Department of Cardiology, Shenzhen Cardiovascular Minimally Invasive Medical Engineering Technology Research and Development Center, Shenzhen People's Hospital, Shenzhen, 518020, Guangdong, China.
The Second Clinical Medical College, Jinan University; The First Affiliated Hospital, Southern University of Science and Technology, Shenzhen, 518020, Guangdong, China.
J Cardiothorac Surg. 2021 Apr 20;16(1):98. doi: 10.1186/s13019-021-01484-0.
Heart failure (HF) is one of the leading causes of mortality and morbidity. The PARACHUTE device is designed to partition for left ventricular (LV) apical aneurysm post extensive anterior myocardial infarction (MI). However, the long-term prognosis of the PARACHUTE device post-implantation is unclear.
From November 2015 to April 2017, six subjects with New York Heart Association Classes II, III and IV ischemic HF, LV ejection fraction between (LVEF) 15 and 40%; and LV anterior apical aneurysm were enrolled in our center. The cumulative event rates for MI, hospitalization, and mortality were documented. Further assessment of LVEF, LV end-diastolic diameter (LVEDD), and estimated pulmonary artery pressure were determined by echocardiography core laboratory. For quantitative data comparison, paired t-test was employed.
Device implantation was successful in all six enrolled subjects, and acute device association adverse events were not observed. At 4.6 ± 1.7 years follow-up, major adverse cardiac events (MACEs) were found in 50% patients, and the survival rate was 86.7%. We observed that the LVEF was significantly elevated after deployment (46.00 ± 6.00% vs. 35.83 ± 1.47%, P = 0.009). Besides, the LVEDD elevated after MI (51.17 ± 3.71 vs. 62.83 ± 3.25, P < 0.001) was revealed, but the device sustained preserved LVEDD after implantation.
The PARACHUTE device is an alternative therapy for patients with severe LV maladaptive remodeling. However, the device seems to increase the HF ratio.
NCT02240940.
心力衰竭（HF）是导致死亡和发病的主要原因之一。PARACHUTE 装置旨在分割广泛前壁心肌梗死（MI）后左心室（LV）心尖部瘤。然而，PARACHUTE 装置植入后的长期预后尚不清楚。
从 2015 年 11 月到 2017 年 4 月，我们中心招募了 6 名纽约心脏协会（NYHA）心功能 II、III 和 IV 级、缺血性 HF、射血分数（LVEF）在 15%到 40%之间且 LV 前心尖部瘤的患者。记录 MI、住院和死亡率的累积事件发生率。通过超声心动图核心实验室进一步评估 LVEF、LV 舒张末期直径（LVEDD）和肺动脉压的估计值。对于定量数据比较，采用配对 t 检验。
所有 6 名入组患者的装置植入均成功，未观察到急性装置相关不良事件。在 4.6±1.7 年的随访中，50%的患者发生了主要不良心脏事件（MACEs），生存率为 86.7%。我们观察到，装置植入后 LVEF 显著升高（46.00±6.00%比 35.83±1.47%，P=0.009）。此外，MI 后 LVEDD 升高（51.17±3.71 比 62.83±3.25，P<0.001），但装置植入后 LVEDD 保持不变。
PARACHUTE 装置是治疗严重 LV 适应性不良重构患者的一种替代疗法。然而，该装置似乎增加了 HF 的比例。
NCT02240940。
