Analysis of hemolysis following pulse field ablation using three different technologies

Abstract Background Pulsed Field Ablation (PFA) is a non-thermal energy modality recently adopted for atrial fibrillation (AF) ablation, with its selectivity for cardiomyocytes contributing to a favorable safety profile. However, evidence from a single commercially-available device indicates that PFA may be associated with a risk of hemolysis that may potentially lead to acute kidney injury. Several PFA technologies have been recently introduced into the market; however, knowledge regarding hemolysis associated with different catheters is limited. Purpose The aim of this study was to evaluate the presence and degree of hemolysis following PFA using three different commercially-available technologies. Methods We prospectively collected blood samples from 58 patients undergoing pulmonary vein isolation (PVI) with or without posterior wall isolation (PWI) using PULSESELEC, VARIPULS, and FARAPULS at a single center. Blood samples were collected pre-procedure (t0) and 24 hours post-procedure (t1). Blood tests included total and indirect bilirubin, lactate dehydrogenase (LDH), haptoglobin, plasma free hemoglobin, urea, creatinine, and estimated glomerular filtration rate (eGFR) using the CKD-EPI-IDMS formula. Results The study population consisted of 58 patients (64,9 ± 11,2 years, 46,6% female sex, 31% persistent AF). Among them, 18 (31%), 21 (36.2%), and 19 (32.8%) patients underwent PFA using PULSESELEC, VARIPULS, and FARAPULS technologies, respectively. PVI only was performed in 30 patients (51.7%), whereas the other patients received additional PWI. The ratio of PVI / PVI+PWI was similar within groups. Overall, total and indirect bilirubin and LDH revealed a significant increase after ablation, while haptoglobin and plasma free hemoglobin showed a significant decrease (1,05 (0,80 – 1,30) vs 0,60 (0,30 – 0,90), p < 0,001; 10,00 (6,00 – 16,25) vs 4,00 (2,00 – 8,00), p < 0,001). Irrespective of lesion set, no significant changes in creatinine levels and eGFR were observed after ablation. No instances of acute kidney injury were documented. Similar findings were confirmed for the subgroup of 30 patients (51.7%) who underwent PVI only and 28 patients (48.3%) who underwent PVI with PWI (Table 1). The %-decrease in haptoglobin levels > 50% was more pronounced in the FARAPULSE™ group compared to VARIPULSE™ and PULSESELECT™ (84.2% vs. 33.3% vs. 16.7%, p < 0.001, respectively, Table 2). However, in no cases hemolysis was clinically relevant. Conclusion Our findings provide consistent biochemical evidence of hemolysis following PFA using three different commercially-available technologies. Hemolysis occurred irrespective of lesion set (PVI vs PVI+PWI). However, no post PFA hemolysis was never clinically relevant, as demonstrated by the absence of acute kidney injury of any degree or other procedure-related adverse events. Further studies are needed to shed light on predictors, clinical implications, and prophylactic strategies for PFA induced-hemolysis.Table 1 Table 2