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European Journal of Heart Failure 2002 4(2):207-214; doi:10.1016/S1388-9842(01)00225-2
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© 2002 European Society of Cardiology

Therapeutic options and heart failure survival score predictability in an academic heart failure center: an analysis of 120 consecutive patients during a 1-year period

Rainer Gradausa,*, Sebastian Kerbera, Dirk Böckera, Hans H. Scheldb, Günter Breithardta and Mario C. Dengb,c

a Universitätsklinikum Münster, Medizinische Klinik und Poliklinik Innere Medizin C (Kardiologie und Angiologie), D-48129 Münster, Germany
b University Hospital Münster, Department of Cardiothoracic Surgery Münster, Germany
c Columbia University New York, USA

* Corresponding author. Tel.: +49-251-834-7617; fax: +49-251-834-7864. E-mail address: gradaus{at}uni-muenster.de


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Background: the incidence and prevalence of patients with advanced heart failure is increasing worldwide and the number of cardiac transplantations remains limited.

Aims: it was the aim of the study to describe our experience with the increasing number of available medical, interventional and cardiac surgery options, and to assess heart failure survival score predictability in an academic heart failure center within a 1-year follow-up.

Methods and Results: in all patients who were referred for cardiac transplant evaluation within a 12-month period between April 1998 and March 1999 at our Interdisciplinary Heart Failure and Transplant Program, our team assessed all medical interventions as well as interventional and surgical treatment options that were available, based on the clinical profile on initial presentation. In 92% of the 120 patients referred for cardiac transplantation evaluation, drug therapy could be optimized. A considerable number of patients could be subjected to an organ-preserving intervention or surgery, either PTCA (n = 11), CABG (n = 4), valve repair (n = 7), multisite pacing (n = 7), or partial ventricular resection (n = 5). Only a small group of patients with the worst heart failure survival score were listed for heart transplantation (n = 17) or received a ventricular assist device (n = 3).

Conclusions: within a contemporary cohort of advanced heart failure patients, only a small number of patients will undergo cardiac transplantation, which is predictable by the heart failure survival score. Most patients will undergo optimized medical therapy and a considerable number will be subjected to interventional or surgical treatment options.

Key Words: Heart failure • Shortage of donor organs • Treatment options

Received December 18, 2000; Revised March 5, 2001; Accepted May 9, 2001


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Since cardiac transplantation has assumed an accepted role in the management of end stage heart failure and an increasing number of patients are referred for transplant evaluation, specialized heart failure centers have evolved [1]. It has been estimated that 1–2% of the population is in heart failure (800 000 persons in Germany), with an estimated 10% suffering from advanced heart failure (roughly 80 000 persons in Germany) [2,3]. Assuming a number of 40 specialized heart failure centers in Germany with an average referral basis of 2 million inhabitants per center, each of these centers would have to take care of roughly 2000 of these advanced heart failure patients. Assuming that 5% of these patients annually would be suitable candidates for cardiac transplantation (roughly 100 persons a year per center) and that the total number of hearts available for cardiac transplantation in Germany is 600–800, this would yield 15–20 cardiac transplants a year per specialized heart failure center. Thus, only 20% of suitable candidates would have a chance of receiving a heart transplant. From these calculations, the need for these regional heart failure centers to offer a full range of medical, interventional and conventional surgical therapy as well as heart replacement is evident. With this background, patients referred for cardiac transplant evaluation should receive optimized medical therapy based on current medical treatment guidelines of heart failure and should be offered an individually tailored management plan, including medical as well as interventional, conventional surgical options and cardiac replacement [4,5].

The specific aim of this study was to assess the use of the current treatment options and the heart failure survival score by Aaronson et al. [6] in analysis of the baseline characteristics of all patients who were referred to the Münster Interdisciplinary Heart Failure and Transplant Program, within a 12-month period. It was not the aim of the study to measure the effect of differential interventions in risk adjusted subgroups of the total cohort.


