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Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial.

ABSTRACT: Introduction:The value of contact force information for ablation of LA anterior line is unknown. In a prospective randomized clinical trial, we investigated if information on contact force during left atrial (LA) anterior line ablation reduces total radiofrequency time and results in higher rates of bidirectional line block in patients undergoing pulmonary vein isolation (PVI) plus substrate modification. Methods:We included patients with indication for pulmonary vein isolation (PVI) and additional substrate modification. For LA anterior line ablation, patients were randomized to contact force information visible (n=35) or blinded (n=37). Patients received contrast enhanced cardiac magnetic resonance imaging (cMRI) before and 3-6 months after ablation to visualize the LA anterior line. Primary endpoint was radiofrequency time to achieve bidirectional line block. Secondary endpoints were completeness of the LA anterior line on cMRI, distribution of contact force, procedural data, adverse events, and 12 months success rate. Results:In 72 patients (64±9 years, 68% male), bidirectional LA anterior line block was achieved in 70 (97%) patients. Radiofrequency time to bidirectional block did not differ significantly across groups (contact force information visible 23±18min versus contact force information blinded 21±15min, p=0.50). The LA anterior line was discernable on cMRI in 40 patients (82%) without significant differences across randomization groups (p=0.46). No difference in applied contact force was found depending on cMRI line visibility. Twelve-month success and adverse event rates were comparable across groups. Conclusion:Information on contact force does not significantly improve the ablation of LA anterior lines. Clinical Trial Registration:The trial was registered at http://www.clinicaltrials.gov by identifier: NCT02217657.

SUBMITTER: Fichtner S

PROVIDER: S-EPMC6167597 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial.

Fichtner Stephanie S Wakili Reza R Rizas Konstantinos K Siebermair Johannes J Sinner Moritz F MF Wiktor Thomas T Lackermair Korbinian K Schuessler Franziska F Olesch Lucia L Rainer Susanne S Kääb Stefan S Curta Adrian A Kramer Harald H Estner Heidi L HL

BioMed research international 20180918

<h4>Introduction</h4>The value of contact force information for ablation of LA anterior line is unknown. In a prospective randomized clinical trial, we investigated if information on contact force during left atrial (LA) anterior line ablation reduces total radiofrequency time and results in higher rates of bidirectional line block in patients undergoing pulmonary vein isolation (PVI) plus substrate modification.<h4>Methods</h4>We included patients with indication for pulmonary vein isolation (P ...[more]

PMID: 30320138

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Project description:BACKGROUND:Lone atrial fibrillation (AF) may reflect a subclinical cardiomyopathy that persists after sinus rhythm (SR) restoration, providing a substrate for AF recurrence. To test this hypothesis, we investigated the effect of restoring SR by catheter ablation on left ventricular (LV) function and energetics in patients with AF but no significant comorbidities. METHODS:Fifty-three patients with symptomatic paroxysmal or persistent AF and without significant valvular disease, uncontrolled hypertension, coronary artery disease, uncontrolled thyroid disease, systemic inflammatory disease, diabetes mellitus, or obstructive sleep apnea (ie, lone AF) undergoing ablation and 25 matched control subjects in SR were investigated. Magnetic resonance imaging quantified LV ejection fraction (LVEF), peak systolic circumferential strain (PSCS), and left atrial volumes and function, whereas phosphorus-31 magnetic resonance spectroscopy evaluated ventricular energetics (ratio of phosphocreatine to ATP). AF burden was determined before and after ablation by 7-day Holter monitoring; intermittent ECG event monitoring was also undertaken after ablation to investigate for asymptomatic AF recurrence. RESULTS:Before ablation, both LV function and energetics were significantly impaired in patients compared with control subjects (LVEF, 61% [interquartile range (IQR), 52%-65%] versus 71% [IQR, 69%-73%], P<0.001; PSCS, -15% [IQR, -11 to -18%] versus -18% [IQR, -17% to -19%], P=0.002; ratio of phosphocreatine to ATP, 1.81±0.35 versus 2.05±0.29, P=0.004). As expected, patients also had dilated and impaired left atria compared with control subjects (all P<0.001). Early after ablation (1-4 days), LVEF and PSCS improved in patients recovering SR from AF (LVEF, 7.0±10%, P=0.005; PSCS, -3.5±4.3%, P=0.001) but were unchanged in those in SR during both assessments (both P=NS). At 6 to 9 months after ablation, AF burden reduced significantly (from 54% [IQR, 1.5%-100%] to 0% [IQR 0%-0.1%]; P<0.001). However, LVEF and PSCS did not improve further (both P=NS) and remained impaired compared with control subjects (P<0.001 and P=0.003, respectively). Similarly, there was no significant improvement in atrial function from before ablation (P=NS), and this remained lower than in control subjects (P<0.001). The ratio of phosphocreatine to ATP was unaffected by heart rhythm during assessment and AF burden before ablation (both P=NS). It was unchanged after ablation (P=0.57), remaining lower than in control subjects regardless of both recovery of SR and freedom from recurrent AF (P=0.006 and P=0.002, respectively). CONCLUSIONS:Patients with lone AF have impaired myocardial energetics and subtle LV dysfunction, which do not normalize after ablation. These findings suggest that AF may be the consequence (rather than the cause) of an occult cardiomyopathy, which persists despite a significant reduction in AF burden after ablation.

Project description:BACKGROUND:Multiple studies have demonstrated the importance of adequate catheter-tissue contact in the creation of effective lesions during radiofrequency catheter ablation. The development of contact force (CF)-sensing catheters has contributed significantly to improve clinical outcomes in atrial fibrillation. However, CF-sensing technology is not used in the ablation of paroxysmal supraventricular tachycardia (PSVT). The possible reason for this is that PSVT ablation with the conventional approach (i.e. nonirrigated, non-CF-sensing catheters) is considered a relatively low-risk procedure with fairly high success rates (short and long term). The aim of this study is to determine whether CF sensing can further improve the outcomes of PSVT ablation. METHODS/DESIGN:The COBRA-PATH study is a single-center, two-armed, randomized controlled trial. Patients without structural heart disease being referred for electrophysiology study, because of PSVT and potential treatment with radiofrequency (RF) catheter ablation, will be randomly assigned to either manual ablation with standard nonirrigated ablation catheters or manual ablation with an open-irrigated ablation catheter equipped with CF sensing (used in a virtual nonirrigated modus). The primary study endpoint is the difference in the number of RF applications during the ablation of atrioventricular nodal re-entry tachycardia, and that of Wolff-Parkinson-White syndrome and atrioventricular re-entrant tachycardia. Secondary outcome parameters include acute and long-term procedural success rates, overall duration of RF applications, procedure/fluoroscopy durations and safety parameters. DISCUSSION:We expect to see a reduced number/duration of RF applications required to achieve effective lesion creation, and consequently a decrease in total procedure/fluoroscopy times. Although a significant improvement in procedural success rates (acute/long term) might not be feasible to demonstrate (given the relatively high success rate of the standard ablation method), the possible decrease in procedure duration and the consequential reduction of radiation exposure has important clinical implications for both operators and patients undergoing the procedure. TRIAL REGISTRATION:ClinicalTrials, NCT04078685. Retrospectively registered on 2 September 2019.

Dataset Information

Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial.

Publications

Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial.

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