ORIGINAL ARTICLE   

Minerva Cardiology and Angiology 2022 December;70(6):677-85

DOI: 10.23736/S2724-5683.22.06173-7

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: English

Transcatheter aortic valve implantation with Allegra: procedural and mid-term outcomes according to experience phase in a high-volume center

Nicola CORCIONE ¹, Paolo FERRARO ², Alberto MORELLO ¹, Michele CIMMINO ¹, Michele ALBANESE ², Martino PEPE ³, Salvatore GIORDANO ⁴, Giuseppe BIONDI-ZOCCAI ^{5, 6} ✉, Arturo GIORDANO ¹

¹ Unit of Cardiovascular Interventions, Pineta Grande Hospital, Castel Volturno, Caserta, Italy; ² Operative Unit of Hemodynamics, Santa Lucia Hospital, San Giuseppe Vesuviano, Naples, Italy; ³ Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation (DETO), University of Bari Aldo Moro, Bari, Italy; ⁴ Division of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Catanzaro, Italy; ⁵ Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy; ⁶ Mediterranea Cardiocentro, Naples, Italy

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis. We aimed at appraising effectiveness of a new self-expandable TAVI device.
METHODS: We retrospectively analyzed our institutional experience with Allegra (Biosensors, Morges, Switzerland) for TAVI, focusing on procedural outcomes and 1-month adverse events. We explored the impact of operator experience with this device, dividing patients according to their time of intervention.
RESULTS: Between 2018 and 2021, a total of 50 patients underwent TAVI with Allegra, with average age of 81 years, 80% women, and 50% at low or intermediate surgical risk. No major significant difference in baseline patient features were found when comparing Phase 1 and Phase 2, except for baseline left ventricular ejection fraction and New York Heart Association, which were worse in Phase 1. All procedures were performed transfemorally and percutaneously, with predilation in 94% and postdilation in 36%, yielding device success in 98%, and procedural success in 96%. No significant differences in procedural features were found when comparing Phase 1 vs. Phase 2 (all P>0.05). One-month follow-up was also favorable, with no significant difference in adverse outcomes according to phase, and a total of 1 (4%) death, 1 (4%) myocardial infarction, 1 (4%) minor vascular complication, and 4 (8%) permanent pacemaker implantations. Consistent findings were obtained at exploratory 6-month follow-up.
CONCLUSIONS: The Allegra TAVI device is associated with favorable short-to-midterm outcomes in experienced hands. Operators already proficient with other devices can achieve satisfactory results even in the early phase of adoption of Allegra.

KEY WORDS: Aortic valve stenosis; Transcatheter aortic valve replacement; Cardiology