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J Thorac Cardiovasc Surg 1997;113:202-209
© 1997 Mosby, Inc.

CARDIOPULMONARY BYPASS, MYOCARDIAL MANAGEMENT, AND SUPPORT TECHNIQUES

PREOPERATIVE AND POSTOPERATIVE COMPARISON OF PATIENTS WITH UNIVENTRICULAR AND BIVENTRICULAR SUPPORT WITH THE THORATEC VENTRICULAR ASSIST DEVICE AS A BRIDGE TO CARDIAC TRANSPLANTATION

Received for publication May 29, 1996 Revisions requested July 30, 1996 Revisions received August 29, 1996 Accepted for publication Sept. 9, 1996 Address for reprints: David J. Farrar, PhD, Department of Cardiac Surgery, California Pacific Medical Center, 2351 Clay St., Room S637, San Francisco, CA 94115.

Abstract

Objectives: The goal of this study was to determine whether there are differences in populations of patients with heart failure who require univentricular or biventricular circulatory support. Methods: Two hundred thirteen patients who were in imminent risk of dying before donor heart procurement and who received Thoratec left (LVAD) and right (RVAD) ventricular assist devices at 35 hospitals were divided into three groups: group 1 (n = 74), patients adequately supported with isolated LVADs; group 2 (n = 37), patients initially receiving an LVAD and later requiring an RVAD; and group 3 (n = 102), patients who received biventricular assistance (BiVAD) from the beginning. Results: There were no significant differences in any preoperative factors between the two BiVAD groups. In the combined BiVAD groups, pre-VAD cardiac index (BiVAD, 1.4 ± 0.6 L/min per square meter, vs LVAD, 1.6 ± 0.6 L/min per square meter) and pulmonary capillary wedge pressure (BiVAD, 27 ± 8 mm Hg, vs LVAD, 30 ± 8 mm Hg) were significantly lower than those in the LVAD group, and pre-VAD creatinine levels were significantly higher (BiVAD, 1.9 ± 1.1 mg/dl, vs LVAD, 1.4 ± 0.6 mg/dl). In addition, greater proportions of patients in the BiVAD groups required mechanical ventilation before VAD placement (60% vs 35%) and were implanted under emergency conditions than in the LVAD group (22% vs 9%). The survival of patients through heart transplantation was significantly better in patients who had an LVAD (74%) than in those who had BiVADs (58%). However, there were no significant differences in posttransplantation survival through hospital discharge (LVAD, 89%; BiVAD, 81%). Conclusion: Patients who received LVADs were less severely ill before the operation and consequently were more likely to survive after the operation. As the severity of illness increases, patients are more likely to require biventricular support(J Thorac Cardiovasc Surg 1997;113:202-9)

The decision to use univentricular or biventricular support is one of the key problems in the successful application of mechanical circulatory support for the treatment of patients with heart failure. With appropriate selection and exclusion criteria, many patients can be identified and supported successfully with an isolated left ventricular assist device (LVAD). However, they represent only part of the total population of patients requiring mechanical circulatory support. Another sizable part of the population requires biventricular (BiVAD) support with both left (LVAD) and right (RVAD) ventricular assist devices; another group of patients, although much smaller in number, require isolated RVAD support. There is continued controversy over the percentage of patients requiring BiVAD support. These figures range from more than 60% in patients selected for treatment with Thoratec LVADs or RVADs, or both (Thoratec Laboratories, Berkeley, Calif.), ^1-5 to 15% to 25% in patient populations selected for isolated LVAD systems. ^6-8 These percentages reflect differences in the patient populations studied, as well as selection bias among different investigators. However, there are no reliable preoperative predictors of right heart failure with isolated LVAD support and no consensus on how to best select univentricular and biventricular devices for the total patient population requiring circulatory support. Accordingly, we tried to determine whether there are differences in populations of patients who require biventricular versus univentricular support by performing a retrospective analysis of the severity of illness and survival of patients receiving Thoratec LVADs compared with patients receiving biventricular support (LVADs and RVADs).

