Is this stent necessary? Is this angioplasty inappropriate? Is this cardiologist uncertain if the procedure will help? Ever since the Appropriate Use Criteria for Coronary Revascularization were published, the three category labels of “appropriate,” “uncertain,” and “inappropriate” have confused the profession, press and population at large. The issue of definitions had still not been addressed in the most recent update of the AUC.
So (drumroll, please) yesterday, new categories were approved by the ACC Appropriateness Use Criteria Working Group. The new terminology will be “Appropriate,” “May Be Appropriate”(which replaces “Uncertain”), and “Rarely Appropriate” (which replaces “Inappropriate”). Continue reading
Artist illustration of the iFR “Wave Free Period”
As previously reported on Angioplasty.Org, a new method for the functional measurement of intracoronary pressures and the severity of blockages has been developed by researchers at Imperial College in London. One of the main advantages of this new method, called Instant Wave-Free Ratio™ (iFR), is that, unlike standard fractional flow reserve (FFR), it does not require injection of a vasodilator drug, such as adenosine, to induce stress on the heart. The result is that the procedure is more comfortable for the patient and potentially useable in clinical scenarios where vasodilation is not feasible, such as acute coronary syndromes, infarctions, unstable patients, patients with breathing problems; it may also be somewhat quicker, easier to use, and more cost-effective. Continue reading
Earlier today, the opening day of EuroPCR, Dr. Bernard De Bruyne presented preliminary results from the FAME II trial which tested the diagnostic power of Fractional Flow Reserve to guide PCI (stenting) of the coronary arteries. I wrote about FAME II back in January, when enrollment in the trial was halted for ethical reasons because the results of the ongoing FAME II trial were showing that the outcomes for stents in patients with stable angina were clearly superior to those in patients who were being treated with medications (a.k.a. Optimal Medical Therapy or OMT) alone. An independent Data Safety Monitoring Board advised that continuing the randomization would not change the findings and so, it was unethical to withhold the option of stents from this patient population. Continue reading
Forgive the perverse Shakespearean pun in the title but, as the Bard wrote: “What’s in a name? That which we call a rose by any other name would smell as sweet.” My topic is pretty much the polar opposite of roses, but the whole concept of labels and what we call things has become increasingly important. It’s one that I touched on in my post over last weekend about the impending CMS audits of stent procedures: namely, that the “official” terms used to describe treatment of a blocked artery are flawed when it comes to proper use of the English language.
The official “Appropriate Use Guidelines” place stent and angioplasty procedures into three categories: Appropriate, Uncertain and Inappropriate. Any patient, potential patient or, for that matter, anyone not steeped in the minutiae of interventional cardiology, would look at those terms and assume that any doctor putting a metal coil into someone’s heart when the procedure was labeled “uncertain” or “inappropriate” should be fined or fired or both. Continue reading
The question of the day, regarding whether or not to stent a coronary artery, is now being brought to the forefront by the U.S. government in the form of a Medicare “Demonstration Project”. And by “brought to the forefront”, I mean MONEY! — as in “we won’t pay you if we determine that the stent procedure was inappropriate.”
The bottom line is that, on November 15, CMS announced “New Demonstrations to Help Curb Improper Medicare, Medicaid Payments“. These so-called “demonstrations” will occur in 11 states where claims “historically result in high rates of improper payments”: Florida, California, Michigan, Texas, New York, Louisiana, Illinois, Pennsylvania, Ohio, North Carolina and Missouri. Continue reading
Dr. Paul Chan sat down with me recently to talk about the study published this week in JAMA that he served as lead author on. The article, “Appropriateness of Percutaneous Coronary Intervention.” has generated hundreds of news reports about “unnecessary stenting”, “overuse of angioplasty”, etc.
In my exclusive interview with Dr. Chan, we talked about the real meaning of this study, what it was meant to do (benchmark the use of PCI in the U.S.) and how it’s being (mis) interpreted by the press (I’ll be discussing this aspect in a subsequent post). Continue reading
Dr. Ralph Brindis is the Immediate Past President of the American College of Cardiology and helmed the National Cardiovascular Data Registry (NCDR) since its inception in 1997 — this is the registry that was the source for the data analyzed and reported in yesterday’s JAMA study, “Appropriateness of Percutaneous Coronary Intervention.”
In my exclusive interview with Dr. Brindis, I talked with him about the study, his feeling about what it showed, both the positive findings and what he calls “opportunities for improvement.” While there was almost 100% adherence to guidelines for acute angioplasties (which made up 71% of the total angioplasties performed) the study also pinpointed the fact that PCIs for non-acute patients had a higher rate of “inappropriates”, as defined by the ACC/SCAI Appropriateness Criteria — and that this rate varied widely from hospital to hospital. This means that those hospitals with higher than average “inappropriate” PCIs needed to look at their cases, their decision-making process and work to bring it closer to the norm. Continue reading