13 research outputs found

    Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

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    Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods: Prospective, multicenter, 'real-world' registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted

    Seguimiento del trasplante cardiaco con una estrategia de monitorización del rechazo basada en ecocardiografía

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    RESUMEN: La realización de biopsias seriadas constituye la base para la detección del rechazo tras un trasplante cardíaco. Esta estrategia implica la realización de un gran número de biopsias. Sin embargo, esta técnica es invasiva y presenta importantes limitaciones. Se plantea una nueva estrategia basada en la utilización de estudios ecocardiográficos seriados con utilización selectiva de la biopsia, con el fin de reducir el número de estos procedimientos. Presentamos la experiencia durante diez años aplicando este enfoque en el Programa de Trasplante Cardíaco del HU Marqués de Valdecilla. Durante la implantación de esta estrategia se pone de manifiesto una reducción drástica del número de biopsias. Se analiza además su repercusión sobre el número de rechazos y sobre la mortalidad, sin encontrar una repercusión negativa en el pronóstico a corto y largo plazo de los pacientes. Por tanto la monitorización clínico-ecocardiografica, podría ser una alternativa a la monitorización con biopsias seriadas.ABSTRACT: Endomyocardial biopsy is considered the most reliable means for the early detection of rejection after a heart transplant. However, this strategy implies carrying out a large number of biopsies, and is an invasive technique with important limitations. A new approach based on the use of serial echocardiographic studies with selective use of biopsy is proposed, in order to reduce the number of these procedures. We report the experience with this approach in the Heart Transplantation Program of the Hospital Universitario Marqués de Valdecilla during a ten years period. In this way, the total number of biopsies was reduced along this time. No impact on the number of rejections and an increased risk of death was found. Therefore clinical-echocardiographic monitoring could be an alternative to traditional monitoring performing periodic endomyocardial biopsies

    Primary prevention implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator in elderly patients: results of a Spanish multicentre study.

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    Currently, there continues to be a lack of evidence regarding outcomes associated with device-based therapy for ventricular arrhythmias in elderly patients, even more in primary-prevention indications. We aimed to describe the follow-up in terms of efficacy and safety of implantable cardioverter-defibrillator (ICD) therapy in a large cohort of elderly patients. Retrospective multicentre study performed in 15 Spanish hospitals. Consecutive patients referred for ICD implantation before 2011 were included. One hundred and sixty-two of 1174 patients (13.8%) ≥75 years were considered as 'elderly'. When compared with those patients In a real-world scenario, elderly patients comprise ∼15% of ICD implantations for primary prevention of sudden cardiac death (SCD). Although the rate of appropriate therapy is similar between groups, the benefit of ICD is attenuated for a major increase in mortality risk among those patients ≥75 years at the moment of device implantation

    Impact of operator's experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

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    Background The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods Prospective, multicenter, ?real-world? registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center?s prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ? 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the cente?s previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operato?s experience with its previous device iteration or the number of Watchman FLX devices implanted.Acknowledgments: We would like to express our gratitude to Jose Santaursula Pastor for the production of the figures in this work
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