Heart: An American Medical Odyssey

by Cheney, Dick

  It had been known for many years that some patients with chronic heart disease die suddenly as a consequence of ventricular fibrillation (V Fib), essentially a chaotic electrical storm that causes the heart to quiver (fibrillate) ineffectively. In 2001 we knew that the risk of developing V Fib was inversely related to how well the heart contracts. A normal heart ejects about 60 percent of the blood that fills the left ventricle after each beat (ejection fraction 60 percent). The lower the ejection fraction (EF), the greater the risk of sudden cardiac death. The threshold for increased risk seemed to be around 35 percent, which is about what we estimated the vice president’s ejection fraction to be. Other risk factors for developing sudden cardiac death included a prior (resuscitated) cardiac arrest (which the vice president had never had) and the identification of ventricular tachycardia by Holter monitoring (which we had just found).

  Mr. Cheney’s Holter monitor recorded more than 130,000 heartbeats over the thirty-four hours he wore it. Although only eight beats (.006 percent), lasting a total of about four seconds, were concerning, that was enough to identify the vice president as being at higher risk for a potentially fatal arrhythmia.

  When we decided a couple of months earlier to have the vice president wear the monitor, a colleague had questioned the wisdom of the decision.

  “Why look for trouble?” he asked.

  To me, the answer was clear: sometimes what you don’t know can kill your patient. Now that we had the data, I knew that Vice President Cheney was going to need a defibrillator.

  • • •

  Mordechai Friedman, a Polish Jew, was born in Warsaw in 1924. When he was a teenager, his name was changed to Mieczyslaw (Michel) Mirowski in an attempt to shield him from the fierce anti-Semitism that would soon become genocide. On September 1, 1939, German troops invaded Poland, the opening act of World War II, and the beginning of a five-year brutal occupation that included the methodical murder of most of Poland’s Jewish population. Of the 3.3 million Jews living in Poland prior to the war, only 350,000 would survive to see the war end.

  Three months after the German invasion, Mirowski, sixteen years old, left Warsaw, never to see his family again, and traveled east through wartime Soviet-occupied Poland, Uzbekistan, and the Ukraine.

  After the war, he attended medical school in Lyon, France, and upon graduation went to Israel, where he worked for a while before moving to Mexico and the United States for training in cardiology. In 1963 he returned to Israel to practice cardiology and met Dr. Harry Heller, who would become his friend and mentor. Mirowski later said:

  In 1966, my old boss, Professor Harry Heller, started having bouts of ventricular tachycardia. He was repeatedly hospitalized and treated with quinidine and procainamide (the leading antiarrhythmic drugs of the time). My wife asked me why I was so concerned. “Because he will die from it,” I told her. And he did, two weeks later while at dinner with his family.

  Heller’s death prompted Mirowski to start thinking about solutions for sudden cardiac death. The 1960s saw the introduction of coronary care units, where high-risk patients were monitored and treated rapidly should a lethal arrhythmia, such as ventricular fibrillation, occur. Mirowski wondered whether the large defibrillators stationed in CCUs could be miniaturized and implanted like a pacemaker in an ambulatory patient. Mirowski said:

  I talked to some cardiologists who knew more about such devices. They all told me that defibrillators couldn’t be miniaturized. In those days, a defibrillator weighed 30 to 40 pounds; it was preposterous to reduce it to the size of a cigarette box. But I had been challenged by the problem, initially because of the death of a man I admired very much, but also because people told me it couldn’t be done.

  Mirowski moved his family to the United States in 1968 and accepted a job as the director of the CCU at Sinai Hospital, a community hospital in Baltimore, where he met Dr. Morton Mower, with whom he would collaborate to build the world’s first implantable defibrillator. Mower later described the focus of the research:

  The initial goal set was a battery operated, automatic defibrillating device to be tested in animals, capable of monitoring in a standby mode and recycling in the event more than a single shock would be required in a particular episode.

