Solving the Mysteries of Heart Disease
Page 15
I ultimately operated on 16 acute heart attack patients at UCLA using our new method. We achieved significant recovery of contractile function (the “so-called dead muscle” contracting and functioning again) in 15 of them. Most important, there were no deaths.
Once again, I was out of the lab and making use of our results. My experience differed from that of many practitioners who repeatedly perform the same job as everyone around them, rather than welcoming revolutionary procedures that may challenge the status quo.
But when you have an advance in treating heart attacks this dramatic, the status quo has to change. The process of constantly growing and doing things better is needed to form the future.
Making the Unknown Known
The time had come for us to report our bench to bedside data. We submitted this four-year package of experimental and now clinical findings (with patients) to the Journal of Cardiothoracic Surgery in 1986.
My choice to wait before publishing any findings for our studies illustrated my belief in Julien Hoffman’s credo “to withhold data until all bases were covered.” Aside from our preliminary report of experimentally restoring heart function after two hours of ischemia and my reporting our experimental successes after six hours (both at American Heart Association), I refrained from publicizing results to any of our sixteen studies, even though any one of them was worthy of reporting since each was a new finding. But I don’t pursue research to publish papers. I do research to provide concepts, and you can’t provide complete concepts if you have one study reported in journal A and another study reported in journal B, etc. You want to have them all published together.
Our submission package was closely reviewed by the Journal of Thoracic and Cardiovascular Surgery. Their evaluation process was extensive, as I needed to answer questions from 3 reviewers of each paper (48 different responses) that resulted in my writing 126 single-spaced pages of replies, and revising the papers to meet each request for improving clarity. All were accepted as I successfully met their challenge. The importance of this novel data was clear, as the entire study was placed into a special supplemental issue. A grand surprise, since over the past 66 years, the only other such Journal supplement was one that recognized C. Walton Lillehei, who was called the Father of Modern Cardiac Surgery.
While the team and I were gratified to have our work published, action needs reaction. The power of our efforts ultimately resides not in publication, but rather in their use to help sick patients. This starts with the crucial step of educating the cardiology community that it was now possible to recover the damaged heart muscle and ventricle after a heart attack. That treatment could be done either by surgeons using grafts in the operating room or by cardiologists performing angioplasties in the cath lab. In either case, you put the patient on full bypass, vent the ventricle to decompress it, and place a catheter beyond the obstruction to give a controlled reperfusion.
But for that to be adopted — the entire medical field first needed to acknowledge the limitations for the patient when normal blood is used as the reperfusate. In particular, the cardiologists must recognize that our treatment works, since they are the gatekeepers that allow the emergence of new developments, and their acceptance will then become the starting place for the initial testing of a new pathway by their cardiac surgeons.
The Three-Step Process
This new way to treat heart attacks does not introduce a competition or turf war between cardiologists and surgeons. Instead there must be a collaborative evolution of treatment that requires three steps.
First, the cardiologist must recognize the limitations of traditional angioplasty, and be open to a way to deliver controlled reperfusion surgically.
Second, surgeons in those same hospitals must learn to perform a new reflow method on acute heart attack victims. Their successes would show their cardiologists that this treatment works.
Third, the cardiologists must then adapt new strategies allowing them to use these approaches in their own catheterization labs.
Fulfillment of this cooperative process will initiate a new treatment for the heart attack patient, the true beneficiary.
Challenging Road
Despite having a clear roadmap for change, I knew altering commonly held beliefs is not easy to do, even with concrete evidence demonstrating that substantial advances are now possible. Battle lines are drawn by members of the medical community who are well-accustomed to practicing in a certain way. Such alterations always take many years to become reality, but there must be a steady forward movement of ideas to push against the status quo.
To help put forward this change, I organized a group of national and international colleagues of cardiac surgeons in 1992 to agree to test the effects of controlled reperfusion on heart attacks in their clinics. This was done to further the credibility of our early results that were reported in the 16 studies, and to encourage the medical community to consider this dynamic new protocol to treat acute heart attacks.
At UCLA, we only had 16 patients.35 But now participating surgeons and cardiologists were not limited to only our UCLA staff, but included surgical colleagues from prominent centers in the United States, France, and Germany. There would be 156 patients.36
Results were excellent.
The average duration of time between the heart attack and treatment was 6.7 hours, with one patient experiencing 23 hours of no blood flow to the damaged heart region. Using our controlled reperfusion methods, the overall mortality for the 156 patients was 3.7%. (Deaths only occurred in 6 of 66 patients in cardiogenic shock, which included 12 patients with sudden death.)
Further, we compared our findings against 1,200 traditional angioplasty patients who underwent only 3.9 hours of ischemia — and who had 8.7% mortality.
Yet most importantly — the surgeons were able to restore contraction (squeezing capacity) in the region undergoing a heart attack in 87% of patients. Something that had never happened before with angioplasty. Ever.
