Differences in hemolysis, myocardial injury and renal safety after pulsed field ablation using a balloon-in-basket and a pentaspline catheter

Background A novel balloon-in-basket pulsed field ablation (BiB-PFA) catheter with integrated contact sensing has recently become available for pulmonary vein isolation (PVI). While energy-specific side effects involving hemolysis and renal function decline were reported for the pentaspline PFA catheter (Penta-PFA), it remains to be elucidated whether the specific BiB-PFA catheter design may mitigate these systemic effects. Purpose To investigate differences in hemolysis, myocardial injury and renal safety between the BiB-PFA and Penta-PFA catheter. Methods We prospectively analyzed n=40 consecutive patients with paroxysmal atrial fibrillation referred for de-novo PVI at our center. PVI was performed in all patients under deep propofol sedation using either BiB-PFA with electroanatomic mapping integration (n=20) or Penta-PFA with fluoroscopy guidance (n=20). No additional ablation lesions were applied. Serial blood samples were collected before the procedure (T1), at the end of ablation (T2) and 24 hours after ablation (T3). Results Baseline characteristics were balanced between groups (age 62.3±10.3 vs. 66.5±10.1 years [p=0.201], female 25.0% vs. 50.0% [p=0.102]). PVI was achieved in all patients after a mean of 12.4±2.5 deliveries with BiB-PFA and 36.2±3.4 deliveries with Penta-PFA (p<0.001). Procedure (72.0±15.6 vs. 53.0±9.8 min, p<0.001) and fluoroscopy duration (21.1±3.9 vs. 9.5±3.4 min, p=0.028) were longer with BiB-PFA. Sedation dosage was similar between groups (Figure 1). Hemolysis was not observed in the BiB-PFA group, while it was significant with Penta-PFA (Hemolysis index [T2] 5.9±2.3 vs. 27.3±11.4; haptoglobin fold change [T3] 1.1±0.1 vs. 0.7±0.2, both p<0.001). BiB-PFA was associated with significantly higher high sensitivity troponin T (2383±928 vs. 1613±799 ng/l, p=0.008), CK (416±167 vs. 295±138 U/l, p=0.017), CK-MB (45±15 vs. 33±10 U/l, p=0.003) and myoglobin (183.6±67.7 vs. 92.6±44.6 ng/ml, p<0.001) release and with lower CRP levels (3.3±2.5 vs. 7.0±4.5 mg/l, p=0.029; Figure 1). Troponin release correlated with PFA delivery number in the BiB-PFA group (Pearson r=0.549, p=0.023), but not in the Penta-PFA group (Pearson r=0.304, p=0.205). No case of acute kidney injury occurred in any group, while a clinically non-significant drop in glomerular filtration rate was more pronounced with BiB-PFA (-2.9±6.2 vs. 2.4±7.4 ml/min, p=0.021 [T3]). New-onset hemoglobinuria occured in 12.5% vs. 50.0% (p=0.167). Conclusions The novel BiB-PFA system for PVI induces a more pronounced myocardial injury and a lower inflammation than the Penta-PFA catheter without causing relevant hemolysis. The slight renal function decline may be related to the higher degree of myocardial injury and myoglobin release with BiB-PFA and warrants further investigation.