  A defibrillator, which sits atop a hospital “crash cart,” contains a power source, usually a big battery that is continually charged through an AC outlet, a large capacitor, and the familiar paddles (now more commonly adhesive patches) that are used to transfer the energy to the patient for resuscitation. Before a defibrillator can deliver a shock, the capacitor must first be charged with several hundred joules of electricity, a process that takes several seconds. Crucially, Mirowski realized that a conventional defibrillator expends a lot of energy overcoming the resistance imposed by the skin and subcutaneous structures and that the heart could be defibrillated with much less energy if a shock was delivered from leads positioned inside the heart.

  Mirowski and colleagues constructed prototypes, sometimes with components ordered from electronic catalogues and even scavenged from a camera flash. Soon they began laboratory tests on dogs. In 1972 Mirowski met Dr. Stephen Heilman, the CEO and founder of Medrad, a Pittsburgh-based manufacturer of angiographic injection devices. Heilman described his meeting with Mirowski:

  More memorable for me was Michel himself. He was intense. His speech was enriched by the expressive movement of his eyes. I knew that he had had contact with several languages and peoples as a result of being Jewish and living in Europe during World War II. His dedication to the project particularly impressed me. . . . I sensed in him a deep intelligence and a dedication that stood out. By the end of lunch we had agreed to collaborate on this exciting idea.

  There were those, however, who derided Mirowski’s implantable defibrillator, among them Dr. Bernard Lown, a world-famous cardiologist (and later winner of the Nobel Peace Prize), who more than a decade earlier had added greatly to the science of resuscitation with his significantly improved design for an external defibrillator. In a 1972 editorial in Circulation, the journal of the American Heart Association, written with Dr. Paul Axelrod, Lown wrote:

  Experience teaches that a rigid solution to a biologic problem is usually no solution. If the patient with such an implanted device is found dead, numerous questions will loom including the gnawing doubt that electrocution may have been a factor. . . . In fact, the implanted defibrillator system represents an imperfect solution in search of a plausible and practical application. In the absence of a clearly defined clinical purpose, what then energizes such undertakings by a number of groups? The rationale for some current bioelectronic development is best exemplified by Edmund Hillary’s reasons for climbing Mt. Everest, “Because it was there.” The same holds for some electronic gadget manufacture: “It was developed because it was possible.”

  Mirowski and colleagues responded to Lown’s criticism:

  The authors” overcautious and negative attitude to the approach under investigation seems certainly premature at this experimental prototype stage. Would it not be more appropriate to postpone disqualification of this new way of approaching a major cause of mortality, however imperfect it may seem to be, until it faces the test of clinical trials?

  Dr. Barry Maron, at the time a researcher at the National Heart Lung and Blood Institute, described Mirowski’s reception as “a graphic illustration of the medical establishment against a guy who had no big name.”

  Undeterred, Mirowski and colleagues continued their research, and on February 4, 1980, at Johns Hopkins Hospital in Baltimore, a fifty-seven-year-old woman with a prior heart attack and multiple episodes of sudden cardiac death requiring defibrillation received the world’s first implantable defibrillator. When the report of the initial implants was published in the New England Journal of Medicine, it was accompanied by an editorial with a decidedly different tone from Lown’s eight years earlier:

  Although considerable additional work is needed to perfect the diagnostic and therapeutic ca
pability of this device, it is a potentially important therapeutic contribution. . . . Viewed optimistically, this is yet another in an impressive series of contributions toward progress in the monitoring and identification of important ventricular arrhythmias and in their pharmacologic and electrical correction.

  In 1985 the FDA approved the implantable defibrillator for commercial use. Since that time, millions of patients around the world have received the device during an outpatient procedure that takes about an hour and can be accomplished through a three-inch incision under the collarbone. Today implantable cardioverter defibrillators (ICDs) are used in patients who have survived cardiac arrest or those with high-risk features such as severely decreased heart function or certain inherited disorders.

