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ONE HEART MAGAZINE HRS Scientific Sessions Supplement • May 8-11, 2013

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Saving Hearts in Need, One Pacemaker at a Time.

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His Legacy Lives On Dr. Henry D. McIntosh and the Early Days of Heartbeat International

By Dr. Harry G. Mond and Dr. Benedict S. Maniscalco

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1,000 Years of Stimulation Therapy

MILESTONES IN CARDIOVASCULAR MEDICAL TECHNOLOGY

By Dr. Paul Levine

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HBI’s Guatemalan Roots

1963 IP-03, the first German pacemaker.

20 25 Memories of

BIOTRONIK Turns 50

1995 Inos CLS, the first rate-adaptive pacemaker with Closed Loop Stimulation (CLS).

2000 BIOTRONIK Home Monitoring®, for early detection of clinically relevant events.

By Dr. Federico Alfaro

2011 Orsiro, the first hybrid drug-eluting stent with a bioabsorbable polymer matrix.

2012 Lumax 740 ProMRI®, the world’s first ICD/CRT-D series that allows patients to undergo MR scans.

2012 BioMonitor, an implantable heart monitor for highly accurate arrhythmia detection.

Lumax 740 VR-T DX - a single-chamber ICD that senses atrial rhythm

Celebrating 50 years of excellence: BIOTRONIK writes a new chapter in the history of pacing.

I

n the world of medical technology, sometimes a single solution can lead to many new questions. To put it another way, one solution can often lead to many more. Take the case of the single-chamber ICD (implantable cardiac defibrillator). The sophisticated electronic devices are used to deliver an electrical shock to the heart when the heart rate becomes dangerously fast. Although miraculous in their ability to help people who suffer from heart disease, the standard single-chamber ICDs come with some limitations: they are designed only to sense www.HeartbeatSavesLives.org changes in ventricular rhythm and are unable to sense atrial arrhythmias, which can result in an increased risk of stroke or an inappropriate shock. Meanwhile, obtaining information about atrial rhythm also requires a second

implantation procedure and allowing for accurate detection and data delivery. Finally, the problem of deciding between single-chamber and dual-chamber ICDs has been given an adequate solution. Just one example of how BIOTRONIK, which is celebrating its 50th anniversary this year, has shown excellence and innovation in the field of pacing since 1963.

Back then, physicist Max Schaldach and electrical engineer Otto Franke kicked off a revolution in biomedical engineering by developing Germany’s first implantable HRS SCIENTIFIC SESSIONS SUPPLEMENT pacemaker. Through a focus on in-house research and development, and by specializing in three business areas— cardiac rhythm management, electrophysiology and vascular intervention—BIOTRONIK has become one of the

Early Pacemakers

By Dr. Harry G. Mond

BIOTRONIK embodies this role with care and responsibility.

In just the last decade, for example, BIOTRONIK has examined the daily lives of patients, changing technology, and the ways physicians work. Realizing that a number of technological solutions were now possible and necessary to ease day-to-day interactions and ongoing care, the company launched BIOTRONIK Home Monitoring®, an automatic remote monitoring system that uses the cellular phone network to give physicians a continuously updated and accurate summary of their patients’ medical status anywhere in the world. In addition, BIOTRONIK´s ProMRI® technology has been used in cardiac devices and leads since 2010, allowing patients with cardiac implants to undergo vital MRI scans. But the work of a medical technology company—like the work of a physician—is never done.

Even when they are about to release a new and important 2013 ONE HEART MAGAZINE development to combat heart disease, members of BIOTRONIK’s widespread and award-winning research and development team are already looking ahead to the next fine-tuning, thinking about how they can come up

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

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• Patients feel more confident returning to their normal daily activities when wearing the LifeVest2 • LifeVest patients don’t worry as much because they know the LifeVest is protecting them2

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.

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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.

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One Heart.

One World.

ONE HEART MAGAZINE HRS Scientific Sessions Supplement • May 8-11, 2013

ONE HEART MAGAZINE

Corporate Headquarters 4302 Henderson Blvd., Ste 102 Tampa, Florida 33629, USA Tel. (813) 259-1213

HRS Scientific Sessions Supplement • May 8-11, 2013

Publisher Adam Longaker The Custom Publishing Company Ed Suyak ESS Media Group Inc.

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

Advertisers

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ECA Medical Instruments 2 Zoll 4 Water Beach Club

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Heartbeat International Foundation 11 Accumetrics 17 TYRX 24 Lancet Indemnity

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Cleveland Heart Lab

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BIOTRONIK 32

www.HeartbeatSavesLives.org

Creative Director Bryan Clapper Editorial Director Kevin Anderson Sales Support Staff Michelle Santiago Alfredo Escandion Contributing Writers Dr. Paul Levine Dr. Benedict Maniscalco Dr. Harry Mond Dr. Federico Alfaro

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 Heart Rhythm Society St. Jude Biotronik Heartbeat International Foundation American College of Cardiology ©Copyright 2013 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.

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THEIR LEGACIES T LIVE ON Welcome to the Heart Rhythm Society 2013!

his year’s symposium is thematically The History of Cardiac Pacing! From the first pacemaker implant 55 years ago in Sweden, the progress in the understanding of the cardiac conduction system in health and disease has been as expansive as in all other fields of cardiovascular medicine. In many ways it is very gratifying to now have diagnostic and therapeutic interventions which in many cases are more than palliative but in fact curative.

The field of electrophysiology and the electrophysiologists of today stand on the shoulders of the early investigators and heroes of yesterday. Three such men are featured in this supplement of One Heart Magazine: Henry D. McIntosh, Harry G. Mond, and Paul A. Levine.

Dr. McIntosh encouraged many cardiac fellows to look into the VPB and other rhythm disturbances of the heart providing research and clinical facilities to do so. Drs. Mond and Levine have provided leadership, creativity, training, and research results that have influenced entire generations of electrophysiologists. The latter two men have been honored by the Heart Rhythm Society as modern day heroes of the field.

Heartbeat International Foundation, Inc. was founded by Henry D. McIntosh and both Paul and Harry have been long time supporters and board members of our organization. Heartbeat International is very proud indeed to bring you this supplement of the history of pacing from the unique and personal perspectives of our heroes that only they can bring, and we know you will enjoy and consider their accomplishments once again.

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

SAVING HEARTS IN NEED, ONE PACEMAKER AT A TIME. www.HeartbeatSavesLives.org

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HIS LEGACY LIVES ON

By Harry G. Mond, OAM, MD, FACC, FHRS, CCDS and Benedict S. Maniscalco MD, FACC, FACCP, FAHA

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n the 26th December 2008, Dr. Henry D. McIntosh MD, MACC passed away in Lakeland Florida following a long illness. A distinguished and much beloved physician and administrator, Dr. McIntosh served on numerous cardiology committees and boards, including the Presidency of the American College of Cardiology in 1974-5.

A humble man and forever a humanitarian and champion of the poor, Dr. McIntosh is best known internationally as founder of Heartbeat International, a charitable 501(c)(3) organization. Heartbeat International, through its strategic alliances with Rotary International and other civic organizations, pacemaker manufacturers and an army of medical and non-medical volunteers is responsible for providing cardiac implantable electronic devices for indigent and needy patients in 25 countries over four continents. His creed “the service we give to 8

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our fellow man, is the rent we pay for the right to live” is a testimony to his lifetime service in helping the poor.

