Update to rules 'not intended to exclude existing or future centers'
Greater experience with the MitraClip has led to new operator and institutional requirements for transcatheter mitral valve (MV) interventions aimed at not making it difficult for centers to create and maintain existing programs.
Drafted by the American Association for Thoracic Surgery, the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons (and endorsed by the Heart Failure Society of America), the new requirements were published in the Journal of the American College of Cardiology and the other societies' respective journals.
This update of the 2014 expert consensus document rules that:
- An interventionalist at a new transcatheter mitral valve intervention program should have performed 50 lifetime structural heart procedures and have prior transcatheter mitral repair experience
- New programs should have a surgeon who has performed 20 mitral valve surgeries in the previous year (or 40 such surgeries over the prior 2 years) and a minimal site volume of 40 cases the last year (or 80 over the last 2 years)
- An established program should achieve at least 20 transcatheter mitral valve interventions per year (or at least 40 over the prior 2 years) and more than 20 mitral valve surgeries per year (or more than 40 surgeries over 2 years)
- Programs new and old should have 300 percutaneous coronary interventions per year
"The writing committee does not consider the recommendations in this document to exceed the capabilities of most centers, as currently structured or with reasonable modifications. Further, the recommendations are not intended to exclude existing or future centers for MV transcatheter intervention," according to the writing committee chaired by ACC representative Robert Bonow, MD, MS, of Northwestern University Feinberg School of Medicine in Chicago.
In 2014, the participating societies had agreed that transcatheter mitral valve programs could be serviced by interventionalists performing 50 structural procedures per year and should be accompanied by a surgical program with an annual case volume of 25 total mitral valve surgeries, among other requirements.
The MitraClip repair system remains the only such device approved by the FDA at this time. Bonow's team noted that there were 361 sites performing MitraClip procedures as of July 2019.
"Newer transcatheter systems for the treatment of severe MR [mitral regurgitation] are anticipated and it is expected that the proposed requirements herein will need to evolve with further advances in equipment, techniques, and patient selection," according to the new document.
The writing committee decided that performance is to be measured against risk-adjustment outcome benchmarks.
They also listed requirements for shared decision-making with the patient, specifying "an individualized approach utilizing patient-specific, data-driven risk assessment; clear explanation of treatment options; explanation of the rationale for the multidisciplinary team's recommendations; and the incorporation of patient goals, preferences, and values into treatment decisions."
The volume requirements for MitraClip and similar transcatheter procedures are markedly relaxed compared with those in the transcatheter aortic valve replacement (TAVR) rules proposed by the same societies in 2018 and ultimately finalized by the Centers for Medicare & Medicaid Services this summer.
For example, the current National Coverage Determination for TAVR rules existing programs should maintain at least 50 transcatheter or surgical aortic valve replacements (SAVRs) per year (or 100 of these procedures every 2 years).
To balance access and performance in TAVR, some have proposed a tiered system such that Level I hospitals (Comprehensive Valve Centers) perform all interventional and surgical procedures and have advanced imaging modalities; whereas Level II sites (Primary Valve Centers) have the capability of at least transfemoral TAVR and SAVR.
Bonow had no disclosures.
Other writing committee members reported personal and institutional ties to industry.
Journal of the American College of Cardiology
Source Reference: Bonow RO, et al "2019 AATS/ACC/SCAI/STS expert consensus systems of care document: operator and institutional recommendations and requirements for transcatheter mitral valve intervention" J Am Coll Cardiol 2019; DOI: https://doi.org/10.1016/j.jacc.2019.12.002.
Read the original article on Medpage Today: MitraClip Volume Requirements Set the Bar Low for Centers