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Ann Thorac Surg 1997;64:1296-1301
© 1997 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Decision-Making in End-Stage Coronary Artery Disease: Revascularization or Heart Transplantation?

Department of Thoracic and Cardiovascular Surgery, German Heart Institute Berlin, Berlin, Germany

Accepted for publication May 1, 1997.

	Abstract

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Background. Left ventricular function is the most important predictor of survival in patients with coronary artery disease. It is also an important indicator for hospital and late mortality after operation for endstage coronary artery disease.

Methods. Between April 1986 and December 1994, 514 patients with end-stage coronary artery disease and left ventricular ejection fraction between 0.10 and 0.30 underwent coronary artery bypass grafting at the German Heart Institute Berlin. Two hundred twenty-five of these patients had been referred as possible candidates for heart transplantation. The prime criterion for bypass grafting was ischemia diagnosed by myocardial scintigraphy and echocardiography ("hibernating myocardium").

Results. Operative mortality for the group was 7.1%. The actuarial survival rate was 90.8% after 2 years, 87.6% after 4, and 78.9% after 6. Left heart catheterizations performed 1 year after the operation showed that left ventricular ejection fraction had increased from a mean of 0.24 ± 0.03 preoperatively to 0.39 ± 0.06 postoperatively (p < 0.0001). Preoperatively 91.6% of the patients were in New York Heart Association (NYHA) class III or IV; 6 months postoperatively 90.2% of the surviving patients were in NYHA class I or II. Two hundred thirty-one patients with end-stage coronary artery disease and predominant heart failure underwent heart transplantation. Their actuarial survival rate was 74.9% after 2 years, 73.2% after 4, and 68.9% after 6. All of the patients could be recategorized into NYHA class I or II after the operation.

Conclusions. We conclude that coronary artery bypass grafting and heart transplantation can be used successfully to improve the life expectancy of patients with end-stage coronary artery disease. Coronary artery bypass grafting leads to an excellent prognosis for these high-risk patients when the myocardium is preoperatively identified as being viable.

	Introduction

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
see also page 1302.

Improvements in the anesthetic and surgical management of patients with left ventricular dysfunction have resulted in a steady decline in perioperative mortality and morbidity, thus permitting these patients to undergo coronary artery bypass grafting (CABG) with acceptable risk [1, 2]. Nevertheless, performing CABG on patients whose left ventricular ejection fraction (LVEF) is 0.30 or less remains a surgical challenge. The border between the decision for CABG or heart transplantation is not well defined [3]. One reason for this continuing controversy is the small number of patient groups that have been investigated. Many facilities measure only LVEF and left ventricular end-diastolic pressure (LVEDP) when assessing left ventricular dysfunction in patients with coronary artery disease (CAD). The experience of the authors of this study indicates that dysfunction of the left ventricle is best described through a combination of hemodynamic parameters, the duration of ventricular dysfunction, an analysis of ventricular segmental wall motions, and myocardial viability measurements. By monitoring a representative number of patients, this study sought to determine the influence of preoperative clinical characteristics, such as the duration of heart insufficiency, incidence of acute and chronic left and right ventricular failure, and myocardial ischemia, as well as hemodynamic features, on operative mortality after CABG in patients with highly impaired left ventricular function with the ultimate goal of identifying differential indications for CABG or heart transplantation (HTx) in patients with end-stage CAD. The identification of reasonable criterions for the decision between CABG or HTx was the aim of this study.

	Material and Methods

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
In a prospective study from April 1986 until December 1994, 514 patients with CAD and LVEF between 0.10 and 0.30 were examined and prepared for CABG. Patients with an aneurysm of the left ventricle, valvular heart disease, ventricular septal defect after myocardial infarction, or cardiomyopathy were not included in this group. Two hundred twenty-five of the patients were referred to the German Heart Institute Berlin as possible HTx candidates. The most important criteria for bypass grafting were ischemia documented by myocardial scintigraphy (all studied patients received thallium scintigraphy preoperatively), hibernating myocardium diagnosed by dobutamine stress echocardiography [4], a positive electrocardiogram, and predominant angina pectoris. Stress echocardiography was performed on 32 patients in 1994. All patients were treated at the German Heart Institute Berlin.

