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Lack of funding
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The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.
Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of more powerful mechanical circulatory support device (MCSD) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely characterize the various "phenotypes" of CS as well as the role of MCSD in this condition with still excessive mortality.
This multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to advance the understanding and application of MCSD in order to improve the persistently dismal survival of patients with CS with the following intents:
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| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival post mechanical circulatory assist device implant | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| survival to discharge post mechanical circulatory assist device implant | until the enrolled patient is discharged. Expected to occur within 90 days of enrollment. | |
| 30-day survival post mechanical circulatory assist device implant | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Potential subjects include all adult patients who underwent evaluation for MCS for cardiogenic shock. Each adult patient who receives an MCSD at an institution will be screened according to the inclusion and exclusion criteria listed below.
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| Name | Affiliation | Role |
|---|---|---|
| Hiroo Takayama, MD, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colarodo | Aurora | Colorado | 80045 | United States | ||
| Minneapolis Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10460813 | Background | Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901. | |
| 22920912 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
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| Number of adverse events during mechanical circulatory assist device support | up to 30-days of weaning from the device. |
| Minneapolis |
| Minnesota |
| 55407 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Newark Beth Israel Medical center | Newark | New Jersey | 07112 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Background |
| Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Bohm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26. |
| 23352390 | Background | Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Baldwin JT, Young JB. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant. 2013 Feb;32(2):141-56. doi: 10.1016/j.healun.2012.12.004. |
| 22795459 | Background | Kirklin JK, Naftel DC, Pagani FD, Kormos RL, Stevenson L, Miller M, Young JB. Long-term mechanical circulatory support (destination therapy): on track to compete with heart transplantation? J Thorac Cardiovasc Surg. 2012 Sep;144(3):584-603; discussion 597-8. doi: 10.1016/j.jtcvs.2012.05.044. Epub 2012 Jul 15. |
| 22920913 | Background | O'Connor CM, Rogers JG. Evidence for overturning the guidelines in cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1349-50. doi: 10.1056/NEJMe1209601. Epub 2012 Aug 26. No abstract available. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |