold standard in Cardiac and Neuro surgery. The commitment of ECA to the Alliance furthers trainings and transfer of knowledge to those in the developing world enabling better care of their citizens; a primary goal of the One Heart Global Cardiovascular Alliance.

The Goodwin Group International works to overcome geographic, linguistic, and technological barriers to connect physicians and care providers around the world with the very best in clinical practice. At its core, The Goodwin Group works to publish MD Conference Express; a highlights publication designed to bring the most clinically-relevant findings from major medical conferences to physicians around the world. This proprietary report is published in more than 20 countries and in more than six different languages. Working with The Goodwin Group allows the Alliance a global audience in the promotion and marketing of its services. Further, it serves to attract additional volunteer organizations and volunteers.

The International Academy of Cardiovascular Sciences has been developing collaborations around the world to make more effective our vision as expressed by our Founding President Dr. Howard Morgan. “The challenge for the Academy and its members is to adopt a mind-set, which continuously raises the question of how new and www.heartbeatsaveslives.org

existing knowledge, can be translated into prevention, improved diagnosis and therapy of cardiovascular disease.

This approach offers the hope of a continued reduction in morbidity and mortality due to cardiovascular diseases.”

The Marafie Foundation in Pakistan has focused its attention on health and education working towards sustainable progress in the community and the availability of treatment to those is need. Along with the Heartbeat International Heart Center of Pakistan, the Alliance will work with the Marafie Foundation in the cardiovascular education, training, screening and treatment in the hopes that sustainable health is achieved.

Cardiovascular Disease is the world’s number one killer, and its impact on the developing world is growing rapidly. The One Heart Global Cardiovascular Alliance, including all its partners, aims to establish and operate long-term programs to provide needed assistance tailored to specific countries to both provide needed services and education related to cardiovascular health. Alliance partners agree and understand that the challenges posed by cardiovascular disease are too immense and complicated for a single organization to address. They further agree that by working together, and with others, they can each make a more significant impact in the fight against cardiovascular disease, for this reason we have all come together for the launch of the One Heart Global Cardiovascular Alliance. All Alliance partners share in goal of working together to fulfill the mission and vision of the Alliance and its promise to the people of the underserved populations.

ONE HEART MAGAZINE

19

Since 1988, EXCOR® has been implanted in more than 3,000 patients worldwide Berlin Heart GmbH is the only company worldwide that develops, produces, and distributes implantable and external ventricular assist devices for patients of every age and body size. The devices INCOR®, EXCOR® Adult and EXCOR® Pediatric can support failing hearts short-, mid- and long-term and therefore offer a life-saving therapy. Customers moreover benefit from clinical and technical support by Berlin Heart VAD specialists who are available 7-24. INCOR® and EXCOR® Adult are not FDA-approved, but widely used in Europe. The company is the market leader in Germany and Europe.

HEADQUARTERS

NORTH AMERICA

Telephone: +49 30 8187-2600 Email: info@berlinheart.de

Telephone: 281-863-9700 Email: info@berlinheart.com

Berlin Heart GmbH Wiesenweg 10 D-12247 Berlin (Steglitz) Germany

Berlin Heart Inc. 200 Valleywood, Suite A500 The Woodlands, Texas 77380 USA

Size

Just the right Former Berlin Heart patient Brady Burch visits Dr Charles Fraser.

BERLIN HEART PROVIDES BRIDGE TO TRANSPLANT FOR CHILDREN

O

n December 6, 1967, Dr Adrian Kantrowitz and his associates in Brooklyn, New York, performed the first pediatric heart transplant on a 17-day-old infant with Ebstein anomaly. This occurred just three days after Dr Christian Barnard’s first human-to-human transplant on Dec. 3, 1967, in South Africa.

In 1984, nearly 20 years later, the first successful infant heart transplant was performed by Dr Denton Cooley and his colleagues on an 8-month-old girl at Texas Children’s Hospital.

Since the 1980s, pediatric heart transplantation has become the safe, effective and an accepted management strategy for pediatric patients with end-stage heart failure resulting from cardiomyopathy or inoperable congenital heart disease.

Since 1982, more than 6,000 pediatric heart transplants have been performed, with consistent improvement in survival.

Improving survival in pediatric cardiac transplantation is predominately related to increased early survival. Increasing early survival, most likely a manifestation of the advancements in perioperative management has been the driving force improving outcomes. www.heartbeatsaveslives.org

While survival has steadily improved after heart transplantation, waitlist mortality, the period of time between official listing for transplant and the heart transplant procedure itself, remains a major problem in the current era. In data analyzed from the United Network for Organ Sharing, it was observed that between January 1999 and July 2006, more than 500 children died on the heart transplant list before a suitable donor could be identified.

This highlighted the need for novel therapies to treat children with or in need of a heart transplant.

When Dr. Charles D. Fraser, Jr. arrived at Texas Children’s Hospital in 1995 to take up his new position as chief of congenital heart surgery, he had a plan to build a surgical team that would provide the finest heart surgery for ONE HEART MAGAZINE 21

children with the best long-term outcomes. He succeeded heart surgeons around the country. in his plan, but one challenge bothered him consistently— In 2005, Dr. Fraser, who had long been an advocate for babies and young children with heart failure awaiting heart small heart assist devices, implanted the Berlin Heart into transplantation. Often he or his colleagues would have a three-month-old baby at Texas Children’s Hospital. The to stand at the bedside of a languishing baby and tell the child had been born with a failing heart and transferred from parents that nothing else could be done to save their child another city to Texas Children’s in Houston. After attempting unless a tiny donor heart became available immediately. all other possible treatments for the baby without success, Dr. Fraser felt frustrated that multiple assist devices the Hospital petitioned the FDA for a “compassionate use” existed for adults with failing hearts, but none of of the Berlin Heart. The baby did well after the those heart pumps were small enough to serve surgery and soon went on to receive a donor an infant population. He and other pediatric heart. The child, 7 years old now, started school cardiovascular colleagues around the country last year. had to rely on ECMO and centrifugal Encouraged by the successful pumps—neither of which was implantation, Dr. Fraser accompanied designed for long-term support.

Berlin Heart representatives to So without an appropriate-sized, Washington, D. C., requesting long-term device, babies and that the FDA allow an young children often died as investigational device they waited for a donor heart exemption (IDE) study. The to become available.

FDA took the information In Germany, engineers under consideration and later at the Berlin Heart Institute agreed to a “Conditional IDE had developed a pediatric approval” that opened the door ventricular assist device for for a multi-center study, allowing older children which they first used clinical trials to begin in late 2007. in 1990. By 1994, they offered a As previously mentioned, the first scaled-down version for infants. successful infant heart transplant was Over the years, the pump was used performed at Texas Children’s Hospital. successfully in Germany and other Fittingly, in January, 2008, Texas parts of Europe, but was not FDAChildren’s Heart Center was chosen approved for use in the United States.

by Berlin Heart Incorporated to serve The early European experience as the national lead center of a first suggested the Berlin Heart VAD could ever, prospective multi-center, North provide stable circulatory support American clinical trial on a pediatric for up to 421 days in children as heart pump, the Berlin Heart EXCOR small as 3 kilograms. Furthermore, Pediatric Ventricular Assist Device the experience indicated that (VAD). Dr. Charles D. Fraser, Jr many EXCOR® Pediatric subjects was named the National Principal could be weaned and extubated Investigator who would coordinate from mechanical ventilation, the multi-center IDE study on the discontinue sedation/paralysis, safety and efficacy of the Berlin transition from parenteral to Heart VAD as a bridge to cardiac enteral nutrition, and even transplantation. Once the study become ambulatory –clinical began, investigators around the benefits widely considered country were able to enroll patients, infeasible with currently implant the device and available options, and keep children alive while beneficial to continued they waited for heart suitability for transplant transplantation.

The Berlin Heart EXCOR is a ventricular assist device that supports the hearts of while waiting for a At the end of the children awaiting a heart transplant. transplant.

3-year clinical trial, Dr. Between 2000 and Fraser and his study 2004, two hospitals colleagues took the used the scaled-down heart pump in infants for the first time Berlin Heart results before a 22-member FDA advisory panel in the U. S. under the FDA’s Humanitarian Device Exemption comprised of pediatric and adult cardiovascular experts. The program for a “compassionate use.” The device took over the panel’s goal was to review the clinical data from the trial heart’s pumping action and improved blood circulation as and to make recommendations to the FDA concerning the the babies waited for donor hearts to become available. The safety and probable benefit of the EXCOR VAD as it pertains news accounts of these uses piqued interest among pediatric to an application for Humanitarian Device Exemption 22

ONE HEART MAGAZINE www.heartbeatsaveslives.org

(HDE) approval. At the end of a challenging day of questions about the study evidence, the panel members voted unanimously to recommend to the FDA that they grant HDE approval. The FDA considered the recommendation and by Dec. 16, 2011, the device received FDA approval for the EXCOR to be used in U.S. children as a bridge to heart transplantation.

For Dr. Fraser and his colleagues from the 17 hospitals who participated in the North American study, this was a landmark event for babies and older children suffering from severe heart failure and needing heart transplantation. They felt this approval ushered in a new era for children with terminal heart failure. It meant that the pediatric medical community could now offer this lifesaving device to support dying children who might not otherwise survive while awaiting donor hearts.

This first-ever perspective clinical trial conducted to investigate the safety and benefit of a pediatric VAD involved an incredible effort from 15 U.S. hospitals and two Canadian centers with extensive experience in pediatric heart failure and transplantation.

Since 2005, when Texas Children’s implanted its first Berlin Heart, Dr. Fraser and his surgical team have implanted this life-saving device into 30 pediatric heart patients, most of which have gone on to receive a transplanted donor heart.

The following story illustrates the foremost benefit to having a device in several sizes to fit young children and an infant population. The device is changing lives of newborns and giving parents the delight of rearing a baby who can enjoy the activities of a normal child.

Leanny Rodriguez, Berlin Heart baby When Leanny’s parents brought their daughter home from the hospital, she seemed to be a healthy, happy baby.

Then her health took a dramatic turn. Within three months, Leanny was fighting for her life at Texas Children’s Heart Center.

Leanny’s problem started with an upset stomach and fussiness that lasted a few days. Soon she was unable to eat, was vomiting and had a noticeably pale color. A worried mom took her to the ER at a local hospital.

Doctors diagnosed her with pneumonia. But the following day, they realized the problem was more complex.

www.heartbeatsaveslives.org

They arranged for a helicopter to transport Leanny to Texas Children’s Hospital There cardiac specialists told Leanny’s parents that she had a serious heart problem called dilated cardiomyopathy.

It meant that her heart was enlarged—particularly the left ventricle-- and was too weak to pump blood to the body’s organs. The parents were shocked when heart doctors said their 3-month-old baby needed a heart transplant.

With a failing heart, time was not on the baby’s side.

Her doctors recommended that Leanny have a Berlin Heart implanted – a pump developed in Germany that could be attached to her own heart by tubes that would assist her circulation. The device, which rests outside the body, could support Leanny’s heart and buy her more time as she waited for a donor heart to become available. Pediatric heart surgeons implanted Leanny with the Berlin Heart during an eight-hour operation.

The device improved Leanny’s circulation, and she grew stronger each day. She was able to be an active baby and meet developmental milestones such as crawling, standing alone and walking. By the time she received a donor heart four months later, she was a healthy candidate for the transplant surgery.

Now with a new heart beating in her chest, the 4-yearold participates in normal childhood activities.

ONE HEART MAGAZINE

23

Photos courtesy of Lancaster General Hospital

Cardiovascular Credentialing International Joins Forces with Heartbeat International to Combat Cardiovascular Diseases

By Stephanie Ricker

A

shared vision is a powerful motivating force.

It serves as a call to action, it lends strength and encouragement, and it has the capability to forge a partnership that is greater than the sum of its parts.

Cardiovascular Credentialing International (CCI) shares Heartbeat International’s vision to save lives through education, prevention, and treatment of cardiovascular diseases. In our 44 years of operation, CCI has built relationships with countless organizations to unite in common goals, and we are thrilled to become a partner with Heartbeat International as a member of the Global Cardiovascular Alliance. We are honored to join Heartbeat International’s worldwide battle against cardiovascular diseases, and we are grateful for the opportunity to contribute to One Heart Magazine and its synthesis of industry and philanthropy.

CCI is a not-for-profit credentialing body with a vision to promote international awareness of its cardiovascular credentialing programs. We seek to be the globally recognized 24

cardiovascular technology credentialing agency by providing competency-based examinations in a variety of cardiovascular specialties. Our innovation, driven by professional ethics and integrity, has placed us at the forefront of worldwide cardiovascular credentialing, and we are striving to increase that international presence even more in the near future. Current CCI President Doug Passey states, “We have always had aspirations to broaden our global awareness and acceptance, and we have found that there is a dire need for educational support and a desire for recognition through credentialing, especially in emerging countries and medically underserved populations.”

CCI began as the National Society of Cardiopulmonary Technology (NSCPT), which was a professional society that administered its first credentialing examinations in 1968.

The American Medical Association officially recognized the

ONE HEART MAGAZINE www.heartbeatsaveslives.org

DROP BY With a recent $2.5 million renovation completed, you'll want to drop by to experience the ultimate boutique hotel in San Juan. Whether it's for business or pleasure, or a little of both, our staff will assist with all the details to assure you have an unforgettable stay!

• Located oceanfront of Puerto Rico’s pristine Isla Verde Beach • Only five minutes from the San Juan International Airport • Boutique Property/Adult Playground – 80 cool, intimate guest rooms, including 4 Ocean Front Suites • Ocean View Meeting & Function Rooms including WIFI

SERVICES/AMENITIES:

Concierge | Beach Services | Rooftop Pool | MIST Lounge ZEST Restaurant | Fitness Center | Business Center | WIFI Available for Corporate Rates, Group Rates, & Catering Events

For more information, please contact the Sales Department at 787.728.3666 or email info@waterbeachhotel.com

w w w. w a t e r b e a c h h o t e l . c o m facebook.com/waterbeachclub

cardiovascular technology profession in 1984. After merging with several other organizations, the society officially changed its name to Cardiovascular Credentialing International in 1988. CCI is governed by a Board of Trustees and is advised on matters pertaining to the cardiovascular field by its Board of Advisors. The Board of Advisors consists of representatives in each cardiovascular specialty field, as nominated by the following professional societies: American College of Cardiology, American College of Phlebology, American Society of Echocardiography, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of

Photo courtesy of Alta Bates Summit Medical Center

Invasive Cardiovascular Professionals, Society of Diagnostic Medical Sonography, and Society for Vascular Ultrasound.

Currently, CCI administers two certificate-level and six registry-level credentialing examinations: • Certified Cardiographic Technician (CCT) • Certified Rhythm Analysis Technician (CRAT) • Registered Congenital Cardiac Sonographer (RCCS) • Registered Electrophysiology Specialist (RCES) • Registered Cardiovascular Invasive Specialist (RCIS) • Registered Cardiac Sonographer (RCS) • Registered Phlebology Sonographer (RPhS) • Registered Vascular Specialist (RVS) CCI’s Board of Trustees is investigating opportunities and the international need for further credentials in the cardiovascular field. All credentialing programs administered

by CCI have gained ISO/IEC 17024 accreditation by the American National Standards Institute (ANSI). Accreditation was awarded to the RCES, RCIS, RCS, and RVS examinations 26

in 2008, and to the CCT, CRAT, RCCS, and RPhS examinations in 2011. Founded in 1918, ANSI accredits developers of standards for a multitude of personnel certification programs and industries, both nationally and internationally. Nearly one million professionals hold credentials in ANSI-accredited organizations, and ANSI accreditation is widely acknowledged as the foremost personnel certification accreditation body in the United States.

ANSI is the United States representative of the International Organization of Standardization (ISO), which is the global developer of international standards dedicated to eliminating obstacles to international trade. ISO standards are established with worldwide consensus, providing rigorous guidelines for products, services, and sound practice. CCI recognizes that accreditation through these bodies is vital to creating an international credentialing presence.

Reciprocity is essential for international relationships and a shared vision that transcends geographic and socioeconomic borders. ISO standards encourage open exchange while providing the necessary regulation to ensure structure and mutual accountability. In such a context, reciprocal benefits can be offered by two or more international partners without fear.

In an effort to promote global awareness of its internationally recognized credentials, CCI exhibited for the first time at the World Congress of Cardiology (WCC) in Dubai, UAE in April of this year. Attendees demonstrated great interest in cardiovascular professional credentialing, and ISO recognition of CCI’s credentials played a vital role in communicating the validity of our programs. Meeting our international colleagues and our registrants (professionals who hold CCI credentials) is part of CCI’s ongoing research into uncovering and providing for the needs of our international constituents. For example, CCI is currently investigating the possibilities of altering our international fee structure according to World Health Organization guidelines so that the economic constraints of certain countries are taken into consideration when determining examination and renewal fees.

