HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dowling, R.D. Articles by Frazier, O.H. Search for Related Content PubMed PubMed Citation Articles by Dowling, R.D. Articles by Frazier, O.H. Related Collections Congestive Heart Failure Mechanical Circulatory Assistance Transplantation - heart

Eur J Cardiothorac Surg 2004;25:958-963
© 2004 Elsevier Science NL

HeartMate^® VE LVAS design enhancements and its impact on device reliability

^a University of Louisville, Louisville, KY, USA
^b California Pacific Medical Center, San Francisco, CA, USA
^c University of Michigan Health System, Ann Arbor, MI, USA
^d St Lukes Medical Center, Milwaukee, WI, USA
^e New York Presbyterian Hospital, New York, NY, USA
^f Sacred Heart Medical Center, Spokane, WA, USA
^g Thoratec Corporation, Pleasanton, CA, USA
^h St Lukes Episcopal Hospital, Houston, TX, USA

Received 22 October 2003; received in revised form 4 March 2004; accepted 5 March 2004.

^* Corresponding author. Address: Jewish Hospital Heart and Lung Institute, 217 East Chestnut Street, Louisville, KY 40202, USA. Tel.: +1-502-561-2180; fax: +1-502-584-2819
e-mail: rdowling{at}ucsamd.com

Objective: The HeartMate^® VE left ventricular assist system (LVAS) has supported more than 2300 patients and has been shown to be effective for bridge to cardiac transplantation and has demonstrated improved outcomes in survival as a destination therapy. Improvements in device durability are needed as bridge to transplant times increase and as we move into the era of LVAD as destination therapy. The purpose of this study is to determine if design enhancements to the HeartMate LVAS have improved device reliability and durability. Methods: A retrospective analysis of serious mechanical failures was performed in 1865 devices (1458 VE, 407 XVE). The analysis of data included devices used to support patients from September 1998 for bridge to transplantation and destination therapy. Serious mechanical failures were defined as inflow valve dysfunction, percutaneous lead breaks, diaphragm fractures or punctures, bearing failures, outflow graft erosion and pump disconnects. Results: Median device duration for the VE was 97 days (max 1206 days), and 85 days (max 517 days) for the XVE. A total of 134 serious mechanical failures occurred and included inflow valve dysfunction (5.3% VE, 2.4% XVE) (P=0.853), percutaneous lead breaks (1.9% VE, 0% XVE) (P<0.001), diaphragm fractures (0.1% VE, 0% XVE) (P=0.134), outflow graft erosion (0.2% VE, 0% XVE) (P=0.1096), pump disconnects (0.1% VE, 0% XVE) (P=0.1336) and bearing failures (0.6% VE, 0.2% XVE) (P=0.5538). Of the XVEs 97% were free of serious mechanical failures at 6 months and 82% at 1 year compared to 92 and 73% for the VE, respectively. The 6-month difference between the devices was statistically significant (P=0.0063) and there was no statistically significant difference at 1 year (P=0.1492). Conclusions: Preliminary experience with the HeartMate XVE LVAS demonstrated a significant reduction in percutaneous lead breaks. Early trends indicate positive impact of recent design modifications on XVE performance. These design modifications may improve device durability and reliability, which is crucial as we enter the era of LVADs as an alternative to medical therapy.

Key Words: Left ventricular assist device • Assisted circulation

This article has been cited by other articles:

				M. J. Russo, K. N. Hong, R. R. Davies, J. M. Chen, R. A. Sorabella, D. D. Ascheim, M. R. Williams, A. C. Gelijns, A. S. Stewart, M. Argenziano, et al. Posttransplant survival is not diminished in heart transplant recipients bridged with implantable left ventricular assist devices J. Thorac. Cardiovasc. Surg., December 1, 2009; 138(6): 1425 - 1432. [Abstract] [Full Text] [PDF]

				F. D. Pagani, L. W. Miller, S. D. Russell, K. D. Aaronson, R. John, A. J. Boyle, J. V. Conte, R. C. Bogaev, T. E. MacGillivray, Y. Naka, et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J. Am. Coll. Cardiol., July 21, 2009; 54(4): 312 - 321. [Abstract] [Full Text] [PDF]

				D. Loisance Mechanical Circulatory Support: a Clinical Reality Asian Cardiovasc Thorac Ann, October 1, 2008; 16(5): 419 - 431. [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]

				I. D. Gregoric, B. A. Bruckner, L. Jacob, B. Kar, W. E. Cohn, S. La Francesca, and O.H. Frazier Clinical Experience With Sternotomy Versus Subcostal Approach for Exchange of the HeartMate XVE to the HeartMate II Ventricular Assist Device Ann. Thorac. Surg., May 1, 2008; 85(5): 1646 - 1649. [Abstract] [Full Text] [PDF]

				D. Esmore, P. Spratt, R. Larbalestier, S. Tsui, A. Fiane, P. Ruygrok, D. Meyers, and J. Woodard VentrAssistTM left ventricular assist device: clinical trial results and Clinical Development Plan update Eur. J. Cardiothorac. Surg., November 1, 2007; 32(5): 735 - 744. [Abstract] [Full Text] [PDF]

				S. Chumnanvej, M. J. Wood, T. E. MacGillivray, and M. F. V. Melo Perioperative Echocardiographic Examination for Ventricular Assist Device Implantation Anesth. Analg., September 1, 2007; 105(3): 583 - 601. [Abstract] [Full Text] [PDF]

				K. Lietz, J. W. Long, A. G. Kfoury, M. S. Slaughter, M. A. Silver, C. A. Milano, J. G. Rogers, Y. Naka, D. Mancini, and L. W. Miller Outcomes of Left Ventricular Assist Device Implantation as Destination Therapy in the Post-REMATCH Era: Implications for Patient Selection Circulation, July 31, 2007; 116(5): 497 - 505. [Abstract] [Full Text] [PDF]

				F. D. Pagani, J. W. Long, W. P. Dembitsky, L. D. Joyce, and L. W. Miller Improved Mechanical Reliability of the HeartMate XVE Left Ventricular Assist System. Ann. Thorac. Surg., October 1, 2006; 82(4): 1413 - 1418. [Abstract] [Full Text] [PDF]

				S. Schenk, S. Weber, W. A. Smith, and K. Fukamachi MagScrew Total Artificial Heart Ann. Thorac. Surg., June 1, 2006; 81(6): 2338 - 2339. [Full Text] [PDF]