Abstract:This study suggests that an ablation protocol respecting strict criteria for lesion depth and contiguity results in acute durable PV isolation followed by a high single-procedure arrhythmia-free survival at 1 year. A prospective, multicenter trial is ongoing.
“…Ethical approval was obtained from the local committee, and informed consent was given by all patients before the procedure. In both groups, the CLOSE protocol, as described by Taghji et al was used, combining predefined ablation index (AI) targets and an interlesion distance (ILD) of ≤6 mm.…”
Introduction
The CLOSE protocol combines ablation index (AI) and ≤6 mm interlesion distance using standard power settings for the treatment of atrial fibrillation (AF). The purpose was to compare the safety and efficacy of a conventional CLOSE and a higher power shorter duration (HPSD)‐CLOSE pulmonary vein isolation (PVI) strategy.
Methods and Results
All consecutive patients referred for PVI were included after informed consent was obtained from them. Group 1 was treated with a standard CLOSE protocol and group 2 with a HPSD‐CLOSE protocol (45 W anterior and 35 W posterior). Procedural parameters and 6‐month follow‐up were analyzed. In total, 174 patients (group 1: n = 94 [paroxysmal: n = 74]; group 2: n = 80 [paroxysmal: n = 65], similar baseline characteristics) were included. PVI was reached in all, but procedure duration (82 ± 18 minutes vs 100 ± 22 minutes; P < .0001) and radiofrequency (RF) time (23 ± 5 minutes vs 36 ± 11 minutes; P < .0001) was shorter in group 2. First pass isolation was similar in groups 2 and 1 (left veins: 94% vs 90%; P = .42 and right veins: 83% vs 84%; P = .79, respectively). Six‐month off‐ antiarrhythmic drugs freedom of AF/AT was similar in groups 2 and 1 (82% [paroxysmal: 86%] vs 83% [paroxysmal: 88%]; P = .93, respectively). Major complications were similar (group 2: 1% vs group 1: 3%; P = .39).
Conclusion
A higher‐power short duration approach can shorten a CLOSE procedure and reduce ablation time without having a negative impact on safety or efficiency.
“…Ethical approval was obtained from the local committee, and informed consent was given by all patients before the procedure. In both groups, the CLOSE protocol, as described by Taghji et al was used, combining predefined ablation index (AI) targets and an interlesion distance (ILD) of ≤6 mm.…”
Introduction
The CLOSE protocol combines ablation index (AI) and ≤6 mm interlesion distance using standard power settings for the treatment of atrial fibrillation (AF). The purpose was to compare the safety and efficacy of a conventional CLOSE and a higher power shorter duration (HPSD)‐CLOSE pulmonary vein isolation (PVI) strategy.
Methods and Results
All consecutive patients referred for PVI were included after informed consent was obtained from them. Group 1 was treated with a standard CLOSE protocol and group 2 with a HPSD‐CLOSE protocol (45 W anterior and 35 W posterior). Procedural parameters and 6‐month follow‐up were analyzed. In total, 174 patients (group 1: n = 94 [paroxysmal: n = 74]; group 2: n = 80 [paroxysmal: n = 65], similar baseline characteristics) were included. PVI was reached in all, but procedure duration (82 ± 18 minutes vs 100 ± 22 minutes; P < .0001) and radiofrequency (RF) time (23 ± 5 minutes vs 36 ± 11 minutes; P < .0001) was shorter in group 2. First pass isolation was similar in groups 2 and 1 (left veins: 94% vs 90%; P = .42 and right veins: 83% vs 84%; P = .79, respectively). Six‐month off‐ antiarrhythmic drugs freedom of AF/AT was similar in groups 2 and 1 (82% [paroxysmal: 86%] vs 83% [paroxysmal: 88%]; P = .93, respectively). Major complications were similar (group 2: 1% vs group 1: 3%; P = .39).
Conclusion
A higher‐power short duration approach can shorten a CLOSE procedure and reduce ablation time without having a negative impact on safety or efficiency.
“…Recently, the pivotal role of contiguity of RF circumferential PVI was re‐emphasized by the so‐called CLOSE protocol . As discussed before, this technique with short and contiguous interlesion steps of point‐by‐point application using single‐tip ablation remains manually difficult and time‐consuming.…”
Introduction
The critical question for technological advancement of catheter ablation of atrial fibrillation (AF) is whether a creative new concept can combine and even improve the options of single‐tip catheters with the simplicity of the use of balloon catheters. Herein are described the results from the first clinical study of a new multielectrode contact‐mapping plus ablation array (Globe) offering such a complete solution.