HISTORY The genesis of Heartbeat International occurred over 30-years ago in Guatemala, Central America, when a local physician, Dr. Federico Alfaro was referred a profoundly symptomatic 19-year old with complete heart block. The family was unable to afford the cost of a potentially “curative” pacemaker and all Dr. Alfaro could do was watch the boy die. He vowed that in the

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future, his countrymen would not die because they could not afford a pacemaker.

With the help of the local Rotary group, Dr. Alfaro organized the first “Pacemaker Bank” in 1977. A board of directors of nonmedical Rotarians, a medical director and cooperating cardiologists and surgeons were responsible for organizing and operating the bank. Initially refurbished pacemakers were used, the recipients were indigent, and the implants performed free of charge. Pacemakers donated to the Guatemala Bank were not limited to their own populace, but also distributed in Nicaragua, Costa Rica, El Salvador, Honduras and the Dominican Republic.

In 1983, while visiting Dr. Alfaro, his former student, Dr. McIntosh learned of the program and was so impressed with the beneficial and humanitarian potential that he felt obligated to help in developing a similar international program. On October 18, 1984, Heartbeat International was born at the Watson Clinic in Lakeland, Florida where Dr. McIntosh was a staff member. This was a cooperative effort of the Watson Clinic, Rotary International of Evanston, Illinois, representatives of the United States pacemaker industry and consultative support of the American College of Cardiology.

Intermedics (Boston Scientific, St Paul, MN) donated 486 new pulse generators together with some leads and Rotary

International provided a grant of $US250,000 for the purchase of extra pacing leads.

By 1986, 16 Pacemaker Banks had been established in the Americas and Asia. The same year Heartbeat International, was awarded a US Presidential Citation for its international humanitarian work. By 1991, the number of pacemaker banks had expanded to 25 centers worldwide. During this period, Dr. McIntosh retired from the Watson Clinic and established Heartbeat International at the St. Joseph’s Heart Institute in Tampa, Florida upon the invitation of Dr. Benedict S. Maniscalco, a former student of Dr. McIntosh.

By the early 1990’s, with the ever increasing demand for more pacemakers, industry donations failed to supply sufficient implantable devices. Pacemaker pulse generators which exceeded “use before dates” were distributed from the Mount Alvernia Convent in Montego Bay, Jamaica, and the Board of Directors discussed the concept of collecting used devices and refurbishing them for use outside the United States. However, the regulatory obstacles were overwhelming.

Thankfully, soon after, inventory donations once again increased to workable levels and the concept of refurbishment was not implemented.

1993 was an active and productive year for Heartbeat International. The organization’s co-mission to educate and

In 1983, while visiting Dr. Alfaro, his former student (in Guatemala), Dr. McIntosh learned of the program and was so impressed that he felt obligated to help in developing a similar international program.

www.HeartbeatSavesLives.org

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train implanting indigent recipients physicians was in predominantly g e n e r o u s l y d eve l o p i n g supported by countries.

The Medtronic and St. organization Jude; and the Arnold employs few staff Zohn Pacemaker and its success is Bank in Chengdu, dependent on the China was opened members of Rotary as a training center; International, at two days of the incredible age, Jose Alirio generosity of the Perez of Medellin, implantable device Colombia, became manufactures the youngest and the dedicated recipient to receive a physicians and donated pacemaker; hospital personnel and Heartbeat in the countries of International operation. was accepted as a member of FUTURE the Independent ENDEAVORS Charities of There can be America. In August only one objective There can only be one objective for Heartbeat International; to 1995 Heartbeat for Heartbeat International earned save and improve the quality of life of those who cannot afford International; to its 501(C)(3) tax to do so themselves, thus making “poor” hearts beat better. save and improve exempt status from the quality of life of the Internal Revenue those who cannot afford to do so themselves, thus making Service. “poor” hearts beat better. Although remarkable, the saving of In 1999, Heartbeat International became the first recipient nearly 11,000 lives is but the tip of an iceberg in regard to the of the North American Society of Pacing and Electrophysiology numbers of indigent patients actually requiring implantable (Heart Rhythm Society, Washington DC) benevolent fund. devices. A conservative estimate of need may exceed one The organization celebrated its 5,000th pacemaker implant million per annum world-wide. and new Pacemaker Banks were established in the Eastern The program is dependent on the continued generosity European block. After many years as its founding champion, of the pacemaker manufacturers, volunteers from the private Dr. Henry McIntosh retired and Dr. Maniscalco took on the and professional sectors, and donors from all sectors of the leadership role as Chairman and Chief Executive Officer and economies within the United States and in the countries continues to serve in this capacity. served by Heartbeat International.

Although Heartbeat International is accountable for the The visionary and philanthropic work of Dr. Henry correct selection of medically and financially appropriate D. McIntosh has served as an inspiration to generations of recipients, the actual work is done locally under the auspices physicians, and all people throughout the world who believe of the Board of Directors for each Pacemaker Bank (now called in the dignity and right to a productive life for all and who a Heart Center). Once a device is implanted, the appropriate serve their fellowman with humility and joy. paper work and follow-up reports are sent to Heartbeat Heartbeat International shall never forget Dr. McIntosh!

International and entered into a data base. In this way every In his honor and in his memory, the Henry D. McIntosh patient and the implanted device are tracked. Recalls and Fellowship was established and recognizes all who wish to other issues can be easily addressed. help Heartbeat International continue his work and to carry Recognizing the need to provide greater economies of out his mission to provide “Pacemakers as Peacemakers”. scale, ensure leadership succession, create local stakeholder When we watch a child or adult with a potentially fatal participation and governance and deal with legislative and cardiac arrhythmia receive an implantable device and return to governmental issues, management began a restructuring of a fully functional and productive life, the joy is immeasurable. the Pacemaker Banks (Heart Centers) in the early 2000’s. With Heartbeat International has only begun to fulfil the mission this came a stricter compliance program and the concept of and welcomes all who may help in the work that Dr. McIntosh one Heart Center per country with multiple implantation has started and we must sustain. Join us in this campaign and centers. become a Henry D. McIntosh Fellow.

Over a time span of nearly 30 years, Heartbeat International Remember “the service we give to our fellow man, is the rent has been responsible for the implantation and follow-up we pay for the right to live”. Let us not fail him. of cardiac implantable electronic devices in nearly 11,000 10

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www.HeartbeatSavesLives.org

His legacy lives on…

ABOUT HEARTBEAT INTERNATIONAL

Heartbeat International Foundation, Inc. (HBI) saves lives globally by providing cardiovascular implantable devices and treatment to the needy people of the world. With the help of generous device manufacturers, compassionate physicians, and kind supporters like you, Heartbeat International provides the pacing device, implantation, and follow-up care for the device at no cost to our indigent patients. Since our founding in 1984, our Pacemaker Program has saved more than 10,000 lives.

