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Ann Thorac Surg 1996;61:301-304
© 1996 The Society of Thoracic Surgeons
Department of Cardiothoracic Surgery, Baylor University Medical Center, Dallas, Texas
Abstract
Background. The ABIOMED BVS 5000 is a two-chambered extracorporeal pulsatile assist device intended for temporary circulatory support. The Food and Drug Administration granted approval for the device for postcardiotomy patients in 1992.
Methods. A worldwide registry is maintained with the BVS 5000. Currently 500 patients have been entered into the registry. The majority of patients were postcardiotomy (53%) and required biventricular assist devices (65%).
Results. Postcardiotomy patients have had a 27% discharge rate compared with cardiomyopathy patients with a more than 40% discharge rate. Comparison at Baylor University Medical Center of the ABIOMED BVS 5000 with a nonpulsatile device demonstrated an improved wean rate (60% versus 47%, respectively) as well as discharge rate (27% versus 17%, respectively).
Conclusions. A worldwide registry combined with the experience at Baylor University Medical Center demonstrates the capability of the BVS 5000 to support postcardiotomy patients. The device is safe, simple, and effective. In addition, the pulsatile nature of the circulatory support appears to offer advantages over other systems.
The ABIOMED BVS 5000 device used for postcardiotomy support will be described and personal as well as worldwide experience will be presented. In addition, the potential advantages of this pulsatile device will be detailed.
Device Description
The BVS 5000 is a biventricular support system manufactured by ABIOMED Cardiovascular, Inc, (Danvers, MA). The system is capable of univentricular or biventricular support. It is a pulsatile pump, is fully automatic, and has a dual-chamber design. There are three components to the system: the pneumatic drive console, a dual-chamber blood pump, and atrial and arterial cannulas.
The blood pumps are extracorporeal and sit at the bedside on an intravenous pole. Filling can be altered by adjusting the level of the pump on the intravenous pole relative to the patient (Fig 1
). The cannulas exit the patient in a subcostal manner.
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There were some design goals with the BVS 5000. These goals were to be safe, simple, and effective. The safety of the pump is due to its design: a dual-chamber pump with a built-in reservoir. There is no vacuum as blood drains merely by gravity.
There are visual and audible alarms as well as multiple backup systems. The experience with the device has demonstrated no significant hemolysis. Postcardiotomy patients usually return from the operating room with very high plasma-free hemoglobin levels due to the prolonged period on cardiopulmonary bypass. As support is initiated and continued, the plasma free hemoglobin level has dropped much less than 10 mg/dL.
The BVS 5000 is very simple to operate. It has an automated control system with on and off operation. It automatically adjusts for changes in the patient preload and afterload, and it requires minimal operator intervention. It has been easier for the nurses to manage than the intraaortic balloon and has required no added personnel for device management.
The BVS has been shown to be very effective for circulatory support. The dual-chamber, two-valve design mimics the natural heart. It fully decompresses the ventricle, allowing it to rest. It provides pulsatile flow to the major organs. The pulse pressures exhibited are physiologic. During support the device will allow withdrawal of inotropes to rest the heart.
Currently more than 500 patients have been supported with the BVS. The premarket approval application study demonstrated a 55% wean rate with 29% discharge [1]. On November 20, 1992, the Food and Drug Administration granted premarket approval of the BVS, making it the only approved postcardiotomy ventricular assist device in the United States.
Experience
The experience seen with this device will be covered as two areas. Initially my own personal experience at Baylor University Medical Center will be detailed followed by the worldwide experience derived from the worldwide registry kept by ABIOMED Cardiovascular, Inc.
Most of our experience with the ABIOMED BVS 5000 at Baylor University Medical Center was derived from the Food and Drug Administration clinical trial, but since the clinical trial more patients have been added. Thus far 15 patients have been supported, 60% of whom were postcardiotomy patients. In addition, patients have been supported after failed transplantations (4), myocarditis (1), and acute myocardial infarction (1). The average age was 48 years with a duration of support of 6.2 days. Seventy-three percent of patients had biventricular assist devices, with a lesser amount with isolated left ventricular assist devices (27%).
Complications were seen with this device as with other devices. Forty percent of our patients had excessive bleeding (1,500 mL in the first 12 hours postoperatively). Only half of these patients, however, needed to be returned to the operating room for bleeding with an overall reoperation rate of 20%. The reduced bleeding is probably due to the arterial cannula, which has a graft sewn to the great vessel, thereby preventing bleeding around the cannulation site.
Fifty percent of BVS patients had respiratory complications. This is mainly related to the inability to extubate the patient. However, 30% of our patients were extubated on support. There was no evidence of emboli, although 30% of our patients had neurologic complications mainly due to preoperative cardiac arrest and diffuse neurologic injury. Only 10% of patients experienced hemolysis, defined as a plasma free hemoglobin level greater than 40 ml/dL.
