The 1-year outcomes among patients who receive commercial transcatheter left atrial appendage occlusion in the US include less than 3% chance of stroke or systemic embolism, with greater than 90% survival rate, according to study findings published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
Atrial fibrillation (AF) can lead to stroke. One way to address stroke prevention in some of these patients is with transcatheter left atrial appendage occlusion (LAAO). Researchers sought to investigate outcomes 1 year after LAAO. Their primary endpoint was ischemic stroke. Secondary endpoints included major bleeding, death, and measuring the rate of stroke or embolism.
To accomplish this, they conducted a retrospective study of patients entered in the National Cardiovascular Data Registry LAAO Registry for a Watchman 2.5 device procedure from January 2016 through December 2018, which included 36,681 patients (76.0±8.1 years of age; 58.9% men; mean CHA2DS2– VASc score 4.8±1.5; mean HAS-BLED score was 3.0±1.1), 25.5% of whom had a previous stroke, 69.5% major bleeding, 37.9% diabetes, and 11.9% intracranial bleeding.
The 1-year survival estimates were calculated using the Kaplan-Meier method which showed the rate of ischemic stroke 1.53% (95% CI, 1.39%-1.69%) and ischemic stroke or systemic embolism 2.19% (95% CI, 2.01%-2.38%); rate of death 8.52% (95% CI, 8.19%-8.87%). The estimate at 1 year for major bleeding was 6.93% (95% CI, 6.65%-7.21%) with the majority of major bleeding after discharge and within 45 days of the procedure.
History of stroke, diabetes, and nonparoxysmal AF were significantly associated with increased risk for ischemic stroke following transcatheter LAAO. They noted that oral anticoagulation (OAC) presents an increased risk for major bleeding, and transcatheter LAAO eliminates the need for long-term OAC, thereby attenuating the long-term bleeding risk.
Study limitations included incomplete follow-up, selection bias, systemic bias, and using Medicare claims data with inherent accuracy issues. Also of significance was the unavailability of medication data, and nonevaluation of Watchman 2.5 device issues.
Researchers noted, “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.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Editor’s Note: The original version of this article included an error where it was reported that the Watchman FLX was evaluated in this study in the third and sixth paragraphs; the correct device was the Watchman 2.5. The article was corrected on May 24, 2022, to reflect this.
Price MJ, Slotwiner D, Du C, et al. Clinical outcomes at 1 year following transcatheter left atrial appendage occlusion in the United States. JACC Cardiovasc Interv. Published online April 11, 2022. doi:10.1016/j.jcin.2022.02.009