Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.

Iacovelli, Fortunato; Burattini, Osvaldo; Sturdà, Francesca; Branca, Mattia; Stabile, Eugenio; Fimiani, Luigi; Salemme, Luigi; Cioppa, Angelo; Pucciarelli, Armando; Cafaro, Alessandro; Bortone, Alessandro Santo; Contegiacomo, Gaetano; Pignatelli, Antonio; Tesorio, Tullio (2024). Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience. (In Press). Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions Wiley 10.1002/ccd.31054

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BACKGROUND

Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated.

AIMS

The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems.

METHODS

This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee.

RESULTS

A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified.

CONCLUSION

This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.

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