Sixty percent of patients were weaned or received a transplant. Twenty-seven percent overall were discharged from the hospital. All of the patients discharged from the hospital were in functional class I.
ABIOMED currently maintains a worldwide registry with the BVS 5000. There are currently 500 patients entered into the registry. It should be emphasized that this is a voluntary registry kept by ABIOMED. The majority of the patients (53%) were postcardiotomy patients. However, another indication is cardiomyopathy with bridge to transplantation. Most of that experience comes from Europe. In addition, there have been patients supported after acute myocardial infarction, failed transplantation, and other.
Interestingly, since the Food and Drug Administration approval of the BVS the percentage of postcardiotomy patients has increased, which is probably due to the experience in the United States. Before the approval, the majority of the experience was in Europe with bridge to transplantation, as this represents the most cost-effective device available.
The average is 58 years for postcardiotomy patients and slightly younger for cardiomyopathy patients. The duration of support is 5 days for postcardiotomy patients and slightly more than 6 days for cardiomyopathy patients. The short support time for cardiomyopathy patients relates to the European experience, where the waiting time for a donor is much less than it is in the United States. The majority of the patients (65%) in the worldwide registry have been supported with biventricular assist devices, with 30% left ventricular assist devices and 5% right ventricular assist devices. The majority of cardiomyopathy patients have required biventricular assist devices, whereas postcardiotomy patients have been evenly divided between biventricular assist devices and left ventricular assist devices.
Complications have occurred most commonly in postcardiotomy patients. This is due to the prolonged cardiopulmonary time on bypass before the insertion of the device in postcardiotomy patients. Cardiomyopathy patients have experienced much less bleeding and, therefore, other complications than postcardiotomy patients. The majority of postcardiotomy patients have been weaned, although some have been bridged to transplantation. The majority of cardiomyopathy patients, however, have received transplants, supporting the main purpose of the device as a bridge to transplantation.
The overall survival using the BVS 5000 is demonstrated in Figure 2. Postcardiotomy patients have had a 27% discharge rate compared with cardiomyopathy patients, who have a more than 40% discharge rate. Acute myocardial infarction discharge rate is close to 40%. The dismal results seen with failed transplants mirrors the experience at Baylor University Medical Center.
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Worldwide experience has also demonstrated that experienced centers have better results than inexperienced centers. The center at Bad Oyenhausen, Germany, has a 62% survival compared with less experienced centers with less than a 40% survival. This reflects a learning curve associated with this device as there is with any other technique and device.
Of particular note is the improved survival with early intervention. In the premarket approval study [1] there was a marked difference in patients who had experienced a cardiac arrest before insertion of the device. The overall discharge rate for patients experiencing a prior cardiac arrest or hemodynamic instability was 29%; however, if there was no prior cardiac arrest or hemodynamic instability the discharge rate was 47%. Therefore, the earlier the insertion is, the better the results.
Advantages
Some of the advantages of the BVS are covered in the device description. The BVS has been demonstrated to be a safe device. The majority of the complications seen with it are patient-related, especially in postcardiotomy patients with prolonged cardiopulmonary bypass times before the insertion of the device. The device is very simple to operate, requiring minimal operator intervention. In addition, no added personnel are required to manage the device. It has also been shown to be quite effective for circulatory support. It has allowed the support of the circulation to allow the heart to rest and recover from its perioperative insult. Another advantage of the BVS is the pulsatile nature of circulatory support. The pulsatile nature of support probably explains the superior results that we have seen with the BVS over nonpulsatile systems, which are also generally available.
There is long-term debate over pulsatile versus nonpulsatile circulatory support. The literature, however, has substantiated some advantages with pulsatile support especially as it relates to cardiopulmonary bypass. Pulsatile support reduces systemic vascular resistance and attenuates the catecholamine response [3], it attenuates the reduction in triiodothyronine level [4], it improves splanchnic perfusion [5], it improves myocardial blood flow [6], and it improves clinical outcomes [7, 8]. The majority of studies about pulsatile support, however, have dealt with cardiopulmonary bypass and have not really addressed the issue of pulsatile support for postcardiotomy patients on a longer duration of support. I believe that the above-mentioned results are biased and the superiority of pulsatile support should be more marked because the amount of pulsativity with these methods is far less than the pulsativity provided by the BVS 5000.
