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Acute and 30-Day Outcomes in Women After TAVR
Study Questions:
What are the safety and outcomes of transcatheter aortic valve replacement (TAVR) in an all-female registry? And, is there an interaction between female sex-specific characteristics and clinical outcomes after TAVR?
Methods:
WIN-TAVI is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis (AS), conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction).
Results:
Between January 2013 and December 2015, 1,019 women were enrolled in 20 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7%, and mean Society of Thoracic Surgeons (STS) score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6%; new-generation devices were used in 42.1%. In more than two-thirds of the cases, an Edwards SAPIEN 23 mm or Medtronic CoreValve ≤26 mm device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0%, with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. Independent predictors of the primary endpoint were age (odds ratio [OR], 1.04; 95% confidence interval [CI], 1.00-1.08), prior stroke (OR, 2.02; 95% CI, 1.07-3.80), ejection fraction <30% (OR, 2.62; 95% CI, 1.07-6.40), device 4 generation (OR, 0.59; 95% CI, 0.38-0.91), and history of pregnancy (adjusted OR, 0.57; 95% CI, 0.37-0.85).
Conclusions:
Women enrolled in this all-female TAVR registry with collection of female sex-specific baseline parameters were at intermediate to high risk; and experienced a 30-day VARC-2 composite safety endpoint of 14.0%, with a low incidence of early mortality and stroke. The authors concluded that randomized assessment of TAVR versus surgical AVR in intermediate-risk women is warranted to determine the optimal strategy.
Perspective:
Women with symptomatic AS tend to be older and have a lower body mass index compared to men, which can influence therapeutic decisions for TAVR. In addition, factors such as frailty and osteoporosis, which are more common among women, have been associated with poor postoperative recovery. Although women appear to be better represented in studies evaluating TAVR than they have been in studies evaluating the management of coronary artery disease (women comprised 42-54% of patients undergoing TAVR in the PARTNER trial and the CoreValve extreme risk pivotal trial), this registry provides insight into some factors that might affect decisions regarding performance of TAVR among women.
Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Cardiac Surgical Procedures, Coronary Occlusion, Female, Geriatrics, Heart Valve Diseases, Hemorrhage, Pregnancy, Stroke, Transcatheter Aortic Valve Replacement, Vascular Diseases
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