Mark B Anderson1, James Goldstein2, Carmelo Milano3, Lynn D Morris4, Robert L Kormos5, Jay Bhama5, Navin K Kapur6, Aditya Bansal7, Jose Garcia8, Joshua N Baker8, Scott Silvestry9, William L Holman10, Pamela S Douglas11, William O'Neill12. 1. Division of Cardiothoracic Surgery and Department of Cardiovascular Medicine, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania. Electronic address: andersom@einstein.edu. 2. Department of Cardiovascular Medicine, William Beaumont Hospital, Royal Oak, Michigan. 3. Department of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, North Carolina. 4. Division of Cardiothoracic Surgery and Department of Cardiovascular Medicine, Albert Einstein Healthcare Network, Philadelphia, Pennsylvania. 5. Division of Cardiothoracic Surgery, Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 6. Department of Medicine, Cardiovascular Center, Tufts University Medical Center, Boston, Massachusetts. 7. Department of Cardiothoracic Surgery, Ochsner Foundation, New Orleans. 8. Division of Cardiothoracic Surgery, Massachusetts General Hospital, Boston, Massachusetts. 9. Division of Cardiothoracic Surgery, Washington University in St. Louis School of Medicine, St. Louis, Missouri. 10. Division of Cardiothoracic Surgery, University of Alabama, Birmingham, Alabama. 11. Duke Clinical Research Institute, Durham, North Carolina. 12. Center for Strucrural Heart Disease, Henry Ford Hospital, Detroit, Michigan.
Abstract
BACKGROUND: Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. METHODS: Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. RESULTS: The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m(2) (p < 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg (p < 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5-7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. CONCLUSIONS: In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.
BACKGROUND: Right ventricular failure (RVF) increases morbidity and mortality. The RECOVER RIGHT study evaluated the safety and efficacy of a novel percutaneous right ventricular assist device, the Impella RP (Abiomed, Danvers, MA), in a prospective, multicenter trial. METHODS: Thirty patients with RVF refractory to medical treatment received the Impella RP device at 15 United States institutions. The study population included 2 cohorts: 18 patients with RVF after left ventricular assist device (LVAD) implantation (Cohort A) and 12 patients with RVF after cardiotomy or myocardial infarction (Cohort B). The primary end point was survival to 30 days or hospital discharge (whichever was longer). Major secondary end points included indices of safety and efficacy. RESULTS: The patients (77% male) were a mean age of 59 ± 15 years, 53% had diabetes, 88.5% had a history of congestive heart failure, and 37.5% had renal dysfunction. Patients were on an average of 3.2 inotropes/pressors. Device delivery was achieved in all but 1 patient. Hemodynamics improved immediately after initiation of Impella RP support, with an increase in cardiac index from 1.8 ± 0.2 to 3.3 ± 0.23 liters/min/m(2) (p < 0.001) and a decrease in central venous pressure from 19.2 ± 4 to 12.6 ± 1 mm Hg (p < 0.001). Patients were supported for an average of 3.0 ± 1.5 days (range, 0.5-7.8 days). The overall survival at 30 days was 73.3%. All patients discharged were alive at 180 days. CONCLUSIONS: In patients with life-threatening RVF, the novel percutaneous Impella RP device was safe, easy to deploy, and reliably resulted in immediate hemodynamic benefit. These data support its probable benefit in this gravely ill patient population.
Authors: Markus A Horvath; Isaac Wamala; Eric Rytkin; Elizabeth Doyle; Christopher J Payne; Thomas Thalhofer; Ignacio Berra; Anna Solovyeva; Mossab Saeed; Sara Hendren; Ellen T Roche; Pedro J Del Nido; Conor J Walsh; Nikolay V Vasilyev Journal: Ann Biomed Eng Date: 2017-05-16 Impact factor: 3.934