Sex-Specific Outcomes of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation: Results From the CLASP IID Trial

Figures

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  Figure 1. Kaplan-Meier estimates of freedom from clinical events committee–adjudicated mortality and heart failure hospitalization. Graphs show Kaplan-Meier analysis time to first event. Event rates at 1 year are Kaplan-Meier estimates with a P value from the log-rank test.

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  Central Illustration. Sex-specificoutcomes of degenerative mitral regurgitation (MR)—the CLASP IID trial. (A) Kaplan-Meier estimates for freedom from major adverse events and freedom from all-cause mortality or heart failure hospitalization (HFH). P values calculated from log-rank test. (B) MR severity by transthoracic echocardiography assessed by an echocardiographic core laboratory (Atlantic Health System Morristown Medical Center). aTransesophageal echocardiography was used for baseline qualification of 5 patients. The graph shows unpaired analysis. P values relative to baseline were calculated from paired analysis using the Wilcoxon signed-rank test, and P values between discharge and 1 year for MR ≤1+ were calculated using the exact McNemar’s test. (C) The graph shows unpaired analysis (mean ± SD). P values for intragroup comparisons were calculated from paired analysis using t test, and P values for intergroup comparisons were calculated from analysis of covariance (ANCOVA) model adjusted for baseline values as covariates. KCCQ, Kansas City Cardiomyopathy Questionnaire.

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  Figure 2. Mitral regurgitation (MR) severity from transthoracic echocardiography by echocardiographic core laboratory, stratified by sex and treatment group. The echocardiographic core laboratory was at the Atlantic Health System Morristown Medical Center. Transesophageal echocardiography was used for baseline qualification of 5 patients. The graph shows unpaired analysis. P values relative to baseline were calculated from paired analysis using the Wilcoxon signed-rank test, and P values for change in proportion of patients with MR ≤1+ from discharge to 1 year were calculated from paired analysis by McNemar’s test.

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  Figure 3. Transmitral gradients at 1 year assessed by an echocardiographic core laboratory. The graph shows mean values. Δ represents change from baseline (BL) to 1 year from paired analysis. Intragroup P values were calculated using t test. Analysis of covariance (ANCOVA) model was used for calculating PANCOVA with sex and BL values as covariates. D, discharge.

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  Figure 4. Indexed left ventricular end-diastolic and end-systolic volumes at 1 year assessed by an echocardiographic core laboratory. Graphs show mean values. Δ represents change from baseline (BL) to 1 year from paired analysis. Intragroup P values were calculated using t test. Analysis of covariance (ANCOVA) model was used for calculating PANCOVA with sex and BL values as covariates. D, discharge; LVEDV, left ventricular end-diastolic volume; LVESV, left ventricular end-systolic volume.

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  Figure 5. New York Heart Association (NYHA) functional class at 1 year. The graph shows unpaired analysis for NYHA functional class. P values for intragroup comparison of baseline to 1 year were calculated from paired analysis using the Wilcoxon signed-rank test. P values for intergroup comparison of NYHA class I/II at 1 year were calculated using Fisher exact test.