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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
84.2K
Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for
Vivek Y Reddy1, David Holmes, Shephal K Doshi
1Helmsley Electrophysiology Center, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1030, New York, NY 10029, USA. vivek.reddy@mountsinai.org
Circulation
|January 19, 2011
Summary
Operator experience significantly improves the safety of Watchman left atrial appendage closure for atrial fibrillation patients. This interventional procedure showed reduced complications with increased procedural expertise.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Device Technology
Background:
- The PROTECT AF trial compared Watchman left atrial appendage closure to warfarin in atrial fibrillation patients.
- While effective for stroke prevention, PROTECT AF noted higher complication rates, including pericardial effusion and procedural stroke.
- This analysis investigates the impact of operator experience on the safety of Watchman implantation.
Purpose of the Study:
- To evaluate the influence of operator experience on the safety outcomes of percutaneous left atrial appendage closure using the Watchman device.
- To assess the reduction in procedure- or device-related safety events with increasing experience.
Main Methods:
- Analysis of patient data from the randomized PROTECT AF trial (n=542) and the nonrandomized Continued Access Protocol (CAP) Registry (n=460).
- Evaluation of safety endpoints including bleeding, pericardial effusion, stroke, and device embolization within 7 days of procedure.
- Comparison of event rates between the two studies and across halves of the PROTECT AF and CAP cohorts to assess experience-related improvements.
Main Results:
- A significant decline in procedure- or device-related safety events was observed with increasing experience (7.7% to 3.7%, P=0.007).
- Serious pericardial effusion rates decreased from 5.0% in PROTECT AF to 2.2% in the CAP Registry (P=0.019).
- Procedure-related stroke rates improved significantly with experience (0.9% to 0%, P=0.039), and functional impact of safety events was superior compared to warfarin.
Conclusions:
- Operator experience is a critical factor in improving the safety profile of Watchman left atrial appendage closure.
- The learning curve associated with this interventional procedure leads to reduced complication rates.
- Watchman implantation demonstrates a favorable safety trajectory with accumulated operator expertise.