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusion
 References
 
2.1. Patients
All patients who were referred to our Interdisciplinary Heart Failure and Transplant Program for cardiac transplant evaluation between April 1, 1998, and March 31, 1999 were included in this study. All patients had at least one episode of cardiac decompensation prior to initial evaluation in our interdisciplinary heart failure clinic. The evaluation procedure has been described in detail elsewhere [1,7,8]. Briefly, a detailed history was obtained and physical examination was performed in the outpatient clinic. Laboratory tests, ECG, chest X-ray, echocardiography, peak oxygen uptake measurements as well as right and left heart catheterization were performed. The noninvasive heart failure survival score according to Aaronson et al. [6] was calculated, this is based on the underlying heart disease, mean resting blood pressure, resting heart rate, intraventricular conduction delay, serum sodium level, peak VO2 and left ventricular ejection fraction. Subsequently, the therapeutic decisions were based on the results of this initial evaluation and the heart failure survival score determined in an interdisciplinary consensus discussion of cardiologists, cardiac surgeons and psychologists.

2.2. Therapeutic decision process
First of all, medical optimization by increasing the drug dosages and/or adding new drugs was attempted, to stabilize and improve the heart failure symptoms in all patients. Secondly, high risk PTCA and/or CABG surgery were discussed for patients with coronary artery disease and viable ischemic areas, as well as dilatable and/or graftable vessels, independent of heart failure status. In patients with primary valve disease, a high-risk valve repair or valve replacement surgery was scheduled. In a third step, multisite pacing was considered as a new therapeutic option in patients with advanced heart failure symptoms, a widened QRS complex (QRS≥150 ms), severely reduced left ventricular function (LV-EF≤30%) and a reduced VO2 max (VO2 max≤18 ml/kg per min). These patients were included in the Path-CHF I or II trial [9]. Fourthly, left ventricular reduction surgery in combination with a valve repair was considered for patients with a severely enlarged and depressed left ventricle (LVEDD≥80 mm), mitral regurgitation grade 3, and otherwise intact mitral valve leaflets as well as an intact but enlarged mitral annulus. Finally, listing to heart transplantation was performed in patients suitable for transplantation with a high-risk stratification according to the heart failure survival score by Aaronson et al. [6] and without any further therapeutic option or contraindications. Left ventricular assist devices were implanted in suitable candidates for heart transplantation, who could not be stabilized hemodynamically by one of the other therapeutic options, whilst awaiting heart transplantation.

The patients were allocated to one of the following three groups according to the therapeutic decision process as described in detail previously [1,6,7]:

  • A=Accepted for transplantation list;
  • B=Before acceptance for heart transplantation; and
  • C=patients with Contraindications for heart transplantation.

Based on the therapeutic decision process, patients with an indication for an organ preserving intervention or surgery were attempted to be stabilized by one of these therapeutic options. These patients were allocated to group B, dividing group B into two subgroups:

  • B1=Before acceptance for heart transplantation in patients considered to have an indication for an organ preserving intervention or surgery; and
  • B2=Before acceptance for heart transplantation in patients having no indication for an organ preserving intervention or surgery and considered too stable for transplant at listing.

The NYHA class, ACE-inhibitor dosage and β-blocker medication at last follow-up was compared with the NYHA class, ACE-inhibitor dosage, and β-blocker medication at initial evaluation. The survival status of all patients was determined at the end of follow-up in March 2000.

2.3. Statistics
All data are presented as mean±S.D. Qualitative characteristics were compared using the Pearson's Chi square test. Quantitative parameters were tested using the t-test for paired as well as unpaired data. The Kaplan–Meier survival curves were calculated and differences between the curves were analyzed with the log-rank test. A value of P<0.05 was considered significant.


