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Original Articles: Cardiovascular

Cardiac Surgery in Patients on Dialysis: Decreased 30-Day Mortality, Unchanged Overall Survival

^a Department of Cardiac Surgery, University of Luebeck, Luebeck, Germany
^b Department of Cardiac Surgery, University of Hamburg, Hamburg, Germany
^c Department of Cardiac Surgery, Friedrich-Alexander University at Erlangen-Nuernberg, Erlangen, Germany
^d Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany
^e Department of Cardiac Surgery, Ruprecht-Karls University, Heidelberg, Germany
^f Department of Cardiac Surgery, Albertinen-Heart Center, Hamburg, Germany
^g Department of Cardiac and Thoracic Surgery, Otto-von-Guericke University, Magdeburg, Germany
^h Department of Cardiac Surgery, Kerckhoff-Klinik, Bad Nauheim, Germany
ⁱ Department of Cardiac Surgery, University of Rostock, Rostock, Germany

Accepted for publication August 22, 2007.

^_* Address correspondence to Dr Bechtel, Klinik fuer Herzchirurgie, Universitaetsklinikum SH, Campus Luebeck, Ratzeburger Allee 160, Luebeck, 23538, Germany (Email: m.bechtel{at}herzchirurgie-luebeck.de).

	Abstract

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 
Background: The risk of cardiac surgery in dialysis-dependent patients is high, but little is known about the determinants of survival. We initiated a retrospective multicenter study to overcome this limitation.

Methods: Nine centers provided data on 522 patients (70% male, aged 61 ± 11 years) who had chronic dialysis-dependent renal failure. A 14-year period was covered. Most patients had coronary artery bypass grafting, either with (n = 103) or without (n = 326) valve surgery. Multivariable analysis of survival was explored using Cox models.

Results: The proportion of patients with diabetes mellitus increased significantly (from 17%, 1989 to 1993, to 32%, 2000 to 2003; p = 0.021) and was independently associated with 30-day mortality (odds ratio = 3.30, p = 0.001) The mean 30-day mortality was 12% (n = 60), but declined significantly during the study period (from 28%, 1989 to 1993, to 7%, 2000 to 2003; p = 0.003). The 5-year survival probability was 42% (95% confidence interval: 36% to 47%). Patients who had renal transplantation during follow-up (n = 17) had the best survival probability (hazard ratio [HR] = 0.14, p = 0.007). Sinus rhythm (HR = 0.48, p < 0.001) and use of internal thoracic artery grafts (HR = 0.67, p = 0.006) proved beneficial for long-term survival. Predictors of death during long-term follow-up were emergency surgery (HR = 2.25, p = 0.001), diabetes mellitus (HR = 1.46, p = 0.020), number of allogenic transfusions (HR = 1.03/unit, p = 0.015), and age (HR = 1.04/year, p < 0.001).

Conclusions: In dialysis-dependent patients, cardiac surgery has become significantly safer in recent years, but the overall prognosis of the patients remains poor. The observed improvements in the perioperative survival do not necessarily translate into an improved long-term prognosis. Diabetes mellitus is an important independent risk factor for perioperative mortality and death during follow-up.

	Introduction

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End-stage renal disease (ESRD) is a frequent and growing problem in the industrialized world. In the United States, the prevalence of ESRD with dialysis dependency had risen in 2003 to 1,070 patients per million people (n = 324,826) [1]. The prevalence in Germany is lower, but also increasing (in 2004, prevalence 710 per million people, n = 55,871) [2]. Despite some advances, the prognosis of ESRD patients remains poor: the estimated 5-year survival rate after initiation of dialysis is only about 34% [1]. The most important cause of mortality in these patients is cardiac disease, which accounts for 39% to 45% of all deaths [2, 3]. The prevalence of coronary artery disease and valvular diseases is higher among dialysis-dependent patients than among the general population [4].

So far, the optimal treatment of heart disease in ESRD patients is unknown. There are no randomized controlled trials that specifically address this question. It is known that cardiac medication is used relatively infrequently for patients on dialysis [3] and that the number of coronary artery bypass grafting (CABG) and valve procedures is lower among them than among the general population, but relatively constant [1]. In contrast, the number of percutaneous coronary interventions (PCI) is increasing [1], despite evidence for better long-term outcome in ESRD patients after CABG as compared with conservative management or PCI [5–7].

