Dataset Information

Cryoballoon ablation guided by a novel wide-band dielectric imaging system.

ABSTRACT:

Background and aim

To investigate the feasibility, acute efficacy, periprocedural safety, and procedural parameters of CB-based PVI guided by KODEX-EPD using different occlusion tool software versions.

Methods and results

A total of 173 patients (60/173 (35%) paroxysmal AF, 64 ± 12 years, 66/173 (38%) female), underwent CB-based PVI guided by KODEX-EPD between August 2019 and October 2021. Acute PVI was achieved in all the patients. Total fluoroscopy time and dye volume were 13.9 [10.6-19.4] min and 47.5 [20-70] ml. Periprocedural complications occurred in 3 (2%) of the 173 patients. As part of the continued development program, different software versions were used, including 1.4.6 on 38 (22%), 1.4.6a on 33 (19%), 1.4.7 on 41 (24%), and 1.4.8 on 61 (35%) of the patients. Outcomes were compared between software versions by a univariate analysis. Sensitivity analyses were performed to account for confounders. Median fluoroscopy time was decreased by 6.4 min (37.3%), and the median volume of dye was decreased by 32.5 ml (52%) from versions 1.4.6 to 1.4.8. Software version was a significant predictor of fluoroscopy time and dye volume, while reductions in procedure duration and dose area product were observed but mainly explained via confounders.

Conclusion

CB-based PVI guided by KODEX-EPD is feasible and safe. Progressive software improvements appear to be associated with lower fluoroscopy duration and dye use. Further studies are needed to evaluate the advantage of KODEX-EPD-guided compared to conventional CB-PVI.

SUBMITTER: Rottner L

PROVIDER: S-EPMC9395685 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

Cryoballoon ablation guided by a novel wide-band dielectric imaging system.

Rottner Laura L Obergassel Julius J My Ilaria I Kirchhof Paulus P Ouyang Feifan F Reissmann Bruno B Metzner Andreas A Rillig Andreas A

Frontiers in cardiovascular medicine 20220809

<h4>Background and aim</h4>To investigate the feasibility, acute efficacy, periprocedural safety, and procedural parameters of CB-based PVI guided by KODEX-EPD using different occlusion tool software versions.<h4>Methods and results</h4>A total of 173 patients (60/173 (35%) paroxysmal AF, 64 ± 12 years, 66/173 (38%) female), underwent CB-based PVI guided by KODEX-EPD between August 2019 and October 2021. Acute PVI was achieved in all the patients. Total fluoroscopy time and dye volume were 13.9 ...[more]

PMID: 36017093

Similar Datasets

Project description:BackgroundCryoballoon ablation (CBA) for pulmonary vein isolation (PVI) is a standard in atrial fibrillation (AF) ablation but might not be enough in complex atrial arrhythmias (AA). An open three-dimensional wide-band dielectric imaging system (3D-WBDIS) has been introduced to guide CBA.Material and methodsPilot study evaluating feasibility and safety of 3D-WBDIS in combination with CBA and optional radiofrequency ablation (RFA) in patients with complex AA defined as (1) history of persistent AF, (2) additional atrial tachycardia/flutter, or (3) previous left atrial ablation.ResultsProspectively, seventeen patients, 68.9 ± 12.2 years of age, with complex AA were enrolled. In 70 pulmonary veins (PV), balloon positioning maneuvers (n = 129) were guided additionally by the occlusion tool (1.84/PV). Compared to angiography, its sensitivity and specificity was 94.5, and 85%, respectively. CBA-PVI was achieved in 100% of PVs including variants. In 68 maps, the median number of mapping points was 251.0 (interquartile range (IQR) 298.0) with a median map volume of 52.8 (IQR 83.9) mL. Following CBA, six additional arrhythmias (two right and two left atrial flutter, one left atrial appendage tachycardia, and one atrioventricular nodal reentry tachycardia) were identified and successfully ablated by means of RFA in five patients (29.4%). Left atrial and fluoroscopy times were 88 (IQR 40) and 20 (IQR 10) minutes, respectively. Dose area product was 1,100 (IQR 1252) cGyxcm2. Freedom from AA after 6 months follow-up time and 90 days blanking period was documented in 10/17 (59%) patients, and 8/17 (47%) without a blanking period. No major complication was observed.ConclusionThe combined use of CBA with optional RFA guided by a novel 3D-WBDIS is feasible and safe in patients suffering from complex AA. The occlusion tool shows high sensitivity and specificity for assessment of the balloon occlusion. Additional arrhythmias were successfully mapped and ablated. Short-term outcome is promising, and subsequent prospective, larger outcome studies are necessary to confirm our observations.

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.

Dataset Information

Cryoballoon ablation guided by a novel wide-band dielectric imaging system.

Background and aim

Methods and results

Conclusion

Publications

Cryoballoon ablation guided by a novel wide-band dielectric imaging system.

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