The state of destination therapy for the treatment of congestive heart failure

Current Opinion in Organ Transplantation

Volumn 11, Issue 5, 2006, Pages 546-552

  Portner, Peer M ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Destination therapy; End stage heart failure; Left ventricular assist; Mechanical circulatory support

Indexed keywords

ASSISTED CIRCULATION; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DATA BASE; DESTINATION THERAPY; EVIDENCE BASED MEDICINE; HEART ASSIST DEVICE; HEART FAILURE; HEART TRANSPLANTATION; HUMAN; OUTCOME ASSESSMENT; PUMP DESIGN; RECIPIENT; RETROSPECTIVE STUDY; REVIEW; RISK ASSESSMENT; RISK FACTOR; TREATMENT OUTCOME; UNITED STATES;

EID: 33748807203     PISSN: 10872418     EISSN: 15317013     Source Type: Journal    
DOI: 10.1097/01.mot.0000244642.62599.d7     Document Type: Review

References (70)

1. Portner PM. Permanent mechanical circulatory assistance. In: Baumgartner WA, Reitz B, Kasper E, Theodore J, editors. Heart and Lung Transplantation, 2nd ed. Philadelphia: W.B. Saunders Co.; 2002. pp. 531-557.
2. American Heart Association. Heart and stroke statistics - 2006 update, Dallas, Texas. American Heart Association. Available at: http://www. americanheart.org/downloadable/heart/1140534985281Statsupdate06-book.pdf. Accessed: 28 June 2006.
3. Hunt SA, Abraham WT, Chin MH, et al., ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure), American College of Cardiology web site. Available at: http://www.acc.org/clinical/guidelines/failure//index.pdf. Accessed: 28 June 2006.
4. Thom TJ, Kannel WB. Congestive heart failure: epidemiology and cost of illness. Dis Manage Health Outcomes 1997; 1:75-83.
5. O'Connell JB, Bristow MR. Economic impact of heart failure in the United States: time for a different approach. J Heart Lung Transplant 1994; 13 (Suppl. 4):S107-S112.
6. McMurray JJ, Petrie MC, Murdoch DR, Davie AP. Clinical epidemiology of heart failure: public and private health burden. Eur Heart J 1998; 19 (Suppl. P):9-16.
7. Cowie MR, Wood DA, Coats AJ, et al. Incidence and aetiology of heart failure: a population-based study. Eur Heart J 1999; 20:421-428.
8. Bourassa MG, Gurne O, Bangiwalla SI, et al. Natural history and patterns of current practice in heart failure: the Studies of Left Ventricular Dysfunction (SOLVD) Investigators. J Am Coll Cardiol 1993; 22 (Suppl. A):14A-19A.
9. Park MH, Pathak H, Starling RC, Young JB. Failure to wean from parenteral inotropes: a strong predictor for early mortality among patients with end stage heart disease [Abstract]. J Heart Lung Transplant 1999; 18:47.
10. Ellenbogen KA, Wood MA, Klein HU. Why should we care about CARE-HF? J Am Coll Cardiol 2005; 46:2199-2203.
11. Daubert JC, Leclercq C, Mabo P. There is plenty of room for cardiac resynchronization therapy devices without back-up defibrillators in the electric treatment of heart failure. J Am Coll Cardiol 2005; 46:2204-2207.
12. Stevenson LW. When is heart failure a surgical disease? In: Rose EA, Stevenson LW, editors. Management of end-stage heart disease. Philadelphia: Lippincott-Raven Publishers; 1998. pp. 129-146.
13. Hunt SA. Current status of cardiac transplantation. JAMA 1998; 280:1692-1698.
14. Taylor DO, Edwards LB, Boucek MM, et al. Registry of the International Society for Heart and Lung Transplantation: 22nd Official adult heart transplant report - 2005. J Heart Lung Transplant 2005; 24:945-955. Report from the International Society for Heart and Lung Transplantation Registry on the status of heart and lung transplantation in 2005.
15. Robbins RC, Barlow CW, Oyer PE, et al. Thirty years of cardiac transplantation at Stanford University. J Thorac Cardiovasc Surg 1999; 117:939-951.
16. Grady KL, Jalowiec A, White-Williams C. Improvement in quality of life in patients with heart failure who undergo transplantation. J Heart Lung Transplant 1996; 15:749-757.
