Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017

Abstract

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.

Sex differences in outcomes of transcatheter edge‐to‐edge repair with MitraClip: A meta‐analysis

“…The definition of stroke and bleeding was according to the individual studies. Procedural success was defined as residual MR of Grade 2 or less 3–14 . The long‐term outcomes included: all‐cause mortality, heart failure (HF) hospitalization, and residual MR of ≥Grade 3 on subsequent imaging.…”

“…Of which, 11,346 were females (45.6%) and 13,559 were males (54.4%). [3][4][5][6][7][8][9][10][11][12][13][14] The study flow diagram is summarized in Figure 1.…”

“…Eight studies reported sex-specific long-term mortality, with a total of 8499 patients (43.6% women), [3][4][5][6]9,[12][13][14] while five studies reported adjusted mortality. 5,6,[12][13][14] There was no difference in the incidence of unadjusted mortality (OR: 0.98, 95% CI: 0.89-1.09; I 2 = 0%) (Figure 3A).…”

“…Eight studies reported sex-specific long-term mortality, with a total of 8499 patients (43.6% women), [3][4][5][6]9,[12][13][14] while five studies reported adjusted mortality. 5,6,[12][13][14] There was no difference in the incidence of unadjusted mortality (OR: 0.98, 95% CI: 0.89-1.09; I 2 = 0%) (Figure 3A). Women had lower incidence of all-cause mortality using the maximally adjusted summary estimates (adjusted HR: 0.77, 95% CI: 0.67-0.88; I 2 = 0%) (Figure 4B).…”

“…Few studies have assessed the sex differences in the clinical profile and outcomes of TEER 3–16 . While some studies showed that women and men undergoing TEER do not share a similar clinical profile, studies also showed conflicting findings regarding the outcomes after TEER.…”