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The Annals of Thoracic Surgery, Vol 53, 1080-1090, Copyright © 1992 by The Society of Thoracic Surgeons
OH Frazier, EA Rose, Q Macmanus, NA Burton, EA Lefrak, VL Poirier and KA Dasse
The Thermo Cardiosystems Inc (Woburn, MA) HeartMate 1000 IP left
ventricular assist device (LVAD) has been evaluated as a bridge to
transplantation in 34 patients for up to 324 days at seven clinical centers
in the United States. Sixty-five percent of the patients underwent
transplantation, 80% of whom were discharged from the hospital. Six
additional control patients, transplant candidates who met the entrance
criteria but who did not receive the device, were also included in the
study. Although 3 (50%) of the control patients received transplants, all 6
died within 77 days of having met the LVAD inclusion criteria (100%
mortality). Complications resulting from use of the device were comparable
with those previously reported for all ventricular assist devices, except
for thromboembolic events: bleeding, 39%; infection, 25%; and right heart
failure, 21%. No device-related thromboembolic events occurred, although 1
patient experienced an event related to a mechanical aortic valve in the
native heart. None of the complications had a significant negative
association with outcome of the patient except for right heart failure. All
survivors had a significant improvement in hepatic function before
transplantation. Total bilirubin values were reduced by 60% during LVAD
support. No significant differences were observed when total bilirubin
values were compared at 30 and 60 days after LVAD support and at 30 and 60
days after transplantation in a cohort of 15 patients (p greater than
0.05). The improvement in renal function was less predictable than that of
hepatic function. Creatinine values decreased significantly before
transplantation; however, the values measured at 30 and 60 days after
transplantation were higher than those measured at the same intervals after
LVAD support had been initiated, and this increase is presumably related to
the immunosuppressive drugs. In conclusion, the HeartMate 1000 IP LVAD has
been shown to be effective in supporting end-stage cardiomyopathy patients
to transplantation. Thromboembolism, previously regarded as a serious
complication with such devices, has not been a problem with this device.
Additional patients are being enrolled into the study to further document
the safety and effectiveness of this technology.
ARTICLES
Multicenter clinical evaluation of the HeartMate 1000 IP left ventricular assist device
Department of Cardiovascular Surgery, Texas Heart Institute, Houston 77225-0345.
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E. A. Rose, A. J. Moskowitz, M. Packer, J. A. Sollano, D. L. Williams, A. R. Tierney, D. F. Heitjan, P. Meier, D. D. Ascheim, R. G. Levitan, et al. The REMATCH trial: rationale, design, and end points Ann. Thorac. Surg., March 1, 1999; 67(3): 723 - 730. [Abstract] [Full Text] [PDF]
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R. John, J. M. Chen, A. Weinberg, M. C. Oz, D. Mancini, S. Itescu, M. E. Galantowicz, C. R. Smith, E. A. Rose, and N. M. Edwards Long-Term Survival After Cardiac Retransplantation: A Twenty-Year Single-Center Experience J. Thorac. Cardiovasc. Surg., March 1, 1999; 117(3): 543 - 555. [Abstract] [Full Text] [PDF]
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J R Beck, L B Mongero, R M Kroslowitz, A F Choudhri, J M Chen, J J DeRose, M Argenziano, A J Smerling, and M C Oz Inhaled nitric oxide improves hemodynamics in patients with acute pulmonary hypertension after high-risk cardiac surgery Perfusion, January 1, 1999; 14(1): 37 - 42. [Abstract] [PDF]
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O. Reinhartz, D. J. Farrar, J. H. Hershon, G. J. Avery Jr, E. A. Haeusslein, and J. D. Hill Importance of preoperative liver function as a predictor of survival in patients supported with Thoratec ventricular assist devices as a bridge to transplantation J. Thorac. Cardiovasc. Surg., October 1, 1998; 116(4): 633 - 640. [Abstract] [Full Text] [PDF]
