A randomized trial of contact force in atrial flutter ablation
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissionsoup.com..
AIMS: Contact force (CF) sensing has emerged as a tool to guide and improve outcomes for catheter ablation (CA) for cardiac arrhythmias. The clinical benefit on patient outcomes remains unknown. To study whether CF-guided CA for typical atrial flutter (AFL) is superior to CA not guided by CF.
METHODS AND RESULTS: In a double-blinded controlled superiority trial, we randomized patients 1:1 to receive CA for typical AFL guided by CF (intervention group) or blinded to CF (control group). In the intervention group, a specific value of the lesion size index (LSI), estimating ablation lesions size was targeted for each ablation lesion. Patients underwent electrophysiological study (EPS) after 3 months to assess occurrence of the primary endpoint of re-conduction across the cavo-tricuspid isthmus (CTI). We included 156 patients with typical AFL, median age was 68 [interquartile range (IQR) 61-74] years and 120 (77%) patients were male. At index procedure median LSI was higher in the intervention group [6.4 (IQR 5.1-7) vs. 5.6 (IQR 4.5-6.9), P < 0.0001]. After 3 months, 126 patients (58 in intervention group) underwent EPS for primary endpoint assessment. Thirty (24%) patients had CTI re-conduction, distributed with 15 patients in each treatment group (P = 0.62). We observed no difference between treatment groups with regard to fluoroscopy, ablation, or procedure times, nor peri-procedural complications.
CONCLUSION: Contact force-guided ablation does not reduce re-conduction across the CTI after 3 months, nor does CF-guided ablation shorten fluoroscopy, ablation, or total procedure times.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology - 22(2020), 6 vom: 01. Juni, Seite 947-955 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Giehm-Reese, Mikkel [VerfasserIn] |
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| Links: |
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| Themen: |
Catheter ablation |
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| Anmerkungen: |
Date Completed 25.06.2021 Date Revised 25.06.2021 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/europace/euaa049 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM308832892 |
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| 245 | 1 | 2 | |a A randomized trial of contact force in atrial flutter ablation |
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| 500 | |a Date Revised 25.06.2021 | ||
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a AIMS: Contact force (CF) sensing has emerged as a tool to guide and improve outcomes for catheter ablation (CA) for cardiac arrhythmias. The clinical benefit on patient outcomes remains unknown. To study whether CF-guided CA for typical atrial flutter (AFL) is superior to CA not guided by CF | ||
| 520 | |a METHODS AND RESULTS: In a double-blinded controlled superiority trial, we randomized patients 1:1 to receive CA for typical AFL guided by CF (intervention group) or blinded to CF (control group). In the intervention group, a specific value of the lesion size index (LSI), estimating ablation lesions size was targeted for each ablation lesion. Patients underwent electrophysiological study (EPS) after 3 months to assess occurrence of the primary endpoint of re-conduction across the cavo-tricuspid isthmus (CTI). We included 156 patients with typical AFL, median age was 68 [interquartile range (IQR) 61-74] years and 120 (77%) patients were male. At index procedure median LSI was higher in the intervention group [6.4 (IQR 5.1-7) vs. 5.6 (IQR 4.5-6.9), P < 0.0001]. After 3 months, 126 patients (58 in intervention group) underwent EPS for primary endpoint assessment. Thirty (24%) patients had CTI re-conduction, distributed with 15 patients in each treatment group (P = 0.62). We observed no difference between treatment groups with regard to fluoroscopy, ablation, or procedure times, nor peri-procedural complications | ||
| 520 | |a CONCLUSION: Contact force-guided ablation does not reduce re-conduction across the CTI after 3 months, nor does CF-guided ablation shorten fluoroscopy, ablation, or total procedure times | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Catheter ablation | |
| 650 | 4 | |a Contact force | |
| 650 | 4 | |a Lesion size index | |
| 650 | 4 | |a Outcome | |
| 650 | 4 | |a Typical atrial flutter | |
| 700 | 1 | |a Kronborg, Mads Brix |e verfasserin |4 aut | |
| 700 | 1 | |a Lukac, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Kristiansen, Steen Buus |e verfasserin |4 aut | |
| 700 | 1 | |a Jensen, Henrik Kjærulf |e verfasserin |4 aut | |
| 700 | 1 | |a Gerdes, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Kristensen, Jens |e verfasserin |4 aut | |
| 700 | 1 | |a Nielsen, Jan Møller |e verfasserin |4 aut | |
| 700 | 1 | |a Nielsen, Jens Cosedis |e verfasserin |4 aut | |
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