This reluctance to refer dialysis-dependent patients to the cardiac surgeon may largely be due to "dialysis" having been identified as a very strong indicator of increased perioperative risk. Operative mortality is inversely related to the preoperative renal function, and perioperative mortality is highest among patients on dialysis [8, 9]. Although dialysis-dependent patients are undoubtedly at increased risk after cardiac surgery as compared with nondialysis patients [8, 9], there are not many publications that specifically deal with the prognosis of patients on dialysis who undergo cardiac surgery. Most of these studies are small (fewer than 100 patients) [10–13]. In the available large multicenter studies, only limited data on comorbidity is included or no effort was made to analyze the predictors of short- and long-term mortality [5, 6, 8, 9, 14]. Therefore, uncertainty prevails regarding risk stratification in ESRD patients who are candidates for cardiac surgery and the factors that influence prognosis after surgery. The aim of this multicenter study was to examine the risk factors for short- and long-term mortality of dialysis-dependent patients undergoing cardiac surgery. The main findings of our efforts are presented herein.

	Patients and Methods

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Nine cardiac surgical units provided data on ESRD patients. Approval for the study was obtained from the Ethics Committee at the University of Luebeck, where the study was initiated and planned. The need for informed consent of the patients for this retrospective study was waived by the Ethics Committee.

Patients
Patients were included in the study if they had had hemodialysis or peritoneal dialysis for 3 months or longer before the index cardiac surgical procedure. At each participating center, a computerized search for patients with a preoperative diagnosis of "dialysis-dependent ESRD" was performed. This was possible because a uniform database is mandatory in Germany. In addition, a manual search through all operation reports was performed.

Data Acquisition
The data sheet to be completed for each patient summarized 109 preoperative, 24 intraoperative, 46 perioperative, and 39 late postoperative variables. (The data documentation sheet is available at http://www.herzchirurgie-luebeck.de/download/Datenblatt%20Dialyse-Studie.pdf.) Definitions of all variables were standardized. Data were collected retrospectively from all available surgical and medical records. If the patient was not known to have died, he or she was contacted by telephone for a short, standardized interview. In addition, general practitioners and physicians at the dialysis centers were interviewed. Closing date for the study was October 31, 2003, the mean follow-up time was 1,040 days (2.8 years). Thirty patients were lost to follow-up (completeness of follow-up = 94.3%).

Statistical Analysis
Postoperative outcome was divided into perioperative (ie, occurring within the first 30 days after the index procedure, even after discharge) and late (ie, later than 30 days after the index procedure) and is reported in these categories. Frequencies are given as absolute numbers and percentages. Continuous data are reported as mean ± SD or median and minimum to maximum, depending on the distribution of the data. All variables captured were checked for an association with 30-day and long-term mortality. Factors associated with perioperative mortality were identified using t tests or Mann-Whitney U tests (quantitative variables) or ² or Fisher exact tests (binary/qualitative variables) as appropriate. The determinants of perioperative mortality were further characterized by multivariable analysis using logistic regression modeling. To allow for differences between the centers, "center" was included in the multivariable analysis, but doing so had virtually no effect on the results.

Late outcome was analyzed taking follow-up time into consideration. Survival was studied using the Kaplan-Meier method. Total survival refers to data including the perioperative period, whereas the determinants of late survival were analyzed separately, after perioperative deaths had been excluded. Factors associated with survival time were identified using the Cox proportional hazards model (continuous variables) or the log rank test (binary/qualitative variables). Multivariable analysis of survival was explored using the Cox model. When using multivariable analysis, the stepwise regression was used, starting with variables with p less than 0.05 in the univariate analysis, for which reasonably complete information was available. Again, to allow for differences, "center" and "period of surgery" were included in the Cox model, but doing so had little effect on the results.

For analysis of trends over time, the study period was divided into four periods of almost equal length: April 1989 to December 1993, n = 47 patients; January 1994 to December 1996, n = 143; January 1997 to December 1999, n = 215; and January 2000 to March 2003, n = 113. To test whether variables had changed between these periods, regression analyses or ² tests were used. Whether the functional status and medical treatment had changed from before to after the operation was analyzed using a matched-pairs t test (quantitative data) or McNemar’s test (binary data). All analyses were performed using Minitab, release 12 (Minitab, State College, Pennsylvania), and SAS, release 8.02 (SAS Institute, Cary, North Carolina).

	Results

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Patients and Comorbidity
The mean age of the 522 patients was 61 ± 11 years, and 70% of them were male; 433 of the patients (83.0%) were in sinus rhythm. Dialysis had been performed for a median of 3 years before surgery, with chronic glomerulonephritis (26.4%) being the most frequent known cause of renal failure followed by diabetes mellitus (21.6%). However, in many patients (28.2%), the cause of renal failure was not specified in the records that could be reviewed. Table 1 summarizes the main preoperative characteristics of the patients.

Thirty-Day Mortality
Overall, 60 patients (11.5%) died during the first 30 days after surgery. The 30-day mortality declined significantly from 27.7%, 1989 to 1993, to 11.2%, 10.7%, and 7.1% in the respective later periods (p = 0.003). This finding remained valid after allowing for comorbid factors by multivariable analysis of the determinants of 30-day mortality (Table 2).