17. Mcmanus RP, O'Hair DP, Beitzinger JM, et al. Patients who die awaiting heart transplantation. J Heart Lung Transplant 1993; 12:159-172.
18. Radovancevic B, Frazier OH. Surgical therapies for heart failure. Curr Opin Cardiol 2000; 15:161-165.
19. Elefteriades JA, Tellides G, Samady H, et al. Coronary artery bypass for advanced left ventricular dysfunction. In: Masters RG, editor. Surgical options for the treatment of heart failure. Dordrecht: Kluwer Academic Publishers; 1999. pp. 15-31.
20. Bolling SF, Pagani FD, Deeb GM, et al. Intermediate-term outcome of mitral reconstruction in cardiomyopathy. J Thorac Cardiovasc Surg 1998; 115:381-388.
21. Dor V, Sabatier M, DiDonato M, et al. Efficacy of endoventricular patch plasty in large postinfarction akinetic scar and severe left ventricular dysfunction: comparison with a series of large dyskinetic scars. J Thorac Cardiovasc Surg 1998; 116:50-59.
22. Batista RJV, Santos JLV, Takeshita N, et al. Partial left ventriculectomy to improve left ventricular function in end-stage heart disease. J Card Surg 1996; 11:96-97.
23. McGregor CGA, Davies WR, Oi K, et al. Cardiac xenotransplantation: recent preclinical progress with 3-month median survival. J Thorac Cardiovasc Surg 2005; 130:844-851.
24. Cooper DKC, Keogh AM, Brink J, et al. Report of the Xenotransplantation Advisory Committee of the International Society for Heart and Lung Transplantation: The present status of xenotransplantation and its potential role in the treatment of end-stage cardiac and pulmonary diseases. J Heart Lung Transplant 2000; 19:1125-1165.
25. Van Citters RL. The artificial heart - progress, problems, prognosis. West J Med 1986; 145:664-669.
26. Portner PM, Oyer PE, McGregor CGA, et al. First human use of an electrically powered implantable ventricular assist system [Abstract]. Artif Organs 1985; 9:36.
27. Kirklin JK, Holman WL, et al. Mechanical circulatory support therapy as a bridge to transplant or recovery (new advances). Curr Opin Cardiol 2006; 21:120-126. A review of MCS, bridge to transplantation and bridge to recovery advances with various systems. Also includes a brief description of new US Interagency MCS Registry (INTERMACS).
28. Frazier OH. First use of an untethered, vented electric left ventricular assist device for long-term support. Circulation 1994; 89:2908-2914.
29. Faggian G, Santini F, Franchi G, et al. Insights from continued use of a Novacor left ventricular assist system for a period of 6 years. J Heart Lung Transplant 2005; 24:1444.e17-1444.e19. A detailed report on experiences of then-longest MCS recipient, including elective replacement at 4+ years and transplant at 6+ years. Important insight into recipient response to therapy, both positive and negative.
30. Kantrowitz A, Krakuaer J, Rubenfire M, et al. Initial clinical experience with a new permanent mechanical ventricle: the dynamic aortic patch. ASAIO Trans 1972; 18:159-167.
31. DeVries WC, Anderson JL, Joyce LD, et al. Clinical use of the total artificial heart. N Engl J Med 1984; 310:273-278.
32. DeVries WC. The permanent artificial heart: four case reports. JAMA 1988; 259:849-859.
33. Semb BKH. The use of the total artificial heart. In: Unger F, editor. Assisted Circulation 3. Berlin, Heidelberg: Springer-Verlag; 1989. pp. 332-339.
34. Cave MH, Wallwork J, Schofield PM. Permanent pacing in a patient with a left ventricular assist system. Heart 1996; 75:525-527.
35. Portner PM, Loisance DY, The Novacor left ventricular assist system. In: Kirklin JK, Frazier OH, editors. ISHLT Monograph on Mechanical Circulatory Support. Oxford, UK: Elsevier Publishers; 2006 (in press).
36. Pennington DG, Griffith BP, McKinlay SM, et al., LVAS Study Group. Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure: study overview. ASAIO J 1995; 41:11-15.
