Co-Author(s):
Jean-Paul Albenque, MD, PhD
Andrea Natale, MD
William Maddox, MD
Frank Cuoco, MD
Petr Neuzil, MD, PhD
Herve Poty, MD
Getman Michael, MS
Shufeng Liu, MS
Zdenek Starek, MD, PhD
Srinivas Dukkipati, MD
B. Judson Colley, MD
Amin Al-Ahmad, MD
Darren Sidney, MD
Josef Kautzner, MD, PhD
University of Alabama Birmingham
Cardiology Clinic at The Kirklin Clinic of UAB Hospital 2000 6th Avenue South, Floor 4 Birmingham, AL 35233
Introduction | Objectives:Background: Radiofrequency (RF) catheter ablation has been a mainstay for the treatment of patients with atrial fibrillation (AF).  Because of the prevalence of AF and desire for treatment improvement, new technologies are introduced regularly.  The learning curve for these new advancements and its potential impact on outcomes is widely appreciated but seldom reported.  Objective: The DiamondTemp Ablation (DTA) system is a novel diamond tip externally irrigated RF ablation catheter that offers accurate tissue-temperature monitoring with real-time energy modulation.  We sought to examine the learning curve of the temperature-controlled irrigated RF ablation system.
Methods:Methods: We assessed the DTA procedural data from the DIAMOND-AF trial (NCT03334630).  Four time-oriented components of the procedure were evaluated as part of the learning curve assessment: total procedure time, left atrial (LA) dwell time, total RF time, and individual ablation duration.
Results:Results: A total of 235 subjects were treated with the DTA system at 23 sites in Europe, United States, and Canada.  140 subjects were treated within procedures 1-10 at a hospital (Group A) and 95 were treated during procedures 11-30 (Group B).  Total procedure time, LA dwell time, total RF time, and individual ablation duration were all significantly shorter in Group B as compared to Group A (p-values < 0.05).  Group A primary effectiveness success rate was 78% (109 of 140), which did not differ against the 80% (76 of 95) seen in Group B, p=0.75.  Similarly, the primary safety event rates seen between Group A and Group B were not different (3% vs 4%, p=0.72).
Conclusions:Conclusion: Investigators experienced a short learning curve with the DiamondTemp Ablation system with procedural efficiencies realized for the temperature-controlled system after the first 10 cases.  This learning curve on procedure efficiency showed no impact on the safety or effectiveness results during the DIAMOND-AF trial.