Clinical Outcomes of the Portico Transcatheter Aortic Valve Delivered via Alternative Access: 30-Day and 1-Year Results of the Portico ALT Study

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OBJECTIVE: The aim of this study was to report the 30-day and 1-year outcomes and performance from the Portico Alternative Access study to obtain CE approval of the alternative access delivery system. METHODS: The Portico Alternative Access study is a multicenter, prospective, non-randomized, investigational study (www.clinicaltrials.gov identifier, NCT03056573) describing 45 patients with severe symptomatic aortic valve stenosis (AS) treated with the self-expanding Portico device using subclavian/axillary access. RESULTS: Forty-five subjects (81.7 ± 5.9 years; 57.8% female; Society of Thoracic Surgeons score, 5.4 ± 4.7%) with severe, symptomatic AS had a Portico bioprosthetic aortic valve implantation attempt via axillary/subclavian access. Implantation was successful in 97.8% of subjects. At 30 days, the rate of major vascular complications at the subclavian/axillary access site was 4.4%. All-cause mortality was 2.2% at 30 days and 4.4% at 1 year. CONCLUSION: The Portico transcatheter aortic valve can be safely delivered by axillary or subclavian access with high implant success rate and low complication rates.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.