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CLINICAL STATEMENTS AND GUIDELINES

January 2, 2024 Circulation. 2024;149:e1–e156. DOI: 10.1161/CIR.0000000000001193 e44

Joglar et al 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation

adjunctive S-LAAO is unclear in patients without preoperative AF.7,9 The results of ongoing RCTs in this population are awaited. Recommendation-Specific Supportive Text 1.	 LAAOS III was performed with 4770 patients with AF and a CHA2DS2-VASc score ≥2 undergoing cardiac surgery randomized to S-LAAO or no S-LAAO. Intraoperative transesophageal echocardiogram (TEE) was recommended to assess successful closure using an endorsed technique. Oral anticoagulation was continued postoperatively. After a mean follow-up of 3.8 years, the primary endpoint of stroke or systemic embolism occurred in 4.8% of the S-LAAO group and 7.0% of the no S-LAAO group (HR, 0.67 [95% CI, 0.53-0.85]; P=0.001). Mortality rate, cross-clamp and bypass time, chest tube output, and bleeding were not different between groups. More than 75% of subjects in both groups received OAC. These data indicate S-LAAO provides additional benefit to oral anticoagulation without increasing risk of adverse events. These findings cannot be extrapolated to

patients without AF or patients who are not candidates for OAC. Most subjects underwent CABG or valve surgery, and the mean CHA2DS2-VASc score was 4.2. Surgical AF ablation was performed in one-third of both groups. Patients undergoing mechanical valve surgery, transplant, off-pump bypass, left ventricular assistive device surgery, and congenital heart disease (CHD) cases were excluded.A subsequent meta-analysis of 5 RCTs and 22 observational studies including 540 111 patients showed a significant decrease in stroke and thromboembolism with S-LAAO.11 The postoperative mortality rate did not differ but, in follow-up, was reduced in the S-LAAO group after 2 years. No difference in major bleeding, all-cause rehospitalizations, or cross-clamp time was observed.11

2 Substantial heterogeneity in S-LAAO methods

exists in the literature, and not all techniques effectively exclude the LAA.4 An increased risk of stroke and thromboembolism is associated with incomplete S-LAAO5,12; however, many studies do not report assessment of occlusion success.9 This inconsistency has likely contributed to the variability in outcome.7,9 LAAOS III permitted 4 techniques: amputation and closure (which was promoted as the preferred technique), used in 56%; stapler closure, used in 11%; doublelayer linear closure (if confirmed by TEE), used in 14%; or an approved LAAO device, used in 15%. Other techniques were approved on a caseby-case basis (4%). Intraoperative TEE was recommended to assess successful closure, defined as absence of flow across the suture line and a stump of <1 cm. If the initial closure was unsuccessful, additional suturing was performed for repair. Contemporary data show closure success of >95% using a surgical clip device.13 In the LAAOS series, the mean cross-clamp and bypass times were similar, and perioperative bleeding was not increased in the S-LAAO group.1,4 These data support the importance of complete S-LAAO in achieving beneficial outcomes. 3.	 In LAAOS III, S-LAAO reduced stroke and throm-

boembolism by 33% in addition to OAC. LAAOS III was not designed to resolve whether oral anticoagulation can be safely stopped after S-LAAO; at hospital discharge, >80% of subjects in both groups were receiving OAC, with >75% on OAC at the 3-year visit.1 A systematic review and metaanalysis focusing on the effects of anticoagulation found no statistically significant difference in stroke rates of S-LAAO/no S-LAAO subjects on OAC versus off OAC, with high heterogeneity noted for both ischemic events and mortality,14 and findings are subject to confounding by indication and the potentially beneficial effects of surgical AF ablation. The LAACS (Left Atrial Appendage Closure with Surgery) study of 187 subjects undergoing CABG, valve surgery, or both who were randomized to S-LAAO versus no S-LAAO showed a reduction in the risk of stroke in the S-LAAO group, independent of anticoagulation status.15 These results must be interpreted with caution, however, because the study was not powered to demonstrate a reduction in stroke, and substantial crossover occurred.

6.6 Active Bleeding on Anticoagulant Therapy

and Reversal Drugs Recommendations for Active Bleeding on Anticoagulant Therapy and Reversal Drugs Referenced studies that support the recommendations are summarized in the Online Data Supplement. COR LOE Recommendations

1 B-NR 1 In patients with AF receiving dabigatran who

develop life-threatening bleeding, treatment with idarucizumab is recommended to rapidly reverse dabigatran’s anticoagulation effect.1–3

2a C-LD 2 In patients with AF receiving dabigatran who develop

life-threatening bleeding, treatment with activated prothrombin complex concentrate (PCC) is reasonable to reverse dabigatran’s anticoagulation effect if idarucizumab is unavailable.4,5

1 B-NR* 3 In patients with AF receiving factor Xa inhibitors

who develop life-threatening bleeding, treatment with either andexanet alfa (apixaban or rivaroxaban,* edoxaban†) or 4-factor prothrombin complex concentrate† is recommended to rapidly reverse factor Xa inhibitor’s anticoagulation effect.6,7 C-LD†

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