Authors: James Forrester
The Heart Healers (17 page)
In Minneapolis, surgeon Walt Lillehei was bedeviled by heart block of a different origin. He was inducing heart block by his placement of sutures during closure of septal defects. The heart’s electrical conduction fibers traverse the ventricular septum perilously close to the stitches that Lillehei used to close the hole in the septum. About 10% of his patients developed heart block, usually caused by transient swelling, following surgery. He now had ten patients who had died due to heart block. It had become the major cause of his operative mortality. Lillehei knew what he wanted: a portable, battery-powered device that could deliver enough current to stimulate the heart to contract at a rate of about sixty beats per minute for at least several weeks. He just did not know where to find it. But he reasoned that he had one huge advantage: since the chest was open, at surgery he could actually suture the pacing electrodes directly to his patient’s heart. He could then tunnel these wires out through the chest wall to a battery, which would provide the pacing stimulus. Nothing that he imagined existed, but when Walt Lillehei ran into a wall he looked around for a door. What he found was not particularly promising: a University of Minnesota electrical engineering graduate student who earned extra income by picking up the hospital’s malfunctioning electrical equipment and repairing it in his northeast Minneapolis garage. You play the hand you are dealt, Lillehei must have thought.
Earl Bakken and his brother-in-law needed a name for their little garage business. Since their makeshift repair business could charitably be envisioned as merging medicine with electronics, they came up with Medtronic. Earl, who now lives on the Kona coast in Hawaii, is a gracious host with whom I have had dinner many times during the American College of Cardiology’s annual conference held in Kona. Just turned ninety, Earl has large wire-rimmed glasses and a narrow nose that give him the appearance of a benevolent wise owl. With a little urging, he will recount the story of how two guys working in a Minneapolis garage created a revolution in medical technology.
One day Lillehei pulled Bakken aside and explained his need for a small battery-powered electrical stimulator that he could sew directly to his patients’ heart. Earl Bakken, the inconsequential shadow that treaded the medical center’s halls with broken equipment, the guy who also repaired your TV set because medical equipment repair was not yet a full-time business, had been granted his own Great American Dream. The diffident young repairman segued to medical inventor. Didn’t he recall seeing a recent article about new miniature devices called transistors in
Popular Mechanics
? He searched through his stack of back issues to find “Five New Jobs for Two Transistors.” One “new job” described how to use transistors to build a musical metronome. Earl Bakken had a hunch, an intuition. A metronome could run at sixty beats per minutes … sixty beats! He did not need a metronome, but he did need a portable device that could run at precisely sixty beats per minute, or any other rate within the normal range of the human heartbeat. He bought a metronome, adding some mercury batteries as his power source. Now he could produce an electrical pulse at sixty beats per minute for Lillehei to connect to his wires. Bakken packaged his prototype parts in a device about the size of a paperback book. With no regulatory agency to demand extensive and costly device testing, and no hospital review board to challenge Lillehei’s research procedure, Bakken brought the device to Operating Room II.
Within a few days, Lillehei confronted intraoperative heart block. He sutured two wires to the external surface of the child’s heart and brought them out through the skin of the chest wall, where he attached them to Bakken’s device. As Lillehei’s hand rested on the switch, he faced the same three uncertain outcomes as Paul Zoll: no effect, death, or capture of the heartbeat. Switch on! It was a magical moment. The child’s heart rate immediately jumped to sixty beats per minute. Within the week, the boy’s normal rhythm reappeared. Lillehei removed the wires and the electrodes. Cured of his septal defect and free of heart block, the child went home to live a normal life.
Bakken had created a portable pacemaker, which could be carried in a harness outside the body. But like Paul Zoll’s external chest wall pacemaker, it was terribly impractical to carry a battery-powered pacemaker outside the body. In Buffalo, New York, Dr. Wilson Greatbatch and engineer Andrew Gage were collaborating to develop a pacemaker that could be implanted beneath the skin. Financially strapped, Medtronic somehow managed to snap up exclusive rights to this crucial invention.
