Interventions for valvular disease and heart failure

Dual ProGlide versus ProGlide and FemoSeal for vascular access haemostasis after transcatheter aortic valve implantation

EuroIntervention 2022;18:812-819. DOI: 10.4244/EIJ-D-22-00311

Jonas Gmeiner
Jonas M.D. Gmeiner1, MD; Marie Linnemann1; Julius Steffen1, MD; Clemens Scherer1, MD; Martin Orban1, MD; Hans Theiss1, MD; Julinda Mehilli2, MD; Sebastian Sadoni3, MD; Sven Peterß3, MD; Dominik Joskowiak3, MD; Christian Hagl3, MD; Nikolaos Tsilimparis4, MD; Adrian Curta5, MD; Stefan Maurus5, MD; Philipp M. Doldi1, MD; Kornelia Löw1, MD; Magda Haum1, MD; Daniel Roden1, MD; Jörg Hausleiter1,6, MD; Steffen Massberg1,6, MD; Konstantinos Rizas1, MD; Simon Deseive1, MD; Daniel Braun1, MD
1. Medizinische Klinik und Poliklinik I, LMU Klinikum München, Munich, Germany; 2. Medizinische Klinik I, Krankenhaus Landshut Achdorf, Landshut, Germany; 3. Herzchirurgische Klinik und Poliklinik, LMU Klinikum München, Munich, Germany; 4. Abteilung für Gefäßchirurgie, LMU Klinikum München, Munich, Germany; 5. Klinik und Poliklinik für Radiologie, LMU Klinikum München, Munich, Germany; 6. Munich Heart Alliance, German Center for Cardiovascular Research (DZHK), Munich, Germany

Background: Large-bore arteriotomy for transcatheter aortic valve implantation (TAVI) requires percutaneous vascular closure devices, but real-world data comparing different closure strategies are limited.

Aims: We sought to compare a dual ProGlide strategy vs a combination of one ProGlide and one FemoSeal for vascular closure after TAVI.

Methods: We retrospectively analysed 874 propensity score-matched patients undergoing TAVI at the Munich University Hospital from August 2018 to October 2020. From August 2018 to August 2019, a dual ProGlide strategy was used for vascular closure. From October 2019 to October 2020, a combination of one ProGlide and one FemoSeal was used. The primary endpoint was defined as access-related major vascular complications or bleeding ≥Type 2 according to Valve Academic Research Consortium 3 criteria.

Results: Patients in the dual ProGlide group (n=437) had a higher incidence of the primary endpoint than patients treated with one ProGlide and one FemoSeal (n=437; 11.4% vs 3.0%; p<0.001). Furthermore, they had a higher rate of closure device failure (2.7% vs 0.9%; p=0.044) and more often required unplanned surgery or endovascular treatment (3.9% vs 0.9%; p=0.004). The incidence of death did not differ significantly between groups (3.4% vs 1.6%; p=0.08).

Conclusions: A combined ProGlide and FemoSeal strategy might have the potential to reduce access-related vascular complications following TAVI.

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