Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation

The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report th...

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Published in:Revista española de cardiología (English ed.) 2023-01, Vol.76 (1), p.25-31
Main Authors: Li, Chi-Hion Pedro, Estévez-Loureiro, Rodrigo, Freixa, Xavier, Teles, Rui, Molina-Ramos, Ana I., Pan, Manuel, Nombela-Franco, Luis, Melica, Bruno, Amat-Santos, Ignacio J., Cruz-González, Ignacio, Asmarats, Lluís, Alarcón, Robert, Sanchis, Laura, Fernández-Peregrina, Estefanía, Baz, José Antonio, Millán, Xavier, Menduiña, Irene, Arzamendi, Dabit
Format: Article
Language:English
Subjects:
Aged
Cardiac catheterization
Cardiac Catheterization - adverse effects
Dispositivo PASCAL
Female
Heart failure
Heart Valve Prosthesis Implantation - methods
Humans
Insuficiencia mitral
Male
Mitral Valve - surgery
Mitral valve insufficiency
Mitral Valve Insufficiency - diagnosis
Mitral Valve Insufficiency - surgery
Pascal device
Reparación percutánea borde a borde
Transcatheter edge-to-edge repair
Treatment Outcome
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cites cdi_FETCH-LOGICAL-c1507-643c2d012b506c1d7b2b495b78cd5bcb5256a3faed96406d31a7baef043740b73
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container_issue 1
container_start_page 25
container_title Revista española de cardiología (English ed.)
container_volume 76
creator Li, Chi-Hion Pedro
Estévez-Loureiro, Rodrigo
Freixa, Xavier
Teles, Rui
Molina-Ramos, Ana I.
Pan, Manuel
Nombela-Franco, Luis
Melica, Bruno
Amat-Santos, Ignacio J.
Cruz-González, Ignacio
Asmarats, Lluís
Alarcón, Robert
Sanchis, Laura
Fernández-Peregrina, Estefanía
Baz, José Antonio
Millán, Xavier
Menduiña, Irene
Arzamendi, Dabit
description The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P
doi_str_mv 10.1016/j.rec.2022.05.003
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The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P&lt;.001). Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status. PASCAL es un dispositivo novedoso de terapia mitral transcatéter basada en la reparación borde a borde. Algunas características únicas podrían tener un impacto relevante en sus resultados. Hay pocos datos sobre los resultados clínicos en registros de la vida real. El objetivo de este estudio es publicar la experiencia ibérica precoz (centros de España y Portugal) del sistema PASCAL. Se incluyó prospectivamente a los pacientes tratados consecutivamente de insuficiencia mitral (IM) grave sintomática en 10 centros. El objetivo primario de eficacia fue el éxito técnico y el grado de regurgitación al alta. El objetivo primario de seguridad fueron los eventos adversos mayores (MAE) a 30 días. Se incluyó a 68 pacientes (75 [68-81] años, 38% mujeres, EuroSCORE II 4,5%). La IM fue degenerativa en el 25% de los casos, funcional en el 65%, y mixta en el 10%. El 71% de pacientes estaban en clase funcional New York Heart Association (NYHA)≥III. El éxito técnico fue del 96% y la captura independiente se usó en el 73% de los procedimientos. Toda la población tratada obtuvo una IM al alta≤2+ (100%) y no hubo muertes intrahospitalarias. A los 30 días, los MAE fueron del 5,9%, la mortalidad global del 1,6%, el 98% estuvieron en clase NYHA≤II y el 95% tuvieron IM≤2+ (p &lt;0,001). El sistema PASCAL de terapia transcatéter mitral fue efectivo y seguro, con elevado éxito técnico y baja tasa de MAE. A los 30 días la IM se redujo significativamente, y hubo una mejoría en la clase funcional.