Journal of Artificial Organs

, Volume 17, Issue 2, pp 142–148

Results of the prospective multicenter Japanese bridge to transplant study with a continuous-flow left ventricular assist device

  • Shunei Kyo
  • Minoru Ono
  • Yoshiki Sawa
  • Takeshi Nakatani
  • Koichi Tabayashi
  • Yoshikatsu Saiki
  • Ryuji Tominaga
  • HeartMate II Japanese Clinical Investigators
Original Article Artificial Heart (Clinical)

Abstract

Continuous-flow left ventricular assist devices (LVADs) are becoming the standard of care for patients with refractory end-stage heart failure. We present the outcomes of patients enrolled in a prospective multicenter clinical study in Japan using the HeartMate II continuous-flow LVAD for bridge to transplantation. The study evaluated 6 inotrope-dependent heart failure patients failing on medical management (3 males and 3 females, age 44.7 ± 15.8 years, BSA 1.58 ± 0.17 m2) implanted with the HMII LVAD at 5 Japanese centers. Functional status, adverse events and outcomes were determined for the first 6 months with follow-up at 2 years. After implant, functional improvement was evident in 6-min walk distance which increased from 268 ± 92 m at baseline to 399 ± 105 m at 6 months, and 100 % of patients were in NYHA class I or II at 6 months compared to 0 % at baseline. Adverse events included localized non-device-related infection (4/6), arrhythmias (3/6) and percutaneous lead infection (1/6). There were no re-thoracotomies for bleeding and no strokes or pump replacements. All patients were alive at 6 months and all were transplanted after 1.96–3.58 years of LVAD support. The results in Japan of the HMII LVAD for BTT are consistent with results from the US pivotal clinical trial. The expanded use of this technology to Japanese heart failure patients is appropriate.

Keywords

LVAD Advanced heart failure Bridge to transplantation 

References

  1. 1.
    Miller LW, Pagani FD, Russell SD, et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med. 2007;357:885–96.PubMedCrossRefGoogle Scholar
  2. 2.
    Pagani FD, Miller LW, Russell SD, et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol. 2009;54:312–21.PubMedCrossRefGoogle Scholar
  3. 3.
    Lahpor J, Khaghani A, Hetzer R, et al. European results with a continuous-flow ventricular assist device for advanced heart-failure patients. Eur J Cardiothorac Surg. 2009;37:357–61.PubMedGoogle Scholar
  4. 4.
    Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361:2241–51.PubMedCrossRefGoogle Scholar
  5. 5.
    Starling RC, Naka Y, Boyle AJ, et al. Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol. 2011;57:1890–8.PubMedCrossRefGoogle Scholar
  6. 6.
    John R, Naka Y, Smedira NG, et al. Continuous flow left ventricular assist device outcomes in commercial use compared with the prior clinical trial. Ann Thorac Surg. 2011;92:1406–13 discussion 1413.PubMedCrossRefGoogle Scholar
  7. 7.
    Park SJ, Milano CA, Tatooles AJ, et al. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012;5:241–8.PubMedCrossRefGoogle Scholar
  8. 8.
    Kyo S, Minami T, Nishimura T, Gojo S, Ono M. New era for therapeutic strategy for heart failure: destination therapy by left ventricular assist device. J Cardiol. 2012;59:101–9.PubMedCrossRefGoogle Scholar
  9. 9.
    Nakatani T. Heart transplantation. Circ J. 2009;73:A55–60.PubMedCrossRefGoogle Scholar
  10. 10.
    Kitamura S, Nakatani T, Kobayashi J, Toda K, Yanase M. Heart transplantation in Japan: critical appraisal of results. Nihon Geka Gakkai Zasshi. 2012;113:297–301.PubMedGoogle Scholar
  11. 11.
    ACC/AHA guidelines for the clinical application of echocardiography. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee to Develop Guidelines for the Clinical Application of Echocardiography). J Am Coll Cardiol. 1990;16:1505–28.CrossRefGoogle Scholar
  12. 12.
    Griffith BP, Kormos RL, Borovetz HS, et al. HeartMate II left ventricular assist system: from concept to first clinical use. Ann Thorac Surg. 2001;71:S116–20 discussion S114–S116.PubMedCrossRefGoogle Scholar
  13. 13.
    Rogers JG, Aaronson KD, Boyle AJ, et al. Continuous flow left ventricular assist device improves functional capacity and quality of life of advanced heart failure patients. J Am Coll Cardiol. 2010;55:1826–34.PubMedCrossRefGoogle Scholar
  14. 14.
    Frazier OH, Delgado RM 3rd, Kar B, Patel V, Gregoric ID, Myers TJ. First clinical use of the redesigned HeartMate II left ventricular assist system in the United States: a case report. Tex Heart Inst J. 2004;31:157–9.PubMedCentralPubMedGoogle Scholar
  15. 15.
    John R, Kamdar F, Eckman P, et al. Lessons learned from experience with over 100 consecutive HeartMate II left ventricular assist devices. Ann Thorac Surg. 2011;92:1593–9.PubMedCrossRefGoogle Scholar
  16. 16.
    Slaughter MS, Naka Y, John R, et al. Post-operative heparin may not be required for transitioning patients with a HeartMate II left ventricular assist system to long-term warfarin therapy. J Heart Lung Transpl. 2010;29:616–24.CrossRefGoogle Scholar
  17. 17.
    Boyle AJ, Russell SD, Teuteberg JJ, et al. Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation. J Heart Lung Transpl. 2009;28:881–7.CrossRefGoogle Scholar

Copyright information

© The Japanese Society for Artificial Organs 2014

Authors and Affiliations

  • Shunei Kyo
    • 1
  • Minoru Ono
    • 2
  • Yoshiki Sawa
    • 3
  • Takeshi Nakatani
    • 4
  • Koichi Tabayashi
    • 5
  • Yoshikatsu Saiki
    • 5
  • Ryuji Tominaga
    • 6
  • HeartMate II Japanese Clinical Investigators
  1. 1.Department of Therapeutic Strategy for Heart FailureThe University of TokyoTokyoJapan
  2. 2.Department of Cardiothoracic SurgeryThe University of TokyoTokyoJapan
  3. 3.Division of Cardiovascular SurgeryOsaka University Graduate School of MedicineOsakaJapan
  4. 4.Department of TransplantationNational Cerebral and Cardiovascular CenterOsakaJapan
  5. 5.Department of Cardiovascular SurgeryTohoku University Graduate School of MedicineSendaiJapan
  6. 6.Department of Cardiovascular SurgeryKyushu UniversityFukuokaJapan

Personalised recommendations