Author + information
- Received October 5, 2016
- Revision received October 13, 2016
- Accepted October 13, 2016
- Published online November 2, 2016.
- Vivek Y. Reddy, MD1,∗∗ (, )
- Douglas N. Gibson, MD2,
- Saibal Kar3,
- William O’Neill, MD4,
- Shephal K. Doshi, MD5,
- Rodney P. Horton, MD6,
- Maurice Buchbinder, MD7,
- Nicole T. Gordon, BSEE8 and
- David R. Holmes, MD9,∗
- 1Icahn School of Medicine at Mount Sinai, New York, NY
- 2Scripps Clinic, La Jolla, CA
- 3Cedars Sinai Medical Center, Los Angeles, CA
- 4Center for Structural Heart Disease, Henry Ford Hospital, Detroit, MI
- 5St. John’s Health Center, Santa Monica, CA
- 6Texas Cardiac Arrhythmia Institute, Austin, TX
- 7Foundation for Cardiovascular Medicine, La Jolla, CA
- 8Boston Scientific Corporation, St. Paul, MN
- 9Department of Cardiology, Mayo Clinic, Rochester, MN
- ↵∗Address for correspondence: Vivek Y. Reddy, M.D. Helmsley Electrophysiology Center Icahn School of Medicine at Mount Sinai One Gustave L. Levy Place, Box 1030 New York, NY 10029, U.S.A. Phone: 1-212-241-7114 Fax: 1-646-537-9691.
Background Left atrial appendage closure (LAAC) using the Watchman device was FDA-approved as a stroke prevention alternative to warfarin for patients with non-valvular atrial fibrillation. However, clinical decision-making is confounded by the fact that while LAAC avoids the anticoagulant-related lifetime risk of bleeding, implantation is associated with up-front complications. Thus, enthusiasm for LAAC as a treatment option has been appropriately tempered, particularly as the therapy is introduced beyond the clinical trial sites into general clinical practice.
Objectives To evaluate the acute procedural performance and complication rates for all Watchman cases performed in the US since FDA approval.
Methods In the absence of a formal national clinical registry since regulatory approval in March 2015, we obtained procedural data on Watchman implantation procedures. Briefly, every LAAC procedure requires the presence of a manufacturer clinical specialist, and procedural parameter and peri-procedural complication data are collected using a standardized process and forms.
Results In 3,822 consecutive cases, implantation was successful in 3,653 (95.6%) with a median procedure time of 50 min (range 10, 210); implanting physicians performing these procedures (n=382) included 71% new, non-clinical trial implanters, performing 50% of the procedures. Procedural complication rates included: 39 pericardial tamponades (1.02%; 24 treated percutaneously, 12 surgically and 3 fatal), three procedure-related strokes (0.078%), 9 device embolizations (0.24%; 6 requiring surgical removal), and 3 procedure-related deaths (0.078%).
Conclusions Despite a large fraction of previously-inexperienced operators, in the real-world post-FDA approval experience of Watchman LAAC, procedural success was high and complication rates low.
↵∗ Both authors contributed equally to the development of this manuscript
CONFLICTS OF INTEREST
Dr. Reddy has received research grant support from and has been a consultant for Boston Scientific, Coherex, Sentreheart and St Jude Medical.; Dr. Gibson has received speaker and proctoring fees from SentreHeart and Boston Scientific. Dr. Kar has received research grants from Boston Scientific, St. Jude Medical, and Abbott Vascular; is a member of the advisory board for left atrial appendage closure; is the national principal investigator of the Continuous Access Registries (CAP and CAP2) has served as a proctor for Boston Scientific.; William O’Neill, MD: no disclosures; Dr. Doshi has received research grants and consultant fees from Boston Scientific, St. Jude Medical, Coherex, and SentreHeart; and is the national principal Investigator of the Continuous Access Registry (CAP2).; Dr. Horton has received consulting fees from Boston Scientific.; Dr. Buchbinder has received research grant support from and has been a consultant for Boston Scientific.; Nicole T. Gordon, BSEE: Employee of Boston Scientific.; David R. Holmes, MD: Both Mayo Clinic and Dr. Holmes have a financial interest in technology related to this research. That technology has been licensed to Boston Scientific.
- Received October 5, 2016.
- Revision received October 13, 2016.
- Accepted October 13, 2016.
- The Authors