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Authors: James Forrester

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In the years following his landmark achievement, Bailey continued to be successful. Yet only a man who suffered no fools would end his career as did Charlie Bailey. He had long fumed at what he considered frivolous lawsuits directed against him. At the age of sixty-three he gave up surgery, earned a law degree from Fordham, joined a law firm, and became active in a new battle, medical malpractice law. Bailey left a legacy of trenchant and still relevant insights about medical malpractice and the doctor-patient relationship. At age eighty-one, he confronted another old enemy … aortic valve disease. He was successfully treated by Denton Cooley, the world-famous Texas cardiac surgeon of the generation that had learned so much from him and Harken. He died a year later.

As Cooley gently wrote in his obituary, Charles Bailey “could well be considered as the father of direct heart surgery, having demonstrated that the human heart could withstand manipulations which were previously considered impossible” (but his) “professional career was somewhat uneven because of his volatile nature and disregard for his critics” and his “aggressive and often uncompromising convictions” that led to controversy.

*   *   *

But what about Dwight Harken, the race’s apparent loser?

 

4

THE PAIN OF THE PIONEER

When you are aspiring to the highest place, it is honorable to reach the second or even the third rank.
—CICERO, ROMAN PHILOSOPHER

JUST FIVE DAYS
after Charles Bailey’s waggling finger in the suburbs of Philadelphia pointed the way to a new era of cardiac surgery, Dwight Harken announced he had accomplished the same feat in Boston, and a few weeks later Russell Brock reported a similar success from London. But as Harken had learned years earlier on his father’s Iowa farm, close only counts in horseshoes.

Dwight Harken, so clearly the father of the idea and the method of closed heart mitral valve surgery, had lost his place in history. It was not that he had not tried. Rather it was that Harken’s initial results were even more dismal than Bailey’s. He had already operated on six patients when Bailey first succeeded. All six had died. In clinical research, tragedies precede triumphs. A salvo of ten consecutive deaths preceded the first successful mitral valve surgery. Harken and Bailey had logged a stupefying twentieth-century proof of the ancient Arab wisdom that “He is not a surgeon who has not killed many patients.”

Harken’s obstacle to continuing the attempt to successfully operate on a diseased heart was different from Bailey’s, but just as potent. Where Bailey faced fierce external opposition, Harken confronted internal guilt. As Harken recalled, “It was pretty grim. With the sixth death, I was so depressed that I came home in the middle of the morning [the patient had died on the table] and went up to my room and went to bed.” For Harken, the torrent of blood in London had transmogrified into a stack of bodies in Boston. Had he crossed a line in the sand that stood for two millennia, drawn by the hand of Hippocrates himself? Primum non nocere. First do no harm. If six deaths were not too many, how many were? Compassion overwhelmed medical progress; Harken had failed, and now he was consumed by guilt. On the day of his sixth consecutive death he vowed to cease his quest, to give up heart surgery.

“No responsible man would continue with the devastation that I have wrought with these people,” he said.

The following day his friend cardiologist Lawrence Brewster Ellis came by. Ellis argued the other side of the moral dilemma intrinsic to innovative research, that without surgery his patients were doomed.

“I think that’s a terribly selfish attitude you have to waste these people’s lives … you must have learned something from losing those six people. Don’t you think you should put whatever you’ve learned to good purpose?” In just two sentences, Ellis encapsulated why in medicine tragedies precede triumphs. We humans simply cannot do things perfectly the first time; we must learn from our mistakes.

Wanting to be convinced while retaining his reluctance, Harken demurred. “Well, I do not think any respectable physician would send me a patient.”

Brewster Ellis countered, “I’m generally considered respectable. I’m the president of the New England Cardiac Society; I’d certainly send you another patient. I’ve never sent you a patient who wasn’t dying and, if you would be willing to try again, I’d be willing to send you patients.” And so Harken agreed to try a seventh time. This time he succeeded, less than a week after Bailey’s success. Harken soon proved that he had indeed learned from his failures: after his initial success “only” two of his next fifteen patients died.

