Randomized comparison of atrioventricular node re-entry tachycardia and atrial flutter catheter ablation with and without fluoroscopic guidance: ZeroFluoro study

Abstract

Background Interventional cardiology procedures may expose patients and staff to considerable radiation doses. We aimed to assess whether exposure to ionizing radiation during catheter ablation of supraventricular tachycardia (SVT) can be completely avoided. Methods In this prospective randomized study, patients with SVT (atrioventricular re-entrant tachycardia n = 94, typical atrial flutter n = 29) were randomly assigned in a 1:1 ratio to catheter ablation with conventional fluoroscopic guidance (CF group) or with the EnSite Precision mapping system [zerofluoro (ZF) group]. Acute procedural parameters, increased stochastic risk of cancer incidence and 6-month follow-up data were assessed. Results Between May 2019 and August 2020, 123 patients were enrolled. Clinical parameters were comparable. Median procedural time was 60.0 and 58.0 min, median fluoroscopy time and estimated median effective dose were 240 s vs. 0 and 0.38 mSv vs. 0 and arrhythmia recurrence was 5% and 7.9% in the CF and ZF groups, respectively. The acute success rate was 98.4% in both groups. No procedure-related complications were reported. At an average age of 55.5 years and median radiation exposure of 0.38 mSv, the estimate of increased incidence was approximately 1 in 14 084. The estimated mortality rate was 1 per 17 857 exposed persons. Conclusions The procedural safety and efficacy of the zero-fluoroscopic approach are similar to those of conventional fluoroscopy-based ablation for atrioventricular nodal re-entrant tachycardia and atrial flutter. Under the assumption of low radiation dose, the excessive lifetime risk of malignancy in the CF group due to electrophysiology procedure is reasonably small, whilst totally reduced in zero fluoroscopy procedures.

Feasibility and safety of cavotricuspid isthmus ablation using exclusive intracardiac echocardiography guidance: a proof-of-concept, observational trial

“…In recent years, the use of EAMSs as an alternative visualization technique in electrophysiology procedures has gained popularity due to its potential to decrease procedural time and reduce or even completely eliminate radiation exposure. Numerous studies have confirmed the feasibility of near-zero and zero-fluoroscopy approaches for CTI ablation, including their successful application as an extension to pulmonary vein isolation procedures within a single session (5,(15)(16)(17)(18)(19)(20)(21)(22)(23). In addition, the advent of visualizable steerable sheaths has yielded significant advancements in mitigating radiation exposure during catheter ablation procedures (24).…”

“…The utilization of 3D electroanatomical mapping systems (EAMS) during ablation procedures for typical flutter has resulted in a significant reduction in exposure to fluoroscopy ( 4 , 9 , 10 ). Recent researches have demonstrated that it is feasible to perform fluoroscopy-free ablation procedures for typical flutter with the guidance of EAMS ( 5 , 6 , 11 ).…”

“…This procedure creates a bidirectional conduction block across the CTI and has a high success rate both in the short term and long term, with a low complication rate (2). Although catheter ablation of the CTI has a high success rate (2,3), it can be particularly challenging in some cases, often due to anatomical abnormalities (4)(5)(6).…”

Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study

“…18 Catheter ablation in the treatment of SVT in adults using non-fluoroscopic mapping systems such as the EnSite system has been reproducibly found to be feasible, safe and effective. [19][20][21][22][23][24][25]…”

“…A parallel comparison in a multicentric registry study of outcomes from a zero-fluoroscopy approach and conventional fluoroscopy approach in the treatment of SVT showed similar ablation and procedure times and comparable success rates in excess of 98% 18. Catheter ablation in the treatment of SVT in adults using non-fluoroscopic mapping systems such as the EnSite system has been reproducibly found to be feasible, safe and effective 19–25…”