Dataset Information

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice-operator learning curve and procedural outcome at a high-volume center.

ABSTRACT:

Background

The novel multielectrode radiofrequency (RF) balloon catheter (HELIOSTAR™, Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining RF-ablation and 3D-mapping visualization with the concept of a "single-shot"-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the multielectrode RF-balloon at a high-volume center.

Methods

The first 40 patients undergoing PVI by multielectrode RF-balloon catheter at Heidelberg University Hospital were included in this prospective study. Procedural outcome was analyzed over the course of increasing experience with the device.

Results

157/157 pulmonary veins (PVs) were successfully isolated with the RF-balloon catheter, in 73.2% by a single RF-application. Median time to isolation (TTI) was 11.0 s (Q1 = 8.0 s; Q3 = 13.8 s). Median procedure time was 62.5 min (Q1 = 50.0 min; Q3 = 70.5 min). LA-dwell time was 28.5 min (Q1 = 23.3 min; Q3 = 36.5 min). Median fluoroscopy duration was 11.6 min (Q1 = 10.1 min; Q3 = 13.7 min). No serious procedure-related complications were observed, apart from one case of unclear, post-procedural acute-on-chronic kidney injury. With increasing operator experience, an additional reduction in procedure duration was observed.

Conclusion

Rapid implementation of a "single shot"-ablation device combining RF-ablation and 3D-mapping can be achieved with high acute procedural efficacy and safety at a high-volume center. Previous experience with "single-shot" ablation devices may be advantageous for time-efficient introduction of the novel RF-balloon catheter into clinical practice.

Clinical trial registration

ClinicalTrials.gov; Identifier NCT0560361.

SUBMITTER: Zylla MM

PROVIDER: S-EPMC10682364 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice-operator learning curve and procedural outcome at a high-volume center.

Zylla Maura M MM Starrach Lydia L Rahm Ann-Kathrin AK Thomas Dierk D Frey Norbert N Lugenbiel Patrick P

Frontiers in cardiovascular medicine 20231114

<h4>Background</h4>The novel multielectrode radiofrequency (RF) balloon catheter (HELIOSTAR™, Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining RF-ablation and 3D-mapping visualization with the concept of a "single-shot"-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the multielectrode RF-balloon at a high-volume center.<h4>Methods</h4>The first 40 patients undergoing ...[more]

PMID: 38034374

Similar Datasets

Project description:IntroductionThe safety and efficacy of paroxysmal atrial fibrillation (PAF) ablation with the HELIOSTAR multielectrode radiofrequency (RF) balloon catheter have been demonstrated in European studies; data from elsewhere are lacking. This prospective, multicenter study conducted in the United States, Italy, and China investigated the safety and efficacy of pulmonary vein isolation (PVI) using HELIOSTAR in drug-refractory symptomatic PAF.MethodsThe primary effectiveness endpoint (PEE) was 12-month freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia plus freedom from acute procedural failure, nonstudy catheter failure, repeat ablation failure, direct current cardioversion (DCCV), and Class I/III antiarrhythmic drug (AAD) failure. The primary safety endpoint was the occurrence of early-onset primary adverse events (PAEs). Cerebral magnetic resonance imaging (MRI) and cardiac computed tomography were performed in a patient subset to assess silent cerebral lesions (SCLs) and severe pulmonary vein (PV) stenosis, respectively.ResultsAcross 36 centers, 257 eligible subjects in the main phase had the study catheter inserted. Acute PVI was achieved in all subjects, with the majority (94.1%) using the balloon catheter only. In 67.7% and 92.2% of subjects, respectively, PEE and freedom from repeat ablation were met; clinical success rate was 77.7%. The PAE rate was 5.1%. One of 15 (6.7%) subjects with MRI showed a new SCL at 1 month postablation, which resolved at 3 months. Clinically meaningful improvements in Atrial Fibrillation Effect on QualiTy-of-life scores were seen at 3 months and were sustained to 12 months postablation, and accompanied with reduction of Class I/III AAD use and DCCV.ConclusionSTELLAR confirmed the safety and efficacy of the HELIOSTAR catheter for PVI, with clinically meaningful improvements in quality of life in patients with drug-refractory symptomatic PAF. Most PVIs were achieved without focal touch-up, and > 90% of patients were free from repeat ablation at 12 months.Trial registrationClinicalTrials.gov Identifier: NCT03683030.

