A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study

DOI: 10.4244/EIJ-D-23-00725

Liesbeth Rosseel
Liesbeth Rosseel1,2, MD; Nicholas J. Montarello1, MD; Philippe Nuyens1, MD; Gabriella Tirado-Conte1, MD; Angelo Quagliana1, MD; Kristoff Cornelis3, MD; Vincent Floré3, MD, PhD; Michael Rosseel2, MD; Gintautas Bieliauskas1, MD; Lars Sondergaard4, MD, DMSc; Ole De Backer1, MD, PhD
1. The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 2. Cardiology Department, Algemeen Stedelijk Ziekenhuis, Aalst, Belgium; 3. Cardiology Department, Algemeen Ziekenhuis Maria Middelares, Ghent, Belgium; 4. Consultant Cardiologist, Abbott, Santa Clara, CA, USA

Background: Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality.

Aims: The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI.

Methods: All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these.

Results: Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively.

Conclusions: Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.

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