TAVR Volume Requirements Spark Continued Debate

CMS considers changing TAVR volume requirements

CMS Considers Changing TAVR Volume Requirements

Debate over transcatheter aortic valve replacement (TAVR) procedures continues as the Centers for Medicare and Medicaid Services (CMS) considers changing the status quo. Are TAVR volume requirements limiting rural and minority access to this life-saving procedure, or are they still necessary for patient safety?

In June 2018, cardiology news sources widely reported that CMS opened public comment on established volume requirements for hospitals and heart teams to perform TAVR. The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) then met on July 25 to discuss the issue. A report in Cardiovascular Business suggested that the committee appeared split on the subject—especially in weighing the potential harms of limiting TAVR to only high volume hospitals.

Cases for and against TAVR volume requirements

The Case for TAVR Volume Requirements

For those on the side of maintaining TAVR volume requirements, the benefits are obvious—volume is associated with positive outcomes and lower rates of complications. In fact, a 2018 expert consensus document from four major cardiology societies actually supported increasing volume requirements to maintain a TAVR program, to ensure adequate data collection for statistically reliable quality metrics and quality assurance.

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Stents not effective? Study sparks debate pt. 1

U.K. PCI study sparks U.S. debate

On Wednesday, November 1, results from the Objective Randomized Blinded Investigation with Optimal Medical Therapy of Angioplasty in Stable Angina (ORBITA) study were published in The Lancet.

The next day, this article was published in the New York Times:

“A procedure used to relieve chest pain in hundreds of thousands of heart patients each year is useless for many of them,” it began… “The new study, published in the Lancet, stunned leading cardiologists by countering decades of clinical experience. The findings raise questions about whether stents should be used so often—or at all—to treat chest pain.”

Without further knowledge, the debate may start right here—the New York Times article had little in the way of medical detail to satisfy invasive cardiovascular professionals and may have further generalized results in a misleading manner.

But let’s hold off on reacting, look at the debate surrounding this particular study and also place the findings in a wider context (part two). Note: this isn’t the first time it has been suggested that stents are overused.

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CT angiography and stress tests can predict heart attacks

Invasive angiography unnecessary?

Noninvasive CT angiography and CT myocardial stress perfusion imaging can adequately predict heart attacks and major adverse cardiovascular events, according to a study published yesterday in Radiologyno invasive coronary angiography (ICA) required.

Invasive coronary angiography (ICA), along with stress tests and single photon emission tomography (SPECT) imaging, has long been the “gold standard” for making determinations of whether a lesion is hemodynamically significant and likely to result in major adverse cardiovascular events, reads a Radiological Society of North America press release.

But this “gold standard” has its drawbacks—in costs and risk.

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Two common ways you might misinterpret medical research

Sophisticated statistics in medical research can be hard to translate to layman’s terms, and when they are, these common misinterpretations can be downright misleading.

1. Odds ratios don’t express relative risk.

In 1999, media reports resulting from a study published in the New England Journal of Medicine wrongly suggested that black patients and women were 40 percent less likely than white patients and men, respectively, to undergo cardiac catheterization.

The study’s authors had used odds ratios to describe the significance of their findings—a common practice among statistically sophisticated researchers—which showed that black patients and women were definitely less likely to be referred for invasive procedures than white patients and men, but not how much less likely.

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