Effectiveness of Upfront Combined Strategy for Endovascular Hemostasis in Transfemoral Transcatheter Aortic Valve Implantation.

BACKGROUND Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI). AIMS To evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular hemostasis after transfemoral (TF) TAVI. METHODS From January 2019 to April 2020, 332 consecutive patients with pre-procedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS were matched using propensity-score method. RESULTS At 30 days, patients receiving SBD+AS had lower rates of major/life-threatening bleeding [1.6% vs. 8.9%; odds ratio (OR) 0.17, 95% confidence interval (CI) 0.04-0.78;p<0.01] and major vascular complications (1.6% vs. 8.9%; OR 0.17, 95% CI 0.04-0.78; p<0.01). In addition, the use of SBD+AS was associated with a significantly costs saving related to the vascular event [mean difference -315.3€ per patient, 95% CI (-566.4€)-(-64.1€);p=0.01], and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs. 16.3%; OR 2.30, 95% CI 1.25-4.25;p<0.01). No difference in all-cause 30-day mortality was observed (3.3% vs. 1.6% for SBD and SBD+AS groups, respectively; OR 0.49, 95% CI 0.09-2.74;p=0.41). CONCLUSIONS An upfront combined strategy with an additional AS plug-based device on top of SBDs showed to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD.