1. Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele Catania, Division of Cardiology, Centro Alte Specialità e Trapianti (CAST), Catania, Italy 2. Division of Cardiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy 3. Division of Cardiac Surgery, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy 4. Division of Radiology, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy 5. Division of Vascular Surgery, Policlinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy 6. Division of Cardiology, Poliiclinico-San Marco Hospital, C.A.S.T., University of Catania, Catania, Italy, Italy
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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).
Conclusion. 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.