Gilbert Christopher R, Casal Roberto F, Lee Hans J, Feller-Kopman David, Frimpong Bernice, Dincer H Erhan, Podgaetz Eitan, Benzaquen Sadia, Majid Adnan, Folch Erik, Gorden Jed A, Chenna Praveen, Chen Alex, Abouzgheib Wissam, Sanny Nonyane Bareng Aletta, Yarmus Lonny B
Division of Pulmonary, Allergy, and Critical Care Medicine, Penn State College of Medicine-Milton S. Hershey Medical Center, Hershey, Pennsylvania.
Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, Texas.
Ann Thorac Surg. 2016 May;101(5):1891-6. doi: 10.1016/j.athoracsur.2015.10.113. Epub 2016 Feb 12.
A persistent air leak represents significant clinical management problems, potentially affecting morbidity, mortality, and health care costs. In 2008, a unidirectional, intrabronchial valve received humanitarian device exemption for use in managing prolonged air leak after pulmonary resection. Since its introduction, numerous reports exist but no large series describe current utilization or outcomes. Our aim was to report current use of intrabronchial valves for air leaks and review outcome data associated with its utilization.
A multicenter, retrospective review of intrabronchial valve utilization from January 2013 to August 2014 was performed at eight centers. Data regarding demographics, valve utilization, and outcomes were analyzed.
We identified 112 patients undergoing evaluation for intrabronchial valve placement, with 67% (75 of 112) undergoing valve implantation. Nearly three quarters of patients underwent valve placement for off-label usage (53 of 75). A total of 195 valves were placed in 75 patients (mean 2.6 per patient; range, 1 to 8) with median time to air leak resolution of 16 days (range, 2 to 156).
We present the largest, multicenter study of patients undergoing evaluation for intrabronchial valve use for air leak management. Our data suggest the majority of intrabronchial valve placements are occurring for off-label indications. Although the use of intrabronchial valves are a minimally invasive intervention for air leak management, the lack of rigorously designed studies demonstrating efficacy remains concerning. Prospective randomized controlled studies remain warranted.
持续性漏气是临床管理中的重大问题，可能影响发病率、死亡率和医疗成本。2008年，一种单向支气管内瓣膜获得人道主义器械豁免，用于处理肺切除术后的持续性漏气。自其引入以来，已有众多报道，但尚无大型系列研究描述其当前的使用情况或治疗结果。我们的目的是报告支气管内瓣膜在漏气治疗中的当前使用情况，并回顾与其使用相关的结果数据。
对2013年1月至2014年8月期间8个中心支气管内瓣膜使用情况进行多中心回顾性研究。分析了有关人口统计学、瓣膜使用情况和治疗结果的数据。
我们确定了112例接受支气管内瓣膜置入评估的患者，其中67%（112例中的75例）接受了瓣膜植入。近四分之三的患者因超说明书使用而接受瓣膜置入（75例中的53例）。共75例患者置入了195个瓣膜（平均每位患者2.6个；范围为1至8个），漏气解决的中位时间为16天（范围为2至156天）。
我们展示了关于接受支气管内瓣膜用于漏气管理评估患者的最大规模多中心研究。我们的数据表明，大多数支气管内瓣膜置入是用于超说明书适应症。尽管支气管内瓣膜的使用是一种用于漏气管理的微创干预措施，但缺乏严格设计的研究证明其疗效仍令人担忧。前瞻性随机对照研究仍然是必要的。
