| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
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.
This article has been cited by other articles:
|
|
 |
|
  N. D. Patel, E. S. Weiss, J. Schaffer, S. L. Ullrich, D. C. Rivard, A. S. Shah, S. D. Russell, and J. V. Conte Right Heart Dysfunction After Left Ventricular Assist Device Implantation: A Comparison of the Pulsatile HeartMate I and Axial-Flow HeartMate II Devices Ann. Thorac. Surg., September 1, 2008; 86(3): 832 - 840. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. W. Long, A. H. Healy, B. Y. Rasmusson, C. G. Cowley, K. E. Nelson, A. G. Kfoury, S. E. Clayson, B. B. Reid, S. A. Moore, D. U. Blank, et al. Improving outcomes with long-term "destination" therapy using left ventricular assist devices. J. Thorac. Cardiovasc. Surg., June 1, 2008; 135(6): 1353 - 1361. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 K. D. Bloch, F. Ichinose, J. D. Roberts Jr., and W. M. Zapol Inhaled NO as a therapeutic agent Cardiovasc Res, July 15, 2007; 75(2): 339 - 348. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. J. Clegg, D. A. Scott, E. Loveman, J. L. Colquitt, P. Royle, and J. Bryant Clinical and cost-effectiveness of left ventricular assist devices as a bridge to heart transplantation for people with end-stage heart failure: a systematic review and economic evaluation Eur. Heart J., December 2, 2006; 27(24): 2929 - 2938. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. Winterhalter, S. Fischer, R. Tessmann, A. Goerler, S. Piepenbrock, A. Haverich, and M. Strueber Using inhaled iloprost to wean from cardiopulmonary bypass after implanting a left ventricular assist device. Anesth. Analg., August 1, 2006; 103(2): 515 - 516. [Full Text] [PDF]
|
|
|
|
|
|
N. C. Dang and Y. Naka Reply to the Editor J. Thorac. Cardiovasc. Surg., May 1, 2006; 131(5): 1212 - 1212. [Full Text] [PDF]
|
|
|
|
|
|
S. J. Park, A. Tector, W. Piccioni, E. Raines, A. Gelijns, A. Moskowitz, E. Rose, W. Holman, S. Furukawa, O. H. Frazier, et al. Left ventricular assist devices as destination therapy: A new look at survival J. Thorac. Cardiovasc. Surg., January 1, 2005; 129(1): 9 - 17. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. W. Stevenson, L. W. Miller, P. Desvigne-Nickens, D. D. Ascheim, M. K. Parides, D. G. Renlund, R. M. Oren, S. K. Krueger, M. R. Costanzo, L. S. Wann, 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, August 24, 2004; 110(8): 975 - 981. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Ichinose, J. D. Roberts Jr, and W. M. Zapol Inhaled Nitric Oxide: A Selective Pulmonary Vasodilator: Current Uses and Therapeutic Potential Circulation, June 29, 2004; 109(25): 3106 - 3111. [Full Text] [PDF]
|
|
|
|
|
|
O.H. Frazier and R. M. Delgado Mechanical Circulatory Support for Advanced Heart Failure: Where Does It Stand in 2003? Circulation, December 23, 2003; 108(25): 3064 - 3068. [Full Text] [PDF]
|
|
|
|
|
|
S. Itescu and R. John Interactions between the recipient immune system and the left ventricular assist device surface: immunological and clinical implications Ann. Thorac. Surg., June 1, 2003; 75(90060): S58 - 65. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 J. R. Lahpor Implantable Devices Seminars in Cardiothoracic and Vascular Anesthesia, March 1, 2003; 7(1): 111 - 112. [PDF]
|
|
|
|
|
|
J. L. Navia, P. M. McCarthy, K. J. Hoercher, N. G. Smedira, M. K. Banbury, and E. H. Blackstone Do left ventricular assist device (LVAD) bridge-to-transplantation outcomes predict the results of permanent LVAD implantation? Ann. Thorac. Surg., December 1, 2002; 74(6): 2051 - 2063. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
O. H. Frazier, T. J. Myers, I. D. Gregoric, T. Khan, R. Delgado, M. Croitoru, K. Miller, R. Jarvik, and S. Westaby Initial Clinical Experience With the Jarvik 2000 Implantable Axial-Flow Left Ventricular Assist System Circulation, June 18, 2002; 105(24): 2855 - 2860. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. P. Siegenthaler, J.u. Martin, A. van de Loo, T. Doenst, W. Bothe, and F. Beyersdorf Implantation of the permanent jarvik-2000 left ventricular assist device: A single-center experience J. Am. Coll. Cardiol., June 5, 2002; 39(11): 1764 - 1772. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
