Postcardiotomy shock: Clinical evaluation of the BVS 5000 biventricular support system

doi:10.1016/0003-4975(93)91174-L

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Postcardiotomy shock: Clinical evaluation of the BVS 5000 biventricular support system

Robert A. Guyton, MD^_*^,a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Jacques P.A.M. Schonberger, MD, PhD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Peter A.M. Everts, CCP^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, G.Kimble Jett, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Laman A. Gray, Jr, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Isaac Gielchinsky, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Daniel H. Raess, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Gus J. Vlahakes, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Stephen R. Woolley, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Deepak M. Gangahar, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Hooshang Soltanzadeh, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, William J. Piccione, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Cecil C. Vaughn, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Piet W. Boonstra, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m, Mortimer J. Buckley, MD^a^,b^,c^,d^,e^,f^,g^,h^,i^,j^,k^,l^,m

^a Emory University, Atlanta, Georgia USA
^b Catharina Hospital, Eindhoven, the Netherlands
^c Baylor University Medical Center, Dallas, Texas USA
^d Jewish Hospital, Louisville, Kentucky USA
^e Newark Beth Israel Medical Center, Newark, New Jersey USA
^f St. Francis Hospital, Beech Grove, Indiana USA
^g Massachusetts General Hospital, Boston, Massachusetts USA
^h University Hospital, Utrecht, the Netherlands
ⁱ Bryan Memorial Hospital, Linccln, Nebraska USA
^j Iowa Methodist Medical Center, Des Moines, Iowa USA
^k Rush-Presbyterian Medical Center, Chicago, Illinois USA
^l Phoenix Baptist Hospital, Phoenix, Arizona USA
^m University Hospital, Groningen, the Netherlands

Accepted for publication April 19, 1993.

^_* Address reprint requests to Dr Guyton, 550 Peachtree, NE, Suite 4356, Atlanta, GA 30365.

This prospective trial evaluated the safety and efficacy ofa new pulsatile, temporary ventricular assist device, the BVS5000. Patients were eligible for treatment if they were hemodynamicallyunstable despite maximal pharmacologic and intraaortic balloonpump therapy, were free of concomitant complications, and wereless than 6 hours from the first attempt to separate from cardiopulmonarybypass. Fifty-five postcardiotomy patients were enrolled; 31met all selection criteria and the remainder failed to meetcriteria (n = 15) or were not successfully supported (n = 9).The BVS 5000 effectively restored hemodynamics: Mean arterialpressure increased (77.1 ± 8.0 mm Hg on-support versus50.1 ± 15.3 mm Hg presupport; p = 0.0001). Cardiac indexincreased (2.3 ± 0.3 L · min^–1 ·m^–2 on-support versus 1.6 ± 0.6 L · min^–1· m^–2 presupport; p = 0.0013). Left ventricularfilling pressure decreased (11.9 ± 4.5 mm Hg on-supportversus 23.8 ± 8.7 mm Hg presupport; p = 0.0030). Themost frequent complication was bleeding in 42 patients (76%).Of the patients meeting all criteria, 17 (55%) were weaned fromsupport and 9 (29%) were discharged. Survival was significantlyinfluenced by presupport cardiac arrest events. Survival amongpatients not experiencing arrest was 47%. Eight patients arelong-term survivors and were asymptomatic in New York HeartAssociation class I or II at 1-year follow-up. The BVS 5000restored hemodynamics, permitted myocardial recovery, and improvedsurvival in a group of patients who would have otherwise died.

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				A. F. Hernandez, J. D. Grab, J. S. Gammie, S. M. O'Brien, B. G. Hammill, J. G. Rogers, M. T. Camacho, M. K. Dullum, T. B. Ferguson, and E. D. Peterson A Decade of Short-Term Outcomes in Post Cardiac Surgery Ventricular Assist Device Implantation: Data From the Society of Thoracic Surgeons' National Cardiac Database Circulation, August 7, 2007; 116(6): 606 - 612. [Abstract] [Full Text] [PDF]

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				P. Naughton and C. A. Bashour Mechanical Support After Cardiac Surgery Seminars in Cardiothoracic and Vascular Anesthesia, September 1, 2002; 6(3): 237 - 257. [Abstract] [PDF]