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusion
 References
 
3.1. Patient characteristics
The clinical profiles at initial evaluation of all patients and the patients of group A (accepted for transplantation, n=17), group B (before acceptance for transplantation, n=96) including the subgroup B1 (indication for an organ preserving intervention or surgery, n=27) and subgroup B2 (considered too stable, n=69), as well as group C (contraindications, n=7) are summarized in Table 1. Contraindications were co-morbidity in four patients (4xlow renal function, 3xchronic obstructive lung disease, 2xmetabolic syndrome, 1xhigh pulmonary vascular resistance, 1xsevere general arteriosclerosis), age, stroke and non-compliance, each in one patient. The heart failure survival score could only be calculated in 53% of patients, mostly due to the fact that peak VO2 measurements were not performed. The peak oxygen uptake was most frequently not performed in patients who were readily stabilized by optimization of medical drug therapy and who became too good for transplantation (group B), in addition some patients with heart failure symptoms at rest were not able to perform a peak VO2 test (groups A and C).


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  		Table 1 Patients characteristics in all patients, in patients of group A (accepted for transplantation), group B (before acceptance for transplantation) including the subgroup B1 (indication for an organ preserving intervention or surgery) and subgroup B2 (considered too stable), as well as group C (contraindications)

 
Patients in group A could be distinguished from those in group B by a variety of functional parameters and the heart failure survival score according to Aaronson et al. [6], as depicted in Table 1. The corresponding mean heart failure survival score for patients accepted for heart transplantation was 7.6±0.7, considering a median risk and an indication for heart transplantation. Patients before acceptance for transplantation had a mean heart failure survival score of 8.9±1.0, implying a low risk. Within the subgroups B1 and B2, patients having an indication for an organ preserving intervention or surgery could be distinguished from those of group B2 by the NYHA class, cardiac index and a worse heart failure survival score. The heart failure survival score was 8.1±1.1 in group B1, considering a median to low risk and being in the range of an indication for heart transplantation. Patients of group B2 had a low mean heart failure survival score of 9.4±0.9.

3.2. Medical drug treatment, interventions and surgery prior to evaluation
The medical treatment profile at initial evaluation is summarized in Table 2. ACE-inhibitors, digitalis and diuretics were used in approximately 80–90% of all patients, however, β-blockers were used in only 50% of patients. The mean ACE-inhibitor dose was as low as an enalapril equivalent of 13±15 mg/day in the total patient population. Additionally, the use of spironolactone was low (<15%) as the referral of patients was before publication of the RALES trial [10]. Prior to initial evaluation, PTCA had been performed in approximately 20–25%, CABG surgery in 20% and a valve repair or replacement surgery in 5–10% of all patients. In patients with contraindications, 47% of patients had a previous PTCA, 43% CABG surgery, and 14% valve repair or replacement surgery.


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  		Table 2 Medical drug treatment and interventions as well as surgeries previous to initial evaluation in all patients, in patients of group A (accepted for transplantation), group B (before acceptance for transplantation) including the subgroup B1 (indication for an organ preserving intervention or surgery) and subgroup B2 (considered too stable), as well as group C (contraindications)

 
3.3. Therapeutic decisions
The changes in heart failure management based on the therapeutic decision are summarized in Table 3. In 92% of all patients, medical drug therapy was modified. ACE-inhibitor dosage and β-blocker treatment could be significantly increased in the total patient population group and especially in the patients of group B. Additionally, a considerable number of patients underwent an organ preserving intervention or surgery as follows: PTCA (9.2%); CABG surgery (3.3%); valve repair (5.8%); multisite pacing within the Path-CHF I and II studies [9] (5.8%); and ventricular reduction surgery (4.2%); a total of 34 interventions or surgeries were performed in 28 patients. In three patients, a hybrid revascularization technique using a combination of PTCA and CABG surgery was performed. Ventricular reduction surgery was combined with a valve repair in three patients. Multisite pacing was scheduled in six more patients (5%) of the total patient population group. These six patients should be included in the Path-CHF study [9] but all of them improved by modification of medical drug therapy to NYHA class II and implantation of a multisite pacemaker was cancelled. In only one patient accepted and listed for heart transplantation was an organ preserving intervention or surgery performed to stabilize the patient. In another three patients, a left ventricular assist device was implanted. Only a small number of patients (n=17) were listed for transplantation. Seven of these patients were transplanted successfully. Two of them died during the further follow-up (28%). Six patients died on the heart transplant waiting list (35%). Four patients were still on heart transplant waiting list at follow-up end.


