Societies release TAVR credentialing recommendations

Issue: April 2012

Four leading CV organizations have released initial recommendations for creating and maintaining transcatheter aortic valve replacement programs. The goal of the recommendations is to ensure optimal care for patients with aortic stenosis as use of transcatheter aortic valve replacement grows in the United States.

Since the first transcatheter aortic valve replacement (TAVR) procedure was approved by the FDA in November, growing interest prompted efforts by professional medical societies to identify institutional and physician credentialing criteria for performing this procedure. The new recommendations represent a joint collaboration of CV specialty societies, including the American Association for Thoracic Surgery, American College of Cardiology Foundation, Society for Cardiovascular Angiography and Interventions, and The Society for Thoracic Surgeons.

“As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care,” Carl Tommaso, MD, chair of the document writing committee and medical director of the cardiac catheterization lab at Skokie Hospital, NorthShore HealthSystem, Chicago, said in a press release issued by the ACC Foundation. “TAVR is a complex procedure that has potential to serve many patients, and it is up to us to deliver the highest standard of care available.”

Defining operator and institutional requirements is a vital step in ensuring optimal program implementation because of the complexity of the TAVR procedure and the rapid rate at which the technology is evolving. The recommendations emphasize a formal collaborative effort between cardiologists and cardiothoracic surgeons as the cornerstone of establishing a successful program. Other factors on which success is based include ensuring patient safety and demonstrated commitment to excellence by the institution and procedural volume requirements, according to the press release.

The recommendations classify operating requirements for those that intend to develop a TAVR program, including credentialing requirements for cardiothoracic surgeons and interventional cardiologists who intend to perform the procedure, and guidance for maintaining approval to perform TAVR. Requirements include:

Annual aortic valve surgery and percutaneous coronary intervention volume requirements for institutions.
Board certification and procedural requirements for surgeons and interventional cardiologists.
Monitoring of complication rates and institutional follow-up.
Participation in a national registry that will include enrollment of all patients undergoing TAVR with continued tracking of outcomes.
Commitment to a heart team concept led by the surgeon and interventional cardiologist that comprises a formal collaborative effort among all medical team members. In all TAVR procedures, the interventional cardiologist and surgeon must both be present during the entire procedure, ensuring joint participation and optimal patient-centered care.

The recommendations serve as “an appropriate starting point,” according to the writing committee. They also said the recommendations may apply more to institutions rather than patients.

“[The professional medical societies] believe that adherence to these recommendations will maximize the chances that these therapies will become a successful part of the armamentarium for treating valvular heart disease in the United States. In addition, these recommendations will hopefully facilitate optimum quality during the delivery of this therapy, which will be important to the development and successful implementation of future, less-invasive approaches to structural heart disease,” the document reads.

According to R. Morton Bolman, MD, co-chair of the document writing committee and chief of the division of cardiac surgery at Brigham and Women’s Hospital, this is “a dynamic document that we will revisit in the future as the technology evolves, experience grows and data accumulate.”

The full recommendations can be found on the professional medical societies’ websites.

Disclosure: Drs. Morton and Tommaso report no relevant financial disclosures.

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