Case volume requirements
The designation of a minimum transcatheter MV intervention case load of 20 procedures a year or 40 every 2 years reflected a “consensus among interventional cardiologists and cardiac surgeons of what the experience had to be for MV repair,” Dr. Bonow said. This number contrasts with a minimum case volume of 50 procedures/year or 100 every 2 years to maintain a TAVR program proposed in 2018 by a similar expert panel organized by U.S. cardiology and cardiac surgery societies (J Am Coll of Cardiol. 2019 Jan;73[3]:340-74). The new MV recommendations “follow a similar template [as the TAVR recommendations], but the numbers are what we thought would be best for optimal transcatheter MV expertise. MV interventions will likely increase, and we felt it would be best to define the transcatheter operators and are the right patients; the volume is unclear. There are a lot of heart failure patients, but we know from COAPT that not everyone is a candidate. The existing MV device does not fit all settings. We thought the numbers we selected were most appropriate, at least when we are starting.”
Dr. Bonow and coauthors who wrote the new recommendations will rely on payers, particularly the Centers for Medicare & Medicaid Services, to adopt the societal recommendations as part of their criteria for reimbursement and thereby give them teeth. In June 2019, CMS announced its Medicare coverage determination for TAVR, which included procedure minimums of 20 per year or 40 over 2 years for TAVR programs, a number that fell substantially below the 50 per year or 100 over 2 years that had been proposed by the societies. “We hope CMS will use our MV recommendations as a starting point,” but the final CMS coverage decision for transcatheter MV intervention could again differ from what the societies proposed, Dr. Bonow acknowledged.
In addition to strongly promoting a multidisciplinary team approach (and spelling out the members of the team) and shared decision making involvement of the patient with the team, the new recommendations also endorse participation of MV intervention programs in the Transcatheter Valve Therapy U.S. patient registry that’s maintained by two of the societies that helped organize the writing committee. The recommendations discuss the need to collect 30-day (and longer) outcomes data from transcatheter MV intervention programs through the registry as is now done for TAVR programs (N Engl J Med. 2019 Jun 27;380[26]:2541-50). Dr. Bonow declined to predict when 30-day outcomes data may start appearing for programs performing transcatheter MV interventions.
Dr. Bonow had no disclosures. The COAPT study was funded by Abbott, the company that markets the MitrClip clip delivery system.
SOURCE: Bonow RO et al. J Am Coll Cardiol. 2019 Dec 16. doi: 10.1016/j.jacc.2019.12.002.