Abstract 14157: Racial Differences in Outcomes of Ischemic Stroke and Mortality With Left Atrial Appendage Closure With Watchman Device in Medicare Population

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rajesh Kabra ◽  
Saket Girotra ◽  
Mary S Vaughan Sarrazin

Introduction: Left atrial appendage closure by Watchman implantation is a novel non-pharmacological alternative for stroke prevention in non-valvular atrial fibrillation (AF) patients who are deemed unable to take long term anticoagulation. Blacks and Hispanics were under-represented in the clinical trials for Watchman device and therefore more outcome data is needed in these populations. Hypothesis: We sought to study racial differences in outcomes of mortality and ischemic stroke in Medicare beneficiaries who received a Watchman device Methods: Medicare claims were used to identify 13,598 patients with AF who underwent Watchman implantation during January 2015 to November 2017. Patient demographics including race and comorbid conditions were identified based on the hospital discharge record. Death and readmission rate for ischemic strokes and transient ischemic attacks (TIA’s) were assessed. Primary readmission diagnoses were classified using the AHRQ Clinical Classification Software. Results: The mean age of patients was 78±6.3 years and 40.3% were female. There were 11,955 whites (88%), 453 blacks (3.3%) and 523 Hispanic patients (3.8%). Mean CHAD 2 S 2 VASc score was 4.7 in blacks, 4.6 in Hispanics and 4.5 in whites. One year mortality after watchman implantation was 6.8% in blacks, 8% in Hispanics and 7.69% in whites. After risk adjustment, compared to whites, the Hazard Ratio for death was 0.82 in blacks (p=0.31) and 0.96 in Hispanics (p=0.82). The rate of ischemic stroke and TIA following Watchman implantation was highest at 4.75 per 100 patient years in blacks followed by 2.87 per 100 patient years in Hispanics and 2.37 per 100 patient years in whites. After risk adjustment, blacks continued to have higher risk for ischemic stroke (HR 1.87, p = 0.01) compared to whites, while Hispanics had a similar risk (HR 1.19, p=0.51). Conclusions: In the Medicare population undergoing Watchman implantation, after risk adjustment, one year mortality following the procedure was similar in whites, Hispanics and blacks. However, the rate of ischemic stroke was significantly higher in blacks compared to whites even after risk adjustment. Further studies are needed in the real world to monitor the outcomes associated with watchman device in minority population.

2021 ◽  
Vol 77 (18) ◽  
pp. 955
Author(s):  
Lauren Sharan Ranard ◽  
Elena Donald ◽  
Shmuel Chen ◽  
Omar Khalique ◽  
Nadira Hamid ◽  
...  

2015 ◽  
Vol 11 (4) ◽  
pp. 334-340 ◽  
Author(s):  
Abhilash Akinapelli ◽  
Ojas Bansal ◽  
Jack P. Chen ◽  
Alex Pflugfelder ◽  
Nicole Gordon ◽  
...  

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Rakesh Gopinathannair ◽  
Scott M Koerber ◽  
Krishna Akella ◽  
Dhanunjaya Lakkireddy

