Single-center evaluation of the safety and efficacy of left ventricular assist device implantation in patients with end-stage heart failure
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摘要: 目的 评估终末期心力衰竭(心衰)患者置入左心室辅助装置(LVAD)的安全性和有效性，探讨个体化出凝血管理策略。方法 纳入2021年1月—2023年12月在阜外华中心血管病医院接受LVAD治疗的18例终末期心衰患者，回顾性分析临床资料。检测术前和术后游离血红蛋白、乳酸脱氢酶、血小板和白细胞，评价血液相容性；检测超敏肌钙蛋白T(hs-cTnT)和肌酸激酶同工酶(CK-MB)，评估心肌损伤。依据超声心动图、6 min步行试验和堪萨斯城心肌病问卷(KCCQ)评分评价手术前后心功能变化。将患者随机分为对照组(9例)和试验组(9例)，对照组出凝血管理过程中只监测凝血功能指标，试验组在对照组基础上增加个体化出凝血监测项目，通过个体化出凝血监测对比分析，探讨个体化出凝血管理和药物治疗方案。结果 患者游离血红蛋白和乳酸脱氢酶术后1周升高，但术后1个月均恢复至术前基线水平，表明LVAD未引起持续性血液破坏。白细胞及hs-cTnT术后1个月较1周时明显降低(P<0.05)，表明LVAD血液相容性较好，不会造成心肌缺血性损伤。超声心动图显示，同术前相比，术后1~6月左心室射血分数明显升高，左心室舒张末期内径明显减小，6 min步行距离和KCCQ评分明显提升(均P<0.05)，表明术后心功能明显改善。18例患者围术期无死亡。对照组术后出血4例(44%)，试验组2例(22%)。15例(83%)术后泵入肝素桥接抗凝，华法林初始剂量1.25~1.5 mg，维持INR 2.0~2.5，11例(61%)术后72 h联合阿司匹林100 mg/d抗血小板治疗。结论 置入LVAD治疗终末期心衰安全有效，个体化出凝血监测和药物治疗方案的制定有助于减少术后并发症的发生。Abstract: Objective To evaluate the safety and efficacy of left ventricular assist device(LVAD) implantation in patients with end-stage heart failure, and to explore individualized coagulation management strategies.Methods A retrospective analysis was conducted on the clinical data of 18 end-stage heart failure patients who underwent LVAD treatment at Fuwai Central China Cardiovascular Hospital from January 2021 to December 2023. Preoperative and postoperative levels of free hemoglobin, lactate dehydrogenase, platelets, and white blood cells were measured to assess blood compatibility. High-sensitivity cardiac troponin T(hs-cTnT) and creatine kinase-MB(CK-MB) were measured to evaluate myocardial injury. Additionally, echocardiography, the 6-minute walk test, and the Kansas City Cardiomyopathy Questionnaire(KCCQ) score were used to assess changes in cardiac function before and after surgery. Patients were randomly divided into the control group(n=9) and the experimental group(n=9). Patients in the control group received coagulation parameter monitoring during coagulation management, while the experimental group underwent additional individualized coagulation monitoring protocols. This comparative analysis aimed to explore personalized coagulation management and pharmacotherapy strategies. Individualized coagulation monitoring and medication regimens were compared and analyzed to explore tailored coagulation management.Results The levels of free hemoglobin and lactate dehydrogenase in patients increased one-week after the operation, but returned to the preoperative baseline levels one month after the operation, indicating that LVAD did not cause persistent blood destruction. Significant reductions in white blood cells and hs-cTnT were observed at one month compared to one week post-surgery(P<0.05), indicating good blood compatibility of the LVAD without causing ischemic myocardial injury. Echocardiography showed that compared with preoperative conditions, left ventricular ejection fraction significantly increased from 1 to 6 months after surgery, left ventricular diastolic end-diastolic diameter significantly decreased, and 6-minute walking distance and KCCQ score significantly improved(all P<0.05), indicating that postoperative cardiac function was significantly improved. There were no perioperative deaths among the 18 patients. In the control group, 4 cases(44%) experienced postoperative bleeding, compared to 2 cases(22%) in the experimental group. Heparin bridging anticoagulation was administered to 15 cases(83%) post-surgery, with initial warfarin doses of 1.25-1.5 mg maintaining an INR of 2.0-2.5, and 11 cases(61%) receiving 100 mg/d aspirin for antiplatelet therapy 72 hours post-surgery.Conclusion LVAD implantation is both safe and effective for treating end-stage heart failure. The development of individualized coagulation monitoring and medication regimens helps reduce postoperative complications.
