1. In this secondary analysis of the PARTNER trial, women who underwent transcatheter aortic valve replacement (TAVR) had more major vascular complications, major bleeding events that caused death or disability and increased unplanned arterial procedures, but fewer paravalvular leaks, than men.
2. At 1 year, women had lower all-cause mortality and rehospitalization when compared to men.
Evidence Rating Level: 2 (Good)
Study Rundown: As many as one third of patients with severe aortic stenosis (AS) are deemed poor candidates for surgical aortic valve replacement (SAVR). However, transcathether aortic valve replacement (TAVR) was recently approved for such higher risk AS. Studies have shown that women who undergo SAVR are at increased risk for adverse events, but studies looking at sex-based differences in outcomes for TAVR have been limited. This study looked at the outcomes of men and women who underwent TAVR. The women at baseline were healthier, with less smoking and fewer comorbidities, such as diabetes, heart disease, heart attack, kidney disease, and peripheral vascular disease. However their Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) cardiac scores were higher. Furthermore, women had more major vascular complications, major bleeding events that caused death or disability and increased unplanned arterial procedures, but also fewer paravalvular leaks. At 30 days after TAVR, there were no differences in all-cause mortality, cardiac mortality, rehospitalization, stroke, heart attack, or permanent pacemaker placement between the sexes. However, women did have a lower incidence of acute kidney injury requiring dialysis. After one year, women had a lower all-cause mortality and rehospitalization rate than men. These results were potentially limited in that they were specific only to Edwards SAPIEN valve system, and that there was no randomized comparison. Overall, these data suggest that sex may play an important role in the outcomes of TAVR.
In-Depth [randomized controlled trial]: This study is a secondary analysis of 1220 women and 1339 men who underwent TAVR as part of the multicenter PARTNER trial. Women had more vascular complications (17.3% v 10.0%, p<0.001), more major vascular complications (9.9% v 5.1%, p<0.001), more major bleeding events (10.5% v 7.7%, p=0.012) and more unplanned arterial procedures (13.9% v. 7.2%, p <0.001), however less frequent mild and moderate/severe paravalvular leaks (35.0% v 47.0%, p <0.001; 6.0% v 14.3%, p <0.001). At 30 days, there were no significant (p >0.05) sex-based differences in all-cause mortality, cardiac mortality, combined death or rehospitalization, stroke, rehospitalization rate, myocardial infarction or permanent pacemaker placement, but women did have a lower incidence of AKI requiring dialysis than men (2.1% v 3.7%, p=0.022). At 1 year, women had lower unadjusted all-cause mortality (HR 0.72, p <0.001), lower rehospitalization rate (HR 0.82, p = 0.043) and lower multivariate-adjusted 1 year mortality (HR 0.72, p <0.001), but there were no differences in stroke incidence (p=0.42). The access site (femoral v. apical) had no impact on 1-year mortality by sex, and women had lower mortality at both access sites.
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