Utilization and procedural adverse outcomes associated with Watchman device implantation.

Published on Feb 5, 2021in Europace4.045
· DOI :10.1093/EUROPACE/EUAA219
Fouad Khalil3
Estimated H-index: 3
(Mayo Clinic),
Shilpkumar Arora2
Estimated H-index: 2
(Case Western Reserve University)
+ 11 AuthorsAbhishek Deshmukh35
Estimated H-index: 35
(Mayo Clinic)
Sources
Abstract
Aims  The Food and Drug Administration (FDA) approval of the Watchman device [percutaneous left atrial appendage occlusion (LAAO)] has resulted in the widespread use of this procedure in many centres across the USA. We sought to estimate the nationwide utilization and frequency of adverse outcomes associated with Watchman device implantation. The objective of this study was to evaluate the Watchman device implantation peri-procedural complications and comparison of the results with the previous studies. Methods and results  The National Inpatient Sample (NIS) was queried for all hospitalizations with a primary diagnosis of atrial fibrillation or atrial flutter during the year 2016 with percutaneous LAAO during the same admission (ICD-10 code-02L73DK). The frequency of peri-procedural complications, including mortality, procedure-related stroke, major bleeding requiring blood transfusion, and pericardial effusion, was assessed. We compared the complication rates with the published randomized controlled trials and the European Watchman registry. An estimated 5175 LAAO procedures were performed in 2016. The majority of procedures was performed in males (59.1%), age ≥75 years (58.7%), and White (83.1%). The overall complication rate was 1.9%. The in-hospital mortality was 0.29%. Pericardial effusion requiring pericardiocentesis was the most frequent complication (0.68%). Bleeding requiring transfusion was noted in 0.1% of device implants. The rates of post-procedure stroke and systemic embolism were 0% and 0.29%, respectively. Conclusion  Percutaneous LAAO with the Watchman device in the USA is associated with low in-hospital complications and a similar safety profile to a recently published EWOLUTION cohort. The complication rates were lower than those reported in the major randomized clinical trials (RCTs). We report the frequency of peri-procedural complications of the LAAO using the Watchman device from the NIS database. We also compare the frequency of peri-procedural complications with the previously published RCTs and EWOLUTION cohort. Our findings are in concordance with findings from EWOLUTION cohort and compare favourably with RCTs.
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Abstract Background The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versu...
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Importance Publicly available data sets hold much potential, but their unique design may require specific analytic approaches. Objective To determine adherence to appropriate research practices for a frequently used large public database, the National Inpatient Sample (NIS) of the Agency for Healthcare Research and Quality (AHRQ). Design, Setting, and Participants In this observational study of the 1082 studies published using the NIS from January 2015 through December 2016, a representative sam...
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Background Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Objective EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. Methods A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophag...
169 CitationsSource
The use of large administrative databases is transforming clinical cardiovascular research. These sources of big data allow the study of practices and outcomes across a spectrum of health systems, providing real-world evidence. However, these databases have peculiarities to their design that require specialized expertise and distinct analytic practices for their appropriate interpretation. We discuss these issues in the context of the National Inpatient Sample (NIS) that is one such data set use...
112 CitationsSource
Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and the rate of ischemic stroke attributed to non-valvular AF is estimated at 5% per year. Several multi-center studies established left atrial appendage closure as a safe and effective alternative to oral anticoagulation, but there is a need for additional real world data. Methods The purpose of this observational, prospective, single-arm, multicenter clinical study is to compile real-world clinical outcome data...
24 CitationsSource
#1Lucas V.A. BoersmaH-Index: 35
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Aims Left atrial appendage closure is a non-pharmacological alternative for stroke prevention in high-risk patients with non-valvular atrial fibrillation. The objective of the multicentre EWOLUTION registry was to obtain clinical data on procedural success and complications, and long-term patient outcomes, including bleeding and incidence of stroke/transient ischaemic attack (TIA). Here, we report on the peri-procedural outcomes of up to 30 days. Methods and results Baseline/implant data are ava...
248 CitationsSource
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TABLE OF CONTENTS Preamble2 1. Introduction2 1.1. Key Questions3 2. Stroke Prevention in AF: Current Evidence and Guidelines3 3. Literature Review4 3.1. Background4 3.2. WATCHMAN4 3.3. Amplatzer Cardiac Plug7 3.4. LARIAT7 3.5. Other Percutaneous Devices and Surgical Approaches8 4. Care Team and Facilities8 4.1. Multidisciplinary Heart Team8 4.2. General Requirements9 4.3. Facilities9 5. Operator Training10 6. Protocols for Care10 7. Assessment of Patient Selection and Outcomes10 Appendix 1. Rele...
28 CitationsSource
Examination of the FDA's review of the Watchman Left Atrial Appendage Closure System clarifies differences in device regulation between the United States and the European Union and highlights the urgency of monitoring devices in a coordinated and rigorous manner.
4 CitationsSource
Cited By1
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Last. Eduardo de Marchena (UM: University of Miami)H-Index: 26
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ABSTRACT Background Select patients with atrial fibrillation and contraindication to anticoagulation may benefit from percutaneous left atrial appendage closure (pLAAC). Objective We sought to evaluate racial disparities in the nationwide utilization and outcomes of pLAAC. Methods We identified 16,830 hospitalizations for pLAAC between 2015-2017 using the National Inpatient Sample. Baseline characteristics, in-hospital mortality, complications, length of stay and discharge disposition were asses...
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