But even so, they were not to be first with the internal pacemaker. In the summer of 1958, forty-one-year-old Swedish engineer Arne Larsson developed intermittent complete heart block following a viral infection of his heart. During these episodes his heart rate fell to less than thirty beats per minute and he frequently fainted. His wife, who resuscitated Arne by chest thumps as often as twenty times a day, learned that physicians at Stockholm’s Karolinska Institute were conducting animal research on an implantable pacemaker driven by rechargeable nickel cadmium cells. She lobbied incessantly for him to be the first to have an internal pacemaker. Arne Larsson’s pacemaker was actually put together on a counter in the kitchen of engineer Rune Elmqvist. The finished product was about the size of a thin hockey puck. In October 1958 Swedish cardiac surgeon Dr. Ake Senning inserted the world’s first implanted pacemaker. Larsson’s pacemaker battery worked off and on for three years before it petered out. During his life Arne Larsson used twenty-two electrical pulse generators and five electrode systems. A billion heartbeats later, Arne Larsson was still going. He died of malignant melanoma in 2002 at the age of eighty-six. Larsson had outlived both engineer Elmqvist, who died in 1996, and surgeon Senning, who died in 2000. In a wonderful touch off irony, the pacemaker designed by Rune Elmqvist was ultimately acquired by St. Jude Medical, where Walt Lillehei would become medical director after his surgical days ended.
The clicking of Earl Bakken’s transistor-powered metronome was about to swell into a drumbeat that heralded the emergence of a new medical device industry. In late 1960 Earl’s little company manufactured and sold their first fifty implantable devices. Within five years, Medtronic and competing companies were delivering electrical pacing impulses from a battery source implanted under the skin connected to wires that passed into the heart through a vein in the neck. To meet expanding demand for pacemakers, Earl Bakken moved from his garage into a 15,000 square foot facility in 1961. Nonetheless Medtronic teetered on the edge of bankruptcy until 1962, when it stabilized through attracting venture capital, and began a period of innovation and growth which led to it becoming one of the world’s most diverse medical technology companies. The company that began in a Minneapolis garage is now the leading corporation in the Fortune 500’s Medical Products & Equipment group, with 41,000 employees. On May 19, 2009, Medtronic announced its annual revenue as $14.6 billion.
Earl Bakken had created a revolution in medical technology that not only saved millions of lives, it also skyrocketed the United States into preeminence in the world’s burgeoning medical technology industry.
The Medtronic story is highly relevant to today’s health care. In its earliest years, Medtronic and its unfettered innovative approach to new technology would not have survived in today’s regulatory environment, which requires that devices meet rigorous manufacturing standards, specialists to deal with the FDA, prior approval by institutional review boards, and multimillion-dollar clinical trials. Many years elapse before the first device is sold. If cardiac surgery’s early experience with failed oxygenation strategies illustrates the need for regulation, the Medtronic success equally illuminates the need for streamlined regulation. Regulation is essential, but regulators must have the Goldilocks touch: not too hot, not too cold, but just right.
After the first use of defibrillators and pacemakers, we made huge steps forward in our ability to combat the electrical depredations of CAD. Both devices became implantable. Today 100,000 pacemakers are implanted each year. About half a million Americans live today with an implanted pacemaker, their hearts too good to die. In other patients, pacemakers and defibrillators are combined within a single device for use in the treatment of heart failure. The pacemaker assures that the heart contracts in a normal coordinated manner. In appropriately selected patients, it can be very effective in relieving the symptoms of heart failure. The defibrillator protects against ventricular arrhythmias, which are common in heart failure, which is, in turn, most commonly a complication of CAD.
* * *
IN THE COMBAT
support hospital electrophysiologist Major Robert Eckart delivered devastating news to the surgeons. The hospital had no electrodes to suture directly to the surface of the soldier’s heart. That particular pacemaker-electrode system lay halfway around the world.