At the WCC, representatives of CCI were struck anew by the desire the international attendees expressed for educational opportunities in the cardiovascular field. The attendees saw the value of credentialing programs, but they also consistently emphasized the desperate need

ONE HEART MAGAZINE www.heartbeatsaveslives.org

for education for associate professionals as a key step in with a better understanding of commonly shared issues combating cardiovascular disease. Meeting our international among healthcare educators.” CCI hopes that this forum will colleagues from a wide variety of countries including the continue to be a useful resource for educators, and in the UAE, Saudi Arabia, India, Pakistan, Sudan, Nigeria, Tanzania, future CERF is expected to be a valuable funding source for and Kenya renewed our drive to fulfill these needs in the the endeavor. worldwide cardiovascular field.

The Global Cardiovascular Alliance founded by Heartbeat CCI’s primary mission is dedicated to the credentialing International is the next logical step in the fight against of cardiovascular professionals, but we as an organization cardiovascular diseases. Created through individual strategic know that education is the vital first step on the road to partnerships, the Alliance maximizes cooperation to expand credentialing. “CCI has always been of the belief that within services. The Alliance unifies members with a common goal the cardiovascular profession there is a triad of specialties that and offers the opportunity for collaboration in Heartbeat works to ensure the success of the profession,” says President International’s three goals of education, prevention, and Passey. “The triad consists of those who educate, those who treatment, thus addressing all aspects of humanitarian efforts credential, and the professional society that represents the against cardiovascular diseases. Each organization in the members of the profession. All are important, and without Alliance, whether it is a charity, society, school, industry, any one component the profession would falter.” For this or government, brings its own contributions to the battle. reason, CCI is working to develop Heartbeat International’s existing an educators’ foundation, called structure and newly expanded the Cardiovascular Education and Heart Center network is the Research Foundation (CERF), key to the approach, bringing as a 501(c)(3). This foundation cardiac care to entire populations. will enable CCI to contribute However, the Heart Centers need to the profession by providing educated health care professionals resources to aid future generations who are prepared for the onslaught of cardiovascular educators of patients headed their way. and students. In keeping with This is where CCI steps Heartbeat International’s vision of onto the battlefield as part of philanthropy, CERF will provide the Alliance. CCI is forming a vehicle for individuals and a partnership with Heartbeat corporations to make charitable International to build the contributions to a vitally important Photo courtesy of Morrison Vein Institute and Compudiagnostics framework of certification cause. Passey states, “CERF gives programs through the Alliance. us the opportunity to support Doug Passey describes the “CCI has always been of the belief that worthwhile educational endeavors, Alliance as “a great opportunity within the cardiovascular profession there is both locally and abroad. In the for CCI to partner with other a triad of specialties that works to ensure the future, CCI would like to become cardiovascular organizations success of the profession.” involved in educational initiatives for the purpose of working with —Doug Passey that extend to those areas of the governments of medically PRESIDENT the world that have limited underserved populations to help CARDIOVASCULAR CREDENTIALING INTERNATIONAL opportunities for education and provide much needed resources training.” in the education, prevention, CCI also demonstrated its commitment to education by diagnosis, and treatment of cardiovascular disease.” The holding the first annual Cardiovascular Educators’ Forum education programs will provide cardiovascular health in Las Vegas, Nevada during March of this year. Fifty-five instruction for cardiovascular professionals preparatory to educators representing 35 schools and colleges attended, these professionals becoming credentialed through CCI. These representing cardiac sonography, vascular ultrasound, programs will be designed to ensure a lasting, meaningful cardiac catheterization, and cardiac electrophysiology impact in the targeted areas and will provide the knowledge programs. Speakers presented on a variety of topics, including and experience that in-country professionals require to meet accreditation, credentialing qualifications, teaching challenges, the cardiovascular health needs of the area long after the and education in the new millennium. Educators discussed programs have been completed. how to nurture the professional development of their students A single organization cannot hope to surmount the and shared effective strategies and techniques in discussion. challenges presented by cardiovascular diseases worldwide.

Kathy Ozols, BS, RRT, CPFT, NPS, RCS, an educator for Such a task requires cooperation, a shared vision, and a Central Florida Institute, said, “Participating in the conference, deeply rooted commitment to our common goals. Together, openly sharing ideas with other educators across the country, as members of the Global Cardiovascular Alliance, we have and listening to presentations from the speakers exceeded even greater power to effect permanent, significant change all of my expectations. I have never attended a conference in the lives of people around the world. CCI is proud of to be that allowed the attendees to interact more positively and a member of this Alliance, creating educational opportunities productively. I returned to my job inspired, motivated, and and supporting our colleagues around the world.

“

www.heartbeatsaveslives.org

”

ONE HEART MAGAZINE

27

Photo courtesy of Lancaster General Hospital

Cardiovascular Credentialing International Credentialing Cardiovascular Professionals since 1968 Photo courtesy of Saint Francis Hospital and Medical Center

• Certified Cardiographic Technician (CCT) • Certified Rhythm Analysis Technician (CRAT) • Registered Congenital Cardiac Sonographer (RCCS) • Registered Cardiac Electrophysiology Specialist (RCES)

• Registered Cardiovascular Invasive Specialist (RCIS) • Registered Cardiac Sonographer (RCS) • Registered Phlebology Sonographer (RPhS) • Registered Vascular Specialist (RVS)

Credentials administered by CCI are accredited by the American National Standards Institute (ANSI) based on the ISO/IEC 17024 Accreditation Standard.

For more information about CCI and examinations offered call 1-800-326-0268 or visit www.cci-online.org

See article on page 24

AMERICAN HEART ASSOCIATION DOESN’T CONFINE EFFORTS TO JUST THE U.S.

By Gordon F. Tomaselli, M.D. President, American Heart Association

F

ounded in 1924, the American Heart Association has long been the United States’ oldest and largest volunteer health organization dedicated to fighting heart disease and stroke — our No. 1 and No. 4 causes of death.

What many people don’t know is that the association also is waging battle on these diseases beyond national borders.

Our volunteers and employees are working on various fronts around the globe to reduce cardiovascular disease —the leading cause of death in the world. It’s part of our mission: building healthier lives, free of cardiovascular diseases and stroke.

“We are committed to forwarding the mission around the world that fosters prevention and early intervention,” said Vincent Bufalino, M.D., chairman of the American Heart Association’s International Committee and senior vice www.heartbeatsaveslives.org

president of the Cardiovascular Institute and senior medical director of cardiology for the Advocate Medical Group in Chicago.

“We think there are tremendous opportunities for us to bring some of our science and programs to areas where the population is underserved.”

The organization’s international focus was highly visible as recently as late April, Gordon F. Tomaselli, M.D. when the American Heart Association joined other leading cardiovascular health organizations at the 2012 World Congress of Cardiology in Dubai, calling for the adoption of a global goal to reduce premature non-communicable disease mortality by 25 percent by 2025.

Adopting those targets “is the first and most important ONE HEART MAGAZINE 29

CardioComm Solutions, Inc Hospitals • Medical Call Centres • Group or single physician practice

GEMS™ Global ECG Management System • An industry standard in ECG arrhythmia management • Compatible with all ELR devices • Wireless and MTC

C4™ ECG Management Service • Full ECG call centre capabilities • Full diagnostic capabilities without any CapEx • Access reports from anywhere over the web or request our cardiologist to report for you • ECG Triage services

Global Leaders in ECG and Cardiac Arrhythmia Management Solutions

GlobalCardio™ 12 Lead • FDA approved ECG interpretation algorithm • Web or paper-based reporting • HL7/EMR ready

Solution’s patented software enables ECG Online CardioComm CME: data to be collected, transmitted, received and managed anywhere in the world using wireless ECG devices, enterprise networks, telephones and the Internet. contact us today

1.866.900.6530

www. cardiocommsolutions .com email: sales@cardiocommsolutions.com

All CardioComms products are FDA & CE approved and HIPPA compliant

HeartCheck™ Handheld ECG Devices • Cost effective patient screening for holter or event loop recorder use • Store up to 200 heart rate and ECG waveforms • View, print, email or online ECGs • A billable service under most plans

The New Era of CME: www.medfound.com

white version The Foundation for Medical Education and Research (FEMR) is a non-pro�it, full-service medical education company that recognizes the importance of medical education as an integral component for the provision of quality healthcare. We pride ourselves on developing and presenting a wide range of educational programs that support physicians and health care professionals in continuous learning throughout their careers.

Upcoming Live Events:

Satellite Symposium: Evaluating the Right Ventricle: A Practical Guide for the Heart Failure Clinician September 18, 2011 | 10:00 am – 12:00 pm Boston, MA

Satellite Symposium: Tips and Pearls for the Clinician: Critical Lessons in Congenital Heart Disease, Advanced Heart Failure and Pulmonary Arterial Hypertension black version November 13, 2011 | 7:00 pm – 10:00 pm Orlando, FL

v

Complimentary Accredited Online CME

An extensive collection of on demand multimedia presentations and interactiveComplimentar case-based learning presented by internationally recognized experts

For a complete list of upcoming CME activities and to join our mailing list

visit www.medfound.com Foundation for Medical Education and Research, Address: 111 South Calvert Street Suite 2700 Baltimore, MD, 21202

Phone: (410) 649-4421

Fax: (443) 320-1496

Email: info@medfound.com

step in creating global change,” said American Heart Association Chief Executive Officer Nancy Brown.

Here is a brief look at some of the many other areas where the American Heart Association is focusing its international efforts: »» Emergency Cardiovascular Care – Of the more than 13 million people the American Heart Association trains in CPR and first aid annually, about 430,000 are in 400 international centers in 140 countries, including priority locations Brazil, China, India and the Middle East. With more than 280,000 instructors around the world, the association’s goal is to train 20 million people by 2020. »» Consumer Education – The association uses emergency cardiovascular care training as a platform to expand its consumer health initiatives internationally, including Go Red For Women, a heart-disease awareness campaign that a number of countries have adapted to their culture.

The association has also partnered with the World Health Federation to share Go Red For Women through its member national heart foundations. »» Scientific Conferences and Meetings – The American Heart Association’s annual Scientific Sessions and International Stroke Conference are incubators for global collaboration, attracting the world’s leading scientists and clinicians who debut groundbreaking findings in heart and stroke research. Scientific Sessions is the world’s largest cardiovascular science meeting and is No. 10 worldwide in professional attendance among all scientific meetings. Of the 15,553 professionals who attended the last conference in November 2011, 7,422 (47 percent) were from more than 100 other countries.

The 2012 International Stroke Conference included 693 professionals from 49 countries. The association conducts other specialty conferences that attract thousands from around the world. For the many unable to attend, the association reprises key presentations in venues outside the United States and provides

key portions of content on its websites and email newsletters. »» Professional Journals – Published in more than 10 languages and in about 50 countries, the 12 scientific journals provide subscribers the latest groundbreaking laboratory discoveries, results of key clinical trials and global perspectives through editorials and reviews by thought leaders in science and medicine. Four of the journals — Circulation, Hypertension, Stroke and Arteriosclerosis, Thrombosis and Vascular Biology — are ranked No. 1 worldwide in their subject categories based on impact factor rating. »» International Partnerships – The American Heart Association is a founding member of the World Heart Federation and a member of the World Stroke Organization. It also founded the InterAmerican Heart Foundation, which focuses on cardiovascular diseases and stroke in Latin America. »» Professional Membership and Education – About 21 percent of the more than 28,000 member clinicians and researchers are from countries outside the United States who network and have access to an array of resources. »» Non-communicable Diseases – A member of the NonCommunicable Disease Alliance, the association was part of the U.S. delegation at the United Nations summit in New York in September 2011, when world health leaders approved a political declaration to address non-communicable diseases. The American Heart Association was also part of the U.S. delegation at the World Health Organization’s First Global Ministerial Conference on Non-Communicable Diseases, held in Moscow in April 2011. »» Heart Doctors Without Borders – The association’s clearing house for volunteer activities around the world helps train physicians in new techniques.

A DOCTOR ON A MISSION

By Gordon F. Tomaselli, M.D. President, American Heart Association The key to our international efforts — and all of our lifesaving work — is the dedication of our volunteers. Their efforts to defeat cardiovascular disease and stroke ignite the American Heart Association.

Here’s a look at one of those volunteers.

Dr. Vemuri S. Murthy, who practices medicine in Oak Park, Ill., is highly committed to serving our mission in his native India. He is one of thousands of our volunteers serving in our global battle against cardiovascular disease, the world’s No. 1 cause of death.

32

W

hen Dr. Vemuri Murthy returns each year to his native Andhra Pradesh, India, he is on a mission.

“My vision, my ambition is for every medical student, every doctor in India to have the basic cardiovascular emergency skills and guidelines of the American Heart Association,” he said. “Having spent 28 years of my life in India, I am quite passionate about developing countries like India, where people don’t have access to basic medical help.”

His dream is gradually becoming a reality.

For the past eight years, armed with the American Heart Association’s emergency cardiovascular care courses and guidelines, Murthy has been developing

high-quality training programs in medical colleges in Andhra Pradesh. He hopes to help start similar programs in all medical colleges throughout India. He has also conducted countless training sessions and coordinated several initiatives that have affected thousands of healthcare providers and patients.

As chairman of the Emergency Medical Care Educational Committee of the Federation of the Andhra Pradesh Medical Graduates in USA, he is leading efforts to have physicians in all medical colleges and hospitals in the state trained in resuscitation science. The organization has signed an agreement with the government and the NTR Medical University in Andhra Pradesh to offer needed help to establish

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Dr. Vemuri Murthy resuscitation science courses in the medical college curriculum with assistance from AHA-trained instructors.

“Even though we have a lot of medical colleges, the basic education doesn’t cover skills like CPR,” said Murthy, who graduated from Guntur Medical College and All India Institute of Medical Sciences in New Delhi. “When it comes to emergency cardiovascular care, they are not armed with evidence-based knowledge and skills that we have in America.”

The main goals of the ambitious project, which Murthy initiated, are to: »» Disseminate American Heart Association training information to save lives.

»» Train and retrain physicians with basic CPR skills.

»» Eventually expand the knowledge and information in every home in India.

www.heartbeatsaveslives.org

“

”

“It’s the only organization taking education to the global arena, reaching out with basic emergency skills.”

“We’re bringing AHA courses to the door steps of colleges,” Murthy said. “We train. We provide manpower.”

Murthy is quite an active volunteer for the American Heart Association in Illinois as well. In addition to being an anesthesiologist in active private practice, he is a regional faculty and member of the Emergency Cardiovascular Care Committee of Illinois. He is also an American Heart Association speaker on resuscitation science and participates in various community health education programs.

“Since I came to the United States in

—Dr. Vemuri Murthy

1980, I have found a need and am quite passionate about getting myself involved with the American Heart Association,” Murthy said. “It’s the only organization taking education to the global arena, reaching out with basic emergency skills.”

And it is those skills developed here that he is taking back home.

“We have a long way to go,” he said, “and my passion is to get every doctor in India to be capable of delivering emergency medical care.”

His passion is the American Heart Association’s mission.

ONE HEART MAGAZINE

33

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.

www.heartbeatsaveslives.org

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.

ONE HEART MAGAZINE

35

ADVANCES IN INFLAMMATORY BIOMARKER TESTING

TO DEFINE CARDIOVASCULAR RISK Marc S. Penn, MD, PhD, FACC, Director of Research, Summa Cardiovascular Institute, Summa Health System, Professor of Medicine and Integrated Medical Sciences, Skirball Laboratory of Cardiovascular Cellular Therapeutics, Northeast Ohio Medical University, Chief Medical Officer, Cleveland HeartLab, Inc. Michelle Beidelschies, PhD Clinical Liaison, Cleveland HeartLab, Inc.

The statistics for incident cardiovascular disease (CVD) continue to rise and will ultimately affect medical costs substantially. At present, approximately 37 percent of the US population has some form of CVD and the real total direct medical costs related to this disease are approximately $272 billion1. By the year 2030, 40 percent of the U.S. population is projected to have some form of CVD and the real total direct medical costs related to this disease are expected to triple to approximately $818 billion1. As a result of these outstanding statistics, the medical field is beginning to shift its way of thinking from responding to the presence of CVD to preventing the onset of CVD. 38

Our increasing understanding of the role of inflammation is changing the way medicine approaches chronic diseases such as CVD, and several studies suggest that monitoring inflammation may be an efficacious strategy to monitor the progression or even prevent the onset of chronic disease. Originally proposed over 35 years ago by Dr. Russell Ross, a vascular biologist, the “Response to Injury Hypothesis” has now become a well-recognized concept for chronic disease progression as it underscores the importance of inflammation in the development of atherosclerosis2,3. In short, the body responds to vascular injury by mounting an immune response which is a tightly regulated and orchestrated response. However, when the injury is chronic, or the tissue cannot be healed, this process can become dysregulated and persists as chronic inflammation. This continuous or episodic recurrence of the positive feedback loop can become detrimental to an individual’s health.

