A Referral Center Experience with Cerebral Protection Devices: Challenging Cardiac Thrombus in the EP Lab

Abstract

BACKGROUND: Cerebral protection devices (CPD) are designed to prevent cardioembolic stroke and most evidence that exists relates to TAVR procedures. There are missing data on the benefits of CPD in patients that are considered high risk for stroke undergoing cardiac procedures like left atrial appendage (LAA) closure or catheter ablation of ventricular tachycardia (VT) when cardiac thrombus is present. PURPOSE: This work aimed to examine the feasibility and safety of the routine use of CPD in patients with cardiac thrombus undergoing interventions in the electrophysiology (EP) lab of a large referral center. METHODS: The CPD was placed under fluoroscopic guidance in all procedures in the beginning of the intervention. Two different CPDs were used according to the physician’s discretion: (1) a capture device consisting of two filters for the brachiocephalic and left common carotid arteries placed over a 6F sheath from a radial artery; or (2) a deflection device covering all three supra-aortic vessels placed over an 8F femoral sheath. Retrospective periprocedural and safety data were obtained from procedural reports and discharge letters. Long-term safety data were obtained by clinical follow-up in our institution and telephone consultations. RESULTS: We identified 30 consecutive patients in our EP lab who underwent interventions (21 LAA closure, 9 VT ablation) with placement of a CPD due to cardiac thrombus. Mean age was 70 ± 10 years and 73% were male, while mean LVEF was 40 ± 14%. The location of the cardiac thrombus was the LAA in all 21 patients (100%) undergoing LAA-closure, whereas, in the 9 patients undergoing VT ablation, thrombus was present in the LAA in 5 cases (56%), left ventricle (n = 3, 33%) and aortic arch (n = 1, 11%). The capture device was used in 19 out of 30 (63%) and the deflection device in 11 out of 30 cases (37%). There were no periprocedural strokes or transitory ischemic attacks (TIA). CPD-related complications comprised the vascular access and were as follows: two cases of pseudoaneurysm of the femoral artery not requiring surgery (7%), 1 hematoma at the arterial puncture site (3%) and 1 venous thrombosis (3%) resolved by warfarin. At long-term follow-up, 1 TIA and 2 non-cardiovascular deaths occurred, with a mean follow-up time of 660 days. CONCLUSIONS: Placement of a cerebral protection device prior to LAA closure or VT ablation in patients with cardiac thrombus proved feasible, but possible vascular complications needed to be taken into account. A benefit in periprocedural stroke prevention for these interventions seemed plausible but has yet to be proven in larger and randomized trials.