Project description:BackgroundMitral valve (MV) repair has become the gold standard for treating degenerative mitral regurgitation (MR), yet the success rate of MV repair is still low in clinical practice. While studies focused on the learning process of MV repair are scarce, fully understanding the learning curve could provide valuable information for education and the quality control of MV repair, thus benefiting patients. This observational study aimed to evaluate the learning process and performances of individual surgeon for MV repair for degenerative mitral disease using data from a single high-volume center.MethodsProfiles of patients who underwent MV repair for degenerative MR at our institution from January 2003 to December 2016 were analyzed retrospectively. Overall and individual learning curves for the repair rate and major adverse events were calculated using sequential probability cumulative sum failure analysis. Average learning curves for major adverse events and operative time were also analyzed, by calculating the average incidence of adverse events and operative time of all operations stratified by accumulated operation numbers of individual surgeon. Altogether, we evaluated 2,482 operations performed by 14 surgeons.ResultsThere was an obvious learning curve for the repair rate at the institution and individual surgeon levels. Altogether, 50 to 200 operations were needed to overcome the repair rate learning curve, yet wide variation was observed among individual surgeons. The learning process for individual surgeons became faster after the turning point in the institutional learning curve appeared. No obvious learning curve was observed at the institution or individual level for major adverse events and in-hospital mortality.ConclusionsThe number of cases required to overcome the learning curve for repair rate is substantial, although there is marked variation among surgeons. Individuals' learning curves accelerate as the institution accumulates experience. MV repair is safe in experienced high-volume center. Close monitoring is necessary when surgeons begin to practice new techniques.

Project description:BackgroundPercutaneous coronary intervention (PCI) outcomes can vary due to various factors, including patient clinical condition, complexity of coronary lesions, expertise of operators, and quality of the PCI center.AimsThis study evaluated the influence of PCI center volume and operator experience on patient outcomes after the procedure.MethodsRetrospective data on demographic, clinical details, and outcomes for all patients undergoing PCI across 39 hospitals in Thailand from 2018 to 2019 were retrieved. PCI center volume was categorized based on annual number of interventions: low (< 200), intermediate (200-499), and high (≥ 500). Operator experience was assessed by years of practice (low [< 5] and high [≥ 5]) and the number of PCI cases performed annually (low [< 75] and high [≥ 75]). The evaluated PCI outcomes were: PCI failure; procedural complications; PCI-related in-hospital mortality; 1 year post-intervention all-cause mortality.ResultsA total of 19,701 patients who underwent PCI were included in the analysis, of whom 17,432 had follow-up data available after 1 year. Of these, 58.1% presented with either ST-elevation or non-ST elevation myocardial infarction/unstable angina, while 41.9% had stable CAD. Nearly half of the patients had triple-vessel or left-main disease, and 8.7% presented with cardiogenic shock. The percent with PCI failure, procedural complications, PCI-related in-hospital death, and 1-year all-cause mortality were 4.9%, 5.1%, 2.7%, and 11.8%, respectively. Despite patients in higher-risk profiles being treated at high-volume PCI centers and by experienced operators, there were no significant differences in PCI failure, PCI-related in-hospital mortality nor 1-year all-cause mortality compared to those treated at low or intermediate volume PCI centers. However, high-volume PCI centers had procedural complications more frequently (4.7%) than did intermediate (3.9%) and low-volume (2.5%) centers (p < 0.001). After adjusting for confounding factors, no significant associations were found between PCI center volume and PCI outcome. Similarly, no significant relationship was found between operator experience and procedural complications, nor 1-year all-cause mortality. Nevertheless, operators with more years of practice were associated with lower PCI-related in-hospital mortality (odds ratio [95% CI] of 0.75 (0.57, 0.98); p < 0.038). Additionally, operators conducting a higher number of PCIs annually tended to have less PCI failures (odds ratio [95% CI] of 0.76 (0.57, 1.01); p = 0.062).ConclusionA center's PCI volume did not significantly impact PCI outcome. In contrast, operator experience did impact outcomes. This result highlights areas for improvement and can help reform strategies for national PCI systems at both center and operator levels.

Dataset Information

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice-operator learning curve and procedural outcome at a high-volume center.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice-operator learning curve and procedural outcome at a high-volume center.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets