The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2018
Outcomes of patients with right ventricular failure requiring short-term hemodynamic support with the Impella RP device.
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Anderson Mark, Morris D Lynn, Tang Daniel, Batsides George, Kirtane Ajay, Hanson Ivan, Meraj Perwais, Kapur Navin Kumar, O'Neill William
Аннотация
BACKGROUND: Right ventricular failure (RVF) after myocardial infarction, cardiotomy, or left ventricular assist device (LVAD) implantation increases morbidity and mortality. RVF also contributes to prolonged length of hospital stay and higher costs of care. The aim of this study was to evaluate the efficacy and safety of the Impella RP (Abiomed, Danvers, MA) in patients with severe RVF in these clinical settings.
METHODS: This is a prospective cohort study of patients with severe RVF treated with a percutaneous right ventricular assist device (RVAD). Sixty patients with RVF refractory to medical treatment received the Impella RP device at 14 United States institutions as part of the Impella RP pre‒ and post‒market approval studies. The study population included 2 cohorts: Cohort A, patients with RVF post-(LVAD) implantation (n = 31); and Cohort B, patients with RVF post-cardiotomy, heart transplant, or myocardial infarction (n = 29). The primary end-point was survival at 30 days or hospital discharge (whichever was longer).
RESULTS: Mean age of patients was 59 ± 15 years; 68% were males, 84% had a history of congestive heart failure, 44% had valvular disease, and 35% had pre-operative renal dysfunction. Patients received an average of 3.4 inotropes/vasopressors before the Impella RP implant. Patients were supported with the Impella RP for 4.0 ± 1.5 (0.5 to 14) days. Hemodynamics improved immediately after initiation of device support, with an increase in cardiac index from 1.9 ± 0.1 to 3.1 ± 0.2 liters/min/m2 (p < 0.001) and a decrease in central venous pressure from 19.0 ± 1 to 13 ± 1 mm Hg (p < 0.001). The overall survival at 30 days (or discharge) was 72%.
CONCLUSIONS: To the best of our knowledge, this study represents the largest prospective study of patients with life-threatening RVF. Mechanical support with the Impella RP device in patients with RVF resulted in rapid hemodynamic improvement with reversal of shock and favorable survival.
METHODS: This is a prospective cohort study of patients with severe RVF treated with a percutaneous right ventricular assist device (RVAD). Sixty patients with RVF refractory to medical treatment received the Impella RP device at 14 United States institutions as part of the Impella RP pre‒ and post‒market approval studies. The study population included 2 cohorts: Cohort A, patients with RVF post-(LVAD) implantation (n = 31); and Cohort B, patients with RVF post-cardiotomy, heart transplant, or myocardial infarction (n = 29). The primary end-point was survival at 30 days or hospital discharge (whichever was longer).
RESULTS: Mean age of patients was 59 ± 15 years; 68% were males, 84% had a history of congestive heart failure, 44% had valvular disease, and 35% had pre-operative renal dysfunction. Patients received an average of 3.4 inotropes/vasopressors before the Impella RP implant. Patients were supported with the Impella RP for 4.0 ± 1.5 (0.5 to 14) days. Hemodynamics improved immediately after initiation of device support, with an increase in cardiac index from 1.9 ± 0.1 to 3.1 ± 0.2 liters/min/m2 (p < 0.001) and a decrease in central venous pressure from 19.0 ± 1 to 13 ± 1 mm Hg (p < 0.001). The overall survival at 30 days (or discharge) was 72%.
CONCLUSIONS: To the best of our knowledge, this study represents the largest prospective study of patients with life-threatening RVF. Mechanical support with the Impella RP device in patients with RVF resulted in rapid hemodynamic improvement with reversal of shock and favorable survival.