S. J. Park, J. Zhang, Y. Ye, S. Ormaza, P. Liang, A. J. Bank, L. W. Miller, and R. J. Bache Myocardial creatine kinase expression after left ventricular assist device support J. Am. Coll. Cardiol., June 5, 2002; 39(11): 1773 - 1779. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. N. Kavarana, M. S. Pessin-Minsley, J. Urtecho, K. A. Catanese, M. Flannery, M. C. Oz, and Y. Naka Right ventricular dysfunction and organ failure in left ventricular assist device recipients: a continuing problem Ann. Thorac. Surg., March 1, 2002; 73(3): 745 - 750. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M.P. Siegenthaler, J. Martin, O.H. Frazier, and F. Beyersdorf Implantation of the permanent Jarvik-2000 left-ventricular-assist-device: surgical technique Eur. J. Cardiothorac. Surg., March 1, 2002; 21(3): 546 - 548. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
H. J. Ankersmit, G. Wieselthaler, B. Moser, S. Gerlitz, G. Roth, G. Boltz-Nitulescu, and E. Wolner Transitory immunologic response after implantation of the DeBakey VAD continuous-axial-flow pump J. Thorac. Cardiovasc. Surg., March 1, 2002; 123(3): 557 - 561. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. Masai, Y. Sawa, S. Ohtake, T. Nishida, M. Nishimura, N. Fukushima, T. Yamaguchi, and H. Matsuda Hepatic dysfunction after left ventricular mechanical assist in patients with end-stage heart failure: role of inflammatory response and hepatic microcirculation Ann. Thorac. Surg., February 1, 2002; 73(2): 549 - 555. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
O.H. Frazier, T. J. Myers, R. K. Jarvik, S. Westaby, D. W. Pigott, I. D. Gregoric, T. Khan, D. W. Tamez, J. L. Conger, and M. P. Macris Research and development of an implantable, axial-flow left ventricular assist device: the Jarvik 2000 Heart Ann. Thorac. Surg., March 1, 2001; 71 (2007): S125 - S132. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
F. Nurozler, M. Argenziano, M. C. Oz, and Y. Naka Fungal left ventricular assist device endocarditis Ann. Thorac. Surg., February 1, 2001; 71(2): 614 - 618. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R. John, H. A. Rajasinghe, S. Itescu, S. Suratwalla, K. Lietz, A. D. Weinberg, A. Kocher, D. M. Mancini, R. E. Drusin, M. C. Oz, et al. Factors affecting long-term survival (>10 years) after cardiac transplantation in the cyclosporine era J. Am. Coll. Cardiol., January 1, 2001; 37(1): 189 - 194. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. N. Helman, S. W. Maybaum, D. L.S. Morales, M. R. Williams, A. Beniaminovitz, N. M. Edwards, D. M. Mancini, and M. C. Oz Recurrent remodeling after ventricular assistance: is long-term myocardial recovery attainable? Ann. Thorac. Surg., October 1, 2000; 70(4): 1255 - 1258. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A K Mahmood, J M Courtney, S Westaby, M Akdis, and H Reul Critical review of current left ventricular assist devices Perfusion, September 1, 2000; 15(5): 399 - 420. [PDF]
|
|
|
|
|
|
D.W. Quinn, T.J.J. Jones, and T.R. Graham Mechanical Circulatory Support Sources of Emboli and Neurological Outcome Seminars in Cardiothoracic and Vascular Anesthesia, July 1, 2000; 4(2): 115 - 120. [Abstract] [PDF]
|
|
|
|
|
|
J. R Pepper Surgery for heart failure: options and outcomes Perfusion, July 1, 2000; 15(4): 287 - 293. [PDF]
|
|
|
|
|
|
D. Gagnon, M. Petty, and J. R Lahpor HeartMate(R) family of left ventricular assist systems Perfusion, July 1, 2000; 15(4): 345 - 354. [PDF]
|
|
|
|
|
|
M E Lewis, M P. Pitt, and R S Bonser Surgical alternatives to mechanical support Perfusion, July 1, 2000; 15(4): 379 - 386. [PDF]
|
|
|
|
|
|
J. C. Stringham, D. A. Bull, and S. V. Karwande PATCH CLOSURE OF THE AORTIC ANULUS IN A RECIPIENT OF A VENTRICULAR ASSIST DEVICE J. Thorac. Cardiovasc. Surg., June 1, 2000; 119(6): 1293 - 1294. [Full Text] [PDF]
|
|
|
|
|
|
