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Page 6 of 19 Masiero et al. Mini-invasive Surg 2022;6:4 https://dx.doi.org/10.20517/2574-1225.2021.104

Table 1. Main characteristics and results of studies comparing TAVI outcomes in women and men

Balloon-
Study/first author Design Overall % expanding valves Self-expanding Follow-up Main results
(Ref.) population (n) women valves (%)
(%)
[85]
FRANCE 2 Registry Prospective 3972 49.5 73.2 26.8 1 year Similar rate of mortality at 1 month (9.5% vs. 9.2%) and lower rate at 1-year than
observational men (19.3% vs. 23.7%)
[86]
Kodali et al. Analysis of 2559 47.6 100 0 1 year Higher rate of vascular complications (17.3% vs. 10%) and bleeding (10.5% vs.
RCT 7.7%) in women than men; similar 30-day mortality and lower 1-year mortality
(19% vs. 25.9%)
[50]
Szerlip et al. Analysis of 1661 39.5 100 0 1 year No difference in mortality at 30 days (2% vs. 1.2%) and 1-year (9.3% vs. 10.2%).
RCT Higher rates of major vascular complications in women (7.9% vs. 4.4%)
[87]
Sannino et al. Retrospective 910 46.5 57.7 42.3 1 year Higher rates of major vascular complications (7.8% vs. 4.1%) and bleeding (4% vs.
observational 1.6%) in women. Lower rates of mortality at 1-year (7% vs. 12.7%)
[88]
Doshi et al. Retrospective 41,050 47.7 NA NA In-hospital Higher rates of mortality (4.7% vs. 3.9%) in women
observational
[89]
Stehli et al. Prospective 683 58 10.4 89.6 1 year Higher rates of major bleeding (3.3% vs. 1%) and 30-day mortality (2.4% vs.
observational 0.3%) in women. Similar rates of 1-year mortality (8.3% vs. 7.8%)
[38]
FRAILTY-AVR Prospective 759 44.8 NA NA 1 year Higher rates of 30-day mortality and major vascular complications in women.
observational Similar rates of 1-year mortality (19% vs. 17%).
[90]
TVT Registry Prospective 23,652 49.9 88.5 11.5 1 year Higher rates of vascular complications (8.3% vs. 4.4%) and bleeding (8% vs.
observational 5.9%) in women. Lower rates of 1-year mortality (21.3% vs. 24.5%)
[91]
Forrest et al. Analysis of 3687 46.3 0 100 1 year Higher rates of vascular complications (9.7% vs. 4.9%) and bleeding (29.7% vs.
RCT 21.7%) in women. Similar rates of 30-day (5.9% vs. 5.8%) and 1-year mortality
(21.3% vs. 24.1%)
[92]
D’Ascenzo et al. Retrospective 377 57.2 NA NA 2 years Higher rates of bleeding (44% vs. 25%) and major vascular complications (12.9%
observational vs. 9.8%). Similar rates of death at 30-day at longest follow-up
Italian Multicenter Prospective 659 55.8 0 100 13 months No significant differences in peri-procedural event rates and mortality
[93]
CoreValve registry Observational
[94]
Humphries et al. Analysis of 641 51.3 100 0 2 years Higher rates of bleeding (21.6% vs. 15.8%) and major vascular complications
RCT (12.4% vs. 5.4%). Lower rates of 30-day (6.5% vs. 11.2%) and 2-year mortality
(27.9% vs. 38.3%)
[95]
Czarnecki et al. Retrospective 999 45.3 57.1 38 1 year Higher rates of bleeding (14.5% vs. 12.6%) and major vascular complications
observational (18.7% vs. 16.7%). Similar rates of 30-day and 1-mortality
[81]
Katz et al. Prospective 819 51 67.7 28.9 1 year Higher rates of bleeding (11% vs. 3.8%), major vascular complications (11.2% vs.
observational 5.5%), and mortality at 30 days (11.5% vs. 6.5%). Similar rates of 1-year mortality
(29.7% vs. 25.9%)

TAVI: Transcatheter aortic valve implantation; RCT: randomized control trial.