Villablanca PA, Vemulapalli S, Stebbins A, Dai D, So CY, Eng MH, Wang DD, Frisoli TM, Lee JC, Kang G, Szerlip M, Ibrahim H, Staniloae C, Gaba P, Lemor A, Finn M, Ramakrishna H, Williams MR, Leon MB, O'Neill WW, and Shah B. Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017. Circ Cardiovasc Interv 2021; 14(11).
Circ Cardiovasc Interv
BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery.
METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes.
RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex.
CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.
Medical Subject Headings
Aged; Female; Heart Valve Prosthesis Implantation; Humans; Male; Medicare; Mitral Valve Insufficiency; Registries; Treatment Outcome; United States