Efficacy of a Novel Bipolar Radiofrequency Clamp: An Acute Porcine Model

Abstract

Objective: Expert consensus guidelines recommend surgical ablation (SA) for patients with symptomatic atrial fibrillation (AF), but less than half of patients with AF undergoing cardiac procedures receive concomitant SA. Complete isolation of the left atrial posterior wall (LAPW) has been shown to be the most critical part of the Cox maze procedure. The purpose of this study was to investigate the performance of a novel radiofrequency (RF) bipolar device, EnCompass™ (AtriCure, Inc., Mason, OH, USA), designed to isolate the LAPW in a single application. Methods: Five adult pigs underwent SA in a beating heart model. After a single ablation, the heart was arrested, explanted, and stained with triphenyl-tetrazolium-chloride for histological assessment. Each lesion was sectioned, and the ablation depth, muscle, and fat thickness were determined. The lesion width, energy delivery, and ablation times were compared with those from a reference RF clamp (Synergy™, AtriCure). Results: Transmurality was documented in 100% of lesions (5 of 5) and cross sections (160 of 160). Electrical isolation was documented in every instance. There was no evidence of clot, charring, or pulmonary vein stenosis. Compared with the reference clamp, the lesions created by the EnCompass™ clamp were 1.5 times wider on average. The average energy delivered was 5 times higher over a duration that was 4.5 times longer due to the increased volume of tissue ablated. Conclusions: The EnCompass™ clamp reproducibly created transmural isolation of the LAPW with a single application. This may allow for simplification of the SA strategy and increased adoption of AF treatment during concomitant surgery.

Influence of concomitant ablation of nonparoxysmal atrial fibrillation during coronary artery bypass grafting on mortality and readmissions

“…Emerging technologies that simplify and potentially reduce the time required to perform SA, such as the EnCompass device from AtriCure, may increase adoption of SA in patients undergoing CABG. 25 …”

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation

“… 1365 Most recently, another bipolar RF ablation device (Isolator Synergy EnCompass Clamp, AtriCure Inc., Mason, OH, USA) has been tested experimentally and has been shown to produce reliable transmurality and isolation of the entire posterior LA wall and all four PVs with a single application in an in-vivo beating heart model. 1366 Further clinical trials will be needed to test its clinical performance.…”

Isolator Synergy EnCompass clamp: surgical notes

“…The EnCompass clamp was uniquely crafted to produce the “Box lesion” with just one application. Utilizing this device could simplify Box lesion creation, eliminate the need for a left atriotomy, and therefore potentially enhance the acceptance of concomitant surgical AF ablation ( 4 ), compared to not performing an ablation at all. The clamp closes in a parallel fashion onto the tissue, exerting consistent pressure along the entire length of its jaws, with increased lesion depth and likelihood of delivering a transmural lesion ( 5 ).…”