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Objectives: We herein aimed to evaluate technical feasibility of transaxillary (Tax) transcatheter aortic valve implantation (TAVI) utilizing a novel vascular closure device with a resorbable collagen plug and absence of suture material.
Methods: Between 05/2018 and 8/2018, eight patients (76.0 ± 5.9 years, 62.5% male, logEuroSCORE I 23.6 ± 4.7) received Tax-TAVI using the MANTA™ vascular closure device. Implanted transcatheter heart valves consisted of Edwards Sapien 3, NVT Allegra, Medtronic CoreValve EvolutR and SJM Portico.
Results: Puncture location depth was variable (3.5-7.5 cm). The left subclavian artery was used in five cases, the right subclavian artery in three cases. Low-pressure balloon-angioplasty for vessel closure was performed in 5/8 patients. VARC-2 defined device success was met in all patients. Major access site complication occurred in one patient with aneurysma spurium of the subclavian artery and consecutive stent implantation on postoperative day 5.
Conclusion: The MANTA™ device is applicable in Tax-TAVI, with potential particular advantages regarding easiness of use and marked access for subsequent interventions in case of vascular complications. Before conclusions regarding clinical efficacy and safety can be made, the device has to be evaluated in larger patient cohorts.
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