EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation

Kautzner, Josef; Neužil, Petr; Lambert, Hendrik; Peichl, Petr; Petrů, Jan; Čihák, Robert; Škoda, J.; Wichterle, Dan; Wißner, Erik; Yulzari, Aude; Kück, Karl‐Heinz

doi:10.1093/europace/euv057

Cited by 344 publications

(316 citation statements)

References 24 publications

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“…The recommendations of CF parameters in PVI procedures include a target average CF value of 10-30 g and a minimum FTI value of 400 g for each RF lesion. 5,14,15 Another landmark study, TOCCASTAR by Reddy et al, confirmed the importance of using CF-guided strategies in meeting primary safety and effectiveness endpoints in PVI ablation procedures. 16 In results published by Neuzil et al, 10 evidence has been offered that supports the concept that an LSI of greater than 5 predicts reconnection risk in PVI ablation.…”

Section: Discussionmentioning

confidence: 94%

“…Hence, an FTI Z400 g/s has been suggested as a surrogate end-point to predict the creation of transmural lesions in RF. 5,6 Booth et al recently highlighted the new real-time CF parameter of lesion size index (LSI). This novel parameter incorporates RF power, ablation duration, and CF in a dimensionless ratio independent of traditional parameters.…”

Section: Introductionmentioning

confidence: 99%

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Lesion Size Index in Maximum Voltage-Guided Cavotricuspid Ablation for Atrial Flutter

Boles

Gül

Fitzpatrick

et al. 2017

JICRM

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ABSTRACT. The application of optimum contact force (CF) can be used to improve ablation procedure success and safety. The lesion size index (LSI) is a novel dimensionless contact force parameter that allows for an accurate estimation of lesion volume in real time by integrating contact force (grams), duration (seconds) and power (watts). The aim was to correlate LSI values with current contact force parameters to achieve successful and safe bidirectional block of the cavotricuspid isthmus (CTI) using a maximum voltage-guided (MVG) ablation strategy. Fifteen consecutive patients (age 69±7.9 years, nine males) with symptomatic atrial flutter (AFL) were evaluated and compared with 23 control (age 66.3 ± 10.4 years, 16 males) non-contact forceguided ablation cases. Irrigated-tip force-sensing ablation catheters (TactiCath Quartzt, St. Jude Medical, St. Paul, MN, USA) were used in the CF group to achieve the primary endpoint of complete bidirectional block of the isthmus. In the CF group, a total of 233 radiofrequency (RF) applications were examined. A mean LSI of 6.4 ± 1.0 correlated with a force-time integral (FTI) of 581.2±230.9 g/s and an average CF of 13.9±4.9 g concurrently. Intraprocedural, fluoroscopy time and RF time demonstrated lower trends in the CF group, but no significance with respect to these trends was observed. The secondary endpoint of no reconnection within 20 min after the procedure was equally attained in both groups, and, likewise, the level of safety was comparable. An LSI value of 45 represents a new effective parameter in MVG ablation for the cavotricuspid region that demonstrates a safe profile. Guidance of CTI ablation using LSI and other contact force parameters of CF 13.9 ± 4.9 g and FTI 581.2 ± 230.9 g/s demonstrated highly effective and safe outcomes.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Lesion Size Index in Maximum Voltage-Guided Cavotricuspid Ablation for Atrial Flutter

Boles

Gül

Fitzpatrick

et al. 2017

JICRM

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“…Six (5%) of the 124 patients withdrew their consent during follow-up and were excluded from the study, resulting in a total of 118 Duration of AF, mo 12 [7,24] 12 [7,24] 12 [7,24] Type of AF Persistent 69 (59) 35 (57) 34 (60) Long-standing persistent 49 (42) 26 (43) 23 (40) CAD 11 (9) 5 (8) 6 (11) Valvular disease 14 (12) 8 (13) 6 (11) Hypertension 64 (54) 35 (57) 29 (51) Diabetes mellitus 9 (8) 5 (8) 4 (7) CHADS 2 score (87) 52 (85) 51 (90) 2-3 14 (12) 8 (13) 6 (11) Values are mean±SD, median [first quartile, third quartile], or n (%). AF indicates atrial fibrillation; BMI, body mass index; CAD, coronary artery disease; CHADS 2 , stroke risk score based on congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke/transient ischemic attack/thromboembolism; CHA 2 DS 2 -VASc, stroke risk score based on congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke/ transient ischemic attack/thromboembolism, vascular disease, age 65-74 years, sex; LA, left atrium; and LVEF, left ventricular ejection fraction.…”