THE HENRY D. MCINTOSH FELLOWSHIP

Formed to honor and recognize the Founding Chairman of Heartbeat International, the Henry D. McIntosh Fellowship is comprised of supporters who recognize and share in the founding vision of Heartbeat International and want to ensure the success of our global mission through a donation of $1,000 or more.

WILL YOU JOIN US IN BUILDING A LEGACY? YES…I WANT TO SAVE LIVES:

Henry D. McIntosh Fellowship: $1,000

PLEASE MAIL YOUR CHECK TO:

Heartbeat International Foundation, Inc. 4302 Henderson Blvd., Suite 102 Tampa, FL 33629

Henry D. McIntosh Fellowship A talented physician, humble man, and compassionate humanitarian, Dr. Henry D. McIntosh left behind a legacy.

As the Founding Chairman of Heartbeat International, Dr. McIntosh believed, “The service we give to our fellow man is the rent we pay for the right to live.”

Prefer to Donate Online?

Please visit our website and submit the secure online donation form. www.HeartbeatSavesLives.org “Henry was my teacher, partner and friend. I shall always honor him for his humility, benevolence and philanthropy. He was a great and noble man!”

Dr. Benedict S. Maniscalco, Chairman and CEO

FEDERAL TAX IDENTIFICATION NUMBER EIN 26-0330887. FLORIDA STATE REGISTRATION NUMBER CH26760. A COPY OF THE OFFICIAL REGISTRATION AND FINANCIAL INFORMATION MAY BE OBTAINED FROM THE DIVISION OF CONSUMER SERVICES BY CALLING, TOLL FREE, 800-435-7352 WITHIN THE STATE. REGISTRATION DOES NOT IMPLY ENDORSEMENT, APPROVAL OR RECOMMENDATION BY THE STATE.

We carry on his vision, saving hearts in need, one pacemaker at a time.

Join the Fellowship.

Honor his legacy.

One Heart. One World www.HeartbeatSavesLives.org

Top from left to right: Arne Larsson and Ake Senning; Bottom – Rune Elmqvist at a party celebrating the 40th Anniversary of the world’s first implanted pacemaker at Europace held in June 1998.

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STIMULATION THERAPY

OVER THE PAST 1,000 YEARS

By Paul A. Levine, MD, FHRS, FACC, CCDS Professor of Medicine, Loma Linda University School of Medicine Clinical Associate Professor of Medicine, Olive View UCLA Medical Center

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he world’s first fully implanted pulse generator and lead were implanted in Mr. Arne Larsson at the Karolinska Hospital in Stockholm Sweden on October 15, 1958 for recurrent Stokes-Adams Syncope, intermittent asystolic complete heart block. Indeed, the world’s second fully implanted pacemaker was also implanted in Mr. Larsson on the very next day as the implanting surgeon did not realize that electrocautery used to control bleeding during an open chest procedure could damage some of the components of this first generation pacemaker.

Dr. Rune Elmqvist, the physician and engineer developed this first pacemaker.

He actually made two so when the first was recognized as being non-functional when a recurrent asystolic episode occurred after the implant, Mr. Larsson was brought back to the OR by his surgeon, Dr. Ake Senning for implantation of the second fully implanted pacemaker. While this was the start of the science of modern pacing, an inauspicious beginning at best, it was not Paul A. Levine, MD, FHRS, FACC, CCDS the start of stimulation therapy.

STIMULATION THERAPY Humankind has been interested in electricity dating back to ancient days. Electric eels and other electricallyactive fish were used therapeutically being touched to individuals with various diseases including but not limited to madness, gout and arthritis. In the mid-17th century, publications speculated about the bioelectric nature of the cardiovascular system and in 1774, Squires made reference www.HeartbeatSavesLives.org

to the external stimulation of the heart in the Registers of the Royale Humane Society. In 1775, a Danish physicist Nickolev Abildgaard conducted the first studies on electrical energy on living organisms. He placed electrodes on either side of a chicken’s head and delivered energy causing the chicken to “drop dead”. He then applied electrodes to different parts of the chicken’s body and when placed across the chest, the hen sat up and staggered away. The presumption, in retrospect, was that the chicken had gone into ventricular fibrillation and had then been defibrillated.

There is a claim that the hen then went on to lay an egg but this has not been verified.

Alexander von Humboldt in 1797 found a dead bird in his garden. He placed a blade of zinc in the beak and a shaft of silver up the rectum following which he applied electrical energy. The bird is said to have flapped its wings and attempted to walk. In the best of scientific tradition of the day, he performed similar experiments using himself as the test subject with reportedly less than pleasant results. In the late 1700’s and early 1800’s, there was great interest in trying to use electrical energy to “reanimate” dead animals and even men. Marie Francois Xavier Bichat experimented on decapitated victims of the guillotine during the French Revolution. He demonstrated that electrical energy could cause the heart to beat.

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A model of the world’s first fully implanted pacemaker. A couple of transistors, some resistors, a capacitor and a few other components including the battery and the coil of wire was the antennae to allow it to communicate with a charging device outside the body since the battery was rechargeable (NiCad).

Alexander von Humboldt in 1797 found a dead bird in his garden. He placed a blade of zinc in the beak and a shaft of silver up the rectum following which he applied electrical energy. The bird is said to have flapped its wings and attempted to walk.

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CARDIAC PACING In 1889, John MacWilliam presented the first integrated theory of cardiac pacing but it would be a little more than half a century before pacing therapy was practical. He described the application of electrical energy across the chest to “excite rhythmic contraction (of the heart) which had been suddenly enfeebled or arrested in diastole by causes of a temporary or transient character.”

In 1928, Mark Lidwell, an Australian anesthesiologist, used alternating electrical energy to save the life of a newborn in cardiac arrest. To deliver this energy, a needle was inserted into the heart. Four years later, Albert Hyman, a cardiologist in New York City, became interested in reviving the stopped heart by means of “intracardial therapy.” This could be a mechanical stimulus delivered via a transthoracic needle inserted into the heart followed by either electricity or drugs delivered through the needle.

He received a grant to pursue this research in 1930 and in 1932, he had successfully resuscitated 43 patients using electrical energy. The electricity was created and delivered by a spring-wound hand-crank motor designed and built by his brother, an engineer. He called his device an “artificial pacemaker” but it never gained in popularity.

In 1949, Wilfred Bigelow made a serendipitous observation on a dog during an open chest experiment.

Heart-lung machines had not yet been invented and to reduce the metabolic rate as well as slow the heart to allow surgery to be done, the total body was cooled to hypothermic levels. Re-warming was often insufficiently rapid to restart the arrested heart. During an experiment on a dog, the heart stopped suddenly. Bigelow reports that “out-of-options and in desperation, I gave the left ventricle a good poke with a probe that I was holding. All four chambers of the heart responded. Further pokes clearly indicated that the heart was beating normally with good blood pressure.”

