Dr. Reddy and Dr. Holmes Comment on the Recent WATCHMAN™ Post-FDA Approval, Initial US Clinical Experience Presented at TCT 2016
What is the Impact of These Data from the Perspective of an EP and an IC?
The purpose of the Post-FDA Approval, Initial US Clinical Experience with WATCHMAN was to analyze procedural safety data of the WATCHMAN device during the US post-approval launch. From March 2015 - May 2016, 3,822 patients received a WATCHMAN device for left-atrial appendage closure at 169 US centers – more than all the clinical trials combined. Successful implants occurred in 95.6% of cases, and 50% of the implants were performed by new operators. Safety complication rates were low and consistent with clinical trial results.
- 1.02% of patients experienced a pericardial tamponade (2/3 of which were treated percutaneously, without the need for surgery).
- An additional 0.29% of patients demonstrated pericardial effusion without hemodynamic effect, requiring no intervention.
- Device embolization, procedure-related stroke, and mortality rates also remained low at 0.24%, 0.08% and 0.08%, respectively
The WATCHMAN Experience in Perspective
Presented by Holmes at TCT 2016
Boston Scientific Resources
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Interested in Performing Left-Atrial Procedures?
WATCHMAN implanters are highly experienced in transseptal crossing with training from advanced atrial fibrillation and structural heart programs, and all implanters complete a detailed training program specific to the WATCHMAN Implant. Contact your Boston Scientific representative to learn more.
Interested in Foundational Transseptal Access Training?
Boston Scientific now offers the first Transseptal Access Training Course for Interventional Cardiologists. This course provides a day of hands-on training for ICs experienced in structural heart, but looking to add transseptal puncture and left atrial access to their practice. The course covers imaging, 3D anatomy, equipment, basic technique, and complications relevant to transseptal access.
Note: This course is intended to provide foundational training prior to transseptal puncture credentialing and is not a substitute for site-specific certification or for WATCHMAN training (see below).
Interested in Learning More about Left Atrial Appendage Therapy with WATCHMAN?
Hear expert faculty discuss Left Atrial Appendage Closure (LAAC) as a treatment option for patients with NVAF, including the supporting clinical data, their experience with WATCHMAN, appropriate patient selection, and shared decision-making during WATCHMAN-focused, Boston Scientific-sponsored programs.
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