SICI-GISE commuNity CAmpania survey doNna TAVI (INCANTA): perioperative and short-term outcome of transcatheter aortic valve implantation in women

Abstract

Nowadays the prognostic role of gender as a relevant factor after transcatheter aortic valve implantation (TAVI) is still unfair, since available data in the literature are few and uneven. The aim of this survey was to collect acute and 30-day safety and efficacy clinical data in high- and intermediate-risk women, who underwent TAVI with new-generation devices, in the Campania Region. All medium and high-volume TAVI centers in Campania have been invited to fulfill an online, ad-hoc questionnaire, collecting pre-, peri- and post-procedural data concerning female patients, treated between January and December 2016. 331 women (representing the 61% of the overall population treated; mean age 83 ± 7 years) underwent TAVI in the participating Campania centers. Age >80 years (72%), high surgical risk score (63%) and frailty (55%) were found to be the top three reasons for the TAVI choice. Overall, 95% of the procedures were performed by transfemoral approach with local anesthesia; the remaining 5% (16 cases) were conducted via transapical (14, 4%) and transaortic (2, 1%) accesses, under general anesthesia. Edwards Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Medtronic Evolut R (Medtronic Inc., Minneapolis, MN, USA) were the most frequently implanted valves (146, 44% and 132, 43%, respectively). The questioned Centers reported a mean length of hospital stay of 5.5 ± 1.1 days, 1.6 ± 0.37 of which in a cardiac care unit. The most prevalent in-hospital complication was pacemaker implantation (15%), followed by life-threatening vascular complications (3%). The 30-day VARC-2 composite endpoint occurred in 7% of cases, all-cause death in 4%, and stroke in 1%. This survey, the first representative of women undergoing TAVI in Campania, appears to confirm the good safety and efficacy profile of this procedure, also in the high- and intermediate-risk settings, probably favored by a prevalent use of new-generation devices and a low rate prevalence of significant patient comorbidities.