				N. G. Smedira, N. Moazami, C. M. Golding, P. M. McCarthy, C. Apperson-Hansen, E. H. Blackstone, and D. M. Cosgrove III Clinical experience with 202 adults receiving extracorporeal membrane oxygenation for cardiac failure: Survival at five years J. Thorac. Cardiovasc. Surg., July 1, 2001; 122(1): 92 - 102. [Abstract] [Full Text] [PDF]

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				N. G. Smedira and E. H. Blackstone Postcardiotomy mechanical support: risk factors and outcomes Ann. Thorac. Surg., March 1, 2001; 71(2007): S60 - S66. [Abstract] [Full Text] [PDF]

				R. J Dekkers, D. J FitzGerald, and G. S Couper Five-year clinical experience with Abiomed BVS 5000 as a ventricular assist device for cardiac failure Perfusion, January 1, 2001; 16(1): 13 - 18. [Abstract] [PDF]

				F. B.Y. Hoy, D. K. Mueller, D. M. Geiss, J. R. Munns, L. M. Bond, C. E. Linett, and R. C. Gomez Bridge to recovery for postcardiotomy failure: is there still a role for centrifugal pumps? Ann. Thorac. Surg., October 1, 2000; 70(4): 1259 - 1263. [Abstract] [Full Text] [PDF]

				G. S. Couper, R. J. Dekkers, and D. H. Adams The logistics and cost-effectiveness of circulatory support: advantages of the ABIOMED BVS 5000 Ann. Thorac. Surg., August 1, 1999; 68(2): 646 - 649. [Abstract] [Full Text] [PDF]

				M. Kitamura, S. Aomi, M. Hachida, H. Nishida, M. Endo, and H. Koyanagi Current strategy of temporary circulatory support for severe cardiac failure after operation Ann. Thorac. Surg., August 1, 1999; 68(2): 662 - 665. [Abstract] [Full Text] [PDF]

				R. Korfer, A. El-Banayosy, L. Arusoglu, K. Minami, T. Breymann, D. Seifert, and L. Kizner Temporary pulsatile ventricular assist devices and biventricular assist devices Ann. Thorac. Surg., August 1, 1999; 68(2): 678 - 683. [Abstract] [Full Text] [PDF]

				E. B. Savage, R. E. Clark, W. P. Griffin, S. A. Davis, S. Hughson, C. J. Conway, and G. J. Magovern Sr The AB-180 circulatory support system: summary of development and plans for phase I clinical trial Ann. Thorac. Surg., August 1, 1999; 68(2): 768 - 774. [Abstract] [Full Text] [PDF]

				M Lachat, C Jaggy, B Leskosek, R Jenni, M Buchi, G Zund, A Kunzli, P Vogt, and M Turina Optimized performance of the Abiomed BVS 5000: adjustment of the pump height based on Doppler control of the flow pattern Perfusion, January 1, 1999; 14(1): 59 - 67. [Abstract] [PDF]

				F. P. Sutter, S. M. Goldman, M. A. C. Wertan, J. M. Mitchell, B. P. Priest, and D. N. Tomasello The ABIOMED and bleeding. Ann. Thorac. Surg., September 1, 1996; 62(3): 950 - 951. [Full Text]

				A. El-Banayosy, H. Posival, K. Minami, L. Arusoglu, L. Kizner, T. Breymann, D. Seifert, M. Korner, H. Kortke, O. Fey, et al. Mechanical circulatory support: lessons from a single centre Perfusion, March 1, 1996; 11(2): 93 - 102. [Abstract] [PDF]

				G. K. Jett ABIOMED BVS 5000: Experience and Potential Advantages Ann. Thorac. Surg., January 1, 1996; 61(1): 301 - 304. [Abstract] [Full Text]

				R. Korfer, A. El-Banayosy, H. Posival, K. Minami, L. Kizner, L. Arusoglu, and M. M. Korner Mechanical Circulatory Support With the Thoratec Assist Device in Patients With Postcardiotomy Cardiogenic Shock Ann. Thorac. Surg., January 1, 1996; 61(1): 314 - 316. [Abstract] [Full Text]

				B. P. Meyns, P. T. Sergeant, W. J. Daenen, and W. J. Flameng Left ventricular assistance with the transthoracic 24F Hemopump for recovery of the failing heart Ann. Thorac. Surg., August 1, 1995; 60(2): 392 - 397. [Abstract] [PDF]

				O. H. Frazier New technologies in the treatment of severe cardiac failure: The Texas Heart Institute experience Ann. Thorac. Surg., February 1, 1995; 59(suppl_1): S31 - S38. [Abstract] [PDF]