The female sex was associated with better baseline clinical characteristics and improved survival, and is identified as a predictor of midterm survival after transcatheter aortic valve implantation (TAVI), according to a study to be published Feb. 8 in the Journal of the American College of Cardiology.
In contrast with PCI studies in which women only account for 15 to 20 percent of patients, women constitute 50 percent of patients eligible for TAVI, which guarantees the statistical relevance of analyses carried out in this context, wrote the study authors. Moreover, they added that the cost-effectiveness of TAVI procedures in women may be further enhanced by their longer life expectancy.
Thus, with this study, Marie-Claude Morice, MD, of the Institut Hospitalier Jacques Cartier in Massy, France, and colleagues sought to clarify the impact of sex-related differences in TAVI for high-risk patients with severe aortic stenosis.
The TAVI patients were included prospectively in a dedicated database from October 2006. The proportion of women (131 patients) was similar to that of men (129 patients).
The researchers used Edwards Lifesciences’ Sapien valve (85.4 percent) and Medtronic’s CoreValve (14.6 percent) through the transfemoral (65 percent), subclavian (3.1 percent) or transapical (31.9 percent) approach. They defined all events according to Valve Academic Research Consortium criteria.
Age was similar (83.1 years), but women had less coronary and peripheral disease, less previous cardiac surgery, higher ejection fraction and lower EuroSCORE (European System for Cardiac Operative Risk Evaluation [22.3 percent vs. 26.2 percent]), according to the study authors. The minimal femoral size (7.74 mm vs. 8.55 mm), annulus size (20.9 vs. 22.9 mm) and valve size (23.9 mm vs. 26.3 mm) were smaller in women.
Morice et al reported that device success was similar between the sexes (90.8 percent vs. 88.4 percent), despite more frequent iliac complications (9 percent vs. 2.5 percent). Residual mean aortic pressure gradient (11.6 vs. 10.9) also was similar. The one-year survival rate was higher for women, 76 percent, than for men, 65 percent; and male sex was identified as a predictor of midterm mortality by a Cox regression analysis.
As part of their study limitations, the authors acknowledged that their study was “a single-center TAVI cohort consisting of a limited number of patients recruited in the initial phase of our experience with this new technology. Multivariate analysis was not performed because of the low endpoint count.”
“Despite women having a smaller body, and femoral, aorta and aortic annulus size, similar device success was achieved in women and men alike with an adequate reduction in the transprosthetic pressure gradient,” the researchers concluded. “Although no relation with the 30-day mortality rate was observed, female sex was associated with better midterm survival after TAVI.”
Morice and colleagues suggested that further studies of larger patient populations are required to confirm our results.