DuraHeart™ magnetically levitated centrifugal left ventricular assist system for advanced heart failure patients

Expert Review of Medical Devices

Volumn 7, Issue 2, 2010, Pages 173-183

  Morshuis, Michiel ^a   Schoenbrodt, Michael ^a   Nojiri, Chisato ^b   Roefe, Daniela ^a   Schulte Eistrup, Sebastian ^a   Boergermann, Jochen ^a   Gummert, Jan F ^a   Arusoglu, Latif ^a  

^a RUHR UNIVERSITY BOCHUM   (Germany)

^b Terumo Heart Inc   (United States)

Author keywords

Heart failure; Heart transplantation; Left ventricular assist device

Indexed keywords

WARFARIN;

ADULT; ADVANCED HEART FAILURE; AGED; ANTICOAGULANT THERAPY; ASSISTED CIRCULATION; CLINICAL TRIAL; DECUBITUS; DEVICE INFECTION; DEVICE THERAPY; EUROPE; EXPLANT; FEMALE; HEART ASSIST DEVICE; HEART FAILURE; HEART TRANSPLANTATION; HUMAN; IMPLANTATION; LEFT VENTRICULAR ASSISST SYSTEM; MAJOR CLINICAL STUDY; MALE; MORTALITY; OUTCOME ASSESSMENT; PATIENT SAFETY; PNEUMONIA; POSTMARKETING SURVEILLANCE; PUMP DESIGN; RESPIRATORY TRACT INFECTION; REVIEW; SURVIVAL RATE; TREATMENT INDICATION; TREATMENT RESPONSE; URINARY TRACT INFECTION; ARTICLE; EQUIPMENT; EQUIPMENT DESIGN; INCIDENCE; INSTRUMENTATION; MAGNETISM; MIDDLE AGED; SURVIVAL; TREATMENT OUTCOME; UTILIZATION REVIEW;

AGED; EQUIPMENT DESIGN; EQUIPMENT FAILURE ANALYSIS; EUROPE; FEMALE; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS; INCIDENCE; MAGNETICS; MALE; MIDDLE AGED; SURVIVAL ANALYSIS; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 77949345123     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/erd.09.68     Document Type: Review

References (37)

