1Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin, Kardiologie und Intensivmedizin Dresden, Deutschland; 2Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 3Sana Herzzentrum Cottbus GmbH Cottbus, Deutschland; 4Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland; 5Herzzentrum Dresden GmbH an der TU Dresden Klinik für Herzchirurgie Dresden, Deutschland; 6Helios Universitätsklinikum Wuppertal - Herzzentrum Klinik für Herz- und Thoraxchirurgie Wuppertal, Deutschland
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. Sex-specific comparisons of ViV-TAVI are 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) vs 78 (74; 82) years, p < 0.001), had a higher surgical risk (STS PROM F: 9.1% (6.1; 13.9) vs 6.3% (4.1; 9.6), p < 0.001) but had less often coronary artery disease (F: 48.8% vs M: 61.9%, p=0.01) or previous CABG (F: 25.6% vs M: 40.0%, p = 0.004). A failed valve sizes <20mm was more common in women (F: 59.4% vs M: 33.4%, p < 0.001) leading to higher gradients at baseline (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 (p=0.038). The number of failed stentless valves was numerically higher in men (F: 8.1% vs M: 14.0%, p = 0.08). The use of a self-expanding TAVI prosthesis was 79.4% in F and 75.8% in M, respectively.
The rates of technical success (F: 75.6% vs M: 83.3%, p =0.069), device success (F: 52.5% vs M: 58.2%, p = 0.272) and early safety (F: 67.5% vs M: 67.0%, p = 0.915) were comparable between genders. There were numerically higher rates of bleeding (F: 20.6% vs M: 13.4%, p=0.067) and access site complications (F: 21.9% vs M: 15.3%, p=0.106) in F compared with M. The rates of stroke, myocardial infarction, kidney failure, and new pacemaker implantation did not differ between groups.
Although statistically significant, the median residual mean gradient was 15mmHg in both groups (F: 15 (11;22) mmHg vs M: 15 (10; 20) mmHg, p = 0.033) with a numerically higher rate of F having a mean gradient ≥20 mmHg (34.6% vs 27.3%, p=0.131). The rate of residual moderate/severe regurgitation was greater in M (F: 0.6% vs M: 5.1%, p = 0.046).
The 30-day (F: 2.5% vs M: 3.3%, p = 0.66) and 1-year mortality (F: 10.0% vs M: 7.4%, p = 0.368) was comparable between genders. In a Cox regression analysis, sex was not associated with 1-year mortality (HR for M: 1.19 (95%-CI 0.53; 2.69), p=0.680), whereas STS PROM remained the only independent predictor (HR for 1% increase: 1.04 (95%-CI 1.01; 1.07), p=0.022).
Conclusion: Female and male patients treated by ViV-TAVI have comparable short-term outcomes according to VARC-3-defined endpoints and similar morality rates at 30 days and 1 year. The haemodynamic findings are most probably related to the structural features of the failed bioprosthetic valves.