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Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial)

Authors :
Christopher B. Pepper
Stephen P. Page
Richard Gillott
Lee N. Graham
Muzahir H. Tayebjee
Richard J. Schilling
Gordon A. Begg
Nicola J. Hill
Jacqueline Walshaw
Andrew J. Hogarth
Afzal Sohaib
Ailsa McLean
James O’Neill
Prapa Kanagaratnam
Source :
PLoS ONE, PLoS ONE, Vol 14, Iss 4, p e0212903 (2019)
Publication Year :
2018

Abstract

IntroductionElectrical coupling index (ECI) and contact force (CF) have been developed to aid lesion formation during catheter ablation. ECI measures tissue impedance and capacitance whilst CF measures direct contact. The aim was to determine whether the presence of catheter / tissue interaction information, such as ECI and CF, reduce time to achieve bidirectional cavotricuspid isthmus block during atrial flutter (AFL) ablation.MethodsPatients with paroxysmal or persistent AFL were randomised to CF visible (range 5-40g), CF not visible, ECI visible (change of 12%) or ECI not visible. Follow-up occurred at 3 and 6 months and included a 7 day ECG recording. The primary endpoint was time to bidirectional cavotricuspid isthmus block.Results114 patients were randomised, 16 were excluded. Time to bidirectional block was significantly shorter when ECI was visible (median 30.0 mins (IQR 31) to median 10.5mins (IQR 12) p 0.023) versus ECI not visible. There was a trend towards a shorter time to bidirectional block when CF was visible. Higher force was applied when CF was visible (median 9.03g (IQR 7.4) vs. 11.3g (5.5) p 0.017). There was no difference in the acute recurrence of conduction between groups. The complication rate was 2%, AFL recurrence was 1.1% and at 6 month follow-up, 12% had atrial fibrillation.ConclusionThe use of tissue contact information during AFL ablation was associated with reduced time taken to achieve bidirectional block when ECI was visible. Contact force data improved contact when visible with a trend towards a reduction in the procedural endpoint. ClinicalTrials.gov trial identifier: NCT02490033.

Details

ISSN :
19326203
Volume :
14
Issue :
4
Database :
OpenAIRE
Journal :
PloS one
Accession number :
edsair.doi.dedup.....26e923e28ce9417f91382778febe7cc8