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W. E. Pae Jr, J. M. Anderson, E. H. Blackstone, H. S. Boroevetz, A. Ciarkowski, J. G. Copeland III, M. R. Costanzo-Nordin, K. Daase, M. A. Dew, M. J. Domanski, et al. Bethesda conference: conference for the design of clinical trials to study circulatory support devices for chronic heart failure Ann. Thorac. Surg., October 1, 1998; 66(4): 1452 - 1465. [Full Text] [PDF]
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M. L. Dickstein Anesthesia for Heart Transplantation Seminars in Cardiothoracic and Vascular Anesthesia, July 1, 1998; 2(2): 131 - 139. [Abstract] [PDF]
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J. F. McCarthy, P. M. McCarthy, M. G. Massad, D. J. Cook, N. G. Smedira, V. Kasirajan, M. Goormastic, K. Hoercher, and J. B. Young Risk Factors for Death After Heart Transplantation: Does a Single-Center Experience Correlate With Multicenter Registries? Ann. Thorac. Surg., June 1, 1998; 65(6): 1574 - 1578. [Abstract] [Full Text] [PDF]
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B. Koul, J.-O. Solem, S. Steen, H. Casimir-Ahn, H. Granfeldt, and U. J. Lonn HeartMate Left Ventricular Assist Device as Bridge to Heart Transplantation Ann. Thorac. Surg., June 1, 1998; 65(6): 1625 - 1630. [Abstract] [Full Text] [PDF]
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W. Piccione Jr., W. G. Kao, A. Mattea, E. R. Rodriguez, and R. G. Trohman Failure Of An Implantable Left Ventricular Assist Device: A Distinctive Electrocardiographic Pattern Before Malfunction J. Thorac. Cardiovasc. Surg., June 1, 1998; 115(6): 1376 - 1378. [Full Text] [PDF]
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M. Argenziano, A. F. Choudhri, N. Moazami, E. A. Rose, C. R. Smith, H. R. Levin, A. J. Smerling, and M. C. Oz Randomized, Double-Blind Trial of Inhaled Nitric Oxide in LVAD Recipients With Pulmonary Hypertension Ann. Thorac. Surg., February 1, 1998; 65(2): 340 - 345. [Abstract] [Full Text] [PDF]
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A. C. Gelijns, A. F. Richards, D. L. Williams, M. C. Oz, J. Oliveira, and A. J. Moskowitz Evolving Costs of Long-Term Left Ventricular Assist Device Implantation Ann. Thorac. Surg., November 1, 1997; 64(5): 1312 - 1319. [Abstract] [Full Text]
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T. W. Prendergast, B. A. Todd, A. J. Beyer III, S. Furukawa, H. J. Eisen, V. P. Addonizio, B. J. Browne, and V. Jeevanandam Management of Left Ventricular Assist Device Infection With Heart Transplantation Ann. Thorac. Surg., July 1, 1997; 64(1): 142 - 147. [Abstract] [Full Text]
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H. R. Levin and M. L. Weisfeldt Deep Thoughts on Tin Men: Fact, Fallacy, and Future of Mechanical Circulatory Support Circulation, May 20, 1997; 95(10): 2340 - 2343. [Full Text]
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J. M. Hare, S. K. Shernan, S. C. Body, E. Graydon, W. S. Colucci, and G. S. Couper Influence of Inhaled Nitric Oxide on Systemic Flow and Ventricular Filling Pressure in Patients Receiving Mechanical Circulatory Assistance Circulation, May 6, 1997; 95(9): 2250 - 2253. [Abstract] [Full Text]
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M. Herrmann, M. Weyand, B. Greshake, C. von Eiff, R. A. Proctor, H. H. Scheld, and G. Peters Left Ventricular Assist Device Infection Is Associated With Increased Mortality but Is Not a Contraindication to Transplantation Circulation, February 18, 1997; 95(4): 814 - 817. [Abstract] [Full Text]
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D. J. Farrar, J. D. Hill, D. G. Pennington, L. R. McBride, W. L. Holman, R. L. Kormos, D. Esmore, L. A. Gray Jr., P. E. Seifert, G. P. Schoettle, et al. PREOPERATIVE AND POSTOPERATIVE COMPARISON OF PATIENTS WITH UNIVENTRICULAR AND BIVENTRICULAR SUPPORT WITH THE THORATEC VENTRICULAR ASSIST DEVICE AS A BRIDGE TO CARDIAC TRANSPLANTATION J. Thorac. Cardiovasc. Surg., January 1, 1997; 113(1): 202 - 209. [Abstract] [Full Text]
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V. Jeevanandam, S. Furukawa, T. W. Prendergast, B. A. Todd, H. J. Eisen, and J. B. McClurken Standard Criteria for an Acceptable Donor Heart Are Restricting Heart Transplantation Ann. Thorac. Surg., November 1, 1996; 62(5): 1268 - 1275. [Abstract] [Full Text]
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J. P. Slater, E. A. Rose, H. R. Levin, O. H. Frazier, J. K. Roberts, A. D. Weinberg, and M. C. Oz Low Thromboembolic Risk Without Anticoagulation Using Advanced-Design Left Ventricular Assist Devices Ann. Thorac. Surg., November 1, 1996; 62(5): 1321 - 1327. [Abstract] [Full Text]
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M. G. Massad, P. M. McCarthy, N. G. Smedira, D. J. Cook, N. B. Ratliff, M. Goormastic, R. L. Vargo, J. Navia, J. B. Young, and R. W. Stewart DOES SUCCESSFUL BRIDGING WITH THE IMPLANTABLE LEFT VENTRICULAR ASSIST DEVICE AFFECT CARDIAC TRANSPLANTATION OUTCOME? J. Thorac. Cardiovasc. Surg., November 1, 1996; 112(5): 1275 - 1283. [Abstract] [Full Text]
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R. G. Masters, P. J. Hendry, R. A. Davies, S. Smith, C. Struthers, V. M. Walley, J. P. Veinot, T. V. Mussivand, and W. J. Keon Cardiac Transplantation After Mechanical Circulatory Support: A Canadian Perspective Ann. Thorac. Surg., June 1, 1996; 61(6): 1734 - 1739. [Abstract] [Full Text]
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K. B. James, P. M. McCarthy, S. Jaalouk, E. L. Bravo, A. Betkowski, J. D. Thomas, S. Nakatani, and F. M. Fouad-Tarazi Plasma Volume and Its Regulatory Factors in Congestive Heart Failure After Implantation of Long-term Left Ventricular Assist Devices Circulation, April 15, 1996; 93(8): 1515 - 1519. [Abstract] [Full Text]
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M. Miyama, W. C. Dihmis, P. H. Deleuze, Y. Uozaki, S. L. Bambang, F. Pasteau, N. Rostaqui, and D. Y. Loisance The Gastrointestinal Tract: An Underestimated Organ as Demonstrated in an Experimental LVAD Pig Model Ann. Thorac. Surg., March 1, 1996; 61(3): 817 - 822. [Abstract] [Full Text]
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S. Y. Kim, A. Montoya, J. P. Zbilut, K. Mawulawde, H. J. Sullivan, V. A. Lonchyna, M. R. Terrell, and R. Pifarre Effect of HeartMate Left Ventricular Assist Device on Cardiac Autonomic Nervous Activity Ann. Thorac. Surg., February 1, 1996; 61(2): 591 - 593. [Abstract] [Full Text]
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J. N. Nanas, C. T. Lolas, C. E. Charitos, S. N. Nanas, Z. J. Margari, E. V. Agapitos, and S. D. Moulopoulos A VAVLELESS HIGH STROKE VOLUME COUNTERPULSATION DEVICE RESTORES HEMODYNAMICS IN PATIENTS WITH CONGESTIVE HEART FAILURE AND INTRACTABLE CARDIOGENIC SHOCK AWAITING HEART TRANSPLANTATION J. Thorac. Cardiovasc. Surg., January 1, 1996; 111(1): 55 - 61. [Abstract] [Full Text]
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P. M. McCarthy, S. K. Schmitt, R. L. Vargo, S. Gordon, T. F. Keys, and R. E. Hobbs Implantable LVAD Infections: Implications for Permanent Use of the Device Ann. Thorac. Surg., January 1, 1996; 61(1): 359 - 365. [Abstract] [Full Text]
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W. L. Holman, C. P. Murrah, E. R. Ferguson, R. C. Bourge, D. C. McGiffin, and J. K. Kirklin Infections During Extended Circulatory Support: University of Alabama at Birmingham Experience 1989 to 1994 Ann. Thorac. Surg., January 1, 1996; 61(1): 366 - 371. [Abstract] [Full Text]
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E. A. Rose and D. J. Goldstein Wearable Long-Term Mechanical Support for Patients With End-Stage Heart Disease: A Tenable Goal Ann. Thorac. Surg., January 1, 1996; 61(1): 399 - 402. [Abstract] [Full Text]
