Dataset Information

Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation.

ABSTRACT:

Purpose

The aim was to report procedural and technical differences of a novel cryoballoon (NCB) ablation catheter for pulmonary vein isolation (PVI) compared to the standard cryoballoon (SCB) catheter.

Methods

Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB were included. Procedural parameters, technical differences, acute efficacy, and safety are reported.

Results

Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, left atrial volume index 40 ± 6 ml/m²) were studied. With the NCB, 156 of 158 PVs (99%) were isolated compared to isolation of 159 of 159 PVs (100%) with the SCB. The median number of freezes in the NCB and the SCB group was 6 (IQR 5-8) and 5 (IQR 4-7), respectively (p = 0.051), with 73% and 71% of the PVs isolated with a single freeze, respectively. Nadir temperature and temperature at isolation were - 59 ± 6 °C and - 45 ± 17 °C in the NCB group and - 46 ± 7 °C and - 32 ± 23 °C in the SCB group, respectively (both p < 0.001) with no difference in time to isolation (TTI). Procedural differences were observed for the total procedure time (84 ± 29 min in the NCB group and 65 ± 17 min in the SCB group, p = 0.003). There was a peri-procedural stroke in one patient in the NCB group. Differences in catheter design were observed that may account for the differences in temperature recordings and ice cap formation.

Conclusions

Acute efficacy and TTI were similar with the NCB compared to the SCB. Measured temperatures were lower with the NCB, most likely due to differences in catheter design.

SUBMITTER: Knecht S

PROVIDER: S-EPMC9399022 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation.

Knecht Sven S Sticherling Christian C Roten Laurent L Badertscher Patrick P Chollet Laurève L Küffer Thomas T Spies Florian F Madaffari Antonio A Mühl Aline A Baldinger Samuel H SH Servatius Helge H Osswald Stefan S Reichlin Tobias T Kühne Michael M

Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing 20210728 2

<h4>Purpose</h4>The aim was to report procedural and technical differences of a novel cryoballoon (NCB) ablation catheter for pulmonary vein isolation (PVI) compared to the standard cryoballoon (SCB) catheter.<h4>Methods</h4>Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB were included. Procedural parameters, technical differences, acute efficacy, and safety are reported.<h4>Results</h4>Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, le ...[more]

PMID: 34319493

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Project description:IntroductionAblation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF).MethodsIndividual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9-15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037-1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted.ResultsPrimary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27-0.95) and matched (0.42, 0.21-0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20-0.85), age and left ventricular ejection fraction (0.37, 0.16-0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13-0.71). Secondary and sensitivity analyses showed similar reductions.ConclusionsRadiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons.

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

Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation.

Purpose

Methods

Results

Conclusions

Publications

Technical and procedural comparison of two different cryoballoon ablation systems in patients with atrial fibrillation.

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