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. 2022 Apr 11;15(7):741-750.
doi: 10.1016/j.jcin.2022.02.009.

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

Matthew J Price  1 , David Slotwiner  2 , Chengan Du  3 , James V Freeman  4 , Zoltan Turi  5 , Chidambaram Rammohan  6 , Fred M Kusumoto  7 , Clifford Kavinsky  8 , Joseph Akar  4 , Paul D Varosy  9 , Christina Koutras  10 , Jeptha P Curtis  11 , Frederick A Masoudi  12
Affiliations

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

Matthew J Price et al. JACC Cardiovasc Interv. .

Abstract

Objectives: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.

Background: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported.

Methods: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.

Results: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.

Conclusions: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.

Keywords: Watchman; atrial fibrillation; bleeding; left atrial appendage; stroke.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute (grants R56HL142765 and R01HL142765). Dr Price has received consulting honoraria, speaker fees, and proctoring fees from Boston Scientific; has received consulting honoraria from W.L. Gore, Baylis Medical, Philips, Biotronik, Biosense Webster, and Shockwave; has received consulting honoraria and speaker fees from Medtronic; and has equity interest in Indian Wells. Dr Freeman has received salary support from the American College of Cardiology NCDR and the National Heart, Lung, and Blood Institute; and has received consulting and advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster. Dr Rammohan has received consulting fees from Medtronic and Abbott Vascular. Dr Turi has received honoraria from Coherex for serving on the clinical events committee for the WAVECREST 2 (Wavecrest vs. Watchman Transseptal LAA Closure to Reduce AF-Mediated Stroke 2) trial. Dr Varosy has received salary support from the National Heart, Lung, and Blood Institute. Dr Curtis has an institutional contract with the American College of Cardiology for his role as senior scientific adviser of the NCDR; has received salary support from the American College of Cardiology and CMS; and has equity in Medtronic. Dr Masoudi has had an institutional contract with the American College of Cardiology for his role as chief scientific adviser of the NCDR. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.. Study population.
Of 66450 patients included in the NCDR LAAO registry, 36681 were eligible for one-year follow-up and had a Watchman device used during the procedure.
Figure 2.
Figure 2.. Kaplan-Meier survival curves for the endpoints of (A) ischemic stroke, (B) death, (C) any stroke, systemic embolism, or death, and (D) major bleeding
Figure 2.
Figure 2.. Kaplan-Meier survival curves for the endpoints of (A) ischemic stroke, (B) death, (C) any stroke, systemic embolism, or death, and (D) major bleeding
Figure 2.
Figure 2.. Kaplan-Meier survival curves for the endpoints of (A) ischemic stroke, (B) death, (C) any stroke, systemic embolism, or death, and (D) major bleeding
Figure 2.
Figure 2.. Kaplan-Meier survival curves for the endpoints of (A) ischemic stroke, (B) death, (C) any stroke, systemic embolism, or death, and (D) major bleeding
Figure 3
Figure 3. (Central Illustration). Ischemic stroke rates in randomized trials and observational registries of transcatheter LAAO with the Watchman and Amulet devices, shown as a function of baseline CHA2DS2VASc score.
The blue dotted line represents untreated atrial fibrillation patients (23), and the green dotted line represents OAC-treated patients.(24) The ischemic stroke rates and 95% confidence intervals from the device arms of the studies are shown, if available. A_GOS, Amulet Global Observational Registry; A_IDE_A, Amulet arm of the Amulet IDE Study; A_IDE_W, Amulet arm of the Amulet IDE Study; CAP, Continued Access to PROTECT AF registry; CAP2, Continued Access to PREVAIL; CHA2DS2-VASc, congestive heart failure, hypertension, 75 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female; EWOLUTION, Registry on Watchman Outcomes in Real-Life Utilization; PREVAIL, Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients with Atrial Fibrillation; PROTECT-AF, Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation.
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References

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