Dr Paul Zoll is commonly credited as the father of modern pacing based on studies first reported in the New England Journal of Medicine in 1954. He connected an output stimulator to two electrodes strapped to the chest and successfully restored a heart beat in individuals who were asystolic. After the introduction of transvenous leads, Dr. Zoll’s external stimulator fell into disuse but was resurrected over the past couple of decades with a very effective external transthoracic stimulator and purportedly a marked improvement in the tolerability level. In a presentation in Boston, Dr. Zoll reminisced about pacing. He reported that “the idea for electrical stimulation to resuscitate the patients from cardiac arrest came to me during the war (World War II) when I observed Dwight Harken (a pioneer in cardiothoracic surgery) doing surgical removal of foreign bodies from the cardiac chambers and wall. I was

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impressed with the responsiveness of the heart to mechanical stimulation” effectively repeating Dr. Bigelow’s observations. Dr. Zoll continued that “it had also been known since Galvani that electrical currents applied to the heart can produce effective cardiac contractions. Therefore I thought it altogether too bad that patients with ventricular standstill should die for want of an appropriate stimulus to the heart.” “In the 1950’s, I heard John Callaghan speak at a surgical meeting on stimulating the sino-atrial node but this would not help patients with AV block.” Dr. Callaghan’s work involved wires placed in the atrium at heart surgery or a temporary lead advanced in the esophagus. Dr. Zoll stated that “the high spot of the whole project was that stimulation across the two sides of the chest was as effective as an esophageal one.”

Dr. Zoll’s first patient to whom his transthoracic external pacemaker was applied died after 20 minutes, another inauspicious beginning, but a subsequent autopsy revealed that death was due to multiple myocardial punctures in association with the attempted resuscitation.

Dr. C. Walton Lillihei working with Mr. Earl Bakken, then President and Founder of Medtronic which was involved in all sorts of medical electrical equipment asked Mr. Bakken if he could make a temporary pacemaker. Dr. Lillihei would apply wires to the heart at the time of heart surgery as these patients commonly had a very slow heart rate when being warmed from their induced hypothermia. This was 1957. It is said that Mr. Bakken made a temporary battery powered external pacemaker Dr. Furman’s patient walking in the corridor with his temporary pacemaker connected to and asked to be notified before Dr. his temporary lead inserted via a surgical cutdown on a vein in his arm accompanied by Lillihei tried to use it as he wanted to a nurse. The pacemaker was connected to a power cord plugged into an electrical outlet be present. Although Mr. Bakken was and the patient could walk as far as the extension cord would allow. called, Dr. Lillihei proceeded to apply the temporary pacemaker to a patient while Mr. Bakken was on his way. By the time Earl arrived, accompanied by a nurse walking in the corridor pushing his the temporary pacemaker was demonstrated that it was pacemaker on a cart in front of him. He could walk as far as working perfectly. the extension cord to the wall outlet would allow.

In 1958 while a surgical resident, Dr. Seymour Furman Later in 1958, the world would be exposed to the developed the first transvenous lead that could be advanced first fully implanted pacemaker. Forty-three year old Arne into the heart by way of a surgical cutdown on an arm in Larsson suffered from recurrent syncopal spells what is the vein without having to open the chest. The temporary today known as Stokes-Adams Syncope. By rights, it should pacemaker that he used was gigantic and run off of line power. be called Gerbezius-Morgagni-Adams-Stokes Syncope.

There is a classic picture of one of Dr. Furman’s patients being In 1717, Gerbezius described symptoms that might be www.HeartbeatSavesLives.org

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Side-by-side comparison of the world’s first fully implanted pacemaker (October 1958) with a current generation pacemaker (2013). The original pacemaker was encased in epoxy so that the components are visible. The current generation pulse generator is totally sealed in a titanium housing.

This view is after one side was cut-off compliments of the manufacturer.

associated with a bradycardia while in Morgagni in 1761 proposed a causal relationship between a slow pulse and syncope. In 1827, Adams suggested that cerebral symptoms might be due to a heart rhythm disorder and in 1846 Stokes described pseudo-epileptic loss of consciousness due to a slow pulse. All of this was done without the assistance of an electrocardiograph machine which would not be invented until the late 1800’s and not begin to gain any popularity until the first quarter of the 20th century. Even then, it involved a machine that took up an entire “laboratory” and individuals were brought to it to have what is now known as an ECG. Regardless of its name, Arne was suffering from repeated fainting spells due to asystolic complete heart block. These would wax and wane in frequency but at times occurring so frequently that he was often obtunded from repeated episodes of asystole and lack of cerebral perfusion. During what his physicians and family thought to be his terminal hospitalization, his wife in talking with the nursing staff learned that a surgeon at the hospital, Dr. Ake Senning, was working with an engineer, Dr. Rune Elmqvist, on something called a temporary pacemaker.

This was connected to a battery with all the circuitry open to the air, what an engineer would call a “bread board”.

Ilsa contacted Dr. Senning and pleaded with him to make a pacemaker for her husband or it was very likely she would lose him and this would be totally unacceptable.

While Dr. Senning agreed to do this, he and Dr. Elmqvist had a real challenge. They couldn’t implant the open circuitry as everything would simply short out. Also the electrical components were unlikely to be biocompatible.

Another challenge was how to attach the pacemaker to the heart. The two wires leading from the pacemaker to the 16

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heart were hardwired to the circuitry of the pulse generator which was a simple output oscillator. Sensing was not an issue and was beyond any capability at the time. To isolate the components from the body fluids, they cleaned a Kiwi shoe polish can, placed the components inside the can and then filled it with medical-grade epoxy. The circuitry was extremely simple by current standards, effectively a proof of concept and it saved Mr. Larsson’s life. One might make the comparison between this first pacemaker and current generation pacemakers with that of the airplane built by the Wright brothers to a Boeing 747.

Following his implant and recovery, after all it was an open chest procedure, he was feeling well. The device, although utilizing a rechargeable battery that could be inductively recharged from outside his body, failed in less than a year but his spells had subsided and he did well until another pacemaker could be implanted. Arne was invited to Europace in 1998 celebrating the 40th anniversary of cardiac pacing and I had the privilege of attending that session as well as meeting Arne and his wife. He commented that following his implant, the entire concept of implanting a man-made electronic device, was according to many clergy of the day and even some newspaper columnist, against the will of God and was unnatural. While the critics did not fault him, they did fault the manufacturer of this device and the slippery slope of other man-made devices to be implanted in the human body. Arne goes on to report that within five years of his receiving his first pacemaker, the major critic of this technology became the proud owner of his own pacemaker.

When employed by St. Jude Medical, I found a copy of Arne’s prepared remarks for his 1998 presentation. He

HRS SCIENTIFIC SESSIONS SUPPLEMENT 2013

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said that “because of my rhythm disorder, I fainted very often. At home, in my office and in the streets. In 1958 my condition was so bad that my wife was told that there was nothing more the doctors could do for me.“ “The best medicine was in fact whiskey, and I can assure you that it was a sight when the nurse entered my room in the morning with a whiskey bottle and a glass on the tray, to the envy of my roommates.” Asking a rhetorical question, he went on say “today (1998) you don’t think of a pacemaker implantation as something sensational. You do agree, don’t you? Well, ladies and gentlemen, then you are all wrong!

It is a sensation – for the patient.” To which he received a standing ovation following which he, Dr. Ake Senning and Dr. Rune Elmqvist shared a celebratory birthday cake.