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S. Rafii, M. C. Oz, J. A. Seldomridge, B. Ferris, A. S. Asch, R. L. Nachman, F. Shapiro, E. A. Rose, and H. R. Levin Characterization of Hematopoietic Cells Arising on the Textured Surface of Left Ventricular Assist Devices Ann. Thorac. Surg., December 1, 1995; 60(6): 1627 - 1632. [Abstract] [Full Text]
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M. C. Oz, D. J. Goldstein, P. Pepino, A. D. Weinberg, S. M. Thompson, K. A. Catanese, R. L. Vargo, P. M. McCarthy, E. A. Rose, and H. R. Levin Screening Scale Predicts Patients Successfully Receiving Long-term Implantable Left Ventricular Assist Devices Circulation, November 1, 1995; 92(9): 169 - 173. [Abstract] [Full Text]
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L. W. Stevenson, G. Couper, B. Natterson, G. Fonarow, M. A. Hamilton, M. Woo, and J. W. Creaser Target Heart Failure Populations for Newer Therapies Circulation, November 1, 1995; 92(9): 174 - 181. [Abstract] [Full Text]
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K. B. James, P. M. McCarthy, J. D. Thomas, R. Vargo, R. E. Hobbs, S. Sapp, and E. Bravo Effect of the Implantable Left Ventricular Assist Device on Neuroendocrine Activation in Heart Failure Circulation, November 1, 1995; 92(9): 191 - 195. [Abstract] [Full Text]
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J. R Beck, L. B Mongero, D. J Goldstein, and M. C Oz Perfusion technique for treatment of right heart failure Perfusion, September 1, 1995; 10(5): 323 - 326. [Abstract] [PDF]
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H. R. Levin, M. C. Oz, J. M. Chen, M. Packer, E. A. Rose, and D. Burkhoff Reversal of Chronic Ventricular Dilation in Patients With End-Stage Cardiomyopathy by Prolonged Mechanical Unloading Circulation, June 1, 1995; 91(11): 2717 - 2720. [Abstract] [Full Text]
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P. M. McCarthy, S. Nakatani, R. Vargo, K. Kottke-Marchant, H. Harasaki, K. B. James, R. M. Savage, and J. D. Thomas Structural and Left Ventricular Histologic Changes After Implantable LVAD Insertion Ann. Thorac. Surg., March 1, 1995; 59(3): 609 - 613. [Abstract] [Full Text]
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P. M. McCarthy, R. M. Savage, C. D. Fraser, R. Vargo, K. B. James, M. Goormastic, R. E. Hobbs, and S. b. D. M. Cosgrove Hemodynamic and physiologic changes during support with an implantable left ventricular assist device J. Thorac. Cardiovasc. Surg., March 1, 1995; 109(3): 409 - 418. [Abstract] [Full Text]
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R. Matsuwaka, H. Matsuda, M. Kaneko, Y. Miyamoto, T. Masai, T. Nakatani, E. Sasaki, and O. H. Frazier Overseas Transport of a Patient With an Extracorporeal Left Ventricular Assist Device Ann. Thorac. Surg., February 1, 1995; 59(2): 522 - 523. [Abstract] [Full Text]
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D. G. Pennington, L. R. McBride, and M. T. Swartz Implantation technique for the Novacor left ventricular assist system J. Thorac. Cardiovasc. Surg., October 1, 1994; 108(4): 604 - 608. [Abstract] [Full Text]
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P. M. McCarthy, K. Fukamachi, F. Fukumura, K. Muramoto, L. A. R. Golding, and H. Harasaki The Cleveland Clinic-Nimbus total artificial heart: In vivo hemodynamic performance in calves and preclinical studies J. Thorac. Cardiovasc. Surg., September 1, 1994; 108(3): 420 - 428. [Abstract] [Full Text]
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D. G. Pennington, L. R. McBride, P. S. Peigh, L. W. Miller, and M. T. Swartz Eight years' experience with bridging to cardiac transplantation J. Thorac. Cardiovasc. Surg., February 1, 1994; 107(2): 472 - 481. [Abstract] [Full Text]
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E. A. Rose, A. C. Gelijns, A. J. Moskowitz, D. F. Heitjan, L. W. Stevenson, W. Dembitsky, J. W. Long, D. D. Ascheim, A. R. Tierney, R. G. Levitan, et al. Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure N. Engl. J. Med., November 15, 2001; 345(20): 1435 - 1443. [Abstract] [Full Text] [PDF]
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