Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial.
OBJECTIVE
The current challenge in atrial fibrillation (AF) treatment is to develop effective, efficient, and safe ablation strategies. This randomized controlled trial assesses the medium-term efficacy of duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) vs. conventional electro-anatomically guided wide-area circumferential ablation (WACA).


RESULTS
One hundred and eighty-eight patients (mean age 62 ± 12 years, 116 M : 72 F) with paroxysmal AF were prospectively randomized to PVAC or WACA strategies and sequentially followed for 12 months. The primary endpoint was freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure. One hundred and eighty-three patients completed 12 m follow-up. Ninety-four patients underwent PVAC PV isolation with 372 of 376 pulmonary veins (PVs) successfully isolated and all PVs isolated in 92 WACA patients. Three WACA and no PVAC patients developed tamponade. Fifty-six percent of WACA and 60% of PVAC patients were free of AF at 12 months post-procedure (P = ns) with a significant attrition rate from 77 to 78%, respectively, at 6 months. The mean procedure (140 ± 43 vs. 167 ± 42 min, P<0.0001), fluoroscopy (35 ± 16 vs. 42 ± 20 min, P<0.05) times were significantly shorter for PVAC than for WACA. Two patients developed strokes within 72 h of the procedure in the PVAC group, one possibly related directly to PVAC ablation in a high-risk patient and none in the WACA group (P = ns). Two of the 47 patients in the PVAC group who underwent repeat ablation had sub-clinical mild PV stenoses of 25-50% and 1 WACA patient developed delayed severe PV stenosis requiring venoplasty.


CONCLUSIONS
The pulmonary vein ablation catheter is equivalent in efficacy to WACA with reduced procedural and fluoroscopy times. However, there is a risk of thrombo-embolic and pulmonary stenosis complications which needs to be addressed and prospectively monitored.


BACKGROUND
NCT00678340.
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
J
J
McCready
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
A W
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Chow
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
M D
MD
Lowe
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
O R
OR
Segal
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
S
S
Ahsan
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
J
J
de Bono
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
M
M
Dhaliwal
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
C
C
Mfuko
Cardiology Department, Glenfield Heart Centre, Leicester, Leicestershire LE39QP, UK.
A
A
Ng
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
E R
ER
Rowland
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK.
R J W
RJ
Bradley
Cardiology Department, Royal Bournemouth Hospital Castle Lane East Bournemouth, Bournemouth BH7 7DW, UK.
J
J
Paisey
Cardiology Department, Southampton General Hospital, Southampton, Hampshire SO16 6YD, UK.
P
P
Roberts
Cardiology Department, Southampton General Hospital, Southampton, Hampshire SO16 6YD, UK.
J M
JM
Morgan
Cardiology Department, Glenfield Heart Centre, Leicester, Leicestershire LE39QP, UK.
A
A
Sandilands
Cardiology Department, Southampton General Hospital, Southampton, Hampshire SO16 6YD, UK.
A
A
Yue
Cardiology Department, The Heart Hospital, University College Hospital and Institute of Cardiovascular Sciences, UCL, 16-18 Westmoreland Street, London W1G 8PH, UK pier.lambiase@uclh.nhs.uk.
P D
PD
Lambiase
D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D062906:Cardiac Catheters; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D004739:England; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000209:etiology / Q000628:therapy; D011667:Pulmonary Veins / Q000503:physiopathology / Q000601:surgery*; D011668:Pulmonary Veno-Occlusive Disease / Q000209:etiology / Q000628:therapy; D012307:Risk Factors; D016037:Single-Blind Method; D020521:Stroke / Q000209:etiology; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
Ablation; Atrial fibrillation; Duty-cycled bipolar and unipolar radiofrequency; Electrophysiology