Ventricular Assist Devices As a Bridge to Cardiac Transplantation. A Prelude to Destination Therapy

Overview

Journal Ann Surg

Specialty General Surgery

Date 1997 Jun 1

PMID 9230810

Citations 3

Authors

W L Holman

R C Bourge

R D Spruell

C P Murrah

D C McGiffin

J K Kirklin

Affiliations

Soon will be listed here.

Abstract

Objective And Background: Ventricular assist devices (VADs) have been used for temporary circulatory support pending transplantation or recovery of the native heart. Outcome in 38 patients treated at the authors' institution with VADs pending transplantation was analyzed to provide information relevant to the future use of VADs as permanent implants.

Methods: Thoratec (Thoratec Laboratories, Pleasanton, CA) or HeartMate (Thermo Cardiosystems, Woburn, MA) VADs were used in all cases. Patients were considered for VAD placement if they were candidates for cardiac transplantation and fulfilled the criteria for the Food and Drug Administration investigational Device Exemption trials. The following adverse events were included in the analysis; death during VAD support, device malfunction, bleeding, neurologic events, support-related events that preclude transplantation, and device-related infections. Patient survival and complication rates were quantified using the Kaplan-Meier method, competing risk analysis, and hazard functions.

Results: Nineteen patients had transplantation. Three patients had VAD removal after cardiac recovery and 16 died without transplantation. The duration of VAD support ranged from 0 to 279 days. The hazard function for death during VAD support had an early phase that lasted for 2 weeks after VAD placement, and early death was related to the preimplant condition of the patient. Device-related infections were noted in 11 patients. Seven of these patients had transplantation after clearing the infection, whereas four died without transplantation. Neurologic events occurred in seven patients. There were no device malfunctions that led to patient death.

Conclusions: The absence of fatal device malfunctions suggests that longer term support with current VAD designs is feasible. Appropriate patient selection, infection control, and avoidance of thromboembolic neurologic complications will be crucial to the success of permanent VAD use.

Citing Articles

The role of ionic interactions in the adherence of the Staphylococcus epidermidis adhesin SdrF to prosthetic material.

Toba F, Visai L, Trivedi S, Lowy F FEMS Microbiol Lett. 2012; 338(1):24-30.

PMID: 23039791 PMC: 3521083. DOI: 10.1111/1574-6968.12018.

Transapical miniaturized ventricular assist device: design and initial testing.

Slaughter M, Giridharan G, Tamez D, Larose J, Sobieski M, Sherwood L J Thorac Cardiovasc Surg. 2011; 142(3):668-74.

PMID: 21320708 PMC: 3810002. DOI: 10.1016/j.jtcvs.2011.01.011.

Mechanical circulatory support: expanding knowledge and experience in a challenging patient subset.

Holman W Intensive Care Med. 2001; 27(8):1245-6.

PMID: 11511934 DOI: 10.1007/s001340101030.

References

Farrar D, Hill J . Recovery of major organ function in patients awaiting heart transplantation with Thoratec ventricular assist devices. Thoratec Ventricular Assist Device Principal Investigators. J Heart Lung Transplant. 1994; 13(6):1125-32. View

Harasaki H, Fukamachi K, Massiello A, Chen J, Himley S, Fukumura F . Progress in Cleveland Clinic-Nimbus total artificial heart development. ASAIO J. 1994; 40(3):M494-8. View

Winowich S, Nastala C, Pristas J, Griffith B, Kormos R . Discharging patients who are undergoing mechanical circulatory support. Ann Thorac Surg. 1996; 61(1):478-9. DOI: 10.1016/0003-4975(95)00993-0. View

Catanese K, Goldstein D, Williams D, Foray A, Illick C, Gardocki M . Outpatient left ventricular assist device support: a destination rather than a bridge. Ann Thorac Surg. 1996; 62(3):646-52; discussion 653. DOI: 10.1016/s0003-4975(96)00456-0. View

