Co-Author(s):
Jean-Paul Albenque, MD, PhD
Andrea Natale, MD
William Maddox, MD
Frank Cuoco, MD
Petr Neuzil, MD, PhD
Herve Poty, MD
Michael Getman, 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: Cardiac ablation via radiofrequency (RF) energy has become the prominent method of treatment for patients with atrial fibrillation (AF).  DiamondTemp Ablation (DTA) is a novel open irrigated temperature-controlled diamond tip RF ablation system which is designed to accurately assess tip-tissue temperatures and modulate power to maintain a target temperature during ablation.  Presently, data are limited on patient and procedural characteristics associated with efficacy following pulmonary vein isolation with DTA.
Methods:Methods: We retrospectively analyzed the baseline characteristics and procedural data of the DTA arm from the DIAMOND-AF trial (NCT03334630).  Univariate and multivariate Cox regression models were used to identify predictors of effectiveness failures.
Results:Results: 239 paroxysmal AF subjects were enrolled in the DTA arm (age 62±11 years, 56.9% male, left atrial diameter 4.0±0.6 cm).  12-month freedom from AF was experienced by 79.1% of the DTA subjects.  Univariate statistical testing of baseline patient characteristics revealed that duration of AF (HR, 1.05; 95% CI, 1.00-1.10; p=0.042) and vascular disease (HR, 3.55; 95% CI, 1.51-8.35; p=0.004) were predictors of atrial arrhythmia recurrence.  By multivariate analysis, vascular disease was the only independent baseline characteristic predictor of recurrence.  Regarding procedural characteristics, univariate testing revealed that a lower average temperature (HR, 1.12; 95% CI, 1.03-1.23; p=0.009), use of conscious sedation (HR, 1.85; 95% CI, 1.05-3.26; p=0.033), and the lack of esophageal temperature monitoring (HR, 2.34; 95% CI, 1.30-4.20; p=0.005) were predictors of atrial arrhythmia recurrence.  By multivariate analysis, lower average temperature and lack of esophageal temperature monitoring were independent procedural characteristic predictors of recurrence.
Conclusions:Conclusion: Primary effectiveness was adversely impacted by the presence of vascular disease.  When assessing the DTA procedural characteristics, effectiveness was negatively associated with lower average temperatures and absence of esophageal temperature monitoring.
AFS 2021-21