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.

Keywords: Ablation; arrhythmia; atrial fibrillation; fluoroscopy; three-dimensional mapping.

Figure 1:

Patient flow in the Grand SANS FLUORO study. Patients were classified based on their presenting primary clinical arrhythmia and were counted only once per laboratory visit. SVT patients included those with AVNRT, AVRT, and AT. VT patients included PVC patients. AF: atrial fibrillation; AFL: atrial flutter; AV: atrioventricular; EP: electrophysiology; FLUORO: fluoroscopy; PVI: pulmonary vein isolation; SANS FLUORO: without fluoroscopy; SVT: supraventricular tachycardia; VT: ventricular tachycardia.

Figure 2:

SANS FLUORO technique. A: RA fast anatomical map with the coronary sinus shown in green and the tricuspid valve cut away. B: RA fast anatomical map with coronary sinus catheter and His bundle shown in yellow as well as the ablation catheter. C: Sheath placement in the SVC is noted by two dark bands and the SH. D: Sheath in the SVC on ICE. E: Tenting of the intra-atrial septum on ICE. F: Placement of the sheath into the LA with confirmation of bubbles in the LA. LA: left atrium; RA: right atrium; SH: sheath.

Figure 3:

PVI efficacy. Kaplan–Meier estimates of AF-free survival within 360 days of PVI ablation procedure by the following PVI modalities: cryoablation with FLUORO, cryoablation SANS FLUORO, RF ablation with FLUORO, and RF ablation SANS FLUORO. Cryo FLUORO: cryoablation with fluoroscopy; Cryo SANS: cryoablation without fluoroscopy; RF FLUORO: radiofrequency ablation with fluoroscopy; RF SANS: radiofrequency ablation without fluoroscopy.

Figure 4:

The odds ratios of AF development based on sex as well as AF ablation modality. CRYO: cryoablation. FLUORO: fluoroscopy; CRYO: cryoablation; RF: radiofrequency; SANS FLUORO; without fluoroscopy.

Figure 5:

PVI efficacy in device patients. Kaplan–Meier estimates of AF-free survival in device patients within 36 months of PVI ablation. All patients had dual-chamber devices (pacemakers or ICDs) or implantable loop recorders. AF was defined as greater than 1% AF burden or an episode lasting more than five minutes.