John Mandrola


October 30, 2013

A rule: The first step in the practice of medicine is seeing the problem.

What follows is a post I wrote on the way home from the American College of Cardiology meeting this spring. It has sat on my desktop since then, blinking at me periodically, but never published. It was too negative. Something would come along to get cardiology out if its rut, I thought.

Then I read Dr Abraham Verghese's review of Eugene Braunwald and the Rise of Modern Medicine. Considering the history of cardiology's achievements in the past two decades only accentuates our current-day doldrums. Dr Braunwald led cardiology during a golden age of innovation. It's worth looking back a few years to compare what has transpired in our field vs what is transpiring now.

What was:

MI care was transformed from a death sentence to just another mulligan. Medications were developed (now generic and inexpensive) that halted heart-failure progression. Catheter ablation of most arrhythmias actually "cured." Implantable defibrillators (when used wisely) added quality life-years. These and other major developments, confirmed effective via the large clinical trial, solidified cardiology's role as a leader in medicine. It was an amazing time to learn and practice this craft.

What is:

Contrast that with the past few years. Where are the major developments, the game changers? Perhaps plateaus in growth are normal; nothing keeps growing forever. In business, small companies with innovative products go through rapid growth, and then their size slows growth. Look at Microsoft, Google, and Apple. Progress slows from exponential to incremental.

This is how cardiology feels now—painfully incremental. A few examples:

Stents: The newest drug-eluting varieties offer slightly less risk of thrombosis and restenosis. It's the same story with bioabsorbable stents. Here the incremental benefit (given the funny name "noninferior") is so modest that device companies are reticent to expose the bioabsorbable stent to the enhanced regulatory climate in the US. The inherent problem with stents, however, is not regulatory scrutiny, but rather one of science and fundamentals. Namely, squishing an atherosclerotic blockage does not address the biology of atherosclerosis. The key to coronary artery disease is not better squishing; it's the ability to identify and modify the vulnerable plaque.

Drug therapy: The four classes of drugs that lower mortality in cardiovascular disease have been around so long they can be had for four dollars per month. After we prescribe ACE inhibitors, beta-blockers, statins, and aspirin, how many more pills can we expect a patient to take? The answer is not many. And again, it's not a failure of biochemistry; it's because complex chemicals can only do so much to negate unhealthy lifestyle choices. The most obvious examples here are the nonstatin lipid drugs. A close second is any substitute for real food. When eating fish pills proves better than eating fish, I will gladly alter such pessimism. The problem with new drugs is the comparators: matching new chemicals against good food, good exercise, good sleep, and good attitudes poses real problems.

Renal denervation: The concept of renal denervation needs a time-out. Medical device companies are salivating over the idea of giving patients with lifestyle-acquired disease an easy out. High blood pressure affects millions. But the idea that whipping a catheter in a kidney artery and buzzing the renal nerves is going to modify the effects of lifelong sedentary habits and dietary indiscretion fits squarely in the free-lunch category. Treating hypertension is a team sport. Truly drug-refractory, lifestyle-adherent patients with persistent hypertension exist, but in awfully small numbers. That's the truth. Can cardiology handle it?

Percutaneous valves: Really? I can't see it yet. Step back and look at this therapy with a wide-angle lens. Taking a frail elderly patient to the lab, inserting a huge stiff device through a tortuous femoral/iliac artery, then squishing the aortic valve and jimmying in a mechanical valve does not impress me as terribly innovative. The mitral-clip devices present a similar scenario: if a frail patient is too frail for heart surgery, how much difference will it make to marginally reduce the MR jet? I hate to sound unimaginative here, but what the elderly patient with valvular disease "needs" most from cardiologists are much bigger doses of Hoosier common sense. Someone needs to look away from the echo and look at the person considered for such furious treatment. We look foolish when we overtreat the elderly.

Electrophysiology stagnation: Interventional and general cardiology aren't the only branches of cardiovascular medicine mired in innovation slumps. The last antiarrhythmic drug was dronedarone—which makes percutaneous valves look superb. My continued wrestling with Sprint Fidelis ICD leads keeps me humble about medical decision making. CRT devices truly do transform, but it's now clear that patient selection is everything—and the number that benefit is lower than we'd like. Perhaps the biggest disappointment in electrophysiology comes in the treatment of AF. We deliver 50+ burns in the left atrium to electrically isolate pulmonary veins. Yet, despite hundreds of cases, years of experience, and eye-popping mapping technology, I still can't keep these veins durably isolated. No one can. But that's not the worst part: the worst part of ablating AF is that I don't even know whether I'm burning in the right spot. I hope Sanjiv Narayan is right. Therein lies some Braunwald-like hope.

As if the stasis of therapeutics isn't bad enough. With the news that United Health Care is terminating Medicare Advantage contracts with thousands of cardiologists across wide swaths of geography, it is now abundantly clear that cardiologists are no longer the quarterbacks calling the plays. Loss of control is a real inflammation booster. Yes, it's a tough time for heart doctors.

In part 2 of this post, I pledge to embrace optimism. I'll tell you where I see the greatest hope, why I think it's still a great time to be a cardiologist, and some ideas on taking back a leadership role in medicine.


PS. Please feel free to correct any excessive pessimism. As a bike-racing cardiologist, I've grown thick skin. Help me with my optimistic post.


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