The pentaspline PFA catheter induced significantly greater hemolysis and a measurable decline in renal function (median eGFR change -4.5 vs -1.0 mL/min, p=0.002) compared to the balloon-in-basket system in patients undergoing pulmonary vein isolation.
Observational (n=81)
No
Does pulsed field ablation with a pentaspline catheter compared to a balloon-in-basket catheter increase hemolysis and renal function decline in patients with atrial fibrillation?
Pentaspline PFA catheters induce significantly more acute hemolysis and renal function decline compared to balloon-in-basket systems, highlighting that catheter design and energy delivery shape the systemic safety profile of PFA.
Absolute Event Rate: -4.5% vs -1%
p-value: p=0.002
BACKGROUND: Pulsed field ablation (PFA) is a non-thermal modality for pulmonary vein isolation (PVI) in atrial fibrillation (AF). While effective, hemolysis and renal effects may occur, potentially modulated by catheter design. METHODS: In this prospective, non-randomized, single-center study, patients underwent PFA-based PVI using either a balloon-in-basket catheter or a pentaspline catheter. Hemolysis (LDH, bilirubin, haptoglobin, myoglobin) and renal markers (creatinine, eGFR) were assessed immediately before and the morning after ablation. RESULTS: Eighty-one patients were included (balloon-in-basket: n=35; pentaspline: n=46), with comparable baseline characteristics. Both groups achieved acute 100% first-pass PVI. The pentaspline group received more PFA applications (32 32-40 vs. 16 16-18, p<0.001). Hemolytic markers increased significantly in both groups but were more pronounced in the pentaspline group: LDH Δ+99 76-121 vs. +59 43-69 U/L, bilirubin Δ+5.2 2.4-8.5 vs. +2.4 0.2-5.1 µmol/L, haptoglobin Δ-28 -39 to -18 vs. -6 -17 to +5 mg/dL (all p<0.001). Myoglobin increased modestly in both groups: Δ+12.0 0-26.0 vs. +11.0 0-21.5 ng/mL (p=0.696). Only the pentaspline group exhibited a significant renal function decline: creatinine Δ+6.0 2.2-11.5 vs. +2.0 -4.0-4.4 µmol/L (p=0.009); eGFR Δ-4.5 -10.8 to -1.3 vs. -1.0 -3.5-5.0 mL/min (p=0.002). CONCLUSION: The pentaspline catheter induced more hemolysis and a measurable decline in renal function. Myoglobin increases were similar in both groups and unlikely to explain the renal findings. Catheter design and energy delivery appear to shape the systemic impact profile of PFA.
Wenzel et al. (Thu,) conducted a observational in Symptomatic atrial fibrillation (n=81). Pentaspline PFA catheter vs. Balloon-in-basket PFA catheter was evaluated on Change in estimated glomerular filtration rate (eGFR) at 24 hours (p=0.002). The pentaspline PFA catheter induced significantly greater hemolysis and a measurable decline in renal function (median eGFR change -4.5 vs -1.0 mL/min, p=0.002) compared to the balloon-in-basket system in patients undergoing pulmonary vein isolation.