Methods

Patient entry criteria
Patients in this study were heart transplant candidates in whom VADs were implanted when the clinical and hemodynamic status indicated that the patient would probably die or have permanent end-organ damage before a donor heart could be located. Hemodynamic guidelines used in the Investigational Device Exemption (IDE) study in the United States were (1) a left atrial pressure greater than 20 mm Hg and either (2) a cardiac index less than 1.8 L/min per square meter or (3) a mean arterial pressure less than 70 mm Hg, despite appropriate use of conventional therapies such as inotropic agents, vasodilators, and intraaortic balloon pumps. No patient was accepted for the study who had known contraindications to cardiac transplantation other than those considered to be reversible after restoration of adequate cardiac output. Once the patient met entry criteria, investigational sites were free to apply LVADs or RVADs (or both) as required for individual patient need.

VAD
The Thoratec VAD system was used for either univentricular or biventricular support in these patients. The system consists of prosthetic ventricles with a 65 ml stroke volume, cannulas for atrial or ventricular inflow and arterial outflow connections, and a pneumatic drive console. The VADs were placed in a paracorporeal position on the anterior abdominal wall and were connected to the heart and great vessels with cannulas crossing the chest wall (Fig. 1). Surgical implantation procedures have been previously published, ⁹ and clinical experiences with the Thoratec VAD system are well described in the literature. ^2-5,10

View larger version (42K): [in this window] [in a new window]   Fig. 1. Schematic diagram showing Thoratec LVAD (A) and biventricular devices (LVAD and RVAD) (B). The LVAD is shown connected from the apex of the left ventricle and returning blood flow to the aorta (Ao). In some patients, left atrial cannulation is used instead of apical cannulation. The RVAD is connected from the right atrium (RA) returning blood flow to the pulmonary artery (PA).

Patients were divided into three groups: group 1 (LVAD), patients who received isolated LVAD support, were supported adequately in this mode, and did not require the addition of an RVAD; group 2 (BiVAD converted from LVAD), patients who initially received an LVAD but subsequently had profound right heart failure refractory to pharmacologic therapy and required the additional use of an RVAD; and group 3 (BiVAD initially), patients in whom biventricular devices (both LVADs and RVADs) were implanted from the beginning.

Patient demographic information and clinical status were determined before VAD implantation. Blood chemistry values for creatinine, blood urea nitrogen, aspartate aminotransaminase, and total bilirubin levels were measured before the operation and throughout VAD support. Patient survival was determined at two stages: pretransplantation survival (the percentage of those receiving a VAD who survived to receive a heart transplant) and posttransplantation survival (through hospital discharge).

Studies in the United States were conducted under investigational-device-exemption (IDE) regulations, with protocol and patient consent forms approved by the institutional review boards and by the U.S. Food and Drug Administration. Informed consent was obtained from either the patient or next of kin.

Statistical methods
Comparisons were made first between the two BiVAD groups (groups 2 and 3), and if no significant differences were found, these two groups were combined. Differences between two groups of patients for continuous variables were assessed with a t test. Univariate tests of association were performed with Fisher's exact test for 2 x 2 comparisons or with a ² test for 2 x k comparisons. A p value of less than 0.05 was considered significant for all evaluations. All statistical analyses were performed with the use of the Crunch (Version 4; Oakland, Calif.) statistical data package on a personal computer.

Results

Distribution of VADs
The distribution of patients in the three groups is illustrated in Table I.

Of the 213 total patients analyzed, 111 patients (52%) were initially supported with isolated LVADs, and 102 patients (48%) were initially supported with LVADs and RVADs. Of the 111 patients initially receiving LVADs, a total of 37 (33%) had profound right heart failure after LVAD support was initiated, requiring additional support with an RVAD. Thus these 111 patients were divided into two groups: group 1 (LVAD) consists of the 74 patients having only LVADs and group 2 (BiVAD converted from LVAD) consists of the 37 patients requiring RVADs in addition to the LVAD. In the 37 patients in group 2, the RVAD was added in 13 patients after failure to wean from cardiopulmonary bypass with an isolated LVAD because of concomitant right ventricular (RV) failure, 18 were converted to BiVAD after termination of bypass demonstrated profound RV failure severe enough to warrant initiation of RV support, and in six patients the RVAD was added during a reoperation 4 to 19 hours after the initial procedure to implant the LVAD. Of the 102 patients in group 3 (initial BiVAD), biventricular devices were used in 30 patients requiring emergency VAD implantation (cardiopulmonary resuscitation in progress or peripheral cardiopulmonary bypass required to stabilize the patient for transfer to the operating room for VAD implantation); BiVADs were also used in 38 patients because of potential lethal arrhythmias and in 34 patients because of a preoperative clinical decision on biventricular failure.

