Background One determinant of failure of atrial fibrillation (AF) ablation is the lack of transmural lesions. Contact force sensing (CFS) catheters enable real-time assessment of the amount of force applied at the catheter-tissue interface, with higher contact force associated with lesions of greater size. Previous meta-analyses have pooled results from randomized controlled trials (RCTs) and observational studies (OSs) and concluded that CFS catheters improve clinical outcomes. This meta-analysis sought to compare the efficacy and safety of CFS catheters with non-CFS catheters for AF radiofrequency ablation.
Methods A total of 28 studies were identified using Embase and Medline databases; 8 RCTs and 20 OSs. For the primary outcome of atrial tachyarrhythmia recurrence, data from RCTs and OSs were analysed according to study design. Secondary outcomes included ablation time and all procedure-related complications. Summary estimates for each variable were calculated using the random-effects model based on DerSimonian and Laird’s meta-analytic statistical method.
Results In the 8 RCTs there were a total of 844 patients (419 in CF group and 425 in non-CF group). In the 20 OS there were 3900 patients (1523 in CF group and 2377 in non-CF group). The median age of patients was 60.3 years (59.0 years in RCTs and 60.7 years in OSs). The majority were male (74.0% in RCTs and 69.6% in OSs). The median follow-up time post-AF ablation was 12 months in both RCTs and OSs.
While CFS did not lead to a significant reduction in atrial tachyarrhythmia recurrence in RCTs (n=844, risk ratio (RR) 0.98, 95% confidence interval (CI) 0.80 to 1.19, p=0.81), a significant reduction was observed in OSs (n=2,259, RR 0.74, 95% CI 0.65 to 0.84, p<0.0001), both at a median follow-up of 12 months.
Data on ablation time were available for 6 RCTs (n=751) and 14 OSs (n=3,152). The use of CFS catheters had no significant impact on ablation time in both RCTs (-0.36 minutes, 95% CI -3.32 to 2.59, p=0.81) and OSs (-3.68 minutes, 95% CI -7.91 to 0.55, p=0.09).
For both RCTs (n=706) and OSs (n=3,427), the incidence of all procedure-related complications was similar in the CFS and non-CFS groups (RCTs, RR 0.99, 95% CI 0.55 to 1.78, p=0.97; OSs, RR 0.78, 95% CI 0.53 to 1.16, p=0.22).
Conclusion Although OSs have demonstrated positive results, data from RCTs have failed to show any significant benefit from CFS catheters in terms of procedural success in AF ablation. The safety profile of CFS catheters was similar to non-CFS catheters in both RCTs and OSs.
Conflict of Interest No conflicts on interest
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