The mean age of the 225 patients who were primary referred as possible transplant candidates yet underwent CABG was 54.6 ± 4.7 years (range, 33 to 59 years). One hundred eighty-eight patients were men and 37 were women. The mean number of preoperative myocardial infarctions was 1.7 ± 0.4 (range, 1 to 4). The mean waiting time between angiography and operation was 2.4 ± 0.8 months. All but 2 patients had three-vessel disease. The coronary score, calculated according to a modification of Gensini's score [5], was a mean of 37.4 ± 4.3 points (maximum value, 55 points). The score is based on counting the highest and most proximal stenosis in each of the three coronary vessels. Nineteen of 225 patients (8.4%) were in New York Heart Association (NYHA) class II, 148 of 225 (65.8%) in class III, and 58 of 225 (25.8%) in class IV. Left ventricular ejection fraction was measured in all patients with a Siemens-Elema (Solna, Sweden) AVD (angiographic ventricular dynamics) computer system and found to have a mean of 0.23 ± 0.04 (range, 0.10 to 0.30) according to Simpson's rule [6]. Pulmonary wedge pressure was measured preoperatively with a Swan-Ganz catheter and found to have a mean of 21.3 ± 6.9 mm Hg (Table 1). The average duration of left heart failure preoperatively was 4.8 ± 2.7 months (range, 0 to 14 months). Right heart failure was only observed in 3 of 225 patients. Although 6 of 225 patients (2.7%) had previously undergone open heart operations, none of them had undergone such a procedure more than once.

All of the patients received aortocoronary venous grafts (mean, 2.9 ± 0.4). Anastomosis of the left mammary artery at the left anterior descending coronary artery (LAD) or the first diagonal branch (D1) was additionally conducted in 116 of 225 (51.6%) of the patients. The indication for using the mammary artery was given by the surgeon and related to the degree of calcification or vessel occlusion of the anterior wall coronary arteries (left anterior descending artery, first diagonal branch).

Antegrade cold crystalloid (Eppendorf) cardioplegia was used in all cases. After the first distal anastomosis was performed, cardioplegia was continually administered through the graft until the aortic cross-clamp was opened. Forty-six patients of 225 (20.4%) who intraoperatively began to develop low cardiac output syndrome were implanted with a Datascope system 90/93 (Datascope Corp, Montvale, NY) intraaortic balloon pump. In 7 patients of 225 (3.1%) a biventricular assist device (Berlin Heart) was implanted as a bridge to HTx during the intraoperative or early postoperative period [7].

Operative mortality (OPM) was defined as survival beyond 30 days after the operation. Selected preoperative criteria were analyzed to determine operative risk and to estimate intermediate survival. Their influence on OPM was investigated retrospectively. All results are reported as mean ± standard deviation. Student's t test was used to analyze the data with a comparison between discontinuous variables assessed by using the Wilcoxon test and Fisher's exact test. Patient characteristics were screened using ² statistics. A p value of less than or equal to 0.05 was considered significant [8].

The mean duration of follow-up was 36.5 months. Follow-up studies were performed by three of the cardiologists who had referred their patients to us for operation. Two performed Swan-Ganz catheterization on 74 patients 6 months postoperatively; left heart catheterization was conducted by one cardiologist on his 50 patients in the bypass group 1 year after surgery. Late survival was calculated according to Kaplan-Meier's survival curves and statistical significance was calculated by the log rank test [9]. All patients were reassessed according to the NYHA classification system.