Minami and associates [3] have demonstrated that pulsatile support attenuates the catecholamine response associated with cardiopulmonary bypass. This not only reduces the fluid overloading of patients but also improves the postoperative recovery period and the tracheal intubation time. Buket and colleagues [4] recently showed that triiodothyronine level was reduced less with pulsatile support versus nonpulsatile support. It was stated in that article that pulsatile flow during cardiopulmonary bypass establishes a more physiologic state and maintains better thyroid hormone metabolism. Gaer and co-workers [5] also recently demonstrated that the gastric mucosal pH is reduced less with pulsatile support and concluded that the reduction was significantly greater when nonpulsatile support was used, which is a reflection of the splanchnic blood flow. Splanchnic blood flow is preserved with pulsatile support versus nonpulsatile support. Ciardullo and associates [6] looked at pulsatile versus nonpulsatile flow in a fibrillating heart distal to a critical coronary stenosis and found that fibrillation-induced regional ischemia distal to a critical coronary stenosis was reduced by pulsatile perfusion during bypass, and the mechanism for the reduction in general ischemia was improved myocardial blood flow. This study suggested that myocardial blood flow is better with pulsatile support versus nonpulsatile support.
Taylor and colleagues [7] looked at the clinical outcomes after cardiopulmonary bypass using pulsatile versus nonpulsatile systems. They demonstrated that when pulsatile support was used overall mortality was reduced, mortality due to low output syndrome was reduced, the need for the intraaortic balloon pump was reduced, and epinephrine requirements were reduced. Minami and co-workers [8] recently reported the results of a ventricular assist device study of pulsatile versus nonpulsatile devices. They found that pulsatile circulatory assistance improved myocardial recovery allowing earlier reduction of inotropic support. In addition pulsatile circulatory assistance eliminated the need for intraaortic balloon counterpulsation.
At Baylor University Medical Center we have recently compared patients supported with pulsatile devices versus nonpulsatile devices. Twenty-five patients were supported with the Bio-Pump (Medtronic, Inc, Minneapolis, MN) and compared with 15 patients supported with the BVS 5000. The Bio-Pump patients were older than the BVS patients (57 years versus 48 years, respectively). The ejection fraction with the BVS patients was worse than with the Bio-Pump patients (0.30 versus 0.40, respectively). Intraoperative parameters are demonstrated in Table 1. Cardiopulmonary bypass time was longer with the BVS, but the cross-clamp time was less. More biventricular assist devices were used with the BVS. A similar number of intraaortic balloon pumps were used preoperatively, but after support most of the intraaortic balloon pumps were removed from the BVS patients.
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. Bleeding and reoperation rates in the BVS patients were approximately half those of the Bio-Pump. The only complications seen more frequently with the BVS were respiratory and infection, which is related to the longer duration of support (6.2 days versus 2.5 days with the Bio-Pump). Sixty percent of BVS patients were weaned and 27% were discharged from the hospital. This is in contrast to only 47% of the Bio-Pump patients weaned with a mere 17% discharged (Table 3).
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Conclusions
The ABIOMED BVS 5000 is a generally available device approved by the Food and Drug Administration for postcardiotomy support. It is safe, simple, and effective. The safety, simplicity, and effectiveness have been demonstrated in their worldwide registry in more than 500 patients. Importantly, the pulsatile support provided by the BVS results in fewer complications despite longer duration of assistance when compared with nonpulsatile support.
Footnotes
Presented at The Third International Conference on Circulatory Support Devices for Severe Cardiac Failure, Pittsburg, PA, Oct 28-30, 1994.
Address reprint requests to Dr Jett, Circulatory Assistance, Baylor University Medical Center, 1151 N Buckner Blvd, Suite 205, Dallas, TX 75218.
