Van Gerpen 1 Katherine J. Van Gerpen Honors English 12 Period 5 Due: December 16, 2011 Pacemakers Keep Ticking My interest in pacemakers began on December 25, 2009, when my dad began having spells causing him to lose consciousness temporarily. He kept brushing the spells off as nothing, but as they got worse, he finally agreed to go to the emergency room. The doctors hooked him up to machines and identified the problem as a weakness in the signal between the top and bottom of his heart. The blizzard outside prevented my parents from immediately flying to Sioux Falls, so for the time being my dad was attached to an external pacemaker. As soon as the weather cleared up enough, my parents flew to Sioux Falls where my dad received his permanent pacemaker. Since then I have found the heart more fascinating. I have also learned that many individuals in the world could benefit from a pacemaker like my dad’s. The Food and Drug Administration (FDA) should allow the United States to reuse pacemakers. Each year many people die because their natural pacemaker stops working correctly. In 1994 the FDA estimated that about 400,000 Americans die every year on account of abnormally fast or irregular heart rhythms (Farley). The reason for these deaths is an unhealthy heartbeat. The heart’s electrical system controls the rate and rhythm of a healthy heartbeat. Every time it beats, the top half of the heart passes an electrical signal to Van Gerpen 2 the lower half. While this signal travels, the heart is able to contract and pump blood (“What Is…”). If the heart’s natural pacemaker is not in good working condition, it is not capable of pumping blood to other parts of the body. The solution to this problem is a pacemaker. A cardiac pacemaker is a complicated mechanism that medical specialists continue to advance. It usually consists of two parts – the generator and the leads. The generator holds the battery and specific information to control the patient’s heartbeat, and the leads are wires that attach the generator to the heart and carry the electrical messages to it (Gandelman). The gadget’s function is to monitor the patient’s fundamental heart rhythm and send electrical signals to cause the heart to beat at a healthy rate (Wood and Ellenbogen). Over the years pacemakers have become smaller thanks to miniaturization techniques. Some are “as small as a quarter and less than an ounce in weight” despite such sophisticated capabilities (Farley). The little device has the power to save lives. This tiny piece of equipment, however, is not cheap. The cost of a pacemaker in the United States is between $10,000 and $35,000 (Moore). It is difficult to predict how long each unit will last; however, the average life of a pacemaker is between five and eight years (Wood and Ellenbogen). Factors such as the requirement to pace every beat, battery size, dual-chamber pacing, and the proximity of the connection to the heart may abbreviate a pacemaker’s life (Farley). On the other hand, some pacemakers purposely have a shorter lifespan. The National Heart Lung and Blood Institute compares the two kinds of pacemakers: “Temporary pacemakers are used to treat temporary heartbeat problems, such as a slow heartbeat that’s caused by a heart attack, heart surgery, or an overdose of Van Gerpen 3 medicine.” Whereas, permanent pacemakers control indefinite heart rhythm problems (“What Is…”). It is clear the technology can help a variety of heart predicaments. Pacemakers have been lengthening lives for more than five decades. Implanted in 1958, the first pacemaker had only one wire and paced at regular intervals. The pioneer improvement, however, did not arise for almost twenty years. The first advance occurred around 1976 with the first design change that permitted “demand” pacing. The device would only kick in if the individual’s heart did not beat after a certain amount of time. Introduced in the early 1980s, a programming function allowed doctors to personalize the pacemaker (Farley). Pacemakers continue to be improved. Monitoring blood temperature, breathing rate, and other factors are just a few of the enhancements found in newer pacemakers (“What Is…”). The cardiac device is now capable of being personalized based on the individual’s lifestyle. “A pacemaker can vary its rate, depending on the person’s activity level” (Crawford 142). The pacemaker is also able to recognize and adjust when its host is sleeping. Many newer models automatically allow for a slower heart rate when the person relaxes or sleeps (Farley). Day or night, pacemakers keep working. The pacemaker is not a rare commodity in the world. In 2006 researchers estimated that three million people worldwide had a pacemaker, and each year doctors implant about 600,000 devices (Wood and Ellenbogen). The majority of these recipients are adults; however, heart defects are the most common type of birth defect affecting nearly eight per 1,000 children (Law). The signs that indicate a person might need a cardiac assistant vary. Symptoms that may lead to the implantation of a pacemaker include lightheadedness, tiredness, fainting spells, and shortness of breath (Gandelman). Clearly, doctors rely on pacemakers to remedy a range of medical problems. Van Gerpen 4 After a doctor decides a patient is due for a pacemaker, the surgery is fairly simple and short. Charles Van Gerpen, a pacemaker dependent, recalls his procedure: “The surgery lasted about an hour. I was just conscious enough that if the doctor shouted at me a few times I would respond. I really didn’t feel anything though.” His implantation was successful. Doctors implant cardiac pacemakers under the skin in the upper left part of the chest and attach it to wires that go through the heart (Farley). The procedure is common, and the risk of surgical complications is slim, about one to two percent. Typically, the only visible evidence after healing is a small bump over the heart (Wood and Ellenbogen). Other than the little lump, patients do not notice the piece of equipment. After patients receive their pacing instrument, it does not take long before they can resume their everyday activities. Recovery from the operation is minimal, but doctors advise patients to limit heavy lifting and excessive motion with the left arm (Wood and Ellenbogen). Every two to three months, people with pacemakers must schedule a checkup. Physicians emphasize the importance of these regular checkups so they can fix problems, such as battery depletion before they get more serious (Farley). Van Gerpen explains the procedure he follows on a regular basis: “Every three months I hook myself up to a machine that the hospital in Sioux Falls gave me. I place an instrument over the pacemaker, and then it takes about twenty minutes to collect, process, and transmit information. The data is used to determine how often my heart is using the pacemaker and other important details.” This quarterly medical test is vital to ensure the device is functioning properly. Many times the pacemaker functions so well it outlives its host. Janet Moore explains this common occurrence: “The truth is most pacemakers last anywhere from five to ten years, and they keep ticking whether the recipient is alive or not” (Moore). Van Gerpen 5 Undeniably, the ticking is not always enough to keep a person alive. Despite the life-saving capability of pacemakers and precautions taken, about thirty-five percent of pacemaker recipients do not live beyond eighteen months of their implantation (Blank 84). This is not the only startling statistic. A survey of Michigan and Illinois morticians revealed that nineteen percent of deceased people had a heart device implanted, but funeral homes bury the majority of the devices along with the body (Norton). Instead of burying or salvaging the appliances, the Heart Rhythm Society encourages funeral directors to send cardiac pacemakers back to the manufacturers for testing (Joelving). Most funeral homes, however, do not take the time to send the gadgets back. Accumulating in funeral homes and crematoriums, morticians throw away eighty-four percent of the pacemakers they remove from the deceased (Moore). These pacemakers still have life support left but do not benefit anyone. While funeral homes are throwing away ticking pacemakers, people are dying because they do not have one. Between one and two million people die each year because they do not have the money to buy a pacemaker or the access to receive one (Norton). Director of the Cardiovascular Center at the University of Michigan Dr. Kim Eagle portrays his feelings on the reuse of pacemakers: “What’s amazing is that the rich countries in the world are throwing away pacemakers, and the poor countries in the world don’t access them. This disparity is probably not completely solvable, but it’s partially solvable if we think creatively” (Moore). In order to make pacemakers safe for reuse, someone must refurbish them, which takes time. Hospitals can use sterilization to clean the pacing apparatuses; however, alternatives exist, such as