Characterizing lesion morphology of a novel diamond-tip temperature-controlled irrigated radiofrequency ablation catheter.

BACKGROUND: The DiamondTemp ablation (DTA) system is a novel temperature-controlled irrigated radiofrequency (RF) ablation system that accurately measures tip-tissue temperatures for real-time power modulation. Lesion morphologies from longer RF durations with the DTA system have not been previously described. We sought to evaluate lesion characteristics of the DTA system when varying the application durations. METHODS: A bench model using porcine myocardium was used to deliver discrete lesions in a simulated clinical environment. The DTA system was power-limited at 50 W with temperature set-points of 50 °C and 60 °C (denoted Group_50 and Group_60). Application durations were randomized with a range of 5-120 s. RESULTS: In total, 280 applications were performed. Steam pops were observed in five applications: two applications at 90 s and three applications at 120 s. Lesion size (depth and maximum width) increased significantly with longer applications, until 60 s for both Group_50 and Group_60 (depth: 4.5 ± 1.2 mm and 5.6 ± 1.3 mm; maximum width: 9.3 ± 2.7mm and 11.2 ± 1.7mm, respectively). As lesions transition from resistive to conductive heating (longer than 10 s), the maximum width progressed in a sub-surface propagation. Using a "Time after Temperature 60 °C" (TaT60) analysis, depths of 2-3 mm occur in 0-5 s and depths plateau at 4.6 ± 0.8 mm between 20 and 30 s. CONCLUSIONS: The DTA system rapidly creates wide lesions with lesion depth increasing over time with application durations up to 60 s. Using a TaT60 approach is a promising ablation guidance that would benefit from further investigation.

Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF.

BACKGROUND: Catheter ablation (CA) technology development reflects the need to improve the effectiveness of atrial fibrillation (AF) treatment. Recently, the DiamondTemp Ablation (DTA) RF generator software was updated with a more responsive power ramp. METHODS: DIAMOND FASTR-AF was a prospective, single-arm, multicenter trial. This study sought to characterize the performance of the updated DTA system for the treatment of patients with drug-refractory paroxysmal and persistent AF (PAF and PsAF). The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence following a 90-day blanking period through 12 months, and the primary safety endpoint was a composite of serious adverse events. RESULTS: In total, 60 subjects (34 PAF and 26 PsAF) underwent CA at three centers. Patients were 71.7% male, (age 63.9 ± 10.2 years, with an AF diagnosis duration 3.1 ± 3.9 years and left atrial size 4.4 ± 0.8 cm). Pulmonary vein isolation-only ablation strategy was performed in 34 (56.7%) subjects. The procedural characteristics show a procedure time 90.8 ± 31.6 min, total RF time 14.7 ± 7.7 min, ablation duration 10.7 ± 3.6 s, and fluid infusion 284.7 ± 111.5 ml. The serious adverse event rate was 8.3% (5/60), 3 pulmonary edema and 2 extended hospitalizations. Freedom from atrial arrhythmia recurrence was achieved in 67.6% of subjects by 12 months. CONCLUSIONS: The updated DTA system demonstrated long-term safety and effectiveness through 12 months of post-ablation follow-up for patients with atrial fibrillation. Additionally, procedures were demonstrated to be highly efficient with short procedure times and low levels of fluid infusion. TRIAL REGISTRATION: Sponsored by Medtronic, Inc.; FASTR-AF ClinicalTrials.gov; NCT03626649.

Assessing the Relationship of Applied Force and Ablation Duration on Lesion Size Using a Diamond Tip Catheter Ablation System.

[Figure: see text].

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

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).

Achieving contrast-free ultra-low radiation exposure without compromising safety and acute efficacy through evolving AF cryoballoon ablation procedure techniques.

INTRODUCTION: In general, early experience with the first-generation cryoballoon introduced an increase in radiation exposure as compared to traditional radiofrequency ablations for atrial fibrillation (AF). However, through operator vigilance and the incorporation of various techniques and technologies, procedural radiation exposure can be managed to an exceptionally low level while maintaining the safety and efficacy of the cryoballoon procedure. METHODS AND RESULTS: A retrospective chart review of all consecutive AF ablation procedures performed by a single operator at a single high-volume center with the second-generation cryoballoon (Arctic Front Advance) was performed between 2014 and 2017. Procedural and radiation exposure data were collected and analyzed year-over-year. 307 cases were reviewed with the majority as index procedures (95%) and patients presenting in paroxysmal AF (87%). The observed median absorbed dose was 2.4 mGy (interquartile range (IQR) = 1.0,6.2) and decreased significantly from 6.7 mGy (IQR = 1.6,6.2) in 2014 to 2.0 mGy (IQR = 1.5,4.5) in 2017 (P < 0.001). Median fluoroscopy time was 0.4 min (IQR = 0.25,0.75) and demonstrated reductions from 0.75 min (IQR = 0.40,1.4) in 2014 to 0.20 min (IQR = 0.10,0.40) in 2017 (P < 0.001). No radiopaque contrast agent was used in any procedure. A complication rate of 2% (6 total events) was observed, and no cases resulted in stroke, death, permanent phrenic nerve injury, or pulmonary vein stenosis. In total, 304 of 307 (99%) procedures resulted in complete isolation of all pulmonary veins. CONCLUSION: Ultra-low radiation doses and contrast-free procedures can be achieved as part of an overall "safety-first" approach during cryoballoon AF ablation without compromising safety or acute efficacy.

Relationship between time-to-isolation and freeze duration: Computational modeling of dosing for Arctic Front Advance and Arctic Front Advance Pro cryoballoons.

BACKGROUND: Preclinical and clinical studies have utilized periprocedural parameters to optimize cryoballoon ablation dosing, including acute time-to-isolation (TTI) of the pulmonary vein, balloon rate of freezing, balloon nadir temperature, and balloon-thawing time. This study sought to predict the Arctic Front Advance (AFA) vs Arctic Front Advance Pro (AFA Pro) ablation durations required for transmural pulmonary vein isolation at varied tissue depths. METHODS: A cardiac-specific, three-dimensional computational model that incorporates structural characteristics, temperature-dependent cellular responses, and thermal-conductive properties was designed to predict the propagation of cold isotherms through tissue. The model assumed complete cryoballoon-to-pulmonary vein (PV) circumferential contact. Using known temperature thresholds of cardiac cellular electrical dormancy (at 23°C) and cellular nonviability (at -20°C), transmural time-to-isolation electrical dormancy (TTIED ) and cellular nonviability (TTINV ) were simulated. RESULTS: For cardiac thickness of 0.5, 1.25, 2.0, 3.0, 4.0, and 5.0 mm, the 23°C isotherm passed transmurally in 33, 38, 46, 62, 80, and 95 seconds during cryoablation utilizing AFA and 33, 38, 46, 63, 80, and 95 seconds with AFA Pro. Using the same cardiac thicknesses, the -20°C isotherm passed transmurally in 40, 55, 78, 161, 354, and 696 seconds during cryoablation with AFA and 40, 54, 78, 160, 352, and 722 seconds with AFA Pro. CONCLUSION: This model predicted a minimum duration of cryoballoon ablation (TTINV ) to obtain a transmural lesion when acute TTI of the PV was observed (TTIED ). Consequently, the model is a useful tool for characterizing CBA dosing, which may guide future cryoablation dosing strategies.