Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement

Craig Basman; Arber Kodra; Ahmad Mustafa; Denny Wang; Michael Cinelli; Kenenna Onyebeke; Bruce Rutkin; Priti Mehla; Gregory Maniatis; Luigi Pirelli; Ythan Goldberg; Shangyi Liu; Sridhar Uttar; Sean Wilson; Robert Kalimi; Derek Brinster; Puneet Gandotra; Elana Koss; Perwaiz Meraj; Efstathia Mihelis; Azhar Supariwala; Alan Hartman; S Jacob Scheinerman; Chad Kliger; Northwell TAVR Investigators

doi:10.1016/j.jscai.2024.101929

Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement

J Soc Cardiovasc Angiogr Interv. 2024 Apr 3;3(6):101929. doi: 10.1016/j.jscai.2024.101929. eCollection 2024 Jun.

Authors

Craig Basman¹, Arber Kodra¹, Ahmad Mustafa², Denny Wang¹, Michael Cinelli², Kenenna Onyebeke¹, Bruce Rutkin³, Priti Mehla¹, Gregory Maniatis², Luigi Pirelli¹, Ythan Goldberg¹, Shangyi Liu¹, Sridhar Uttar¹, Sean Wilson³, Robert Kalimi⁴, Derek Brinster¹, Puneet Gandotra³, Elana Koss³, Perwaiz Meraj³, Efstathia Mihelis¹, Azhar Supariwala⁴, Alan Hartman³, S Jacob Scheinerman¹, Chad Kliger¹; Northwell TAVR Investigators

Affiliations

¹ Department of Cardiovascular & Thoracic Surgery, Lenox Hill Hospital/Northwell Health, New York, New York.
² Department of Cardiovascular & Thoracic Surgery, Staten Island University Hospital/Northwell Health, New York, New York.
³ Department of Cardiovascular & Thoracic Surgery, Northshore University Hospital/Northwell Health, New York, New York.
⁴ Department of Cardiovascular & Thoracic Surgery, Southside Hospital/Northwell Health, New York, New York.

Abstract

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized.

Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria.

Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD.

Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

Keywords: Angio-Seal; Perclose; transcatheter aortic valve replacement; vascular complications.