The positive outcomes of our controlled reperfusion patients were clear, as they had a short hospitalization, and the dangers of them developing arrhythmias and heart failure were minimized or eliminated. All members of our team believed this accomplishment would lead to widespread acceptance and success of our new treatment for heart attacks.
So what happened next?
Our results for 156 consecutive patients with acute myocardial infarction were presented at an international meeting of the American Association of Thoracic Surgeons (AATS) in 1992 — and were met with a deafening silence.36
There was only marginal discussion by the surgeons after our presentation. Yet what we put forward was amazing — solid evidence that our techniques had helped hearts recover the ability to contract again following acute heart attacks in 156 patients from three different countries.
Echoes of the Past
Though frustrating at the time, I now realize that the absence of audience response following my presentation of a new way to treat heart attacks reflected an unending dilemma.
My recent attendance at the Centennial Anniversary Meeting of AATS was revealing, as I learned the classic adage of “history repeats itself” was integral to the organization’s inception. In 1913, Willy Meyer (who would later become our second president) attended the American Medical Association meeting in Minneapolis, where he was to describe the first successful treatment of cancer of the esophagus. Until then, this was considered a universally fatal disease. The AMA meeting was attended by 3,246 physicians (matching the 3,000 to 4,000 that attend our meetings), and Meyer’s talk followed papers by four established leaders, like Charles Mayo. They described traditional surgical problems like use of bone clamps, elbow trauma, thyroid operations, and foot gangrene management. Considerable discussion followed each speech, as these heated debates generated a buzz of excitement that went on for three hours.
Willy Meyer finally took his turn to introduce his groundbreaking solution to a dreaded disease. Yet his anticipation of a bright ne
w future was not fulfilled. He was met with stony silence. The zeal had disappeared. No questions were asked and there was no discussion. His remarkable findings were met by utter apathy from the AMA general surgeons. Yet Meyer was not dejected. This rigidity simply sparked his drive to ignite a new society in 1917, and the American Association for Thoracic Surgeons just celebrated our 2017 Centennial Meeting.
Unfortunately, unyielding opposition to new ideas was not alleviated by the new organization’s creation. Echoes of the past rang again for our new treatment of an acute heart attack. Resistance now came from cardiac surgeons, not general surgeons, as the evidence that acute heart attack muscle can recover function — despite treatment occurring six or more hours after the coronary vessel closed — was discarded.
The irony is that the AATS was formed because nobody listened to Willie Meyer, yet such a barrier has continued to persist for 100 years.
In truth, this blockade reflects an eternal counterforce against new approaches. Resistance to our new treatment for heart attacks isn’t due to differences between cardiologists vs. surgeons, or surgeons vs. surgeons. It is the disparity between the rigid mind and the open mind. This goes beyond just the world of medicine.
My understanding of this behavior pattern became clearer after reading Spencer Johnson’s 1998 book, Who Moved My Cheese? This internationally best-selling volume sold over 10 million copies and deals with resistance to change.
The book describes that while the world is constantly transforming, many people fiercely hold onto wanting things to stay as they have been. Yet the book proposes: “If you don’t change… you will become extinct.” Such fates of decline or disappearance have certainly befallen major companies like Kodak, Circuit City, and Tower Records — all of whom had resisted change.
People are apprehensive of what dramatic change might demand of them. Yet the book poses the profound question:
What would you do if you were not afraid?
It is a far-reaching question about life as well as about science.
This query also parallels the guidance offered in 1865 by Claude Bernard, the previously mentioned French physiologist and my “historical” mentor. The search for a new answer must involve acceptance of the possibility of failure — and what it may reveal. That differs greatly from the inflexible stance of “excluding contradictions” because of your wanting the answer to be what you already believe.
Ultimately proof, not rigidity, always win. The solution to the devastating problem of acute heart attacks is never determined by canvassing a vote from the medical or surgical audience. Instead, validation comes from the recovery of the heart attack muscle’s ability to contract, following application of a new innovative treatment.
Acceptance has not yet come… but it will.
The Fear Factor
One might well have expected a much better response from cardiac surgeons. But another factor came into play: most of the surgeons had never operated on heart attacks.
The accepted protocol was that heart attack patients are cared for by the cardiologists. Very few surgeons operated on acute heart attacks, because mortality was higher in these patients than when using just angioplasty (at least prior to our protection methods), and given what was known, they believed the heart attack area itself could not be helped. They could only improve reflow to the remote muscle. But as I described earlier, remote muscle is very vulnerable right after an attack, and could be easily injured when performing a bypass graft to improve blood flow to it. Such damage would impair heart function and jeopardize survival.
Because of this concern, surgeons did not usually operate on heart attacks for fear of losing their patients. Such deaths raise their operative mortality report card and will substantially hamper referrals. Consequently, in order to lower risk, a five-to-six-week waiting period was customary before operating on a patient with a heart attack.
