Angermann Christiane E, Assmus Birgit, Anker Stefan D, Asselbergs Folkert W, Brachmann Johannes, Brett Marie-Elena, Brugts Jasper J, Ertl Georg, Ginn Greg, Hilker Lutz, Koehler Friedrich, Rosenkranz Stephan, Zhou Qian, Adamson Philip B, Böhm Michael
Comprehensive Heart Failure Center, University and University Hospital, Würzburg, University Hospital Würzburg, Würzburg, Germany.
Department of Medicine, Cardiology, Goethe University Hospital, Frankfurt, Germany.
Eur J Heart Fail. 2020 Oct;22(10):1891-1901. doi: 10.1002/ejhf.1943. Epub 2020 Aug 9.
Heart failure (HF) leads to repeat hospitalisations and reduces the duration and quality of life. Pulmonary artery pressure (PAP)-guided HF management using the CardioMEMS™ HF system was shown to be safe and reduce HF hospitalisation (HFH) rates in New York Heart Association (NYHA) class III patients. However, these findings have not been replicated in health systems outside the United States. Therefore, the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF) evaluated the safety, feasibility, and performance of this device in Germany, The Netherlands, and Ireland.
A total of 234 NYHA class III patients (68 ± 11 years, 22% female, ≥1 HFH in the preceding year) from 31 centres were implanted with a CardioMEMS sensor and underwent PAP-guided HF management. One-year rates of freedom from device- or system-related complications and from sensor failure (co-primary outcomes) were 98.3% [95% confidence interval (CI) 95.8-100.0] and 99.6% (95% CI 97.6-100.0), respectively. Survival rate was 86.2%. For the 12 months post- vs. pre-implant, HFHs decreased by 62% (0.60 vs. 1.55 events/patient-year; hazard ratio 0.38, 95% CI 0.31-0.48; P < 0.0001). After 12 months, mean PAP decreased by 5.1 ± 7.4 mmHg, Kansas City Cardiomyopathy Questionnaire (KCCQ) overall/clinical summary scores increased from 47.0 ± 24.0/51.2 ± 24.8 to 60.5 ± 24.3/62.4 ± 24.1 (P < 0.0001), and the 9-item Patient Health Questionnaire sum score improved from 8.7 ± 5.9 to 6.3 ± 5.1 (P < 0.0001).
Haemodynamic-guided HF management proved feasible and safe in the health systems of Germany, The Netherlands, and Ireland. Physician-directed treatment modifications based on remotely obtained PAP values were associated with fewer HFH, sustainable PAP decreases, marked KCCQ improvements, and remission of depressive symptoms.
心力衰竭（HF）会导致再次住院，并缩短寿命和降低生活质量。使用CardioMEMS™ HF系统进行肺动脉压（PAP）引导的HF管理已被证明是安全的，并可降低纽约心脏协会（NYHA）III级患者的HF住院（HFH）率。然而，这些研究结果尚未在美国以外的卫生系统中得到重复验证。因此，欧洲心力衰竭CardioMEMS监测研究（MEMS-HF）评估了该设备在德国、荷兰和爱尔兰的安全性、可行性和性能。
来自31个中心的总共234例NYHA III级患者（68±11岁，22%为女性，前一年至少有1次HFH）植入了CardioMEMS传感器，并接受了PAP引导的HF管理。与设备或系统相关并发症以及传感器故障（共同主要结局）的1年无事件发生率分别为98.3%[95%置信区间（CI）95.8-100.0]和99.6%（95%CI 97.6-100.0）。生存率为86.2%。与植入前的12个月相比，HFH减少了62%（0.60次/患者年对1.55次/患者年；风险比0.38，95%CI 0.31-0.48；P<0.0001）。12个月后，平均PAP下降了5.1±7.4 mmHg，堪萨斯城心肌病问卷（KCCQ）总体/临床总结评分从47.0±24.0/51.2±24.8提高到60.5±24.3/62.4±24.1（P<0.0001），9项患者健康问卷总分从8.7±5.9提高到6.3±5.1（P<0.0001）。
在德国、荷兰和爱尔兰的卫生系统中，血流动力学引导的HF管理被证明是可行和安全的。基于远程获取的PAP值由医生指导进行治疗调整，可减少HFH、持续降低PAP、显著改善KCCQ并缓解抑郁症状。
