Tom De Potter1, Hugo Van Herendael2, Richard Balasubramaniam3, Matthew Wright4,5, Sharad C Agarwal6, Prashanthan Sanders7, Yaariv Khaykin8, Decebal-Gabriel Latcu9, Philippe Maury10, Antonio Pani11, John Hayes12, Jonathan Kalman13, Pablo Nery14, Edward Duncan15. 1. Cardiovascular Center, OLV Hospital, Moorselbaan 169, Aalst, Belgium. 2. Ziekenhuis Oost-Limburg, Genk, Belgium. 3. Royal Bournemouth Hospital, Bournemouth, UK. 4. Division of Imaging Sciences and Biomedical Engineering, King's College London, London, UK. 5. Department of Cardiology, St. Thomas' Hospital, London, UK. 6. Papworth Hospital NHS Foundation Trust, Cambridge, UK. 7. Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia. 8. Southlake Regional Health Centre, Ontario, Canada. 9. Centre Hospitalier Princesse Grace, Monaco, Monaco. 10. University Hospital Rangueil, Toulouse, France. 11. Struttura di Cardiologia, Lecco, Italy. 12. St. Andrew's War Memorial Hospital, Queensland, Australia. 13. Royal Melbourne Hospital and University of Melbourne, Victoria, Australia. 14. University of Ottawa Heart Institute, Ontario, Canada. 15. Bristol Heart Institute, Bristol, UK.
Abstract
Aims: Real-time contact force (CF)-sensing radiofrequency ablation catheter for treatment of paroxysmal atrial fibrillation (PAF) allows optimization of electrode-tissue contact, which correlates with long-term success. This prospective, multicentre observational registry assessed the real-world clinical effectiveness of a CF-sensing catheter for ablation of drug-refractory PAF. Methods and results: Patients were followed-up at 3, 6, and 12 months after ablation. Outcome measures included isolation of targeted pulmonary veins (PVs) confirmed by entrance block (acute success), patient-reported freedom from symptomatic atrial fibrillation (AF) at 12 months (long-term effectiveness), Atrial Fibrillation Effect on Quality-of-life scores at 6 and 12 months, and incidence of predefined procedural complications. The registry enrolled 261 PAF patients (mean age 58.8 ± 11.3 years; 70.7% men; 91.7% Caucasian). Acute PV isolation was reported in 98.8% of patients [95% confidence interval (CI): 96.4-99.7%], and 12-month success for freedom from symptomatic AF was 75.7% (95% CI: 69.7-80.7%). Average CF for the evaluable cohort was 16.4 ± 3.9 g. There was a significant correlation between long-term effectiveness and stability of CF use [percentage of time CF was within investigator-selected working range; odds ratio (95% Wald CI), 1.0 (1.00-1.1); P = 0.030]. Average CF did not correlate with 12-month success. Clinically meaningful quality of life (QoL) improvements were observed at 6 and 12 months. Primary adverse events occurred in 2.7% patients. Conclusion: This observational registry showed that PAF ablation with a CF-sensing catheter had high acute success rates, favourable 12-month outcomes, and a good safety profile. Patients' QoL improved significantly. Long-term effectiveness significantly correlated with stable CF with adequate catheter-tissue contact (NCT01677052).
Aims: Real-time contact force (CF)-sensing radiofrequency ablation catheter for treatment of paroxysmal atrial fibrillation (PAF) allows optimization of electrode-tissue contact, which correlates with long-term success. This prospective, multicentre observational registry assessed the real-world clinical effectiveness of a CF-sensing catheter for ablation of drug-refractory PAF. Methods and results: Patients were followed-up at 3, 6, and 12 months after ablation. Outcome measures included isolation of targeted pulmonary veins (PVs) confirmed by entrance block (acute success), patient-reported freedom from symptomatic atrial fibrillation (AF) at 12 months (long-term effectiveness), Atrial Fibrillation Effect on Quality-of-life scores at 6 and 12 months, and incidence of predefined procedural complications. The registry enrolled 261 PAF patients (mean age 58.8 ± 11.3 years; 70.7% men; 91.7% Caucasian). Acute PV isolation was reported in 98.8% of patients [95% confidence interval (CI): 96.4-99.7%], and 12-month success for freedom from symptomatic AF was 75.7% (95% CI: 69.7-80.7%). Average CF for the evaluable cohort was 16.4 ± 3.9 g. There was a significant correlation between long-term effectiveness and stability of CF use [percentage of time CF was within investigator-selected working range; odds ratio (95% Wald CI), 1.0 (1.00-1.1); P = 0.030]. Average CF did not correlate with 12-month success. Clinically meaningful quality of life (QoL) improvements were observed at 6 and 12 months. Primary adverse events occurred in 2.7% patients. Conclusion: This observational registry showed that PAF ablation with a CF-sensing catheter had high acute success rates, favourable 12-month outcomes, and a good safety profile. Patients' QoL improved significantly. Long-term effectiveness significantly correlated with stable CF with adequate catheter-tissue contact (NCT01677052).
Authors: Rudy R Unni; Ross T Prager; Roupen Odabashian; Jimmy J Zhang; Nicholas Ng Fat Hing; Pablo B Nery; Lebei Pi; Wafa Aldawood; Mouhannad M Sadek; Calum J Redpath; David H Birnie; Wael Alqarawi; Amin Zagzoog; Mehrdad Golian; Andres Klein; F Daniel Ramirez; Martin S Green; Li Chen; Sarah Visintini; George A Wells; Girish M Nair Journal: CJC Open Date: 2022-02-10
Authors: Tom De Potter; Hugo Van Herendael; Richard Balasubramaniam; Matthew Wright; Decebal-Gabriel Laţcu; Sharad C Agarwal; Baohui Zhang; Lee Ming Boo; Antonio Pani Journal: J Atr Fibrillation Date: 2019-08-31
Authors: Mark T Stewart; David E Haines; Damijan Miklavčič; Bor Kos; Nicole Kirchhof; Noah Barka; Lars Mattison; Matt Martien; Birce Onal; Brian Howard; Atul Verma Journal: J Cardiovasc Electrophysiol Date: 2021-03-10