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Venoarterial Extracorporeal Membrane Oxygenation in the New Heart Allocation Scheme
Circulation: Heart Failure ( IF 7.8 ) Pub Date : 2018-09-18 , DOI: 10.1161/circheartfailure.118.005322
Muddassir Mehmood 1
Affiliation  

The United Network for Organ Sharing will implement changes to the adult heart allocation system this fall. Adults supported by Venoarterial extracorporeal membrane oxygenation (VA ECMO) will be eligible for the highest status listing during the first 7 days, and for status 2, from the seventh through 14th day of support, renewable thereafter.1 The new policy strives to reduce wait-list mortality by prioritizing heart allocation to the most critically ill. Many have raised concerns about the status of ECMO in the new allocation scheme with regards to its impact on organ allocation. But there is an elephant in the room. Is VA ECMO ready for prime time as the standard of care for managing profound cardiogenic shock in the United States?


Since the first ECMO intervention in 1972, the extracorporeal life support family of therapies has evolved. In 1989, therapeutic advances in extracorporeal life support contributed to the formation of a scientific platform, the Extracorporeal Life Support Organization. In the year 2017, 379 centers provided ECMO therapy worldwide, a number that has steadily increased from 83 in 1990.2 The ECMO financial market is anticipated to reach USD 305.3 million by 2021 from USD 247.2 million in 2016.3


However, despite the advances, ECMO therapy faces several challenges. The management of patients on ECMO remains complex and resource intense. As a result, the use of ECMO remains restricted to specialized centers with center-specific utilization protocols. Ironically, to date, there is not a single blood pump with Food and Drug Administration approval for providing >6 hours of circulatory support, in a VA ECMO configuration, for patients with cardiogenic shock from left ventricular or combined right and left ventricular failure.


The paradigm shift in heart allocation policy should serve as a call to action to transform advances in extracorporeal life support therapy to standards of care for managing profound cardiogenic shock and refractory cardiac arrest. To accomplish this, a multifaceted approach is suggested as follows: (1) at the healthcare delivery level, a system based approach should integrate ECMO into existing networks of ST-segment–elevation myocardial infarction care. Hub and spoke models for advanced heart failure care must be clearly delineated such that community cardiology centers establish efficient channels of communication and transfer mechanisms to advanced heart failure centers for patients on or in need for ECMO support. (2) At the scientific level, working knowledge of extracorporeal life support therapies should be integrated into resident and fellow training curricula across multiple specialties. Key scientific societies need to collaboratively update recommendations for VA ECMO therapy and monitor utilization via a single registry. The American Heart Association needs to work toward taking the Mission: Lifeline to the next level by incorporating ECMO assisted cardiopulmonary resuscitation for refractory cardiac arrest. (3) At the regulatory level, the Food and Drug Administration needs to ensure that the process of applying for ECMO product labeling is conducive to inviting competition from the industry to help curtail cost and deal with future supply shortages. (4) At the industry level, manufacturers need to gear up for innovations to make ECMO safer for longer-term support, resource efficient, portable, and cost effective.


I think the status of ECMO in the new United Network for Organ Sharing scheme is well intended. Given the severity of illness of patients requiring ECMO support, its impact on heart allocation may be less than generally perceived. More importantly, we need to get our act together to make VA ECMO an accessible standard of care across the United States. In my opinion, the implications of the latter will be far greater.


None.


The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.


https://www.ahajournals.org/journal/circheartfailure




中文翻译:

新的心脏分配方案中的静脉动脉体外膜氧合

器官共享联合网络将于今年秋天对成人心脏分配系统进行更改。经静脉动脉体外膜氧合作用(VA ECMO)支持的成年人将有资格在头7天内获得最高状态列表,并从支持的第七天到第14天获得状态2,然后可以续签。1新政策致力于通过优先分配重病患者的重心来降低等候名单上的死亡率。许多人对ECMO在新分配方案中对器官分配的影响表示关注。但是房间里有一头大象。VA ECMO是否已准备好在黄金时段作为治疗美国严重心源性休克的护理标准?


自1972年首次实施ECMO干预以来,体外生命支持疗法家族不断发展。1989年,体外生命支持的治疗进展为体外生命支持组织科学平台的形成做出了贡献。2017年,全球有379个中心提供ECMO治疗,这一数字从1990年的83个稳步增长。2 ECMO金融市场预计将从2016年的2.472亿美元增长到2021年的3.053亿美元。3


然而,尽管取得了进展,ECMO治疗仍面临一些挑战。使用ECMO的患者管理仍然很复杂且资源紧张。结果,ECMO的使用仍然仅限于具有特定于中心的使用协议的专门中心。具有讽刺意味的是,迄今为止,还没有获得美国食品药品监督管理局批准的单台血泵,以VA ECMO的配置为患者提供超过6小时的循环支持,以左心室或右,左和左心室合并衰竭为源性休克。


心脏分配政策的范式转变应呼吁采取行动,将体外生命支持治疗的进展转化为治疗严重心源性休克和难治性心脏骤停的护理标准。为此,建议采取以下多方面的方法:(1)在医疗保健提供方面,基于系统的方法应将ECMO整合到现有的ST段抬高型心肌梗死护理网络中。必须清楚地描述用于高级心力衰竭护理的中心模型和轮辐模型,以便社区心脏病学中心为需要ECMO支持或需要ECMO支持的患者建立到高级心力衰竭中心的有效沟通和转移机制。(2)在科学层面上,体外生命支持疗法的工作知识应整合到多个专业的住院医师和同伴培训课程中。关键科学学会需要共同更新有关VA ECMO治疗的建议,并通过一个注册表来监控使用情况。美国心脏协会需要努力,将ECMO辅助的心肺复苏纳入难治性心脏骤停,以将“使命:生命线”提升到一个新的水平。(3)在法规层面,美国食品药品管理局需要确保ECMO产品标签的申请程序有利于吸引行业竞争,以帮助降低成本并应对未来的供应短缺。(4)在行业层面,制造商需要加大创新力度,以使ECMO更安全地获得长期支持,


我认为ECMO在新的器官共享联合网络计划中的地位是正确的。考虑到需要ECMO支持的患者的病情严重程度,其对心脏分配的影响可能比一般人想象的要小。更重要的是,我们需要采取行动,使VA ECMO成为全美可及的护理标准。我认为,后者的影响将更大。


没有任何。


本文表达的观点不一定是编辑者或美国心脏协会的观点。


https://www.ahajournals.org/journal/circheartfailure


更新日期:2018-09-19
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