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  		Table 3 Changes of medical drug treatment and medical interventions/surgeries in all patients, in patients of group A (accepted for transplantation), group B (before acceptance for transplantation) including the subgroup B1 (indication for an organ preserving intervention or surgery) and subgroup B2 (considered too stable), as well as group C (contraindications)

 
3.4. Impact of functional class and survival analysis
The changes in medical management of heart failure improved the NYHA functional class as summarized in Table 4. In group A and C, a significant change in NYHA functional class could only be achieved in the patients successfully transplanted during a mean follow-up of 12.9±7.7–16.2±0.8 months. In the group before listing to heart transplantation (group B) and in both subgroups B1 and B2, a significant improvement occurred during a mean follow-up of 17.8±4.4 months. This improvement could be validated by the VO2 max, which significantly increased in group B to 17.4 ml/kg per min during follow-up.


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  		Table 4 Changes in NYHA class in all patients, in patients of group A (accepted for transplantation), group B (before acceptance for transplantation) including the subgroup B1 (indication for an organ preserving intervention or surgery) and subgroup B2 (considered too stable), as well as group C (contraindications)

 
The survival according to intention-to-treat analysis of group A, group B1 and B2, and group C is depicted in Fig. 1. The survival difference was significant according to log-rank testing comparing group A vs. group B1 (P<0.005) and group A vs. group B2 (P<0.001). The survival difference between the patients group listed for heart transplantation and the total group B was also significant according to log-rank testing (P<0.0001). This survival probability could be predicted by the heart failure survival score (P<0.001) [8].


Figure 1
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  		Fig. 1 Kaplan–Meier survival curves according to the intention-to-treat analysis of the group A, group B1, group B2 and group C.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusion
 References
 
In the context of an increasing incidence and prevalence of patients with advanced heart failure in industrialized countries, the role of cardiac transplantation is changing as a consequence of the shortage of organs and the increasing number of organ preserving interventions and surgeries for heart failure patients. Additionally, cardiac transplantation in Germany is only associated with a survival benefit in patients with a predicted high risk of dying on the waiting list [11]. Based on this scenario, a therapeutic decision was made utilizing the increasing number of medical, interventional and cardiac surgery options available for all patients who were referred to our Interdisciplinary Heart Failure and Transplant Program for cardiac transplant evaluation between April 1, 1998, and March 31, 1999 with a consecutive 12-month follow-up period. The majority of patients referred for heart transplantation evaluation could be stabilized with medical treatment, a considerable fraction of patients underwent an organ preserving intervention or surgery. Only a comparatively small number of patients with the worst heart failure survival score had to undergo transplant listing. However, the results of this analysis are limited by the low rate of determination of the heart failure survival score (53% of all patients).

4.1. Medical drug therapy
Unfortunately, the guidelines for the treatment of heart failure have not been adequately incorporated into clinical practice and many patients remain suboptimally treated, mostly receiving suboptimal doses of ACE-inhibitors, β-blockers, or diuretics [4,5,12,13]. Consequently, the pre-eminent task is to optimize medical drug therapy according to established treatment consensus guidelines, including an adequately dosed ACE inhibitor therapy [14,15], β-blocker therapy [16–18] and treatment with diuretics and aldactone [10].

In comparison with the data from the University of California, LA, we could achieve a similar improvement in the NYHA functional class and peak oxygen consumption by optimizing the medical drug treatment: Fonarow et al. [13] reported 214 patients with NYHA functional class III or IV, a left ventricular ejection fraction of 21% and a peak oxygen consumption of 11.0 ml/kg per min at initial presentation. By optimization of medical drug therapy alone, 179 of these patients improved to NYHA functional class 2.4±0.8 and a peak oxygen consumption of 15.2 ml/kg per min. The daily dosage of ACE-inhibitors could nearly be doubled in these patients as well as in our patients.