During the same time period 788 patients underwent orthotopic HTx. Two hundred thirty-one had end-stage CAD. The mean age of this group was 50.5 ± 5.6 years. Left ventricular ejection fraction was found to be an average of 0.21 ± 0.06. The coronary score was significantly higher (mean, 43.2 ± 3.3) in these patients than in the bypass group. Eighty-five of 231 (36.8%) of the patients had previously undergone open heart operations. The mean pulmonary wedge pressure was 29.0 ± 5.4 mm Hg. Forty patients of 231 (21.7%) also had right ventricular failure. On average the duration between left heart failure and transplantation was 13.7 ± 4.1 months. All patients were on diuretic therapy preoperatively. Eighty-nine of 231 (39.6%) were administered catecholamines preoperatively. Only 9 of 231 patients had previously exhibited angina pectoris symptoms. These patients had undergone several unsuccessful attempts at CABG (maximum four). All of the patients underwent left and right catheterization postoperatively.

Immunosuppression consisted of the standard combination of cyclosporine, azathioprine, and methylprednisolone [10].

	Results

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Operative mortality was 7.1% (16 of 225) in the CABG group. One patient died of septicemia and multiple organ failure. Fifteen patients died of early postoperative low cardiac output syndrome. Intraaortic balloon pumps were implanted in 46 of 225 patients (20.4%) to aid weaning from heart-lung bypass; 29 (63.0%) of these 46 were successfully explanted preoperatively. In 2 patients the intraaortic balloon pump had to be implanted through the ascending aorta because of peripheral arteriosclerosis, otherwise it was implanted through a transfemoral access. In 7 patients a biventricular assist device (Berlin Heart) was implanted either intraoperatively or postoperatively as a bridge to HTx; 5 of these subsequently underwent transplantation. The mean duration of circulatory support was 31 ± 16 days. Two patients died of septicemia while on the assist device. Four of 225 patients suffered from an acute infarction before undergoing CABG. One of them died intraoperatively because of low output syndrome. Thirty-two of 225 patients had unstable angina before undergoing operation; 5 of these died early. Altogether, 6 of these high-risk patients (n = 36) died early (OPM, 16.7%). Angina was either not present or was stable in 189 of 225 patients (84.0%); 10 of these patients (OPM, 5.3%) died early.

Operative mortality increased significantly in patients with a history of multiple myocardial infarctions (more than two infarctions 11.3% [6 of 53], compared with 5.8% [10 of 172] in patients with one or two infarctions preoperatively, p < 0.05) or a cardiac index of less than 2.0 L • min^-1 • m^2-1 (OPM, 14.3%). Patients with increased left ventricular end-diastolic pressure (more than 24 mm Hg) had a higher operative risk than those whose left ventricular end-diastolic pressure was less than 24 mm Hg (OPM, 11.4% versus 5.2%, p < 0.01). Patients with an LVEF between 0.10 and 0.20 had an OPM of 7.5% (7 of 93) compared with 6.8% (9 of 132) in patients with an LVEF between 0.21 and 0.30. Patients with LVEF of 0.10 to 0.15 had an OPM of 8.3%, OPM was 7.4% in patients with LVEF of 0.16 to 0.20, 7.1% in patients with LVEF of 0.21 to 0.25, and in those with LVEF of 0.26 to 0.30, OPM was 6.3%. These differences were not statistically significant (p > 0.05). Operative risk was independent of the number of grafts applied. Operative mortality was 5.2% in patients who received an anastomosis of the left internal mammary artery compared with 7.8% in those who had venous grafts only (p < 0.05). Operative mortality was 5.3% for patients who were preoperatively in NYHA classes II and III and 16.7% for those in class IV (Table 2).

In 1988, 84 left ventricular segments of 12 patients in the CABG group were analyzed with the AVD system for wall motion and with thallium-201 imaging [11] for myocardial viability. Myocardial scintigraphy was positive in 33 segments (39.3%) preoperatively. One year after coronary revascularization wall motion had increased significantly in 58 (69.0%) segments.

