Heart and Lung Transplant Unit, St. Vincent's Hospital, Sydney, NSW, Australia; Victor Chang Cardiac Research Institute, Sydney, NSW, Australia; School of Clinical Medicine, University of New South Wales, Sydney, NSW, Australia.
Alfred Health and Monash University, Melbourne, Vic, Australia.
Heart Lung Circ. 2024 Aug;33(8):1173-1183. doi: 10.1016/j.hlc.2024.03.004. Epub 2024 Apr 11.
Heart transplantation is an effective treatment for end-stage congestive heart failure, however, achieving the right balance of immunosuppression to maintain graft function while minimising adverse effects is challenging. Serial endomyocardial biopsies (EMBs) are currently the standard for rejection surveillance, despite being invasive. Replacing EMB-based surveillance with cardiac magnetic resonance (CMR)-based surveillance for acute cardiac allograft rejection has shown feasibility. This study aimed to assess the cost-effectiveness of CMR-based surveillance in the first year after heart transplantation.
A prospective clinical trial was conducted with 40 orthotopic heart transplant (OHT) recipients. Participants were randomly allocated into two surveillance groups: EMB-based, and CMR-based. The trial included economic evaluations, comparing the frequency and cost of surveillance modalities in relation to quality-adjusted life years (QALYs) within the first year post-transplantation. Sensitivity analysis encompassed modelled data from observed EMB and CMR arms, integrating two hypothetical models of expedited CMR-based surveillance.
In the CMR cohort, 238 CMR scans and 15 EMBs were conducted, versus (vs) 235 EMBs in the EMB group. CMR surveillance yielded comparable rejection rates (CMR 74 vs EMB 94 events, p=0.10) and did not increase hospitalisation risk (CMR 32 vs EMB 46 events, p=0.031). It significantly reduced the necessity for invasive EMBs by 94%, lowered costs by an average of AUD$32,878.61, and enhanced cumulative QALY by 0.588 compared with EMB. Sensitivity analysis showed that increased surveillance with expedited CMR Models 1 and 2 were more cost-effective than EMB (all p<0.01), with CMR Model 1 achieving the greatest cost savings (AUD$34,091.12±AUD$23,271.86 less) and utility increase (+0.62±1.49 QALYs, p=0.011), signifying an optimal cost-utility ratio. Model 2 showed comparable utility to the base CMR model (p=0.900) while offering the benefit of heightened surveillance frequency during periods of elevated rejection risk.
CMR-based rejection surveillance in orthotopic heart transplant recipients provides a cost-effective alternative to EMB-based surveillance. Furthermore, it reduces the need for invasive procedures, without increased risk of rejection or hospitalisation for patients, and can be incorporated economically for expedited surveillance. These findings have important implications for improving patient care and optimising resource allocation in post-transplant management.
心脏移植是治疗终末期充血性心力衰竭的有效方法，然而，在维持移植物功能的同时最大限度地减少不良反应，实现免疫抑制的适当平衡具有挑战性。尽管有创，但是心脏内膜心肌活检（EMB）仍是目前排斥反应监测的标准方法。用心脏磁共振（CMR）监测取代 EMB 监测急性心脏同种异体移植排斥反应已显示出可行性。本研究旨在评估心脏移植后第一年 CMR 监测的成本效益。
对 40 例原位心脏移植（OHT）受者进行前瞻性临床试验。参与者被随机分配到两组监测组：EMB 组和 CMR 组。该试验包括经济评估，比较了两种监测方式的频率和成本，以及移植后第一年的质量调整生命年（QALY）。敏感性分析包括观察到的 EMB 和 CMR 臂的模型数据，整合了两种加速 CMR 监测的假设模型。
在 CMR 组中，进行了 238 次 CMR 扫描和 15 次 EMB，而 EMB 组中进行了 235 次 EMB。CMR 监测的排斥反应率相当（CMR 74 次 vs. EMB 94 次，p=0.10），且并未增加住院风险（CMR 32 次 vs. EMB 46 次，p=0.031）。它显著减少了 94%的有创 EMB 需求，平均降低成本 32878.61 澳元，并与 EMB 相比，累积 QALY 增加了 0.588。敏感性分析表明，加速 CMR 模型 1 和 2 的增加监测比 EMB 更具成本效益（均 p<0.01），其中 CMR 模型 1 实现了最大的成本节约（减少 34091.12±23271.86 澳元）和效用增加（增加 0.62±1.49 QALYs，p=0.011），表明具有最佳的成本效益比。模型 2 与基础 CMR 模型的效用相当（p=0.900），同时在排斥反应风险升高期间提供了更高的监测频率的优势。
在原位心脏移植受者中，基于 CMR 的排斥反应监测是 EMB 监测的一种具有成本效益的替代方法。此外，它减少了对有创程序的需求，同时不会增加患者排斥反应或住院的风险，并且可以经济地纳入加速监测。这些发现对改善患者护理和优化移植后管理中的资源分配具有重要意义。
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