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Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart
Published on: May 11, 2018
The use of the Berlin Heart EXCOR in patients with functional single ventricle
Samuel Weinstein1, Ricardo Bello1, Christian Pizarro2
1Cardiothoracic and Vascular Surgery, Montefiore Medical Center, New York, NY.
Insights
Pediatric ventricular assist devices (VADs) offer a bridge to transplant for children with single ventricle (SV) physiology, but with lower success rates compared to biventricular (BV) circulation. Caution is advised for SV patients with shunted pulmonary blood flow.
Area of Science:
- Pediatric Cardiology
- Cardiothoracic Surgery
- Biomedical Engineering
Background:
- Pediatric ventricular assist device (VAD) use is increasing for bridge to transplantation.
- Experience with VADs in complex congenital heart disease, specifically single ventricle (SV) physiology, is limited.
- This study reviews VAD use in SV patients compared to biventricular (BV) circulation.
Purpose of the Study:
- To evaluate the effectiveness of the Berlin Heart EXCOR VAD in pediatric patients with single ventricle (SV) anatomy or physiology.
- To compare VAD outcomes in SV patients with those in biventricular (BV) circulation.
Main Methods:
- Retrospective review of the EXCOR Investigational Device Exemption study database.
- Inclusion of VAD implants between May 2007 and December 2011.
- Comparison of outcomes between SV and BV patient groups.
Main Results:
- Twenty-six of 281 VAD patients had SV physiology; hypoplastic left heart syndrome was most common.
- SV patients had shorter support times and lower rates of bridging to transplant or recovery (42.3%) compared to BV patients (72.5%).
- Outcomes varied by surgical palliation, with better results in patients after superior cavopulmonary connection (SCPC) and total cavopulmonary connection (TCPC) compared to those after stage I procedures.
Conclusions:
- The EXCOR Pediatric VAD can serve as a bridge to transplant for children with SV physiology, but with lower success than in BV patients.
- Results suggest better outcomes for SV patients with TCPC and SCPC compared to other palliative procedures.
- VAD support in SV patients with shunted pulmonary blood flow requires careful consideration.
Introduction:
The frequency and successful use of pediatric ventricular assist devices (VADs) as a bridge to cardiac transplantation have been steadily increasing since 2003, but the experience in patients with complex congenital heart disease has not been well described. Using a large prospectively collected dataset of children supported with the Berlin Heart EXCOR VAD, we have reviewed the experience in children with single ventricular anatomy or physiology (SV), and compared the results with those supported with biventricular circulation (BV) over the same time period.
Methods:
The EXCOR Investigational Device Exemption study database was retrospectively reviewed. VAD implants under the primary cohort and compassionate use cohort between May 2007 and December 2011 were included in this review.
Results:
Twenty-six of 281 patients supported with a VAD were SV. The most common diagnosis was hypoplastic left heart syndrome (15 of 26). Nine patients were supported after neonatal palliative surgery (Blalock-Taussig shunt or Sano), 12 after a superior cavopulmonary connection (SCPC), and 5 after total cavopulmonary connection (TCPC). Two patients received biventricular assist devices, 1 after stage I surgery and 1 after stage II. SV patients were supported for a median time of 10.5 days (range, 1-363 days) versus 39 days (range, 0-435 days) for BV (P = .01). The ability to be bridged to transplant or recovery in SV patients is lower than for BV patients (11 of 26 [42.3%] vs 185 of 255 [72.5%]; P = .001). Three of 5 patients with TCPC were successfully bridged to transplant and were supported with 1 VAD. Seven of 12 patients with SCPC were bridged to transplant, and only 1 of 9 patients supported after a stage I procedure survived.
Conclusions:
The EXCOR Pediatric VAD can provide a bridge to transplant for children with SV anatomy or physiology, albeit less successfully than in children with BV. In this small series, results are better in patients with SCPC and TCPC. VAD support for patients with shunted sources of pulmonary blood flow should be applied with caution.
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