Abstract
Background: Frailty has been shown to significantly affect outcomes after transcatheter aortic valve replacement (TAVR). The impact of pre-frailty on TAVR outcomes in women is still unclear. Aim: To assess the impact of pre-frailty and frailty on outcomes in women enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. Materials and methods: WIN-TAVI was a multinational, prospective, observational registry, which enrolled women at intermediate or high preoperative risk undergoing TAVR. Patients included in this registry were divided into three groups, based on the number of fulfilled Fried frailty criteria: non-frail (no criteria, reference group), pre-frail (1-2 criteria) and frail (≥3 criteria). The primary outcome was the Valve Academic Research Consortium (VARC)-2 efficacy endpoint at 1-year after TAVR. The key secondary outcome was VARC-2 safety endpoint. Results: Out of 1,019 patients, 264 (25.9%) were pre-frail and 33 (3.2%) frail. The risk of VARC-2 efficacy endpoint at 1-year was increased in pre-frail (19.7%, HR 1.36, 95% CI 0.98-1.89) and frail (24.2%, HR 1.74, 95% CI 0.85-3.57) as compared to non-frail patients (14.9%, reference group), although it didn’t reach statistical significance. The risk of VARC-2 safety endpoint was significantly higher in pre-frail (25.8%, HR 1.43, 95% CI 1.07-1.91) and frail (42.4%, HR 2.77, 95% CI 1.60-4.80) than in non-frail subjects (19%, reference group); this difference was driven by an excess of major vascular complications and life-threatening or major bleeding in the pre-frail and frail group. In addition, in pre-frail patients hospitalizations for heart failure or valve-related symptoms at 1-year were higher than in non-frail patients. Conclusion: In women at intermediate or high preoperative risk undergoing TAVR, pre-frailty and frailty increased the risk of safety endpoints such as vascular complications and major bleeding.
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