Abstract
The study demonstrates the safety, feasibility and effectiveness of a comprehensive approach to minimize fluoroscopy and contrast use during Watchman left atrial closure device implantation.Background. The introduction of Watchman left atrial appendage occlusion device (WM) has provided an effective alternative to anticoagulation for patients with a high risk of cerebrovascular accidents (CVA) and high risk of bleeding and who are unable to take long-term anticoagulation therapy. Since its introduction, WM has been implanted more than 50,000 times worldwide. While the implant procedure is relatively safe, it involves the use of fluoroscopy and contrast and, as such, poses some associated risk to patient safety. The adoption of procedural techniques which reduce fluoroscopy exposure and contrast use have the potential to provide clinical patient benefit without compromising safety or efficacy. Aim To demonstrate that WM implant can be performed with minimal exposure to both ionizing radiation and IV contrast without compromising safety or efficacy.Methods. A retrospective chart review of all 75 consecutive Watchman implantations by a single operator at a single center between December 2015 and December 2017. Every effort to optimize the WM implant procedure and minimize radiation and contrast exposure was incorporated as implant techniques evolved. Contrast and radiation exposure data were collected and analyzed year-over-year.Results. Charts from 75 consecutive cases were reviewed with all cases at index procedure (100%), and included the majority of patients presenting in paroxysmal AF (63%). Baseline patient characteristics were consistent across years. Procedural characteristics also were consistent over time. The median absorbed radiation dose was low (75 mGy in 2015) and did not change significantly over time. Similarly, the median fluoroscopy time used after the initial case was low (2.8 minutes) and did not vary. 73 of 75 (97%) of procedures resulted in successful implantation. There were no procedural complications; notably, no cases resulted in stroke, death, pericardial effusion, vascular accidents or device embolization.Conclusion.The current generation of WM can be successfully implanted using low fluoroscopy and contrast without compromising safety or efficacy using the techniques described.
Highlights
For patients with AF who are at elevated risk of thromboembolic cerebrovascular accidents (CVA), an elevated risk of bleeding and a relative contraindication to the use of anticoagulants, left atrial occlusion device placement is a proven safe and effective alternative to OAC [1, 2]
While the implant procedure is relatively safe, it involves the use of fluoroscopy and contrast and, as such, poses some associated risk to patient safety
For patients with AF who are at elevated risk of thromboembolic CVA, an elevated risk of bleeding and a relative contraindication to the use of anticoagulants, left atrial occlusion device placement is a proven safe and effective alternative to OAC [1, 2]
Summary
For patients with AF who are at elevated risk of thromboembolic CVA, an elevated risk of bleeding and a relative contraindication to the use of anticoagulants, left atrial occlusion device placement is a proven safe and effective alternative to OAC [1, 2]. WM is a novel technology which involves the delivery of a LAA occlusion device via a transeptal approach and is widely in use in the United States and Europe. While standard implant techniques have been refined since the early clinical trials, device delivery continues to require both fluoroscopy and direct injection of IV contrast into the left atrium to ensure appropriate positioning and to verify appendage occlusion
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