Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.
St. Luke's Mid-America Heart Institute, Kansas City, Missouri.
JACC Heart Fail. 2014 Oct;2(5):526-33. doi: 10.1016/j.jchf.2014.04.014.
The study sought to assess feasibility, safety, and potential efficacy of a novel implantable extra-aortic counterpulsation system (C-Pulse) in functional class III and ambulatory functional class IV heart failure (HF) patients.
30% to 40% of HF patients suffer from poor functional status and quality of life (QoL) but are not in need of end-stage treatments. We undertook a multicenter single-arm study to assess the C-Pulse System in such patients.
New York Heart Association (NYHA) functional class III or ambulatory functional class IV HF patients were eligible. Safety was assessed continuously through 12 months. Efficacy measurements included changes from baseline to 6 and 12 months in NYHA functional class, Minnesota Living with Heart Failure (MLWHF) and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, 6-min walk distance (6MWD), and exercise peak oxygen consumption (pVO2; 6 months only).
Twelve men and 8 women (56.7 ± 7 years, 34 to 71 years of age) with ischemic (n = 7) or nonischemic (n = 13) cardiomyopathy were implanted. There was no 30-day mortality and no neurological events or myocardial infarctions through 12 months. At 6 months, there were 3 deaths (1 device-related). One-year survival was 85%. At 6 months, C-Pulse produced improvements in NYHA functional class (3.1 ± 0.3 to 1.9 ± 0.7, p = 0.0005), MLWHF (63.6 ± 19.9 to 40.2 ± 23.2, p = 0.0005), and KCCQ scores (43.6 ± 21.1 to 65.6 ± 21.5, p = 0.0002), but not 6MWD (275.5 ± 64.0 to 296.4 ± 104.9, p = NS) or pVO2 (14.5 ± 3.6 to 13.1 ± 4.4, p = NS). Improvements continued at 12 months, with 6MWD change becoming statistically significant (336.5 ± 91.8, p = 0.0425).
Use of C-Pulse in this population is feasible, appears safe, and improves functional status and QoL. A prospective, multicenter, randomized controlled trial is underway. (C-Pulse IDE Feasability Study-A Heart Assist System; NCT00815880).
本研究旨在评估新型主动脉外反搏系统（C-Pulse）在纽约心脏协会（NYHA）心功能 III 级和可走动心功能 IV 级心力衰竭（HF）患者中的可行性、安全性和潜在疗效。
30%至 40%的 HF 患者存在较差的功能状态和生活质量（QoL），但不需要终末期治疗。我们进行了一项多中心单臂研究，以评估 C-Pulse 系统在这类患者中的应用。
符合条件的患者为 NYHA 心功能 III 级或可走动心功能 IV 级 HF 患者。安全性通过 12 个月持续评估。疗效评估包括基线至 6 个月和 12 个月时 NYHA 心功能分级、明尼苏达心力衰竭生活质量量表（MLWHF）和堪萨斯城心肌病问卷（KCCQ）评分、6 分钟步行距离（6MWD）和运动峰值耗氧量（pVO2；仅 6 个月评估）的变化。
12 名男性和 8 名女性（56.7 ± 7 岁，34 至 71 岁）植入了缺血性（n = 7）或非缺血性（n = 13）心肌病的患者。无 30 天死亡率，无神经事件或心肌梗死。12 个月时，有 3 例死亡（1 例与器械相关）。1 年生存率为 85%。6 个月时，C-Pulse 改善了 NYHA 心功能分级（3.1 ± 0.3 至 1.9 ± 0.7，p = 0.0005）、MLWHF（63.6 ± 19.9 至 40.2 ± 23.2，p = 0.0005）和 KCCQ 评分（43.6 ± 21.1 至 65.6 ± 21.5，p = 0.0002），但 6MWD（275.5 ± 64.0 至 296.4 ± 104.9，p = NS）或 pVO2（14.5 ± 3.6 至 13.1 ± 4.4，p = NS）无统计学意义。12 个月时持续改善，6MWD 变化具有统计学意义（336.5 ± 91.8，p = 0.0425）。
在该人群中使用 C-Pulse 是可行的，似乎是安全的，可改善功能状态和 QoL。一项前瞻性、多中心、随机对照试验正在进行中（C-Pulse IDE 可行性研究-心脏辅助系统；NCT00815880）。