4.2. Differential interventional and surgical treatment modalities
In addition to an optimization of the medical drug therapy and adjustment of lifestyle habits, a number of potentially reversible factors, such as superimposed or persistent myocardial ischemia, valvular dysfunction, arrhythmias, and conduction diseases contribute to the severity of heart failure and have to be taken into consideration. During the last 2–5 years, a variety of interventional and/or surgical treatment modalities have emerged to improve pump function as well as arrhythmias. High-risk PTCA, CABG surgery, and hybrid revascularisation as a combination of PTCA and CABG surgery has been developed as a further therapeutic option in patients with severe ischemic cardiomyopathy, viable myocardium, and graftable vessels [19]. In patients with severe mitral regurgitation and depressed left ventricular function, mitral valve repair is a further organ preserving surgical option [20]. Postoperatively, a significant improvement of the NYHA functional class and the left ventricular ejection fraction could be demonstrated for both surgical interventions [19,20]. The therapy with implantable cardioverter-defibrillators demonstrated a mortality reduction in patients who suffered a life-threatening arrhythmic event or even in patients with a high risk for fatal arrhythmias [21,22]. Further randomized trials are ongoing to assess the beneficial effect of a primary prevention therapy with implantable cardioverter defibrillators in patients with severe congestive heart failure [23]. A significant improvement of heart failure symptoms, hemodynamic parameters, and maximal oxygen uptake could be demonstrated by biventricular pacing in patients with severe heart failure symptoms and a wide QRS complex [9]. The results of large randomized trials to assess potential survival benefit by biventricular pacing in this specific patient group are still awaited. Left ventricular reduction surgery with or without mitral valve repair is a new surgical therapeutic option in patients with severely dilated left ventricles. This surgery revealed an increase in NYHA functional class, cardiac index, stroke volume and left ventricular ejection fraction [24,25].

4.3. Left ventricular assist device therapy and heart transplantation
Left ventricular assist device therapy is another, although not organ preserving, surgical procedure. It is usually used as a bridge to transplantation. Only in a minority of patients with end-stage heart failure will a left ventricular assist device be implanted for permanent support or as bridge to recovery [26,27]. The overall survival in patients undergoing an elective implantation of a left ventricular assist device at our institution is as least as good as that in patients who were stable on the waiting list and did not undergo heart transplantation during follow-up [28]. Heart transplantation is an accepted therapeutic modality in patients with end-stage heart failure. According to the data from the sixteenth official report of the registry of the International Society for Heart and Lung Transplantation, the overall one year survival for cardiac transplantation is 79% and the patient 1/2 life (time to 50% survival) is 8.8 years [29]. However, the COCPIT study group recently showed that only patients with a predicted high risk of dying according to the heart failure survival score have a survival benefit from cardiac transplantation in Germany [11]. This result might be caused by a lack of improvement of outcomes after heart transplantation due to listing more critically ill patients and the use of so called marginal donor hearts, driven by the increasing scarcity of donors. On the other hand, scientific advances have improved medical, interventional and surgical therapeutic options in heart failure patients as described above.


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
References
 
The classical pattern of management of patients referred to a transplant center for acceptance or rejection for heart transplantation has been replaced by a more differentiated pattern of interdisciplinary evaluation and decision making heart failure management algorithm. First, the importance of optimized medical treatment should be emphasized. We think that this concept of advanced heart failure management requires the expertise of an Interdisciplinary Academic Heart Failure and Transplant Center. Close cooperation and dialogue is necessary between these Interdisciplinary Academic Heart Failure and Transplant Centers and community hospitals to deal with the increasing number of patients with severe congestive heart failure. To achieve an evidence base in advanced heart failure medicine, these different interventions have to be tested in a rigorous way to assess their comparative benefits in comparable cohorts. A step in this direction is the creation of large data bases which incorporate prognostic markers and the heart failure management, which can be used to characterize the severity of the status of heart failure and the comparable benefit of organ preserving procedures in this cohort.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 

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