Minority of US Patients Discharged Following LAAO Receive FDA-Approved Perprotocol Care

Practitioners in the United States (US) rarely follow all US Food and Drug Administration (FDA)-approved postprocedural treatment recommendations for patients that receive left atrial appendage occlusion (LAAO). These findings were published in the Journal of the American College of Cardiology.

Data from the National Cardiovascular Data Registry were analyzed for this study. Patients who received LAAO with a Watchman device between 2016 and 2018 were evaluated for the postprocedural treatment protocol used. Patients were determined to have received perprotocol treatment if they met all US FDA criteria including the following:

• Discharge on daily warfarin and aspirin
• First follow-up at 45±14 days postprocedure with transesophageal echocardiography
• Discontinuation of warfarin if residual leak is 0 to 5 mm with no atrial thrombus detected at follow-up
• Continuation of warfarin if residual leak is 5 mm or lager or atrial thrombus is disclosed on transesophageal echocardiography
• Use of clopidogrel and aspirin or warfarin and aspirin until the second follow-up
• Second follow-up at 6 months (-30/+60 days) postprocedure

The study cohort comprised 31,994 patients aged mean 76 years, 41% were women.

Only 12.2% of patients received FDA-approved perprotocol postprocedural care.

Patients were discharged with warfarin and aspirin (36.92%), direct oral anticoagulant (DOAC) and aspirin (20.78%), warfarin only (13.53%), DOAC only (12.34%), dual antiplatelet therapy (DAPT) with aspirin and a P2Y₁₂ inhibitor (5.04%), or other (11.38%).

The median follow-up time for the first follow-up was 47 days and second follow-up was 183 days.

Stratified by discharge regimen, 5.72% of warfarin and aspirin, 5.56% of DAPT, 5.27% of DOAC and aspirin, 4.01% of warfarin only, and 3.83% of DOAC only recipients had an adverse event from discharge to day 45±14 (P <.0001).

Compared with warfarin and aspirin, warfarin alone was associated with decreased risk for any adverse event (adjusted hazard ratio [aHR], 0.692; 95% CI, 0.569-0.841; P <.001) and any major adverse event (aHR, 0.658; 95% CI, 0.536-0.808; P <.001) but increased risk for any readmission (aHR, 1.405; 95% CI, 1.167-1.692; P <.001). Similarly, DOAC was associated with decreased risk for any adverse event (aHR, 0.731; P =.011) and any major adverse event (aHR, 0.767; P =.038) but increased risk for any readmission (aHR, 1.275; P =.046).

From discharge through 6 months, 10.27% of warfarin and aspirin, 9.14% of DAPT, 9.07% of DOAC and aspirin, 8.54% of warfarin only, and 8.29% of DOAC only recipients had an adverse event (P =.0006). From discharge to 6 months, warfarin alone was associated with decreased risk for any adverse event (aHR, 0.814; 95% CI, 0.712-0.931; P =.003) and any major adverse event (aHR, 0.840; 95% CI, 0.737-0.958; P =.010).

This study may have included missing or miscoded information as it was based on registry data.

“Our study showed that in real-world contemporary practice, strict adherence to the full FDA-approved postprocedure protocols studied in the pivotal trials…was rare, and the most common deviations were discharges on unstudied antithrombotic regimens,” the study authors wrote. “As LAAO devices iterate and new devices are approved, ongoing study of postprocedure antithrombotic therapy will be vital to optimize patient outcomes.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Freeman JV, Higgins AY, Wang Y, et al. Antithrombotic therapy after left atrial appendage occlusion in patients with atrial fibrillation. J Am Coll Cardiol. Published online May 2, 2022. doi:10.1016/j.jacc.2022.02.047