Department of Cardiology, Erasmus MC, Thorax Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Department of Interventional Cardiology, Erasmus MC, Thorax Center, University Medical Center Rotterdam, Rotterdam, The Netherlands.
J Card Surg. 2021 Sep;36(9):3271-3280. doi: 10.1111/jocs.15767. Epub 2021 Jun 22.
There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages.
Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance.
No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group.
Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.
需要额外的远程工具来改善左心室辅助装置（LVAD）患者的管理。本先导概念研究的目的是评估使用 CardioMEMS 在 LVAD 患者不同治疗阶段进行附加远程血液动力学监测以优化患者管理的安全性和可行性。
连续纳入 10 例接受并准备进行（半）择期 HeartMate 3 LVAD 手术的患者。所有患者在手术前均接受 CardioMEMS 以优化充盈压。将患者分为平均肺动脉压（mPAP）正常（≤25mmHg，n=4）或升高（>25mmHg，n=6）组，并与历史队列（n=20）进行比较。终点为 CardioMEMS 设备安全性以及 1 年随访时全因死亡率、急性肾损伤、肾脏替代治疗和/或右心衰竭的复合终点。此外，我们还研究了无住院生存率以及生活质量（QoL）和运动耐量的改善。
未观察到设备安全性问题或信号干扰。历史对照组的复合终点发生率为 60%，正常 mPAP 组为 0%，升高 mPAP 组为 83%。出院后，正常 mPAP 组的无住院生存率显著提高，QoL 改善程度也明显优于升高 mPAP 组。
CardioMEMS 用于 LVAD 患者的远程血液动力学监测是安全可行的，它可以识别处于并发症高风险的患者，并在门诊阶段通过减少住院次数来远程优化患者管理。需要进行更大的关键性研究来验证该概念研究中提出的假设。