A. J. Bank, S. H. Mir, D. Q. Nguyen, R. M. Bolman III, S. J. Shumway, L. W. Miller, D. R. Kaiser, S. M. Ormaza, and S. J. Park Effects of left ventricular assist devices on outcomes in patients undergoing heart transplantation Ann. Thorac. Surg., May 1, 2000; 69(5): 1369 - 1374. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. Westaby HEART FAILURE: Non-transplant surgery for heart failure Heart, May 1, 2000; 83(5): 603 - 603. [Full Text]
|
|
|
|
|
|
S. J. Park, D. Q. Nguyen, A. J. Bank, S. Ormaza, and R. M. Bolman III Left ventricular assist device bridge therapy for acute myocardial infarction Ann. Thorac. Surg., April 1, 2000; 69(4): 1146 - 1151. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
R.-B. Hsu, S.-H. Chu, and S.-S. Wang Simple method of hemostasis in implantation and explantation of HeartMate left ventricular assist device Eur. J. Cardiothorac. Surg., March 1, 2000; 17(3): 336 - 337. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
K. Fukamachi, P. M. McCarthy, N. G. Smedira, R. L. Vargo, R. C. Starling, and J. B. Young Preoperative risk factors for right ventricular failure after implantable left ventricular assist device insertion Ann. Thorac. Surg., December 1, 1999; 68(6): 2181 - 2184. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. N. Helman, D. L.S. Morales, N. M. Edwards, D. M. Mancini, J. M. Chen, E. A. Rose, and M. C. Oz Left ventricular assist device bridge-to-transplant network improves survival after failed cardiotomy Ann. Thorac. Surg., October 1, 1999; 68(4): 1187 - 1194. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
T. B. Spanier, J. M. Chen, M. C. Oz, D. M. Stern, E. A. Rose, and A. M. Schmidt TIME-DEPENDENT CELLULAR POPULATION OF TEXTURED-SURFACE LEFT VENTRICULAR ASSIST DEVICES CONTRIBUTES TO THE DEVELOPMENT OF A BIPHASIC SYSTEMIC PROCOAGULANT RESPONSE J. Thorac. Cardiovasc. Surg., September 1, 1999; 118(3): 404 - 413. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
C. S Hayward, R. P Kelly, and P. S Macdonald Inhaled nitric oxide in cardiology practice Cardiovasc Res, August 15, 1999; 43(3): 628 - 638. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Mavroidis, B. C. Sun, and W. E. Pae Jr Bridge to transplantation: the Penn State experience Ann. Thorac. Surg., August 1, 1999; 68(2): 684 - 687. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
Y. Nose, K.-i. Nakata, M. Yoshikawa, G. V. Letsou, A. Fujisawa, E. Wolner, and H. Schima Development of a totally implantable biventricular bypass centrifugal blood pump system Ann. Thorac. Surg., August 1, 1999; 68(2): 775 - 779. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. Noirhomme, L. Jacquet, M. Underwood, G. El Khoury, M. Goenen, and R. Dion The effect of chronic mechanical circulatory support on neuroendocrine activation in patients with end-stage heart failure Eur. J. Cardiothorac. Surg., July 1, 1999; 16(1): 63 - 67. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
 |
|
 D. J. Goldstein, M. C. Oz, and E. A. Rose Implantable Left Ventricular Assist Devices N. Engl. J. Med., November 19, 1998; 339(21): 1522 - 1533. [Full Text] [PDF]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
M. L. Dickstein Anesthesia for Heart Transplantation Seminars in Cardiothoracic and Vascular Anesthesia, July 1, 1998; 2(2): 131 - 139. [Abstract] [PDF]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
H. H. Scheld, R. Soeparwata, C. Schmid, M. Loick, M. Weyand, and D. Hammel RUPTURE OF INFLOW CONDUITS IN THE TCI-HEARTMATE SYSTEM J. Thorac. Cardiovasc. Surg., August 1, 1997; 114(2): 287 - 289. [Full Text]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
B. E. Jaski, J. Kim, R. S. Maly, K. R. Branch, R. Adamson, L. K. Favrot, S. C. Smith Jr, and W. P. Dembitsky Effects of Exercise During Long-term Support With a Left Ventricular Assist Device : Results of the Experience With Left Ventricular Assist Device With Exercise (EVADE) Pilot Trial Circulation, May 20, 1997; 95(10): 2401 - 2406. [Abstract] [Full Text]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
|
|
|
|
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]
|
|
