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CLINICAL STATEMENTS AND GUIDELINES

Circulation. 2024;149:e1–e156. DOI: 10.1161/CIR.0000000000001193 January 2, 2024 e43

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

surgery or major endovascular intervention).7 Registry data have shown substantial variation in postprocedure antithrombotic regimens in realworld practice compared with protocols in the pivotal RCTs; the effect this has on long-term outcomes has not been clearly established.8 ASAP- TOO (Assessment of the Watchman Device in Patients Unsuitable for Oral Anticoagulation) is an ongoing RCT evaluating the safety and efficacy of LAAO in patients with AF who are deemed ineligible for oral anticoagulation.9

2 PROTECT AF (Watchman Left Atrial Appendage

System for Embolic Protection in Patients With Atrial Fibrillation) was a noninferiority RCT comparing pLAAO with the Watchman device with warfarin in patients with AF at an increased risk for stroke. pLAAO was noninferior to warfarin for both primary composite efficacy (stroke, systemic embolism, and cardiovascular/unexplained death) and safety (procedure-related events and major bleeding) endpoints.1 pLAAO was superior to warfarin in terms of cardiovascular mortality (HR, 0.40, 95% CI, 0.21-0.75; P=0.005) and allcause mortality (HR, 0.66, 95% CI, 0.45-0.98; P=0.004). The PREVAIL (Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) study was a follow-up RCT that compared the Watchman device with warfarin in a similar patient population.2 pLAAO did not achieve noninferiority for the first primary composite efficacy endpoint (stroke, systemic embolism, and cardiovascular/unexplained death) but was limited in statistical power because of unexpectedly low event rates. pLAAO was statistically noninferior to warfarin for nonprocedure-related strokes. Higher implant success and lower procedure-related safety event rates were observed in PREVAIL than PROTECT AF. A 5-year patient-level meta-analysis of these trials demonstrated similar efficacy of pLAAO for stroke prevention and reduced rates of major bleeding compared with warfarin.3 PRAGUE-17 (Left Atrial Appendage Closure vs Novel Anticoagulation Agents in Atrial Fibrillation) was an RCT that compared pLAAO with DOACs in patients with nonvalvular AF.4 pLAAO was noninferior to DOACs for the combined safety and efficacy composite endpoint (stroke, TIA, systemic embolism, cardiovascular death, major or nonmajor clinically relevant bleeding, or procedure-/device-related complications).

6.5.2 Cardiac Surgery—LAA Exclusion/Excision

Recommendations for Cardiac Surgery—LAA Exclusion/Excision Referenced studies that support the recommendations are summarized in the Online Data Supplement. COR LOE Recommendations

1 A 1 In patients with AF undergoing cardiac surgery with

a CHA2DS2-VASc score ≥2 or equivalent stroke risk, surgical LAA exclusion, in addition to continued anticoagulation, is indicated to reduce the risk of stroke and systemic embolism.1–3

1 A 2 In patients with AF undergoing cardiac surgery and

LAA exclusion, a surgical technique resulting in absence of flow across the suture line and a stump of <1 cm as determined by intraoperative transesophageal echocardiography should be used.1,4,5

2b A 3 In patients with AF undergoing cardiac surgery

with CHA2DS2-VASc score ≥2 or equivalent stroke risk, the benefit of surgical LAA exclusion in the absence of continued anticoagulation to reduce the risk of stroke and systemic embolism is uncertain.1–3

Synopsis Surgical left atrial appendage occlusion (S-LAAO) for reduction in the risk of recurrent arterial thromboemboli was first reported in 1949.6 After decades of relative clinical equipoise,7,8 accumulating evidence,2,8–10 culminating in the large RCT LAAOS III (Left Atrial Appendage Occlusion Study),1 supports a benefit of S-LAAO in patients with AF who undergo2,9 coronary artery bypass graft surgery (CABG) or valve surgeries. A 2019 meta-analysis before the publication of LAAOS III reviewed 22 studies, including 280 585 patients of whom 36 686 underwent S-LAAO during cardiac surgery. S- LAAO showed an association with a 29% lower risk of stroke or thromboembolism. The all-cause mortality rate at 2 years was lower in patients who underwent S- LAAO. No benefit was found in the subgroup of studies that included patients without preoperative AF.9 These favorable findings were validated by the 4770-subject LAAOS III, which confirmed S-LAAO in addition to OAC provides a 33% reduction in risk of stroke and systemic embolism.1 LAAOS III enrolled only patients with preexisting AF; evidence of the effectiveness of S-LAAO in patients without AF is inconsistent and suggests the benefit of

Table 14.  Situations in Which Long-Term Anticoagulation Is Contraindicated and Situations When It Remains Reasonable Long-Term Anticoagulation Contraindicated Long-Term Anticoagulation Is Still Reasonable Severe bleeding due to a nonreversible cause involving the gastrointestinal, pulmonary, or genitourinary systems Spontaneous intracranial/ intraspinal bleeding due to a nonreversible cause Serious bleeding related to recurrent falls when cause of falls is not felt to be treatable Bleeding involving the gastrointestinal, pulmonary, or genitourinary systems that is treatable

Bleeding related to isolated trauma Bleeding related to procedural complications

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