Multicenter evaluation of high-risk mitral valve operations: Implications for novel transcatheter valve therapies

Background The MitraClip REALISM (Abbott Vascular, Menlo Park, CA) trial included several inclusion criteria to identify patients at high risk for conventional mitral valve (MV) surgery. This study evaluated contemporary surgical outcomes for high-risk surgical patients who met these defined criteria to serve as a benchmark to evaluate appropriateness in treatment allocation between surgical and percutaneous MV repair.

Methods A statewide Society for Thoracic Surgeons (STS) database was queried for patients undergoing isolated mitral valve surgery over a 12-year study period from 17 different hospitals. Patients were stratified into high-risk (HR) versus non-high-risk (non-HR) cohorts based upon clinical criteria similar to those utilized in the REALISM trial. Mixed effects multivariable regression modeling was used to evaluate study endpoints including mortality, morbidity, and resource utilization.

Results Of 2,440 isolated mitral operations, 29% (n = 698) were HR per REALISM criteria. Median STS Predicted Risk of Mortality (PROM) for HR patients was 6.6% compared with 1.6% for non-HR patients (p < 0.001). The HR patients more commonly underwent MV replacement as well as urgent (30% vs 19%, p < 0.001) operations. High-risk patients incurred higher morbidity and mortality (7% vs 1.6%) with longer intensive care unit (48 vs 41 hours) and hospital stays (7 vs 6 days, all p < 0.001). Among REALISM criteria, STS PROM 12% or greater and high-risk STS criteria were the only criteria associated with mortality.

Conclusions Select REALISM criteria, including reoperation with patent grafts and functional MR with ejection fraction less than 0.40, may not identify patients truly at high risk of death with surgery. In addition to conventional STS criteria, risk assessment by surgeons is essential to direct appropriate treatment allocation for high-risk mitral disease.