ONE HEART MAGAZINE www.heartbeatsaveslives.org

With the advent of various types of statin therapies aimed at lowering LDL cholesterol (LDL-C) levels, physicians are now able to substantially reduce the incidence of injury to the vasculature, and ultimately an individual’s risk for CVD. Statin therapy is an important treatment option that has contributed to the >50 percent decrease in the prevalence of ST elevation myocardial infarction in the United States over the past 15 years. However, the landmark JUPITER (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin) trial recently published in the New England Journal of Medicine, suggests that lowering LDL-C levels alone may not be enough4. The trial enrolled

THERE IS A MORE VASCULAR-SPECIFIC BIOMARKER OF VULNERABLE PLAQUE FORMATION CALLED MYELOPEROXIDASE, OR MPO, THAT CAN BE EASILY MEASURED IN THE BLOODSTREAM.

over 17,800 individuals without a history of cardiovascular disease who exhibited LDL-C levels <130 mg/dL and hsCRP (high-sensitivity C-reactive protein) levels ≥2 mg/dL. These individuals were randomly assigned rosuvastatin therapy (20 mg/daily; Crestor, AstraZeneca) or placebo and monitored for incident vascular events. The trial was actually stopped early due to an overwhelming benefit to individuals taking rosuvastatin therapy who experienced less vascular events (a 54 percent reduction in myocardial infarction and a 48 percent reduction in stroke). These benefits also paralleled the individuals’ laboratory results (50 percent reduction in LDL-C and 37 percent reduction in hsCRP). Interestingly, a maximum benefit was seen in individuals who had significant reductions in both LDL-C and hsCRP ultimately underscoring the importance of reducing inflammation alongside LDL-C levels. The results of the JUPITER trial have ultimately led to the relabeling of rosuvastatin and increased interest in utilizing hsCRP in the clinical setting.

Since the JUPITER trial, the use of inflammatory biomarkers in the clinical setting to assess CV risk has significantly increased especially since biomarker testing is quite simple and inexpensive compared to more invasive tests such as angiography or coronary artery calcium scoring.

However, certain biomarker tests do have their limitations as well. In particular, hsCRP testing is useful for measuring systemic inflammation, but lacks specificity for vascular injury suggesting that it is more of a measure of the initiation and development of CVD or plaque burden, rather than for plaque activity5.

For this purpose, there is a more vascular-specific biomarker of vulnerable plaque formation called myeloperoxidase, or MPO, that can be easily measured in the bloodstream. MPO is an enzyme released from white blood cells during the inflammatory process, and its www.heartbeatsaveslives.org

pathophysiology is well-documented in the literature6.

Clinically, free MPO levels in the bloodstream can be measured to examine the release of MPO by white blood cells in response to vulnerable plaque/erosions/fissures in the artery wall. This was documented in a landmark study in 2003 when Brennan and colleagues looked at a large group of individuals who reported to the emergency room with chest pain5. The investigators found that individuals at admission with the highest MPO levels, even if they were persistently negative for Troponin T, were almost 4 times more likely to require revascularization due to vulnerable plaque rupture soon after admission than those with the lowest levels5.

Thus, the investigators concluded that free MPO in the bloodstream was a biomarker that could identify the presence of vulnerable plaque.

Since this seminal report, over 100 manuscripts have been published on the clinical utility of MPO outside of the acute care setting. Among the middle-aged, healthy individuals in the MONICA/KORA Ausburg study, individuals with the highest levels of MPO at baseline were almost twice as likely to have a cardiac event over the ensuing 10 years7. In a slightly older population, increased MPO levels at baseline were associated with an increased risk of cardiovascular events, especially fatal events, particularly among individuals who had normal LDL-C, HDL-C, and CRP levels8. These studies highlight the utility of MPO testing to identify patients who have vulnerable plaque even in individuals who are negative for traditional risk factors and may inappropriately be assumed to be at low or intermediate risk.

Overall, the great interest in inflammatory biomarkers such as MPO is in large part due to the fact that traditional risk factors, such as LDL-C, fail to identify the majority of individuals at risk of developing CVD and adverse cardiac events as was demonstrated by the JUPITER trial. In fact, physicians may be missing approximately 50% of the patient population at risk for a heart attack or stroke if basing risk solely on ‘normal’ LDL-C. Therefore, a closer examination of residual risk due to inflammation through the measurement of MPO as well as other novel biomarkers may result in better prognostication and risk stratification which may ultimately reduce long-term medical costs and the incidence of CVD. REFERENCES

1. Heidenreich PA et al. Forecasting the future of cardiovascular disease in the United States: A policy statement from the American Heart Association. Circulation. 2011; 123: 933-944.

2. Ross R and Glomset JA. The pathogenesis of atherosclerosis (First of two parts). N Engl J Med. 1976; 295: 369-377.

3. Ross R and Glomset JA. The pathogenesis of atherosclerosis (Second of two parts). N Engl J Med. 1976; 295: 420-425.

4. Ridker PM et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008; 359: 21952207.

5. Brennan ML et al. Prognostic value of myeloperoxidase in patients with chest pain. N Engl J Med. 2003; 349: 1595-1604.

6. Nicholls SJ and Hazen SL. Myeloperoxidase and cardiovascular disease.

Arterioscler Thromb Vasc Biol. 2005; 25: 1102-1111.

7. Karakas M et al. Myeloperoxidase is associated with incident coronary heart disease independently of traditional risk factors: results from the MONICA/KORA Ausburg Study. J Intern Med. 2012; 271: 43-50.

8. Meuwese MC et al. Serum myeloperoxidase levels are associated with the future risk of coronary artery disease in apparently healthy individuals.

The EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol. 2007; 50: 159-165.

ONE HEART MAGAZINE

39

Improving access to life-saving cardiovascular treatment in Mexico Collaboration between BIOTRONIK and Heartbeat International saves 11-month-old girl with Down syndrome

Geraldine Ariana Suarez, a little girl who was born in Saltillo, Mexico, in December 2010, faced many challenges already in her first years. Not only was she born with Down syndrome and an atrioventricular (AV) block, but the federal government’s health care program under which she was receiving health care would not cover the cost of implanting a life-saving pacemaker. Since her mother was single and unemployed, Geraldine and her family were left helpless.

“When she was born, we thought we were going to lose her,” said Geraldine’s mother, Ana Gabriela Suarez. “At the hospital they told us her heart was asleep. It was just so painful because for us she was a little angel arriving into our lives.”

In line with its commitment to provide access to life-saving cardiac care for the most vulnerable people, BIOTRONIK formed an alliance with Heartbeat International Foundation (HBI) in 2010. The goal of the alliance is to donate new implantable cardiac devices to economically disadvantaged patients at HBI Heart Centers in Mexico and all around the globe. To date more than 1000 devices have been donated by BIOTRONIK. “Our products, aside from everything else, save patients lives. We are strongly committed to increasing access to life-saving cardiovascular treatment for economically disadvantaged people and wholeheartedly support HBI’s program,” says Christoph Böhmer, Managing Director of BIOTRONIK. “A little girl was dying,” explained Ariel Garcia, Heartbeat International Foundation (HBI) Chairman of the Saltillo Heart Center in northeastern Mexico. “Geraldine Ariana Suarez, 11 months old at the time, had been born with and

1

World Health Organization statistics, 2009.

suffered from AV block, a form of bradycardia heart disease.

They were looking for help everywhere.”

“She finally received a BIOTRONIK pacemaker, and now she’s doing just fine,” continued Garcia. “She’s laughing, she’s happy, and she’s starting to talk. Her grandparents and her mother cry with joy almost every day.”

“You have returned the light to our lives,” said Geraldine’s mother. “It is incredible that the sum of the wills of BIOTRONIK, Heartbeat International and the group of Rotarians who run the Saltillo Heart Center have made it possible to save her life. God bless all who have given me the greatest gift in life – the health of my daughter.”

Cardiovascular diseases are the world’s number one killer, and for people in developing countries without the resources to take advantage of today’s advanced medical technologies, their prognosis is poor. This can be especially true in places like Mexico, where government spending per capita is low – with the total expenditure on health as a percentage of gross domestic product (GDP) is just 6.5% compared with countries like the United States and Germany where rates are 16.2% and 11.4% respectively.1

In Mexico, federal government programs offer assistance to patients with cardiac problems. The cost of a required pacemaker implantation, however, is not covered – meaning that many patients do not receive the treatment they need.

“In Mexico, there are so many people who cannot afford to buy a pacemaker. At the hospital, they are offered no option other than to go home – and most of them die a sudden death,” said Dr. Jorge Bahena, Medical Director of Mexico National Heart Centers. “With HBI’s program, this scenario has turned completely around. Patients do not go home because they cannot afford an implantable cardiac device.

In our heart center alone we have saved more than 100 lives with outstanding support from BIOTRONIK.” Comprised almost completely of volunteers, including 120 physicians, social workers, administrators, support staff and other medical professionals, Heartbeat International´s Heart Centers are running in five locations in Mexico: Aguascalientes, Mexico City, Monterrey, Puebla and Saltillo.

A sixth location is scheduled to open soon in Guadalajara.

“The commitment BIOTRONIK made at the end of 2010 to help Heartbeat International save 1000 lives with BIOTRONIK devices by 2013 has set a high standard,” explained Benedict S. Maniscalco, MD, Chairman and CEO of Heartbeat International Foundation. “BIOTRONIK’s donation goal has already been exceeded – one year early. We would like to use this opportunity to appeal to others to follow their lead and join our cause to fight against the socioeconomic disparity of patients who desperately need care.”

The power of an industry commitment to HBI’s Global Cardiovascular Alliance 350

334

329

310

300 250 200 200

200 150 100

202 136

110

194 128

50 0 Units Shipped

5

2 2011

2010

Pacemakers

ICDs

ICD-Leads

Programmers

2012 (Jan.-May)

Pacemaker-Leads

“As a leading global manufacturer of cardiovascular therapies, we firmly believe that it is our responsibility to be at the forefront with initiatives to increase patient access to life-saving, high quality care. While proud of our mutual achievement, our work is far from done. We look forward to strengthening our strategic alliance with HBI in the months and years to come.”

Christoph Böhmer Managing Director, BIOTRONIK

www.biotronik.com

Puerto Rico P

uerto Rico, officially the Commonwealth of Puerto Rico, is an unincorporated territory of the United States. It is located in the northeastern Caribbean, east of the Dominican Republic and west of both the U.S. Virgin Islands and the British Virgin Islands.

Puerto Rico is only 100 miles long by 35 miles wide, making it the smallest island of the Greater Antilles. Puerto Rico (Spanish for “rich port”) consists of an archipelago that includes several striking islands, such as the main island, Vieques, Culebra, Mona, and numerous islets.

It is said to be the best of the Caribbean with over 270 miles of white-sand beaches, consistent warm temperatures throughout the year, tropical flavors and rhythms and, of course, plenty of rum! The Island stands out even amongst its fellow Caribbean Island inhabitants.

Puerto Rico’s culture is a colorful, festive fusion of Taíno, African, and Spanish influences. Every day is a celebration of the diversity of cultures that have shaped the island for over 1,000 years through rich cuisine, distinctive arts and crafts, vibrant music, and traditional festivals and parades. There is always a spot

42

THE BEST OF THE CARIBBEAN

to hear the beating of the drums to salsa, bomba and plenas.

These percussion-driven musical traditions keep the people of Puerto Rico ready to congregate, dance and celebrate! Puerto Rico is inhabited by extremely proud people and they love to show their island off to visitors. Great pride, humility and passion run through the veins of Puerto Ricans. Puerto Rico is a paradise retreat 24/7, 365 days a year. Visit historic El Morro Fort on the northwestern tip of the island and learn how it defended the city of Old San Juan from seaborne enemies. Explore lush foliage, waterfalls and rivers at El Yunque Rainforest and national park.

The rainforest has a number of trails to walk, hike, and climb.

Take an eco-tour of the fascinating and beautiful bioluminescent Vieques Bay where water microorganisms emit a flash of bluish light when agitated at night. Adventure seekers may even dare to experience the intense water sports offered right off the shore.

These are all excursions that should be placed on your to-do list while visiting Puerto Rico.

Isla Verde is one of the many sensational areas to visit while in Puerto Rico. This area is a district of Carolina which borders the Atlantic Ocean, south of Gurabo, east of San Juan, and west of

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Canovanas. Isla Verde is a destination unto itself.

Over a mile-long strip of some the most beautiful white sand beaches and generally calm water make it a perfect playground for water sports, swimming, and of course sunbathing. This strip plays host to some of the largest luxury resorts and casinos, filled with plenty of boutique shops and divine restaurants. Isla Verde is perfect for leisure and extremely welcoming for business.

With some of the largest resorts and casinos taking up much of the real estate along the beachfront on Isla Verde Beach, one might miss the hidden gem of the area. Located directly across from one Puerto Rico’s most pristine beaches, the San Juan Water Beach Club Hotel is truly a David amongst several large Goliaths.

This chic property brings the transparent waters of the Caribbean Sea flowing through the hotel.

A cool mix of blues that swirl, ripple, and cascade throughout the sleek, modern building play point with brilliant shades of white, to a soundtrack all its own. With its new renovation complete, this hotel is perfect for a leisure fantasy escape or company retreat. Trip Advisor awarded the San Juan Water Beach Club Hotel the 2012 Certificate of Excellence as well as the 2012 Travelers’ Choice Award.

The San Juan Water Beach Club Hotel offers executive services with an intimate Caribbean flare. The hotel has an oceanfront business center and indoor and outdoor function venues for board meetings, corporate training, or special corporate functions. At your disposal, the hotel offers an executive boardroom, state-of-the-art audio/visual and telecommunications equipment, and other technology you may need upon request.

Whether you are here for leisure or business, your stay will be first class. With the hotel located only five minutes from the Luis Muñoz Marin International Airport, it is extremely easy to bring larger groups or plan a stay for two on a romantic getaway. From the moment you disembark your transportation, you are greeted and pampered by the Beach Club staff. Every thought to make your stay more pleasurable is taken into consideration and executed by all staff members. Give them one day, and not only will they know your name, they will also personalize their service based on your desires. No detail is missed—and a few might be added, based on your individual needs. No matter what you set your heart on while visiting Puerto Rico—a day at the beach, a couples massage on the beach, a tour of old San Juan, zip-lining on one of the longest lines in the United Sates, water sports, fishing, salsa dancing, trying your luck at one of the many outstanding casinos, exploring the rain forest, viewing a waterfall (and these are just the tip of things to do)—the Beach Club staff will make it their mission to fulfill your every request.

The hotel has 80 rooms and suites that feature floor-to-ceiling windows with views of the tropical Atlantic and San Juan’s finest beach.

When you decide to finally sleep, you will rest on www.heartbeatsaveslives.org

ONE HEART MAGAZINE

43

44

ONE HEART MAGAZINE www.heartbeatsaveslives.org

a pillow-top mattress and snuggle up in fine linens. Your room comes with complimentary high-speed internet access, LCD flat screen TVs, an iHOME docking station, in-room safe, telescope, nightly turn-down service, plush towels, calming bath amenities, and of course coffee service with Puerto Rican Yaucono coffee for when you arise. Once you work up an appetite, you have two first-class dining options from which to choose.

The San Juan Water Beach Club Hotel has two spectacular restaurants under the helm of local celebrity executive Raul Correa. Located on the rooftop of the hotel, Mist is the renowned hot spot for locals and tourists. Mist offers comfortable white plush couch- and bed-style seating areas, as well as dining tables facing the pristine water and scenic view of the Puerto Rican Mountain range. Words cannot describe the ambiance in this setting. The menu boasts an Island-Italian-Spanish fusion flare, featuring “socializers”—or small plates—that you can share, all prepared with fresh, locally grown ingredients. Once you’re done dining, grab one of their signature cocktails and take a dip in the rooftop pool overlooking the Atlantic Ocean. When you feel satisfied and have made every attempt to overindulge yourself at the rooftop oasis, you might check out the second restaurant on the main level. Zest is an avant-garde culinary experience that takes you beneath the waves, with special visual effects including dancing ripples on the walls, an ocean surface simulation on the

www.heartbeatsaveslives.org

ceiling, illuminated floors, and a cascading waterfall adjacent the bar. Zest is an amazing sub-aquatic atmosphere with a mouthwatering modern-Latino cuisine, prepared using only sustainable local ingredients. Executive Chef Raul Correa’s unique style of cooking embraces both the sensory and scientific qualities of food, as he infuses each dish with a distinct panache designed to stimulate every sense. This executive chef is hands-on, and it is very likely that when your taste buds explode with one of his dynamite dishes, he will soon be table-side making sure your experience is like no other.

