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CLINICAL STATEMENTS AND GUIDELINES

January 2, 2024 Circulation. 2024;149:e1–e156. DOI: 10.1161/CIR.0000000000001193 e42

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

were not associated with stroke or systemic embolism compared with patients without AHREs.1 The CHA2DS2-VASc score of this subpopulation was 2.2±1.0 (mean±SD). In the aforementioned study linking administrative claims data to a device database in which continuous rhythm monitoring data were available, the risk of stroke and systemic embolism off anticoagulation exceeded 1% among patients with a sex-modified CHA2DS2-VASc score of 3 to 4 and exceeded 2% among patients with a sex-modified CHA2DS2-VASc score ≥5.2

3 Brief episodes of subclinical AF are at low risk of clin-

ical events. In RATE (Registry of Atrial Tachycardia and Atrial Fibrillation), patients with clinical events such as hospitalization, death, or stroke were more likely than those without to have AHREs with either onset or offset of an adjudicated, single ECG (31.9% versus 22.1% among patients with pacemakers and 28.7% and 20.2% among patients with implantable cardioverter-defibrillators [ICDs]).4 AHREs >5 minutes are highly correlated with AF and AFL, whereas shorter episodes often represent other tachyarrhythmias.9 To remove most episodes of oversensing, AHREs lasting ≤5 minutes were excluded from analysis of MOST (Mode Selection Trial).10 A similar threshold was used in several subsequent key studies to exclude spurious events.1,3,5,11,12

6.5 Nonpharmacological Stroke Prevention

Although oral anticoagulation is the standard of care to reduce the risk of ischemic stroke in patients with AF, it is contraindicated in some patients due to an excess risk of major bleeding. Surgical and percutaneous techniques to occlude the LAA have been developed to reduce the risk of ischemic stroke. These techniques have the potential to obviate the need for or supplement long-term oral anticoagulation in select patients. Surgical LAAO is a particularly important consideration in patients with AF who undergo cardiac surgery.

6.5.1 Percutaneous Approaches to Occlude the LAA

Recommendations for Percutaneous Approaches to Occlude the LAA Referenced studies that support the recommendations are summarized in the Online Data Supplement. COR LOE Recommendations

2a B-NR 1 In patients with AF, a moderate to high risk of stroke

(CHA2DS2-VASc score ≥2), and a contraindication (Table 14) to long-term oral anticoagulation due to a nonreversible cause, percutaneous LAAO (pLAAO) is reasonable.1–4

2b B-R 2 In patients with AF and a moderate to high risk of

stroke and a high risk of major bleeding on oral anticoagulation, pLAAO may be a reasonable alternative to oral anticoagulation based on patient preference, with careful consideration of procedural risk and with the understanding that the evidence for oral anticoagulation is more extensive.1–3,5,6 Synopsis A large body of evidence supports the use of OACs to reduce the risk of ischemic stroke in patients with AF; however, OACs may be contraindicated in some patients (Table 14). pLAAO devices are designed to prevent embolization of LAA thrombi and potentially obviate the need for OAC for stroke risk reduction. RCTs have demonstrated pLAAO to be noninferior to warfarin and DOACs for stroke and systemic embolism with a reduced risk of major bleeding.1–4 A prospective nonrandomized study has shown that patients deemed unsuitable for OAC who undergo pLAAO implant have a lower-than-expected risk of ischemic stroke.5 Prospective registries of pLAAO device implant in patients who are not on long-term OAC have shown a high rate of procedural success, a low risk of major procedure-related complications, and a low rate of ischemic stroke in follow-up.6,7 Based on these findings, pLAAO is reasonable in patients with nonvalvular AF who have a contraindication to long-term OAC due to a nonreversible cause. Additionally, pLAAO may be reasonable as an alternative to OAC based on patient preference after careful consideration of procedural risk and with the understanding that there is a much greater body of evidence supporting OAC in this population in general.

Recommendation-Specific Supportive Text 1.	 pLAAO has been evaluated in patients with AF

and a contraindication to OAC. The ASAP (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology) study was a nonrandomized trial evaluating the performance of the Watchman device in 150 patients with AF who were deemed ineligible for OAC with warfarin.5 The rate of ischemic stroke was lower in patients who received the Watchman device than would be expected based on the CHADS2 scores of the cohort (2.3% versus 7.3%). The EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) prospective registry showed a high rate of Watchman device procedural success (98.5%) with a low ischemic stroke risk (1.1%). This low ischemic stroke was demonstrated despite most of the patients (73%) not using oral anticoagulation periprocedurally.6 The PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) prospective registry of the next-generation Watchman FLX device showed a high rate of procedural success (98.8%) and a low rate (0.5%) of the primary safety endpoint (death, ischemic stroke, systemic embolism, procedure-related events requiring open cardiac

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