Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE

Abstract

Aims: To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI).

Methods and results: This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7 days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12 months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of ≥1 PVs after adenosine/isoproterenol challenge was observed in 9.3% (30/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12 months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12 months.

Conclusion: PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life.

Clinicaltrials.gov registration number: NCT03437733.

Keywords: Atrial fibrillation; Electrophysiological mapping; Pulmonary vein isolation; Quality of life; Radiofrequency ablation; Radiofrequency balloon catheter.

Graphical abstract

Figure 1

The RFB and circular diagnostic catheter as visualised using the electroanatomical mapping system. The RFB and the circular diagnostic catheter are shown at the ostium of LIPV during ablation, where the bottom panel reflects the RF power being delivered (yellow bar, 0–40 W), temperature measured (orange bar, 0–60 Celsius), starting impedance (dark green, 0–150 Ohms), and current impedance (bright green, 0–150 Ohms) for each of the 10 individual electrodes. The bottom panel also shows the posterior electrodes #1–#3 are turned off. LIPV, left inferior pulmonary vein; LSPV, left superior pulmonary vein; RF, radiofrequency; RFB, radiofrequency balloon catheter; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein.

Figure 2

(A) Voltage map of the left atrium and electrogram recorded by the circular diagnostic catheter (B) before, (C) during, and (D) after LSPV isolation with the RFB. LSPV, left superior pulmonary vein; RFB, radiofrequency balloon; RIPV, right inferior pulmonary vein; RSPV, right superior pulmonary vein.

Figure 3

Kaplan–Meier analysis of 6- and 12-month effectiveness endpoint, time to first documented symptomatic effectiveness failure (per-protocol population, N = 85). AF, atrial fibrillation; AFL, atrial flutter; AT, atrial tachycardia.

Figure 4

AFEQT scores at study baseline and at 3, 6, and 12 months post-ablation (per-protocol population, N = 85). AFEQT, Atrial Fibrillation Effect on Quality-of-life questionnaire. ^†Satisfaction level—‘How well current treatment controls your atrial fibrillation’. ^‡Satisfaction level—‘The extent to which treatment has relieved your symptoms of atrial fibrillation’.