Heart failure: end-stage: left ventricular assist devices reduced death, but caused many complications

Clinical bottom line (level 1b)

  1. Patients with end-stage heart failure who received a left ventricular assist device compared with optimal medical management were less likely to die (NNT = 4 at 2 years) .
  2. Adverse effects were common, particularly infection and bleeding.
Rose et al: N Engl J Med 2001; 345 : 1435-1443
Expires June 2004

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 20 cardiac surgery units, USA

129 patients (aged mean 67, 80% male)
  • end-stage heart failure (NYHA class IV for at least 60 days and peak oxygen consumption of 14 ml/kg/min or less; or NYHA class III or IV for at least 28 days on iv inotropes or balloon pump for at least 14 days with 2 failed weaning attempts and
  • contraindication to transplantation (aged 65 or more; type I diabetes with end-organ damage; chronic renal failure with serum creatinine 221 micromol/l for at least 90 days, presence of other clinically significant conditions)
aindications to transplantation
Control Group: (n = 61, 61 analysed): optimal medical therapy
Experimental Group: (n = 68, 68 analysed): left ventricular assist device

98% followed for 2 years

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
death 2 years 54
(88.5%)		 41
(60.3%)		 32%
(16% to 45%)		 28.2%
(14.1% to 42.3%)		 4
(2 to 7)

  • Adverse events were commoner in the LV assist device group (RR: 2.35; 95% CI: 1.86 to 2.95), particularly bleeding, neurological dysfunction, supraventricular arrhythmias, peripheral embolic events and sepsis.
  • 28% of patients developed an infection of the assist device within 3 months. 42% had bleeding within 6 months of implantation. 15% required replacement of the device.

Comments

  1. Patients were stratified for centre before randomisation.

Citation

  1. Rose EA, Gelijns A, Moskowitz AJ, et al: long-term use of a left ventricular assist device for end-stage heart failure (REMATCH). N Engl J Med 2001; 345 : 1435-1443
Search Terms: from ACP Journal Club
Contributor: Chris Ball, June 2002
Reviewer:

Clinical Question.
Patient end-stage heart failure
Intervention or Exposure left ventricular assist device
Comparison optimal medical management
Outcome death, adverse effects