References
This article has been cited by other articles:
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  A. Nasir, P. Bonde, and A. N. J. Graham Ventricular assist device therapy in post-cardiotomy cardiogenic shock: historical outcomes and current trends Interact CardioVasc Thorac Surg, February 7, 2012; (2012) ivr150v1. [Abstract] [Full Text] [PDF]
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Y. Topilsky, T. N. Price, F. W. Atchison, and L. D. Joyce Atypical tamponade hemodynamic in a patient with temporary left ventricular assist device Interact CardioVasc Thorac Surg, May 1, 2011; 12(5): 832 - 834. [Abstract] [Full Text] [PDF]
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|
|
 |
|
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|
 J. W. Haft, F. D. Pagani, M. A. Romano, C. L. Leventhal, D. B. Dyke, and J. C. Matthews Short- and Long-Term Survival of Patients Transferred to a Tertiary Care Center on Temporary Extracorporeal Circulatory Support Ann. Thorac. Surg., September 1, 2009; 88(3): 711 - 718. [Abstract] [Full Text] [PDF]
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 B. Shamloo, J. L. Taylor, T. Yusufali, and N. D' Attellis Can a broken heart be fixed? J Intensive Care Med, September 1, 2009; 24(5): 338 - 343. [PDF]
|
|
|
|
 |
|
 E. C. McGee Jr., P. M. McCarthy, and N. Moazami Temporary Mechanical Circulatory Support Card. Surg. Adult, January 1, 2008; 3(2008): 507 - 534. [Full Text]
|
|
|
|
|
|
S. Aggarwal, F. Cheema, M. C. Oz, and Y. Naka Long-Term Mechanical Circulatory Support Card. Surg. Adult, January 1, 2008; 3(2008): 1609 - 1628. [Full Text]
|
|
|
|
|
|
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|
|
|
|
 |
|
 J. A. Petrofski, V. S. Patel, S. D. Russell, and C. A. Milano BVS5000 support after cardiac transplantation J. Thorac. Cardiovasc. Surg., August 1, 2003; 126(2): 442 - 447. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. Moazami and P. M. McCarthy Temporary Circulatory Support Card. Surg. Adult, January 1, 2003; 2(2003): 495 - 520. [Full Text]
|
|
|
|
|
|
H. Hausmann, E. V. Potapov, A. Koster, T. Krabatsch, J. Stein, R. Yeter, M. Kukucka, R. Sodian, H. Kuppe, and R. Hetzer Prognosis After the Implantation of an Intra-Aortic Balloon Pump in Cardiac Surgery Calculated With a New Score Circulation, September 24, 2002; 106(12_suppl_1): I-203 - I-206. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M. E. Stone, W. Soong, M. Krol, and D. L. Reich The Anesthetic Considerations in Patients with Ventricular Assist Devices Presenting for Noncardiac Surgery: A Review of Eight Cases Anesth. Analg., July 1, 2002; 95(1): 42 - 49. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Y. Schure, P. C. Laussen, and F. X. McGowan JR Mechanical Cardiopulmonary Support of Infants and Children With Congenital Heart Disease Seminars in Cardiothoracic and Vascular Anesthesia, March 1, 2001; 5(1): 46 - 54. [Abstract] [PDF]
|
|
|
|
|
|
A. El-Banayosy, R. Korfer, L. Arusoglu, L. Kizner, M. Morshuis, H. Milting, G. Tenderich, O. Fey, and K. Minami Device and patient management in a bridge-to-transplant setting Ann. Thorac. Surg., March 1, 2001; 71(2007): S98 - S102. [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]
|
|
|
|
|
|
B. Meyns, P. Sergeant, P. Wouters, F. Casselman, P. Herijgers, W. Daenen, K. Bogaerts, and W. Flameng Mechanical support with microaxial blood pumps for postcardiotomy left ventricular failure: Can outcome be predicted? J. Thorac. Cardiovasc. Surg., August 1, 2000; 120(2): 393 - 400. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Marelli, H. Laks, D. Fazio, M. A. Hamilton, G. C. Fonarow, D. A. Meehan, and J. D. Moriguchi Mechanical assist strategy using the BVS 5000i for patients with heart failure Ann. Thorac. Surg., July 1, 2000; 70(1): 59 - 66. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A El-Banayosy, L Arusoglu, L Kizner, O Fey, K Minami, and R Korfer Complications of circulatory assist Perfusion, July 1, 2000; 15(4): 327 - 331. [PDF]
|
|
|
|
|
|
R. Sharony, E. Porat, Y. Nishimura, B. Meyns, S. Ozaki, R. Racz, W. Flameng, and G. Uretzky THE INTRA-AORTIC CANNULA PUMP: A NOVEL ASSIST DEVICE FOR THE ACUTELY FAILING HEART J. Thorac. Cardiovasc. Surg., November 1, 1999; 118(5): 924 - 929. [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]
|
|
|
|
|
|
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]
|
|
|
|
|
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K. Smart and G. K. Jett Late tamponade with mechanical circulatory support Ann. Thorac. Surg., December 1, 1998; 66(6): 2027 - 2028. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. G. Smedira, C. C. Hlozek, and P. M. McCarthy Mechanical Support After Cardiac Surgery Seminars in Cardiothoracic and Vascular Anesthesia, March 1, 1998; 2(1): 66 - 77. [Abstract] [PDF]
|
|
|
|
|
|
J. J. DeRose Jr, J. P. Umana, M. Argenziano, K. A. Catanese, H. R. Levin, B. C. Sun, E. A. Rose, and M. C. Oz Improved Results for Postcardiotomy Cardiogenic Shock With the Use of Implantable Left Ventricular Assist Devices Ann. Thorac. Surg., December 1, 1997; 64(6): 1757 - 1762. [Abstract] [Full Text]
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