可植入式器械获准用于心衰患者肺动脉压远程监测

5月28日，美国食品药品管理局（FDA）批准了一种能够提供纽约心脏协会（NYHA）III级心衰患者肺动脉压数据的可植入式医疗器械。该批准令是基于一项研究表明，使用该器械对患者进行远程监测可减少患者心衰住院率。

FDA 声明指出，CardioMEMS HF系统是首个可提供肺动脉压数据的永久性可植入式无线系统， 测量数据包括收缩、舒张和平均肺动脉压。医生对这些信息进行远程分析后，可针对患者状况作出治疗决定，如有必要，可改变治疗药物以减少因心衰导致的住院治疗。

批准令明确了该器械用于过去一年曾因心衰住院的NYHA III级心衰患者。

CardioMEMS HF系统由三部分组成：永久性植入肺动脉的无需电池的传感器/监测器、将传感器置于肺动脉远端的静脉导管、以及接受和处理传感器/监测器信号并将肺动脉压数据传输至安全数据库的电子系统。医生利用该系统可对居家或远程患者进行监测。

批准令是基于一项纳入550例NYHA III级心衰患者及器械植入患者近期心衰住院情况的研究。医生只能得到随机入组治疗组患者的每日肺动脉压数据，并根据这些数据调整心衰治疗药物。6个月时，治疗组患者心衰住院率显著较低。FDA声明指出，6个月时，近99%的器械植入患者或尝试植入患者未见与器械或系统相关的并发症，所有植入器械均运行正常。

不过，在过去几年中，专家一直对于支持器械获批的这项试验存有疑虑。在2011年12月召开的FDA循环系统器械专家会议上，大多数专家认为该器械的风险大于受益。制造商 CardioMEMS在2013年10月的专家会议上提交了患者随访数据和对有关数据的进一步分析。在这次会议上，大多数专家认为该器械对于符合获批适应症规定的患者，其获益大于风险。

FDA声明要求该公司开展一项上市后研究，以评价该器械用于临床试验受试者之外患者的疗效。在2013年专家会议上支持批准该器械的专家所担心的一个问题是，该研究中女性患者心衰住院率方面的获益并不明显。他们认为这可能与女性患者入组数量较少有关，因此，建议应针对更多女性患者进行进一步研究。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

 MAY. 28, 2014

An implantable device that provides measurements of pulmonary arterial pressure in patients with class III heart failure has been approved by the Food and Drug Administration, based on a study that showed the use of the device to remotely monitor patients reduced heart failure hospitalization rates.

The CardioMEMS HF System "is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic, and mean PA pressures," according to the FDA statement announcing the approval on May 28. This information is remotely reviewed by the patient’s physician, who "can make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of reducing hospitalization due to heart failure," the statement said.

It is specifically approved for patients with New York Heart Association (NYHA) class III heart failure (HF) who have been hospitalized for heart failure in the previous year.

The three components of the system are the battery-free sensor/monitor that is permanently implanted in the pulmonary artery, a transvenous catheter that deploys the sensor in the distal PA, and an electronic system that receives and processes the signals from the sensor/monitor and transfers the PA pressure measurements to a secure database, the statement said. Patients can be monitored from their home or another remote location.

Approval was based on a study of 550 patients with NYHA class III HF and a recent hospitalization for HF, who had the device implanted. Physicians had access to daily PA measurements only for the patients randomized to the treatment group, and adjusted HF medications based on the values provided. At 6 months, the HF hospitalization rate was significantly lower among those in the treatment group. The FDA statement noted that at 6 months, almost 99% of the patients who had the device implanted or in whom implantation was attempted had no complications related to the device or system, and all of the devices that were implanted were operating normally.

However, concerns about the study held up approval of the device for several years, and at a meeting in December 2011, the majority of the FDA’s Circulatory System Devices Panel agreed that the risks of the device outweighed the benefits. The manufacturer, CardioMEMS, provided follow-up data and further analyses of the data that were provided at another meeting of the panel, in October 2013. At that meeting, the majority of the panel agreed that the benefits of the device outweighed its risks for monitoring patients who met the criteria specified in the indication that has been approved, patients with NYHA class III heart failure who have been hospitalized for HF in the previous year.

In the May 28 statement, the FDA said that the company is required to conduct a postmarketing study to evaluate the performance of the device when used outside of a clinical trial. One concern of the panelists who supported approval at the 2013 meeting was that the benefit in terms of HF hospitalizations was not evident in women in the study, which they said could have been due to the low number of women enrolled in the trial, and they recommended that the device be studied in more women.