Thoracoscopic Ablation with Appendage Ligation versus Medical Therapy for Stroke Prevention a Proof-of-Concept Randomized Trial

Abstract

<jats:sec><jats:title>Objective</jats:title><jats:p> Atrial fibrillation (AF) has a demonstrable effect on quality of life (QOL). Recurrent stroke occurs in 10% of patients with AF. The objective of this study was to demonstrate proof of concept that thoracoscopic pulmonary vein isolation and atrial appendage ligation (TPVIAL) could prevent recurrent stroke and could potentially improve QOL in patients with AF with a previous stroke. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> The study was a National Institutes of Health-funded single-center proof-of-concept design that randomized 23 patients with AF-related stroke to TPVIAL (n = 12) or to medical management (n = 11). Quality of life was the primary outcome variable; secondary end points included restoration of rhythm, recurrent stroke, and surgical morbidity. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Quality-of-life subscores at 3 and 6 months revealed improvements in energy and decreases in fatigue in the TPVIAL arm [baseline, 33 (19.8); 3 months, 49.5 (20.6), P = 0.01; 6 months, 55.5 (14.4), P = 0.03]. At 12-month follow-up, there were no recurrent strokes in the TPVIAL group. In the medically treated arm, two patients at 6 months (P = 0.22) and three total patients at 12 months (P = 0.09) had recurrent ischemic stroke. There was one death in the medical management arm. In the TPVIAL arm, no AF recurrence occurred in patients with paroxysmal AF, and one patient had recurrence of persistent and long-standing AF. Seven patients in the TPVIAL arm discontinued warfarin therapy for secondary stroke prevention. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> This small proof-of-concept study showed that TPVIAL improved QOL on two subscores and restored normal sinus rhythm in all but one patient, and it showed the potential to prevent secondary stroke. A larger study will be needed. </jats:p></jats:sec>

The effects of rhythm control strategies versus rate control strategies for atrial fibrillation and atrial flutter: A systematic review with meta-analysis and Trial Sequential Analysis

“…We have summarized the inclusion- and exclusion criteria for each included trial in S2 Table and other trial characteristics in S3 Table . Additionally, we have summarized the characteristics of excluded studies [ 97 – 102 ] and characteristics of ongoing trials [ 103 – 105 ] in S3 Table .…”

Early and Middle-Term Results and Anticoagulation Strategy after Left Atrial Appendage Exclusion Using an Epicardial Clip Device

“…Successful closure was defined as the absence of a residual stump (<1 cm) and no persistent flow into the LAA. 1,2) An early postoperative computed tomography (CT) scan was evaluated by experienced radiologists to assess the clip's stability and thrombus at the LAA stump. All patients except those with severe renal dysfunction underwent a repeat CT scan after approximately three months.…”

“…1) In addition, it has been reported that patients with remnant flow into the LAA after closure have a greater likelihood of thrombosis in the left atrium. 2) Thus, these surgical procedures are not feasible options for stroke prevention in patients with AF.…”

“…Atrial fibrillation (AF) is a well-known risk factor for disabling stroke; patients with AF are five to six times more likely to have a stroke than patients with normal sinus rhythm. 1,2) A previous report estimated that 20% to 30% of strokes can be attributed to embolic events that develop as a result of AF. 1) In addition, there is evidence that up to 90% of embolic strokes occurring in AF patients originate from the left atrial appendage (LAA).…”

“…Moreover, several major studies have reported that, even in those who receive optimal anticoagulation, patients with AF with previous stroke have an 8% to 10% risk of recurrence. 2) For these reasons, a new therapeutic strategy, targeting the LAA (including resection or exclusion) for stroke prophylaxis in AF patients as a potential alternative that avoids the use of OAC, 5,6) has been explored recently.…”