Evidence map›Paper›PMID 26310300›Full record

Trial reportJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2015

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.

S J Podd, A N Sulke, C Sugihara, S S Furniss

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01095770 (Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01095770 naunknown statusnot on this map

Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP

TypeinterventionalSponsorEastbourne General HospitalRan2010 to 2012Enrolled50ConditionsParoxysmal Atrial FibrillationArmsAF Ablation with Ablation Frontiers Technology, AF Ablation with LASSO catheter, Reveal XT, Permanent Dual Chamber Pacemaker
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Comparative efficacy and safety of catheter ablation interventions for atrial fibrillation: comprehensive network meta-analysis of randomized controlled trials.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

S J PoddCardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK.
A N SulkeCardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK.
C SugiharaCardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK.
S S FurnissCardiology Research Department, East Sussex Healthcare NHS Trust, Eastbourne Gen Hospital, Kings Drive, Eastbourne, East Sussex, BN21 2UD, UK. stephen.furniss@esht.nhs.uk.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePulmonary 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.

methodsFifty 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.

resultsThe 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%.

conclusionPMRA 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.

trial registrationNCT01095770. URL: https://clinicaltrials.gov/ct2/show/NCT01095770.

Indexed as

AgedAtrial FibrillationBody Surface Potential MappingCatheter AblationEquipment DesignEquipment Failure AnalysisFemaleFollow-Up StudiesHeart Conduction SystemHumansLongitudinal StudiesMalePacemaker, ArtificialPostoperative ComplicationsProspective StudiesProstheses and ImplantsAF AblationImplantable cardiac monitorsPPM monitoringPulmonary vein isolationPVACReveal XT

Identifiers

PMID26310300

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.