Kugler Christiane, Spielmann Hannah, Richter Fabian, Lauenroth Volker, Semmig-Könze Sandra, Spitz-Köberich Christine, Bertsche Tim, Staus Paulina, Weber Susanne, Albert Wolfgang, Tigges-Limmer Katharina
Faculty of Medicine, Institute of Nursing Science, University of Freiburg, Freiburg, Germany.
Department of Cardiothoracic and Vascular Surgery, German Heart Center Charité, Berlin, Germany.
Artif Organs. 2025 Mar;49(3):373-389. doi: 10.1111/aor.14918. Epub 2024 Dec 3.
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.
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).
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.
A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.
终末期心力衰竭患者使用心室辅助装置（VAD）进行支持治疗已相当成熟。最近的研究强调，需要为接受VAD植入的患者制定和评估基于证据的心理社会支持干预措施。
在德国四个成熟的心脏中心开展了一项全国性、多中心研究。制定了基于证据的VAD课程；一项随机对照试验评估了跨专业干预随时间的影响。主要联合终点是不良事件（血栓栓塞事件、驱动线感染、出血、再次住院和死亡）的发生；次要终点是心理社会结局（焦虑、抑郁[医院焦虑抑郁量表]、生活质量[VAD生活质量量表]、社会支持[社会支持问卷]和自我管理[自我管理量表]）。总共140例患者按随机区组法随机分为干预组（IG，n = 70）或对照组（CG，n = 70）。考虑了中心效应。在四个时间点（T0 - T3）完成各项评估工具。
基线时，干预组（IG）患者中女性占19%（对照组[CG]为19%；p = 0.982）；年龄为58 ± 11岁（CG为58 ± 11岁；p = 0.966）；80%为择期植入（CG为79%；p = 0.968）。IG组与CG组在主要终点方面未发现显著差异（p > 0.05）。对于次要终点，混合线性回归显示，与CG组相比，IG组的抑郁评分显著降低（估计值1.18；95%置信区间为 -2.17至 -0.18；p = 0.021）。IG组患者在T0至T3期间焦虑的临床显著降低幅度更大（IG组为51.9%；CG组为40.7%）；IG组报告焦虑增加的比例为3.7%（CG组为11.1%）。混合线性回归分析在生活质量、社会支持和自我管理方面更倾向于IG组（均>0.05）。
全面的课程式VAD干预有可能降低接受VAD支持患者的抑郁水平并改善其心理社会结局。
