PCI boundaries & barriers

Are the federal government’s watchdogs deliberately going too far? And are the medical profession’s guide dogs inadvertently leading clinicians astray?

Physicians in two exclusive stories published online this week in Cardiovascular Business have challenged organizations that can influence practice: first, the FDA and second, the professional societies that collaborate to define appropriate use criteria (AUC).

George W. Vetrovec, MD, of Virginia Commonwealth University's Pauley Heart Center in Richmond, Va., recently testified at a meeting of the FDA’s Circulatory System Devices Panel, which was reviewing the use of nonroller type blood pumps. The FDA proposed that pump manufacturers be required to submit premarket approvals (PMAs) for the pump’s use for ventricular support during some high-risk interventional or surgical procedures. The agency also proposed to change the device’s classification.

Vetrovec testified before the panel on behalf of the Society for Cardiovascular Angiography and Interventions, which favors continued access to the pump for left ventricular support and PCI. Vetrovec, himself a former panel member, expressed concern in an interview about the FDA’s directive concerning PCI and said that “the FDA seemed to be guiding the panel toward a decision.”  

In agreement with the FDA, the majority of panel members recommended retaining the pumps (for temporary ventricular support) as Class III devices, which would allow the pumps to remain on the market but manufacturers would need to submit PMAs by a specified time to continue marketing the devices.  

In a separate interview, Tony Farah, MD, chief medical officer at West Penn Allegheny Health System in Pittsburgh, discussed the drawbacks of the terminology used with the current AUC to categorize patient care in interventional cardiology. As has been noted before, some unambiguous PCI cases clearly fall in the appropriate or inappropriate baskets. But for many, physician judgment and patient preference may tilt a decision toward what could be classified as inappropriate use.

“The term ‘inappropriate’ might be misconstrued, especially when it comes to clinical decisions that are not as clearly defined—where the physicians and the patients truly should have more input,” Farah said in the interview. As a consequence, physicians may defer to AUC, although it may not be in the best interest of their patients.

Farah, who is not involved in writing AUC, suggested that it might be beneficial to reassess the terminology to free physicians from this bind and clarify the issue for patients, payers and regulators.   

Vetrovec, speaking about the pumps and FDA, put it another way. “It isn’t the job of FDA to decide how doctors choose to use hemodynamic support. It isn’t their concern. The FDA cannot regulate the practice of medicine.”