After a long day taking in all that the Beach Club has to offer, it’s time to relax in your luxury room. No need to go to sleep, because the party on Isla Verde’s trendiest favorite night spot is just above you on the roof top lounge. Mist offers nightly DJs who spin a variety of music to get you out of your seat and onto the dance floor. Dance the night away, and get ready to do it all again tomorrow.

There is so much to do and see while staying in the Isla Verde area of Puerto Rico, not to mention on Puerto Rico as a whole.

The only way to really experience, enjoy, and absorb it all is to stop reading this article and book your trip to Puerto Rico! Isla Verde should be a definite stop while exploring the island, and the San Juan Water Beach Club Hotel should be your destination of choice.

ONE HEART MAGAZINE

45

FIGHTING HEART DISEASE IN

China

By Dayi Hu China Medical Association

T

wo generations of my family have desired to serve as volunteers. Now, at the age of 95, my mother is still working in a community in Zhengzhou, China, and goes to serve the outpatients every morning. She is the oldest “young volunteer.”

I have deep feelings for the Chinese countryside that are related to my upbringing. In 1965, I was admitted by Beijing Medical University while reading Mao Zedong’s Instruction on 26 June 1965. In that year, Chairman Mao proposed to “lay stress of medical work on the countryside” and build the “barefoot doctor” system, a great creation. In such a large and 46

ONE HEART MAGAZINE www.heartbeatsaveslives.org

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. 

poor country as China, medical security for the majority of people in rural areas has been solved with relatively low cost, and has resulted in the realization of a basically fair medical service. When I was studying, I helped to build the medical system through the countryside. Since the 1970s, I have engaged in medical work and participated in the Hexi Corridor Medical Team and Tibetan Ali Medical Team appointed by Premier Zhou that year, walking the whole Hexi Corridor on foot. Back then, Ali was called the “roof of the roof, snowland of snowland, and plateau of

The incidence rate of congenital heart disease in China was nearly 7 percent, and there were nearly four million patients with congenital heart disease.

48

plateau.” In Ali, I came to recognize five “extreme” spirits that characterize the region and the task of establishing the volunteer medical sytem: most hard-working, most patient, most dedicated, most united, and most fighting. These spirits were the spiritual support of the Ali liberation army and medical team that year.

After completing Ali medical assistance and returning to Beijing, I continued to engage in work related to cardiovascular disease treatment. In the early 1990s, I developed technology for treating tachyarrhythmias with radiofrequency catheter ablation in China, and held seminars to promote its application. I founded the Great Wall International Congress of Cardiology (GWICC), introduced and initiated the technology, trained medical personnel, and explored and established the “green channel” service mode for acute myocardial infarction. In 2002, I began to pay attention to congenital heart disease treatment. As both the radiofrequency ablation of cardiac arrhythmia and interventional therapy of congenital heart disease were radical cure technologies, I was lucky in my life to promote and apply these two technologies to benefit chronic patients. In that year, I opened two outpatient departments for congenital heart disease, in Peking University People’s Hospital and Beijing Tongren Hospital. The incidence rate of congenital heart disease in China was nearly 7 percent, and there were nearly four million patients with congenital heart disease. However, in 2002, only a few dozen patients went to the outpatient department. I asked myself, why did the hospital have a large sign there, if it had no patients?

In the long “May Day” holiday after the SARS outbreak in 2003, I led a medical team to Anhui Taihe County for free medical service, which was an impoverished area in central China. During the five-day holiday, we screened more than 400 children with congenital heart disease. Bian Hong, a young doctor in our team, said, “Mr. Hu, I see not only the congenital heart disease encyclopedia, but also the health status encyclopedia in China in these five days, which is never seen in Beijing before and is very astonishing.”

Most astonishing was that: 1) Disease that could have been radically cured was delayed in treatment to the point of being an incurable disease. Congenital heart disease could be radically cured when the patient is 3 years old, but would difficult to cure when the patient is 13 years old, and could not be cured when the patient is 30 years old. Many people eventually fell within the range of incurable disease. 2) Very few of these children went elsewhere to treat the disease, because of poverty. During the “May Day” holiday, the weather was not very warm, children slept all over the ground, and they could not afford to live in even the cheapest guest house. 3) Lack of fundamental knowledge. One child with congenital defects suffered from blood poisoning due to the bacterial infection in his blood, but his father tried to save his life by giving him a wedding to counteract bad luck. This would never have been seen in the city.

As a result, I concluded that our health care system had problems at the time. I called it “watching the fire from the other side of the river.” Advanced technology made enormous progress on one side of the river, which was

ONE HEART MAGAZINE www.heartbeatsaveslives.org

PERSISTENT AF TREATMENT Did you know...

Maze IV

is safe and effective when performed during open heart procedures?

Only 1 in 10

AF patients receive complete Maze IV during open heart procedure?

AtriCure offers training to CV surgeons on the FDA approved device for persistent AF treatment?

84% of persistent AF patients are

1, 2

with no increase in perioperative risk?

ONLY

AF free

Is your CV surgeon offering the Maze IV procedure?

Do you want to get them trained?

Visit www.TargetAF.com to learn more First in Surgical AF Treatment

(1) ABLATE Trial G070080, (2) Niv Ad, MD, et al. J Thorac Cardiovasc Surg 2012;143:936-944. AtriCure Synergy OLL2/OSL2 clamps that are approved to ablate cardiac tissue for the treatment of PAF or LSP AF in patients who are undergoing open concomitant CABG and/or valve replacement or repair. MKT-1642A-G 1. ABLATE Trial G070080 2. Niv Ad, MD, et al. J Thorac Cardiovasc Surg 2012;143:936-944.

wonderful; numerous patients to be treated were on the other side, however, and were very helpless. The technology could not reach the patient to be treated—it was rendered “reachless,” without value. In response, I immediately organized and established the “volunteer service team” and initiated the “Loving Care Project.” My only goal was to achieve three tasks through the “Loving Care Project” activities: 1) keep going, do “addition or subtraction,” and reduce healthcare costs through utilizing the nearest local screening and treatment facilities; 2) develop health knowledge lectures to disseminate health knowledge and promote a healthy lifestyle; and 3) carry out medical technical training and establish medical teams that would not leave local districts. Such work was especially favored by grassroots supporters.

In 2007, supported by the Chinese Red Cross, the “Loving Care Project of the Chinese Red Cross—Hu Dayi volunteer service team” was set up. When we went to the rural areas, we had a volunteer flag, a “100-word declaration,” and a flag-giving ceremony very rich with content. The “100-word declaration” included “acting as a volunteer with a public spirit,” “tempering in rural areas and communities,” and more.

Do “addition or subtraction” and locally treat patients in the nearest facilities. Why was the nearest local treatment necessary? Because there was not enough time to travel in cases of acute disease, impoverished people did not have enough money to treat diseases elsewhere, and it was not cost efficient to treat frequently-occurring diseases elsewhere. Many patients with congenital heart disease did not have money and could not go to the city with large hospitals; how much more challenged were patients with acute myocardial infarction? In such a district as Xinjiang Hetian, a patient with myocardial infarction could not go to Beijing, and did not have enough time to go to Urumqi. Therefore, we needed to help strengthen the grassroots medical institutions of the county and city so

50

that the disease could be locally treated. I suggested doing “addition or subtraction.” What was addition or subtraction?

“Subtraction” referred to accessing the nearest local treatment, providing convenience for the masses, and cost reduction. “Addition” started with sporadic things, mobilizing various social resources, organizing beneficent funds, caring for parents’ love, and returning healthy hearts to the children. “Addition” allowed more children to be treated.

Carry out training of grassroots physicians, and establish medical teams that would not leave. We emphasized that health was fair and attainable, medical service should be fair, and it was necessary to make grassroots medical institutions stronger. If the grassroots system was not strong, it would be hard to solve the difficulty of going to see a doctor. The most serious problem of grassroots hospitals was backward technology. In the year our medical team went to Ali and the Hexi Corridor, Premier Zhou Enlai repeatedly exhorted us that the most important goal was to establish medical teams that would not leave. This point remained most crucial: we should leave behind technology and medical teams that would not leave local districts. Through utilizing the nearest local treatment centers, “practical experience” was given to grassroots medical personnel and technology was left for them. Our experts operated at the grassroots level, allowing grassroots doctors to participate in the practical training, who were sure to learn through teach-by-doing!

This was my experience as a doctor and a teacher for many years. Grassroots treatment was not only convenient for the patients but also saved on costs, and more importantly was establishing medical teams that would not leave the area.

Establish health care lectures and guarantee people’s health and warmth. I think that the greatest value a doctor can learn in medicine is to prevent disease and allow fewer people to fall ill. Do not allow serious disease to occur, and promptly treat it when it does. At present, our cardiovascular disease assumes the trend of “well blowout.” In order to achieve early success in the two inflection points of disease

ONE HEART MAGAZINE www.heartbeatsaveslives.org

In 2010, the Ministries of Health and of Civil Affairs of the People’s Republic of China developed a related policy for congenital heart disease treatment which was integrated into the social security treatment system. Seventy to ninety percent of the treatment cost can be reimbursed in various regions, which was an important measure to treat poor youth patients with congenital heart disease.

control and medical cost reduction, it is very important to promote health nationwide. Therefore, my approach is to try to change the doctors’ concept, and extensively promote activities whereby everyone pays attention to health and participates in health promotion. Therefore, in our volunteer activities, we established health care lectures, guaranteed people’s health and warmth, told the public about disease prevention knowledge, and advocated a healthy and civilized lifestyle so that thousands of households were healthy.

The public was in favor of the activities. Each time, a large cinema or a hall was packed out, which showed that the masses longed for health.

By now, we have established cooperative relationships with 75 hospitals in 24 provinces, held more than 200 large-scale free medical service and health care lectures, screened nearly 200,000 people, guided and carried out 6,120 operations, and raised nearly 30 million yuan of beneficent funds and equipment. What was particularly important was that our volunteer service team went to the grassroots hospitals in the county and city to provide the nearest local treatment for patients, trained grassroots doctors, and left behind medical teams that would not leave.

As a result, many medical institutions have become regional cardiovascular disease treatment centers, and together formed a congenital heart disease treatment network and system in China. For example, the Anhui Taihe Hospital of Traditional Chinese Medicine developed into a national

www.heartbeatsaveslives.org

third-grade class-A hospital of traditional Chinese medicine; the First Hospital of Nanchang increased its capacity for congenital heart disease treatment, from more than 200 cases four years ago to 1,000 cases; and Xinjiang Hetian People’s Hospital established emergency green channels, significantly improved its capacity for cardiovascular disease treatment, and realized the objective of establishing medical teams that would not leave local districts.

In addition to the above activities, we actively promoted standardized treatment of congenital heart disease and organized experts to study and formulate the Common Knowledge about the Interventional Therapy of Frequent Congenital Heart Diseases among Chinese Experts; at the same time, at the Great Wall International Congress of Cardiology, we organized a special forum of structural cardiology and promoted academic exchanges and technical popularization. We cooperated with famous foreign institutions and established the “International Training Base for Congenital Heart Disease.” Such work has vigorously promoted the popularization of technology needed to treat congenital heart disease in China.

Driven by the Loving Care Project, the government and all social circles pay attention to congenital heart disease treatment. In 2010, the Ministries of Health and of Civil Affairs of the People’s Republic of China developed a related policy for congenital heart disease treatment which was integrated into the social security treatment system. Seventy

ONE HEART MAGAZINE

51

to ninety percent of the treatment cost can be reimbursed in various regions, which was an important measure to treat poor youth patients with congenital heart disease.

In April 2011, based on the Loving Care Project volunteer service team for treatment of the children patients with congenital heart disease, I organized more than 150 experts in various medical fields to establish the “general service team for medical volunteers.” Medical volunteers were not limited to congenital heart disease treatment, but included a number of other medical fields. Volunteers operated regardless of borders, with “all for the people’s health” as the mission, “excellent doctors having perfect skills and absolute sincerity” as the tenet, and followed the volunteer spirit of “dedication, love, mutual help, and progress.” The majority of physicians were asked to go to places where they were most needed by the state, society, and patients. There, they exchanged technical knowledge with grassroots physicians, guaranteed the health and warmth of the masses, and advanced the physician volunteers’ operation to a new stage.

Medical volunteers follow the concept that “great doctors walk on the road, great doctors offer great love, great doctors advocate great virtue, and great doctors act as important persons.”

Volunteers dedicate their love. In the past 20 years, I seldom rest on weekends and holidays, and I spend most of my time helping the academic and general promotion of grassroots medical technology. After the setup of a general volunteer team, I devoted a lot of time to volunteer work and led the team to develop relevant work in order to promote medical technology in western China and underdeveloped grassroots regions. In 2011, these activities required more than 410 hours of my volunteer service, including health lectures; free medical service; ward inspection, guidance and assistance; training, fundraising and donation of instruments and medicines; etc. Through volunteer assistance, we explored a feasible volunteer service model, namely: small action + many people + standardization = great

52

difference. A number of expert volunteers from various hospitals all over the country shared the tasks and provided centralized assistance, rapidly achieved medical technology promotion in assisted areas, and trained medical teams that would not leave local districts.

Under the current background of momentous medical reform in China, volunteers of the Loving Care Project cooperate with the government from the point of view of an NGO, carrying out a series of very fruitful tasks centering on the overall grassroots objective. The essence of the volunteer spirit is dedication, love, mutual help, and progress. What we do is to repay our motherland. The doctors can neither grow nor become experts without our national culture, social support, and patients. We go to places where we are most needed by the state, society, and patients; share our knowledge and technology; exchange technology and knowledge with the grassroots doctors; and guarantee health and warmth of the masses, so that more patients and more people benefit from our operation, thereby realizing both a harmonious doctor-patient relationship and harmonious society. The above work is highly praised by the government, society, media, and service interests.

I often advise people to have a healthy and happy life, and to take the opportunity to do the right thing. What is the right thing? I think that the right thing should take into account not only the interests of numerous people, but also the law of the development of things. Carrying out the Loving Care Project volunteer service is a right thing. At present, development of the grassroots medical technology in China is not balanced and needs to be enhanced.

Promoting fair and attainable medical service still has a long way to go, and a number of poor patients in underdeveloped areas need to be treated. We also need to appeal to more expert teams to participate in and support the volunteer service work. I believe that as a way of life and a life attitude, volunteer service is bound to be accepted by more and more people. In conclusion: we are walking on the road!

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Why is this patient short of breath?

O2 uptake, delivery or utilization

Cardiac output

Ventilation-perfusion matching

Pulmonary blood flow

Congestion Deconditioning

Early onset lactic acidosis

Systemic blood flow

Muscle energy metabolism

A simple, six-minute in-office test can help you find out with no capital risk to your practice.

In just six minutes Shape® can help drill down to the root cause of exertional dyspnea – right in the clinic. Shape is simple, objective and intuitive. With our pay-per-procedure plan there’s no cost for the device. Shape elevates cardiopulmonary exercise testing to a new level.

Learn more by calling 1-888-SHAPE98 (888-742-7398) or by visiting www.shapemedsystems.com.

SHAPE

™

Americans share something that cuts across race, gender and politics: A risk of heart disease.

Heart disease is the number one killer in the U.S. Your gender, age, race and ethnicity can affect your chance of developing heart disease. So itâ&#x20AC;&#x2122;s important to take charge of your heart health. Start by talking to your doctor and learning about your risk factors. You can also explore resources at Close the Gap, an initiative dedicated to helping people in your community live longer, healthier lives. Get the facts about heart disease at Your-Heart-Health.com.

Follow Close The Gap on: Copyright Š 2012 by Boston Scientific Corporation or its affiliates. All rights reserved.

Five-star luxury with charm T

he Turks and Caicos has been heralded by many as the perfect Caribbean destination for those looking to relax, be pampered, and get away from it all.

Turks and Caicos is located south east of the Bahamas and is made up of forty islands, although only eight are inhabited. Providenciales is the most developed of all the islands and is home to an international air hub, making it easily accessible from anywhere. Flights from Miami arrive in about an hour and a half and from New York it takes less than three hours.

