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

Abstract

Objective: 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. Methods: The study was a National Institutes of HealthYfunded 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. Results: 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.

Thoracoscopic Left Atrial Appendage Exclusion for Atrial Fibrillation Patients Intolerant to Anticoagulation

“…In a proof-of-concept randomized trial, 0 of 12 patients randomized to thoracoscopic pulmonary vein isolation and atrial appendage ligation (TPVIAL) had recurrent stroke at 12-month follow-up, while 3 of 12 patients randomized to anticoagulation alone had recurrent stroke at 12 months ( P = 0.09). 17 Quality of life metrics also revealed improvements in energy and decreases in fatigue in the group undergoing TPVIAL. While these important findings suggest the potential for isolated LAA exclusion along with epicardial AF ablation to reduce secondary stroke risk in patients with prior AF-related stroke, the individual contributions of pulmonary vein ablation versus LAA ligation alone remain unclear.…”

Pilot Investigation: Older Adults With Atrial Fibrillation Demonstrate Greater Brain Leukoaraiosis in Infracortical and Deep Regions Relative to Non-Atrial Fibrillation Peers

“…To be eligible for the surgical procedure additional exclusion criteria for the AF group included: age <18 or >80, presence of a left atrial appendage thrombus on CT or echocardiography, stroke fewer than 30 days prior to screening, ejection fraction <25%, previous thoracic surgery or empyema, left atrial diameter more than 55 mm, contraindication to anticoagulation with warfarin, mitral valve insufficiency (>2+) that would require open surgery, or prior cardiac surgery. The surgical subsample of the participants with atrial fibrillation are reported in a previous publication (Beaver et al, 2016).…”

“…A board certified neuroradiologist (IL) with extensive stroke rating experience (Price et al, 2012(Price et al, , 2014(Price et al, , 2015Beaver et al, 2016) completed all stroke and lacunae measurements while blinded to group and any identifying medical or personal information. Ischemic strokes were measured on T1 and T2 sequences with volume calculated via the diameter approach in two-dimensions (Liem et al, 2007).…”