</description><identifier>ISSN: 1885-5857</identifier><identifier>EISSN: 1885-5857</identifier><identifier>DOI: 10.1016/j.rec.2022.05.003</identifier><identifier>PMID: 35691867</identifier><language>eng</language><publisher>Spain: Elsevier España, S.L.U</publisher><subject>Aged ; Cardiac catheterization ; Cardiac Catheterization - adverse effects ; Dispositivo PASCAL ; Female ; Heart failure ; Heart Valve Prosthesis Implantation - methods ; Humans ; Insuficiencia mitral ; Male ; Mitral Valve - surgery ; Mitral valve insufficiency ; Mitral Valve Insufficiency - diagnosis ; Mitral Valve Insufficiency - surgery ; Pascal device ; Reparación percutánea borde a borde ; Transcatheter edge-to-edge repair ; Treatment Outcome</subject><ispartof>Revista española de cardiología (English ed.), 2023-01, Vol.76 (1), p.25-31</ispartof><rights>2022 Sociedad Española de Cardiología</rights><rights>Copyright © 2022 Sociedad Española de Cardiología. 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The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P&lt;.001). Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status. PASCAL es un dispositivo novedoso de terapia mitral transcatéter basada en la reparación borde a borde. Algunas características únicas podrían tener un impacto relevante en sus resultados. Hay pocos datos sobre los resultados clínicos en registros de la vida real. El objetivo de este estudio es publicar la experiencia ibérica precoz (centros de España y Portugal) del sistema PASCAL. Se incluyó prospectivamente a los pacientes tratados consecutivamente de insuficiencia mitral (IM) grave sintomática en 10 centros. El objetivo primario de eficacia fue el éxito técnico y el grado de regurgitación al alta. El objetivo primario de seguridad fueron los eventos adversos mayores (MAE) a 30 días. Se incluyó a 68 pacientes (75 [68-81] años, 38% mujeres, EuroSCORE II 4,5%). La IM fue degenerativa en el 25% de los casos, funcional en el 65%, y mixta en el 10%. El 71% de pacientes estaban en clase funcional New York Heart Association (NYHA)≥III. El éxito técnico fue del 96% y la captura independiente se usó en el 73% de los procedimientos. Toda la población tratada obtuvo una IM al alta≤2+ (100%) y no hubo muertes intrahospitalarias. A los 30 días, los MAE fueron del 5,9%, la mortalidad global del 1,6%, el 98% estuvieron en clase NYHA≤II y el 95% tuvieron IM≤2+ (p &lt;0,001). El sistema PASCAL de terapia transcatéter mitral fue efectivo y seguro, con elevado éxito técnico y baja tasa de MAE. A los 30 días la IM se redujo significativamente, y hubo una mejoría en la clase funcional.</description><subject>Aged</subject><subject>Cardiac catheterization</subject><subject>Cardiac Catheterization - adverse effects</subject><subject>Dispositivo PASCAL</subject><subject>Female</subject><subject>Heart failure</subject><subject>Heart Valve Prosthesis Implantation - methods</subject><subject>Humans</subject><subject>Insuficiencia mitral</subject><subject>Male</subject><subject>Mitral Valve - surgery</subject><subject>Mitral valve insufficiency</subject><subject>Mitral Valve Insufficiency - diagnosis</subject><subject>Mitral Valve Insufficiency - surgery</subject><subject>Pascal device</subject><subject>Reparación percutánea borde a borde</subject><subject>Transcatheter edge-to-edge repair</subject><subject>Treatment Outcome</subject><issn>1885-5857</issn><issn>1885-5857</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kE1PGzEQhq2qqEDaH9BL5WMvu_hjbW_EKYr4kiKBRHu2_DEbHG12U9sJ8O9xCEWcOM1o9Mw7mgehn5TUlFB5tqojuJoRxmoiakL4F3RC21ZUohXq64f-GJ2mtCJE8FY139AxF3JKW6lOkL6xEIMZMDxtSgODA_wY8gO-m93PZwucoxmSM_kBMkQMfglVHqt9xRE2JkTcjRGvQ-F6vDP9bj9fbuMyZJPDOHxHR53pE_x4qxP09_Liz_y6Wtxe3ZQDlaOCqEo23DFPKLOCSEe9ssw2U2FV67ywzgompOGdAT-VDZGeU6OsgY40XDXEKj5Bvw-5mzj-20LKeh2Sg743A4zbpJlUYto2DeMFpQfUxTGlCJ3exLA28VlTovde9UoXr3rvVROhi9ey8-stfmvX4N83_osswPkBgPLkLkDUyb3a9KFkZe3H8En8C66_iNs</recordid><startdate>202301</startdate><enddate>202301</enddate><creator>Li, Chi-Hion Pedro</creator><creator>Estévez-Loureiro, Rodrigo</creator><creator>Freixa, Xavier</creator><creator>Teles, Rui</creator><creator>Molina-Ramos, Ana I.