Validation of the Hemodynamic Classification System for Hemodynamic‐Related Events in Patients With Durable Left Ventricular Assist Devices

Background: Durable left ventricular assist device (dLVAD) physiology predisposes to right heart failure (RHF) and aortic insufficiency (AI), recently labeled hemodynamic-related events (HDREs). We sought to validate the recently proposed dLVAD Hemodynamic Classification System for HDREs. Methods: RHF and AI HDREs were adjudicated, staged, and phenotyped on the basis of the Hemodynamic Classification System assessed at 6 months after dLVAD implantation. The primary outcome was a composite of HF hospitalization or cardiovascular death between 6 and 24 months after dLVAD implantation. Results: Among 183 qualifying consecutive patients with 6-month assessments, RHF HDRE was adjudicated in all cases and AI HDRE in 161 (88.0%). Overall, 53 (29.0%) patients developed an RHF HDRE and 26 (16.0%) an AI HDRE (phenotypes: 39 isolated RHF, 15 isolated AI, 11 combined RHF-AI, 3 not adjudicated). At pre-dLVAD assessment, age and pulmonary artery pulsatility index were independently associated with RHF HDRE and pre-dLVAD AI and systolic pulmonary artery pressure with AI HDRE. RHF HDRE (adjusted hazard ratio [HR], 2.69 [95% CI, 1.14-6.34]; P=0.024), AI HDRE (adjusted HR, 4.21 [95% CI, 1.70-10.40]; P=0.002), and HDRE phenotypes (isolated RHF/AI HDRE versus no HDRE: adjusted HR, 2.80 [95% CI, 1.03-7.62]; P=0.044; combined RHF/AI HDRE versus no HDRE: adjusted HR, 4.53 [95% CI, 1.33-15.35]; P=0.015) were associated with the primary outcome. A graded increase in primary outcome was observed with increasing RHF and AI stages. Conclusions: We validated the dLVAD Hemodynamic Classification System for HDREs as a valuable tool to identify pathophysiological and clinical clusters of patients, linking it with significant prognostic implications. Its adoption may pave the way for targeted strategies aimed at mitigating HDREs and enhancing the long-term success of dLVAD support.