ABSTRACT
Pulmonary vein isolation (PVI) is widely used for the ablation of atrial fibrillation, with prior reports suggesting good efficacy. Due to the widespread use of three-dimensional electroanatomic mapping systems and advances in intracardiac echocardiography, fluoroless ablation has been made possible. Fluoroless ablation with a cryoballoon (CB), however, has not been widely performed because of the need to prove occlusion of the vein with contrast dye and fluoroscopy. The objective of this study is to show that CB ablation can be performed safely and effectively without fluoroscopy. A dual-center, case-control study was performed of patients undergoing CB PVI with a fluoroless approach and a control group with traditional fluoroscopic techniques. The absence of color-flow Doppler signals around the periphery of the CB on intracardiac echocardiography and an increase in mean pressure by 5 mmHg, loss of the A-wave, and an increase in the V-wave as measured with continuous-wave pressure monitoring were adopted as indicators of vein occlusion in the absence of fluoroscopy. Temperature at 30 seconds, minimum temperature, time to isolation, procedure length, and complications were evaluated. During the study period of November 15, 2018 to November 15, 2019, a total of 100 patients underwent CB PVI at the participating centers. A total of 50 patients were enrolled in the fluoroless arm [35 men (70%), mean age: 64.9 ± 12 years, mean left atrium size: 44.2 ± 16 mL/m2, left ventricular ejection fraction: 61% ± 5%], while 50 patients were enrolled in the control arm with similar characteristics. Four hundred forty-one 441 PVs were evaluated in the study cohort compared to 339 PVs in the control arm. When comparing fluoroless and traditional techniques, the mean temperature at 30 seconds was -31.7°C ± 6°C versus -32.8°C ± 5°C (p = 0.037), the minimum temperature was -47.4°C ± 6°C versus -47.7°C ± 9°C (p = 0.677), the time to isolation was 56.8 ± 28 seconds versus 74.8 ± 45 seconds (p = 0.212), and the procedure time was 102.2 ± 27.3 seconds versus 104.5 ± 16.9 seconds (p = 0.6436). Ultimately, this proof-of-concept study revealed that fluoroless ablation can be performed with success and efficiency outcomes similar to those of a traditional ablation approach. This suggests that the ablation of atrial fibrillation with CB can be performed safely and effectively without the use of fluoroscopy by experienced operators.
ABSTRACT
BACKGROUND: This study describes the use of lesion index (LSI) as a direct measure to assess the adequacy of ablation lesion formation with force-sensing catheters in ablation of paroxysmal atrial fibrillation (PAF). LSI is calculated by the formula:LSI = CF (g) ×Current (mA) ×Time (sec). METHODS: Fifty consecutive patients with PAF underwent pulmonary vein (PV) isolation using a catheter dragging technique and targeting different LSI values in different anatomical areas.A force-sensing ablation catheter was used to continuously measure contact force (CF) and guide radiofrequency ablation (RF) lesion formation. Ablation lesions were delivered to achieve an LSI value of 5.0 in posterior locations, 5.5 in anterior locations and 6.0 in the regionbetween the left atrial appendage and left superiorpulmonary vein ridge. Force-time Integral (FTI) was not used to evaluate lesion formation. RESULTS: A single center, retrospective analysis was performed with 196/198 (99%) PVs acutely isolated. The mean procedure time was 134 ± 34 mins and the mean fluoroscopy time was 7.8 ± 3.2 mins. At a mean follow up of two years, 43/50 (86%) of patients were in normal sinus rhythm with no documented recurrences of atrial fibrillation. CONCLUSION: LSI can be used to guide the placement of durable lesion formation with RF ablation using CF catheters in patients with PAF.
