Successful support of biventricular heart failure patients by new EXCOR® Adult pumps with bileaflet valves: a prospective study
- 77 Downloads
The Berlin Heart EXCOR® Adult biventricular assist device (BiVAD) is an approved mechanical circulatory support for patients with end-stage biventricular heart failure. In this prospective post-market clinical follow-up study, we present the first clinical experience of the new EXCOR® Adult pump with bileaflet (BL) valves in Europe.
Methods and results
After CE-mark approval in August 2014, a total of 12 patients were enrolled with a mean age of 44 years ± 11 (range 21–58 years). The majority of patients (n = 11) were in INTERMACS level 1 or 2. Eight patients had a median pre-operative extracorporeal life support (ECLS) of 6 days (range 1–37 days). Primary end point was survival, either to heart transplantation (HTx), recovery or alive at 12 months on device, whichever occurred first. Secondary end point was the number of adverse events throughout EXCOR® BiVAD support. Median support time up to last follow-up on EXCOR® BiVAD device was 248 days (range 57–381 days) and patient survival at 1 year was 92%. Half of the EXCOR® BiVAD patients (n = 6) were transplanted and five patients were still on support at 1 year post-implantation. Complications during EXCOR® BiVAD support were thoracic bleeding, exit site infection and ischemic cerebrovascular incidents in three cases, respectively.
The new EXCOR® Adult pump with BL provides pulsatile high cardiac output with excellent outcome and successful bridging to HTx, particularly in critically ill patients with INTERMACS level 1 or 2 at the time of implantation.
KeywordsBiventricular heart failure Ventricular assist device Bridge to transplant
We thank all other VAD coordinators as well as health-care providers involved at each participating center for the professional and cooperative work.
Compliance with Ethical Standards
Conflict of interest
AR and BS received travel grant (for international conferences) from BH and consultancy fees from BH. MJW received speaker honoraria and travel grants from BH. AKM and NJ are employees of Berlin Heart GmbH.
- 1.Takeda K, Naka Y, Yang JA, Uriel N, Colombo PC, Jorde UP, Takayama H (2013) Timing of temporary right ventricular assist device insertion for severe right heart failure after left ventricular assist device implantation. ASAIO J 59(6):564–569. https://doi.org/10.1097/MAT.0b013e3182a816d1CrossRefPubMedGoogle Scholar
- 2.Aissaoui N, Morshuis M, Schoenbrodt M, Hakim Meibodi K, Kizner L, Borgermann J, Gummert J (2013) Temporary right ventricular mechanical circulatory support for the management of right ventricular failure in critically ill patients. J Thorac Cardiovasc Surg 146(1):186–191. https://doi.org/10.1016/j.jtcvs.2013.01.044CrossRefPubMedGoogle Scholar
- 4.Shehab S, Macdonald PS, Keogh AM, Kotlyar E, Jabbour A, Robson D, Newton PJ, Rao S, Wang L, Allida S, Connellan M, Granger E, Dhital K, Spratt P, Jansz PC, Hayward CS (2016) Long-term biventricular HeartWare ventricular assist device support—case series of right atrial and right ventricular implantation outcomes. J Heart Lung Transpl 35(4):466–473. https://doi.org/10.1016/j.healun.2015.12.001CrossRefGoogle Scholar
- 5.Levin AP, Jaramillo N, Garan AR, Takeda K, Takayama H, Yuzefpolskaya M, Mancini DM, Naka Y, Colombo PC, Topkara VK (2016) Outcomes of contemporary mechanical circulatory support device configurations in patients with severe biventricular failure. J Thorac Cardiovasc Surg 151(2):530–535 e532. https://doi.org/10.1016/j.jtcvs.2015.10.019CrossRefPubMedGoogle Scholar
- 6.Ozbaran M, Yagdi T, Engin C, Erkul S, Balcioglu O, Baysal B, Nalbantgil S, Ertugay S (2013) Long-term paracorporeal ventricular support systems: a single-center experience. Transpl Proc 45(3):1013–1016. https://doi.org/10.1016/j.transproceed.2013.02.073CrossRefGoogle Scholar
- 8.Aissaoui N, Morshuis M, Paluszkiewicz L, Lauenroth V, Borgermann J, Gummert J (2014) Comparison of biventricular and left ventricular assist devices for the management of severe right ventricular dysfunction in patients with end-stage heart failure. ASAIO J 60(4):400–406. https://doi.org/10.1097/MAT.0000000000000082CrossRefPubMedGoogle Scholar
- 9.Takeda K, Naka Y, Yang JA, Uriel N, Colombo PC, Jorde UP, Takayama H (2014) Outcome of unplanned right ventricular assist device support for severe right heart failure after implantable left ventricular assist device insertion. J Heart Lung Transpl 33(2):141–148. https://doi.org/10.1016/j.healun.2013.06.025CrossRefGoogle Scholar
- 10.Takeda K, Takayama H, Colombo PC, Jorde UP, Yuzefpolskaya M, Fukuhara S, Mancini DM, Naka Y (2015) Late right heart failure during support with continuous-flow left ventricular assist devices adversely affects post-transplant outcome. J Heart Lung Transpl 34(5):667–674. https://doi.org/10.1016/j.healun.2014.10.005CrossRefGoogle Scholar
- 13.Slaughter MS, Pagani FD, McGee EC, Birks EJ, Cotts WG, Gregoric I, Howard Frazier O, Icenogle T, Najjar SS, Boyce SW, Acker MA, John R, Hathaway DR, Najarian KB, Aaronson KD, HeartWare Bridge to Transplant ATI (2013) HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transpl 32 (7):675–683. https://doi.org/10.1016/j.healun.2013.04.004CrossRefGoogle Scholar
- 14.Crow S, John R, Boyle A, Shumway S, Liao K, Colvin-Adams M, Toninato C, Missov E, Pritzker M, Martin C, Garry D, Thomas W, Joyce L (2009) Gastrointestinal bleeding rates in recipients of nonpulsatile and pulsatile left ventricular assist devices. J Thorac Cardiovasc Surg 137(1):208–215. https://doi.org/10.1016/j.jtcvs.2008.07.032CrossRefPubMedGoogle Scholar
- 16.Creaser JW, Rourke D, Vandenbogaart E, Chaker T, Nsair A, Cheng R, Fonarow G, Livingston N, Howell E, Huie N, Baas AS, Deng M, Hickey A, Shemin RJ, MacLellan WR (2015) Outcomes of biventricular mechanical support patients discharged to home to await heart transplantation. J Cardiovasc Nurs 30(4):E13–E20. https://doi.org/10.1097/JCN.0000000000000168CrossRefPubMedGoogle Scholar