  • • •

  On June 25, 2001, Gary and I went to the White House to discuss the results of the Holter monitor with the vice president. Lew arranged for us to meet in Dr. Tubb’s office, and we asked Dr. Sung Lee, a cardiac electrophysiologist with our group at George Washington, to join us. We told the vice president that the monitor recorded a few brief episodes of ventricular tachycardia, and in the context of his prior heart attacks and impaired left ventricular function, this finding identified him as being at higher risk of developing a potentially fatal arrhythmia. I told the vice president that the risk could be reduced with the implantation of an ICD, and Sung described the procedure and the technology in great detail.

  I acknowledged that the vice president had unique medical coverage in that Lew or one of his people was always nearby with an external defibrillator, but I reminded him that there were times when those precautions would be inadequate, for instance, when he was alone in his office or sleeping or showering. The ICD would be a 24/7 internal sentry. I told the vice president that if he received an ICD but never needed it, the decision to place it would still be correct.

  Mr. Cheney asked Sung Lee some questions about the procedure itself and device durability, and finally said, “It makes sense.”

  • • •

  Mary Matalin called a few days later to talk about the ICD and how the public announcement would be made. She told me that she cried when the vice president told her what we were planning to do. I reassured her that he was going to do well and that the device would protect him.

  The plan was to bring the vice president to George Washington University Hospital early in the morning on Saturday, June 30. She said the vice president was going to make the announcement himself, in the White House briefing room on the Friday before the procedure, and they wanted me to join him there to answer questions from the press.

  “That’s a bad idea,” I said.

  “The president’s people really want you to do it,” she replied. “You’re going to have to give me something to convince them.”

  “Tell them that if I have to field questions before the procedure, I almost certainly will be asked, ‘What can go wrong?’ ”

  “What can go wrong?”

  “We can put a hole in a lung, or a hole in the heart, or cause severe bleeding,” I responded. “After the procedure on Saturday, when there are no complications, no one will ask us what could have happened but didn’t.”

  “Done,” Mary said.

  • • •

  Instead of having me answer questions prior to the procedure, the White House released a statement I wrote. In it, I described the findings on the Holter monitor that prompted this procedure and stated that we were going to first do a test to verify that the vice president was indeed at risk, and if the test was abnormal, the vice president would receive an ICD:

  The electrophysiology study scheduled for June 30 involves the analysis of waveforms acquired from wires passed into the heart through the veins accessible at the top of the leg. This test will help assess Mr. Cheney’s future risk of developing a sustained cardiac arrhythmia and determine if an implantable cardioverter defibrillator should be placed during the same procedure. An implantable cardioverter defibrillator (ICD) is a small electronic device, roughly the size of a small pager, weighing less than 80 grams, that is placed under the skin of the upper chest and has the capacity to continuously monitor and analyze a patient’s heart rhythm. The ICD’s main function is to interrupt rapid heart rhythms. If the ICD detects an arrhythmia, it can terminate the abnormal rhythm with either a pacemaker function or the delivery of a low-energy electrical shock. The device, which is designed to last 5–8 years before needing replacement, is placed with the aid of local anesthesia and intravenous sedation. Patients are usually discharged from the hospital later the same day and may return to work the next day.

  Vice President Cheney’s motorcade arrived at George Washington University Hospital early the next day, and we escorted him to the cath lab, where Sung Lee again reviewed the planned procedure, as well as its risks and alternatives, and the vice president signed the informed consent.

  Sung was a graduate of the Medical College of Virginia and had completed a residency in internal medicine at the University of Maryland before spending four years as a research fellow at the National Institutes of Health. I was a few years ahead of Sung when he came to do his fellowship at George Washington University Hospital and was glad that he accepted a job with our group when he finished his training. He is a smart, easygoing guy with a warm spirit, but in the electrophysiology (EP) lab he is all business.

  I’d sat down to talk with Sung the day before Cheney’s procedure because he looked uncharacteristically nervous.

