The Ohio State University Wexner Medical Center, Department of Internal Medicine, Division of Cardiovascular Medicine, Columbus, OH, United States of America; Nationwide Children's Hospital, Department of Pediatrics, Division of Cardiovascular Medicine, Columbus, OH, United States of America.
Nationwide Children's Hospital, Department of Pediatrics, Division of Cardiovascular Medicine, Columbus, OH, United States of America.
Int J Cardiol. 2019 Jun 1;284:22-27. doi: 10.1016/j.ijcard.2018.10.081. Epub 2018 Oct 28.
Implantable invasive hemodynamic monitoring (IHM) using the CardioMEMS™ HF system has been shown to reduce heart failure (HF) hospitalizations. IHMs have not yet been used in congenital heart disease (CHD). We aimed to evaluate feasibility and mid-term outcomes of IHM use in the single ventricle/Fontan population.
Six adult Fontan patients (>1 HF admission, NYHA FC >3) were enrolled (30 ± 7 years old, mean pulmonary artery pressure (mPA) 16 ± 4.7 mm Hg). Heart failure mediated events (HFME) were evaluated for 12 months: CV medication change, hospital admission, paracentesis, and change in orthotopic heart transplant (OHT) listing status.
The IHM device was successfully placed in all participants. In total there were 671 IHM transmissions and 25(3.7%) HFME. The mean PA pressure across all episodes was 18.2 ± 6.6 mm Hg (range 6-40 mm Hg). Higher mPA pressures were associated with greater odds of having a HFME (OR 1.17 [1.09, 1.25], p < 0.0001). Mean PA pressure had good ability to discriminate transmissions associated with HFME (AUC 0.76 [0.654, 0.866]), with mean PA pressures >24 mm Hg or individual mPA change >4 mm Hg, best discriminating transmissions associated with HFME.
In the first feasibility series of adult Fontan patients undergoing CardioMEMS™ implantation we demonstrate early technical success and no device-related adverse events. We propose that ambulatory mean PA pressures >24 mm Hg or individual mPA change >4 mm Hg may be associated with more HFME. Further large-scale studies in this population are recommended.
使用 CardioMEMS™ HF 系统的植入式侵入性血流动力学监测 (IHM) 已被证明可减少心力衰竭 (HF) 住院次数。IHM 尚未在先天性心脏病 (CHD) 中使用。我们旨在评估 IHM 在单心室/Fontan 人群中的应用的可行性和中期结果。
纳入 6 例成年 Fontan 患者（HF 住院次数≥1 次，NYHA FC >3）（30±7 岁，平均肺动脉压 (mPA) 16±4.7mmHg）。在 12 个月内评估心力衰竭介导的事件 (HFME)：CV 药物变化、住院、穿刺放液以及原位心脏移植 (OHT) 登记状态的变化。
所有参与者均成功放置了 IHM 设备。总共有 671 次 IHM 传输和 25 次 (3.7%) HFME。所有发作的平均 PA 压力为 18.2±6.6mmHg（范围 6-40mmHg）。较高的 mPA 压力与发生 HFME 的几率更高相关（OR 1.17[1.09, 1.25]，p<0.0001）。平均 PA 压能很好地区分与 HFME 相关的传输（AUC 0.76[0.654, 0.866]），平均 PA 压>24mmHg 或个体 mPA 变化>4mmHg 时，最佳区分与 HFME 相关的传输。
在对接受 CardioMEMS™ 植入的成年 Fontan 患者进行的首次可行性系列研究中，我们证明了早期的技术成功，且无器械相关不良事件。我们提出，动态平均 PA 压>24mmHg 或个体 mPA 变化>4mmHg 可能与更多的 HFME 相关。建议在该人群中进行更大规模的研究。