</creator><creator>Pan, Manuel</creator><creator>Nombela-Franco, Luis</creator><creator>Melica, Bruno</creator><creator>Amat-Santos, Ignacio J.</creator><creator>Cruz-González, Ignacio</creator><creator>Asmarats, Lluís</creator><creator>Alarcón, Robert</creator><creator>Sanchis, Laura</creator><creator>Fernández-Peregrina, Estefanía</creator><creator>Baz, José Antonio</creator><creator>Millán, Xavier</creator><creator>Menduiña, Irene</creator><creator>Arzamendi, Dabit</creator><general>Elsevier España, S.L.U</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202301</creationdate><title>Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation</title><author>Li, Chi-Hion Pedro ; 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The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P&lt;.001). Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status. PASCAL es un dispositivo novedoso de terapia mitral transcatéter basada en la reparación borde a borde. Algunas características únicas podrían tener un impacto relevante en sus resultados. Hay pocos datos sobre los resultados clínicos en registros de la vida real. El objetivo de este estudio es publicar la experiencia ibérica precoz (centros de España y Portugal) del sistema PASCAL. Se incluyó prospectivamente a los pacientes tratados consecutivamente de insuficiencia mitral (IM) grave sintomática en 10 centros. El objetivo primario de eficacia fue el éxito técnico y el grado de regurgitación al alta. El objetivo primario de seguridad fueron los eventos adversos mayores (MAE) a 30 días. Se incluyó a 68 pacientes (75 [68-81] años, 38% mujeres, EuroSCORE II 4,5%). La IM fue degenerativa en el 25% de los casos, funcional en el 65%, y mixta en el 10%. El 71% de pacientes estaban en clase funcional New York Heart Association (NYHA)≥III. El éxito técnico fue del 96% y la captura independiente se usó en el 73% de los procedimientos. Toda la población tratada obtuvo una IM al alta≤2+ (100%) y no hubo muertes intrahospitalarias. A los 30 días, los MAE fueron del 5,9%, la mortalidad global del 1,6%, el 98% estuvieron en clase NYHA≤II y el 95% tuvieron IM≤2+ (p &lt;0,001). El sistema PASCAL de terapia transcatéter mitral fue efectivo y seguro, con elevado éxito técnico y baja tasa de MAE. A los 30 días la IM se redujo significativamente, y hubo una mejoría en la clase funcional.</abstract><cop>Spain</cop><pub>Elsevier España, S.L.U</pub><pmid>35691867</pmid><doi>10.1016/j.rec.2022.05.003</doi><tpages>7</tpages></addata></record>
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identifier ISSN: 1885-5857
ispartof Revista española de cardiología (English ed.), 2023-01, Vol.76 (1), p.25-31
issn 1885-5857
1885-5857
language eng
recordid cdi_proquest_miscellaneous_2675984423
source ScienceDirect Freedom Collection 2022-2024
subjects Aged
Cardiac catheterization
Cardiac Catheterization - adverse effects
Dispositivo PASCAL
Female
Heart failure
Heart Valve Prosthesis Implantation - methods
Humans
Insuficiencia mitral
Male
Mitral Valve - surgery
Mitral valve insufficiency
Mitral Valve Insufficiency - diagnosis
Mitral Valve Insufficiency - surgery
Pascal device
Reparación percutánea borde a borde
Transcatheter edge-to-edge repair
Treatment Outcome
title Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation
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