Factors during VAD support
Comparisons of the LVAD and BiVAD groups during VAD support are shown in Table III. Bleeding and renal failure were more frequent complications in patients receiving biventricular support, as indicated by the greater percentage of patients requiring renal dialysis and reoperations to control bleeding. However, creatinine, total bilirubin, and aspartate aminotransferase levels (Fig. 2) improved significantly during the first 2 to 3 weeks, especially for patients with biventricular support. The LV apex was the favored cannulation site for inflow from the heart to the LVAD in all groups of patients. There was no difference in LVAD blood flow index in patients with univentricular or biventricular support, when comparing patients with left heart cannulation from either the LV apex or left atrium. The average duration of VAD support was 41 days (longest was 247 days) for the LVAD group compared with 22 days (longest was 236 days) for the BiVAD groups.

View larger version (49K): [in this window] [in a new window]   Fig. 2. Preoperative creatinine (A) and total bilirubin (B) levels were greater in patients receiving BiVAD support than in those receiving LVAD support, but differences in aspartate aminotransaminase (AST) (C) did not reach significance. All values improved over several weeks of VAD support, and there was no difference between patients in the LVAD and BiVAD groups by 30 days. Values shown are mean ± standard error of the mean.

Discussion

The principal results from this study indicate that patients receiving univentricular and biventricular VADs as a bridge to cardiac transplantation are from different but overlapping patient populations. Although all patients were in imminent risk of dying before VAD support, patients who received isolated LVADs were less severely ill in the preoperative period and consequently had a lower mortality rate after the operation. As the severity of illness increased, patients were more likely to require biventricular support. The results of this study are consistent with the belief that the earlier the implantation, before significant major organ dysfunction, the more likely that univentricular support will be all that is required, and the greater the likelihood of survival through transplantation.

In addition to more severe preoperative cardiac dysfunction, patients who received biventricular support had more severe pre-VAD renal, hepatic, and respiratory failure than did patients receiving an LVAD. Consistent with this preoperative clinical state, these patients had more frequent renal failure and bleeding complications during VAD support. With the restoration of systemic blood flow, recovery of renal and hepatic function appeared to take 2 to 4 weeks of VAD support in most patients, which is consistent with our previous report. ⁴ Although pre-VAD creatinine and total bilirubin levels were significantly greater in patients receiving biventricular support, by the third week of support the levels in these patients were not significantly different from those in patients having an LVAD.

One interesting finding is that hemodynamic measurements were not of much value in separating patients who required univentricular versus biventricular support. Pre-VAD cardiac indexes and pulmonary capillary wedge pressures were significantly lower in patients requiring BiVAD support, which is consistent with a greater severity of right heart failure, as is the nonsignificant increase in central venous pressure. However, the differences between group averages in these factors were only about 10%.

Once patients met the bridge-to-transplantation entry criteria in this study, investigators were free to choose univentricular or biventricular support. The results clearly reflect a wide range in severity of disease in patients studied and different philosophies of different surgical groups over a 10-year experience with this device. Many groups prefer to try to use isolated LVADs if possible and to add an RVAD only when required. This is a reasonable approach, because the extent of RV dysfunction sometimes becomes apparent only when the LVAD unmasks RV failure by attempting to increase venous return to the right ventricle. However, because of the lack of reliable predictive risk factors and of the severe consequences if RV failure was present during isolated LVAD support, other groups use biventricular support in a large majority of patients. This approach simplifies medical management of RV failure, pulmonary hypertension, or arrhythmias and obviates the need to implant an RVAD at a later time.

Group 3 (the initial BiVAD group) represents the latter approach and probably contains patients who could have been successfully supported if only isolated LVADs had been used. However, there would be no a priori knowledge of which particular patients those would be. In group 2 (converted BiVAD group), all patients (n = 37) had a demonstrated need for the addition of RVAD support, which represents 33% of those patients in whom isolated LVAD support was originally thought to be sufficient. No doubt, as improved selection criteria are developed, and as VADs are implanted earlier, it will become easier to predict which patients will require univentricular or biventricular support.

