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The Great Coronary Angioplasty Debate: Giving Patients the Right to Speak

Earlier this month, the editors of THCB saw fit to post my essay, “The End of the Era of Coronary Angioplasty.”

The comments posted on THCB in response to the essay, and those the editors and I have directly received, have been most gratifying. The essay is an exercise in informing medical decisions, which is my creed as a clinician and perspective as a clinical investigator.

I use the recent British federal guideline document as my object lesson. This Guideline examines the science that speaks to the efficacy of the last consensus indication for angioplasty, the setting of an acute ST-elevation myocardial infarction (STEMI). Clinical science has rendered all other indications, by consensus, relative at best. But in the case of STEMI, the British guideline panel supports the consensus and concludes that angioplasty should be “offered” in a timely fashion.

I will not repeat my original essay here since it is only a click away. The exercise I display is how I would take this last consensus statement into a trusting, empathic patient-physician discourse. This is a hypothetical exercise to the extent that little in the way of clear thinking can be expected of a patient in the throes of a STEMI, and not much more of the patient’s caring community.

So all of us, we the people regardless of our credentials, need to consider and value the putative efficacy of angioplasty (with or without stenting) a priori. For me, personally, there is no value to be had rushing me from the “door to the balloon” regardless of the speed. You may not share this value for yourself, but my essay speaks to the upper limits of benefit you are seeking in the race to the putative cure by dissecting and displaying the data upon which the British guideline is based.

There is an informative science, most of which cannot deduce any benefit and that which deduces benefit finds the likelihood too remote for me to consider it worth my attempt. A hundred or more patients with STEMI would have to be rushed to the catheterization lab to perhaps benefit one (and to harm more than one).

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The End of the Era of Coronary Angioplasty

In a single generation, the evidentiary basis for the practice of medicine has grown from a dream to a massif. No longer need physicians rely solely on experience and opinion in formulating diagnostic and therapeutic approaches to the care of the patient.

However, for any given clinical challenge, the available science is never flawless, monolithic or comprehensive, nor is it likely to be durable in the face of newer studies.

The international medical community has mounted two approaches to sorting the wheat from the chaff: One targets the doctor in convening committees to formulate guidelines for patient care. The other targets the patient for evaluating options, so-called informed medical decision making. Both approaches are now sizable undertakings clothed in organizational imprimaturs and girded by self-promotion.

But they are largely parallel undertakings with work products that can cause considerable cognitive dissonance on the part of the patient and the physician. In a recent article in the British Medical Journal [1] the Guideline Development Group convened by the National Institute for Health and Clinical Excellence (NICE) summarized the thinking behind the guidance it was offering regarding the management of STEMI. This is an object lesson in such cognitive dissonance.

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Risks and the Benefits: What Health Policy Can Learn from Clinical Medicine

A few months back, we admitted a patient we’ll call Mr. Jones to the hospital for a severe gastrointestinal bleed.  We had discharged him two weeks earlier after he had come in with a heart attack and made sure he was on aspirin to prevent future cardiac events.  He dutifully took his aspirin and on the day of the readmission, had a massive bleed.  He made it to the hospital barely alive and an endoscopy in the ICU showed an active bleeding gastric ulcer.  For Mr. Jones, the gastrointestinal bleed, likely brought on by the aspirin, was an “unintended consequence” that almost killed him. Yet no one questioned whether we should have given him aspirin in the first place.  I felt terrible about what had happened but found solace in knowing that while for some patients the risks of aspirin are worse than the benefits, for the general population of people like Mr. Jones, the benefits are clearly worth the side-effects.

We do risk-benefit analyses every day in clinical care, knowing that for some patients, the benefits will be outweighed by the harm.  We try to be thoughtful about who might be hurt or not, but most of the time, we just can’t predict.  So, when the benefits appear to outweigh the risks, we move forward and try to learn from cases like Mr. Jones.

While this kind of risk-benefit analysis is common in clinical practice, it’s unfortunately not how we discuss health policy interventions.  No policy intervention is ever without risks, and it is rare that a new policy will have no side-effects at all.  Yet, every time policymakers put in a new initiative, they sell it as a panacea. Critics, upon finding an unintended consequence, then declare the whole thing a failure.

An excellent example of this is health information technology, a topic that I have blogged about in the past.  Proponents only talk about its benefits, allowing critics to highlight every shortcoming and failure.  Thank goodness I don’t have to deal with proponents and critics like that every time I consider prescribing aspirin to my patients.

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CABG in Decline

The number of Americans with serious heart disease in need of hospital treatment is on the decline. A new study in today’s Journal of the American Medical Association shows the overall rate of coronary revascularizations — ranging from the coronary artery bypass graft (CABG) surgeries to in-and-out catheter-based procedures like angioplasties and stent insertions — fell from just under 1,500 per million adults a quarter in 2001 to less than 1,250 per million adults a quarter in 2008, a 15 percent decline.

The most intriguing finding in the data was that virtually all of the decline was in the most serious cases — those requiring CABG, which fell by about a third. The rate of percutaneous coronary interventions (where they snake a catheter through the thigh into the blood vessels feeding the heart, propping them open with either drug-eluting or bare metal stents) remained virtually unchanged.

The study authors, who hailed from the Philadelphia Veterans Affairs Medical Center, suspect the decline in CABG was driven by “a sizable shift in cardiovascular clinical practice patterns away from surgical treatment toward percutaneous coronary interventions” using catheters (so-called PCI). In other words, in recent years people with serious heart disease are more likely to be treated with the less invasive procedure.Continue reading…

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