82:, he/she will have presented with end-stage heart failure, and will be ineligible for a transplant due to age, additional health problems, or other complications. In addition, patients may be eligible but are not suitable for heart transplant because they have other circulatory conditions unrelated to the heart.
431:
As of
September 2009, the Thoratec HeartMate XVE is the only FDA-approved device for use specifically as destination therapy. Other devices are currently under investigation for this indication, including the next generation of the device, HeartMate II, which is expected receive FDA-approval in early
169:
The REMATCH study randomly assigned 129 patients with Class IV end-stage heart failure who were ineligible for cardiac transplantation. Within the study, 68 patients received an LVAD and 61 patients received optimal medical management. Among the patients who received the LVAD, there was a reduction
90:
In 2000, the
Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial was conducted. REMATCH was a multi-center study supported by the National Heart, Lung, and Blood Institute to compare long-term implantation of left ventricular assist devices
148:
will be given to keep the patients blood from clotting. The blood is rerouted to a heart-lung machine that will pump and oxygenate blood. A pocket for the LVAD is formed in the abdominal wall. A tube is then used to channel blood from the ventricle to the LVAD. Another tube is used to connect the
157:
During the REMATCH trial, several complications were reported for patients who received the LVAD. They reported post-operative pain after LVAD implantation. During an average 400 days of survival, 30 percent of the devices had an internal failure requiring another operation, and almost every
216:
The frequency of serious adverse events in the LVAD group was 2.35 times that in the medical-therapy group, with a predominance of infection, bleeding and malfunction of the device. However, the quality of life was significantly improved at one year in the LVAD group.
62:
in industrialized economies. Among those with serious heart illness some are, for a variety of possible medical circumstances, ineligible for a heart transplant. Destination therapy provides a possibility to extend their lives and improve their quality of life.
69:
Estimates place the population in the United States that may benefit from destination therapy at 50,000 – 100,000 patients per year. The addressable population outside of the US is thought be similar in size.
124:
in the coronary care unit (CCU) usually stabilizes and prepares the patient for surgery. Some patients will have invasive monitoring instituted in the CCU and will be supported with
91:
with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation. Based on the results of this study, the
40:
445:
136:. In addition, recent laboratory results and assessment of the patient's physical status are required. Patients are typically cross-matched for four units of blood.
92:
149:
pump to the aorta. When the pump is adequately supporting the heart, the patient will be removed from the heart-lung machine and the chest will be closed.
96:
270:
304:"The beneficial role of left ventricular assist device destination therapy in the reversal of contraindications to cardiac transplantation"
116:
Most LVADs are implanted in scheduled operations and require careful preparation of the patient for surgery, including an assessment by an
144:
Ventricular assist devices require open-heart surgery for implantation. An incision is made through the breastbone to expose the heart.
464:
158:
patient who had a re-operation did not survive. Other adverse effects included bleeding, infection and lengthened hospital stays.
233:
Birks, EJ; Bogaev, RC (2011), "A changing trend toward destination therapy: are we treating the same patients differently?",
95:(FDA) granted a Premarket Approval for the Thoratec HeartMate XVE LVAD to be used for destination therapy. In addition, the
161:
Quality of Life (QoL) measures found that the LVAD group scored better or equal to the medical-therapy management group.
66:
In addition, destination therapy may in some cases turn out to remedy the condition that excluded transplantation
79:
39:
can occur, but for the rest of the patient's life expectancy. It is thus a course of treatment for severe (e.g.,
28:
100:
27:, a destination in itself rather than merely a bridge or road to the destination. The term usually refers to
52:
36:
274:
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is a way to stay alive long enough, and stay healthy enough, to await transplant while maintaining
23:
that is final rather than being a transitional stage until another therapy—thus, in transportation
404:. Department of Health and Human Services/Centers for Medicare and Medicaid Services. 2007-04-17.
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of 48 percent in the risk of death from any cause, compared with the medical-therapy group.
371:
344:
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117:
48:
458:
345:"Ethical challenges with the left ventricular assist device as a destination therapy"
59:
44:
343:
Rizzieri, Aaron; Joseph L Verheijde; Mohamed Y Rady; Joan L McGregor (2008-08-11).
395:"Pub 100-03 Medicare National Coverage Determinations/Ventricular assist devices"
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129:
121:
125:
380:
361:
329:
256:
78:
In order for a patient to be recommended for destination therapy with an
24:
145:
20:
302:
Choong, Cliff; Michael Pasque; Kim
Shelton; et al. (2005-02-10).
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patients who are not likely candidates for transplant. In contrast,
418:
Next
Generation Ventricular Assist Devices for Destination Therapy
32:
133:
31:
or mechanical circulatory support to keep the existing
175:
308:The Journal of Thoracic and Cardiovascular Surgery
446:"Implantation of Left Ventricular Assist Device"
271:"Cardiovascular disease: prevention and control"
173:Rates of survival among REMATCH study patients:
349:Philosophy, Ethics, and Humanities in Medicine
440:
438:
8:
177:Survival rates among REMATCH study patients
273:. World Health Organization. Archived from
188:Patients receiving optimal medical therapy
421:. National Heart Blood and Lung Institute.
97:Centers for Medicare and Medicaid Services
370:
360:
319:
291:. American Heart Association. 2009-10-27.
246:
225:
7:
103:coverage to include such therapy.
14:
93:U.S. Food and Drug Administration
415:Baldwin, Timothy (2005-04-30).
1:
448:. Baylor College of Medicine.
49:bridge-to-transplant therapy
321:10.1016/j.jtcvs.2005.02.014
481:
53:eligibility for transplant
29:ventricular assist devices
465:Interventional cardiology
60:a leading cause of death
35:going, not just until a
362:10.1186/1747-5341-3-20
43:class IV/ACC stage D)
178:
17:Destination therapy
185:Patients with LVAD
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402:CMS Manual System
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58:Heart failure is
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277:on May 25, 2004.
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235:Tex Heart Inst J
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118:anesthesiologist
37:heart transplant
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289:"Heart Failure"
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5:
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314:(3): 879–880.
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241:(5): 552–554,
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153:Post-operative
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140:Peri-operative
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112:Pre-operative
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45:heart failure
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26:
22:
18:
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389:
352:
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275:the original
265:
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204:At 24 months
193:At 12 months
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160:
156:
143:
130:vasopressors
122:cardiologist
115:
89:
77:
68:
65:
57:
16:
15:
74:Indications
355:(20): 20.
221:References
182:Time frame
165:Prognosis
126:inotropes
107:Procedure
99:expanded
459:Category
381:18694496
330:16153944
257:22163133
101:Medicare
25:metaphor
372:2527574
248:3231550
146:Heparin
120:. The
86:History
21:therapy
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369:
328:
255:
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432:2010.
398:(PDF)
33:heart
19:is a
377:PMID
326:PMID
253:PMID
199:25%
134:IABP
132:and
80:LVAD
41:NYHA
367:PMC
357:doi
316:doi
312:130
243:PMC
210:8%
207:23%
196:52%
461::
437:^
400:.
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365:.
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347:.
324:.
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306:.
251:,
239:38
237:,
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55:.
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