Berlin Heart

• Circulation 2013;127:1702-11
• Pediatric Cardiology

Berlin Heart EXCOR Pediatric Ventricular Assist Device for Bridge to Heart Transplantation in US Children

1. Christopher S. Almond, MD, MPH*; et al.

1. From Boston Children’s Hospital, Boston, MA (C.S.A.); Cincinnati Children’s Hospital, Cincinnati, OH (D.L.M.); Heart and Vascular Institute and Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH (E.H.B., L.T.); Riley Hospital for Children, Indianapolis, IN (M.W.T.); Arkansas Children’s Hospital, Little Rock (M.I.); Stollery Children’s Hospital, Edmonton, AB, Canada (M.P.M., H.B.); Vanderbilt University Medical Center, Nashville, TN (L.C.J.); C.S. Mott Children’s Hospital, Ann Arbor, MI (E.J.D.); Children’s Hospital of Philadelphia, Philadelphia, PA (C.R.); Children’s Healthcare of Atlanta, Atlanta, GA (K.R.K.); University of Alabama at Birmingham, Birmingham (W.H.); Berlin Heart, Inc, The Woodlands, TX (R.K., C.T.); Children’s Hospital and Regional Medical Center Seattle, Seattle, WA (G.A.C.); University of Minnesota, Minneapolis (J.D.S.L.); Mount Sinai, New York, NY (K.N.); Medical College of Wisconsin, Milwaukee (R.A.N.); Children’s Hospital of Michigan, Detroit (H.L.W.); Mattel Children’s Hospital UCLA, Los Angeles, CA (B.R.); Children’s Hospital of Pittsburgh, Pittsburgh, PA (P.D.W.); Stanford University, Palo Alto, CA (O.R.); Children’s Medical Center Dallas, Dallas, TX (K.J.G.); Children’s Hospital Colorado, Aurora (M.B.M.); University of Florida, Gainesville (M.S.B.); St. Louis Children’s Hospital, St. Louis, MO (C.E.C.); and The Hospital for Sick Children, Toronto, ON, Canada (T.H.). Dr Morales was formerly at the Texas Children’s Hospital, Houston.

1. Correspondence to Christopher S. Almond, MD, MPH, The Heart Center, Boston Children’s Hospital, Department of Pediatrics, Harvard Medical School, 300 Longwood Ave, Boston, MA 02115. E-mailchristopher.almond@childrens.harvard.edu

1. Abstract

Background—Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is superior to extracorporeal membrane oxygenation for bridge to heart transplantation. Published data are limited to 1 in 4 children who received the device as part of the US clinical trial. We analyzed outcomes for all US children who received the EXCOR to characterize device outcomes in an unselected cohort and to identify risk factors for mortality to facilitate patient selection.

Methods and Results—This multicenter, prospective cohort study involved all children implanted with the Berlin Heart EXCOR Pediatric ventricular assist device (47 centers; May 2007 to Dec 2010). n = 204 children. Median duration of support was 40 days (range, 1–435 days). Survival at 12 months was 75%, including 64% who reached transplantation, 6% who recovered, and 5% who were alive on the device. Multivariable analysis identified lower weight, biventricular assist device support, and elevated bilirubin as risk factors for early mortality and bilirubin extremes and renal dysfunction as risk factors for late mortality. Neurological dysfunction occurred in 29% and was the leading cause of death.

Conclusions—Use of the Berlin Heart EXCOR has risen dramatically over the past decade. The EXCOR has emerged as a new treatment standard in the United States for pediatric bridge to transplantation. Three-quarters of children survived to transplantation or recovery; an important fraction experienced neurological dysfunction. Smaller patient size, renal dysfunction, hepatic dysfunction, and biventricular assist device use were associated with mortality, whereas extracorporeal membrane oxygenation before implantation and congenital heart disease were not.

Ventricular Assist Device: "HeartWare" - Intrapericardial placement

JACC 2011;57:1375-82.


J Am Coll Cardiol, 2011; 57:1375-1382,

Multicenter Evaluation of an Intrapericardial Left Ventricular Assist System





Martin Strueber, MD*,*, Gerry O'Driscoll, MD, PhD, Paul Jansz, MB, PhD, Asghar Khaghani, MD, Wayne C. Levy, MD, George M. Wieselthaler, MD¶ HeartWare Investigators



Objectives: The aim of this study was to conduct an initial clinical evaluation of the new HeartWare Ventricular Assist System (HeartWare, Inc., Framingham, Massachusetts) in a multicenter, prospective, nonrandomized single-arm clinical trial.



Background: Heart failure is a worldwide epidemic. The effectiveness of heart transplantation and medical therapy is limited, resulting in the emergence of mechanical circulatory support as a primary treatment for end-stage heart disease. Left ventricular assist devices that use rotary pumps are small and durable, which might reduce morbidity and mortality during support.



Methods: Fifty heart transplant candidates with New York Heart Association functional class IV symptoms were supported at 5 international centers by the HeartWare System for 180 days, until heart transplant, myocardial recovery and device explant, or death. Patients who continue to be supported have been followed for a minimum of 2 years.



Results: Of the 50 patients, 20 (40%) received transplants, 4 (8%) had the pump explanted after myocardial recovery, and 17 (34%) continue support at 2 years. Nine (18%) patients died during support from sepsis (n = 3), multiple organ failure (n = 3), or hemorrhagic stroke (n = 3). The actual survival at 6, 12, and 24 months was 90%, 84%, and 79%, respectively. In the survivors, measures of quality of life showed a significant improvement over baseline values. Significant improvements were found for recognition memory at 3 months after implant (p = 0.006). The most frequent adverse events were infection and bleeding.



Conclusions: Patients with end-stage heart failure can be safely and effectively supported by the HeartWare Ventricular Assist System with improved quality of life and neurocognitive function.