Requirements For TMVr Accreditation

Requirements for the accreditation of individual operators are:

General

  • Completion of training in Interventional Cardiology as per CSANZ requirements OR completion of training in Cardiothoracic Surgery as per ANZSCTS requirements.
  • Interventional Cardiology operators should have a broad procedural experience that includes complex coronary interventions, transseptal puncture, placement of large calibre arterial and venous sheaths, balloon dilatation of the aortic and/or mitral valve, transcatheter valve implantation and pericardiocentesis.
  • Anticipated annual TMVT procedural volume ≥20 cases.

Established Operators

  • ≥40 TS-TMVT cases (TS-TMVr or TS-TMVR) during the past 5 years as primary or secondary operator in Australia with 30-day stroke, mortality, open surgical conversion, major vascular complication, and death rates <5%. At least 20 of these cases must be have been completed using the MitraClip™ implant.
  • Interventional Cardiologists: Involvement as primary or secondary operator in ≥100 transcatheter structural heart procedures (not including pericardiocentesis, endomyocardial biopsy, device closure for patent foramen ovale/atrial septal defect/patent ductus arteriosus (PFO/ASD/PDA).
  • CT Surgeons: Involvement as primary or secondary operator in ≥50 transcatheter structural heart procedures (not including pericardiocentesis, endomyocardial biopsy, device closure for patent foramen ovale/atrial septal defect/patent ductus arteriosus (PFO/ASD/PDA).

New Operators

  • Involvement as primary or secondary operator in ≥20 TS-TMVT cases (TS-TMVr or TS-TMVR) in the last 2 years, including a minimum of 10 cases in Australia under proctor supervision. Proctoring should be performed on-site by an accredited TMVT operator. Supervised cases must be certified by the physician-proctor and co-signed by an industry representative. It is expected that industry supervision will continue well beyond the initial period of physician proctoring. At least 10 cases must have been completed using the MitraClip™ implant
  • Involvement as primary or secondary operator in ≥50 structural heart procedures
  • Interventional cardiologist: first operator experience of ≥20 transseptal procedures
  • Interventional cardiologist: ≥300 career PCIs
  • CT surgeon: ≥20 MV surgeries/year (50% repairs)

Refer to the Operator and Institutional Requirements for Transcatheter Mitral Valve Therapies in Australia: a CSANZ and ANZSCTS Position Statement for full details.