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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.
Transcatheter Mitral Valve Repair in a Patient with Osteogenesis Imperfecta: A Case Report and Literature Review.
Interv Cardiol
November 2024
Department of Cardiology, Heart, Vascular and Thoracic Institute, Cleveland Clinic Abu Dhabi Abu Dhabi, United Arab Emirates.
With the emergence of less invasive transcatheter valvular therapies, there remains a limited understanding of the feasibility and durability of these approaches in patients with osteogenesis imperfecta and whether they can offer a suitable alternative to conventional surgery. In this context, and with a focus on mitral repair, we report on a case of mitral transcatheter edge-to-edge repair in a patient with osteogenesis imperfecta and conduct a comprehensive review of the characteristics and outcomes of reported osteogenesis imperfecta cases undergoing surgical or transcatheter mitral repair. Given the high burden of complications of surgery in this population, transcatheter mitral repair could potentially serve as a suitable alternative to conventional surgery in this challenging population.
View Article and Find Full Text PDFImplications of an Off-Hours Setting in Patients Undergoing Transcatheter Edge-to-Edge Repair for Mitral Regurgitation.
Am Heart J
January 2025
Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address:
Article Synopsis
- The study examines the outcomes of mitral transcatheter edge-to-edge repair (TEER) performed during off-hours (before 7:30 am, after 5:30 pm, or on weekends/holidays) to see how they compare to procedures done during regular hours.
- The analysis included 1,177 procedures, with 117 (9.9%) occurring off-hours; off-hours procedures were often urgent and involved higher-risk patients, yet technical success was high in both groups.
- Although baseline MR severity and functional class improved for both groups, off-hours patients experienced higher rates of deaths and heart failure hospitalizations, with no procedural timing linked to outcomes in matched comparisons, suggesting experienced interventionalists can conduct these procedures safely regardless
Successful treatment of cardiac dysfunction due to left main trunk obstruction and severe acute aortic regurgitation secondary to acute type A aortic dissection using Impella: a case report.
J Cardiothorac Surg
December 2024
Department of Cardiovascular Surgery, Kanazawa University, Takaramachi 13-1, Kanazawa, 920-8641, Japan.
Background: Acute type A aortic dissection (A-AAD) with severe acute aortic regurgitation (AR) and coronary involvement is a potentially fatal condition that causes left ventricular volume overload and catastrophic acute myocardial infarction. We present the successful management of a patient using Impella 5.5 following cardiopulmonary arrest caused by A-AAD with severe acute AR and left main trunk (LMT) obstruction.
View Article and Find Full Text PDFA Novel Transcatheter Posterior Ventricular Anchoring Neochordoplasty Mitral Valve Repair Device.
Cardiovasc Eng Technol
December 2024
Department of Cardiothoracic Surgery, Stanford University, Stanford, CA, USA.
Purpose: Advancements in minimally invasive technologies to decrease postoperative morbidity and recovery times represent a large opportunity for mitral valve repair operations. However, current technologies are unable to replicate gold standard surgical neochord implantation.
Methods: We developed a novel neochordal repair device, Minimally Invasive Ventricular Anchoring Neochordoplasty (MIVAN), which operates via transcatheter, trans-septal anchoring to the posterior ventricular wall.
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