A sex-specific comparison of valve-in-valve transcatheter aortic valve implantation

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Since patients receiving initially a new bioprosthetic aortic valve are predominantly male, data on a sex-specific comparison of ViV-TAVI is scarce. Thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of female (F) versus male (M) patients with failing bioprosthetic aortic valves undergoing ViV-TAVI. Methods A total of 375 Patients at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 160 (42.6 %) women and 215 (57.4 %) men were included. Women were older (F 81 (77; 84), p < 0.001), had a greater surgical risk (STS PROM F: 9.1 (6.1; 13,9) %, p < 0.001) and a higher rate of previous coronary bypass surgery (F: 25.6 % vs M: 40 %, p = 0.004), while presenting mostly failed valve sizes < 20 mm (F: 59.4 % vs M: 33.4 %, p < 0.001) and therefore higher gradients (F: 40 (31; 50) mmHg vs M: 32 (25; 42) mmHg, p < 0.001). Aortic regurgitation was the mode of failure in 7.5 % of F vs. 14.4 % of M. The number of stentless valves was higher in men (F: 8,1 % vs M: 14 %, p = 0.08). Patients received a self-expanding TAVI prostheses in 79.4 % and 75.8 % respectively in F and M patients. The rates of technical success (F: 75.6 % vs M: 83.3 %, p =0.06), device success (F: 52.5 % vs M: 58.2 %, p = 0.27) and early safety (F: 67.5 % vs M: 67 %, p = 0.91) were comparable between genders. Residual mean gradients were higher in F (F: 15 (11;22) mmHg vs M: 15 (10; 20) mmHg, p = 0.03), while the rates of residual regurgitations were greater in M patients (F: 1 (0.6 %) vs M: 11 (5.1 %), p = 0.04). The Kaplan-Meier estimated 30-day mortality rate (F: 2.5% vs M: 3.3%, p = 0.66) and 1-year mortality rates (F: 10 % vs M: 92.6 %, p = 0.37) were comparable between genders. Conclusion: F and M patients treated by ViV-TAVI have comparable short-term outcomes according to VARC-3-defined endpoints and similar mortality rates after 30 days and 1 year. The residual gradients in F and residual regurgitations in M could be explained by structural features of their failed valves. Further large scale studies are needed to determine, if such procedural outcomes are truly sex-specific.