Abstract 246 Impact of sex on vascular closure device outcomes after transcatheter aortic valve implantation: A subgroup analysis of the randomized CHOICE-CLOSURE trial

Background: Female sex has been consistently described as a risk factor for bleeding and vascular complications after transcatheter aortic valve implantation (TAVI). However, and despite the growing awareness about sex-specific disparities in this setting, studies investigating sex-specific treatment strategies of vascular access-site closure after TAVI remain limited. We therefore sought to evaluate sex-specific outcomes of percutaneous access-site closure techniques in the CHOICE-CLOSURE (Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation) trial.

Methods: The CHOICE-CLOSURE trial randomized 516 patients undergoing transfemoral TAVI to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) or a primary suture-based technique (ProGlide, Abbott Vascular). The primary endpoint of access-site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-2 definition during index hospitalization was significantly less frequent in the suture-based group. This pre-specified subgroup analysis examines study outcome measures stratified by sex.

Results: The study population included 230 (44.6%) females (n=115 in each group) and 286 (55.4%) males (n=143 in each group). Compared to males, female patients were older (81.1 ± 5.52 vs. 80.1 ± 6.49 years, p=0.028) and had a significantly higher Society of Thoracic Surgeons score (4.52 ± 2.92 vs. 3.72, ± 2.77 %, p=0.002). In addition, females had significantly smaller vascular diameters (p<0.001) resulting in the use of significantly smaller sheath sizes (14.71 ± 1.50 vs. 15.46 ± 1.81 French, p<0.001).

The primary end-point was more common in the plug-based group compared to the suture-based group in both females (22.6% vs. 13.9%, relative risk [RR] 1.62, 95% confidence interval [CI] 0.92-2.86, p=0.125) and males (16.8% vs. 10.5%, RR 1.60, 95%CI 0.88-2.92, p=0.168). Females treated with the plug-based technique experienced significantly higher rates of pseudoaneurysms and clinically-significant access-site hematomas compared to those treated with the suture-based technique (6.1% vs. 0%, p=0.021, and 16.5% vs. 7.0%, p=0.041, respectively), with a similar trend in males (7% vs. 4.2%, p=0.440, and 14.7% vs. 7.7%, p=0.091). Median time to hemostasis was significantly shorter with the plug-based technique in both sex groups (females: 67 [34, 148] vs. 226 [152, 280] seconds, p<0.001, males: 88 [30,180] vs. 248 [182-346] seconds, p<0.001).

Conclusion: Despite female-specific vascular access site characteristics, findings of this subgroup analysis of the CHOICE-CLOSURE trial support the overall superiority of the suture-based technique compared to the plug-based technique during transfemoral TAVI, with no sex-specific interaction.

Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5
Impact of sex on vascular closure device outcomes after transcatheter aortic valve implantation: A subgroup analysis of the randomized CHOICE-CLOSURE trial
I. Richter¹, P. Hartung¹, O. Dumpies¹, D. Obradovic², J. Wilde¹, N. Majunke¹, P. Boekstegers³, R. Müller³, M. Seyfarth⁴, M. M. Vorpahl⁴, P. Kiefer⁵, T. Noack⁵, S. Leontyev⁵, J. Rotta Detto Loria¹, A.-K. Funkat⁶, S. Hohenstein⁶, S. Desch¹, D. Holzhey⁷, H. Thiele¹, M. Abdel-Wahab¹, für die Studiengruppe: CHOICE-CLOSURE
¹Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; ²Klinik für Innere Medizin I - Kardiologie, Angiologie, Helios Park-Klinikum Leipzig, Leipzig; ³Herzzentrum Siegburg, Klinik für Kardiologie, Angiologie, HELIOS Klinikum Siegburg, Siegburg; ⁴Medizinische Klinik 3 - Kardiologie, Helios Klinikum Wuppertal - Herzzentrum, Wuppertal; ⁵Universitätsklinik für Herzchirurgie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; ⁶Leipzig Heart Institute, Leipzig; ⁷Klinik für Herz- und Thoraxchirurgie, Helios Klinikum Wuppertal - Herzzentrum, Wuppertal;
Background: Female sex has been consistently described as a risk factor for bleeding and vascular complications after transcatheter aortic valve implantation (TAVI). However, and despite the growing awareness about sex-specific disparities in this setting, studies investigating sex-specific treatment strategies of vascular access-site closure after TAVI remain limited. We therefore sought to evaluate sex-specific outcomes of percutaneous access-site closure techniques in the CHOICE-CLOSURE (Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation) trial. Methods: The CHOICE-CLOSURE trial randomized 516 patients undergoing transfemoral TAVI to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) or a primary suture-based technique (ProGlide, Abbott Vascular). The primary endpoint of access-site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-2 definition during index hospitalization was significantly less frequent in the suture-based group. This pre-specified subgroup analysis examines study outcome measures stratified by sex. Results: The study population included 230 (44.6%) females (n=115 in each group) and 286 (55.4%) males (n=143 in each group). Compared to males, female patients were older (81.1 ± 5.52 vs. 80.1 ± 6.49 years, p=0.028) and had a significantly higher Society of Thoracic Surgeons score (4.52 ± 2.92 vs. 3.72, ± 2.77 %, p=0.002). In addition, females had significantly smaller vascular diameters (p<0.001) resulting in the use of significantly smaller sheath sizes (14.71 ± 1.50 vs. 15.46 ± 1.81 French, p<0.001). The primary end-point was more common in the plug-based group compared to the suture-based group in both females (22.6% vs. 13.9%, relative risk [RR] 1.62, 95% confidence interval [CI] 0.92-2.86, p=0.125) and males (16.8% vs. 10.5%, RR 1.60, 95%CI 0.88-2.92, p=0.168). Females treated with the plug-based technique experienced significantly higher rates of pseudoaneurysms and clinically-significant access-site hematomas compared to those treated with the suture-based technique (6.1% vs. 0%, p=0.021, and 16.5% vs. 7.0%, p=0.041, respectively), with a similar trend in males (7% vs. 4.2%, p=0.440, and 14.7% vs. 7.7%, p=0.091). Median time to hemostasis was significantly shorter with the plug-based technique in both sex groups (females: 67 [34, 148] vs. 226 [152, 280] seconds, p<0.001, males: 88 [30,180] vs. 248 [182-346] seconds, p<0.001). Conclusion: Despite female-specific vascular access site characteristics, findings of this subgroup analysis of the CHOICE-CLOSURE trial support the overall superiority of the suture-based technique compared to the plug-based technique during transfemoral TAVI, with no sex-specific interaction.
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