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Death incidents following transcatheter edge-to-edge repair (TEER) with the MitraClip device: analysis of 10-years post-marketing death reports from the Manufacturer and User Facility Device Experience (MAUDE) registry.
BMC Cardiovasc Disord
January 2025
Department of Cardiology, Peking University International Hospital, Life Park Road No.1, Life Science Park of Zhongguancun, Chang Ping District, Beijing, 102206, China.
Background: The transcatheter edge-to-edge repair (TEER) technique, facilitated by the MitraClip device, is a minimally invasive intervention designed for high-risk patients with mitral regurgitation (MR). This study conducts a retrospective analysis of death events associated with MitraClip implantation over a ten-year decade, utilizing data from the FDA's Manufacturer and User Facility Device Experience (MAUDE) database to evaluate trends in safety outcomes.
Methods: A comprehensive search of the publicly accessible MAUDE database was conducted to retrieve reports of deaths and injuries related to MitraClip implantation from October 2013 to September 2023.
[Predictors of atrial fibrillation recurrence after biatrial cryo-maze procedure: a systematic review].
Khirurgiia (Mosk)
November 2024
Volosevich Arkhangelsk City Clinical Hospital, Arkhangelsk, Russia.
Today, the issue of atrial fibrillation recurrence after ablation is increasingly discussed in the literature. Many authors analyze the factors predicting success or failure of cryo-maze procedure. This review is devoted to predictors of atrial fibrillation recurrence in long-term period after biatrial cryo-maze procedure.
View Article and Find Full Text PDFThree-dimensional computed tomography analysis of the mitral annulus for mitral annuloplasty in 100 cases of robotic mitral valve repair.
Front Cardiovasc Med
September 2024
Department of Cardiovascular Surgery, Osaka Metropolitan University Postgraduate School of Medicine, Osaka, Japan.
Objectives: This study aimed to evaluate the efficacy of preoperative computed tomography in assessing mitral annulus anatomy and the posterior annular plication rate in mitral valve repair with annuloplasty.
Methods: From July 2018 to August 2023, we performed robotic mitral valve repair with ring annuloplasty using a semi-rigid ring in 100 patients. Preoperative anatomical assessment of the mitral annulus was conducted by three-dimensional computed tomography.
The study of loading mode with in-vitro fatigue testing for mitral annuloplasty ring.
J Biomech
March 2024
Key Laboratory of Biomechanics and Mechanobiology (Beihang University), Ministry of Education, Beijing Advanced Innovation Center for Biomedical Engineering, School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China. Electronic address:
To maintain the physiological dynamics of the mitral annulus, mitral annuloplasty rings (MAR) must be flexible. Enhanced flexibility implies decreased resistance to fatigue and potential for fatigue fracture. This study established new methods to test the flexible fatigue life of MAR in-vitro using numerical analysis; the purpose is that the fatigue test could reflect the real stress distribution in-vivo.
View Article and Find Full Text PDFSystematic review of first-in-human and early phase clinical trials for surgically implantable biological mitral valve substitutes.
J Cardiothorac Surg
November 2023
Department of Surgery, Yong Loo Lin School of Medicine, Centre for Translational Medicine, National University of Singapore, MD6, 14 Medical Drive, Level-8 (South), Singapore, 117599, Singapore.
Background: The aim of this review was the creation of uniform protocols to carry out and disclose First-In-Human and preliminary clinical trials of biological mitral valve replacement. The need for consistent methodology in these early trials was highlighted by the observation of significant variability in the methods and protocols used across different research.
Methods: An extensive search through six major databases was carried out to retrieve First-In-Human (FIH) clinical studies evaluating surgically implanted bio-prostheses in the mitral position.
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