TCT Leadership Outlines the State of Intervention

San Francisco, CA—The continued growth of interventional cardiology depends on the collective willingness of those in the subspecialty to evolve into all branches of cardiology, according to David R. Holmes Jr., MD, of the Mayo Clinic in Rochester, Minn., who delivered a plenary address at TCT 2013.

Holmes first acknowledged the challenges that interventional cardiology has faced in the media. However, he encouraged attendees to focus on the strides that have been made historically and in recent years.

“The first angiography procedures were highly invasive, far from the minimally invasive procedures we see today,” he said. Moving beyond the clinic, Holmes noted, “We have become the most well-published specialty in terms of randomized controlled trials. We have also challenged our colleagues more than almost any other specialty.”

Self-evaluation

The history of self-scrutiny within TCT has brought the organization to where it is today, according to Holmes, who stressed movement into other areas of cardiology. 

“Atrial fibrillation (AF) and stroke prevention, structural heart disease, acute ischemic diseases and hypertension: these are the opportunities and fields we must engage and explore,” he said. 

Holmes highlighted the fact that 6 million individuals in the United States have AF, and that number is projected to increase to 16 million by 2050. “Interventionalists need to be in that space,” he said.

Regarding hypertension, Holmes spotlighted the groundbreaking research on renal nerve denervation that has been presented at this year’s meeting. “This represents a great opportunity for our specialty,” he said.

Role of regulation

TCT course director Gregg W. Stone, MD, of Columbia University Medical Center, New York, conducted a panel discussion with key members of the TCT leadership on the challenges faced by the community and organization. He asked Paul G. Yock, MD, of the Stanford University Biodesign Program about the role of the US Food and Drug Administration and government regulation. Yock suggested that the community has not encouraged enough patient advocacy. “Patients provide a critical and effective voice with the media or Congress,” he said.

However, Richard S. Stack, MD, of Duke University in Durham, N.C., tempered this point. “We all want good regulation, but we want to make sure we are keeping patients in mind,” he said. “Nobody wants approval for fly-by-night companies and products that may hurt patients.”

Stone directed the discussion toward Alain G. Cribier, MD, of the Hôpital Charles Nicolle, Rouen, France, who noted that the time from innovation to approval is faster in Europe than in the United States. “It is not a perfect system in Europe, but it is maybe a little better than the United States,” he said. “Patients are benefiting from these devices.”

TCT course director Martin B. Leon, MD, of Columbia University Medical Center in New York expressed optimism that the US approval process may speed up. “The pendulum is swinging,” he said. “There is new leadership, and the FDA may be evolving to become more like Europe. We may be moving in a positive direction.”

For Rafael Beyar, MD, of the Rambam Medical Center in Haifa, Israel, a critical component to the approval continuum is the relationship between innovators and clinicians. “We need to break down the walls between us and academia,” he said. 

William W. O’Neill, MD, of Henry Ford Hospital in Detroit, tied together many issues discussed by the panel. “Patients are experiencing improved outcomes, but, in many cases, they don’t feel better,” he said. “These patients are pressing charges publically, and interventional cardiologists are losing their licenses and being criminally prosecuted. We need to maintain focus on the basics and make sure our patients feel better.”

Disclosures: 

Holmes and the panelists report no relevant conflicts of interest.