Long-term study of patients undergoing transcatheter paravalvular leak closure due to hemolysis

Abstract Background/Introduction Paravalvular leak is a complication of valve replacement with 1% to 3% of patients developing symptoms including heart failure or hemolysis. Purpose This study aims to evaluate the long-term outcomes in whom the primary indication for paravalvular leak closure was hemolysis. Methods We included patients from five Greek hospitals between February 2013 and March 2024. The primary endpoint was the assessment of short and long-term changes in hemolysis parameters, including lactate dehydrogenase, hemoglobin, and indirect bilirubin at 1, 6, 12, and 24 months post-procedure versus baseline values. Secondary endpoints included clinical success, defined as improved hemolysis with transfusion-free status for at least 6 months and survival analysis during the follow-up. Results The study included 42 patients who underwent transcatheter closure of paravalvular leak for hemolytic anemia, with a 15±9 month follow up. Mean age was 69.7±10.3 years and 69% were male. For the primary endpoint, the mean pre-procedural lactate dehydrogenase was 1196±592 IU/L. Although reductions at 1 month (891±1051 IU/L, p=0.221), 6 months (504±378 IU/L, p=0.060), and 12 months (569±312 IU/L, p=0.085) were not statistically significant, a remarkable decrease was observed at 24 months (479±364 IU/L, p=0.040). Hemoglobin levels did not significantly change from pre-procedural values (9.91±1.7 g/dl) at 1 month (10.85±4.3 g/dl, p=0.196), 6 months (10.98±1.91 g/dl, p=0.051), 12 months (10.98±2.19 g/dl, p=0.097) and 24 months (13.09±5.7 g/dl, p=0.065). Indirect bilirubin, with a baseline of 2.4±2.19 mg/dl, showed significant reductions at all time points: 1 month (1.50±1.9 mg/dl, p0.001), 6 months (0.66±0.44 mg/dl, p=0.003) and 12 months (0.76±0.42 mg/dl, p=0.005). A more than 50% reduction in lactate dehydrogenase was achieved by 44.4% of patients at 1 month, 61.5% at 6 months, 66.7% at 12 months, and 81.3% at 24 months. Similarly, 50% reduction in indirect bilirubin was observed in 58.3% at 1 month, 62.5% at 6 months, and 80% at 12 months. For the secondary endpoints, the need for transfusions significantly decreased from 63.4% pre-procedure to 14.7% at 6 months (p0.001). Clinical success was achieved in 85.3% of patients. The technical success was 88.1%. The rates of remaining moderate paravalvular leak were 88.1% pre procedurally versus 7.1% at discharge, p0.001. During the follow-up period of 15±9 months, the survival rate was 66.7%, with 14 patient deaths. Conclusions Transcatheter paravalvular leak closure significantly reduced hemolysis indices (lactate dehydrogenase, indirect bilirubin) with sustained benefits over 24 months. While hemoglobin showed a non-significant increase, transfusion requirements markedly decreased, with most patients remaining transfusion-free for at least 6 months. Overall, transcatheter paravalvular leak closure appears to be an effective option for selected patients.