Abstract 234 Implementation of the Heliostar<SUP>TM</SUP>-catheter in real-world clinical practice – procedural outcome and operator learning curve in comparison to the cryoballoon

Background: The HELIOSTAR^TM catheter (Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF). It combines visualization in the CARTO® 3D-mapping system with the concept of “single-shot”-ablation device, potentially reducing procedure times and complexity of operator training. With increasing demand for interventional AF-therapies, a time-efficient introduction of new technologies into clinical routine is of utmost importance. This study evaluates the operator learning curve und procedural parameters during implementation of the HELIOSTAR^TM in comparison to the cryoballoon (Arctic Front^TM, Medtronic) at a high-volume ablation centre.

Methods: The first 30 patients (age 61.0±12.0 years; 66% male) undergoing PVI by HELIOSTAR^TM at Heidelberg University Hospital were included in this observational study. Procedures were performed by an operator proficient in cryoballoon (CB)-ablation (>600 procedures). Acute efficacy and procedure-associated complications were recorded. Procedural parameters were analysed over the course of increasing experience with the device and compared between the first and the last 10 patients of this cohort, as well as to a previous patient cohort (n=30) investigated during implementation of the Arctic Front^TM CB at the centre. For descriptive analyses, continuous variables are reported as median with inter-quartile range (Q1, Q3).

Results: Median procedure time with HELIOSTAR^TM was 68min (Q1=59min; Q3=75min). LA-dwell time was 30min (Q1=28min; Q3=35min). Median fluoroscopy duration was 12min (Q1=11min; Q3=14min). 119/119 pulmonary veins (PVs) could be isolated successfully. In 79 PVs (67%) a single RF-application was sufficient for effective local ablation. In cases with visible PV-signal, median time to isolation was 10sec (Q1=8sec; Q3=13sec). RF-application had to be prematurely terminated at 11 PVs due to temperature rise in the oesophageal probe. At 4 PVs, only segmental ablation was performed due to phrenic capture at safety pacing via the HELIOSTAR^TM-electrodes. In 9 PVs, acute reconnection was observed resulting in re-ablation during the index procedure. During 7 procedures, intraprocedural troubleshooting was necessary due to technical issues with generator, sheath or mapping system. No severe procedure-related complications were observed. There was no significant change in procedure duration (median: 68min vs. 69min; P=0.912), or fluoroscopy duration (median: 11min vs. 12min; P=0.393) between the first and the last 10 patients of this cohort. In comparison to CB-implementation, procedure times (median: 68min vs. 136min; P<0.001) and fluoroscopy duration (median: 12min vs. 21min; P<0.001) were lower in the cohort undergoing HELIOSTAR^TM-ablation (see Figure).

Conclusion: Implementation of the HELIOSTAR^TM can be achieved with high acute procedural efficacy and safety at a high-volume centre. In an operator experienced in CB-ablation, procedure and fluoroscopy duration with the HELIOSTAR^TM were lower than during initial implementation of single-shot devices at this centre. Over the course of the first 30 cases there was no significant decrease in procedure duration and fluoroscopy. Previous experience with CB-ablation may be advantageous for time-efficient introduction of the HELIOSTAR^TM in clinical practice.

Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02087-y
Implementation of the Heliostar^TM-catheter in real-world clinical practice – procedural outcome and operator learning curve in comparison to the cryoballoon
M. M. Zylla¹, L. Starrach¹, P. Schweizer¹, A.-K. Rahm¹, E. P. Scholz², D. Thomas¹, N. Frey¹, P. Lugenbiel¹
¹Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie, Universitätsklinikum Heidelberg, Heidelberg; ²Innere Medizin I, Kardiologie, GRN Klinik Schwetzingen gGmbH, Schwetzingen;
Background: The HELIOSTAR^TM catheter (Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF). It combines visualization in the CARTO® 3D-mapping system with the concept of “single-shot”-ablation device, potentially reducing procedure times and complexity of operator training. With increasing demand for interventional AF-therapies, a time-efficient introduction of new technologies into clinical routine is of utmost importance. This study evaluates the operator learning curve und procedural parameters during implementation of the HELIOSTAR^TM in comparison to the cryoballoon (Arctic Front^TM, Medtronic) at a high-volume ablation centre. Methods: The first 30 patients (age 61.0±12.0 years; 66% male) undergoing PVI by HELIOSTAR^TM at Heidelberg University Hospital were included in this observational study. Procedures were performed by an operator proficient in cryoballoon (CB)-ablation (>600 procedures). Acute efficacy and procedure-associated complications were recorded. Procedural parameters were analysed over the course of increasing experience with the device and compared between the first and the last 10 patients of this cohort, as well as to a previous patient cohort (n=30) investigated during implementation of the Arctic Front^TM CB at the centre. For descriptive analyses, continuous variables are reported as median with inter-quartile range (Q1, Q3). Results: Median procedure time with HELIOSTAR^TM was 68min (Q1=59min; Q3=75min). LA-dwell time was 30min (Q1=28min; Q3=35min). Median fluoroscopy duration was 12min (Q1=11min; Q3=14min). 119/119 pulmonary veins (PVs) could be isolated successfully. In 79 PVs (67%) a single RF-application was sufficient for effective local ablation. In cases with visible PV-signal, median time to isolation was 10sec (Q1=8sec; Q3=13sec). RF-application had to be prematurely terminated at 11 PVs due to temperature rise in the oesophageal probe. At 4 PVs, only segmental ablation was performed due to phrenic capture at safety pacing via the HELIOSTAR^TM-electrodes. In 9 PVs, acute reconnection was observed resulting in re-ablation during the index procedure. During 7 procedures, intraprocedural troubleshooting was necessary due to technical issues with generator, sheath or mapping system. No severe procedure-related complications were observed. There was no significant change in procedure duration (median: 68min vs. 69min; P=0.912), or fluoroscopy duration (median: 11min vs. 12min; P=0.393) between the first and the last 10 patients of this cohort. In comparison to CB-implementation, procedure times (median: 68min vs. 136min; P<0.001) and fluoroscopy duration (median: 12min vs. 21min; P<0.001) were lower in the cohort undergoing HELIOSTAR^TM-ablation (see Figure). Conclusion: Implementation of the HELIOSTAR^TM can be achieved with high acute procedural efficacy and safety at a high-volume centre. In an operator experienced in CB-ablation, procedure and fluoroscopy duration with the HELIOSTAR^TM were lower than during initial implementation of single-shot devices at this centre. Over the course of the first 30 cases there was no significant decrease in procedure duration and fluoroscopy. Previous experience with CB-ablation may be advantageous for time-efficient introduction of the HELIOSTAR^TM in clinical practice.
https://dgk.org/kongress_programme/ht2022/aP326.html