New Initial Guidelines for TAVR ProgramsMonday, March 5th, 2012
Four leading heart organizations have released initial recommendations today for creating and maintaining transcatheter aortic valve replacement (TAVR) programs. TAVR is a minimally invasive procedure approved by the Food and Drug Administration (FDA) and indicated for the treatment of patients with severe aortic stenosis who cannot undergo surgery and have the absence of comorbidities as described in the FDA label. TAVR is performed using a catheter to thread the replacement valve from a blood vessel in the groin to the heart’s diseased aortic valve, which is then replaced with the new valve. The only approved valve to be used for this procedure is the Sapien® Transcatheter Heart Valve.
The recommendations are aimed at ensuring optimal care for patients with aortic stenosis as use of the new TAVR procedure grows. The recommendations represent a joint collaboration between the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), and the Society for Thoracic Surgeons (STS). The document was published in anticipation of possible Medicare coverage for TAVR.
Since FDA approval of TAVR in November 2011, interest in the procedure has quickly grown, prompting efforts by professional medical societies to identify institutional and physician credentialing criteria for performing the procedure.
The recommendations emphasize a formal collaborative effort between cardiologists and cardiothoracic surgeons as the cornerstone for establishing a successful program, noting that a program without both specialties would be fundamentally deficient. Other factors on which success is based include ensuring patient safety and demonstrated commitment to excellence by the institution and procedural volume requirements. The document also outlines the physical space required for TAVR, as well as the need to maintain a patient registry that will track long-term outcomes of all patients undergoing TAVR.
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. The requirements include:
- Annual heart (aortic valve) surgery and percutaneous coronary intervention (PCI) volume requirements for institutions.
- Board certification and procedural requirements for both surgeons and interventional cardiologists.
- Monitoring of complication rates and institutional follow-up.
- Commitment to a heart team concept that is led by the surgeon and interventional cardiologist and made up of 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.
- Tommaso CL, Bolman M, Feldman T, et al. SCAI/AATS/ACCF/STS multisociety expert consensus statement: operator & institutional requirements for transcatheter valve repair and replacement; part 1 TAVR. 2012. J Am Coll Cardol. March 1, 2012. Available at: http://content.onlinejacc.org/cgi/reprint/j.jacc.2012.02.016v1.pdf. Accessed March 5, 2012.