Recommended Citation
Malas K, Erickson L, Boulware D, et al. Procedure Metrics and 30-Day Clinical Outcomes of Two Pulsed Field Ablation Platforms for Atrial Fibrillation: A Comparative Study. Presented at Scientific Day; May 20, 2026; Milwaukee, WI.
Abstract
Background/Significance:
Pulsed field ablation (PFA) for the management of atrial fibrillation is efficacious and safe. As adoption rapidly grows, there is interest in understanding how commercially available PFA platforms differ in operational characteristics and short-term clinical outcomes.
Purpose:
We compared procedural metrics and 30-day clinical outcomes between the first-time use of the Boston Scientific FARAPULSE pentaspline and Medtronic Affera Sphere-9 PFA systems.
Methods:
We analyzed the first cases who underwent PFA with no prior ablation using the pentaspline (n=35, 55.6%) or the Sphere-9 catheter (n=28, 44.4%) at our center. Continuous variables are presented as median (Q1, Q3) and categorical variables as n (%). A chi-square test or Fisher’s exact test was used for categorical variables and the Wilcoxon rank-sum test for continuous variables.
Results:
Baseline demographics and comorbidities were similar between both systems. There was no significant difference in total procedure time (pentaspline: 126.0 [102.2, 153.8] min, Sphere-9: 110.0 [90.5, 148.0] min, p=0.250). Procedures using the Sphere-9 catheter had shorter fluoroscopy duration (Sphere-9: 10.0 [6.6, 15.6] min, pentaspline: 18.6 [14.5, 25.2] min, p<0.001) and lower fluoroscopy dose (Sphere-9: 80.0 [35.5, 184.5] mGy, pentaspline: 214.0 [102.0, 374.0] mGy, p<0.001). Difference in left atrial (LA) dwell time was not significant but trended to shorter with the use of the Sphere-9 catheter (Sphere-9: 56 [15, 86] min, pentaspline: 75 [55, 89] min, p=0.053). Many cases included combined right-sided electrophysiology interventions. The Sphere-9 catheter had significantly more pulmonary vein isolation (PVI) plus cavo-tricuspid isthmus (CTI) ablations (Sphere-9: 14 [50.0 %] cases, pentaspline: 8 [22.9 %] cases, p=0.025) and less PVI plus any other lesion (Sphere- 9: 4 [14.3%] cases, pentaspline: 15 [42.9 %], p=0.014). Both catheters had similar frequency of PVI only cases. One Sphere-9 patient had a concomitant LA appendage occlusion procedure. No major adverse events occurred in either group. One patient (3.6%) who underwent ablation with the Sphere- 9 catheter had a minor groin hematoma that did not require intervention.
Conclusion:
With experienced operators, first-time use of the Sphere-9 catheter demonstrated markedly lower fluoroscopy time and dose compared with the pentaspline catheter, while total procedure time was similar. Both platforms demonstrated excellent acute safety.
Presentation Notes
Presented at Scientific Day; May 20, 2026; Milwaukee, WI.
Full Text of Presentation
wf_yes
Document Type
Oral/Podium Presentation
Procedure Metrics and 30-Day Clinical Outcomes of Two Pulsed Field Ablation Platforms for Atrial Fibrillation: A Comparative Study
Background/Significance:
Pulsed field ablation (PFA) for the management of atrial fibrillation is efficacious and safe. As adoption rapidly grows, there is interest in understanding how commercially available PFA platforms differ in operational characteristics and short-term clinical outcomes.
Purpose:
We compared procedural metrics and 30-day clinical outcomes between the first-time use of the Boston Scientific FARAPULSE pentaspline and Medtronic Affera Sphere-9 PFA systems.
Methods:
We analyzed the first cases who underwent PFA with no prior ablation using the pentaspline (n=35, 55.6%) or the Sphere-9 catheter (n=28, 44.4%) at our center. Continuous variables are presented as median (Q1, Q3) and categorical variables as n (%). A chi-square test or Fisher’s exact test was used for categorical variables and the Wilcoxon rank-sum test for continuous variables.
Results:
Baseline demographics and comorbidities were similar between both systems. There was no significant difference in total procedure time (pentaspline: 126.0 [102.2, 153.8] min, Sphere-9: 110.0 [90.5, 148.0] min, p=0.250). Procedures using the Sphere-9 catheter had shorter fluoroscopy duration (Sphere-9: 10.0 [6.6, 15.6] min, pentaspline: 18.6 [14.5, 25.2] min, p<0.001) and lower fluoroscopy dose (Sphere-9: 80.0 [35.5, 184.5] mGy, pentaspline: 214.0 [102.0, 374.0] mGy, p<0.001). Difference in left atrial (LA) dwell time was not significant but trended to shorter with the use of the Sphere-9 catheter (Sphere-9: 56 [15, 86] min, pentaspline: 75 [55, 89] min, p=0.053). Many cases included combined right-sided electrophysiology interventions. The Sphere-9 catheter had significantly more pulmonary vein isolation (PVI) plus cavo-tricuspid isthmus (CTI) ablations (Sphere-9: 14 [50.0 %] cases, pentaspline: 8 [22.9 %] cases, p=0.025) and less PVI plus any other lesion (Sphere- 9: 4 [14.3%] cases, pentaspline: 15 [42.9 %], p=0.014). Both catheters had similar frequency of PVI only cases. One Sphere-9 patient had a concomitant LA appendage occlusion procedure. No major adverse events occurred in either group. One patient (3.6%) who underwent ablation with the Sphere- 9 catheter had a minor groin hematoma that did not require intervention.
Conclusion:
With experienced operators, first-time use of the Sphere-9 catheter demonstrated markedly lower fluoroscopy time and dose compared with the pentaspline catheter, while total procedure time was similar. Both platforms demonstrated excellent acute safety.
Affiliations
Aurora Sinai Medical Center, Aurora St. Luke’s Medical Center