Providenciales is also home to the world’s most beautiful beach. Grace Bay Beach has been named the world’s best beach several times and is consistently recognized as one of the most beautiful beaches by Conde Nast’s “Best in the World” polls. The flawless white sand stretches on for 12 miles and is known for its impossibly blue water and vibrant coral reefs. Situated at the heart of the exquisite Grace Bay Beach, the Regent Palms fuses traditional Caribbean hospitality with prestigious amenities and guest services, to deliver all the charm of the Caribbean with five star luxury and comfort. Boundless ocean views from stylishlyappointed suites ensure peace and tranquility.

The 72-suite Regent Palms resort in Turks and Caicos is one of the Caribbean’s best-kept secrets, however this year it was awarded the coveted ‘Hotel of The Year’ Award by the Turks and Caicos Hotel and Tourism Association. This is a testament not only to the splendor of the hotel, but also to the attentiveness of the staff that will go out of their way to pamper and indulge you.

Often lauded as the Turks and Caicos’ best property, the Regent Palms Spa has been listed by Conde’ Nast Traveler as the #2 in the Caribbean for the second year in a row.

Regent Palms’s signature dining experience at Parallel 23, an award winning AAA 3-Diamond restaurant was also honored as the Turks and Caicos number one restaurant last year. Parallel23 restaurant combines the best of Caribbean fusion cuisine with today’s more casual restaurant ambiance.

Endless full-height French doors and a hi-tech display kitchen with wow-factor wood-burning oven invite diners to enjoy the theatre of food preparation, while an extensive boutique wine list introduces even the most knowledgeable guest to a new www.heartbeatsaveslives.org

experience. Culinary tributes to land and sea include the freshest crab rolls and sea bass or melt-in-the-mouth veal tenderloin and Moulard duck, while for guests requiring a more intimate setting, private functions are catered for via a magnificent outdoor, domed dining room.

For those looking to indulge in a spa day, the Regent Palms

will not disappoint. The Spa at Regent Palms has recently revitalized and expanded its offerings to meet your individual needs. The newly launched spa menu offers results orientated treatments inspired by Eastern and Western rituals to heal the body, rest the mind, and soothe the soul. The Fitness Center has a complete set of cardiovascular and strength training equipment with a personal trainer available to guide you through an efficient and effective workout. The Wellness & Fitness Program includes a variety of beginner and advance classes to accommodate the activity levels of all guests. Flavorful, organic healthy dishes and beverages by an award-winning chef have been added to the spa and fitness programming. The perfect ending to your spa day is to attend the ‘Sunset Reflection’ inspired by an ancient royal Thai Ritual as well as the original explorers of the Caribbean Islands. The ceremony combines the healing properties of water, with the power and discovery of light.

ONE HEART MAGAZINE

55

Expe rience Experience

S

the Caribbean’s Best-Kept

The resort with the best awards gives you the best rewards.

Turks and Caicos’ leading resort, as proclaimed by the 2011 World Travel Awards, proudly introduces the Great Savings Upgrade.* » Deluxe Ocean Front Suites for the » Ocean View Suites for the price of price of Ocean Front Suites Pool View Suites » Ocean Front Penthouses for the price » Ocean Front Suites for the price of of Ocean View Penthouses Ocean View Suites Book through your favorite Travel Professional, Tour Operator or call 1.866.877.7256

* Great Savings Upgrade: Travel Dates: Now to December 19, 2012. Booking Dates: Now to December 15, 2012. 3 Night Minimum Stay Required. Based on availability. Cannot be combined with other promotions. Promo Code GSU. Reservation to be transmitted to the resort in the room type to be occupied. Valid for new reservations only.

Star Awards 2011 TCHTA Hotel of the Year | World Travel Awards 2011 Turks and Caicos Leading Travel + Leisure 500 World’s Best Hotels

Secret Secret.

www.regenthotels.com | 866-877-7256 Resort | Conde Nast Traveler 2011 & 2012 Readersâ&#x20AC;&#x2122; Poll Awards #2 Top Resort Spa: The Caribbean Awards 2010, Number 1 in Turks and Caicos

Million Hearts™

GALVANIZING CLINICIANS AND COMMUNITIES TO PREVENT U.S. HEART ATTACKS AND STROKES

By Janet Wright, MD, FACC Executive Director Million Hearts™ Initiative

C

ardiovascular disease is the leading cause of death for men and women of all races and ethnicities in the United States. Every day, nearly 5,500 Americans have a heart attack or stroke and more than 2,000 die from heart disease and stroke. What’s more, treatment of these diseases accounts for about $1 of every $6 spent on health care.

We have the science and the tools to fight heart disease and stroke and we have seen improvements, but we could prevent much more disability and save many more lives.

Janet Wright, MD, FACC That’s why in September 2011, the U.S. Department of Health and Human Services launched the Million HeartsTM initiative—a national effort by leaders in the public and private sectors to address the critical threat that cardiovascular disease poses to the nation.

Million Hearts™ is focused on preventing one million heart attacks and strokes by 2017. The initiative will achieve this goal through clinical and community prevention.

Through community prevention, we will reduce the number of people who need treatment; through clinical prevention, we will optimize care for those who do need treatment.

Over the past few months, we have brought together an unprecedented commitment from partners across the government, and across society, to put those tools to use like never before for a common purpose.

Within the U.S. federal government, this effort is led by the Centers for Disease Control and Prevention and the Centers for Medicare & Medicaid Services. However, this commitment goes beyond the federal government to include a broad range of medical and public health associations, non-profits, foundations, community organizations, government agencies, and businesses. By bringing their ingenuity, their resources, and their leadership to this effort we will have a much greater impact than if the government acted alone.

Specifically, the initiative focuses on improving the ABCS (Aspirin for those at risk, Blood pressure control, Cholesterol management, Smoking cessation) to prevent one million heart attacks and strokes in the United States by the end of 2016.

58

To reach that goal, we are taking steps to help: »» 10 million more Americans with high blood pressure bring it under control »» 5 million more Americans with high cholesterol bring it under control »» 4 million Americans quit smoking »» Reduce the average sodium intake by 20% »» Reduce the average trans fat intake by 50% We’re early in our journey and we know that the road ahead will present many challenges. But in its first year, the Million Hearts™ initiative has made tremendous progress in raising awareness among health care professionals, patients, and communities about how they can help reach the goal of preventing a million heart attacks and strokes. For example, we emphasized the importance of blood pressure control through a number of activities: »» Million Hearts™ promoted the Community Preventive Services Task Force new recommendation that team-based care (TBC) improves blood pressure

ONE HEART MAGAZINE www.heartbeatsaveslives.org

consumers’ awareness about the importance of asking the pharmacist for help with taking medications.

control. The Task Force’s review of 77 studies showed that patients’ control of blood pressure improved when their care was provided by a team of health professionals—including nurses and pharmacists—rather than by a single physician. »» CDC, co-lead of the initiative, published the latest data on the toll that hypertension takes among Americans. Vital Signs: Awareness and Treatment among US Adults with Uncontrolled Blood Pressure stated strongly that there are many missed opportunities for blood pressure control. A collaborative effort and increased focus on blood pressure from individuals, healthcare providers and healthcare systems is key to better control and reduced risk for heart attack and stroke. »» CDC also launched the “Team Up. Pressure Down” campaign in support of Million Hearts™ to increase the number of pharmacists who provide advice, especially tips on taking blood pressure medications as prescribed, to their customers with high blood pressure. The campaign also is working to increase www.heartbeatsaveslives.org

Million Hearts™ public and private partners in 2012 also contributed to growing awareness of and engagement with the initiative through a variety of activities, including educating consumers about heart health; sharing lessons learned about integrating heart health into state and local programs, clinical practices and health systems; and providing blood pressure screenings and referrals for treatment when needed.

In future years of the initiative, we will be able to share reports on progress in attaining our goal. We will report on improvements on the ABCS every one to two years through surveillance and surveys and on deaths annually through the vital statistics system. The initiative continually seeks information about best practices and results from “high performers” that can be shared broadly for maximum impact.

Over time, Million Hearts™ expects to be able to share its experience globally. It’s no secret that cardiovascular disease is the world’s leading cause of death. As news has spread about the U.S. effort, other countries have expressed interest in the Million Hearts™ framework as they develop their own initiatives to reduce cardiovascular disease within their borders. Just as this initiative seeks to share best practices domestically, Million Hearts™ leaders have engaged in conversations with Ministries of Health in other countries about their efforts to document and monitor the burden of cardiovascular disease and set achievable targets.

The U.S. government has a long history of engaging with the global community on a variety of communicable and noncommunicable diseases, including cardiovascular disease. Besides providing expert guidance on disease surveillance and research priority setting, the U.S. government has provided faculty to teach cardiovascular disease epidemiology and prevention to increase the numbers of people worldwide who can conduct epidemiologic studies and strengthen other efforts to prevent cardiovascular disease. To date, more than 1,300 physicians and scientists from more than 100 nations have participated in more than 40 seminars. The U.S. government has also collaborated on cardiovascular disease prevention, including reducing sodium consumption and improving high blood pressure control, with Australia, China, the United Kingdom, India, the European Union, and countries in Africa, the Americas, and Southeast Asia. These experiences have taught us that the public health learning community is not limited by national boundaries. We have been pleased to share our experiences and technical expertise and have also learned from the best practices of other countries.

I look forward to the day when we see a sustained decline in the number of the world’s citizens who are disabled or who die as a result of heart disease and stroke.

To be successful, every nation’s clinicians, health systems, communities, corporations, employers, and citizens must work together to improve their ABCS and realize the benefits for individuals and society of living a healthier lifestyle.

ONE HEART MAGAZINE

59

Imagine a private island with a spectacular two-mile, white sand beach and the only footprints are yours.

Such a place really exists.

Just 13 beachfront units and several private rental homes.

No cars, no crowds, no hassles.

It will win your heart.

Elegant cuisine and as much or as little as you want to do.

Daily Snorkeling Trips Bone, Reef, Deep Sea Fishing Off-Island Excursions New Spa Services

The Meridian Club on Pine Cay Turks and CaiCos islands For inFormation 649.941.7011 reservations@meridianclub.com meridianclub.com

Intersection of

common goals,

imploding diseases

and the will to tackle them

HEARTBEAT INTERNATIONAL FOUNDATION (HBI) AND ASSOCIATION OF PAKISTANIDESCENT CARDIOLOGIST OF NORTH AMERICA (APCNA) TACKLE NON COMMUNICABLE DISEASE IN RESOURCE POOR ENVIRONMENTS.

By Nadeem Afridi, MD, FACC Secretary, APCNA

N

CD’s (non communicable diseases) are threatening the physical health and economic security of many lower and middle-income countries (LMIC). In southeast Asia, it has been estimated that the share of death from NCD’s will increase from 51 percent to 72 percent of all deaths by 2030. In the Pakistan region, 1.3 billion people are at risk.

In most LMIC, there is wide spread prevalence of communicable diseases like Nadeem Afridi, MD, FACC malaria and tuberculosis.

Now these populations face a “double burden” of disease with the onslaught of NCD’s.

There is emerging evidence that due to infectious disease related inflammatory burden plus the prevalence of risk factors for NCD’s and heart disease is emerging

www.heartbeatsaveslives.org

at a much younger age. Another factor exacerbating the problem is that large populations are now living in poorly structured cities with congested housing, narrow streets and lack of open space for physical activity. This problem is far more severe for women since in many such societies women are expected to remain indoors. Consequently obesity, diabetes and hypertension have risen at an alarming rate for women in their 30’s and 40’s. This has lead to a higher burden of heart attacks and strokes which makes heart disease the number one killer for women internationally.

By 2030, it is estimated the population of Pakistan will exceed 245 million. Due to the Pakistani population transitioning from rural to urban areas, 60 percent of the population will be living in large cities. The infrastructure to accommodate such populations from rural area is lacking.

This will continue to lead people to compete for fewer resources, increase stress, raise tobacco consumption and reduce mobility with diets that are calorie dense as well as rich in sugars.

Limited access to healthcare, lack of understanding of diseases processes along with the inability to afford medical care, puts such populations at a high risk of developing NCD’s that remain undetected until it is too late. In addition, health insurance is not accessible to a large majority of our population. This leaves 80 percent to 90 percent of all health care being paid as an out of pocket expense in this group.

There is now ample evidence, that once the breadwinner

In southeast Asia, it has been estimated that the share of death from NCD’s will increase from 51 percent to 72 percent of all deaths by 2030. In the Pakistan region, 1.3 billion people are at risk.

ONE HEART MAGAZINE

61

in a household becomes ill, (earning less than $1,000 a year), the entire family is affected. Money has to be borrowed for treatment, children have to leave schools to join the work force at an early age and women have to sacrifice health for food. These circumstances are the factors that continue this vicious cycle of “poverty and ill health.” They will never be able to beat poverty therefore generations have to work their whole life to pay back debt.

Much of the rise in NCD’s in low to middle income countries is attributable to modifiable risk factors such as physical inactivity, unhealthy diet (including excessive sugars, fats and salt), tobacco use and exposure to environmental pollution.

There is evidence to suggest that half of the burden of the NCD’s may be reduced through effective health promotion and disease prevention programs.

Most countries in this region lack the means to “treat there way out” of the NCD challenge (as seen in the West). To achieve MDG’s (Millennium Development Goals), strategies have to be devised that emphasize prevention and health promotion along with targeted screening and treatments.

All strategies going forward have to be evidence based, context specific and cost effective. Community involvement, political will and multi-sector response are essential ingredients for such strategic planning.

Targeted health system adaptations can stem the tide of uncontrolled, NCD related and outcomes.

The role of the health sector is to assess the magnitude of the problem. First, present the evidence to society at large, help shape interventions, monitor and evaluate the outcome.

To generate evidence of prevalence of life style, vascular risk factors and disease, Association of Pakistani-Decent Cardiologist of North America (APCNA) with its partners (IRD Research, Indus Hospital and University of Texas) conducted a population based study and randomly selected a cohort in a poor suburb of Karachi, Pakistan. Our goal was to assess the prevalence of life style risk factors that were leading to physical and biochemical changes which lead to predisposing the population to NCD’s

Ours is the first study among randomly selected households in a transition population in Karachi and provides evidence that Karachi, one of the largest and fastest growing Asian megacities, has both high rates of anthropometric and biological markers for NCD risk factors and infectious diseases. Our study identified 20 percent of the population was overweight and 8 percent obese, while 18 percent of the participants had hypertension, 8 percent were diabetic and 16 percent had borderline-to-high cholesterol. We also found that 23 percent of the population was underweight, 24 percent 62

of the population had been exposed to hepatitis B virus, and 8 percent were positive for hepatitis C virus. Our findings confirm that Karachi is experiencing a classic demographic and epidemiological transition with an increasing burden of over-nutrition and NCD’s adding to an existing burden of under-nutrition and infectious diseases. We believe that our findings highlight the need for longitudinal research in highburden transition communities and the urgency of public health intervention programs tailored for these transition communities.

Despite the enormity of the problem especially in the low income communities, funding for NCD research and intervention is lagging.

To conduct long term surveillance work and devise cost effective interventions, consortiums and collaborations have to be built such that stake holders with common interests can pool there resources (both technical and financial) together. This would allow supervision, targeted, contest specific, cost effective interventions. Later, policy work can be conducted with governments to apply these learned lessons to larger populations.

Areas that need immediate attention include, community screening for disease and its risk factors (60 percent of hypertensive’s and 40 percent of diabetics, who have disease and do not know that they have disease), health education at schools on NCD’s at grades eight to twelve (including exercise, sweet drinks, and tobacco prevention), health promotion at the work place (educating tobacco abstinence, diet rich in fruits and vegetables). Community profiling including play grounds, stake holders, healthy food availability, accessibility to tobacco for kids under 18, has to be developed to devise a comprehensive response (Matrix of NCD). Most importantly, strategies have to be devised to educate and provide avenues for exercise for women, who are home bound (culturally promoted), giving the greatest sacrifices for the family and now getting afflicted by a higher share of the burden of NCD. Heartbeat International Foundation and APCNA, along with groups with shared interests in combating NCD’s in LMIC, is embarking on a challenging task to prevent heart disease and promote health. Although the distances are long and Pakistan is a tougher environment to work in, it is these very populations that need the most help to beat the cycle of poverty of disease and ill health. With our previously built networks (pacemaker bank initiative), extensive knowledge of people and language, and recently completed survey work, the ground has been laid to tackle NCD’s at its roots.

