Novel Low-Voltage MultiPulse Therapy to Terminate Atrial Fibrillation

• Published in: JACC. Clinical electrophysiology 2021-08, Vol.7 (8), p.988-999
• Main Authors: Ng, Fu Siong, Toman, Ondřej, Petru, Jan, Peichl, Petr, Winkle, Roger A., Reddy, Vivek Y., Neuzil, Petr, Mead, R. Hardwin, Qureshi, Norman A., Whinnett, Zachary I., Bourn, David W., Shelton, M. Brent, Kautzner, Josef, Sharma, Arjun D., Hocini, Meleze, Haïssaguerre, Michel, Peters, Nicholas S., Efimov, Igor R.
• Format: Article
• Language: English
• Subjects: atrial fibrillation; cardioversion; defibrillation; MultiPulse Therapy
• ISSN: 2405-500X; 2405-5018
• DOI: 10.1016/j.jacep.2020.12.014

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. 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. 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 of varied amplitude, duration, and interpulse timing, was delivered via temporary intracardiac leads. MPT parameters and delivery methods were iteratively optimized. 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% of AF terminations occurred within 2 seconds of MPT delivery (p