Arne became an ambassador for this nascent pacemaker industry being the poster child for which ever Company provided his current pacemaker. He passed away in 2001 at the age of 86 having had a total of 22 pacemakers and 26 operations, some for leads or other procedures related to his pacing system. In my personal discussions with his cardiologist during his later years, I learned that Arne would often get the latest and greatest device when it would become available even if his implanted pulse generator had not yet reached its elective replacement indicator.

Technology advanced slowly at first as devices utilized discrete components and mercury zinc oxide batteries which despite the manufacturers’ claims of lasting 5 years or more, often last for two years if lucky. Pulse generators were replaced frequently for battery depletion allowing the physicians to provide their patient with the newest technology. The first pacemakers were single chamber asynchronous devices – they only delivered a pulse and could not respond to the patient’s intrinsic rhythm. When competition between the pacemaker and the patient’s intrinsic rhythm was demonstrated to be a problem, the ability to detect and respond to intrinsic beats was invented (the demand pacemaker). Then programmability was introduced. This was the ability to adjust the various settings of the pulse generator, much like a physician might adjust the dose of a medication, but without having to re-operate and is a benefit to all of us from the technology developed by our efforts to reach space. It utilized radiofrequency signals generated by an external device called a programmer. The process by which the programmer and pulse generator communicated was called telemetry. Bidirectional telemetry allowed the programmer and the pacemaker to effectively talk to one another. Current generation pulse generators have a microprocessor which can hold onto data as to how the 18

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pulse generator has functioned between scheduled visits to provide this information to the physician at the time of the follow-up evaluation and more recently, allowing this data to be retrieved remotely.

The first generation dual chamber pacemakers could either pace in both chambers of the heart but only sense in the ventricle (DVI) or sense in one chamber while pacing in the other chamber (VAT). Next was the full dual chamber (DDD) pacemaker. This was followed by rate modulation utilizing a number of different sensors and today, there is the ability to stimulate at multiple different sites in multiple chambers while varying the output and intervals between the stimuli and this technology is not only being used to treat rhythm disorders in the heart but special circumstances associated with systolic heart failure when there is a disordered electrical activation pattern even if the heart rate was totally normal.

DEFIBRILLATION AND THE IMPLANTABLE DEFIBRILLATOR The late 1950’s and early 1960’s also saw technology develop to deliver a high voltage shock to the heart to terminate a pathologically rapid heart rhythm restoring it to normal. Although there was much skepticism at the time within the medical profession, Dr. Michel Mirowski had a vision of being able to harness this technology into a battery powered implantable device.

His first device was known as an Artificial Implantable Defibrillator or AID which would have been a very poor acronym given the ensuing development of the AIDs epidemic.

The first devices were very large, often larger than a pack of cigarettes and similar to the early pacemakers, required an open chest procedure to place patches on the heart with the defibrillator being located in a subcutaneous pocket located in the upper abdomen. At this time, the U.S Food and Drug Administration was involved with approving devices similar to their charter to evaluate and approve pharmaceutical agents. As such, formal prospective clinical trials were required to demonstrate the effectiveness and relative safety of this new technology before it could be approved for commercial release. There were a couple of key requirements for a patient to be eligible to participate in the clinical trial. First the patient had to have experienced sudden death and obviously been successfully resuscitated. The common practice was to then place the patient on an antiarrhythmic agent which would, theoretically, prevent a recurrence. So it was also necessary to demonstrate that the pharmaceutical agent was NOT effective in preventing a recurrence. The individual who would receive an implantable defibrillator had to

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COMPARISON OF FEATURES OF THE WORLD’S FIRST FULLY IMPLANTED PACEMAKER TO A 2013 PACEMAKER

1958 2013

Implantation Technique Anesthesia Duration of procedure Hospital stay Size Dimensions (volume,thickness)

Open Thoracotomy

Transvenous

General

Local + conscious sedation

3 to 4 hours

1 hour

Weeks

1 day or less

38 cc, 83 grams

12 cc, 29 grams

24 cm2, 16 mm thick

19 cm2, 6 mm thick

Longevity

< 1 year

10 years

Modes of operation

1 (preset)

Over 20

Rates

1 (preset)

30 to 180 pulses per minute

Rate Response (sensor)

None

Tailored to patient

Parameter combinations

1

Trillions

Components — transistors

2

20,000,000+

experience a second episode of symptomatic ventricular tachycardia or fibrillation (sudden death) and again be successfully resuscitated in order to qualify for one of these new devices. The implant of a defibrillator involved significant operative morbidity and even some mortality. In 2013, this indication would be called secondary prevention because the patient had already manifested a symptomatic ventricular tachyarrhythmia. Then cardioversion capability was added to manage more organized rhythms, the ability to pace rapidly at low voltage outputs called Anti-Tachycardia Pacing was incorporated and defibrillators were combined with pacing capability so that two devices would not be required if patients required both technologies. Studies were also performed demonstrating a high incidence of complications and ineffectiveness with drugs and identifying clinical conditions which placed individuals at a markedly increased risk of sudden death prior to ever experiencing such an episode. The field has progressively changed from implantable cardioverter defibrillators (ICDs) from being a therapy of last resort after trials of various drugs either singly or in combination had been shown to fail to being the therapy of choice even in patients who had not yet experienced a life-threatening tachyarrhythmia but who, because of their underlying disease, were at increased risk. This is known as primary prevention. While patients will still qualify for an ICD if they present with a life-threatening tachyarrhythmia (secondary prevention), we no longer go the route of drugs first and then an ICD. Rather it is an ICD first and if there are appropriate shocks which are certainly uncomfortable, then pharmacologic therapy is used to reduce the incidence of symptomatic tachyarrhythmias in an effort to minimize the number of shocks a patient experiences.

STIMULATION THERAPY TODAY Current generation ICDs are smaller than first generation pacemakers. Pacemakers, defibrillators and cardiac resynchronization systems are implanted by physicians with specialized training in device therapy. www.HeartbeatSavesLives.org

While their primary specialty can be surgery, pediatrics or cardiology, most have a focus in the subspecialty of electrophysiology. Most implant procedures can be done under local anesthesia using conscious sedation and many do not even require an overnight hospital stay. Advancing technology allows many systems to be followed remotely with the patient called into the clinician’s office on an as needed basis or, at a minimum, a less frequent basis than previously for a detailed programming evaluation that cannot yet be performed remotely. These devices are all run by a microprocessor that, in addition to delivering low voltage (pacing) or high voltage (shock) therapy, can acquire and store data as to how the device has been used since the last evaluation, what abnormal rhythms may have occurred, how active the patient is while monitoring the electrical performance of the pulse generator and the leads. Much of this data can be downloaded remotely via the internet utilizing special transmitters provided by each manufacturer for its devices or retrieved at the time of an office- or clinic-based evaluation. Devices have gone from a projected longevity of less than 1 year to more than ten years although the longevity of a specific pulse generator depends on how it is programmed and how being used by the individual patient.