Eckart’s only available pacemaker system was one designed with pads that are attached to an intact chest wall. But since the surgeons were relying on manual cardiac compression to keep their patient alive, they could not close the chest wall. Eckart thought outside the box. Perhaps he could cut off the pacemaker pads and expose the wires leading to them. If he could do this, then perhaps the surgeons could suture the ends of the wires to the heart’s surface. Eckart ripped off the two pads, exposed the wires leading to the pads, and fashioned two tips that surgeons Stewart and Falta sutured to the heart’s surface. They turned on the pacemaker. Nothing.
Facing death on the table, Eckart tried anew. He got a second set of electrode pads. This time he stripped the wire from just one pad, and the surgeons sutured the exposed wire to the heart’s surface. Eckart attached a second intact pad to the chest wall in the way it was designed to be used. Again he turned on the pacemaker. Capture! They had control of the soldier’s heartbeat at fifty beats per minute. They could cease manual compression and the soldier would at least survive to have his chest closed and be moved from the operating room to the intensive care unit. But in the ensuing hours he still needed a functioning pacemaker system. The improvised system was fragile. Until the cavalry arrived in the form of a permanent pacemaker system, the soldier was skewered to his bed by his lifesaving device. His life depended on a trivial detail: avoid an inadvertent tug that dislodged one of the wires.
Eckart called the United States and Germany trying to arrange the urgent delivery of a suitable pacemaker system to Baghdad. He could get overnight delivery of a pacing system to an air base forty miles north of Baghdad, but the logistics of travel through the war zone meant that an additional day would be lost in delivery to the combat hospital. Imagine being told, “Do not move. A simple movement could kill you. But don’t worry. We are pretty sure we will get a device in a couple of days that could help.”
Eckart, desperate for a better solution, called other contacts. Baghdad diplomatic sources sprang into action. They were able to find a pacemaker system, but it was in a civilian hospital miles away. Perhaps for the first time in medical history a pacemaker was given an armed escort. At the hospital, the Iraqi physicians got out the pacemaker system. Then, at great personal risk they trundled it into the armed convoy, winding along hazardous serpentine Baghdad streets until they reached the heavily fortified perimeter of the U.S. combat support hospital to deliver the lifesaving permanent pacemaker system.
The convoy arrived at the hospital entrance, and like Olympic relay runners the Iraqis handed the precious baton to Eckart, who rushed to the operating area. He implanted the pacemaker and its battery beneath his soldier’s left collarbone. Next he connected the pacemaker to a catheter that he passed into the right ventricle. The moment of destiny had arrived. Like Zoll and Lillehei decades earlier, he, too, flicked a switch. Capture!
In a remote corner of the world, unrecognized and unknown, the life of a young man was saved by a near-miracle of circumstances. Despite his terrible injuries, the soldier now was able to get out of bed and walk. Within days the soldier, with skin staples from his neck to his pubis, was ready to plan for his long trip home. The story ends with Major Eckart offering an understated acknowledgment, capturing an otherwise forgotten act of anonymous, selfless wartime heroism: “The authors wish to express gratitude to the Iraqi physicians who helped this U.S. soldier in a time of need.” And I will express our country’s gratitude to the brave soldier and his doctors for their heroism.
* * *
THE INVENTION OF
the defibrillator and the pacemaker was a huge forward step in overcoming heart disease, because within it lay a fantastic new idea: many hearts too good to die could be saved. And yet, it was still only an idea. Disorders of the heart’s rhythm appeared suddenly, and more often than not without prior warning. When they appeared they were so lethal that we had no way to bring a defibrillator or a pacemaker to the patient in time. Outside the operating room, sudden death always seemed to catch us completely unprepared. In theory, we could save thousands of lives. In theory there’s no difference between theory and practice, but in practice there is. The practical impact of defibrillators and pacemakers, the future savior of patients with acute heart attack, remained minimal. But a decade later, we will see them merge in the creation of the first coronary care unit.
When all is lost, ask the I.R.S.—they’ll find something.
—DOUG HORTON, CONTEMPORARY APHORIST
IN THE SEARCH
for medical cures and scientific breakthroughs, we always encounter both triumphs and failures. Human beings who seem superhuman exhibit faults. No failure is, perhaps, as heartbreaking as that of Walt Lillehei.