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Karachi is experiencing a classic demographic and epidemiological transition with an increasing burden of over-nutrition and NCDâ&#x20AC;&#x2122;s adding to an existing burden of under-nutrition and infectious diseases. www.heartbeatsaveslives.org

ONE HEART MAGAZINE

63

[

]

I WEAR IT BECAUSE...

when you’re married to your best friend, 20 years just isn’t enough.

Prescribe it to protect her from sudden cardiac arrest.

She will wear it for so many other reasons.

LifeVest median daily use is 94% or 22.6 hours per day

1

• 3 out of 4 patients sleep significantly better knowing they are protected by the LifeVest2 • LifeVest gives patients peace of mind2

800.543.3267 | www.zoll.com ©2012 ZOLL Medical Corporation. All rights reserved. ZOLL and LifeVest are trademarks and/or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries.

ZOLL. Patient Use, Indications, and Coverage. February 2012. Available at http://www.lifevest.zoll.com/medical-professionals/patientuse.asp, Accessed February 28, 2012.

1

Whiting J, Simon M. Health and Lifestyle Benefits Resulting from Wearable Cardioverter Defibrillator Use. The Journal of Innovations in Cardiac Rhythm Management, March 2012: 1-2.

2

20C0157revFI

Our Time:

A CALL TO SAVE PREVENTABLE DEATH FROM CARDIOVASCULAR DISEASE (HEART DISEASE AND STROKE) Writing Committee: Sidney C. Smith, Jr, MD, FACC, FAHA, FESC, Chair, Amy Collins, MA, Roberto Ferrari, MD, PhD, FESC, David R. Holmes, Jr, MACC, FAHA, FESC, Susanne Logstrup, Cand. Jur., MBA, FESC, Diana Vaca McGhie, MPA, Johanna Ralston, MA, MSc, Ralph L. Sacco, MS, MD, FAAN, FAHA, Hans Stam, PhD, Kathryn Taubert, PhD, FAHA, David A. Wood, MSc, FRCP, FRCPE, FFPHM, FESC, William A. Zoghbi, MD, FACC, FAHA The writing committee members represent the following participating organizations: World Heart Federation (S.C.S., A.C., J.R., K.T.), American Heart Association (D.V.M., R.L.S.), American College of Cardiology Foundation (D.R.H., W.A.Z.), European Heart Network (S.L., H.S.), and European Society of Cardiology (R.F., D.A.W.).

W

orldwide, the aging population, globalization, rapid urbanization, and population growth have fundamentally changed disease patterns.

Noncommunicable diseases (NCDs), of which cardiovascular disease (CVD) accounts for nearly half, have overtaken communicable diseases as the worldâ&#x20AC;&#x2122;s major disease burden.

CVD remains the No. 1 global cause of death, accounting for 17.3 million deaths per year, a number that is expected to grow to >23.6 million by 2030. Increasingly, the populations affected are those in low- and middle-income countries, where 80% of these deaths occur, usually at younger ages than in higher-income countries, and where the human and financial resources to address them are most limited [1]. www.heartbeatsaveslives.org

The epidemiological transition occurring is exacerbated by the lack of vital investment in sustainable health policies to address and curtail the risk factors associated with CVD and NCDs. Recognizing the profound mismatch between the need for investment in the prevention and control of CVD at the global and national level and the actual resources allocated, the international CVD community, under the umbrella of the World Heart Federation, joined the NCD community to call for a United Nations (UN) High-level Meeting on Non-communicable Diseases, held in September 2011. At this meeting, heads of state signed a Political Declaration that committed governments to the development of 4 specific measures to address the ONE HEART MAGAZINE

65

in low- and middle-income settings. Yearly, per

NCD burden in a Table 1. Suggested Global Targets to Address NCDs With Wide Support (See Appendix C) specific timeline: (1) Best Recommendation to Recommendations for Proposed Target Buy Member States a global monitoring framework that 1 Physical inactivity: 10% Relative reduction in prevalence of insufficient physical activity U Adopt 2 Raised blood pressure: 25% Relative reduction in prevalence of raised blood pressure U Adopt included 4NCD targets G L O B A L H EART, VOL. -, NO. -, 2012 Smith et al.

- 2012: 1–9 3 Salt/sodium intake: 30% Relative reduction in mean population intake of salt, with aim of achieving U Adopt to be completed by A Call to Save Preventable Death From CVD recommended level of <5 g/d (2000 mg of sodium) the end of 2012; (2) 4 Tobacco: 30% Relative reduction in prevalence of current tobacco smoking U Adopt development of a NCDs indicate noncommunicable diseases. plan for an effective multisector partnership by the end of 2012; Table 2. Proposed Targets and Indicators to Address NCDs With Some Support (See Appendix C) (3) national NCD plans Best Recommendation to by 2013; and (4) a Proposed Target Buy Member States comprehensive review 5 Saturated fat intake: 15% Relative reduction in mean proportion of total energy intake from U Adopt with modification to evaluate progress, to saturated fatty acids (SFA), with aim of achieving a recommended level of <10% of total energy take place in 2014 [2]. intake

6 Obesity: Halt the rise in obesity prevalence

Adopt

CELEBRATING THE 7 Alcohol: 10% Relative reduction in overall alcohol consumption (especially hazardous, excessive, and U Adopt with modification 2025 GLOBAL NCD harmful drinking) MORTALITY TARGET 8 Raised cholesterol: 20% Relative reduction in prevalence of raised total cholesterol Adopt Celebrating the 9 Drug therapy to prevent heart attacks and strokes: 50% Of eligible people receive drug therapy to U Adopt 1-year anniversary prevent heart attacks and strokes, and counseling 10 Essential NCD medicines and basic technologies to treat major NCDs: 80% Availability of basic Adopt of the passage of technologies and generic essential medicines required to treat major NCDs in both public and the UN Political private facilities Declaration, it is timely NCDs indicate noncommunicable diseases. that our respective organizations speak be necessary to address this emerging 21st century global with a single voice to advocate for a set of public health health priority and begin to reverse the devastating toll of interventions that have the potential to mitigate and reverse CVD and NCDs in our communities. the rising rates of CVD and NCDs. In May 2012, during the World Health Assembly, Ministers of Healthtotook the a day (US$0.43- may vary slightly in different regions of the world. person, this translates <US$1 MAINTAINING THE MOMENTUM TO ADDRESS first critical step by agreeing to adopt a global target to US$0.90) across low-income countries andTARGETS As such, when considering national NCD action OTHER reduce premature NCD mortality 2025, a target <US$3 25% a day by (US$0.54-US$2.93) across middleplans, all targets require adequate and wellA first step toward global will action has been the passage of the global CVD community has been advocating income countries [11]. since the developedtarget, indicators improvethe global mortality whichthat willencourage provide a the shared vision UN High-level Meeting on Non-communicable Diseases Several of the 10 targets being supported by the forment of data at the andtargets providearean on NCDs all stakeholders andcountry ensure level that all [3]. We applaud the WorldNCD Health Assembly for a community have reaching been identified within this impetus to countries thatthis have the tools togoal. collect appropriately developed to achieve overarching consensus on this bold goal. core set of “Best Buy” interventions and As are the at risk andorganizations monitor data.that Moreover, improved healthcare leading represent thousands of The UN Political Declaration and the of failingontoNCDs be adopted as recent global targets, members including indelivery and an expanded nearly every country, and health for theworkforce millions ofwith resolution to reduce premature NCD deaths drug by 25% are regimen to address coordination of local and national approaches are the evidence-based therapy individuals with, or at risk of CVD, we are aligning with the landmark achievements for the health and CVD community. those at highest risk for developing CVD. StudiesNCDparamount health broader communityinin building support ofcomprehensive a comprehensive set For the first time in history, NCDs have that beennearly recognized have indicated 17.9 million deaths could systems achieve this end. of additional targetsto that will ensure this global reduction is as a development issue. These targets indicators have be averted overand a 10-year period with the implemenachieved. the potential to address longstanding health challenges, tation of multidrug therapy [11]. The cost would The challenge faced by countries will be to reach including the fragmentation of health funding, gapsainday theannually. Beyond amount to just over US$1 agreement concerning G L O B A L Cthe A Radditional D I O V A S Ctargets U L A R and indicators healthcare infrastructure, the andlives the saved lack of local reliable and the and life-years extended,toreducing be part ofTthe comprehensive monitoring A S K F O R C E S U M M A R Y P O Sframework ITION: data, and will address thethe growing demand for integrated mortality rate for ischemic heart disease and the to achieve overarching global mortality target.

InDthe P R E V E N T I O N , R I S K F A C T O R S, AN disease management. As stroke the Millennium Development by 10% would also reduce economic lossesof 2010, T R E AaT World M E N THealth Organization (WHO) summer Goals come to a close in 2015, theand CVDmiddle-income community iscountries set in lowbytechnical an esti- working group developed 10 proposed global to ensure that the single largest cause of death—CVD—is mated US$25 billion per year [12]. Drugtargets therapy, Member taken virtually the first unchanged step and set (Appendix A), States whichhave remained addressed. As such, all relevant need to be multiple part singly stakeholders or in combination with drugs, a bold overarching reducing mortality from until theisspring of 2012 [4]. Atgoal thatof time, Member of the process, putting optimal health to atbe thea concrete cornerstone of documented investment and should NCDs by 25% by 2025.and We other now have the opportuStates, civil society organizations, relevant development. be a target to be accomplished. to asked make meaningful changes in our countries by stakeholdersnity were to comment on and make It is our desire to see heart stroke As disease Memberand States look receive to finalize targets in the adopting evidence-based and implementing specific recommendations regardingtargets the global monitoring the attention they deserve.

We recognize the process is country-level coming months,that doubt regarding tactics thatand willthe guide healthtargets policy,and chronic disease framework for NCDs specific indicators complex and the time is short, but we an opportunityof NCD intercompliance inhave the implementation plans and, ultimately, resources national public that would be used to guide countries and for measure progress. to ensure that the commitments in September 2011 ventions,made as a result of underdeveloped monitoring interventions. of before these are feasible The original health set of 10 targets was Many reduced completion translate into real global, and thus national, actionmust for years and surveillance systems, not overshadow the consultations and cost-effective.

Reducing NCDs central to of regional and with limited inputare of Member to come. Collaboration among appropriate stakeholders real, cost-effective, and feasible will solutions offered a country’s economic growth. As such, we respectby the WHO “Best Buys.” Collection of data, for fully request Member States to consider our recom66 ONE HEART MAGAZINE www.heartbeatsaveslives.org all targets, remains a critical issue that can, and mendations and adopt the evidence-based targets to should, be addressed through the Global Moni- address CVD and NCDs and avert millions of toring Framework. It is recognized that target levels

HEART DISEASE Is More Than Just

HIGH CHOLESTEROL… 1.

Chronic inflammation is increasingly recognized as a more significant risk factor than elevated serum lipids.

2.

Risk assessment of cardiovascular disease should now include a comprehensive aray of metabolic markers.

3.

Abnormal levels of these analytes can often be corrected using individualized integrative therapies.

Chronic Inflammatory Markers: High Sensitivity C-Reactive Protein is a general marker of chronic inflammation or infection in the vascular network.

Fibrinogen is a better marker for a coronary event than elevated cholesterol.

Ferritin is the greatest measure of iron deficiency, as well as a marker for hemochromatosis.

Oxidant Stress Factors: Coenzyme Q10, critical to the generation of mitochondrial ATP and for myocardial efficiency; inhibited by “statin” drugs.

Serum Lipid Peroxides, a monitor of the tissue damaging effects of oxidative stress.

Homocysteine, which, when elevated, has shown a close association with CVD. Responds to doses of B6, B12, and folate.

Vitamin E is well recognized for its antioxidant role; now though to prevent the oxidation of LDL.

Other Unique Indicators: Erythrocyte Magnesium has been shown to be inversely related with hypertension. Mg supplenation may be a healthier alternative to calcium channel blockers.

Fasting Insulin is a good predictor of insulin insenstivity associated with Metabolic Syndrome, which is now recognized as a major contributor to the development and progression of CVD and Type II diabetes.

Total Testosterone and Sex Hormone Binding Globulin are used to calculate the Free Androgen Index, an accurate approximation of free testosterone. The FAI is linked to many aspects of heart disease in both men and women. When used to normalize testosterone levels, cardiac function and many known CVD risk factors are improved.

-Combines conventional and innovative new markers to better evaluate risk for cardiovascular disease.

-Comprehensive, going beyond blood lipids to include markers of nutrition, oxidative damage, inflammation, and hormone imbalances -Includes customizable treatment options based on each patient’s risk profile.

Defy Medical Cardiovascular Panel Specimen Requirements

-6ml total (2 tubes, 3ml each) of serum -1-2ml of plasma -whole blood

Method

-Automated Chemistry -Immunometric Assay -EIA -HPLC

Turnaround Time

-10-14 days (12-day average)

Analytes Reported Lipoprotein Factors

-Total Cholesterol -HDL Cholesterol -Triglycerides -Lipoprotein (a) -LDL Cholesterol (Direct)

Lipoprotein Ratios -LDL/HDL -Total/HDL

Chronic Inflammatory Markers -Ferritin -Fibrinogen -C-Reactive Protein (HS)

Oxidant Stress Factors -Coenzyme Q10 -Vitamin E -Lipid Perozides -Homocysteine

Other Important Indicators

-RBC Magnesium -Insulin -Testosterone -Sex Hormone Binding Globulin -Free Androgen Index (calc.)

To learn more about our services please

CALL: 407-808-3396

www.defymedical.com (813) 445-7342

Luxury Oceanfront Resort and Yacht Harbour

Discover Another World

1.888.800.8959 sales@oldbahamabay.com

Just 56 miles off the coast of Florida, situated on the western tip of Grand Bahama Island, lies Old Bahama Bay, the ultimate getaway for tranquility, relaxation and pampered service. Combining Bahamian charm and luxury, Old Bahama Bay features 72 spacious beachfront suites, oceanfront pool, state-of-the-art marina and the region's - if not the world's - finest fishing, diving, snorkeling and boating activities.

- 2012: 1–9

A Call to Save Preventable Death From CVD

States (Appendix B) [5]. Calls to action from the CVD, NCD, and specific riskfactor communities did, however, lead to positive changes within this reduced set of targets and included the insertion of a new target on physical activity.

The inclusion of this target in the list of recommendations was a milestone in NCD advocacy efforts, ensuring that each of the major risk factors leading to NCDs was addressed. With the release of the third WHO discussion paper [6], the NCD community’s advocacy efforts are to be noted as the list of recommended targets for adoption includes 10 strong, evidencebased strategies. Together, the Global Cardiovascular Disease Taskforce calls on the CVD community to endorse and support the top 4 widely supported exposure targets (Table 1) on physical inactivity, hypertension/blood pressure, dietary salt intake, and tobacco as those required to achieve the overarching goal of a 25% reduction in premature mortality by 2025.

Other, originally proposed targets to address NCDs that were dropped in the second WHO discussion paper include evidence-based targets on obesity, trans fat/fat intake, alcohol, and multidrug therapy to prevent and treat CVD (Table 2) [7]. Although these targets have been included in the most recent discussion paper, they have been identified as having limited support and will need further advocacy to ensure their adoption [7]. In addition to supporting the NCD community in their call for Member States to agree on this global set of 10 voluntary targets, we also explicitly call for Member States to be ambitious and ensure that they address those persons at highest risk now by adopting the additional exposure and health systems targets currently under consideration.