establishing pacemaker banks or sending the devices back to the manufacturer to be reprocessed (Rosengarten 1275). The Van Gerpen 6 possibility of infection is the main risk doctors and patients meet when implanting previously used pacemakers (Moore). What appears to be an obvious solution has numerous obstacles. “… [T]here are still significant barriers to getting recycled pacemakers to the world’s poor on any large scale” (Norton). If medical experts can overcome these hurdles, pacemaker reuse could be successful. Despite the number of humans dying because of heart rate difficulties, companies producing the technology do not approve of their reuse. Medtronic Inc., Boston Scientific Corp., St. Jude Medical Inc., and other large med-tech companies defy the concept of pacemaker reuse. The companies express concern that “the integrity and performance of devices intended for single use may be compromised” if reused (Moore). The corporations discourage use of recycled pacemakers due to concern for the health of individuals receiving them. The FDA takes a similar stand: “FDA spokeswoman Karen Riley said pacemakers need to be capable of withstanding necessary cleaning, disinfection, or sterilization without adverse effect to the devices while continuing to comply with applicable FDA requirements” (“Reusing…”). The devices must withstand refurbishment before they can save other lives. On the other hand, well-respected medical experts believe pacemaker reuse is plausible. Michael Rosengarten, chair of the Pacemaker Committee and director of the Electrophysiology Laboratory at Montreal General Hospital, explains that assessing reused pacemakers should occur on a case-by-case basis: “To assume that a recovered pacemaker will have a shorter service life than a new one is to misunderstand the fundamental principles of pacemakers. A used pacemaker with voltage and rate programming that has a life expectancy of nineteen years will easily outlive a new nonprogrammable pacemaker Van Gerpen 7 that has a life expectancy of eight years.” Regardless of the long life of pacemakers, a common concern is battery decay or pacemaker failure. Yet death following pacemaker stoppage is very unusual. In most cases in which the battery stops, the natural heartbeat takes over until a doctor can implant a new device or hook up an external pacemaker (Farley). Just as some hearts stop working without notice, some pacemakers do as well. Since 1985 acquired data has proved that the recycling of pacemakers is safe. Recently, the United States acquired the data, but the first studies that evaluated the safety of pacemaker reuse came from Sweden, Canada, and the Netherlands (Kolettis 162). Dr. Richard L. Page, immediate past president of the Heart Rhythm Society, said reuse “is clearly preferred over failure to treat, especially now that we have data to suggest it is safe” (Joelving). Medical professionals should weigh the potential reward of lengthening lives versus the medical risks. The North American Society of Pacing and Electrophysiology announced in 1985 that of the nearly 200 reused pacemakers implanted only one failure resulted (Munshi 186). Additional reuse results also show promise. “Doctors from the University of Michigan in Ann Arbor presented pooled data from hundreds of patients showing there was no increase in infections, malfunctioning or overall complication when reusing pacemakers” (Joelving). These success stories illustrate the life-saving odds of reuse. Pacemaker banks have made the reuse of pacing implements achievable in developing countries. The treatment of irregular heart rhythms is minimal in third-world countries due to fewer medical providers and the lack of funding for the devices and implantation (Moore). Of all the humans with pacemakers, eighty-seven percent would willingly donate their device to a patient in a third-world country (Collier). Only a fraction Van Gerpen 8 of these devices would be suitable for reuse though. Investigators retrieved 121 pacemakers from funeral homes between 2004 and 2010, and fifty-three were acceptable for reuse and thus taken to India (Miller). These devices end up in pacemaker banks. Reuse programs have created banks in over twenty-four countries where devices can now be donated (Hasan et al. 657). Several charitable programs work with the banks to fill patients’ needs. Heartbeat International, a charitable organization, is responsible for the implantation of recycled cardiac pacemakers in the last twenty-five years. They continue to follow up