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表 1 我院使用的3款LVAD特点总结
Table 1. Characteristics of three LVAD devices utilized in our hospital
项目 EVAHEART CH-VAD CorHeart 6 上市时间 2019年9月 2021年11月 2023年6月 适应证 长期辅助+短期辅助 短期辅助 短期辅助 产品代别 三代离心泵 三代离心泵 三代离心泵 直径/mm 51 50 34 厚度/mm 67 26 26 重量/g 420(EVAHEART Ⅰ)
262(EVAHEART Ⅱ)180 90 轴承技术 纯水悬浮 磁力悬浮 磁力悬浮 置入方式 体内置入 体内置入 体内置入 产品分类 置入式VAD 置入式VAD 置入式VAD 转速/(r/min) 1 800~2 200 2 500~3 100 2 200~4 300 最大流量/(L/min) 20 10 10 功率/W 7~8 6~7 3.5 
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表 2 置入LVAD的18例患者基线资料
Table 2. Baseline data of 18 LVAD-implanted patients
病例 组别 性别 年龄/岁 BMI/(kg/m2) NYHA分级 术前血管活性药物 术前机械循环支持 LVEF/% LVEDD/mm 术前肌酐/(μmol/L) 1 试验组 男 40 27.5 Ⅳ 无 无 29 76 67 2 试验组 男 43 20.4 Ⅳ 多巴胺 无 28 78 76 3 试验组 男 39 31.9 Ⅲ 多巴胺 IABP 18 93 114 4 试验组 男 43 21.2 Ⅳ 多巴胺 无 29 91 100 5 对照组 男 58 26.4 Ⅳ 无 无 21 89 104 6 试验组 男 38 22.9 Ⅳ 多巴胺+去甲肾上腺素 IABP 19 75 134 7 对照组 男 61 20.6 Ⅳ 无 无 25 80 88 8 试验组 男 37 26.6 Ⅳ 多巴胺 无 22 77 60 9 试验组 女 52 19.2 Ⅳ 多巴胺 无 21 73 49 10 对照组 男 52 25.1 Ⅳ 多巴胺 无 18 91 223 11 对照组 女 54 25.4 Ⅳ 多巴胺+多巴酚丁胺 IABP 15 86 71 12 对照组 男 49 28.6 Ⅳ 多巴胺+去甲肾上腺素 IABP 21 105 90 13 对照组 男 16 19.5 Ⅳ 无 无 17 65 63 14 试验组 女 67 17.0 Ⅳ 无 无 35 72 123 15 对照组 男 60 20.1 Ⅳ 无 无 31 68 140 16 对照组 男 14 20.9 Ⅳ 无 无 19 66 83 17 对照组 男 59 23.5 Ⅳ 无 ECMO 21 83 111 18 试验组 男 49 27.3 Ⅲ 无 无 25 72 74
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表 3 对照组与试验组基线特征比较
Table 3. Comparison of baseline characteristics between the control group and the experimental group
X±S 基线特征 对照组(9例) 试验组(9例) t/χ2 P 年龄/岁 47.2±17.1 46.4±16.9 0.11 0.916 男/女/例 8/1 7/2 0.50 0.480 BMI/(kg/m2) 23.8±4.2 24.1±3.9 0.18 0.860 术前LVEF/% 22.5±5.3 23.1±5.8 0.26 0.799 术前LVEDD/mm 78.9±11.2 80.3±10.6 0.29 0.775 术前肌酐/(μmol/L) 109.4±55.6 87.2±30.6 1.11 0.284
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表 4 置入LVAD的18例患者围术期资料
Table 4. Perioperative data of 18 LVAD-implanted patients
病例 人工心脏 手术类型 SICU时间/h 术后住院时间/d 术后24 h胸腔引流液/mL 使用肝素桥接 华法林初始剂量/mg 华法林剂量/mg 术后72 h内联合阿司匹林 个体化出凝血监测 术后出血或血栓 1 EVAHEART Ⅰ LVAD置入 312.8 88 520 是 1.5 1.5~3.0 是 是 无 2 CH-VAD LVAD置入 336.2 29 620 是 1.5 0.75~3.75 是 是 无 3 CH-VAD LVAD置入 216.6 23 480 是 1.5 1.25~6 是 是 下肢静脉血栓 4 CorHeart 6
