In a recent meta-analysis published in the Journal of the American College of Cardiology, it was found that postoperative complications of Transcatheter Aortic Valve Replacement (TAVR) were different between males and females. While females were at increased risk of short-term complications (within 30 days) such as bleeding, stroke, and vascular complications, they had a lower incidence all-cause mortality within one year of the procedure.
Previously, observational studies have demonstrated that women undergoing TAVR are more likely to develop short-term complications such as major bleeding, transient ischemic attack (TIA) and stroke. However, the differences between males and females regarding the long-term outcomes was a matter of debate between the different experts. The principal investigator, Dr. Jinnette Abbott remarked, “Female sex has repeatedly been shown to be associated with in hospital TAVR complications such as bleeding and vascular complications but the long term results are favorable and the risk of mortality is lower compared to men.”
“The study suggests that bleeding avoidance strategies need to be developed for women undergoing TAVR and surveillance for stroke risk factors needs to be increased post TAVR”-Dr. Jinnette Abbott
The meta-analysis pooled data from 17 studies that investigated the clinical outcomes of TAVR in both males and females. The primary outcome was all-cause mortality at thirty days, one year and long term (>1year) follow up. Secondary outcomes such included MI, cardiovascular mortality, TIA and stroke at 30 days and at the longest follow-up duration available.
The investigators reported that at 30 days, gender had no impact on all-cause mortality; however, at 1 year and longer, female sex was associated with lower all-cause mortality compared to men. Conversely, women were more likely to experience major bleeding, vascular complications, or require blood transfusion compared to men. In addition, females undergoing TAVR had increased risk of stroke/TIA and a numerical increase in the incidence of myocardial infarction.
The increased risk of short term complications in females was thought to be due to the older age of females undergoing TAVR in addition to their lower body surface area and smaller vessel diameter. The improved long term survival is attributed to the smaller annular size in females and thus decreased risk of developing postoperative aortic insufficiency (AI). Additionally, males included in the studies had more comorbidities such as diabetes mellitus, hypertension, and decreased ejection fraction which may have impacted their survival.
In the publication, the authors note that “the current study, including 8 TAVR registries from multiple countries, is the largest analysis aiming to provide physicians and their patients with real-world data about sex-specific outcomes of TAVR at the longest follow-up available in the literature to date.” However, they also acknowledged that the inclusion of observational data from various registries and studies, the high heterogeneity in some outcomes and the absence of data at the patient-level may have been a deterrent to a more robust analysis.
When asked about the implications of this study on his clinical practice, Dr. Abbott said that “the study suggests that bleeding avoidance strategies need to be developed for women undergoing TAVR and surveillance for stroke risk factors needs to be increased post TAVR”