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Georg Nickenig, Christoph Hammerstingl, Robert Schueler, Yan Topilsky, Paul A Grayburn, Alec Vahanian, David Messika-Zeitoun, Marina Urena Alcazar, Stephan Baldus, Rudolph Volker, Michael Huntgeburth, Ottavio Alfieri, Azeem Latib, Giovanni La Canna, Eustachio Agricola, Antonio Colombo, Karl-Heinz Kuck, Felix Kreidel, Christian Frerker, Felix C Tanner, Ori Ben-Yehuda, Francesco Maisano
OBJECTIVES: This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment. BACKGROUND: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device. METHODS: Thirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled...
October 10, 2016: JACC. Cardiovascular Interventions
Francesco Maisano, Maurizio Taramasso, Andrea Guidotti, Fabian Nietlispach
No abstract text is available yet for this article.
September 18, 2016: EuroIntervention
Azeem Latib, Marco B Ancona, Luca Ferri, Matteo Montorfano, Antonio Mangieri, Damiano Regazzoli, Francesco Giannini, Fabrizio Monaco, Manuela Giglio, Stefano De Servi, Ottavio Alfieri, Antonio Colombo, Eustachio Agricola
No abstract text is available yet for this article.
September 26, 2016: JACC. Cardiovascular Interventions
Mani Arsalan, Eustachio Agricola, Ottavio Alfieri, Stephan Baldus, Antonio Colombo, Giovanni Filardo, Christophe Hammerstingl, Michael Huntgeburth, Felix Kreidel, Karl-Heinz Kuck, Giovanni LaCanna, David Messika-Zeitoun, Francesco Maisano, Georg Nickenig, Benjamin D Pollock, Bradley J Roberts, Alec Vahanian, Paul A Grayburn
This study was performed to assess the acute intraprocedural effects of transcatheter direct mitral annuloplasty using the Cardioband device on 3-dimensional (3D) anatomy of the mitral annulus. Of 45 patients with functional mitral regurgitation (MR) enrolled in a single arm, multicenter, prospective trial, 22 had complete pre- and post-implant 3D transesophageal echocardiography (TEE) images stored in native data format that allowed off-line 3D reconstruction. Images with the highest volume rate and best image quality were selected for analysis...
September 1, 2016: American Journal of Cardiology
Maurizio Taramasso, Devdas T Inderbitzin, Andrea Guidotti, Fabian Nietlispach, Oliver Gaemperli, Michel Zuber, Francesco Maisano
Direct mitral valve annuloplasty is a transcatheter mitral valve repair approach that mimics the conventional surgical approach to treat functional mitral regurgitation. The Cardioband system (Valtech Cardio, Inc., Or-Yehuda, Israel) is delivered by a trans-septal approach and the implant is performed on the atrial side of the mitral annulus, under live echo and fluoroscopic guidance using multiple anchor elements. The Cardioband system obtained CE mark approval in October 2015, and initial clinical experiences are promising with regard to feasibility, safety and efficacy...
2016: Multimedia Manual of Cardiothoracic Surgery: MMCTS
Mathias Orban, D Braun, Martin Orban, L Gross, M Näbauer, C M Hagl, S Massberg, J Hausleiter
Severe mitral regurgitation (MR) is a growing medical challenge in today's aging population, leading to increased health expenditure due to the resultant morbidity and mortality. Surgery, either replacement or repair, has been the mainstay of therapy for primary MR. In high-risk or inoperable patients, treatment was limited to medical therapy until 2008. Since then, alternative percutaneous therapies have been introduced and have proven to be safe and effective in patients with secondary MR. Edge-to-edge repair with the MitraClip system is applied worldwide for primary and secondary MR...
February 2016: Herz
Francesco Maisano, Maurizio Taramasso, Georg Nickenig, Christoph Hammerstingl, Alec Vahanian, David Messika-Zeitoun, Stephan Baldus, Michael Huntgeburth, Ottavio Alfieri, Antonio Colombo, Giovanni La Canna, Eustachio Agricola, Michel Zuber, Felix C Tanner, Yan Topilsky, Felix Kreidel, Karl-Heinz Kuck
AIMS: Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. METHODS AND RESULTS: The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy...
March 7, 2016: European Heart Journal
Francesco Maisano, Maurizio Taramasso
No abstract text is available yet for this article.
September 2015: EuroIntervention
Simon H Sündermann, Sonja Gordic, Robert Manka, Nikola Cesarovic, Volkmar Falk, Francesco Maisano, Hatem Alkadhi
To investigate the use of computed tomography (CT) to measure the mitral valve annulus size before implantation of a percutaneous mitral valve annuloplasty device in an animal trial. Seven domestic pigs underwent CT before and after implantation of a Cardioband™ (a percutaneously implantable mitral valve annuloplasty device) with a second-generation 128-section dual-source CT machine. Implantation of the Cardioband™ was performed in a standard fashion according to a protocol. Animals were sacrificed afterwards and the hearts explanted...
January 2015: International Journal of Cardiovascular Imaging
Francesco Maisano, Hugo Vanermen, Joerg Seeburger, Michael Mack, Volkmar Falk, Paolo Denti, Maurizio Taramasso, Ottavio Alfieri
OBJECTIVES: The aim of the study was to evaluate the technical feasibility and performance of a transcatheter mitral annuloplasty system. METHODS: Adult swines (n = 15) underwent left thoracotomy through the 4th-5th intercostal space. A transcatheter device (CardioBand, Valtech-Cardio Ltd) was introduced through an 18F sheath through the left atrium and attached to the annulus between the posterior and anterior commissures using echocardiographic and fluoroscopic guidance, on the beating heart...
September 2012: European Journal of Cardio-thoracic Surgery
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