Randomized trial comparing pulmonary vein isolation using the SmartTouch catheter with or without real-time contact force data

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• 作者：Waqas Ullah ; MBBS ; PhD^* ; ^{waqas@doctors.org.uk" class="auth_mail" title="E-mail the corresponding author} ; Ailsa McLean ; RN^* ; Muzahir H. Tayebjee ; MD^&dagger ; ; Dhiraj Gupta ; MBBS ; MD^&Dagger ; ; Matthew R. Ginks ; MBBS ; MD^§ ; ; Guy A. Haywood ; MB BChir MD^¶ ; ; Mark O&rsquo ; Neill ; DPhil ; FRCP ; FHRS^║ ; Pier D. Lambiase ; PhD ; FRCP ; FHRS^# ; Mark J. Earley ; MBBS ; MD^* ; Richard J. Schilling ; MBBS ; MD^* ; on behalf of the UK Multicentre Trials Group**
• 关键词：Atrial fibrillation ; Catheter ablation ; Contact force sensing ; Randomized controlled trial
• 刊名：Heart Rhythm
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：13
• 期：9
• 页码：1761-1767
• 全文大小：535 K

文摘

Contact force (CF) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation (PAF).

Objective

The purpose of this study was to assess the impact of CF data on ablation for PAF.

Methods

Patients undergoing first-time PAF ablation were randomized at 7 UK centers to ablation with (CF-on) or without (CF-off) CF data available to the operator, using the same ablation catheter and mapping system. An ablation CF of 5–40g was targeted. Pulmonary vein (PV) reconnection was assessed with adenosine at 60 minutes. Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months.

Results

One hundred seventeen patients were studied (59 CF-on, 58 CF-off). In the CF-on group, a reduction in acute PV reconnection rates (22% vs 32%, P = .03) but no significant difference in 1-year success rates off antiarrhythmic drugs (49% vs 52%, P = .9) was observed. There was no difference in major complication rates: 2 of 59 (3%) CF-on, 3 of 58 (5%) CF-off (P = .7). Procedural and fluoroscopy times were not significantly different (P>.5). Overall mean CFs per ablation were not different between groups (13.4 [9.1–19.6]g CF-on, 13.4 [7.4–22.4]g CF-off, P = .5), but a greater proportion of readings in the CF-on group were in the target range (80% vs 68%, P<.001).

Conclusion

This randomized multicenter study demonstrated that CF data availability was associated with reduced acute PV reconnection but not improved 1-year success rates, procedural and fluoroscopy times, or complication rates. There was a reduction in extremes of CF, above and below the study target range, suggesting greater CF control during ablation.