The overall 5-year survival probability after surgery was 41.5% (95% confidence interval: 36.3% to 46.8%), if all patients are considered (Fig 1A). In univariate analysis, survival was dependent on the type of surgery (CABG, valve, or CABG plus valve) performed (p = 0.015), and was best for patients receiving isolated CABG surgery (Fig 1B).

View larger version (28K): [in this window] [in a new window]   Fig 1. Kaplan-Meier curves of survival probability. (A) Overall survival (including 30-day mortality) of all patients is shown (bold black line); the 95% confidence interval is indicated by the gray area. (B) Overall survival is significantly dependent (p = 0.015) on the type of surgery: the dark gray, black, and light gray lines represent isolated coronary artery bypass graft surgery (CABG), isolated valve surgery, and CABG with concomitant valve surgery. The 95% confidence intervals are also shown, either as an area (isolated CABG) or at specific time points.

The overall probability of survival of the patients did not change during the study period (p = 0.31), in other words, despite the improving perioperative survival, the number of patients surviving to 3 or 5 years postoperatively did not change considerably (Fig 2).

View larger version (21K): [in this window] [in a new window]   Fig 2. Kaplan-Meier curves of survival probability by period of surgery, all patients. The 30-day mortality is included. There is an early difference between the curves (reflecting the decreasing 30-day mortality) that vanishes with time, so that overall survival does not differ significantly (p = 0.31). (Dark gray dotted line = 1989–1993; dark gray solid line = 1994–1996; light gray dotted line = 1997–1999; solid black line = 2000–2002.)

	Comment

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This multicenter study provides the most detailed analysis on the risk factors for short- and long-term mortality to date of patients on dialysis undergoing cardiac surgery. So far, the optimal treatment of dialysis-dependent patients with significant heart disease is unknown. Although ESRD is a growing problem and the prognosis of the patients is largely dependent on their cardiac status, there are no randomized controlled trials that specifically address this question. Our study lacks a control group and is retrospective, but it is considerably larger than most other studies on the subject [10–13] and contains much more information on cardiac or operative variables that are potentially important for the prognosis than other, even larger studies [5, 6, 8, 9, 14]. We therefore hope that our analyses can help to reduce the supposed reluctancy to refer dialysis-dependent patients to the cardiac surgeon. Clearly, however, our study or studies of similar design cannot substitute a randomized trial to identify the best treatment modality in dialysis-dependent patients—for example, on the question of how symptomatic coronary heart disease should be treated or whether bioprostheses or mechanical prostheses should be used for valve replacement.

When studying the perioperative period, we observed that the perioperative risk of dialysis-dependent patients who undergo cardiac surgery is still high, but we were able to demonstrate significant improvements in more recent years. This improvement is not unexpected [16], but it had not been demonstrated for dialysis-dependent patients before. In addition, we identified several predictors of the 30-day mortality. In our opinion, these findings indicate that the perioperative risk of dialyis-dependent patients is higher than normal, but not prohibitive, and that good candidates for surgery can be identified preoperatively.

Furthermore, we could demonstrate that cardiac surgery provides lasting symptomatic relief to the majority of patients. Most of our other findings regarding the follow-up period are more difficult to interpret. Despite the improved perioperative outcome, we did not observe an improvement regarding the overall prognosis of the patients. In our opinion, this finding should not be stressed too much for two reasons. First, as more and more patients survive the perioperative period, sicker patients with a limited prognosis enter the the follow-up period, introducing a bias against the more recent periods. Second, the proportion of patients with diabetes mellitus (17%, 1989 to 1993, but 24%, 31%, and 32% in the respective later periods, p = 0.021) and number of diseased epicardial vessels (p = 0.031) increased significantly during the study period. Both variables likely affect the prognosis of the patients adversely. Although the multivariable analysis accounts for such known baseline dysbalances, unmeasured other variables may have obscured differences between the time periods. In the USRDS database, as in our study, no changes regarding the long-term survival of those ESRD patients undergoing CABG could be detected [6], although the mortality rates of all ESRD patients on dialysis were shown to have dropped by 11% since 1988 [1]. That latter analysis [1], of course, deals with a much larger population, and more covariables are considered in the analysis than in the analysis of the results of CABG surgery [6].

