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.