Mohammad-Ali Jazayeri1, Venkat Vuddanda1, Mohit K Turagam2, Valay Parikh1, Madhav Lavu1, Donita Atkins1, Matthew Earnest1,3, Luigi Di Biase4, Andrea Natale5, David Wilber6, Yeruva Madhu Reddy1,3, Dhanunjaya R Lakkireddy1,3. 1. Division of Cardiovascular Diseases, Cardiovascular Research Institute, University of Kansas Hospital & Medical Center, Kansas City, KS, USA. 2. Division of Cardiovascular Disease, University of Missouri Hospital & Clinics, Columbia, MO, USA. 3. Mid-America Cardiology, Bloch Heart Rhythm Center, University of Kansas Hospital & Medical Center, Kansas City, KS, USA. 4. Electrophysiology Section, Albert Einstein College of Medicine at Montefiore Medical Center, Bronx, NY, USA. 5. Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, TX, USA. 6. Division of Cardiovascular Medicine, Loyola University Medical Center, Chicago, IL.
Abstract
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AF patients who are unable to tolerate long-term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. RESULTS: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. CONCLUSIONS: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) is a viable option for AFpatients who are unable to tolerate long-term oral anticoagulation (OAC). OBJECTIVE: We sought to assess the safety of two commonly used percutaneous devices for LAA closure in the United States by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was queried between May 1, 2006 and May 1, 2016 for LARIAT® (SentreHEART Inc., Redwood City, CA, USA) and WATCHMAN™ (Boston Scientific Corp., Marlborough, MA, USA) devices. Among 622 retrieved medical device reports, 356 unique and relevant reports were analyzed. The cumulative incidence of safety events was calculated over the study period and compared between the two devices. RESULTS: LAAC was performed with LARIAT in 4,889 cases. WATCHMAN was implanted in 2,027 patients prior to FDA approval in March 2015 and 3,822 patients postapproval. The composite outcome of stroke/TIA, pericardiocentesis, cardiac surgery, and death occurred more frequently with WATCHMAN (cumulative incidence, 1.93% vs. 1.15%; P = 0.001). The same phenomenon was observed when comparing the WATCHMAN pre- and postapproval experiences for the composite outcome, as well as device embolization, cardiac surgery, and myocardial infarction. CONCLUSIONS: MAUDE-reported data show that postapproval, new technology adoption is fraught with increased complications. Improved collaboration between operators, device manufacturers, and regulators can better serve patients through increased transparency and practical postmarket training and monitoring mechanisms.
Authors: Thomas Fink; Michael Schlüter; Roland Richard Tilz; Christian-Hendrik Heeger; Christine Lemes; Tilmann Maurer; Bruno Reissmann; Laura Rottner; Francesco Santoro; Shibu Mathew; Andreas Rillig; Feifan Ouyang; Karl-Heinz Kuck; Andreas Metzner Journal: Clin Res Cardiol Date: 2018-06-07 Impact factor: 5.460
Authors: Karin Nentwich; Elena Ene; Philipp Halbfass; Arthur Berkowitz; Kai Sonne; Sebastian Kerber; Randall Lee; Thomas Deneke Journal: Indian Pacing Electrophysiol J Date: 2021-01-15