"Left Ventricular Assist Device as Destination Therapy in End-Stage Heart Failure".The New England Journal of Medicine. 2001. 345(20):1435-1443.PubMed•Full text•PDF

Contents

1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
7Interventions
8Outcomes
8.1Primary Outcomes
8.2Secondary Outcomes
9Criticisms
10Funding
11Further Reading

Clinical Question

Does long-term use of a left ventricular assist device compared with optimal medical management improve survival and quality of life in patients with end-stage heart failure who are ineligible for cardiac transplantation?

Bottom Line

The long-term use of left ventricular assist devices in select patients with end-stage heart failure ineligible for cardiac transplantation significantly improved survival and quality of life compared to optimal medical management, despite the occurrence of serious adverse events, including infection and device malfunction.

Major Points

Guidelines

Design

- Multicenter, randomized controlled trial.
- N=129 patients with end-stage heart failure ineligible for cardiac transplantation.
- Intervention group: left ventricular assist device (n=68).
- Control group: optimal medical management (n=61).
- Stratification according to center.
- Primary outcome: all-cause mortality.
- Mean follow-up: until 92 deaths occurred (approx. 18 months for the trial).

Population

Inclusion Criteria

- Chronic end-stage heart failure.
- NYHA class IV symptoms for at least 60-90 days despite medical therapy.
- Left ventricular ejection fraction ≤25%.
- Peak oxygen consumption ≤12-14 ml/kg/min, or dependent on IV inotropic therapy or intraaortic balloon pump.

Exclusion Criteria

- Eligibility for cardiac transplantation.
- Life expectancy limited by noncardiac conditions.

Baseline Characteristics

- Mean patient age ranged from 18 to over 70 years.
- Most common reason for ineligibility for transplantation: age over 65 years.
- Other comorbidities: insulin-dependent diabetes with end-organ damage, chronic renal failure, or other significant conditions.

Interventions

- Device group: implantation of a vented electric left ventricular assist device.
- Medical-therapy group: optimal medical management according to contemporary heart failure treatment guidelines.

Outcomes

Primary Outcome

- Risk of death from any cause: 48% risk reduction with the left ventricular assist device (P=0.001).
- Kaplan–Meier survival estimates at one year: 52% in the device group vs. 25% in the medical-therapy group (P=0.002).
- Kaplan–Meier survival estimates at two years: 23% in the device group vs. 8% in the medical-therapy group (P=0.09).

Secondary Outcomes

- Serious adverse events rate was higher in the device group (ratio of 2.35).
- Quality of life at one year was significantly improved in the device group.
- Hospitalization: both the median number of days in and out of the hospital were higher in the device group.

Criticisms

- Adverse events associated with the left ventricular assist device, including infection and mechanical failure, were a significant concern.
- The trial’s limitations included the obviousness of the device and associated surgical risk, precluding a double-blind design.

Funding

- The trial was supported in part by a cooperative agreement with the National Heart, Lung, and Blood Institute of the National Institutes of Health and Thoratec Corporation.

Further Reading

For more details, readers are directed to The New England Journal of Medicine, 2001, volume 345, issue 20, pages 1435-1443, and additional articles on the longer-term outcomes of left ventricular assist device therapy.