37. Rose EA, Moskowitz AJ, Packer M, et al. The REMATCH trial: rationale, design, and end points. Ann Thorac Surg 1999; 67:723-730.
38. Rose EA, Gelijns AC, Moskowitz AJ, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001; 345:1435-1443.
39. Stevenson LW, Miller LW, Desvigne-Nickens P, et al. Left ventricular assist device as destination for patients undergoing intravenous inotropic therapy: A subset analysis from REMATCH (Randomized Evaluation of Mechanical Assistance in Treatment of Chronic Heart Failure). Circulation 2004; 110:975-981.
40. Park SJ, Tector A, Piccioni W, et al. Left ventricular assist devices as destination therapy: a new look at survival. J Thorac Cardiovasc Surg 2005; 129:9-17. Outcome analysis for REMATCH showing improvements in the latter half, attributed to better recipient management and device refinements.
41. Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID trial [Abstract]. Circulation 2005; 112 (Suppl. 2):2-401.
42. El-Banayosy A, Arusoglu L, Kizner L, et al. Preliminary experience with the LionHeart left ventricular assist device in patients with end-stage heart failure. Ann Thorac Surg 2003; 75:1469-1475.
43. Arrow International, Inc. Reports modifications in cardiac assist strategy, press release, 7 April 2005. Available at: http://www.arrowintl.com/ about/investor/040705.asp. Accessed: 28 June 2006.
44. Dowling RD, Gray LA, Etoch SW, et al. Initial experience with the AbioCor implantable replacement heart system. J Thorac Cardiovasc Surg 2004; 127:131-141.
45. FDA Advisory Panel voted ABIOMED's ABIOCOR submission did not yet meet HDE standards; additional data is requested, press release, 23 June 2005. Available at: http://www.abiomed.com/news/FDA_Panel_Vote.cfm. Accessed: 28 June 2006.
46. Slaughter MS. Destination therapy: the future is arriving. CHF 2005; 11:155-156. A succinct editorial, reviewing the recent state of the art for destination therapy in the post-REMATCH era.
47. Centers for Medicare and Medicaid Services, VAC destination therapy facilities (CMS-approved destination therapy centers). Available at: http://www.cms.hhs.gov/MedicareApprovedFacilitie/VAD/list.asp#TopOfPage. Accessed: 28 June 2006.
48. Lietz K, Long J, Kfoury AG, et al. The impact of patient selection on long-term outcomes of left-ventricular assist device implantation as destination therapy for end-stage heart failure [Abstract]. J Heart Lung Transplant 2006; 25 (2 Suppl.):S131.
49. Long J, Kfoury AG, Slaughter MS, et al. Long-term destination therapy with the HeartMate XVE left ventricular assist device: improved outcomes since the REMATCH study. CHF 2005; 11:133-138. A detailed review of outcome improvements analysed for four most active destination therapy centers in the post-REMATCH era. Forty-two consecutive HeartMate XVE recipients during 2-year period.
50. Holman WL, Park SJ, Long JW, et al. Infection in permanent circulatory support. Experience from the REMATCH trial. J Heart Lung Transplant 2004; 23:1359-1365.
51. Dembitsky WP, Tector A, Park S, et al. Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial. Ann Thorac Surg 2004; 78:2123-2130.
52. Healy AH, Horne BD, Renlund DG, et al. Patient selection scale for destination therapy left ventricular assist device placement [Abstract]. ASAIO J 2006; 52:38A.
53. Noon GP, Morley DL, Irwin S, et al. Clinical experience with the MicroMed DeBakey ventricular assist device. Ann Thorac Surg 2001; 71 (3 Suppl.):S133-S138.
54. MicroMed Cardiovascular, Inc., SEC filing 8-K, 17 October 2005. Available at: http://www.sec.gov/Archives/edgar/data/1269515/000095012905009898/ h29459e8vk.htm. Accessed: 28 June 2006.
55. Frazier OH, Delgado RM, Kar B, et al. First clinical use of the redesigned HeartMate II left ventricular assist system in the United States: a case report. Tex Heart Inst J 2004; 31:157-159.
