title: Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial.
abstract: OBJECTIVE
  Pulmonary vein isolation (PVI) is conventionally performed using 3D electroanatomical mapping to guide point-to-point ablation. The Pulmonary Vein Ablation Catheter (PVAC)® is a phased multipolar ablation (PMRA) catheter designed for rapid PVI using radiological anatomical information. Comparison of these methods of PVI using continuous beat-to-beat monitoring was undertaken.
  
  
  METHODS
  Fifty patients with drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF) were recruited. Patients all had REVEAL® XT ILR or a DDDRP permanent pacemaker (PPM) inserted prior to PVI. PPM was programmed to monitoring mode (ODO). Patients were randomised 1:1 to undergo PVI with either point-to-point irrigated radiofrequency ablation (Conv) or PMRA technology. Follow-up was performed at 0, 3, 6, 9, and 12 months using Holter downloads to assess arrhythmia burden. Outcomes were examined following a 3-month blanking period.
  
  
  RESULTS
  The AF burden pre-ablation, at 3-month and at 12-month post-ablations, was not significantly different (pre-ablation AF burdens (mean ± SE) Conv 16.6 ± 5.0%, PVAC 17.0 ± 5.6 %, 3 months Conv 4.0 ± 1.6 %, PVAC 4.7 ± 1.5%, 12 months Conv 4.3 ± 2.3%, PVAC 3.8 ± 1.5%). In both groups, there was a significant reduction in AF burden from pre-ablation (at 3 months p = 0.01, p = 0.04, at 12 months p = 0.04, p = 0.03 for Conv and PMRA groups, respectively). Overall success rate for zero AF recurrence at 12 months was 54%.
  
  
  CONCLUSIONS
  PMRA PVI is comparable to conventional technology for AF extinction at 1 year. The PMRA is as safe as conventional technology but enables the operator to perform the procedure faster. Device monitored success rates were lower than other studies not utilising such intensive monitoring confirming that sporadic ECG monitoring is not sufficient to detect all AF recurrence.
  
  
  BACKGROUND
  NCT01095770. URL: https://clinicaltrials.gov/ct2/show/NCT01095770.
authors: Cardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK.
authors: S J
authors: SJ
authors: Podd
authors: Cardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK.
authors: A N
authors: AN
authors: Sulke
authors: Cardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK.
authors: C
authors: C
authors: Sugihara
authors: Cardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK. stephen.furniss@esht.nhs.uk.
authors: S S
authors: SS
authors: Furniss
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000175:diagnosis* / Q000601:surgery*; D018780:Body Surface Potential Mapping / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006329:Heart Conduction System / Q000601:surgery; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010138:Pacemaker, Artificial; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D019736:Prostheses and Implants; D011667:Pulmonary Veins / Q000601:surgery*; D007507:Therapeutic Irrigation / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
keywords: AF Ablation; Implantable cardiac monitors; PPM monitoring; PVAC; Pulmonary vein isolation; Reveal XT