Novel Low-Voltage MultiPulse Therapy to Terminate Atrial Fibrillation

OBJECTIVES This first-in-human feasibility study was undertaken to translate the novel low-voltage MultiPulse Therapy (MPT) (Cardialen, Inc., Minneapolis, Minnesota), which was previously been shown to be effective in preclinical studies in terminating atrial fibrillation (AF), into clinical use. BACKGROUND Current treatment options for AF, the most common arrhythmia in clinical practice, have limited success. Previous attempts at treating AF by using implantable devices have been limited by the painful nature of high voltage shocks.& nbsp; METHODS Forty-two patients undergoing AF ablation were recruited at 6 investigational centers worldwide. Before ablation, electrode catheters were placed in the coronary sinus, right and/or left atrium, for recording and stimulation. After the induction of AF, MPT, which consists of up to a 3-stage sequence of far-and near -field stimulation pulses varied amplitude, duration, and interpulse timing, was delivered via temporary intracardiac leads. MPT parameters delivery methods were iteratively optimized. RESULTS In the 14 patients from the efficacy phase, MPT terminated 37 of 52 (71%) of AF episodes, with the lowest median energy of 0.36 J (interquartile range [IQR]: 0.14 to 1.21 J) and voltage of 42.5 V (IQR: 25 to 75 V). Overall, 38% AF terminations occurred within 2 seconds of MPT delivery (p < 0.0001). Shorter time between AF induction and predicted success of MPT in terminating AF (p < 0.001).& nbsp; & nbsp;CONCLUSIONS MPT effectively terminated AF at voltages and energies known to be well tolerated or painless in some patients. Our results support further studies of the concept of implanted devices for early AF conversion to reduce burden, symptoms, and progression. (J Am Coll Cardiol EP 2021;7:988 & ndash;999) (c) 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).