These devices have enabled individuals with complete heart block or sinus node dysfunction who, prior to pacemakers, were relegated to sitting in the proverbial rocking chair watching the world go by to resuming an active life style. It has markedly reduced the risk of a patient who has serious ventricular dysfunction from dropping dead unexpectedly and device therapy is starting to help individuals who have marked weakness of their heart muscle if accompanied by other specific findings to also return to a more active and normal life. The science has progressed from only implanting a very simple pacemaker in individuals who were virtually devoid of a heart beat and hence, very seriously limited, to treating not only slow heart beats but extremely fast heart rhythms and even heart failure.

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Lumax 740 VR-T DX - a single-chamber ICD that senses atrial rhythm

Celebrating 50 years of excellence: BIOTRONIK writes a new chapter in the history of pacing.

I

n the world of medical technology, sometimes a single solution can lead to many new questions. To put it another way, one solution can often lead to many more. Take the case of the single-chamber ICD (implantable cardiac defibrillator). The sophisticated electronic devices are used to deliver an electrical shock to the heart when the heart rate becomes dangerously fast. Although miraculous in their ability to help people who suffer from heart disease, the standard single-chamber ICDs come with some limitations: they are designed only to sense changes in ventricular rhythm and are unable to sense atrial arrhythmias, which can result in an increased risk of stroke or an inappropriate shock. Meanwhile, obtaining information about atrial rhythm also requires a second lead in the dual-chamber ICDs calling for a more complex implantation procedure.

Recognizing the need for a more effective method of detection, BIOTRONIK, one of the world’s leading manufacturers of cardiovascular medical devices, rose to the challenge. Early this year the company received FDA approval for its Lumax 740 DX System, which utilizes the Linoxsmart S DX lead. This single lead enables both ventricular and atrial sensing, thereby easing the 20

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implantation procedure and allowing for accurate detection and data delivery. Finally, the problem of deciding between single-chamber and dual-chamber ICDs has been given an adequate solution. Just one example of how BIOTRONIK, which is celebrating its 50th anniversary this year, has shown excellence and innovation in the field of pacing since 1963.

Back then, physicist Max Schaldach and electrical engineer Otto Franke kicked off a revolution in biomedical engineering by developing Germany’s first implantable pacemaker. Through a focus on in-house research and development, and by specializing in three business areas— cardiac rhythm management, electrophysiology and vascular intervention—BIOTRONIK has become one of the largest cardiovascular medical technology companies in the world, well known and respected for its high quality and precision. It is with continuous innovation and striving for excellence, always anticipating the next applicable solution before the problem has even arisen, that BIOTRONIK manages to remain at the forefront of patient care.

By collaborating closely with physicians to find out what they need to provide the best treatment available, and by subjecting each and every product to meticulous studies,

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MILESTONES IN CARDIOVASCULAR MEDICAL TECHNOLOGY

1963 IP-03, the first German pacemaker.

1995 Inos CLS, the first rate-adaptive pacemaker with Closed Loop Stimulation (CLS).

2000 BIOTRONIK Home Monitoring®, for early detection of clinically relevant events.

2009 Evia, an advanced pacemaker series with extended longevity and a smaller size.

2011 Orsiro, the first hybrid drug-eluting stent with a bioabsorbable polymer matrix.

2012 Lumax 740 ProMRI®, the world’s first ICD/CRT-D series that allows patients to undergo MR scans.

2012 BioMonitor, an implantable heart monitor for highly accurate arrhythmia detection.

2013 Ilesto 7 series, represents the second generation of ProMRI® ICDs/CRT-Ds.

BIOTRONIK embodies this role with care and responsibility.

In just the last decade, for example, BIOTRONIK has examined the daily lives of patients, changing technology, and the ways physicians work. Realizing that a number of technological solutions were now possible and necessary to ease day-to-day interactions and ongoing care, the company launched BIOTRONIK Home Monitoring®, an automatic remote monitoring system that uses the cellular phone network to give physicians a continuously updated and accurate summary of their patients’ medical status anywhere in the world. In addition, BIOTRONIK´s ProMRI® technology has been used in cardiac devices and leads since 2010, allowing patients with cardiac implants to undergo vital MRI scans. But the work of a medical technology company—like the work of a physician—is never done.

Even when they are about to release a new and important development to combat heart disease, members of BIOTRONIK’s widespread and award-winning research and development team are already looking ahead to the next fine-tuning, thinking about how they can come up with the next life-saving solution.

BIOTRONIK OUTREACH: BEYOND THE LAB Today, BIOTRONIK is represented in more than 100 countries worldwide, and has 5,600 employees contributing to the day-to-day success of the company. But part of their work is also to go beyond the walls of their offices and labs by organizing and implementing vital outreach programs. www.HeartbeatSavesLives.org

Rachid Merzouki, Quality Assurance Leads, BIOTRONIK

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IMPROVING ACCESS TO LIFE-SAVING CARDIOVASCULAR TREATMENT Devices donated

by BIOTRONIK 544

550

530

500 450 400 350

329

300

290

250 200

200 150 100

202

200

117

115

128

50

4

2

0 2010

Pacemakers Pacemaker-Leads

2011

ICDs ICD-Leads

3

10

2012 (Jan. - Sept.)

Programmers Effective October 2012

Working closely with physicians to find new solutions

Training and education guarantee that physicians and medical professionals are putting BIOTRONIK products to their best uses while philanthropic initiatives provide cutting-edge, life-saving technological devices to patients who might not otherwise have access to them. Through all its programs, BIOTRONIK shows a commitment to patient care, not just the bottom line.

BIOTRONIK’s world-class education programs give healthcare professionals the opportunity to meet and discuss new developments, actively shaping the future of cardiovascular medicine. Education programs address a number of topics surrounding cardiac rhythm management, electrophysiology and vascular intervention and are led by world-renowned experts in their fields. Through these workshops, courses and training sessions, physicians are supported in maintaining the highest level of knowledge of BIOTRONIK’s state of the art products.

In the last two years of this partnership, more than 1,000 lives have been saved, and BIOTRONIK, aware that demand is great and time is short, continues to reach people in need as quickly and effectively as possible.

HELPING HEARTS AROUND THE WORLD Cardiovascular disease is the world’s number one killer, and 82% of it originates in low and middle-income countries. There are one million - and possibly as many as three million - people who suffer or even die each year, because they cannot afford a pacemaker or ICD. Through a strategic partnership with the Heartbeat International Foundation (HBI), a global charity dedicated to providing much-needed heart devices to patients in the developing world, BIOTRONIK has dedicated its efforts to bringing those numbers down. BIOTRONIK donates pacemakers and defibrillators, while HBI organizes medical care.

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Arturo from Mexico lives with a life saving pacemaker thanks to Heartbeat International

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A STORY OF SUCCESS Over the past 50 years, BIOTRONIK has been able to grow tremendously while remaining true to the pioneering spirit of the company that began with that very first innovation at Berlin’s Technical University in the 1960s.

Its dedication to the highest levels of quality and reliability can be traced through everything it has done since then: 1963

Max Schaldach and Otto Franke develop the first German pacemaker in Berlin and found BIOTRONIK.

1967

The renowned hospital, Charité, based in the eastern part of Berlin, places its first order for a BIOTRONIK pacemaker.

1979

BIOTRONIK opens a new production facility in the United States in Lake Oswego, Oregon.