Massad M, McCarthy P, Smedira N, Cook D, Ratliff N, Goormastic M . Does successful bridging with the implantable left ventricular assist device affect cardiac transplantation outcome?. J Thorac Cardiovasc Surg. 1996; 112(5):1275-81; discussion 1282-3. DOI: 10.1016/S0022-5223(96)70141-1. View

Davis R, Whittington R . Aprotinin. A review of its pharmacology and therapeutic efficacy in reducing blood loss associated with cardiac surgery. Drugs. 1995; 49(6):954-83. DOI: 10.2165/00003495-199549060-00008. View

Gristina A . Biomaterial-centered infection: microbial adhesion versus tissue integration. Science. 1987; 237(4822):1588-95. DOI: 10.1126/science.3629258. View

Pennington D, McBride L, Swartz M, Kanter K, Kaiser G, BARNER H . Use of the Pierce-Donachy ventricular assist device in patients with cardiogenic shock after cardiac operations. Ann Thorac Surg. 1989; 47(1):130-5. DOI: 10.1016/0003-4975(89)90254-3. View

Didisheim P, Olsen D, Farrar D, Portner P, Griffith B, Pennington D . Infections and thromboembolism with implantable cardiovascular devices. ASAIO Trans. 1989; 35(1):54-70. View

10.

Graham T, Dasse K, Coumbe A, Salih V, Marrinan M, Frazier O . Neo-intimal development on textured biomaterial surfaces during clinical use of an implantable left ventricular assist device. Eur J Cardiothorac Surg. 1990; 4(4):182-90. DOI: 10.1016/1010-7940(90)90002-h. View

11.

Evans R, Orians C, Ascher N . The potential supply of organ donors. An assessment of the efficacy of organ procurement efforts in the United States. JAMA. 1992; 267(2):239-46. View

12.

Sasaki T, Takatani S, Shiono M, Sakuma I, Noon G, Nose Y . A biolized, compact, low noise, high performance implantable electromechanical ventricular assist system. ASAIO Trans. 1991; 37(3):M249-51. View

13.

Reedy J, Pennington D, Miller L, McBride L, Lohmann D, Noedel N . Status I heart transplant patients: conventional versus ventricular assist device support. J Heart Lung Transplant. 1992; 11(2 Pt 1):246-52. View

14.

Frazier O, Rose E, Macmanus Q, Burton N, Lefrak E, Poirier V . Multicenter clinical evaluation of the HeartMate 1000 IP left ventricular assist device. Ann Thorac Surg. 1992; 53(6):1080-90. DOI: 10.1016/0003-4975(92)90393-i. View

15.

Farrar D, Hill J . Univentricular and biventricular Thoratec VAD support as a bridge to transplantation. Ann Thorac Surg. 1993; 55(1):276-82. DOI: 10.1016/0003-4975(93)90537-r. View

16.

Dew M, Kormos R, Roth L, Armitage J, Pristas J, Harris R . Life quality in the era of bridging to cardiac transplantation. Bridge patients in an outpatient setting. ASAIO J. 1993; 39(2):145-52. View

17.

Salih V, Graham T, Berry C, Coumbe A, Smith S, Dasse K . The lining of textured surfaces in implantable left ventricular assist devices. An immunocytochemical and electronmicroscopic study. Am J Cardiovasc Pathol. 1993; 4(4):317-25. View

18.

Gristina A . Implant failure and the immuno-incompetent fibro-inflammatory zone. Clin Orthop Relat Res. 1994; (298):106-18. View

19.

McCarthy P, Wang N, Vargo R . Preperitoneal insertion of the HeartMate 1000 IP implantable left ventricular assist device. Ann Thorac Surg. 1994; 57(3):634-7; discussion 637-8. DOI: 10.1016/0003-4975(94)90557-6. View

20.

Gristina A, Giridhar G, Gabriel B, Naylor P, Myrvik Q . Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs. 1993; 16(11):755-63. View