@article{126c42dd5c96464c9dfa8e8cb220f422,
title = "Low-Voltage MultiPulse Therapy: Novel, Nonpharmacological, and Nonablation Method to Terminate Atrial Fibrillation",
keywords = "MultiPulse Therapy, atrial fibrillation, cardioversion, defibrillation, implantable cardiac devices",
author = "Kantharia, \{Bharat K.\}",
note = "Funding Information: As with any initial in-human feasibility studies, the scientific merit and limitations of the current index study need to be assessed carefully. It is a single arm, unblinded study with no predefined statistical endpoints. The study cohort is small and comprised relatively healthier patients who had “paroxysmal” AF and in whom AF had to be induced to assess MPT. Patients with New York Heart Association functional class III to IV HF, and ejection fraction <40\%, who are more likely to have ICDs or cardiac resynchronization therapy with defibrillator devices were excluded. Hence, the study results cannot be extrapolated to this group, and the study would need to be repeated to determine safety and efficacy of MPT in patients with “persistent” AF in whom significant atrial remodeling is expected to have occurred. The small sample size of the study is also not adequate for evaluating possible effects of AADs on the safety and efficacy of MPT. Concerns that need to be evaluated with more scrutiny include: 1) risk of developing VF with MPT in patients with rapid ventricular rate; 2) a proarrhythmic (induction of AF) effect of MPT; 3) potential occurrence of device-device interaction, leading to triggering therapies for VT and VF due to an oversensing of MPT event in the CS and atria; 4) safety and effectiveness of MPT in events when the leads get dislodged; 5) battery longevity; 6) extraction of larger and wider coils in the event of malfunction and infection; and 7) pain tolerance—certainly receiving painful shocks for non–life-threatening arrhythmia would be difficult and unacceptable for many patients. During the course of the study, methodology and consistency was not maintained with regard to the MPT parameters and vectors, locations of the leads and catheters, or the time from induction of AF to therapy onset. Approximately 7\% of electrogram traces of MPT deliveries were not recorded on the recording system. Additionally, the study was supported by a research grant from the manufacturer of MPT technology, requiring paramount transparency in individual conflict(s) of interest of the authors prior to the agencies{\textquoteright} approval of this technology. ",
year = "2021",
month = aug,
doi = "10.1016/j.jacep.2021.01.012",
language = "English",
volume = "7",
pages = "1000--1002",
journal = "JACC: Clinical Electrophysiology",
issn = "2405-500X",
publisher = "Elsevier Inc.",
number = "8",
}