Hemolysis induced by PFA - A comparison of a balloon based catheter and other contemporary Single-Shot solutions

Introduction The level of hemolysis induced by pulmonary vein isolation (PVI) using pulsed field ablation (PFA) varies between PFA systems. Data on hemolysis induced by the novel balloon-in-basket catheter (BIBC) is scarce. We compared the levels of hemolysis observed with the 3 most commonly used, commercially available single-shot PFA catheters: pentaspline catheter (PSC), variable-loop circular catheter (VLCC) and BIBC. Methods Patients undergoing PVI were prospectively enrolled in a registry. BIBC cases were matched to VLCC and PSC cases using TriMatch, an algorithm creating matched triplets. Pre- and postprocedural measurements included LDH, total and direct bilirubin, haptoglobin and creatinine. Absolute and relative differences were compared using the Wilcoxon rank sum test. Results One hundred and nine patients were included in this study (26% female, 37% persistent AF). Of the final matched cohort, 43 patients underwent PVI with the BIBC, 37 with the PSC and 29 with the VLCC. Baseline characteristics and baseline hemolysis markers were similar across patient groups, the BIBC group did not include redo interventions (Table). The BIBC had the lowest post-interventional decrease in haptoglobin concentration (Figure panel a): Δ Haptoglobin -0.18 vs -0.66 (vs. PSC: p<0.001), vs -0.56 g/L (vs. VLCC: p<0.001). Direct and total bilirubin increase was lowest in the BIBC Group (Figure panel b and c): Δ Direct bilirubin 0.75 vs 2.1 (vs. PSC: p<0.001) vs 2.1 µmol/L (vs. VLCC: p<0.01). Δ Total bilirubin 1.9 vs 6.3 (vs. PSC: p< 0.001) vs 4.6 µmol/L (vs. VLCC: p<0.05). The PSC group showed a significantly larger increase in LDH compared to the BIBC, but there was no significant difference in Δ LDH to the VLCC (Figure panel d). Changes in creatinine/eGFR (Figure panels e/f) did not differ (all comparisons p>0.1). No patient developed acute kidney injury. Conclusions The magnitude of hemolysis is PFA system dependent. The novel BIBC shows the smallest increase in hemolysis markers after PVI while the VLCC and PSC have similar hemolytic signatures. No significant difference in impact on renal function was observed between the catheters. Further studies are necessary to identify potential clinical relevance of these findings.FigureTable