with these patients. More than 9,000 patients living in developing countries benefit from recycled pacemakers donated by this cause (657). The advancements in developing countries continue to grow. Heartbeat International is not the only project aimed at the reuse of pacemakers. Project My Heart Your Heart is the latest effort to the reuse of pacemakers and has become a cooperative initiative between funeral directors, citizens, and physicians at the World Medical Relief, Inc. and the University of Minnesota Cardiovascular Center (Collier). The project has accumulated 4,000 pacemakers since it began (Reusing). The initiative works closely with funeral homes. “…Project My Heart Your Heart relies on participating funeral homes to find consenting families who are willing to donate their loved ones’ pacemakers” (“Reusing…”). The project would not be successful without these families. If the FDA gives permission, the project will carry out a broad medical trial to examine device implantation using hospitals with insufficient access to extensive heart care, such as Vietnam, Pakistan, the Philippines, and Nicaragua (“Reusing…”). This study exemplifies the hope for patients in developing countries in need of heart-assisting pacemakers. Van Gerpen 9 The FDA should reexamine pacemaker reuse as the rewards may now exceed the risks and allow the United States to salvage these costly apparatuses. Heart patients in third-world countries can benefit from the life-saving devices as opposed to discarding the valuable technology in established countries such as the United States. An abundance of evidence is available that proves pacemakers have life beyond the initial patient’s use. Numerous programs exist that focus solely on the reuse of pacing devices. Therefore, ignoring this valuable resource is wasteful. One country’s discarded technology can become another country’s life-saving treasure. Van Gerpen 10 Works Cited Blank, Robert. The Price of Life. New York: Columbia University Press, 1997. Google Book Search. Web. 24 Nov. 2011. Collier, Andrea King. “Reusing Pacemakers May Save Lives Globally.” healthymagination.com. General Electric Company, 16 Mar. 2011. Web. 20 Nov. 2011. Crawford, Michael H. “Heart.” The World Book Encyclopedia. Vol. 9. Chicago: World Book, Inc., 2001. Print. Farley, Dixie. “Implanted Defibrillators and Pacemakers A Gentler Jolt and Tickle…” FDA Consumer (U.S. Food and Drug Administration). April 1994: 10-14. SIRS Issues Researcher. Web. 18 Nov. 2011. Gandelman, Glenn. “Heart Pacemaker.” nlm.nih.gov/medlineplus. U.S. National Library of Medicine, National Institutes of Health, 8 Nov. 2010. Web. 18 Nov. 2011. Hasan, Reema, et al. “Safety, Efficacy, and Performance of Implanted Recycled Cardiac Rhythm Management (CRM) Devices in Underprivileged Patients.” PACE 34 (June 2011): 653-658. myheartyourheart.org. University of Michigan Health System. PDF. 12 Dec. 2011. Joelving, Frederik. “A Life After Death For Used Pacemakers.” reuters.com. Thompson Reuters, 20 May 2010. Web. 29 Nov. 2011. Van Gerpen 11 Kolettis, Theofilos. “Reuse of Electrode Catheters.” Hospital Chronicles 2.4 (2007): 160-163. PDF. 1 Dec. 2011. Law, Ian. “Heart Problems Are Not Limited to Adults—Babies Have Them Too.” uihealthcare.com. University of Iowa Hospitals and Clinics, 21 Dec. 2007. Web. 20 Nov. 2011. Miller, Reed. “Recycled Pacemakers Save Lives in India.” theheart.org. WebMD, LLC, 21 Oct. 2011. Web. 29 Nov. 2011. Moore, Janet. “Pacemakers Keep On Ticking: Why Not Reuse Them?” McClatchy – Tribune Business News. 14 Nov. 2010: n.p. SIRS Issues Researcher. Web. 18 Nov. 2011. Munshi, M. Zafar A. Handbook of Solid State Batteries And Capacitators. Singapore: World Scientific Publishing Co. Pte. Ltd., 1995. Google Book Search. Web. 29 Nov. 2011. Norton, Amy. “Reused Pacemakers Safe Option in Poor Nations.” reuters.com. Thompson Reuters, 26 Oct. 2011. Web. 19 Nov. 2011. “Reusing Pacemakers.” Vindy.com. The Vindicator, 22 Sept. 2011. Web. 29. Nov. 2011. Rosengarten, Michael. “Medical Devices Labeled For Single Use: The Reuse of Permanent Cardiac Pacemakers.” Canadian Medical Association Journal 140 (1 June 1989): 1274-1276. PDF. 1 Dec. 2011. Van Gerpen, Charles. Personal Interview. 21 Nov. 2011. “What Is a Pacemaker?” nhlbi.nih.gov. National Heart Lung and Blood Institute, 1 Dec. 2009. Web. 20 Nov. 2011. Van Gerpen 12 Wood, Mark, Kenneth Ellenbogen. “Cardiology Patient Page.” Circulation 105 (5 Mar. 2002): 2136-2138. circ.ahajournals.org. The American Heart Association, Inc. Web. 12 Dec. 2011.