Two hundred nine of 225 patients could be followed up after the perioperative period of 30 days in the bypass group. Sixteen of 209 patients were lost to follow-up. Causes of death included cancer (1 patient) and cardiac failure (15 patients). The actuarial survival rate in the CABG group was 78.9% after 6 years (Fig 1). Most of the patients were reclassified postoperatively into a lower class according to the NYHA classification system (Fig 2). Only 6 patients had mild angina (Canadian Cardiovascular Society classification class II). Swan-Ganz catheterization was performed on 74 patients 6 months after surgery. The pulmonary capillary pressure had decreased from a preoperative mean of 19.2 ± 4.3 mm Hg to a postoperative mean of 13.1 ± 2.7 mm Hg (p < 0.01). Mean pulmonary artery pressure had decreased from 28.2 ± 4.7 mm Hg to 21.2 ± 3.9 mm Hg (p < 0.01). Left heart catheterization was conducted on 50 patients 1 year postoperatively. The graft patency rate was 88.0%. Left ventricular ejection fraction had increased from a mean of 0.24 ± 0.03 to 0.39 ± 0.06 (p < 0.001).

View larger version (16K): [in this window] [in a new window]   Fig 1. . Actuarial survival curves for patients (pts.) after coronary artery bypass grafting (CABG) and heart transplantation (HTx) in end-stage coronary artery disease (CAD)

View larger version (20K): [in this window] [in a new window]   Fig 2. . Preoperative (preop) and postoperative (postop) New York Heart Association (NYHA) classification in patients (pts.) with end-stage coronary artery disease who received coronary artery bypass grafting (CABG) and heart transplantation (HTx)

	Comment

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Clinical characteristics and angiographic features associated with increased OPM after CABG on patients with normal or mildly reduced ventricular function were first described in the medical literature more than a decade ago [12, 13]. At that time LVEF was considered the most important predictor of survival after CABG. In recent years parallel improvements in surgical procedures and medical management in intensive and outpatient care have lead to increased success in performing CABG on patients who have impaired left ventricular function. Alderman and coworkers [14] reported a 5-year survival rate of 41% for patients with endstage CAD who were treated medically. The corresponding 5-year survival rate of the surgical control group was 62%. Coronary artery bypass grafting is the conventional therapy of choice for patients whose LVEF is less than 0.30 [15–17]. The OPM in the present study was 7.1% in the CABG group. In contrast to earlier results [14] OPM was not dependent on LVEF in our study. We trace this finding back to a precise identification of viable myocardium preoperatively and the completeness of our bypass operations. After analyzing the data it appeared that OPM correlated less with LVEF than with the number of preexisting myocardial infarctions, the degree of heart insufficiency (NYHA IV), and preoperative hemodynamic parameters such as left ventricular end-diastolic pressure and cardiac index.

This study did not aim to simply draw conclusions from the results of operation in individuals with low ejection fraction, a subject that already has been well reported by many others [18, 19]; rather it was to subdivide patients with low ejection fraction into specific groups with different characteristics to reveal important inter-group differences that might aid in deciding between CABG and HTx. The current climate in the medical community, which includes ever-increasing scrutiny of OPM, outcome analysis, and surgical statistics in general, may have caused many surgeons, consciously or not, to decrease their level of risk-taking in planning treatment strategies. These factors, coupled with the option of cardiac transplantation, with its excellent short- and intermediate-term results, may have encouraged over-reliance on transplantation [20]. On the other hand, several factors are currently challenging HTx. The recipient population is growing as a result of increased acceptance of the efficacy of HTx by the public and medical professionals alike. Additionally, refinement of the transplant procedure and of postoperative care has expanded to recipient criteria, which in turn has dramatically increased the number of eligible recipients. Unfortunately, despite all efforts by medical professionals and organ procurement organizations to increase consent rates, the number of donor hearts remains limited [21]. Moreover, the progress, development, and approval of mechanical assist devices increases the number of patients who are on the waiting list for HTx [10].

All these factors lead to a dilemma for potential transplant recipients and their physicians: as the waiting time increases, the mortality of those on the waiting list increases as well. There are a number of strategies for managing the growing recipient population. Expansion of the number of potential cardiac donors by broadening acceptance criteria is one option [22]. Surgical alternatives to transplantation, such as cardiomyoplasty in the formation of skeletal muscle ventricles, continue to be developed and tested through clinical trials. Implantation of ventricular assist devices becomes more frequent and physicians more experienced with this procedure [23]. And finally, high-risk operations are being reconsidered in the proposed transplant patient population [15, 20, 21, 24].