So the cardiac surgeons ignored our results, even though we reported for the first time in history that 87% of patients had recovered full heart function in muscle that was without blood flow for over 6 hours, and had demonstrated an extremely low rate of mortality (3.7%).
The result was a lack of acknowledgement for these findings in both the cardiology and surgical communities — even though most recognized that angioplasty does not provide recovery of function. The patient bears the brunt of this impasse, since about 20% to 30% of them will develop heart failure over time.
Unfortunately, this distressing situation remains just as true today as it did in 1992. This disinterest continues despite our showing that the use of controlled reperfusion “does not pit cardiac surgery against cardiology” — since these techniques can be used equally well when the surgeons perform grafts or the cardiologists conduct angioplasty.
Resisting Change: To Preserve What Has Always Been Done
Part of the reason the medical community resists these findings is that adopting them will require a fundamental shift in methods of treatment. Our approach would dramatically alter catheterization lab procedures, as cardiologists would need to learn a new skill set as they must adopt and use different types of technologies and instrumentation. Their routine and established cath lab approaches would further be amended by adding perfusionists to run a portable heart-lung machine (which is available). The costs would increase, but markedly superior clinical outcomes could result from this innovative treatment.
Ideally, hospitals might construct a single integrated treatment room that houses both a catheterization laboratory and an operating room, perhaps locating such rooms in the ER to maximize coordinated efforts. A fresh series of protocols would naturally develop around these hub areas, enabling their cath lab to work as smoothly as our operating rooms.
The bottom line is, at the time of this writing, none of these changes have been either contemplated or achieved. It is as if our findings had never been discovered.
Certainly there are costs associated with the modifications I’ve described. But what is the real price of this resistance to change? In the nearly 30 years since our breakthroughs, millions of heart attack patients have been admitted to hospitals across the world. Thousands upon thousands have died of either the heart attack, or they developed heart failure at a later date due to the damaged muscle not being saved.
Unfortunately, these avoidable patterns of patient suffering and early death mimic the sad pattern of my father and grandfather. While the incidence of cardiovascular disease has been reduced by around 30% using today’s standard treatments… the death rate from heart failure has remained unchanged between 1995 and 2009 (latest figures reported).37 Plus the estimated financial cost in 2030 to care for these patients — will be $1 trillion.38 (Figure 1)
Figure 1: Projected costs for office visits to treat heart failure between 2005 and 2030.
The Challenge of New Ideas
Though startled by the medical community’s resistance to our new life-saving knowledge revealed in this chapter, this would not prove to be an isolated case.
I have often wondered why so many surgeons readily welcomed the innovative ideas for protecting the heart during a cardiac operation (blood cardioplegia) that I developed at the initiation of my career — while others within our cardiovascular profession almost automatically and fiercely oppose implementation of the other new solutions to the major cardiac problems addressed during the next 45 years of my career — including treatments for heart failure and sudden death (cardiac arrest). All of these (and more) will be described in the following chapters.
Is it complacency — believing that what you already do is sufficient? A fear of failure — afraid to try new things that depart from what’s familiar? Erring on the side of caution by continuing what’s been done before is always easiest and creates less risk (even if that path may fairly consistently create an unsuccessful result for many patients).
So why was there such an enthusiastic acceptance of blood cardioplegia?
I realized it comes down to a simple
truth: if the heart’s performance is severely impaired after an operation has corrected the underlying defect, the surgeons feel at fault. In other words, the heart was more hurt by the procedure than it was helped. They recognized their actions had a detrimental impact — as they were active participants in the problem — which fosters an eagerness to embrace new fundamental solutions that will improve treatment.
In contrast, patients afflicted with a heart attack, heart failure, or sudden death are often looked upon as being affected by “natural events.” It is not the physician’s fault if they don’t recover. The problem is the disease. The comment that “our treatment is what everyone does all the time” is commonplace. In such cases, it seems to me that the cardiologist may become an observing participant, perhaps passive as they monitor pharmaceutical approaches to see how they produce positive changes to the patient’s symptoms (the role angioplasty plays will be discussed later).
Still, I cannot be certain. These observations are personal reflections, and have not been evaluated for validation.
The Road Before Us
As I’ve said, even with the opposition I would repeatedly experience to my discoveries, I never become discouraged. I believe my task is to find the answers and to make them known. In the same way that my grandfather found a way to telegraph his intent even while speaking only Yiddish, I must continue to find ways to get the message out — even to those who don’t want to hear it — as well as to those who may not speak the scientific language of researchers or the medical vernacular of cardiologists… you. As I mentioned, part of the intent for telling my story here is for the public to become aware that we have ways to counter the all-too-frequent misery and early death that still accompanies heart attacks, as well as ways to resolve the other conditions described in this book.
As acclaimed astrophysicist, author, and recipient of the NASA Distinguished Public Service Medal, Neil de-Grasse Tyson, once said: “The good thing about science is that it’s true whether or not you believe in it.”