To halt and reverse the NCD epidemic, it is paramount that the CVD burden be adequately addressed, which requires that those living with CVD and at highest risk of developing CVD have access to treatment and care. The 2011 report by the WHO, Scaling Up Action Against Noncommunicable Diseases: How Much Will It Cost?, details a core set of low-cost strategies, identified as “Best Buys” that all countries can implement to prevent and treat 70

APPENDIX A. ORIGINAL SET OF TARGETS

Outcome Targets

Indicator

Source

Premature mortality from NCDs

Unconditional probability of dying between

Civil registration system, with medical

25% Relative reduction in overall

ages 30 and 70 y from CVD, cancer, dia-

certification of cause of death, or survey

mortality from CVD, cancer, diabetes,

betes, or chronic respiratory disease

with verbal autopsy

Age-standardized prevalence of diabetes

National survey (with measurement)

or chronic respiratory disease Diabetes 10% Relative reduction in the prevalence of diabetes mellitus (elevated blood glucose level 7.0 mmol/L [26 mg/dL]

mellitus among persons age 25 y (defined

as fasting plasma glucose 7.0 mmol/L

[126 mg/dL] or on treatment for diabetes)

or on treatment for diabetes) Exposure Targets Tobacco smoking

40% Relative reduction in prevalence of current tobacco smoking Alcohol 10% Relative reduction in alcohol per capita consumption among persons age 15 y

Dietary salt intake Mean adult population intake of salt

Age-standardized prevalence of current

National survey

tobacco smoking among persons age 15 y Per capita consumption of pure liters of

Official statistics and reporting systems for

alcohol among persons age 15 y

production, import, export, and sale or

Age-standardized mean population intake

National survey (with measurement)

taxation data and national survey

of salt per day in grams

<5 g/d (2000 mg of sodium) Blood pressure/hypertension

National survey (with measurement)

25% Relative reduction in the prevalence of elevated blood pressure (defined as systolic blood pressure 140 mm Hg and/

or diastolic blood pressure 90 mm Hg)

Obesity

No increase in obesity prevalence Prevention of heart attack and stroke 80% Coverage of multidrug therapy (including glycemic control) for people age 30 y with a 10-y risk of heart attack or stroke 30%, or existing CVD

Cervical cancer screening

Age-standardized prevalence of obesity

National survey (with measurement)

(defined as BMI 30 kg/m2) in persons age 25 y

Percentage of people age 30 y with a 10-y

National survey (with measurement)

risk of heart attack or stroke 30%, or

existing CVD who are currently on multidrug therapy (including glycemic control) Prevalence of women between ages 30 and

80% Of women between ages 30 and

49 y screened for cervical cancer at least

49 y screened for cervical cancer at least

once

National survey; health facility data

once Elimination of industrially produced trans

GLOBAL HEART, VOL. -, NO. -, 2012 -fatty 2 0 1 2acids : 1 – 9 (PHVO) from the food supply

Adoption of national policies that eliminate

Policy review

PHVOs in the food supply

Smith et al.

A Call to Save Preventable Death From CVD

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease; BMI, body mass index; and PHVO, partially hydrogenated vegetable oil.

APPENDIX B. REDUCED LIST OF TARGETS

Outcome Targets

Indicator

Data Source(s)

Mortality from NCDs

Unconditional probability of dying

Civil registration system, with medical certifi-

25% Relative reduction in overall

between ages 30 and 70 y from CVD,

cation of cause of death, or survey with verbal

mortality from CVD, cancer, diabetes,

cancer, diabetes, or chronic respiratory

autopsy

or chronic respiratory disease

disease

Blood pressure/hypertension

25% relative reduction in the prevalence

National survey (with measurement)

25% Relative reduction in the prevalence of elevated blood pressure (defined as of elevated blood pressure (defined as systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg)

Tobacco smoking

systolic blood pressure 140 mm Hg and/or diastolic blood pressure 90 mm Hg)

Age-standardized prevalence of current

40% Relative reduction in prevalence

tobacco smoking among persons

of current tobacco smoking

age 15 y

Dietary salt intake Mean adult population intake of

Age-standardized mean population

National survey

National survey (with measurement)

intake of salt per day in grams

salt <5 g/d (2000 mg of sodium) Physical inactivity 10% Relative reduction in prevalence of insufficient physical activity in adults aged 18 y

Age-standardized prevalence of obesity

National survey

(defined as BMI 30 kg/m2) in persons age 25 y

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease; and BMI, body mass index.

APPENDIX C. CURRENT SET OF ONE HEART MAGAZINE www.heartbeatsaveslives.org TARGETS

of insufficient physical activity in adults aged 18 y

age 25 y

NCDs indicate noncommunicable diseases; CVD, cardiovascular disease; and BMI, body mass index.

APPENDIX C. CURRENT SET OF TARGETS

Outcome Targets

Indicator

Premature mortality from NCDs

Unconditional probability of dying between Civil registration system, with medical certifi-

Data Source(s)

25% Relative reduction in overall

ages 30-70 y from CVD, cancer, diabetes, or cation of cause of death, or survey with verbal

mortality from CVD, cancer, diabetes,

chronic respiratory disease

autopsy

or chronic respiratory disease Exposure Targets Alcohol

Total (recorded and unrecorded) alcohol

Official statistics and reporting systems for

10% Relative reduction in overall alcohol

per capita ( 15 y) consumption within

production, import, export, and sales or taxa-

consumption (including hazardous and

a calendar year in liters of pure alcohol

tion data

Age-standardized mean proportion of

National survey

harmful drinking) Fat intake 15% Relative reduction in mean proportion of total energy intake from Smith et al.

A Call to Save Preventable From(SFA), CVD with aim of saturated Death fatty acids

total energy intake from saturated fatty acids (SFA) in adults aged 18 y

GLOBAL HEART, VOL. -, NO. -, 2012 - 2012: 1–9

achieving recommended level of <10% of total energy intake Obesity Halt the rise in obesity prevalence

Age-standardized prevalence of obesity among adults aged 18 y

National survey (with measurement)

Physical inactivity continued 10% Relative reduction in prevalence Outcome Targetsphysical activity of insufficient

Age-standardized prevalence of insufficient

National survey

physical activity in adults aged 18 y Indicator

Data Source(s)

Raised blood pressure

Age-standardized prevalence of raised

National survey (with (continued measurement) on next page)

25% Relative reduction in prevalence of raised blood pressure Raised cholesterol 20% Relative reduction in prevalence of raised total cholesterol Salt/sodium intake 30% Relative reduction in mean

blood pressure among adults aged 18 y Age-standardized prevalence of raised total National survey (with measurement) cholesterol among adults aged 18 y Age-standardized mean adult (aged 18 y)

National survey (with measurement)

Age-standardized prevalence of current

National survey

population intake of salt per day

population intake of salt, with aim of achieving recommended level of <5 g/d (2000 mg of sodium) Tobacco 30% Relative reduction in prevalence

tobacco smoking among persons

of current tobacco smoking

aged 15 y

Health Systems Response Targets Drug therapy to prevent heart attacks

Drug therapy to prevent heart attacks and

and strokes

strokes (including glycemic control), and

50% Of eligible people receive drug therapy to prevent heart attacks and strokes, and counseling

National survey

counseling for people aged 40 y with

a 10-year cardiovascular risk 30% (includes

those with existing cardiovascular disease)

Essential NCD medicines and basic

Availability of basic technologies and

technologies to treat major NCDs

generic essential medicines required to

80% Availability of basic technologies

treat major NCDs in public and private

and generic essential medicines required

sector facilities, including primary care

to treat major NCDs in both public and

facilities

Facility data

private facilities NCDs indicate noncommunicable diseases; CVD, cardiovascular disease.

NCDs. This list includes populationcontributor to global mortality, based measures to address risk accounting for nearly half of the factors and specific individual-based 36 million NCD deaths, and with a R E F E R E N C E Sincluding a multidrug interventions, global cost of nearly US $863 billion, 1. World regimen Health Organization, World a statin, A65/54: Second report of Committee nmh/events/2012/targets_feedback_ therapy of aspirin, achieving the global target to reduce Heart Federation, World Stroke A. Published May 25, 2012. Available summary_22032012.pdf.

Accessed and Organization. blood pressure-lowering to Global atlas on cardio- agents at: http://apps.who.int/gb/ebwha/pdf_ 7, 2012. premature NCDAugust deaths by 25% vascular disease prevention and files/WHA65/A65_54-en.pdf.

6. World Health Organization. Revised prevent and andAugust 7,requires that CVD and itsdiscussion risk factors be control:heart policies, disease strategies, and inter-stroke Accessed 2012. [third] WHO paper on the ventions.

Published 2011.

Available 4.

World Health Organization.

WHO development of a comprehensive global to treat those with, or at highest risk adequately addressed [9].

The Global at: http://www.who.int/ discussion paper: a comprehensive monitoring framework, including indiof, heart disease and stroke [8].global As monitoringCardiovascular Taskforce supports cardiovascular_diseases/publications/ framework and cators, and a set of voluntary the global atlas_cvd/en/. Accessed August 7, voluntary global targets for the targets for the prevention and control Member States determine how best to set of recommendations identified 2012. prevention and control of NCDs. of NCDs. Published July 2012. Avail2. United this Nations Generaltarget, Assembly.

Updated Decemberby 21, the 2011.WHO Avail- as able at: Buys,” http://www.who.int/nmh/ achieve global the global “Best feasible Resolution adopted by the General able at: http://www.who.int/nmh/ events/2012/ncd_discussion_paper/en/ CVDAssembly: community looks to this package and cost-effective interventions that 66/2: Political Declaration events/2011/consultation_dec_2011/ index.html.

Accessed July 25, 2012. of the High-level Meeting of the WHO_Discussion_Paper_FINAL. 7. World Health Organization. Second of the WHO’s “Best Buys” as a critical can be undertaken regardless of the General Assembly on the Prevention pdf. Accessed August 7, 2012.

WHO discussion paper: a comprehenControl of Non-communicable 5. World Health Organization. global monitoring framework wayand forward. incomeWHO level of sive a country.

This core Diseases. Adopted September 19, discussion paper: summary of feedincluding indicators and a set of are recommended 2011; published January 24, 2012. back from memberset statesof on interventions the first voluntary global targets for the prevenhttp://www.who.int/ discussion paper on the proposed tion and control of noncommunicable CVDAvailable ANDat:THE WHO BEST BUYS at 2 levelsepopulationwide measures nmh/events/un_ncd_summit2011/ global monitoring framework and diseases. Published March 22, 2012. political_declaration_en.pdf. indicators and targets the prevenAvailable at: http://www.who.int/ With CVD as the largest single to for reduce exposure to risk factors and Accessed June 26, 2012.

3. World Health Organization. 65th

www.heartbeatsaveslives.org World Health Assembly document

tion and control of noncommunicable diseases. Published March 22, 2012.

Available at: http://www.who.int/

nmh/events/2012/discussion_paper2_ 20120322.pdf. Accessed August 7, 2012.

interventions targeting individuals who already have NCDs or are at high risk of developing themeand are implemented through a systematic layered approach.

Regarding population-wide risk factor measures, the WHO has identified “Best Buys” in the areas of tobacco use, harmful use of alcohol, salt intake, physical activity, and replacement of trans fat with polyunsaturated fat.

Interventions targeting individuals include evidence-based, cost-effective medical therapies alongside counseling, as well as aspirin therapy for acute myocardial infarction [10].

On the occasion of the UN Highlevel Meeting in September 2011, the WHO introduced a tool for low-, middle-, and high-income countries to guide and estimate the feasibility of the implemention of this core set of NCD interventions [8]. The cost of the interventions is <US$11.4 billion per year in low- and middle-income settings. Yearly, per person, this translates to <US$1 a day (US$0.43US$0.90) across low-income countries and <US$3 a day (US$0.54-US$2.93) across middleincome countries [11].

Several of the 10 targets being supported by the NCD community have been identified within this core set of “Best Buy” interventions and are at risk of failing to be adopted as global targets, including the evidencebased drug therapy regimen to address those at highest risk for developing CVD. Studies have indicated that nearly 17.9 million deaths could be averted over a 10-year period with the implementation of multidrug therapy [11]. The cost would amount to just over US$1 a day annually. Beyond the lives saved and the life-years extended, reducing the mortality rate for ischemic heart disease and stroke by 10% would also reduce economic losses in lowand middle-income countries by an estimated US$25 billion per year [12].

Drug therapy, singly or in combination with multiple drugs, is documented to be a concrete investment and should be a target to be accomplished.

As Member States look to finalize targets in the coming months, doubt regarding country-level compliance in the implementation of NCD interventions, as a result of underdeveloped monitoring and ONE HEART MAGAZINE

71

surveillance systems, must not overshadow the real, costeffective, and feasible solutions offered by the WHO “Best Buys.” Collection of data, for all targets, remains a critical issue that can, and should, be addressed through the Global Monitoring Framework. It is recognized that target levels may vary slightly in different regions of the world. As such, when considering national NCD action plans, all targets will require adequate and welldeveloped indicators that encourage the improvement of data at the country level and provide an impetus to countries that have the tools to collect and monitor data. Moreover, improved healthcare delivery and an expanded health workforce with coordination of local and national approaches are paramount in building comprehensive health systems to achieve this end.

GLOBAL CARDIOVASCULAR TASKFORCE SUMMARY POSITION: PREVENTION, RI S K FACTORS, AND TREATMENT Member States have taken the first step and set a bold overarching goal of reducing mortality from NCDs by 25% by 2025. We now have the opportunity to make meaningful changes in our countries by adopting evidence-based targets and implementing tactics that will guide health policy, chronic disease plans and, ultimately, resources for national public health interventions. Many of these are feasible and cost-effective. Reducing NCDs are central to a country’s economic growth. As such, we respectfully request Member States to consider our recommendations and adopt the evidence-based targets to address CVD and NCDs and avert millions of deaths by 2025.

REFERENCES

1. World Health Organization, World Heart Federation, World Stroke Organization. Global atlas on cardiovascular disease prevention and control: policies, strategies, and interventions. Published 2011. Available at: http://www.who.int/cardiovascular_diseases/publications/atlas_cvd/en/.

Accessed August 7, 2012.

2. United Nations General Assembly. Resolution adopted by the General Assembly: 66/2: Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable

72

Diseases. Adopted September 19, 2011; published January 24, 2012.

Available at: http://www.who.int/nmh/events/un_ncd_summit2011/ political_declaration_en.pdf. Accessed June 26, 2012.

3. World Health Organization. 65th World Health Assembly document A65/54: Second report of Committee A. Published May 25, 2012.

Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA65/A65_54-en. pdf. Accessed August 7, 2012.

4. World Health Organization. WHO discussion paper: a comprehensive global monitoring framework and voluntary global targets for the prevention and control of NCDs. Updated December 21, 2011. Available at: http://www.who.int/nmh/events/2011/consultation_dec_2011/WHO_ Discussion_Paper_FINAL.pdf. Accessed August 7, 2012.

5. World Health Organization. WHO discussion paper: summary of feedback from member states on the first discussion paper on the proposed global monitoring framework and indicators and targets for the prevention and control of noncommunicable diseases. Published March 22, 2012.

Available at: http://www.who.int/nmh/events/2012/targets_feedback_ summary_22032012.pdf. Accessed August 7, 2012.

6. World Health Organization. Revised [third] WHO discussion paper on the development of a comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of NCDs. Published July 2012. Available at: http://www.who.int/ nmh/events/2012/ncd_discussion_paper/en/index.html. Accessed July 25, 2012.

7. World Health Organization. Second WHOdiscussion paper: a comprehensive global monitoring framework including indicators and a set of voluntary global targets for the prevention and control of noncommunicable diseases. Published March 22, 2012. Available at: http://www.who.int/nmh/events/2012/discussion_paper2_20120322.pdf.

Accessed August 7, 2012.

8. World Health Organization, 2011. Scaling up action against noncommunicable diseases: how much will it cost? Published September 2011. Available at: http://www.who.int/nmh/publications/cost_of_inaction/ en/. Accessed August 7, 2012.

9. Bloom DE, Cafiero ET, Jané-Llopis E, Abrahams-Gessel S, Bloom LR, Fathima S, Feigl AB, Gaziano T, Mowafi M, Pandya A, Prettner K, Rosenberg L, Seligman B, Stein AZ, Weinstein C. The Global Economic Burden of Non-communicable Diseases. Geneva, Switzerland: World Economic Forum; 2011.

10. World Health Organization. Global status report on noncommunicable diseases 2010. Published April 2011. Available at: http://www.who.int/ nmh/publications/ncd_report2010/en/. Accessed August 7, 2012.

11. World Economic Forum and World Health Organization. From burden to “best buys”: reducing the economic impact of non-communicable diseases in low- and middle-income countries. Published September 2011. Available at: http://www.who.int/nmh/publications/best_buys_ summary/en/index.html. Accessed August 7, 2012.

12. Lim SS, Gaziano TA, Gakidou E, Reddy KS, Farzadfar F, Lozano R, Rodgers A. Prevention of cardiovascular disease in high-risk individuals in low-income and middle-income countries: health effects and costs.

Lancet 2007;370:2054–62.

ONE HEART MAGAZINE www.heartbeatsaveslives.org

The World Leader In External Counterpulsation Lumenair™ EECP® Therapy System

A Non-Invasive Treatment for Angina and Heart Failure  U.S. FDA Cleared  Covered by Medicare & Private Insurers  Evidence-Based Science, with Over 150 Peer Reviewed Publications  CE Mark ISO 13485 Certified MDD Annex II  Regulatory Clearances In Many Other Countries

Expect More...

Accept No Substitute...

Demand the Very Best.

Vasomedical EECP® improves endothelial function, prevents the progression of cardiovascular disease and supresses vascular aging & organ damage.