1982

BIOTRONIK marks its commitment to the Latin-American market by establishing its first office in Brazil.

1993

BIOTRONIK develops the first German implantable defibrillator (ICD).

1995

BIOTRONIK expands its company portfolio by adding vascular intervention devices, later beginning their production in Switzerland.

1998

BIOTRONIK develops its first fully computersupported electrophysiological measuring station.

2000

BIOTRONIK launches BIOTRONIK Home Monitoring®, a milestone in telecardiology.

2001

BIOTRONIK Home Monitoring® earns a place in the U.S. Food and Drug Administration’s (FDA) Technology Hall of Fame.

2003

BIOTRONIK develops its first cardiac resynchronization therapy (CRT) implants – the first CRT devices in the world to allow patients to be monitored remotely.

2010

BIOTRONIK pacemakers now feature innovative ProMRI® technology, allowing patients to receive vital magnetic resonance (MR) scans postimplant.

2012

BIOTRONIK opens its Singapore office, affirming its commitment to the Asia-Pacific region.

LOOKING TO THE FUTURE Today, BIOTRONIK is stronger than ever, continuing to expand its product portfolio and global presence.

To ensure the highest quality, BIOTRONIK has a vertically integrated production model, meaning that all critical components are produced in-house, and only in three countries world-renowned for their technical expertise: Germany, Switzerland and the United States.

BIOTRONIK boldly takes on the responsibility of contributing to developments that will write the next chapter in the history of pacing. As a forward-thinking model of what a 21st century company can be, BIOTRONIK aims to lead the way.

BIOTRONIK headquarters, Cardiac Rhythm Management, R&D and production, Berlin, Germany

BIOTRONIK Vascular Intervention, R&D and production, Bülach, Switzerland

www.HeartbeatSavesLives.org

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BIOTRONIK USA, Cardiac Rhythm Management, R&D, Lake Oswego, Oregon, USA ONE HEART MAGAZINE

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Antibacterial Envelope

Re N su ew lts S Pu tud bli y sh ed !

Help Prevent CIED Infection

More Protection.

Less Risk.™

with the AIGISRx® Antibacterial Envelope

Vanderbilt Study Shows 87% Decline in CIED Infections with the AIGISRx Antibacterial Envelope6 • A retrospective cohort study of patients at risk for infection undergoing a CIED implantation with and without the AIGISRx Envelope.

• Patients & procedure characteristics were used to identify patients at high risk for CIED infection.

• Results show 0.4% CIED infections in patients who received the AIGISRx implant, compared to 3.0% in the control group (p=0.04).

The AIGISRx® 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 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. Kolek et al. Pacing Clin Electrophysiol. ePub ahead of print, December 17, 2012.

CAUTION: Federal (USA) 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-23-102 Rev 5A

TRANSVENOUS CARDIAC PACING:

By Harry G. Mond OAM, MD, FHRS, CCDS, FACC Department of Cardiology, The Royal Melbourne Hospital, Department of Medicine, University of Melbourne, Parkville, Victoria, Australia

FADING MEMORIES

T

he development of an implantable cardiac pacemaker depended on the commercialization of the transistor in 1956, allowing the design of miniature battery-powered electrical circuits. In October 1958, Elmqvist and Senning in Sweden implanted the first artificial pacemaker using epicardial leads and a pulse generator with a rechargeable battery.

A year later, Greatbatch built a non-rechargeable pacemaker, which was implanted by Chardack in Buffalo, New York. At about the same time, Seymour Furman in New York successfully experimented with a transvenous pacing lead consisting of a Cournand catheter containing a steel wire soldered distally to a piece of tin foil cathode electrode.

It was remarkably soon Harry G Mond OAM, MD, after in early 1961, that cardioFHRS, CCDS, FACC thoracic surgeons at the Royal Melbourne commenced implanting pacemakers. The earliest models had epicardial leads attached during manufacture necessitating replacement of all the hardware if one component failed. This was www.HeartbeatSavesLives.org

soon replaced by separate leads and pulse generators with connectors created at the time of surgery. These pacing systems rarely lasted more than six months and the thoracic surgeons were reluctant to perform implants because of age and frailty of patients coupled with a very high incidence of complications.

A few years later, non-surgically trained cardiologists in the same hospital commenced the tedious task of implanting transvenous leads. The concept of interfering with heart function by inserting pacing wires internally was anathema to the honorary consultant physicians who referred all patients.

However, by the early 1960â&#x20AC;&#x2122;s, a low output external pulse generator with a temporary transvenous pacing lead inserted into the basilic vein by a right cubital fossa cut-down and guided to the right ventricle under fluoroscopic control was used in critically ill patients. It was an era where physicians were unrestricted as there were no clinical Research Committees, Boards of Ethics, nor need to make applications to the Hospital Administration. Research protocols, if prepared were

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rudimentary and continually changed during the study. Patient consent, if sought was verbal.

In 1966, permanent transvenous endocardial pacing leads became available at the Royal Melbourne Hospital and non-trained physicians took on the arduous task of implanting these leads. This was an era when all international communications were done by correspondence. There were no pacemaker training courses, no meetings and nobody to speak to. There were probably only a handful of physicians in the world experimenting with transvenous pacemaker implantation.

The unipolar transvenous lead available in Australia was the Elema-Schonander EM 588. By modern comparisons, implantable pulse generators were large and thick. The power source was four to six â&#x20AC;&#x153;hearing aidâ&#x20AC;? zinc-mercury batteries with an average life of 18-months to three years.

TRANSVENOUS ENDOCARDIAL PACEMAKER IMPLANTATION Early pacemaker recipients were required to earn their implants.

Symptoms had to be dramatic and the prognosis without a pacemaker poor.

A temporary pacing lead was inserted prior to the procedure. Although general anesthesia was occasionally used, the anesthesiologists deemed most patients too ill for this lengthy procedure and thus local anesthesia was preferred.

The venous entry site was a cephalic or external jugular vein cut down.

To allow positioning of the lead at the right ventricular apex, a large stiff Cournand diagnostic catheter flushed with heparinized saline was used. The lead was inserted from the distal end as the terminal electrode was larger than the catheter lumen.

The loaded catheter was passed to the right atrium and then directed toward the right ventricular apex. Without a fixation device or a stylet, there was no way to know whether the lead was simply lying against the endocardium or entrapped beneath or between trabeculae. However, once positioned, the formidable challenge was to remove the catheter without dislodging the lead as the lead had usually become adherent to the inner wall of the Cournand catheter with clotted blood.

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Illustration highlighting the early transvenous implant technique.

A: After the lead was positioned at the right ventricular apex via the cephalic vein, it was tunneled to the suprapubic region and attached to a temporary pacemaker. The lead was unipolar and an implanted anode plate is also required.

B: The implantation of the pulse generator was a separate procedure. The lead was cut short and connected to the pulse generator, which is implanted deep to the rectus sheath.

Arne Larson, the first implantable pacemaker recipient.

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Once successfully withdrawn, the lead was secured directly to the pectoralis major muscle using silk suture, being careful not to damage the soft insulation as there was no lead collar.

