A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation

Josef Kautzner; Jean-Paul Albenque; Andrea Natale; William Maddox; Frank Cuoco; Petr Neuzil; Herve Poty; Michael K Getman; Shufeng Liu; Zdenek Starek; Srinivas R Dukkipati; B Judson Colley 3rd; Amin Al-Ahmad; Darren S Sidney; H Thomas McElderry

doi:10.1016/j.jacep.2020.11.009

A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation

JACC Clin Electrophysiol. 2021 Mar;7(3):352-363. doi: 10.1016/j.jacep.2020.11.009. Epub 2021 Jan 27.

Authors

Affiliations

¹ Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
² Clinique Pasteur, Toulouse, France.
³ Texas Cardiac Arrhythmia Institute at St. David's Medical Center, Austin, Texas, USA.
⁴ University of Alabama Birmingham, Birmingham, Alabama, USA.
⁵ Trident Medical Center, Charleston, South Carolina, USA.
⁶ Na Homolce Hospital, Prague, Czech Republic.
⁷ Clinique du Tonkin, Valleurbanne, France.
⁸ Medtronic, Inc., Minneapolis, Minnesota, USA.
⁹ St. Anne's University Hospital, Brno, Czech Republic.
¹⁰ Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹¹ Jackson Heart Clinic, Jackson, Mississippi, USA.
¹² University of Alabama Birmingham, Birmingham, Alabama, USA. Electronic address: tommcelderry@uabmc.edu.

PMID: 33516712
DOI: 10.1016/j.jacep.2020.11.009

Abstract

Objectives: DIAMOND-AF (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation) was a prospective, multicenter, noninferiority, randomized trial that compared the safety and effectiveness of the DTA system versus those of a force-sensing RF ablation system (control) for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF).

Background: Irrigated radiofrequency (RF) ablation catheters lose tissue temperature acuity, which is vital in assessing lesion formation. DiamondTemp Ablation (DTA) was designed to re-establish accurate tissue temperature measurements during ablation.

Methods: A total of 482 patients with paroxysmal AF were randomized (239 DTA, 243 control) to undergo pulmonary vein isolation and were followed up at 23 sites. Patients were screened for disease progression, cardiac characteristics, and prior interventions. Primary endpoints were effectiveness (freedom from atrial arrhythmia recurrence) and safety (composite of procedure- and device-related serious adverse events).

Results: The primary safety event rate was 3.3% in the DTA group versus 6.6% in the control group (p < 0.001 vs. 6.5% noninferiority margin). Primary effectiveness was met in 79.1% of DTA subjects and 75.7% of control subjects (p < 0.001 vs. -12.5% noninferiority margin). Secondary endpoint analysis found that off-drug effectiveness favored DTA compared with the control (142 [59.4%] vs. 120 [49.4%], respectively; p = 0.03). Total RF time and individual RF ablation duration were significantly shorter with less saline infused through the DTA catheter (p < 0.001). Both arms saw clinically meaningful improvements in quality of life at 12 months.

Conclusions: Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation in a paroxysmal AF population. Efficiencies were observed using DTA with shorter total RF times, individual RF ablation durations, and less saline infusion. (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation; NCT03334630).

Keywords: DiamondTemp; atrial fibrillation; catheter ablation; contact force; radiofrequency.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Atrial Fibrillation* / surgery
Catheter Ablation* / adverse effects
Catheters
Humans
Prospective Studies
Quality of Life
Temperature
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03334630