Based on the findings of the current study, we would normally perform conventional revascularization on patients with an LVEF less than or equal to 0.30 when myocardial ischemia can be demonstrated either from the symptomatic aspect or with myocardial scintigraphy, with echocardiography using the stress technique [4], or with the most reliable of the established techniques, positron emission tomography [19, 25]. The disadvantages of positron emission tomography are its high cost, nonportability, and need of an on-site cyclotron to produce 18FDG [4]. Cheirif and associates [4] found that dobutamine echocardiography provided excellent results as an alternative to positron emission tomography. Naturally, echocardiography, especially used to identify hibernating myocardium, is more dependent on the experience of the investigator than positron emission tomographic scanning is. Nevertheless, in our experience an area (or two or more together) of 20% or of the total heart muscle mass defined as viable exhibits promising results after CABG. All 20 patients who had stress echocardiography before receiving CABG and in whom viable myocardium was diagnosed in the area of interest (akinetic or severely hypokinetic segments), survived the operation and could be discharged from the hospital. Left ventricular shortening fraction of these segments increased significantly after a mean time of 4.5 months. Based on these results we postulate that stress echocardiography is able to identify viable myocardium in these patients. Escobar and associates [26] described pulmonary wedge pressure as the most predictive parameter for selecting patients with endstage CAD for HTx at the highest priority. The findings in this report demonstrate that CABG leads to a good prognosis and significant hemodynamic improvement in patients with a short duration of ventricular dysfunction, left ventricular end-diastolic pressure not elevated above 24 mm Hg at rest, and a cardiac index more than 2.0 L • min^-1 • m^-2. Consequently HTx is considered when no ischemia is evident, ventricular filling pressures have drastically increased (more than 24 mm Hg), ventricular end-diastolic diameter has widened markedly, and coronary arteries are not graftable after multiple unsuccessful revascularization attempts. Heart transplantation is also considered more appropriate for patients undergoing high-dose diuretic therapy who also exhibit both right and left ventricular failure and have a long history of heart insufficiency (Table 3). In our hands a patient with three-vessel CAD, LVEF between 0.10 and 0.30, a short history of left heart failure (<6 months), moderate end-diastolic left ventricular filling pressure (<25 mm Hg), and no angina pectoris, but with viable myocardium diagnosed by stress echocardiography, is a good candidate for CABG. Left ventricular ejection fraction was not predictive for operative risk in our study. We are convinced that a patient with an ejection fraction of 0.10 to 0.20 and a huge hibernating area in the left ventricle will have a better prognosis for CABG than a patient with an ejection fraction of 0.20 to 0.30 who has only small areas of still viable myocardium in the left ventricle but extended fibrosis. For this reason we decided to draw the line of our study at LVEF of 0.30 and not at 0.20 as other investigators did before.

With these guidelines in place, patients with end-stage CAD represent 29.3% of the transplant recipients at the German Heart Institute Berlin. In comparison the 1994 registry of the International Society of Heart and Lung Transplantation showed that 47.2% of the patients who underwent HTx had end-stage CAD [27, 28]. Finally, it has to be commented that drawing a definitive line between HTx and CABG is not possible in all NYHA class IV patients with severely depressed ventricular function. It has to be emphasized that the decision in these cases should be mainly substantiated by the subjective impression of the individual aspect the surgeon has of the patient.

	Acknowledgments

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
We thank Jonathan Davis for proofreading the manuscript.

	Footnotes

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 
Address reprint requests to Dr Hausmann, German Heart Institute Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.

	References

Top Footnotes Abstract Introduction Material and Methods Results Comment Acknowledgments References

 

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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): Harald Hausmann Roland Hetzer Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Hausmann, H. Articles by Hetzer, R. Search for Related Content PubMed PubMed Citation Articles by Hausmann, H. Articles by Hetzer, R. Related Collections Related Article