Abstract Background Catheter ablation using radiofrequency (RF) energy, is a well-recognized treatment option for patients with ventricular arrhythmias. However, procedural complications may be high, and efficacy is often suboptimal with high recurrence rates. Purpose The TRAC-VT study evaluated safety and efficacy of the DiamondTemp Ablation (DTA) System for the treatment of patients with ventricular arrhythmias by catheter ablation. Methods A temperature-controlled, irrigated RF catheter (with six thermocouples and an internal network of diamond coatings) was utilized to treat subjects with either sustained monomorphic ventricular tachycardia (VT) and structural heart disease or with frequent monomorphic symptomatic ventricular premature beats (VPBs) and normal hearts. Patients were enrolled at five hospital centers in five European countries and were followed for 6 months. Ablation was performed in temperature-control mode with an irrigation flow of 8 mL/min for all power deliveries. The target temperature was set to 55 or 60 °C with a power output limited to 50 Watts. RF energy was applied for a maximum of 45 seconds per target site, depending on impedance drop and electrogram abatement. Results The study enrolled 49 subjects (age 67±12 years, 80% male) in total (38 with sustained monomorphic VT and structural heart disease and 11 with symptomatic VPBs). In all cases, mapping and navigation was used with EnSite systems (Abbott). The average ablation time (defined as time from the insertion of the DTA catheter until removal from body) was 87 ± 44 minutes. During this time, RF energy was applied for an average of 28.2 ± 10.2 seconds with a power of 44.0 ± 7.0 W and a temperature of 50.9 ± 3.9 °C during 35.0 ± 23.2 applications. Acute procedural success was 100% (93%-100%), and it was defined as the elimination of VPBs or non-inducibility for sustained VT (using solely the DTA catheter). The primary safety procedure-related endpoint was an evaluation of cardiovascular-related death, stroke / TIA, cardiac tamponade/perforation, bleeding complication, myocardial infarction, thromboembolism, and pulmonary edema. In total review of the primary safety endpoint, one subject had a confirmation of a stroke / TIA event. Regarding longer term procedural efficacy, the 6-month follow-up was completed in 92% of subjects. For the whole study population chronic success from recurrence of ventricular arrhythmia (faster than 100 beats/min after 6 months) was 73.4% (58.6%-83.6%) for non-sustained ventricular arrhythmias (≥3 beats) and 87.7% (74.7%-94.3%) for sustained ventricular arrhythmias (≥30 sec). Conclusions VT/VPBs ablation using a temperature-controlled irrigated RF catheter was safe and effective with low VT recurrence at 6 months of follow-up.
Read full abstract