Diabetes mellitus deserves special consideration in ESRD patients as it was found by us and others to be an independent risk factor for perioperative mortality as well as an factor adversely affecting long-term prognosis [1, 12, 17]. The proportion of patients with diabetes mellitus in our study is lower (28%) than in the United States (where about 44% of all ESRD patients have diabetes mellitus [1] and about 61% of those undergoing cardiac surgery [8]), but appears to be representative for Germany [2]. During the period under study, however, we observed a significant increase in the frequency of patients with diabetes mellitus. All perioperative improvements in the treatment of diabetic patients [18, 19] appear to have been outweighed by this increasing prevalence of diabetes mellitus and the adverse long-term effects of diabetes mellitus on the long-term prognosis of ESRD patients.

Another remarkable finding of our study is the adverse association of perioperative transfusions with long-term outcome. Although this is not the first report of such an association in the literature on cardiac surgery [20, 21], no causality should be assumed. The observed association may well be a result of confounding by other, unmeasured variables. According to our results, however, the implementation of blood conservation strategies [22] should be considered.

We identified three factors that were associated with longer survival: use of an ITA graft, the presence of sinus rhythm, and receiving a renal transplantation. Given the overwhelming evidence that the ITA has significantly better patency rates than vein grafts, the first association is not surprising. However, there is also good evidence that two ITA grafts are better than one [23–25]. Whether this also holds true for ESRD patients has not been studied. In our database, the use of bilateral ITAs was too infrequent (n = 5) to permit a meaningful analysis. Surgeons are often reluctant to perform bilateral ITA grafting in ESRD patients because excessive blood loss and mediastinitis are feared. The two reports that specifically deal with this question, however, indicate that both ITAs can be used without a significant increase of the perioperative risk [26, 27]. Randomized studies may be inevitable to assess the potential risks and benefits of bilateral ITA grafting in ESRD patients.

Atrial fibrillation is a frequent complication in patients with ESRD [1, 28] and is associated with poorer long-term survival [1, 29]. In many patients with atrial fibrillation, however, sinus rhythm can be restored surgically, but to date there are hardly any data on the use of the Maze procedure or akin procedures in patients with ESRD.

Only a small minority of our patients (n = 17) subsequently received a renal transplant. Patients who undergo renal transplantation are usually highly selected patients with a favorable risk profile [30]; therefore, it is not surprising that these patients had the best overall survival. It is a limitation of our study that it is unknown how many of our patients were on the waiting list for renal transplantation at the time of cardiac surgery. However, there is evidence that patients on the waiting list who do not receive a renal transplantation differ unfavorably from transplanted patients with respect to several factors potentially affecting survival [30]. For this reason, and because our results were virtually unchanged when the few transplanted patients were excluded from the Cox model, we believe that the transplanted patients and the unknown number of patients on the waiting list do not affect our analyses of the predictors of survival significantly.

Only a minority of our patients received beta-blocking agents, angiotensin-converting enzyme inhibitors, statins, or even aspirin—an observation that is in accordance with the US Renal Data System report [3]. Medical treatment of ESRD patients is difficult because of their multimorbidity, the requirement of many drugs, possible interactions, and disturbed metabolism. Nevertheless, our data suggest that the medical treatment for cardiac diseases is lacking in a significant number of dialysis-dependent patients before and after cardiac surgery. Unfortunately, our data did not allow an analysis whether this had any impact on the prognosis.

Only 13 patients in our study underwent off-pump CABG surgery. With this low number of off-pump procedures, our data do not allow exploration of the potential for off-pump surgery to reduce the perioperative risk, as claimed by some surgeons [27, 31].

In summary, we were able to demonstrate significant improvements regarding the perioperative outcome of ESRD patients who needed cardiac surgery, most often CABG surgery, and a functional benefit from surgery during later follow-up. However, the overall prognosis of the patients remains poor. Diabetes mellitus was found to adversely affect the perioperative results and the overall prognosis. If CABG is to be performed, use of the ITA should be standard of care, even in this group of patients at high risk for bleeding.

	Acknowledgments

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We are grateful to all colleagues, nurses, and students who provided data and helped in collecting them. Special appreciation is expressed to Ute Schubert for her meticulous central data management at the University of Luebeck, Germany; and to Derek Robinson, DPhil, Department of Mathematics, School of Science and Technology, University of Sussex, United Kingdom, for expert statistical analysis and his kind advice when planning the study. We are especially indebted to our patients and their relatives; without their help, this study would not have been possible.

	References

Top Abstract Introduction Patients and Methods Results Comment Acknowledgments References

 

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This Article Abstract Full Text (PDF) 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): Christian Detter Thomas Krabatsch Brigitte R. Osswald Friedrich-Christian Rieß Christof Stamm Hans-Hinrich Sievers Claus Bartels Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Bechtel, J.F. M. Articles by Bartels, C. Search for Related Content PubMed PubMed Citation Articles by Bechtel, J.F. M. Articles by Bartels, C. Related Collections Coronary disease Valve disease