Because pulse generators were too large for subclavicular positioning, the lead was then tunneled using a long large bore needle along the subcutaneous anterior chest and abdominal walls to a suprapubic site. This painful procedure, usually under local anesthesia, involved making five or six small skin incisions and then using these as entry portals pushing the needle subcutaneously and retrograde from a distal site back to the lead position. Once the lead had reached the lateral suprapubic region, it was secured to the skin with silk sutures and the remaining lead exteriorized and used for temporary external pacing. Because the lead was unipolar, an anode plate was implanted subcutaneously in the ipsilateral thigh or anterior abdominal wall.

The operative procedure often took more than three exhausting hours. The fluoroscopy times were long and the X-ray equipment primitive, resulting in excessive irradiation with marked scatter. Without a fixation device, the incidence of lead dislodgement and high threshold exit block was high.

If re-operation was required a new lead was inserted from a new venous access site as there was no way to reposition the implanted lead. Following implantation of the lead, temporary pacing through the permanent lead was instituted for up to one week. Sensing was not an issue as all pulse generators were VOO. Prior to the lead implantation, a pulse generator was purchased and gas sterilized in-house. At pulse

www.HeartbeatSavesLives.org

generator implantation, a pocket was prepared by a surgeon in the upper abdomen deep to the rectus sheath. The lead, which traversed this incision was retrieved and cut short leaving sufficient length to prepare a rudimentary connector by biomedical engineers. The pulse generator was buried in the pocket and the redundant lead and anode plate removed.

Pacemaker complications were very common. During calendar year 1971, 38 new transvenous implants were performed at the Royal Melbourne hospital. There were nine acute lead dislodgements, two high threshold exit blocks, two very premature pulse generator failures and one post-operative septicemia giving rise to an early complication incidence of 37%. Almost all patients would have a pulse generator replacement within three years and in some cases within six months. Conductor fracture or insulation breakdown were also common.

CONCLUDING COMMENTS Today, the modern pacing system is taken for granted by well-trained implanters, who have little knowledge of the trials and tribulations undertaken by the early pacemaker physicians in a now bygone and forgotten era. This short transitional period in pacemaker development is not widely known as the vast majority of pacemaker implants at that time were undertaken by cardiac surgeons using epicardial leads. The introduction of stylet-driven leads, however, made the epicardial technique obsolete, allowing the development of current implant procedures.

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HEARTBEATâ&#x20AC;&#x2122;S

GUATEMALAN ROOTS M

By Dr. Federico Alfaro

y name is Federico Alfaro. I am a cardiologist and practice in Guatemala City in Central America. I am a proud member of Heartbeat International Foundation, a great humanitarian effort to give pacemakers to those that cannot afford them around the world.

The foundation of a pacemaker bank in Guatemala in 1977 came about due to the fact that there were people dying because they needed a pacemaker, they were extremely poor and there was no way for them to obtain one. It was hard to accept that a human being could die because lack of availability of a piece of equipment that could stimulate his heart when needed.

Federico Alfaro I realized then that I could be a part of a humanitarian effort that to date has prevented the deaths of nearly 11,000 people allowing them to continue to live and contribute to society. The Heartbeat International program is indeed a miracle which revolves around goodness, good will, caring for a better world, and staff members that have worked to help poor hearts beat better. It has been a spiritual journey for me; a miracle for which I am grateful to god.

I will briefly take you through this journey as I see it.

www.HeartbeatSavesLives.org

I graduated in June of 1970 as a physician and had the great opportunity to go to the United States for post-graduate training in internal medicine and cardiology at Baylor College of Medicine, at the Texas Medical Center in Houston, Texas.

This was a period of my life that I would not change for anything. This is where I grew, matured, and went through the mill, internship, residency, and became Chief Medical Resident and Cardiac Fellow. At Baylor, I met Dr. Henry D. McIntosh; an extraordinary human being whose example had a great impact on my life and still guides me. Dr. McIntosh, who was chief of cardiology at Duke University, became the chairman for the internal medicine program at Baylor in 1970 and he did an exemplary job. He remodeled and transformed the entire program.

I returned to my country in March of 1976 and became part of the medical staff at Roosevelt Hospital, one of the two teaching general hospitals in my country. It was a period of adaptation, growth, great teaching opportunity, and lots of suffering, as I witnessed with astonishment the lack of resources to help my people. My brother Ramiro had been a Rotarian for 15 years and invited me to be a part of Rotary, which I can affirm that has been one of the greatest happenings in my life, because Rotary is an organization that

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As I was a young and enthusiastic president at my club, I called attention to the members that in the public hospitals, people could die because of the lack of pacemakers. permits us to project, resolve, and lead in our communities through friendship, and honesty.

As I was a young and enthusiastic President at my club, I called attention to the members that in the public hospitals people could die because of the lack of pacemakers, a new world to them. They took the time to learn about the pacemakers, human conduction system disorders and the possibility of solving them. They accepted with great energy and enthusiasm the idea of creating a pacemaker bank, which we did and it is still running with continuing, uninterrupted service. We formed a set of guidelines that potential recipients of the pacemakers had to meet to qualify as patients.

1. The patient had to prove that they were below the poverty line.

2. The patient had to be admitted to a general hospital.

3. The doctors and hospitals working for the program would not charge honoraries at all.

4. The patient had to agree to abide by our plans for follow up care Eighty three pacemakers were implanted from 19781983, many of them refurbished, with no adverse effects.

Rotarians from the Central American region started to request pacemakers from Guatemalan Rotarians and Rotarians from the United States started to help obtain more pacemakers.

In October 1983, I invited Dr. McIntosh to lecture at the Guatemalan Congress of Cardiology. His visit is still remembered by Guatemalan cardiologists; but he did not only lecture, he was interested in everything we were doing! We visited Roosevelt Hospital and examined some patients, I told Dr. McIntosh about the pacemaker bank effort with the Rotary 30

ONE HEART MAGAZINE

Club of Guatemala De La Asuncion.

He was immediately very interested in the program and its humanitarian impact. He told me: “Federico, this is a great program, I will work in providing a continuous flow of pacemakers.” I knew beyond a shadow of a doubt that he would follow through on this promise. True to his word, Dr. McIntosh did not rest until he accomplished his goal.

Throughout the years I have never wavered in my belief that this program is nothing short of a miracle and every day that thought reinforces my resolve.

If we would have planned this outcome, we would have never achieved it; but it has been given to us little by little through the generosity of many good people who have donated their time and effort to make it possible and that generosity is what carries us on today.

Twenty five years have gone by and nearly 11,000 fellow inhabitants of our planet have been given a second chance.

We have been able to help people of all ages, from babies to the elderly. What an accomplishment.

But, we need to maintain and increase this program.

It needs our continuous dedication, effort, and time. Your participation is needed. As cardiologists, I truly believe that this is our chance to have a positive impact on our world. It is a grain of salt in all of the negativity that surrounds us. Let’s not miss this opportunity!

I am sure that you have frequently received blessings from your grateful patients & pacemaker recipients; but today I take their words and thank you all.

“Thank you very much, God bless you forever. Please keep working to help others like me.”

HRS SCIENTIFIC SESSIONS SUPPLEMENT 2013

www.HeartbeatSavesLives.org

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