Two-year event-free survival following heartmate 3 implantation: insights from a contemporary single-center cohort
T Bajec, G Zemljic, A Cerar, M Sebestjen, S Frljak, N Zorz, R Okrajsek, S Koletnik, K Boben, M Jelenc, J Ksela, T Pintar, S Music, I Knezevic, G PoglajenAbstract
Background
Despite advances in durable LVAD therapy, post-implant complications remain frequent and drive morbidity, mortality, and resource use. Real-world data linking pre-implant patient profiles to event-free survival in contemporary LVAD cohorts remain limited.
Purpose
To assess event-free survival in patients undergoing HM3 LVAD support and identify pre-implant predictors of long-term outcomes.
Methods
We performed a retrospective, single-center analysis of 63 consecutive patients undergoing HM3 implantation at our institution (January 2017–October 2023). The primary composite endpoint was time to death, disabling stroke or reoperation to replace or remove a malfunctioning device. Event-free urvival through 2 years was estimated using Kaplan–Meier methods, with follow-up administratively truncated at 2 years; heart transplantation (HTX) before 2 years was treated as censoring (unless performed for device malfunction) event. Associations with baseline variables were assessed using Cox proportional hazards models. Pre-implant RV dysfunction was defined as TAPSE ≤1.7 cm.
Results
Of 63 patients 55 (87.3 %) were male with the mean age of 63.0±9.5 years. 40 (63.5 %) patients had non-ischemic cardiomyopathy, and RV dysfunction was present in 27 (62.8 %) patients. Baseline INTERMACS profile distribution was 49.2 % and 50.8 % in profiles 2 and 3, respectively. At the time of LVAD implantation 53 (84.1 %) patients required inotropic support and 21 (33.3 %) patients were on temporary mechanical circulatory support. At 2 years, 7 (11.1 %) patients met the primary composite endpoint, including on-device death in 6 (9.5 %) patients and disabling stroke in 2 (3.2 %) patients, with one patient experiencing both events. Importantly, no reoperations for device malfunction occurred. 25 (39.7 %) patients underwent HTX and 30 (47.6 %) patients were censored due to an ongoing event-free LVAD support at 2 years. Within 2 years, gastrointestinal or other major bleeding occurred in 24 (38.1 %) patients, right ventricular failure in 20 (31.7 %) patients, arrhythmias in 8 (12.7 %) patients, driveline infection in 8 (12.7 %) patients, and pump thrombosis in 1 (1.6 %) patient. Female sex was associated with worse outcomes (HR 8.13, 95% CI 2.00–33.00; p=0.003), whereas no other baseline clinical, biochemical or echocardiographic variable showed a statistically significant association with a composite primary endpoint.
Conclusions
In this real-world cohort of patients with advanced heart failure supported with contemporary centrifugal-flow LVAD therapy, event-free survival at 2 years was high, with a low incidence of death, disabling stroke, and no device-malfunction reoperations. These findings underscore the overall safety and durability of modern LVAD support while highlighting female sex as a potential high-risk subgroup that may warrant closer pre-implant risk stratification and tailored management strategies in advanced heart failure care.