{"id":"b5c2d59aec13","type":"article","url":"https://hartvaat.nl/2026/08/21/allegra-kunstklep-toont-veelbelovende-techniek-en-veiligheidsresultaten-bij-valv/","title":"Allegra-kunstklep toont veelbelovende techniek- en veiligheidsresultaten bij valve-in-valve TAVI","title_en":"Clinical Outcomes of the Allegra Transcatheter System in Bioprosthetic Aortic Valve Failure: A Multicentre Valve-in-Valve Registry.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","doi":"10.1002/ccd.70811","source_url":"https://doi.org/10.1002/ccd.70811","authors":["Hilal Khan","Mohamed Ali","Abdalazeem Ibrahem","Karim Ratib","Nur Ilia Mohd Zaki","Freidoon Keshavarzi","Alok Shah","Hesham Abdelaziz","Ayush Khurana","Alexander Chase","Diana A Gorog","Rajiv Das","Azfar Zaman","Mohammad AlKhalil","Mohamed Farag"],"significance":5,"published":"2026-08-30","source_date":"2026-08-21","image":"","kennis":["https://hartvaat.nl/kennis/kleplijden/tavi-transcatheter-aortaklepimplantatie/","https://hartvaat.nl/kennis/kleplijden/chirurgische-klepvervanging/"],"congress":"","summary_en":"A retrospective multicentre registry evaluated the Allegra transcatheter heart valve system in 106 high-risk patients undergoing valve-in-valve TAVI for failing bioprosthetic aortic valves. Technical and early safety success rates were both 86.8%, with device success at 75.5%, 30-day mortality at 0%, and a median 15-month all-cause mortality of 6.6%. Post-implant haemodynamics were favourable, with a mean gradient of 12 mmHg. These findings position the Allegra system as a promising option for complex valve-in-valve procedures, though larger randomised trials are required to confirm long-term efficacy and safety.","created":"2026-08-23T01:32:41Z","updated":"2026-08-23T01:32:41Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Een retrospectieve multicenter-cohortstudie onderzocht de veiligheid en effectiviteit van het Allegra-transcatheter hartklepsysteem bij 106 patiënten met een mislukte bioprostetische aortaklep die een valve-in-valve TAVI ondergingen. De techniek- en vroege veiligheidsuccessen bedroegen beide 86,8%, met een apparaatsuccesspercentage van 75,5% en een 30-dagen mortaliteit van 0%. Na een mediane follow-up van 15 maanden was de algehele mortaliteit 6,6%, terwijl de hemodynamische resultaten (gemiddelde gradiënt 12 mmHg) gunstig waren. Deze resultaten suggereren dat het Allegra-systeem een veilige optie is voor complexe valve-in-valve-procedures, hoewel grotere gerandomiseerde studies de bevindingen moeten bevestigen.","abstract_original":"INTRODUCTION: The prevalence of bioprosthetic aortic valve failure is increasing due to the broader use of bioprosthetic valves, both surgical and transcatheter, and an ageing population. Registry data indicate a higher risk of coronary obstruction and elevated gradients following valve-in-valve transcatheter aortic valve implantation (TAVI). We report outcomes of the Allegra transcatheter heart valve system in valve-in-valve TAVI. METHODS: In this retrospective multicentre cohort study, all patients undergoing valve-in-valve TAVI with the Allegra system between 2019 and 2025 at five UK centers were included. The combined primary outcomes were technical success, device success, and early safety at 30 days, as per the VARC-3 (Valve Academic Research Consortium-3) criteria. A key secondary outcome was all-cause mortality at the longest documented follow-up. RESULTS: A total of 106 patients underwent valve-in-valve TAVI. The mean age was 79 ± 6 years, with 57.5% being female. Almost half of the patients had an index valve ≤ 21 mm, with an STS (Society of Thoracic Surgery) score of 7.1% (5.1-12.0). The post-implant aortic valve mean pressure gradient was 12 ± 6 mmHg, and the mean valve area was 1.7 ± 0.5 cm2. The combined primary outcomes were technical success of 86.8% (CI 80.3%-93.2%), device success of 75.5% (CI 67.3%-83.7%), and early safety of 86.8% (CI 80.3%-93.2%). All-cause mortality at 30 days was 0%. All-cause mortality occurred in 6.6% at a median follow-up of 15 months. CONCLUSIONS: The Allegra TAVI system demonstrates promising technical and device success rates, with early safety and good post-implant haemodynamic performance in high-risk patients undergoing valve-in-valve TAVI. Larger randomized trials are needed to confirm these results."}