Rogers Joseph G, Butler Javed, Lansman Steven L, Gass Alan, Portner Peer M, Pasque Michael K, Pierson Richard N
Cardiovascular Medicine Division, Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA.
J Am Coll Cardiol. 2007 Aug 21;50(8):741-7. doi: 10.1016/j.jacc.2007.03.063. Epub 2007 Aug 6.
This study evaluated the impact of left ventricular assist device (LVAD) support on survival and quality of life in inotrope-dependent heart failure patients ineligible for cardiac transplantation.
The role for LVADs as a bridge to cardiac transplantation has been established, but data supporting their role as permanent therapy in nontransplant candidates are limited.
The INTrEPID (Investigation of Nontransplant-Eligible Patients Who Are Inotrope Dependent) trial was a prospective, nonrandomized clinical trial comparing LVAD with optimal medical therapy (OMT). Fifty-five patients with New York Heart Association functional class IV symptoms who failed weaning from inotropic support were offered a Novacor LVAD. Eighteen of these patients did not receive an LVAD owing to patient preference (n = 14) or unavailability of the device (n = 4) but consented to follow-up and constitute a contemporaneous control group.
The LVAD and OMT patients were well matched for demographic and disease severity measures, except OMT patients had a lower mean serum sodium (128 mg/dl vs. 134 mg/dl; p = 0.001) and a higher mean blood urea nitrogen concentration (59 vs. 40; p = 0.02). The LVAD-treated patients had superior survival rates at 6 months (46% vs. 22%; p = 0.03) and 12 months (27% vs. 11%; p = 0.02). Adverse event rates were higher in the OMT group. Eighty-five percent of the LVAD-treated patients had minimal or no heart failure symptoms. Five LVAD patients and 1 OMT patient improved sufficiently while on therapy to qualify for cardiac transplantation.
Inotrope-dependent heart failure patients who are ineligible for transplantation have a high short-term mortality rate and derive a significant survival advantage from "destination" mechanical circulatory support.
本研究评估了左心室辅助装置（LVAD）支持对不符合心脏移植条件的依赖血管活性药物的心衰患者生存率和生活质量的影响。
LVAD作为心脏移植桥梁的作用已得到确立，但支持其在非移植候选患者中作为永久治疗手段的数据有限。
INTrEPID（对依赖血管活性药物且不符合移植条件患者的研究）试验是一项前瞻性、非随机临床试验，比较了LVAD与最佳药物治疗（OMT）。55例纽约心脏协会功能分级为IV级且撤掉血管活性药物支持失败的患者接受了诺瓦科尔LVAD。其中18例患者因患者偏好（n = 14）或设备不可用（n = 4）未接受LVAD，但同意随访并构成同期对照组。
LVAD组和OMT组在人口统计学和疾病严重程度指标方面匹配良好，但OMT组患者平均血清钠水平较低（128 mg/dl对134 mg/dl；p = 0.001），平均血尿素氮浓度较高（59对40；p = 0.02）。接受LVAD治疗的患者在6个月时生存率更高（46%对22%；p = 0.03），12个月时也是如此（27%对11%；p = 0.02）。OMT组不良事件发生率更高。85%接受LVAD治疗的患者心力衰竭症状轻微或没有症状。5例LVAD患者和1例OMT患者在治疗期间病情改善到足以符合心脏移植条件。
不符合移植条件的依赖血管活性药物的心衰患者短期死亡率高，“目标”机械循环支持可显著提高其生存率。
