Updated systematic review and meta-analysis of the impact of contact force sensing on the safety and efficacy of atrial fibrillation ablation: discrepancy between observational studies and randomized control trial data

Abstract Aims Despite widespread adoption of contact force (CF) sensing technology in atrial fibrillation (AF) ablation, randomized data suggests lack of improvement in clinical outcomes. We aimed to assess the safety and efficacy of CF-guided vs. non CF-guided AF ablation. Methods and results Elect...

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Bibliographic Details
Published in:Europace (London, England) England), 2019-02, Vol.21 (2), p.239-249
Main Authors: Virk, Sohaib A, Ariyaratnam, Jonathan, Bennett, Richard G, Kumar, Saurabh
Format: Article
Language:English
Subjects:
Action Potentials
Atrial Fibrillation - diagnosis
Atrial Fibrillation - physiopathology
Atrial Fibrillation - surgery
Cardiac Catheters
Catheter Ablation - adverse effects
Catheter Ablation - instrumentation
Equipment Design
Heart Conduction System - physiopathology
Heart Conduction System - surgery
Heart Rate
Humans
Observational Studies as Topic
Patient Safety
Randomized Controlled Trials as Topic
Risk Assessment
Risk Factors
Transducers, Pressure
Treatment Outcome
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Summary:Abstract Aims Despite widespread adoption of contact force (CF) sensing technology in atrial fibrillation (AF) ablation, randomized data suggests lack of improvement in clinical outcomes. We aimed to assess the safety and efficacy of CF-guided vs. non CF-guided AF ablation. Methods and results Electronic databases were searched for randomized controlled trials (RCTs) and controlled observational studies (OS) comparing outcomes of AF ablation performed with vs. without CF guidance. The primary efficacy endpoint was freedom from AF at follow-up. The primary safety endpoint was major peri-procedural complications. Secondary endpoints included procedural, fluoroscopy, and ablation duration. Subgroup analyses were performed by AF type and study design. Nine RCTs (n = 903) and 26 OS (n = 8919) were included. Overall, CF guidance was associated with improved freedom from AF [relative risk (RR) 1.10; 95% confidence interval (CI) 1.02–1.18], and reduced total procedure duration [mean difference (MD) 15.33 min; 95% CI 6.98–23.68], ablation duration (MD 3.07 min; 95% CI 0.29–5.84), and fluoroscopy duration (MD 5.72 min; 95% CI 2.51–8.92). When restricted to RCTs however, CF guidance neither improved freedom from AF (RR 1.03; 95% CI 0.95-1.11), independent of AF type, nor did it reduce procedural, fluoroscopy, or ablation duration. Contact force guidance did not reduce the incidence of major peri-procedural complications (RR 0.89; 95% CI 0.64–1.24). Conclusion Meta-analysis of randomized data demonstrated that CF guidance does not improve the safety or efficacy of AF ablation, despite initial observational data showing dramatic improvement. Rigorous evaluation in randomized trials is needed before widespread adoption of new technologies.
ISSN:1099-5129
1532-2092
DOI:10.1093/europace/euy266