TY - JOUR
T1 - Performance of Purpose-Built vs Off-Label Transcatheter Devices for Aortic Regurgitation
T2 - The PURPOSE Study
AU - Poletti, Enrico
AU - Adam, Matti
AU - Wienemann, Hendrik
AU - Sisinni, Antonio
AU - Patel, Kush P.
AU - Amat-Santos, Ignacio J.
AU - Orzalkiewicz, Mateusz
AU - Saia, Francesco
AU - Regazzoli, Damiano
AU - Fiorina, Claudia
AU - Panoulas, Vasileios
AU - Brinkmann, Christina
AU - Giordano, Arturo
AU - Taramasso, Maurizio
AU - Maisano, Francesco
AU - Barbanti, Marco
AU - De Backer, Ole
AU - Van Mieghem, Nicolas M.
AU - Latib, Azeem
AU - Squillace, Mattia
AU - Baldus, Stephan
AU - Geyer, Martin
AU - Baumbach, Andreas
AU - Bedogni, Francesco
AU - Rudolph, Tanja K.
AU - Testa, Luca
N1 - Publisher Copyright:
© 2024 American College of Cardiology Foundation
PY - 2024/7/8
Y1 - 2024/7/8
N2 - Background: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated “purpose-built” Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. Objectives: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. Methods: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. Results: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). Conclusions: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.
AB - Background: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated “purpose-built” Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. Objectives: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. Methods: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. Results: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). Conclusions: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.
UR - http://www.scopus.com/inward/record.url?scp=85196938830&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2024.05.019
DO - 10.1016/j.jcin.2024.05.019
M3 - Article
C2 - 38986659
AN - SCOPUS:85196938830
SN - 1936-8798
VL - 17
SP - 1597
EP - 1606
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 13
ER -