Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria; Department of Thoracic Surgery and Surgical Endoscopy, Ruhrlandklinik-University Clinic Essen, Essen, Germany.
Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
J Heart Lung Transplant. 2017 Jul;36(7):744-753. doi: 10.1016/j.healun.2017.02.011. Epub 2017 Feb 20.
Ex vivo lung perfusion (EVLP) was primarily developed for evaluation of impaired donor lungs. The good clinical results raise the question for its possible impact on lungs meeting standard criteria. Before application of EVLP on such lungs enters routine clinical practice, it must be demonstrated whether EVLP would affect or improve outcome when used in standard donor lungs. We performed a prospective randomized trial to investigate the role of EVLP in standard lung transplantation (Tx).
This prospective randomized clinical trial compared patients who underwent Tx with ex vivo evaluated donor lungs with an equivalent patient population without previous EVLP.
From October 2013 to May 2015, 193 lung Tx were performed at the Medical University of Vienna. During this period, 80 recipient/donor pairs that met the inclusion criteria were included in this trial, 41 pairs in the control group, and 39 in the EVLP group. In the EVLP group, 4 lungs (10.2%) ultimately did not qualify for Tx and were rejected for lung Tx owing to technical reasons (n = 2) and quality criteria (n = 2). Donor and recipient characteristics were comparable in both groups. Total cold ischemic time in the EVLP group was significantly longer for both implanted lungs (first side, 372 minutes vs 291 minutes, p < 0.001; second side, 437 minutes vs 370 minutes, p = 0.001); median duration of surgery showed no differences (277 minutes vs 275 minutes). Median oxygen partial pressure/fraction of inspired oxygen ratio at 24 hours after Tx was 516 (range, 280-557) in the EVLP group and 491 (range, 352-575) in the control group (p = 0.63). Incidence of primary graft dysfunction >1 was lower in the EVLP group at all time points compared with the control group (24 hours, 5.7% vs 19.5%, p = 0.10), and need for post-operative prolonged extracorporeal membrane oxygenation was lower in the EVLP group (5.7% vs 12.2%, p = 0.44). Short-term clinical outcomes did not differ between recipients in the 2 groups. Patients remained intubated (1.6 days vs 1.6 days, p = 0.67), in the intensive care unit (6 days vs 6 days, p = 0.76), and in the hospital (23 days vs 19 days, p = 0.42) for a comparable period of time. The 30-day survival was 97.1% vs 100% (p = 0.46).
This study provides evidence that EVLP can safely be used in standard donor lungs. Functional results and perioperative outcome are comparable to those achieved with standard donor lung preservation techniques. As an evaluation tool, EVLP allows clinicians to identify and to possibly exclude lungs with functional impairment. Finally, EVLP can safely extend total preservation time.
离体肺灌注（EVLP）主要用于评估受损供体肺。良好的临床结果引发了一个问题，即其是否会对符合标准的肺产生影响。在 EVLP 常规应用于这类肺之前，必须证明在标准供体肺中使用 EVLP 是否会影响或改善结果。我们进行了一项前瞻性随机试验，以研究 EVLP 在标准肺移植（Tx）中的作用。
这项前瞻性随机临床试验比较了接受 EVLP 评估的供体肺移植患者与无 EVLP 治疗的等效患者人群。
2013 年 10 月至 2015 年 5 月，维也纳医科大学共进行了 193 例肺移植。在此期间，符合纳入标准的 80 对受体/供体中，有 41 对纳入对照组，39 对纳入 EVLP 组。在 EVLP 组中，由于技术原因（n=2）和质量标准（n=2），最终有 4 个肺（10.2%）不符合 Tx 标准而被拒绝。两组供体和受体特征相似。EVLP 组的两个植入肺的总冷缺血时间明显延长（第一侧：372 分钟比 291 分钟，p＜0.001；第二侧：437 分钟比 370 分钟，p=0.001）；手术持续时间中位数无差异（277 分钟比 275 分钟）。EVLP 组在 Tx 后 24 小时的氧分压/吸入氧分数中位数为 516（范围：280-557），对照组为 491（范围：352-575）（p=0.63）。与对照组相比，EVLP 组在所有时间点的原发性移植物功能障碍发生率＞1的情况均较低（24 小时：5.7%比 19.5%，p=0.10），需要术后长时间体外膜肺氧合的情况也较低（5.7%比 12.2%，p=0.44）。两组患者的短期临床结局无差异。两组患者的气管插管时间（1.6 天比 1.6 天，p=0.67）、重症监护病房时间（6 天比 6 天，p=0.76）和住院时间（23 天比 19 天，p=0.42）相似。30 天生存率为 97.1%比 100%（p=0.46）。
本研究表明 EVLP 可安全用于标准供体肺。功能结果和围手术期结局与标准供体肺保存技术相当。作为一种评估工具，EVLP 可让临床医生识别并可能排除功能受损的肺。最后，EVLP 可安全延长总保存时间。