Increases blood flow, coronary perfusion and cardiac output

Decreases endothelin and arterial stiffness

Increases coronary fractional flow reserve and collateral circulation

Decreases vascular resistance and intimal hyperplasia

Increases nitric oxide, circulating endothelial progenitor cells and angiogenic growth factors

Decreases proinflammatory cytokines, TNF-α and MCP-1

Write: Vasomedical, Inc. 180 Linden Avenue Westbury, NY 11590 USA Call: +1 800-455-3327 Ext. 149 +1 516-997-4600 Ext. 149 Fax: +1 516-997-2299 E-mail: sales@vasomedical.com

AngioNew®-V Portable EECP® Therapy System

Clinical Results also Documented In:*  Peripheral Vascular Disease  Cerebral Vascular Disease  Renal Disease  Hypertension  Erectile Dysfunction www.heartbeatsaveslives.org

For More Information,

*

Not FDA Cleared Indications

Visit: www.eecp.com www.eecpforum.com www.vasomedical.com Download: The EECP® Therapy iPhone Application

ONE HEART MAGAZINE Available on the App Store

73

Making a

Global

Difference in Battling Cardiovascular Disease

AMERICAN COLLEGE OF CARDIOLOGY EXPANDS INTERNATIONAL FOCUS THROUGH EDUCATION, PRACTICE STANDARDS INITIATIVES, COMMUNICATIONS

74

ONE HEART MAGAZINE www.heartbeatsaveslives.org

C

ardiovascular disease (CVD) has no borders. It remains the number one cause of death around the globe. According to the World Health Organization, deaths from CVD and stroke currently account for 30% of global death and are expected to reach more than 20 million within the next decade and 24 million by 2030.

Given these statistics, there is no denying room for considerable improvement in care.

There is also a unique opportunity, particularly given today’s mobile and digital technologies, for cardiovascular professionals around the world to come together to help ease this global burden through the sharing of education and knowledge. Comparisons across the globe of issues and approaches to treating and preventing cardiovascular disease can provide important insights, unattainable within any one homogeneous group.

To these ends, the American College of Cardiology (ACC) has developed a comprehensive international strategy focused on expanding international participation in educational activities, furthering international knowledge exchange, encouraging international participation in practice standards and quality initiatives, and increasing communications around international issues and activities.

TAKING EDUCATION GLOBAL On the education front, the College’s international leaders have spent the last several years enhancing the breadth of the ACC’s international education activities.

Meetings like the ACC’s Annual Scientific Sessions and others held by national societies around the world are important for bringing together cardiovascular professionals, promoting knowledge exchange, and providing information on the latest evidence-based science. Ever-increasing web and video access make these meetings more globally accessible, particularly to those in countries with greater deprivation or conflict.

Among the changes, the ACC has developed a comprehensive international track at its own annual meeting with popular lunchtime symposia highlighting international society efforts on various topics of import to their respective communities. For example, with imaging and patient selection top of mind for physicians using catheter-based and minimally invasive surgeries, the joint ACC session with the Canadian Cardiovascular Society (CCS) focused on three-dimensional echocardiographic imaging, minimally invasive mitral repair, transcatheter aortic valve intervention, periprosthetic regurgitation closure and structural heart disease interventions. A Joint Session of the ACC and the Saudi Heart Association (SHA) featured representatives from the U.S. and the Kingdom of Saudi Arabia comparing and contrasting their countries’ registries and the patient experience. www.heartbeatsaveslives.org

In an interview during the conference, Huon Gray, M.D., chair of the ACC Assembly of International Governors (AIG) at the time and consultant cardiologist at the University of Southampton in the United Kingdom, explained the importance of these joint international sessions the best: “Cardiovascular diseases are conditions with global relevance,” he said, “and whilst their underlying causes are broadly the same the world over, the approach that countries take to their prevention and management vary significantly.”

In addition to the ACC’s annual scientific session, ACC faculty attends over 50 meetings each year around the world. The College also partners with international organizations to host innovative events abroad. After each year’s Scientific Sessions, a condensed “Best of ACC” program has attracted large audiences when presented in countries overseas. The ACC Cardiovascular Symposium, featuring Valentin Fuster and hosted in conjunction with the Brazilian Society of Cardiology (SBC), was another highly popular international presentation which drew 2,000 attendees in Sao Paulo in 2012.

The College has also tailored its Cardiovascular Leadership Institute program for international audiences.

In February 2012, the ACC held its first-ever international program for Cardiovascular Trainees in Mexico. This two-day program featured case presentations and was hosted by the ACC Mexico Chapter. ACC’s international efforts also include cross-sectorial collaboration. One such initiative is the new ACC and ACC China Chapter atrial fibrillation (AFib) training program sponsored by Boehringer Ingelheim. This one-day program will be delivered at 10 different hospitals across China in 2013 and will help educate approximately 3,500 Chinese physicians.

SHARED KNOWLEDGE LEADS TO BETTER OUTCOMES With nearly 1 in 4 cardiologists in the U.S. being ONE HEART MAGAZINE

75

foreign medical graduates, it is natural for us to reach across national borders to improve cardiovascular care through the sharing of information. Knowledge exchange is a key tenet for improving global cardiovascular health.

A great example of collaboration is the “Twinning Program” partnerships between several ACC chapters in the United Sates and international societies. The Twinning project between the ACC California Chapter and the British Cardiovascular Society (BCS) is the longest running of the programs. Despite being more than 5,000 miles apart, the program provides many opportunities for collaboration on educational programs, resources, and participation in institutional visits, lecture tours, and observerships. Other Twinning programs between Pennsylvania and Italy, and most recently Florida and the Spanish Cardiology Society, are also currently underway.

“ACC’s international strategy has been immensely successful over the last several years,” said John Gordon Harold, M.D., ACC’s incoming president-elect, who launched the Twinning program with BCS. “It has stimulated the Twinning initiative, and created over 20 international chapters, the creation of the AIG, international fellowships, and many highly rewarding personal relationships that might never have come to be without the drive and support of ACC state chapters.”

Sharing knowledge with the next generation of cardiovascular professionals is also of vital importance.

The ACC is working both within the United States and with several international chapters to develop mentoring programs for Fellows in Training (FITs). Currently, ACC’s FIT network consists of 825 young cardiologists from around the world. The ACC’s Mexico Chapter is one of the most active when it comes to mentoring FITs and finding innovative ways to integrate them into the chapter. In fact, the Mexico Chapter recently sponsored a FIT to attend the College’s 2012 Legislative Conference in Washington, D.C., in order to better understand the policymaking process in the United States and take back lessons learned to Mexico.

Of course, sharing information with patients is another important element. The ACC’s public-facing CardioSmart initiative aims to involve patients in their own care and educate them about heart disease and healthy lifestyle choices. Currently the majority of CardioSmart content is available in English and Spanish, but plans are in the works to translate the material into Arabic, Mandarin Chinese, and Portuguese as well. CardioSmart content in Mandarin will be featured prominently in the patient education event to be held at the 23rd Great Wall International Congress of Cardiology in Beijing.

QUALITY KNOWS NO BOUNDARIES Quality improvement is also an area in which international collaboration can go a long way toward improving global health statistics. Online communities, such as the ACC’s Door-to-Balloon (D2B) Alliance, Hospital to Home (H2H), and Imaging in FOCUS communities, can now provide important forums for sharing best practices, raising questions about challenging cases, and providing information on local, regional, and/or country-specific 76

THE COLLEGE HAS LAUNCHED ITS OUTPATIENT PINNACLE REGISTRY IN INDIA AND WILL LAUNCH IN BRAZIL LATER THIS YEAR, FOLLOWED BY CHINA IN 2013.

activities. Other, more public online communities like Facebook, Twitter and LinkedIn are also proving to be popular distribution channels for updates on the latest research and evidence-based guidelines, international activities, and opportunities to participate in case studies.

Currently, the ACC’s social media properties have more international than U.S. followers.

Registry participation is also a growing area internationally that can also help with quality improvement.

The ACC is exploring international participation in the National Cardiovascular Data Registry (NCDR) with several international hospitals from the United Arab Emirates,

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Saudi Arabia, Brazil, and India. The College has launched its outpatient PINNACLE Registry in India and will launch in Brazil later this year, followed by China in 2013.

Using standardized, clinically-relevant data elements, international use of NCDR registries can potentially help reduce wasteful or inefficient clinical practices. The NCDR has made a considerable contribution toward improving the quality of cardiac care in the United States, and there is tremendous potential internationally to use registries to identify global gaps in care and help providers develop global best practices related to cardiovascular outcomes.

The College is also collaborating with its international counterparts on clinical documents and research. Most recently, the ACC was involved in developing an updated universal definition of myocardial infarction (MI), incorporating new developments related to cardiac biomarkers, more sensitive imaging techniques, and improvements in the management of patients with MI. The definition also distinguishes the various settings in which MI occurs, such as “spontaneous” and “procedure-related” MI. “This is a truly global document that will be used worldwide. It will help doctors diagnose their patients so that they can provide the most appropriate treatment, and help researchers design clinical trials with standardized endpoints,” said Kristian Thygesen, M.D., co-chair of the document task force, upon the document’s release.

SHAPING GLOBAL HEALTH POLICY Global health policy is another important focus of the ACC’s international efforts. Last year, in collaboration with the World Heart Federation, the American Heart Association, and the European Society of Cardiology, the ACC launched an advocacy effort during the first United Nations Summit on Non-Communicable Diseases (NCDs). The result was the publication of a U.N. Political Declaration that frames the global effort to combat NCDs, and in May 2012, the World Health Organization (WHO) approved the goal of reducing mortality from NCDs by 25 percent by 2025.

Currently, the ACC and its partner organizations are calling on governments and the cardiovascular community to accelerate the progress on the commitments made last year and support the 10 evidence-based prevention targets, including the top four exposure targets on physical activity, tobacco, dietary salt intake, and hypertension/ blood pressure. Additionally, the ACC is strongly urging the WHO to adopt treatment targets to treat the millions in www.heartbeatsaveslives.org

global cities who are already burdened with cardiovascular disease. In September, the Global Cardiovascular Disease Taskforce, a group of experts representing the ACC Foundation (ACCF), World Heart Federation, American Heart Association, European Heart Network, and European Society of Cardiology, jointly released a health policy statement urging timely global action to save preventable death from cardiovascular disease, including heart disease and stroke.

Among the recommendations: uptake of a set of interventions designed by the WHO which include costeffective treatments that can be delivered regardless of the income level of a country. These include the widespread adoption of multidrug therapy regiment of aspirin, a statin, and blood pressure-lowering agents to prevent heart disease and stroke and to treat those with, or at high risk of, heart disease and stroke.

THE ROAD AHEAD As a result of the ACC’s successes in implementing its international strategies to date, the ACC’s international member group is the fastest growing member segment in the College with representation in 125 countries. To meet the growing global needs of these members, the ACC recently transformed its international leadership structure, from an International Council to an Assembly of International Governors (AIG) made up of all of the governors from the more than 20 new international chapters. The AIG includes a steering committee made up of leaders representing the Americas, Asia, Europe, and the Middle East/Africa.

The goal of the AIG is to ensure a more efficient engagement with international members and encourage greater participation in the College’s activities. “We want to create a United Nations of cardiologists by tackling some of the worldwide challenges in heart health care through concerted action and, above all, through education,” said AIG Chair Christoph Bode, M.D. “Education is essential for the development of mankind and we want to contribute by expanding our knowledge of the heart through research, as well as translating the results into better prevention of and care for heart disease.”

There is still much to learn about the treatment of cardiovascular disease. Disease type, occurrence, and treatment vary with many factors. Yet, as a disease category, cardiovascular disease is unquestionably a leading cause of morbidity and mortality around the world. Moving forward, the ACC will continue to make progress toward: »» increasing international participation in educational activities, »» increasing international knowledge exchange, »» increasing international participation in practice standards and quality initiatives, and »» increasing communication on international activities.

These goals are driven by the seriousness of the challenges we face. As the world seems to get smaller, there has never been a time of greater opportunity to forge stronger personal and professional relationships. We look forward to joining forces with our international partners and celebrating our shared progress.

ONE HEART MAGAZINE

77

PACE MEDICAL Over 30 years of experience providing the medical community Temporary Cardiac Pacemakers, Pacing Analyzers and Patient/Threshold cables.

Discover the Difference.â&#x201E;˘ PACE Medical, Inc. www.pacemedicalinc.com

310 South Street Plainville, MA 02762 USA Tel: +1 858-452-2222 Email: pacemedicalinfo@gmail.com

GALAPAGOS ISLANDS

Expedition Cruising with Ecoventura

(800) 633-7972 | (305) 262-6264 Fax: (305) 262-9609 Email: info@galapagosnetwork.com www.ecoventura.com Mention this ad for 5% oďŹ&#x20AC;

KEEPING

PACE WITH THE

80

WORLD

ONE HEART MAGAZINE www.heartbeatsaveslives.org

BIOTRONIK TRAVEL GUIDE GIVES PATIENTS EASE OF MIND DURING THEIR TRAVELS

W

ith its new Travel Guide, BIOTRONIK gives patients with an implanted cardiac device – pacemaker, ICD or CRT device – a tool to easily and quickly find hospitals and medical centres that can provide expert care to patients with BIOTRONIK implantable cardiac devices during their travels.

www.heartbeatsaveslives.org

ONE HEART MAGAZINE

81

“I am already planning a trip to Germany - a heartfelt wish I have had for many years.”

—T.Q., male patient from Brazil

82

Many patients with an implanted cardiac device are concerned about whether or not they can travel. Activity and travel restrictions usually result from underlying medical problems and not from the device itself. With the right preparation and after consulting with their physician, patients should encounter no problems travelling with an implanted cardiac device. However, unforeseeable events may occur and with the new BIOTRONIK Travel Guide, which details hospitals for possible unexpected device follow up in countries all over the world, patients will have ease of mind during their travels.

By always carrying the patient and implantable cardiac device identification card, given at the time of the implantation, patients can have their device check up done in almost any part of the world. The new BIOTRONIK® Travel Guide now provides patients with a tool to find hospitals that offer support for BIOTRONIK devices at their holiday destination all over the world.

The Travel Guide can be found in the patient section of the BIOTRONIK web site. To find a device check up clinic for BIOTRONIK implants, the patient just needs to select the country and city of destination from the drop-down menu and the tool will give an overview of the closest clinic and how to reach it.

The BIOTRONIK Travel Guide currently lists hospitals and addresses information about clinics for over 100 countries. The Travel Guide is currently available in Dutch, English, French, German, Italian, Portuguese and Spanish.

Information about clinics in additional countries and other languages will be added in the near future.

ONE HEART MAGAZINE www.heartbeatsaveslives.org

Increased patient safety Travelling with a BIOTRONIK cardiac implant – whether it is an ICD, pacemaker or CRT device – was, with the right preparation, already safe from a device point of view. Unless patients with an implanted cardiac device are restricted by an underlying medical condition, patients can, after consultation with their physician, now enjoy their holidays, even during a longer stay or at (more) remote destinations.

The new Travel Guide now allows patients to travel fully prepared for unexpected situations, having the information about hospitals that offer support for BIOTRONIK implanted devices in more than 100 countries at their fingertips.

Due to the sensitive nature of active implantable devices, there are a few things that patients need to keep in mind when preparing for travel: »» Talk to your physician about your travel plans to ensure everything is fine with your implanted device in relation to the activities you plan to undertake. »» If you have a Cardio Messenger for Home Monitoring®, ask your doctor about taking it abroad. »» Ask your physician for a printout of your medical status, for example, a print-out report from the last device follow-up as well as for your medication.

»» Make sure you pack your medication and your BIOTRONIK pacemaker / ICD identification card. You will need it at the airport security and it provides important information about your device if you should need a medical check-up during your holiday. »» While metal detectors will not interfere with your implanted device, it is advisable to not lean on or stand near metal detectors for any extended period of time. Instead ask the security personal for a private search instead of going through the detectors.

BIOTRONIK GmbH & Co. KG As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees.

Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide. For more information, visit www.biotronik.com For more information about the Travel Guide, to register your clinic or have your clinic’s details updated, please visit the patient section of the BIOTRONIK web site. We suggest bookmarking the page for easy and quick access during your travels.

The patient can search for clinics that offer support for BIOTRONIK® implanted devices all over the world.

The simple lay-out and drop-down menu make the tool easy to use. www.heartbeatsaveslives.org

ONE HEART MAGAZINE

83

quality and

protection Living with a BIOTRONIK cardiac device Our patient-first attitude motivates us to provide customers and their families with an ever-increasing sense of security. Therefore BIOTRONIKâ&#x20AC;&#x2122;s quality standards not only are among the highest in the industry, but we take great pride in exceeding them.

Eleven-month-old baby girl with Down syndrome saved by a clinical team using a pacemaker donated by BIOTRONIK.

www.biotronik.com