The results from this study are in agreement with those of Kormos and associates, ⁸ who also concluded that the need for biventricular support is more dependent on the patient's clinical status than on hemodynamic parameters. There were no differences in preimplantation hemodynamics in the Kormos study between patients who exhibited RV failure during LV assist. Patients with biventricular failure during LV assist had significantly lower preoperative mixed venous oxygen saturation, a greater level of inotropic need, impaired mental status, and a lower ratio of RV ejection fraction to inotropic need.

Other factors that have been proposed as to when biventricular support might be strongly indicated include biventricular infarction, ¹¹ potentially lethal arrhythmias, ¹² low (<15%) RV ejection fraction and large RV volumes, ¹³ elevated fixed pulmonary vascular resistance, and liver dysfunction. RV free wall ischemia, ¹⁴ septal ischemia, ¹⁵ and global cardiac ischemia ¹⁶ have also been proposed to be factors in RV failure when it is seen during LVAD support. Intraoperative bleeding and greater transfusion requirements of blood and blood products may also play a role in increasing pulmonary vascular resistance and in the development of right heart failure, possibly requiring RVAD use. In this study postoperative bleeding requiring a reoperation was more prevalent in patients with biventricular devices, but it is not known how much this is related to the patient's preoperative status or to the procedure itself.

In general, the criteria for predicting which patients will require biventricular support are not well established. Clinical experience suggests that the earlier the implant, the better the chances of succeeding with isolated LVAD support, which is consistent with the finding that the need for biventricular support increases with severity of illness. Also, as new therapies become available, such as inhaled nitric oxide for pulmonary vasodilation, ^17,18 medical management of RV dysfunction may be improved but would have to be weighed against the known hemodynamic stability that can be achieved with biventricular support.

The basic pathophysiologic principles of the interaction between the right and left ventricles as it pertains to RV function during LVAD support are reasonably well understood. ¹⁹ Because of the close anatomic coupling between the right and left sides of the heart, the volume and pressure of one ventricle can affect the other ventricle, ^20-26 and an LVAD can have some effects on both hemodynamic interactions (e.g., increased RV venous return, reduced pulmonary pressures) and anatomic mechanical interactions (e.g., leftward septal shift during LV unloading). Depending on pathophysiologic conditions, these effects can be either detrimental or beneficial to the determinants of RV function. ^27,28 In normal animal models these effects tend to balance during left heart support, resulting in no overall change in RV performance. However, in human patients with LVADs as a bridge to cardiac transplantation, the dominant effect is beneficial: a reduction in RV afterload and an improvement in RV function owing to relief from passive pulmonary hypertension during LVAD support. ^7,8,19,29,30 Therefore anatomic interactions between the ventricles appear to play a minor role in determining overall RV function during LVAD support compared with effects of preexisting or acquired pathologic conditions.

In conclusion, the results of this study indicate that patients are more likely to require biventricular support as the severity of illness increases. The earlier the implant the more likely the patient can be supported with a isolated LVAD and the greater the likelihood of survival through transplantation. However, both groups of patients can be successfully supported, with posttransplantation survival comparable with that of conventional transplantation.

Acknowledgments

We gratefully acknowledge the contributions of the principle investigators and support staff from all 35 hospitals that performed implants with the Thoratec VAD and collected the data used in this article.

Footnotes

From the California Pacific Medical Center, San Francisco, Calif.;^a St. Louis University, St. Louis, Mo.;^b University of Alabama Medical Center, Birmingham, Ala.;^c University of Pittsburgh, Pittsburgh, Pa.;^d Alfred Hospital, Melbourne, Australia;^e Jewish Hospital, Louisville, Ky.;^f St. Lukes Hospital, Milwaukee, Wis.;^g Methodist Hospital, Memphis, Tenn.;^h San Antonio Regional Hospital, San Antonio, Tex.;ⁱ Ottawa Heart Center, Ottawa, Canada;^j Buffalo General Hospital, Buffalo, N.Y.;^k Thoratec Laboratories, Berkeley, Calif.;^l (Present affiliation: Bowman Gray School of Medicine, Winston-Salem, N.C.).^m

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This Article Abstract 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 Author home page(s): Lawrence R. McBride William L. Holman Robert L. Kormos Donald Esmore Laman A. Gray, Jr. Paul E. Seifert G. Phillip Schoettle Charles H. Moore Paul J. Hendry Joginder N. Bhayana Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Farrar, D. J. Articles by Bhayana, J. N. Search for Related Content PubMed PubMed Citation Articles by Farrar, D. J. Articles by Bhayana, J. N.