First Implantable Wireless Hemodynamic Monitoring Device Shown to Reduce Hospitalizations

The CardioMEMS™ HF System is the first Food and Drug Administration (FDA)-approved heart failure (HF) monitor proven to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients.¹This implanted, wireless, battery-free device measures key vital signs, including pulmonary artery pressure in HF patients, and transmits this information remotely to the patient’s doctors for proactive management. The device was evaluated in 550 people in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial;Penn State Health Milton S. Hershey Medical Centerparticipated as an active enrolling center. During 15 months of follow-up, the treatment group had a 39 percent reduction in heart failure-related hospitalization compared with the control group.¹

To participate, patients must have been hospitalized for HF in the 12 months prior. “That defines a relatively unstable population,” saysJohn P. Boehmer, MD,Penn State Heart and Vascular Institute。Once implanted, the CardioMEMS device requires patients to lie on a special mat every day. The mat includes an antenna that wirelessly connects and transmits data securely to a monitor that records 18 seconds of a pulmonary pressure tracing.

“目标是让心力衰竭患者从医院中留出，在它们变得有问题之前管理任何潜在的问题。Cardiems是一种允许我们这样做的诊断工具，“博尔默仍然存在。通常，当临床医生观察肺动脉压的升高时，它们调整利尿剂的剂量，可能是其他心脏病药物，以减少流体和钠堆积并降低压力。

The study met its pre-specified endpoints, often by a large margin, adds Boehmer, but the FDA expressed concern regarding the possible influence of nurse communications in the CardioMEMS group.²Consequently, researchers conducted a long-term single-blind follow-up after the initial assessment at six months.¹这种后续行动表明，护士沟通中包含的建议中有84％与药物变化无关。²

Hershey Medical Cent的团队计划利用CardieMs进行特别具有挑战性的患者的长期随访。这些挑战性案例可能包括在没有伴随体重增加的情况下产生心力衰竭相关问题的患者，这通常表明流体保留。Boehmer国家，“心脏病不是本身的治疗。它需要连接到一个可以提供适当疗法的系统，以响应患者条件的变化产生所需的结果。“医疗中心还需要考虑设备的“后端”，识别如何存储和传播数据。这种重要数据有可能彻底改变心力衰竭的治疗，防止否则要求将患者预留为医院的急性发作。

References:

1. Abraham WT, Adamson PB, Bourge RC, et al.Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial。《柳叶刀》。2011, 377 (9766): 658-66.
2. CardioMEMS Champion HF Monitoring System PMA Amendment P100045; FDA and CardioMEMS Panel Package Prepared for the October 9, 2013 Circulatory System Devices Panel Meeting.