1. Lloyd-Jones D, Adams R, Carnethon M et al. Heart disease and stroke statistics 2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistic Subcommittee. Circulation 119 (3), 480-486 (2009).
2. Rose EA, Gelijns AC, Moskowitz AJ et al. Long-term use of a left ventricular assist device for end-stage heart failure. N. Eng. J. Med. 345, 1435-1443 (2001).
3. Hershberger RE, Nauman D, Walker TL et al. Care processes and clinical outcome of continuous outpatinet support with inotropes (COSI) in patients with refractory endstage heart failure. J. Card. Fail. 9, 180-187 (2003).
4. Taylor DO, Edwards LB, Aurora R et al. Registry of the International Society for Heart and Lung Transplantation: twenty-fifth offcial adult heart transplant report 2008. J. Heart Lung Transplant. 27, 943-956 (2008).
5. Massad MG. Current trends in heart transplantation. Cardiology 101, 79-92 (2004).
6. Frazier OH, Rose EA, Oz MC et al. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J. Thorac. Cardiovasc. Surg. 122, 1186-1195 (2001).
7. El-Banayosy A, Arusoglu L, Kizner L et al. Novacor left ventricular assist system versus HeartMate vented electric left ventricular assist system as a long-term mechanical circulatory support device in bridging patients: a prospective study. J. Thorac. Cardiovasc. Surg. 119(3), 581-587 (2000).
8. Morgan JA, John R, Rao V et al. Bridging to transplant with the HeartMate left ventricular assist device: The Columbia Presbyterian 12-year experience. J. Thorac. Cardiovasc. Surg. 127, 1309-1316 (2004).
9. Joyce LD, Noon GP, Joyce DL et al. Mechanical circulatory support-a historical review. ASAIO J. 50(6), x-xii (2004).
10. Park SJ, Tector A, Piccioni W et al. Left ventricular assist devices as destination therapy: a new look at survival. J. Thorac. Cardiovasc. Surg. 129, 9-17 (2005).
11. Slaughter MS, Tsui SS, El-Banayosy A et al. Results of a multicenter clinical trial with the thoratec implantable ventricular assist device. J. Thorac. Cardiovasc. Surg. 133, 1573-1580 (2007).
12. Dembitsky WP, Tector AJ, Park S et al. Left ventricular assist device performance with long term circulatory support: lessons from the REMATCH trial. Ann. Thorac. Surg. 78, 2123-2130 (2004).
13. Pagani FD, Long JW, Dembitsky WP et al. Improved mechanical reliability of the HeartMate XVE left ventricular assist system. Ann. Thorac. Surg. 82, 1413-1419 (2006).
14. Goldstein DJ, Zucker M, Arroyo L et al. Safety and feasibility trial of the MicroMed DeBakey ventricular assist device as a bridge to transplantation. J. Am. Coll. Cardiol. 45, 962-963 (2005).
15. Frazier OH, Myers TJ, Westaby S, Gregoric JD. Clinical experiences with an implantable, intracardiac, continuous fow circulatory support device: physiologic implication and their relationship to patient selection. Ann. Thorac. Surg. 77, 133-142 (2004).
16. Haj-Yahia S, Birks E, Rogers P et al. Midterm experience with the Jarvik 2000 axial fow left ventricular assist device. J. Thorac. Cardiovasc. Surg. 134, 199-203 (2007).
17. Miller LW, Pagani FD, Russsell SD et al. Use of continuous-fow device in patients awaiting heart transplantation. N. Engl. J. Med. 357, 885-896 (2007).
18. Struber M, Sander K, Laphor J et al. HeartMate II left ventricular assist device; early European experience. Eur. J. Cardiothorac. Surg. 34, 289-294 (2008).
19. Pagani FD, Mller LW, Russel SD, et al. Extended mechanical circulatory support with a continuous-fow rotary left ventricular assist device. J. Am. Coll. Cardiol. 54, 312-321 (2009).
20. Hetzer R, Weng Y, Potapov EV et al. First experiences with a novel magnetically suspended axial fow left ventricular assist device. Eur. J. Cardiothorac. Surg. 25, 961-970 (2004).
21. Schmid C, Tjan TDT, Etz C et al. First clinical experience with the Incor left ventricular assist device. J. Heart Lung Transplant. 24, 1188-1194 (2005).
22. Göttel P, Hetzer R, Schmid C et al. Clinical results of the frst 99 patients with the axial fow pump Incor. J. Heart Lung Transplant. 24(Suppl. 1), S57 (2005).
23. Esmore DS, Kaye D, Spratt C at al. A prospective, multicenter trial of the VentrAssist left ventricular assist device for bridge to transplant: safety and efficacy. J. Heart Lung Transplant. 27, 579-588 (2008).
24. Strueber M, Birks E, Jansz P et al. Clinical results of the international HeartWare LVAS bridge to transplant trial. J. Heart Lung Transplant. 28, S255 (2009)
25. Nojiri C, Kijima T, Maekawa J et al. Terumo implantable left ventricular assist system: results of long-term animal study. ASAIO J. 46, 117-122 (2000).
26. Saito S, Westaby S, Piggot D et al. Reliable long-term non-pulsatile circulatory support without anticoagulation. Eur. J. Cardiothorac. Surg. 19, 678-683 (2001).
27. Eya K, Tuzum E, Conger J et al. Effect of pump fow mode of novel left ventricular assist device upon end organ perfusion in dogs with doxorubicin induced heart failure. ASAIO J. 51, 41-49 (2005).
28. Nishinaka T, Schima H, Roety W et al. The DuraHeart VAD, a magnetically levitated centrifugal pump-the University of Vienna bridge-to-transplant experience. Circ. J. 70, 1421-1425 (2006).
29. Morshuis M, El-Banayosy A, Arusoglu L et al. European experience of DuraHeart magnetically levitated centrifugal left ventricular assist system. Eur. J. Cardiothorac. Surg. 35, 1020-1028 (2009).
30. Deng MC, Edwards LB, Hertz MI et al. Mechanical circulatory support device database of the international society for heart and lung transplantation: third annual report 2005. J. Heart Lung Transplant. 25, 1182-1197 (2005).
31. Holman WL, Pae WE, Teutenberg JJ et al. INTERMACS: interval analysis of registry data. J. Am. Coll Surg. 208, 755-762 (2009).
32. Lietz K, Long J W, Kfoury AG et al. Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: implications for patient selection. Circulation 116, 497-505 (2007).
33. Miller LW, Lietz K. Candidate selection for long-term left ventricular assist device therapy for refractory heart failure. J. Heart Lung Transplant. 25, 756-764 (2006).
34. Stevenson LW, Pagani FD, Ypong JB et al. INTERMACS profles of advanced heart failure: the current picture. J. Heart Lung Transplant. 28, 535-541 (2009).
35. Crow S, John R, Boyle A et al. Gastrointestinal bleeding rates in recipients of nonpulsatile and pulsatile left ventricular assist devices. J. Thorac. Cardiovasc. Surg. 137, 208-215 (2009).
36. Klovaite J, Gustafsson F, Mortensen SA et al. Severely impaired von Willebrand factor-dependent platelet aggregation in patients with a continuous-fow left ventricular assist device (HeartMate II). J. Am. Coll. Cardiol. 53, 2162-2167 (2009).
37. Rosamonda W, Flegal K, Friday G et al. Heart disease and stroke statistics-2007 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 115, e69-e171 (2007).