Clinical Research in Cardiology

, Volume 107, Issue 5, pp 413–420 | Cite as

Successful support of biventricular heart failure patients by new EXCOR® Adult pumps with bileaflet valves: a prospective study

  • Bastian Schmack
  • Alexander Weymann
  • Frank Ruschitzka
  • Rüdiger Autschbach
  • Philip W. Raake
  • Nadine Jurrmann
  • Ares K. Menon
  • Matthias Karck
  • Markus J. Wilhelm
  • Arjang Ruhparwar
Original Paper



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.


Biventricular 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.


This work was part of an investigator-initiated post-market clinical follow-up study and was supported by a grant of Berlin Heart GmbH, Berlin, Germany. All centers were equally supported financially by the investigator company Berlin Heart GmbH to refund the efforts of patient inclusion and the preparation of all case individual reports required as per study protocol. All contracted financial support has been reviewed and approved by each individual local ethics committee.

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. 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. CrossRefPubMedGoogle Scholar
  2. 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. CrossRefPubMedGoogle Scholar
  3. 3.
    Krabatsch T, Potapov E, Stepanenko A, Schweiger M, Kukucka M, Huebler M, Hennig E, Hetzer R (2011) Biventricular circulatory support with two miniaturized implantable assist devices. Circulation 124(11 Suppl):S179–S186. CrossRefPubMedGoogle Scholar
  4. 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. CrossRefGoogle Scholar
  5. 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. CrossRefPubMedGoogle Scholar
  6. 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. CrossRefGoogle Scholar
  7. 7.
    Schmid C, Tjan T, Etz C, Welp H, Rukosujew A, Klotz S, Drees G, Gogarten W, Scheld HH (2006) The excor device—revival of an old system with excellent results. Thorac Cardiovasc Surg 54(6):393–399. CrossRefPubMedGoogle Scholar
  8. 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. CrossRefPubMedGoogle Scholar
  9. 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. CrossRefGoogle Scholar
  10. 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. CrossRefGoogle Scholar
  11. 11.
    Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB (2012) The Fourth INTERMACS Annual Report: 4,000 implants and counting. J Heart Lung Transpl 31 (2):117–126. CrossRefGoogle Scholar
  12. 12.
    Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson LW, Blume ED, Myers SL, Miller MA, Baldwin JT, Young JB (2015) Seventh INTERMACS annual report: 15,000 patients and counting. J Heart Lung Transpl 34 (12):1495–1504. CrossRefGoogle Scholar
  13. 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. CrossRefGoogle Scholar
  14. 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. CrossRefPubMedGoogle Scholar
  15. 15.
    Cheng A, Trivedi JR, Van Berkel VH, Massey HT, Slaughter MS (2016) Comparison of total artificial heart and biventricular assist device support as bridge-to-transplantation. J Card Surg 31(10):648–653. CrossRefPubMedGoogle Scholar
  16. 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. CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Bastian Schmack
    • 1
  • Alexander Weymann
    • 1
  • Frank Ruschitzka
    • 2
  • Rüdiger Autschbach
    • 3
  • Philip W. Raake
    • 4
  • Nadine Jurrmann
    • 5
  • Ares K. Menon
    • 5
  • Matthias Karck
    • 1
  • Markus J. Wilhelm
    • 6
  • Arjang Ruhparwar
    • 1
  1. 1.Department of Cardiac SurgeryUniversity Hospital HeidelbergHeidelbergGermany
  2. 2.Department of Cardiology, University Heart Centre ZurichUniversity Hospital ZurichZurichSwitzerland
  3. 3.Clinic for Heart and Thoracic SurgeryRWTH University Hospital AachenAachenGermany
  4. 4.Department of Internal Medicine III, Division of CardiologyUniversity Hospital HeidelbergHeidelbergGermany
  5. 5.Berlin Heart GmbHBerlinGermany
  6. 6.Department of Cardiovascular SurgeryUniversity Hospital ZurichZurichSwitzerland

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