56. Westaby S, Banning AP, Saito S, et al. Circulatory support for long-term treatment of heart failure: experience with an intraventricular continuous flow pump. Circulation 2002; 105:2588-2591.
57. Esmore DS, Kaye D, Salamonsen R, et al. First clinical implant of the VentrAssist left ventricular assist system as destination therapy for end-stage heart failure. J Heart Lung Transplant 2005; 24:1150-1154. Report on the first VentrAssist destination therapy recipient in an Australian trial.
58. Portner PM, Oyer PE, Pennington DG, et al. Implantable electrical left ventricular assist system: bridge to transplantation and the future. Ann Thorac Surg 1989; 47:142-150.
59. McCarthy PM, Schmitt SK, Vargo RL, et al. Implantable LVAS infections: implications for permanent use of the device. Ann Thorac Surg 1996; 61:359-365.
60. Griffith BP, Kormos RL, Nastala CJ, et al. Results of extended bridge to transplantation: window into the future of permanent ventricular assist devices. Ann Thorac Surg 1996; 61:396-398.
61. Lazar RM, Shapiro PA, Jaski BE, et al. Neurological events during long-term mechanical circulatory support for heart failure: the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) experience. Circulation 2004; 109:2423-2427.
62. Cadeiras M, Von Bayern MP, Pal A, et al. Destination therapy: an alternative for end-stage heart failure patients not eligible for heart transplantation. Curr Opin Organ Transplant 2005; 10:369-375. A good description of the evaluation of destination therapy candidates, consensus meeting on patient selection, and MCS device clinical complications.
63. Deng MC, Edwards LB, Hertz MI, et al. Mechanical Circulatory Support Device Database of the International Society for Heart and Lung Transplantation: 3rd Annual report - 2005. J Heart Lung Transplant 2005; 24:1182-1187. Annual report of International Society for Heart and Lung Transplantation voluntary MCS database, providing information on recipients, indications, outcomes and complications.
64. Siegenthaler MP, Martin J, Pernice K, et al. The Jarvik 2000 is associated with less infections than the HeartMate left ventricular assist device. Eur J Cardiothorac Surg 2003; 23:748-755.
65. Thalmann M, Schima H, Wieselthaler G, Wolner E. Physiology of continuous blood flow in recipients of rotary cardiac assist devices. J Heart Lung Transplant 2005; 24:237-245. An excellent review of the physiology of continuous flow. A comprehensive report on the pathophysiological consequences, history, animal studies, organ function, and tissue response.
66. Letsou GV, Shah N, Gregoric ID, et al. Gastrointestinal bleeding from arteriovenous malformations in patients supported by the Jarvik 2000 axial-flow left ventricular assist device. J Heart Lung Transplant 2005; 24:105-109. An interesting report on the pathophysiology of continuous flow. Unremitting gastrointestinal bleeding as a consequence of AVM formation in small intestine. Resolved on transplantation.
67. Amir O, Radovancevic B, Delgado RM, et al. Peripheral vascular reactivity in patients with pulsatile vs axial flow left ventricular assist device support. J Heart Lung Transplant 2006; 25:391-394. An interesting report on the pathophysiology of continuous flow. Examined peripheral vascular reactivity unfavourable comparison continuous-flow compared with pulsatile.
68. Jassawalla J, LaForge D, Miller P, Portner P. Next generation Novacor LVAS - a miniaturized pulsatile pump [Abstract]. ASAIO J 2000; 46:157.
69. Grady KL, Meyer PM, Dressler D, et al. Longitudinal change in quality of life and impact on survival after left ventricular assist device implantation. Ann Thorac Surg 2004; 77:1321-1327.
70. Houghton P. Living with the Jarvik 2000: a five-plus year experience. Artif Organs 2006; 30:322-323. A very interesting review of his 5-year experience by a Jarvik 2000 recipient - in particular, his reaction to dependence on technology.