After ten successive deaths between them, Bailey and Harken each had a survivor. Like me, some readers may feel queasy at how it came about, when surgeons offered unproven, potentially lethal treatments to vulnerable, desperate patients. Nonetheless that was the accepted ethical norm of the time. But the most critical part of this story is the part that remains true about medical research today: innovators cannot do things perfectly the first time—they learn from their mistakes. The stunning, unspoken consequence is that for great medical advances to occur, patients will be injured and some will die. Later in our story I will confront this wrenching conundrum as a leader of a large research program in a lethal disease, CAD.

With Bailey’s success just days earlier, Dwight Harken chafed with the realization that he was destined to be the bridesmaid instead of the bride. “Unless … what if…?” Harken pondered. Didn’t it really depend on the meaning of “first”? Some might think
first
meant, “first to perform cardiac surgery successfully,” but couldn’t it just as easily mean, “first to publish a description of successful cardiac surgery”? Fifty years from now, historians would not know the precise date of the original surgery, but they would certainly have the journal in which its first description was published. Harken was in Boston, home of the world’s most prestigious medical journal,
The New England Journal of Medicine,
whose editor was his good friend Dr. Joe Garland. As chance would have it, a cynic might say, Harken’s manuscript was published that year whereas feisty Charles Bailey’s manuscript was not published until the following year. As Harken later lamely suggested, “Whether one gives priority to the first operation or the first publication is a matter of personal opinion.”

Time
magazine, however, suffered no semantic confusion. On March 25, 1957, Charles Bailey’s face appeared alone on its cover. As Harken later admitted to many of us, “He beat me to the punch.” Harken’s technical knockout defeat in cardiac surgical fisticuffs was to foreshadow an even more sensational and controversial defeat for the world’s most talented cardiac transplant surgeon two decades hence.

Harken’s shrapnel extraction and Bailey’s crude repair of the narrowed mitral valve (mitral stenosis) established the first two signposts in the emergence of cardiac surgery after World War II. It would be nineteen years until the final jewel, coronary artery bypass surgery for CAD, would be inserted in cardiac surgery’s crown. In those two decades CAD blossomed and mitral stenosis withered. Today the only mitral stenosis patients I see are immigrants from underdeveloped countries. The reason is penicillin: it effectively prevents acute rheumatic fever in children with streptococcal sore throat. Preventing rheumatic fever has in turn eliminated mitral stenosis among residents of the developed world.

Very early in my career in the 1960s in Philadelphia and much later as a visiting professor in underdeveloped countries, however, I saw my share of mitral stenosis patients. One was a very thin once-athletic twentysomething auburn-haired young woman about the same age as me, now approaching the end of her brief life. She struggled with the routine chores of housewife and mother, as Harken liked to say “preserving her steps like gold pieces.” Surgical relief of her mitral stenosis led to one of the most dramatic changes in quality of life that I have seen in my years of cardiology, a life restored by the ten who had lost theirs to Harken and Bailey’s learning curve. I believe it was then that I first began to wonder if it would ever be possible for me to reconcile the likely sacrifice of the life of individual patient in high-risk research with its uncertain future benefit to society. I will let you grapple with this question and later give the answer I found for myself.

Within a few weeks of Bailey’s and Harken’s breakthroughs, Russell Brock succeeded with the same “finger fracture” technique for mitral stenosis in London. With the Philadelphia success confirmed in Boston and London, there could be no doubt, as surgeons now restored vitality to thousands of mitral stenosis victims in the prime of their lives. The era of cardiac surgery had been born, midwifed by shrapnel in the hearts of dying young men, a modern echo of the wisdom of Dominican philosopher Saint Thomas Aquinas that “Good can exist without evil, whereas evil cannot exist without good.”

*   *   *

BAILEY’S GROUNDBREAKING REVELATION,
that mitral stenosis could be “cured” surgically, led to a new question: can the same technique be used on other valves? The surgeons’ new target became the other major valve of the heart, the one between the left ventricle and the aorta, called the aortic valve. When the heart contracts, blood flows into the body’s major blood vessel (the aorta) for transport to all the body’s organs. Like all cardiac valves, the aortic valve is prone to both narrowing (called stenosis) and to failure to close completely (called insufficiency or regurgitation).

