Safety of TAVR examined in all-female cohort

(HealthDay)—In an all-female transcatheter aortic valve replacement (TAVR) registry, 14.0 percent of women experienced a 30-day Valve Academic Research Consortium (VARC-2) composite safety end point, according to a study published online May 17 in JACC: Cardiovascular Interventions to coincide with EuroPCR 2016, held from May 17 to 20 in Paris.

Alaide Chieffo, M.D., from the San Raffaele Scientific Institute in Milan, and colleagues examined the safety and performance of TAVR using an all-female registry. A total of 1,019 women undergoing TAVR for aortic stenosis were enrolled across 20 European and North American centers between January 2013 and December 2015.

The researchers found that TAVR was performed via transfemoral access in 90.6 percent of women, and new-generation devices were used in 42.1 percent. In 14.0 percent of participants, the 30-day VARC-2 composite end point (composite of mortality, stroke, major vascular complications, life threatening bleeding, stage 2 or 3 kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction) occurred, with 3.4, 1.3, 7.7, and 4.4 percent all-cause mortality, stroke, major vascular complications, and VARC life threatening bleeding, respectively. Independent predictors of the primary end point were age, prior stroke, ejection fraction <30 percent, device generation, and history of pregnancy.

"Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy," the authors write.

Several authors disclosed financial ties to the pharmaceutical and medical device industries.