Medical Care Versus Ventricular Assist Device in Patients With NYHA Class IV Congestive Heart Failure: a Non Randomized Comparison of Clinical and Economic Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 主要终点
- Survival
研究概览
简要总结
End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presenting with end-stage heart failure defined as:
- •A left ventricular ejection fraction ≤25%
- •Or an oxygen consumption peak < 14 mL/kg/min
- •Or severe symptoms (NYHA class III or IV) despite optimal medical treatment
- •Or a cardiogenic shock
排除标准
- •Age over 70 years
- •Active neoplasia
- •Suspected or active systemic infection
- •Body mass index ≥40 kg/m2
- •Severe chronic obstruction pulmonary disease
- •Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal within 4 days before the randomisation, or biopsy proven liver cirrhosis
- •Significant chronic renal impairment with persistent creatinine >2.5 or clearance < 25ml/min
- •Pregnant or lactating female
- •Patient under consideration for conventional revascularization procedures, therapeutic valvular repair, left ventricular procedure or cardiomyoplasty
- •Presence of implanted mechanical aortic valve that will not be converted to bioprothesis at the time of ventricular assist device implantation
- •Evidence of intrinsic hepatic diseases defined as liver enzyme values ≥ 5 times the upper limit of normal, or biopsy proven liver cirrhosis
- •Occurrence of stroke within 90 days or history of cerebrovascular disease with major (≥ 80%) extracranial or carotid stenosis documented by Doppler study
- •Confirmation by neurologist of impairment of cognitive function, presence of Alzheimer's disease or any other form of irreversible dementia or both
- •Major peripheral vascular disease accompanied by pain on rest or leg ulceration
- •Recent history of psychiatric disease that is likely to impair compliance
- •Drug or alcohol dependence
- •Difficult social surroundings
结局指标
主要结局
Survival
时间窗: two years
The primary outcome was comparison of survival at two years between the two treatment strategies
次要结局
- Resource consumption(Two years)
- Costs(Two years)
- Costs versus survival(Two years)
研究者
Joe Elie Salem
MD, PhD
Groupe Hospitalier Pitie-Salpetriere