Section: Patientsmentioning

confidence: 99%

“…Contact force-sensing catheters were not used. The EFFICAS I and II studies (TactiCath Prospective Effectiveness) have shown a reduction in gap formation around the PVs when ablation was guided by contact force sensing, 23,24 but, to date, a randomized controlled trial showing better clinical outcomes associated with contact force-guided ablation is lacking. Follow-up did not use loop recorder systems.…”

Section: Fink Et Al Catheter Ablation Strategies For Persistent Af LImentioning

confidence: 99%

Stand-Alone Pulmonary Vein Isolation Versus Pulmonary Vein Isolation With Additional Substrate Modification as Index Ablation Procedures in Patients With Persistent and Long-Standing Persistent Atrial Fibrillation

Fink

Schlüter

Heeger

et al. 2017

Circ: Arrhythmia and Electrophysiology

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150

105

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C atheter ablation has become a routine treatment option for patients experiencing symptomatic paroxysmal atrial fibrillation (AF). Long-term clinical success rates of ≤80% after 5 years have been reported for the treatment of paroxysmal AF by initial stand-alone pulmonary vein isolation (PVI) as the accepted cornerstone of all AF ablation strategies; however, to achieve permanent PVI, multiple procedures are often required. 1,2 In contrast, the results for ablation of persistent AF are less convincing. 3 The optimal strategy for persistent AF is not known, and previous studies investigating more extensive ablation strategies in addition to PVI demonstrated heterogeneous results. [4][5][6][7][8][9][10][11][12] The recently published STAR AF 2 trial (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial) compared initial stand-alone PVI to PVI with additional ablation of complex fractionated atrial electrograms (CFAEs) or additional linear ablation and could not demonstrate a superior outcome for the additional ablation strategies. 13 The prospective and randomized Alster-Lost-AF © 2017 American Heart Association, Inc. Original ArticleBackground-Pulmonary vein isolation (PVI) for persistent atrial fibrillation is associated with limited success rates and often requires multiple procedures to maintain stable sinus rhythm. In the prospective and randomized Alster-Lost-AF trial (Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation), we sought to assess, in patients with symptomatic persistent or long-standing persistent atrial fibrillation, the outcomes of initial ablative strategies comprising either stand-alone PVI (PVI-only approach) or a stepwise approach of PVI followed by complex fractionated atrial electrogram ablation and linear ablation (Substrate-modification approach). Methods and Results-Patients were randomized 1:1 to stand-alone PVI or PVI plus substrate modification. The primary study end point was freedom from recurrence of any atrial tachyarrhythmia, outside a 90-day blanking period, at 12 months. A total of 124 patients were enrolled, with 118 patients included in the analysis (61 in the PVI-only group, 57 in the Substrate-modification group). Atrial tachyarrhythmias recurred in 28 PVI-only group patients and 24 Substratemodification group patients, for 1-year freedom from tachyarrhythmia recurrence after a single ablation procedure of 54% (95% confidence interval, 43%-68%) in the PVI-only and 57% (95% confidence interval, 46%-72%) in the Substratemodification group (P=0.86). Twenty-four patients in the PVI-only group (39%) and 18 in the Substrate-modification group (32%) were without arrhythmia recurrence and off antiarrhythmic drug therapy at the end of the 12-month follow-up. Conclusions-In

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“…Ablation was performed where the atrial myocardium connects to the PV sleeve, and typically with a >2 cm distance between the ablated anterior and posterior carina. Lesions were closely spaced: an ILD max ≤6 mm, based on previous study findings 20,22,23 and energy (35 W) was delivered to reach a minimal AI ≥400 at the posterior wall and ≥550…”

Section: Towards a Standardised Protocol For Durable Pvi: The Close Pmentioning

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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EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation

Cited by 344 publications

References 24 publications

Lesion Size Index in Maximum Voltage-Guided Cavotricuspid Ablation for Atrial Flutter

Lesion Size Index in Maximum Voltage-Guided Cavotricuspid Ablation for Atrial Flutter

Stand-Alone Pulmonary Vein Isolation Versus Pulmonary Vein Isolation With Additional Substrate Modification as Index Ablation Procedures in Patients With Persistent and Long-Standing Persistent Atrial Fibrillation

Increasing the Single-Procedure Success Rate of Pulmonary Vein Isolation

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