BACKGROUND: According to results of the REMATCH trial, left ventricular assist device therapy in patients with severe heart failure has resulted in a 48% reduction in mortality. A decision tool will be necessary to aid in the selection of patients for destination left ventricular assist devices (LVADs) as the technology progresses for implantation in ambulatory Stage D heart failure patients. The purpose of this analysis was to determine whether the Seattle Heart Failure Model (SHFM) can be used to risk-stratify heart failure patients for potential LVAD therapy. METHODS: The SHFM was applied to REMATCH patients with the prospective addition of inotropic agents and intra-aortic balloon pump (IABP) +/- ventilator. RESULTS: The SHFM was highly predictive of survival (p = 0.0004). One-year SHFM-predicted survival was similar to actual survival for both the REMATCH medical (30% vs 28%) and LVAD (49% vs 52%) groups. The estimated 1-year survival with medical therapy for patients in REMATCH was 30 +/- 21%, but with a range of 0% to 74%. The 1- and 2-year estimated survival was </=50% for 81% and 98% of patients, respectively. There was no evidence that the benefit of the LVAD varied in the lower vs higher risk patients. CONCLUSIONS: The SHFM can be used to risk-stratify end-stage heart failure patients, provided known markers of increased risk are included such inotrope use and IABP +/- ventilator support. The SHFM may facilitate identification of high-risk patients to evaluate for potential LVAD implantation by providing an estimate of 1-year survival with medical therapy.
BACKGROUND: According to results of the REMATCH trial, left ventricular assist device therapy in patients with severe heart failure has resulted in a 48% reduction in mortality. A decision tool will be necessary to aid in the selection of patients for destination left ventricular assist devices (LVADs) as the technology progresses for implantation in ambulatory Stage D heart failurepatients. The purpose of this analysis was to determine whether the Seattle Heart Failure Model (SHFM) can be used to risk-stratify heart failurepatients for potential LVAD therapy. METHODS: The SHFM was applied to REMATCH patients with the prospective addition of inotropic agents and intra-aortic balloon pump (IABP) +/- ventilator. RESULTS: The SHFM was highly predictive of survival (p = 0.0004). One-year SHFM-predicted survival was similar to actual survival for both the REMATCH medical (30% vs 28%) and LVAD (49% vs 52%) groups. The estimated 1-year survival with medical therapy for patients in REMATCH was 30 +/- 21%, but with a range of 0% to 74%. The 1- and 2-year estimated survival was </=50% for 81% and 98% of patients, respectively. There was no evidence that the benefit of the LVAD varied in the lower vs higher risk patients. CONCLUSIONS: The SHFM can be used to risk-stratify end-stage heart failurepatients, provided known markers of increased risk are included such inotrope use and IABP +/- ventilator support. The SHFM may facilitate identification of high-risk patients to evaluate for potential LVAD implantation by providing an estimate of 1-year survival with medical therapy.
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