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美国成年人肺移植名单后程序偏好和意向治疗结果。一项队列研究。

Procedure Preference and Intention-to-Treat Outcomes after Listing for Lung Transplantation among U.S. Adults. A Cohort Study.

机构信息

1 Department of Medicine, and.

2 Department of Epidemiology, Columbia University Medical Center, New York, New York.

出版信息

Ann Am Thorac Soc. 2019 Feb;16(2):231-239. doi: 10.1513/AnnalsATS.201804-258OC.

Abstract

RATIONALE

Bilateral lung transplantation is widely used to treat chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD), on the basis of an expectation of improved survival after transplantation. Yet, waiting list mortality is higher while awaiting bilateral transplantation. The net effect of procedure preference on overall survival is unknown.

OBJECTIVES

To determine whether an unrestricted procedure preference is associated with improved overall outcomes after listing for lung transplantation.

METHODS

We performed a retrospective cohort study of 12,155 adults with COPD or ILD listed for lung transplantation in the United States between May 4, 2005, and December 31, 2014. We defined a "restricted" procedure preference as listing for "bilateral transplantation only" and an "unrestricted" procedure preference as listing for any combination of bilateral or single lung transplantation. We used a composite "intention-to-treat" primary outcome that included events both before and after transplantation, defined as the number of days between listing and death, removal from the list for clinical deterioration, or retransplantation.

RESULTS

In adjusted analyses, an unrestricted procedure preference was associated with a 3% lower rate of the primary intention-to-treat outcome in COPD (adjusted hazard ratio [aHR], 0.97; 95% confidence interval [CI], 0.89-1.07) and a 1% higher rate in ILD (aHR, 1.01; 95% CI, 0.94-1.08). There was no convincing evidence that these associations varied by age, disease severity, or the use of mechanical support. Among those with ILD and concomitant severe pulmonary hypertension, an unrestricted preference was associated with a 17% increased rate of the primary outcome (aHR, 1.17; 95% CI, 0.99-1.39). An unrestricted preference was consistently associated with lower rates of death or removal from the list for clinical deterioration and with higher rates of transplantation. Graft failure rates were similar among those listed with restricted and unrestricted preferences.

CONCLUSION

When considering outcomes both before and after transplantation, we found no evidence that patients with COPD or ILD benefit from listing for bilateral lung transplantation compared with listing for a more liberal procedure preference. An unrestricted listing strategy for suitable candidates may increase the number of transplants performed without impacting overall survival.

摘要

背景

双侧肺移植被广泛用于治疗慢性阻塞性肺疾病(COPD)和间质性肺疾病(ILD),基于移植后生存率提高的预期。然而,在等待双侧移植时,等待名单上的死亡率更高。手术偏好对总生存的净效应尚不清楚。

目的

确定不受限制的手术偏好是否与肺移植后整体结果的改善相关。

方法

我们对 2005 年 5 月 4 日至 2014 年 12 月 31 日期间在美国接受肺移植的 12155 名 COPD 或 ILD 成年患者进行了回顾性队列研究。我们将“受限”手术偏好定义为仅“双侧移植”,将“不受限制”手术偏好定义为双侧或单侧肺移植的任何组合。我们使用了一种复合的“意向治疗”主要结局,包括移植前后的事件,定义为从登记到死亡、因临床恶化而从名单中删除或再次移植的天数。

结果

在调整分析中,COPD 中不受限制的手术偏好与主要意向治疗结局的发生率降低 3%相关(调整后的危险比 [aHR],0.97;95%置信区间 [CI],0.89-1.07),ILD 中发生率增加 1%(aHR,1.01;95%CI,0.94-1.08)。没有令人信服的证据表明这些关联因年龄、疾病严重程度或机械支持的使用而有所不同。在ILD 合并严重肺动脉高压的患者中,不受限制的偏好与主要结局的发生率增加 17%相关(aHR,1.17;95%CI,0.99-1.39)。不受限制的偏好与较低的死亡率或因临床恶化而从名单中删除的发生率以及较高的移植率相关。在限制和不受限制的偏好下登记的患者中,移植物失功率相似。

结论

在考虑移植前后的结果时,我们没有发现 COPD 或 ILD 患者从双侧肺移植登记中获益的证据,而不是从更宽松的手术偏好登记中获益。对于合适的患者,不受限制的登记策略可能会增加移植的数量,而不会影响整体生存率。

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