Dataset Information

Comparison of the Efficacy of PVAC® and nMARQ™ for paroxysmal atrial fibrillation.

ABSTRACT: Pulmonary vein isolation (PVI) has become the mainstay of therapy for atrial fibrillation (AF) and one of the most frequently performed procedures in the cardiac electrophysiology laboratory. PVI by a single-tip radiofrequency (RF) ablation catheter remains a complex and time-consuming procedure, especially in centers with limited experience. In order to simplify the PVI procedure, to shorten it and reduce the complication rate, circular multi-electrode catheters were introduced for simultaneous mapping and ablation. The common concept of these "single-shot" AF ablation technologies is the creation of circular lesions for PVI by placing the ablation device at the antrum of the pulmonary veins without the need for continuous repositioning. In this review we describe the main features of two circular non-balloon ablation catheters- PVAC®, which is based on the phased RF, duty-cycled ablation technology, and nMARQ™, the irrigated multi-electrode electro-anatomically guided catheter - and compare the clinical outcomes of these technologies, mainly for paroxysmal AF patients, based on current available data.

SUBMITTER: Laish-Farkash A

PROVIDER: S-EPMC5673342 | biostudies-literature | 2017 Apr-May

REPOSITORIES: biostudies-literature

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Comparison of the Efficacy of PVAC<sup>®</sup> and nMARQ<sup>™</sup> for paroxysmal atrial fibrillation.

Laish-Farkash Avishag A Suleiman Mahmoud M

Journal of atrial fibrillation 20170430 6

Pulmonary vein isolation (PVI) has become the mainstay of therapy for atrial fibrillation (AF) and one of the most frequently performed procedures in the cardiac electrophysiology laboratory. PVI by a single-tip radiofrequency (RF) ablation catheter remains a complex and time-consuming procedure, especially in centers with limited experience. In order to simplify the PVI procedure, to shorten it and reduce the complication rate, circular multi-electrode catheters were introduced for simultaneous ...[more]

PMID: 29250292

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Project description:BackgroundThe optimal rhythm management strategy for people with non-paroxysmal (persistent or long-standing persistent) atrial fibrilation is currently not well defined. Antiarrhythmic drugs have been the mainstay of therapy. But recently, in people who have not responded to antiarrhythmic drugs, the use of ablation (catheter and surgical) has emerged as an alternative to maintain sinus rhythm to avoid long-term atrial fibrillation complications. However, evidence from randomised trials about the efficacy and safety of ablation in non-paroxysmal atrial fibrillation is limited.ObjectivesTo determine the efficacy and safety of ablation (catheter and surgical) in people with non-paroxysmal (persistent or long-standing persistent) atrial fibrillation compared to antiarrhythmic drugs.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, conference abstracts, clinical trial registries, and Health Technology Assessment Database. We searched these databases from their inception to 1 April 2016. We used no language restrictions.Selection criteriaWe included randomised trials evaluating the effect of radiofrequency catheter ablation (RFCA) or surgical ablation compared with antiarrhythmic drugs in adults with non-paroxysmal atrial fibrillation, regardless of any concomitant underlying heart disease, with at least 12 months of follow-up.Data collection and analysisTwo review authors independently selected studies and extracted data. We evaluated risk of bias using the Cochrane 'Risk of bias' tool. We calculated risk ratios (RRs) for dichotomous data with 95% confidence intervals (CIs) a using fixed-effect model when heterogeneity was low (I² <= 40%) and a random-effects model when heterogeneity was moderate or substantial (I² > 40%). Using the GRADE approach, we evaluated the quality of the evidence and used the GRADE profiler (GRADEpro) to import data from Review Manager 5 to create 'Summary of findings' tables.Main resultsWe included three randomised trials with 261 participants (mean age: 60 years) comparing RFCA (159 participants) to antiarrhythmic drugs (102) for non-paroxysmal atrial fibrillation. We generally assessed the included studies as having low or unclear risk of bias across multiple domains, with reported outcomes generally lacking precision due to low event rates. Evidence showed that RFCA was superior to antiarrhythmic drugs in achieving freedom from atrial arrhythmias (RR 1.84, 95% CI 1.17 to 2.88; 3 studies, 261 participants; low-quality evidence), reducing the need for cardioversion (RR 0.62, 95% CI 0.47 to 0.82; 3 studies, 261 participants; moderate-quality evidence), and reducing cardiac-related hospitalisation (RR 0.27, 95% CI 0.10 to 0.72; 2 studies, 216 participants; low-quality evidence) at 12 months follow-up. There was substantial uncertainty surrounding the effect of RFCA regarding significant bradycardia (or need for a pacemaker) (RR 0.20, 95% CI 0.02 to 1.63; 3 studies, 261 participants; low-quality evidence), periprocedural complications, and other safety outcomes (RR 0.94, 95% CI 0.16 to 5.68; 3 studies, 261 participants; very low-quality evidence).Authors' conclusionsIn people with non-paroxysmal atrial fibrillation, evidence suggests a superiority of RFCA to antiarrhythmic drugs in achieving freedom from atrial arrhythmias, reducing the need for cardioversion, and reducing cardiac-related hospitalisations. There was uncertainty surrounding the effect of RFCA with significant bradycardia (or need for a pacemaker), periprocedural complications, and other safety outcomes. Evidence should be interpreted with caution, as event rates were low and quality of evidence ranged from moderate to very low.

Project description:BackgroundCryoballoon ablation (CBA) is recommended for patients with symptomatic drug refractory paroxysmal atrial fibrillation (pAF). However, substantial atrial fibrillation (AF) recurrence is common during follow-up. Searching for a potential biomarker representing both myocardial injury and inflammation to identify patients at high risk of AF recurrence after CBA is very meaningful for postoperative management of AF patients.HypothesisTo evaluate the clinical efficacy of high-mobility group box 1 (HMGB1) protein released from the left atrium to predict AF recurrence in pAF patients after CBA at 1-year follow-up.MethodsWe included 72 pAF patients who underwent CBA. To determine the expression levels of HMGB1, left atrial blood samples were collected from the patients before CBA and after the procedure through the transseptal sheath. Patients were followed up for AF recurrence for 1 year.ResultsA total of 19 patients of the 72 experienced AF recurrence. The level of postoperative HMGB1 (HMGB1post) was higher in the AF recurrence group than in the AF non recurrence group (p = .03). However, no differences were noted in the levels of other biomarkers such as preoperative high-sensitivity C-reactive protein (hs-CRP), postoperativehs-CRP, and preoperative HMGB1 between the two groups. Multiple logistic regression analysis revealed that a higher level of serum HMGB1post was associated with AF recurrence (odds ratio: 5.29 [1.17-23.92], p = .04). Receiver operating characteristic analysis revealed that HMGB1post had a moderate predictive power for AF recurrence (area under the curve: 0.68; sensitivity: 72%; and specificity: 68%). The 1-year AF-free survival was significantly lower in patients with a high HMGB1post level than in those with a low HMGB1post level (hazard ratio: 3.81 [1.49-9.75], p = .005).ConclusionIn pAF patients who under went CBA, the level of HMGB1 after CBA was associated with AF recurrence and demonstrated a moderate predictive power. Thus, we offer a potential biomarker to identify pAF patients at high risk of AF recurrence.

Dataset Information

Comparison of the Efficacy of PVAC® and nMARQ™ for paroxysmal atrial fibrillation.

Publications

Comparison of the Efficacy of PVAC<sup>®</sup> and nMARQ<sup>™</sup> for paroxysmal atrial fibrillation.

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