Author + information
- Received November 25, 2013
- Revision received February 27, 2014
- Accepted March 13, 2014
- Published online July 1, 2014.
- Saibal Kar, MD∗,
- Dongming Hou, MD, PhD†,
- Russell Jones‡,
- Dennis Werner, BS†,
- Lynne Swanson, DVM†,
- Brian Tischler, BS†,
- Kenneth Stein, MD†,
- Barbara Huibregtse, DVM†,
- Elena Ladich, MD‡,
- Robert Kutys, MS‡ and
- Renu Virmani, MD‡∗ ()
- ∗Heart Institute, Cedars Sinai Medical Center, Los Angeles, California
- †Boston Scientific Corporation, Natick, Massachusetts
- ‡CVPath, Gaithersburg, Maryland
- ↵∗Reprint requests and correspondence:
Dr. Renu Virmani, CVPath, 19 Firstfield Road, Gaithersburg, Maryland 20878.
Objectives This study was designed for conducting a comparative evaluation of the healing response after Watchman (WM) (Boston Scientific, Plymouth, Minnesota) and Amplatzer Cardiac Plug (ACP) (St. Jude Medical, Minneapolis, Minnesota) in a canine left atrial appendage (LAA) model.
Background There is no direct comparison of the WM and ACP device in pre-clinical or clinical settings.
Methods The LAA from canine (n = 6) and human (n = 19) hearts were compared to determine the feasibility of the canine model and its relevance to clinical applications. Subsequently, implantation of WM and ACP in the canine LAA was performed (n = 3 per device) to evaluate the device conformation to the LA anatomy as well as the healing response at 28 days.
Results The LAA is a variable tubular structure in both canine and human hearts. Gross examination showed that the WM was properly seated inside the LAA ostium, in comparison to the ACP where the disk was outside of the LAA orifice and extended to the edge of the left superior pulmonary vein and mitral valve. At 28 days, complete neo-endocardial coverage of the WM was observed; however, the ACP showed an incomplete covering on the disk surface especially at the lower edge and end-screw hub regions.
Conclusions There are differences in conformation of LAA surrounding structures with variable healing response between WM and ACP after LAA closure in the canine model. WM does not obstruct or impact the LAA adjacent structures, resulting in a favorable surface recovery. In comparison, the disk of ACP could potentially jeopardize LAA neighboring structures and leads to delayed healing.
This study was funded by Boston Scientific. Dr. Kar has received research grants from Boston Scientific and St. Jude Medicalhttp://dx.doi.org/10.13039/100006279; serves on the left atrial appendage advisory committee for Boston Scientific; and also serves as the national principal investigator of the CAP2 (Continuous Access Registry) registry and as an investigator for clinical trials for both devices. Drs. Hou, Swanson, Tischler, Stein, Huibregtse, and Mr. Werner are full-time employees and shareholders of Boston Scientific. Dr. Virmani has received research support from 480 Biomedical, Abbott Vascular, Atrium, Biosensors International, Biotronik, Boston Scientific, CeloNova, Cordis Corp. (Johnson & Johnson), GlaxoSmithKlinehttp://dx.doi.org/10.13039/100004330, Medtronichttp://dx.doi.org/10.13039/100004374, MicroPort Medical, OrbusNeich, ReCor Medical, SINO Medical Technology, Terumo Corporation, and W. L. Gore; and has received consulting fees and/or honoraria from 480 Biomedical, Abbott Vascular, Biosensors International, Boston Scientific, CeloNova, Cordis Corp. (Johnson & Johnson), Lutonix, Medtronic, Terumo Corporation, Merck, and W. L. Gore. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Kar and Hou contributed equally to this work.
- Received November 25, 2013.
- Revision received February 27, 2014.
- Accepted March 13, 2014.
- American College of Cardiology Foundation