BACKGROUND: Utilization of ventricular assist device (VAD) support in patients with end-stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence-based psychosocial support interventions for patients following VAD implantation. METHODS: A national, multi-center study in four established German heart centers was initiated. An evidence-based VAD curriculum was developed
a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death)
secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self-management [SELMA]). A total of 140 patients were randomized block-wise to intervention (IG n = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3). RESULTS: At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%
p = 0.982)
58 ± 11 years. (CG 58 ± 11 years.
p = 0.966)
80% were implanted electively (CG 79%
p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p >
0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18
95% CI -2.17 to -0.18
p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%
CG 40.7%)
increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >
0.05) for QoL, social support, and self-management. CONCLUSION: A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.