In the autopsy room, Harken found that he could reach the aortic valve by inserting his index finger through a purse-string suture on the external surface of the ventricle just below the aortic valve. The only difference was that his entry point into the heart was the high-pressure left ventricular pumping chamber rather than the low-pressure left atrial blood-collecting chamber. For his first experiment he chose an older lady from the Massachusetts North Shore whose frequent fainting attacks and heart failure suggested she had a very short life ahead of her. He obtained her consent, even after carefully explaining that he had never performed the procedure in aortic stenosis. In reasoning that he could open the stenosed aortic valve using the same method finger-fracture he had with mitral stenosis, Harken overlooked one critical fact. In severe aortic stenosis the pressure within the ventricular chamber, normally 120 mm Hg, can skyrocket to twice that value because the heart has to generate much greater force to eject blood across the severely narrowed aortic valve. Here is Harken’s own description of the horror that ensued: “I exposed the heart; and I put a purse string around the upper portion of the left ventricle; and I made a little stab wound first (and then) insinuated my finger into the ventricle only to discover pressures previously unheard of … I tried to stem this hemorrhage by pulling up on the tourniquet around my finger and it only tore and so I put in two fingers and then three fingers and then more bleeding and four fingers and then the dear lady succumbed.”

Harken had experienced the uncontrollable fury of the wounded heart that engulfed Charles Bailey in his very first mitral valve surgery. Both men punched a hole in the heart, believing they could control bleeding, desperately applied clamps to control it, lost control within seconds, then stood helpless in the face of exsanguination, facing a task as impossible as stemming the flow from a ruptured fire hydrant. Overwhelmed with his own acute flood of remorse, Harken again retreated to home and went to bed. Harken, always an endearing mix of bombast and uncompromising self-criticism, referred to his decision to enter the high-pressure left ventricular chamber as “my devastating mistake.” Doctors who care for terribly ill patients, including me, all know the awful feeling … a decision, an action, a path taken, a mistake that cost a patient’s life.

During my years in clinical cardiovascular research, I have felt the remorse that Harken felt that day. He called it the Pain of the Pioneer. The pain seems far more intense than that experienced when you have an adverse outcome in the course of patient management. When patients have complications during routine care, the rationalization that I did the best that could be done comes easily enough, since both physicians and patients recognize complications are an inevitable consequence of disease. But when I am testing an unproven new drug or device and experience an adverse outcome, I replace the disease as the cause of the adverse outcome with myself, even though the disease itself may be fatal. The difference is guilt. Whether rational or not, it is a tough emotion to shed. As Harken so poignantly observed, “When we’ve created the vehicle of death, the bridge to destruction for our patient, that’s another kind of pain.” He had convinced himself that he would do great good, and now had to confront the reality that instead he had done great harm.

Late that afternoon a woman appeared at the door of Dwight Harken’s home, carrying a note she had promised to deliver in the event of her friend’s death. Harken opened the note, which read:

Dear Dr. Harken:
Thanks for the chance. A small portion of my estate has been left to see that this doesn’t happen again.

The voice of forgiveness had come from the grave.

Remarkably, Harken was not the only surgeon to attempt the closed approach to aortic stenosis. In the South, following Bailey and Harken’s lead, young surgeon Dr. Horace Smithy was also gaining success with closed heart surgery on mitral stenosis. He convinced Johns Hopkins Medical Center’s renowned thoracic surgeon Dr. Alfred Blalock that they should jointly attempt closed aortic valve surgery. He identified a suitable patient and brought him to Blalock. Smithy had a very personal reason for approaching Blalock. He, too, had aortic stenosis. He knew from experience that once symptoms began he had only a few years to live. If he and Blalock were successful, Smithy wanted to be the famous surgeon’s next patient. But when Blalock put a finger-sized hole in the left ventricle, it was like a bullet hole: their patient’s heart literally blew up in their faces. Blalock, never enthusiastic about Smithy’s idea, now adamantly refused to attempt another case. A few months later, Charleston lost its brilliant young cardiac surgeon when Horace Smithy collapsed and died of aortic and mitral valve stenosis at the age of thirty-four.

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