(FIM)LVAD置入+PBMV 242.4 22 300 是 1.25 1.25~3.75 是 是 无 5 CorHeart 6 LVAD置入+PBMV 233.3 19 600 是 1.25 1.25~2.5 是 否 无 6 CorHeart 6 LVAD置入+PBMV 73.0 29 300 是 1.5 1.5~3.75 是 是 无 7 CorHeart 6 LVAD置入+PBMV 120.9 15 400 是 1.5 1.5~2.5 否 否 无 8 CorHeart 6 LVAD置入+PBMV 115.3 31 380 是 1.25 1.25~1.875 是 是 皮肤瘀斑 9 CorHeart 6 LVAD置入+PBMV+TVP 139.6 33 410 是 1.5 0.75~1.5 否 是 无 10 CorHeart 6 LVAD置入+TAVR 288.9 23 390 是 1.25 1.25~2 否 否 无 11 CorHeart 6 LVAD置入+PBMV+TVP 523.7 46 510 是 1.25 1.25~2.25 否 否 消化道出血 12 CorHeart 6 LVAD置入+PBMV+PFO封堵术 216.3 72 650 是 1.5 0.75~3 是 否 吻合口出血 13 CorHeart 6 LVAD置入+PBMV+TVP 67.1 33 300 是 1.25 0.75~2.5 是 否 黑便 14 CorHeart 6 LVAD置入+PBMV 164.9 31 800 否 1.25 0.625~1.875 否 是 无 15 CorHeart 6 LVAD置入+PBMV 238.2 37 600 否 1.25 1.25~2.5 否 否 无 16 CorHeart 6 LVAD置入+PBMV 187.6 38 730 否 1.25 0.625~3.75 否 否 无 17 CorHeart 6 LVAD置入+PBMV 485.3 56 570 是 1.25 0.625~2.5 是 否 消化道出血 18 CH-VAD LVAD置入+PBMV 168.3 42 450 是 1.5 1.5~4.5 是 是 无
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表 5 EVAHERT Ⅰ的安全性评价
Table 5. Safety evaluation of EVAHERT Ⅰ
X±S 项目 术前 术后1周 术后1个月 术后2个月 1)P 2)P 3)P 血浆游离血红蛋白/(mg/dL) 7.86±4.53 11.43±8.33 10.57±1.59 11.29±2.63 0.31 0.22 0.55 乳酸脱氢酶/(U/L) 298.6±85.3 415.4±120.5 285.1±78.9 270.8±65.2 < 0.05 < 0.05 0.11 血红蛋白/(g/L) 137.39±19.55 117.89±11.45 128.12±28.35 138.13±19.61 < 0.05 < 0.05 0.52 血小板/(×109/L) 200.22±61.42 205.56±71.83 250.47±92.11 253.53±84.63 0.80 < 0.05 < 0.05 白细胞计数/(×109/L) 7.39±1.83 15.15±7.77 7.59±2.41 9.01±5.37 < 0.05 < 0.05 0.70 CK-MB/(ng/mL) 2.91±4.12 2.88±1.73 2.56±1.43 3.29±3.24 1.00 0.84 0.71 hs-cTnT/(pg/mL) 45.64±43.45 1 122.98±579.05 177.10±225.14 92.63±79.69 < 0.05 < 0.05 < 0.05 1)术后1周与术前比较；2)术后1个月与术后1周比较；3)术后1个月与术前相比。
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表 6 18例患者LVAD植入前后心功能变化及客观功能指标
Table 6. Cardiac function and objective functional parameters before and after LVAD implantation in 18 patients
X±S 项目 术前 术后1个月 术后2个月 术后6个月 1)P 2)P 3)P LVEF/% 25.0±5.0 27.5±5.2 28.1±5.6 29.5±5.8 0.015 0.008 < 0.001 LVEDD/mm 79.56±10.88 71.06±10.29 71.06±7.93 71.60±10.45 < 0.001 < 0.001 0.005 NYHA分级 Ⅲ~Ⅳ级 Ⅰ~Ⅱ级 Ⅰ~Ⅱ级 Ⅰ~Ⅱ级 6 min步行距离/m 82±35 195±58 240±64 280±76 < 0.001 < 0.001 < 0.001 KCCQ评分 45±12 58±14 63±15 68±15 0.003 0.001 < 0.001 1)术后1个月与术前相比；2)术后2个月与术前相比；3)术后6个月与术前相比。
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