Methods and Results
The multielectrode Globe array consists of 16 flat ribs with 122 gold‐plated electrodes. Each electrode can record electrograms, ablate, pace, and can measure tissue contact and temperature. Single‐shot pulmonary vein isolation (PVI) is possible with temperature‐guided ablation of up to 24 electrodes simultaneously with automatic, individual power control of every electrode. Sixty patients with symptomatic AF underwent PVI using the Globe. In all sixty patients, acute PVI was achieved in 232 of 234 attempted PVs (99.1%). In 34 patients treated with “single‐hot‐shot” ablation, PVI was achieved in 136 of 136 PVs (100%). Single‐procedure 12‐month freedom from AF off antiarrhythmic drugs in the “single‐hot‐shot” group was 75.5% and freedom from AF/atrial tachycardia 72.3%. In two patients, pericardial tamponade was observed, one after a transseptal puncture, and one during array insertion with an over‐advanced sheath. There were no other device‐related serious adverse events, including stroke, PV stenosis, esophageal perforation, or phrenic nerve palsy.
Conclusions
In this first clinical series, the Globe catheter was found to be an easy‐to‐use system for single‐shot PVI. The continuously updated multielectrode voltage and activation mapping data indicate future options for mapping and ablation beyond PVI.
“…20 It was therefore hypothesised that an RF strategy aiming to enclose the PVs with strict criteria for lesion depth and ILD would lead to durable PV isolation. 21 This CLOSE protocol was evaluated in >400 patients with PAF. The protocol involved creating one prespecified circle enclosing the veins.…”
Section: Towards a Standardised Protocol For Durable Pvi: The Close Pmentioning
confidence: 99%
“…Using the CARTO VISITAG Module and respiratory gating, the lesion marker settings were based upon stability ( Recently, procedural-and 1-year outcome in 130 patients with PAF were reported by Taghji et al 21 An unprecedented high rate of acute durable PV isolation (98 % adenosine-proof isolation) was AER_Duytschaever_FINAL.indd 220 05/12/2017 18:01…”
Section: Towards a Standardised Protocol For Durable Pvi: The Close Pmentioning
To improve the single-procedural success and long-term outcomes of catheter ablation techniques for AF, there is a need for durable, contiguous and transmural lesions encircling the pulmonary veins (PV). Measurement of contact force (CF) between the catheter tip and the target tissue can optimise ablation procedures. A new approach to obtain single-procedure durable PV isolation (PVI) using the latest CF technology combined with the CARTO VISITAG ™ Module with Ablation Index (Biosense Webster) has been shown in small studies to almost eliminate recurrence of paroxysmal AF at 1-year follow up and to make PVI procedures more reproducible. The use of a standardised workflow is expected to increase the reproducibility of results and to increase the efficiency of PVI procedures.
KeywordsCatheter ablation, contact force, pulmonary vein isolation, CARTO VISITAG™ Module, ablation index Disclosure: Mark O'Neill has received research support, honoraria and consulting fees from Biosense Webster; and research support, honoraria and consulting fees from Abbott/St Jude. Mattias Duytschaever has received honoraria for presentation and consulting from Biosense Webster.
Acknowledgement:The authors are grateful to the technical editing support provided by Katrina Mountfort of Medical Media Communications (Scientific) Ltd, which was funded by Biosense Webster.
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Diagnostic Electrophysiology and Ablation
Clinical Impact of Contact Force TechnologiesOptimising Outcomes in Pulmonary Vein Isolation
What About Randomised Trials?The importance of optimal contact has been demonstrated in the prospective randomised non-inferiority Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) study, which compared the TactiCath catheter with a non-CF-sensing catheter (NAVISTAR ® ThermoCool ® ;Biosense Webster) in 300 patients undergoing catheter ablation of PAF. 14 When the CF arm was stratified into optimal CF (≥90 % ablations with ≥10 g) and non-optimal CF groups, effectiveness was achieved in 75.9 % versus 58.1 %, respectively (p=0.018).In a recent randomised trial performed at seven UK centres, 117 patients undergoing first-time PAF ablation were randomised to ablation with (CF-on) or without (CF-off) CF data available to the operator. A reduction in acute PV reconnection rates was seen in the CF-on group (22 % versus 32 %, p=0.03) but there was no significant difference in 1-year success rates (49 % versus 52 %, p=0.9). Furthermore, there was no difference in major complication rates, procedural times and fluoroscopy times. The investigators concluded that CF data availability as used in this study was associated with improved catheter control but did not impact on the clinical outcome. This confirms that CF is only one of multiple factors that determine lesion efficacy and safety.
15Three other small prospective randomised studies have compared CF versus non-CF-sensing catheter ablation. These studies have shown that some operators are able to est...
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