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53. A Single Institutional Experience with 65 Children Supported with the Berlin Heart Ventricular Assist Device Over 16 years: Comparison of Patients with Biventricular Versus Univentricular Circulation

May 15, 2022


Source:
102nd Annual Meeting, Boston, MA, USA
Hynes Convention Center, Room 210
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Objective:

To evaluate outcomes in patients supported with the Berlin Heart Ventricular Assist Device, comparing those with functionally univentricular circulation to those with biventricular circulation.

Methods:

We retrospectively reviewed 65 pediatric and congenital heart disease patients. The primary outcome was mortality. Kaplan-Meier methods and log-rank tests were used to assess group differences in long-term survival. T-tests using KM-estimated survival proportions and standard errors were used to compare groups at specific time points.

Results:

40 patients with biventricular circulation were supported (Age [years]: mean+/-standard deviation (SD) = 4.1+/-4.8, median=1.3, range=17 days-16 years; Weight [kilograms]: mean+/-SD=15.0+/-15.6, median=7.5, range=3.1-60), including 37 BiVAD and 3 LVAD only. In biventricular patients, duration of VAD support [days]: mean =99.9, median=88.5, range=2-315. Of 40 biventricular patients, 30 underwent heart transplantation, 5 died on VAD, 4 weaned off VAD (1 of whom underwent heart transplantation 334 days after weaning), and 1 is still on VAD.

25 patients with univentricular circulation were supported with single VAD (SVAD) (Age [years]: mean+/-SD=2.0+/-3.6, median=34 days, range=4 days-13 years; Weight [kilograms]: mean+/-SD=7.7+/-8.1, median=4, range=2.4-32.6). In univentricular patients, duration of VAD support [days]: mean=149.3, median=142, range=4-310. Of 25 univentricular patients, 18 underwent heart transplantation, 6 died on VAD, and 1 is still on VAD.

One-year survival was 84.5% (95% CI=73.8%-96.7%) in biventricular patients and 70.5% (95% CI=54.3%-91.5%) in univentricular patients, p=0.102. Five-year survival was 80.8% (95% CI=68.8%-94.9%) in biventricular patients and (64.1% CI=46.5%-88.4%) in univentricular patients, p=0.09.

Figure 1 documents the longitudinal Kaplan-Meier survival (log-rank P=0.2) and reveals no statistically significant difference between the groups.

Conclusions: Berlin Heart VAD facilitates bridge to transplantation in neonates, infants, and children with functionally univentricular circulation, with outcomes nearly as good as those with biventricular circulation.


Jeffrey Jacobs (1), Mark Bleiweis (1), Yuriy Stukov (1), Joseph Philip (1), Giles Peek (1), Andrew Pitkin (1), Kevin Sullivan (1), Jeffrey Jacobs (1), (1) Congenital Heart Center, University of Florida, Gainesville, FL


Iki Adachi

Invited Discussant

Dr. Adachi is an associate professor of surgery, Baylor College of Medicine, and Director of Mechanical Circulatory Support and Heart Transplant at Texas Children’s Hospital. Dr. Adachi received his medical doctorate from Osaka University Graduate School of Medicine and completed cardiovascular training at National Cardiovascular Center, Japan. As a recipient of the Fontan prize from European Association of Cardio-Thoracic Surgery, Dr. Adachi spent two years conducting clinical studies at the Royal Brompton Hospital and Imperial College London in England. Dr. Adachi’s career has been deeply inspired by his interaction with Professor Francis Fontan, the inventor of the ‘Fontan operation’ that has saved numerous lives of children with complex single-ventricle congenital heart disease. It is increasingly becoming evident that, even after a perfect Fontan operation, these patients are faced with an inevitable fate of late attrition. Dr. Adachi has set his career goal to develop a method to improve the outlook for patients with single-ventricle heart disease using Ventricular Assist Device (VAD) technology.

To fulfill this goal, Dr. Adachi joined Texas Children’s Hospital in 2010 and has been serving as the Director of VAD program since 2012. Texas Children’s Hospital VAD program is considered as the largest of its kind and is an integral part of the busiest pediatric thoracic (heart and lung) organ transplant program. Development of a newer generation of VADs and their clinical application drive Dr. Adachi’s academic interest. The devices Dr. Adachi has worked on previously or currently in the laboratory under NIH grant support include Jarvik 2015 VAD and BiVACOR implantable total artificial heart. 

Mark Bleiweis

Abstract Presenter

Mark S. Bleiweis, MD, is board-certified in surgery, thoracic and cardiac surgery and congenital heart surgery. He graduated with distinction from Cornell University with a bachelor’s degree in chemistry, and earned his medical degree from the University of California at San Diego. He served his general surgery residency at Harbor-UCLA Medical Center in Torrance, California; his thoracic surgery residency at the University of North Carolina at Chapel Hill; and his pediatric cardiothoracic surgery fellowship at the University of California San Francisco.

Since his arrival at the University of Florida in 2005, Dr. Bleiweis has been instrumental in expanding the center’s complement of pediatric cardiac specialists and making the UF Health Congenital Heart Center among the top centers in the country. Dr. Bleiweis’ cardiac team was the first in Florida to use the Berlin Heart® Ventricular Assist Device (a pediatric VAD), and the SynCardia® Total Artificial Heart. His team also was the first to use the SynCardia® Total Artificial Heart paired with the Freedom® portable driver for a pediatric patient.

Dr. Bleiweis has extensive experience in the pre- and postoperative management of newborns, including premature and low-birthweight babies. His expertise includes repairing complex, single-ventricle and valve defects, as well as treating patients who have underlying syndromes. 

Prior to his UF appointment, Dr. Bleiweis was medical director of Children’s Hospital of Orange County Heart Institute in Orange, California. He also served as medical director of the cardiothoracic intensive care unit at the University of North Carolina School of Medicine, Chapel Hill. 

In addition to his roles with the Congenital Heart Center, Dr. Bleiweis is a professor of surgery and pediatrics at UF, and serves as a mentor to students pursuing professions in the health care field. He is a widely sought speaker and was selected as the American Heart Association Heart Ball Honoree in February 2015. 

Specialties: Congenital, Transplant, Treatment/Procedure/Operation/Surgery, Neonatal Surgery, Transplant, Treatment/Procedure/Operation/Surgery, Transplantation--Heart, Pediatric Heart Transplantation