Background: The Amulet IDE trial is an ongoing, randomized, worldwide trial, enrolled but following patients with non-valvular atrial fibrillation (AF) at high risk of stroke. The study is comparing the safety and effectiveness of the Amplatzer™ Amulet™ left atrial appendage (LAA) Occluder to the Watchman device. At US sites, the implanting physicians only had experience with the Watchman device; therefore, up to three roll-in subjects with Amplatzer Amulet device implantation were permitted prior to randomization. The purpose of this analysis is to describe the peri-procedural outcomes for the roll-in cohort. Methods: Roll-in subjects met the same eligibility criteria and have the same data collection requirements as randomized subjects. Adverse events were adjudicated by an independent clinical events committee and LAA occlusion was assessed by an independent core laboratory based on the 45-day TEE. Major adverse events included all cause death, ischemic stroke, systemic embolism or device-/procedure-related events requiring open cardiac surgery or major endovascular intervention within 7 days post implant or hospital discharge, whichever is later. Results: From August 2016 to November 2018, 201 patients with non-valvular AF at high risk of stroke and bleeding were enrolled at 82 sites as roll-in subjects. Mean age was 74.2 ± 7.5 years and 62% of subjects were male. The Amplatzer Amulet device was successfully deployed in 99% of subjects. Major adverse events within 7 days or hospital discharge occurred in 2.5% of patients and included death (n=3), ischemic stroke (n=1) and vascular access site bleeding (n=1). The majority (79%) of patients were discharged on antiplatelet therapy only or no anti-thrombotic medication. TEE follow-up at the 45-day visit revealed adequate (≤ 5 mm jet) occlusion of the appendage in 98.9% (178/180) of patients. Device-related thrombus (DRT) was identified by the core laboratory in 6 patients (3%); no patient experienced a thrombo-embolic event. Conclusions: In the roll-in cohort, with implanting physicians having no prior experience using the Amplatzer™ Amulet™ device, there was a low rate of procedural complications and high rates of both implant success and adequate LAA sealing at follow up.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Maarse ◽  
L Wintgens ◽  
E Aarnink ◽  
M Huijboom ◽  
B Abeln ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): This work was supported by an unrestricted grant from Boston Scientific. Boston Scientific was not involved in the design/conduct of the study, data collection/analysis and interpretation of the data and preparation of the manuscript. Background Percutaneous left atrial appendage occlusion is an emerging alternative to anticoagulation in the prevention for stroke in patients with atrial fibrillation, especially in patients with a contra-indication for oral anticoagulation therapy. Long-term results on the efficacy and safety of this treatment remain scarce. Methods In this single-center prospective registry, data of all consecutive patients that underwent percutaneous left atrial appendage closure between 2009 and 2019 were collected. Patients with successful left atrial appendage closure (peri-device leakage ≤5mm) and at least one year of follow-up data were analyzed. The occurrence of thrombo-embolic events (ischemic stroke, TIA and systemic embolism), major bleeding events (BARC >2) and anticoagulation use during long-term follow-up were evaluated. Results A total of 192 patients after left atrial appendage occlusion were included (61 % male, age 69.0 ± 8.4 years, CHA2DS2-VASc 4.0[3.0-5.0], HAS-BLED 3.0[2.0-3.25]) with a mean follow-up duration of 5.7 ± 2.8 years (in total 1087 patient-years). During follow-up 36 patients (19%) died. 49 thrombo-embolic complications were observed in 38 patients. The ischemic stroke rate was 1.9 events per 100 patient-years, accounting for a 70% reduction compared to CHA2DS2-VASc predicted rate. Device-related thrombus (DRT) occurred in 5 patients (2.6%), 3 were observed during routine follow-up and were not associated with thrombo-embolic complications. The other 2 DRT were observed in patients presenting with ischemic stroke more than 3 years after device implantation. Furthermore, 38 non-procedural major bleeding complications occurred in 19 patients, resulting in 3.5 events per 100-patients years, accounting for a reduction of 43% compared to estimated bleeding rates under OAC use. At the end of the study 71% of all patients were on single antiplatelet or no antiplatelet/anticoagulation treatment at all. Conclusions During long-term follow-up thrombo-embolic event rates and non-procedural major bleeding rates were consistently low (ischemic stroke rate reduction 70% and non-procedural major bleeding rate reduction 40% compared to predicted rates). These results confirm the efficacy of left atrial appendage occlusion. Abstract Figure. Ischemic stroke rates


EP Europace ◽  
2016 ◽  
Vol 18 (7) ◽  
pp. 979-986 ◽  
Author(s):  
Vivek Y. Reddy ◽  
Ronald L. Akehurst ◽  
Shannon O. Armstrong ◽  
Stacey L. Amorosi ◽  
Nic Brereton ◽  
...  

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