The Grand SANS FLUORO (SAy No Series to FLUOROsopy) Study: Examining Fluoroscopy Use in More than 1,000 Ablation Procedures

Abstract

The majority of electrophysiologists routinely use fluoroscopy (FLUORO) during ablation procedures for common arrhythmias despite the known complications of radiation exposure and protective lead use. This study assessed the safety of catheter ablation (CA) with FLUORO versus without FLUORO (SANS FLUORO) in patients with the following common arrhythmias: atrial fibrillation (AF), atrial flutter, supraventricular tachycardia, and ventricular tachycardia. A total of 1,258 CA procedures were performed in 816 consecutive patients over a 53-month period (SANS FLUORO CA: 609 patients; FLUORO CA: 209 patients). The secondary outcome was the efficacy of AF ablation in FLUORO versus SANS FLUORO patients. Ultimately, there was no statistically significant difference found concerning the safety of CA in the SANS FLUORO and FLUORO groups in terms of procedure time, vascular complications, tamponade, stroke, or death. FLUORO patients had markedly increased FLUORO time, increased radiation exposure, and increased dose-area product (all p < 0.0001). AF development after SANS FLUORO CA of AF was not different from that after FLUORO CA regardless of the pulmonary vein isolation (PVI) modality used (cryoablation versus radiofrequency) at 24 months (p = 0.21). Additionally, women fared just as well as men after CA ablation for AF. At 36 months, 58% of SANS FLUORO AF device patients were free from AF. As such, SANS FLUORO CA of common arrhythmias appears to be as safe as FLUORO CA but with a markedly reduced level of radiation exposure. Also, SANS FLUORO CA remains as effective as FLUORO CA in the prevention of AF for up to 24 months.

Minimal fluoroscopy approach for right‐sided supraventricular tachycardia ablation with a novel ablation technology: Insights from the multicenter CHARISMA clinical registry

“…Over the past decades the rapid development of new electroanatomic mapping technologies is leading to significant reductions of fluoroscopy exposure, from the lowest "reasonably achievable" to more often "zero fluoroscopy" approaches. 1,26 In fact, large retrospective and prospective series have reported on safety and efficacy of several commonly used 3-D mapping systems for a wide range of arrhythmias [12][13][14][15][16][17][18] . Data on the Rhythmia, a novel 3-D mapping system, instead, are scarce, based on a limited (n = 20), single-center experience 19 .…”

“…In fact, the rapid development of new electroanatomic mapping technologies is leading to significant reductions of fluoroscopy exposure, from the lowest "reasonably achievable" to more often "zero fluoroscopy" approaches [9][10][11] . Despite large retrospective and prospective series [12][13][14][15][16][17][18] reporting on safety and efficacy for several commonly used 3-D mapping systems, only anecdotal data 19 exists on the ability, in this respect, of the novel Rhythmia™ mapping system (Boston Scientific). The aim of this study is to report data on the feasibility and safety of a minimal fluoroscopic approach using the Rhythmia mapping system for right-sided supraventricular tachycardia (SVT) transcatheter ablation procedures in a routine clinical setting.…”

The Fluoroless Future in Electrophysiology: A State-of-the-Art Review

“…A solid experience in conventional procedures is also needed in order to use fluoroscopy as low as possible if needed. Of paramount interest, it has been demonstrated that being a female operator is an independent predictor for low radiation exposure [110].…”