BACKGROUND Pulmonary arterial hypertension (PAH) is a chronic disease that ultimately progresses to right-sided heart failure (HF) and death. Close monitoring of pulmonary artery pressure (PAP) and right ventricular (RV) function allows clinicians to appropriately guide therapy. However, the burden of commonly used methods to assess RV hemodynamics, such as right heart catheterization, precludes frequent monitoring. The CardioMEMS™ HF System is an ambulatory implantable hemodynamic monitor, previously only used in NYHA Class III HF patients. In this study, we evaluate the feasibility and early safety of monitoring PAH patients with right-sided heart failure (HF) using the CardioMEMS system. METHODS CardioMEMS sensors were implanted in 26 PAH patients with NYHA class III or IV right-sided HF (51.3±18.3 years old, 92% female, 81% NYHA class III). PAH therapy was tracked using a minimum of weekly reviews of CardioMEMS daily hemodynamic measurements. Safety, functional response, and hemodynamic response were tracked up to 4 years with in-clinic follow-ups. RESULTS CardioMEMS was safely used to monitor PAH therapy, with no device-related serious adverse events observed and a single pre-implant serious adverse event. Significant PAP reduction and cardiac output (CO) elevation were observed as early as 1 month post-implant using trends of CardioMEMS data, coupled with significant NYHA class and quality of life improvements within 1 year. CONCLUSIONS The CardioMEMS HF System provided useful information to monitor PAH therapy, and demonstrated short- and long-term safety. Larger clinical trials are needed before its widespread use to guide therapy in severe PAH patients with right-sided HF.

中文翻译：

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使用植入式血流动力学传感器监测肺动脉高压

背景技术肺动脉高压（PAH）是一种慢性疾病，最终进展为右心衰竭（HF）和死亡。密切监测肺动脉压 (PAP) 和右心室 (RV) 功能使临床医生能够适当地指导治疗。然而，评估右心室血流动力学的常用方法（如右心导管插入术）的负担妨碍了频繁监测。CardioMEMS™ HF 系统是一种可移动的植入式血流动力学监测器，以前仅用于 NYHA III 级 HF 患者。在这项研究中，我们评估了使用 CardioMEMS 系统监测 PAH 患者右侧心力衰竭 (HF) 的可行性和早期安全性。方法 CardioMEMS 传感器被植入 26 名 NYHA III 或 IV 级右侧心力衰竭的 PAH 患者（51.3±18.3 岁，92% 女性，81% NYHA III 级）。使用 CardioMEMS 每日血流动力学测量的最少每周回顾来跟踪 PAH 治疗。通过临床随访，对安全性、功能反应和血流动力学反应进行了长达 4 年的跟踪。结果 CardioMEMS 被安全地用于监测 PAH 治疗，没有观察到与设备相关的严重不良事件和单一的植入前严重不良事件。使用 CardioMEMS 数据的趋势，早在植入后 1 个月就观察到 PAP 显着降低和心输出量 (CO) 升高，并在 1 年内显着改善了 NYHA 等级和生活质量。结论 CardioMEMS HF 系统为监测 PAH 治疗提供了有用的信息，并证明了短期和长期的安全性。在广泛用于指导右侧心衰严重 PAH 患者的治疗之前，需要进行更大规模的临床试验。