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

Ullah, Waqas; McLean, Ailsa; Tayebjee, Muzahir H.; Gupta, Dhiraj; Ginks, Matthew; Haywood, Guy A.; O’Neill, Mark; Lambiase, Pier D.; Earley, Mark J.; Schilling, Richard J.

doi:10.1016/j.hrthm.2016.05.011

Cited by 140 publications

(117 citation statements)

References 31 publications

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“…6 A recent randomized, multicenter study, however, showed that CF data availability was associated with reduced acute PV reconnections but not improved 1-year success rates, procedure and fluoroscopy times, or complication rates. 7 The failure of CF monitoring to improve clinical outcome of AF ablation might be due to a lack of information on the catheter stability as well as the precise location of ablated lesions, and subsequent heterogeneous ablation intensity. A new ablation annotation system (CARTO3 System, PVI: Guided Novel Annotation 0.67 mL/min/kg for 15 s, followed by a saline bolus flush.…”

Section: Subjectsmentioning

confidence: 99%

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Automated Ablation Annotation Algorithm Reduces Re-conduction of Isolated Pulmonary Vein and Improves Outcome After Catheter Ablation for Atrial Fibrillation

Tanaka

Inoue

Toyoshima

et al. 2017

Circ J

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VISITAG Module) uses an algorithm for the automated annotation of RF ablation applications based on objective, predefined parameters. Because it provides crucial information on catheter stability and ablation intensity at each site, it may be helpful in accomplishing durable PVI.The aim of this study was therefore to evaluate the utility of automated ablation lesion annotation by comparing procedure parameters and outcomes between automated annotation-guided and non-guided procedures. Methods SubjectsThe study was conducted under a retrospective, singlecenter observational design. We included 91 AF patients who underwent initial PVI by an experienced operator between June 2013 and January 2015. We performed 51 initial AF ablations from June 2014 to January 2015. We C atheter ablation (CA) is an effective therapy of atrial fibrillation (AF). The cornerstone of CA for AF is pulmonary vein isolation (PVI). 1,2 Despite initially successful PVI, however, recurrence of AF after CA occurs frequently and is often related to the recovery of conduction between the pulmonary vein (PV) and left atrium (LA). 3-5 Contact force (CF) monitoring of the ablation catheter might help achieve more durable lesions and substantially improve procedural outcomes. 6 A recent randomized, multicenter study, however, showed that CF data availability was associated with reduced acute PV reconnections but not improved 1-year success rates, procedure and fluoroscopy times, or complication rates. 7 The failure of CF monitoring to improve clinical outcome of AF ablation might be due to a lack of information on the catheter stability as well as the precise location of ablated lesions, and subsequent heterogeneous ablation intensity. Background: Durable pulmonary vein isolation (PVI) is critical in reducing recurrence after radiofrequency catheter ablation for atrial fibrillation (AF). The VISITAG Module, an automatic annotation system that takes account of catheter stability and contact force (CF), might be useful in accomplishing this.

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Section: Subjectsmentioning

confidence: 99%

“…7 The failure of CF monitoring to improve clinical outcomes of AF ablation might be due to a lack of information on catheter stability during energy delivery, and heterogeneous RF ablation intensity. If so, real-time information on catheter stability and ablation intensity would possibly improve lesion completeness.…”

Section: Efficacy Of Visitag Modulementioning

confidence: 99%

Automated Ablation Annotation Algorithm Reduces Re-conduction of Isolated Pulmonary Vein and Improves Outcome After Catheter Ablation for Atrial Fibrillation

Tanaka

Inoue

Toyoshima

et al. 2017

Circ J

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“…This confirms that CF is only one of multiple factors that determine lesion efficacy and safety. 15 Three other small prospective randomised studies have compared CF versus non-CF-sensing catheter ablation. These studies have shown that some operators are able to estimate CF with a high degree of accuracy when CF information is not available and may explain why, when the CF information was available, none of these studies demonstrated a statistically significant improvement in long-term outcomes.…”

Section: Clinical Impact Of Contact Force Technologiesmentioning

confidence: 99%

Increasing the Single-Procedure Success Rate of Pulmonary Vein Isolation

Duytschaever

O’Neill

Martinek

2017

Arrhythmia &Amp; Electrophysiology Review

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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. Received A R R H Y T H M I A & E L E C T R O P H Y S I O L O G Y R E V I E W 218 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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“…Additionally, a recent randomized head-to-head comparison study that sought to see if contact force improved results demonstrated that, despite contact force data being associated with reduced acute PV reconnection, it did not improve oneyear success rates. 30 Though contact force information is helpful, many operators prefer other options because contact force catheters are often stiff and unwieldy. If an operator does choose to use a contact force catheter, then expert guidelines recommend a starting point minimum targeted contact force of 5 g to 10 g (Class IIa, LOE C).…”

Section: Ablation Lesion Formationmentioning

confidence: 99%

Atrial Fibrillation Catheter Ablation: Overcoming Complications and Improving Success

Mathew

2017

J Innov Cardiac Rhythm Manage

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ABSTRACT. Careful patient selection and optimization of the management of active medical conditions prior to proceeding with catheter ablation for atrial fibrillation (AF) is critical to reducing complications and improving ablation success. AF ablation performed on patients who have not been offered appropriate antiarrhythmic drug therapy must be tempered with the procedure risks, particularly for those patients having multiple comorbidities. The inability to comply with systemic anticoagulation for thromboembolic prophylaxis in AF is a contraindication to AF ablation, as premature termination of anticoagulation therapy can lead to catastrophic thromboembolic complications. Successful pulmonary vein isolation (PVI), the cornerstone of AF ablation, is demonstrated by entrance and exit block post ablation, with sustained absence of atrium-to-pulmonary vein conduction in both directions. Beyond PVI, there is no consensus for other endpoints for AF ablation, particularly in patients with persistent or longstanding persistent AF. Complications of PVI for AF have decreased in recent years as technology and knowledge in this field has evolved; however, the risks of cardiac tamponade, thromboembolic complications, esophageal injury, and pulmonary vein stenosis may still be formidable.

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

Cited by 140 publications

References 31 publications

Automated Ablation Annotation Algorithm Reduces Re-conduction of Isolated Pulmonary Vein and Improves Outcome After Catheter Ablation for Atrial Fibrillation

Automated Ablation Annotation Algorithm Reduces Re-conduction of Isolated Pulmonary Vein and Improves Outcome After Catheter Ablation for Atrial Fibrillation

Increasing the Single-Procedure Success Rate of Pulmonary Vein Isolation

Atrial Fibrillation Catheter Ablation: Overcoming Complications and Improving Success

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