Multisociety (AATS, ACCF, SCAI, and STS) Expert Consensus Statement: Operator and Institutional Requirements for Transcatheter Valve Repair and Replacement, Part 1: Transcatheter Aortic Valve Replacement

Perspective:

The following are 10 points to remember about this Expert Consensus Statement:

1. The critical cornerstone for establishing a transcatheter aortic valve replacement (TAVR) program is the formal collaborative effort between interventional cardiologists and cardiac surgeons.

2. The multi-disciplinary team (MDT), however, goes well beyond this collaboration, and must include key providers from other physician groups (e.g., anesthesiology, radiology, noninvasive cardiology, intensive care) and should meet formally as a group on a regular basis to review all patients referred for procedures, performance of recent procedures (to discuss both favorable and unfavorable outcomes), and follow-up of prior procedures.

3. Minimum requirements for transcatheter valve therapies include an understanding of basic radiation safety necessary for optimal imaging, operator and patient exposure protection, and knowledge of the use of X-ray contrast agents, which may not be standard in cardiac surgery training and experience.

4. The institutional interventional program should perform 1,000 catheterizations/400 percutaneous coronary interventions per year, with acceptable outcomes for conventional procedures compared to National Cardiovascular Data Registry (NCDR) benchmarks.

5. The TAVR interventionalist should have performed 100 structural procedures in a lifetime or 30 left-sided structural procedures per year, of which 60% should be balloon aortic valvuloplasty.

6. The institutional surgical program should perform 50 total aortic valve replacements (AVRs) per year, of which at least 10 AVRs should be high-risk (Society of Thoracic Surgeons [STS] score ≥6). There should be a minimum of two institutionally-based cardiac surgeons in the program (more than 50% of the time at a hospital with a surgical program).

7. The TAVR surgeon should have performed 100 AVRs in his/her career, at least 10 of which are ‘‘high-risk’’ (STS score ≥6) OR 25 AVRs per year OR 50 AVRs in 2 years and at least 20 AVRs in the last year prior to TAVR initiation.

8. The existing TAVR programs with >18 months of experience should have performed 30 TAVRs (total experience), and programs in existence <18 months should perform >2 procedures per month.

9. Long-term outcome reporting is obligatory, to track not only survival, but also other parameters including periprocedural complications (cerebrovascular accident, vascular, renal, infectious, etc.), aortic regurgitation, the need for reintervention, subsequent surgery, and quality of life.

10. It is inappropriate to perform these novel and innovative procedures without the institutional infrastructure to ensure adequate early data collection and later follow-up.


< Back to Listings