  “What are you worrying about?” I asked.

  “The press conference,” he said a little sheepishly.

  “The press conference?” I said, laughing. “I’ll take care of that; you just concentrate on not killing the vice president.”

  With the vice president asleep on the examination table, Sung introduced a catheter into a vein in Mr. Cheney’s leg and maneuvered it to the heart. Without much difficulty, Sung was able to induce ventricular tachycardia by stimulating the heart with three premature impulses, additional evidence that the vice president was prone to this arrhythmia. Outside the hospital, this heart rhythm could lead to death, but in the controlled environment of the electrophysiology lab, Sung quickly terminated the dangerous rapid rhythm.

  I picked up a phone in the lab and called the control room on the other side of the glass to tell Alan Wasserman that we had found what we were looking for and Sung was going to implant the ICD. From the table, Sung said he might try to induce the arrhythmia one more time, and when I relayed that to the control room, Alan said, “Tell Sung if he tries to do that again I’m going to have the Secret Service shoot him.” When the laughter subsided, the tension in the room had abated noticeably, no doubt just what Alan had intended.

  Sung infiltrated lidocaine under the skin near the vice president’s left collarbone and then made a small incision. A large vein, the subclavian, courses under the collarbone, and Sung promptly found it with a needle. He then passed two thick wires into Cheney’s heart, anchoring one in the right atrium and the second larger lead in the right ventricle. Sung worked quickly but not hurriedly, and next made a small pocket under the skin for the ICD.

  The 2.75-ounce device, less than half the size of a deck of cards and the price of a small Lexus, is the direct descendant of Michel Mirowski’s original invention and a triumph of bioengineering. Inside the smooth, sealed titanium enclosure sits a sophisticated programmable computer for rhythm analysis and treatment customization, a pulse generator for pacing, and capacitors for defibrillation. The battery will last on average about six years, when the entire ICD has to be replaced.

  A few days prior to the procedure, before it was announced that we were going to implant a defibrillator in the vice president, I’d asked Sung to acquire an ICD still sealed in its original packaging and lock it away. A manufacturer’s representative typically attends all defibrillator implants and will select a device from a giant bag of mobile inventory at the time of insertion. For this case, however, I thought it wo
uld be safer to choose a random ICD before anyone knew for whom it was destined.

  Using a special screwdriver, Sung tightened the leads securely into the device before slipping it under the skin. Because the ICD is intended to treat ventricular fibrillation, the only way to know for sure that it will work is to induce the lethal arrhythmia in the lab and watch the device administer a shock. The vice president, who had been groggy but arousable after getting IV sedatives during the procedure, was given a dose of propofol, a short-acting hypnotic that induces sleep very quickly but dissipates rapidly when it is discontinued. With the patient asleep, a programming command was given to the ICD, which a moment later induced ventricular fibrillation.

  We looked at the monitor and watched as the vice president’s EKG suddenly changed from its slow, stable rhythm to a fast and chaotic pattern that, left untreated, would kill him in a few minutes. We watched as the ICD recognized the arrhythmia and charged its capacitor. The process took an excruciatingly long fifteen seconds. The device is programmed to check again for the arrhythmia before delivering its energy and, still detecting it, the ICD delivered a low-energy shock. There was a muffled pop, and Vice President Cheney shuddered under the sterile drapes. All eyes turned to the EKG monitor, which demonstrated that Cheney was still in V Fib. The device recharged, and while we waited for the ICD to deliver a higher-energy shock I saw Julia instinctively move closer to the external defibrillator, the backup plan in case the second ICD shock also failed. Again Cheney jerked a little with the shock. This time, the monitor showed that he had been successfully restored to a normal rhythm. Satisfied that the higher-energy setting would defibrillate the vice president, Sung grabbed a needle driver and suture and began to close the small wound as everyone in the room congratulated him on his cool performance. Julia called Sung a “rock star.” I couldn’t agree more.