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NDT Advance Access published online on July 7, 2008
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfn337
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© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Prosthesis type has minimal impact on survival after valve surgery in patients with moderate to end-stage renal failure

Farzan Filsoufi1, Joanna Chikwe1, Javier G. Castillo1, Parwis B. Rahmanian1, Joseph Vassalotti2 and David H. Adams1

1 Department of Cardiothoracic Surgery 2 Division of Nephrology, Mount Sinai School of Medicine, New York, NY, USA

Correspondence and offprint requests to: Farzan Filsoufi, Department of Cardiothoracic Surgery, Mount Sinai School of Medicine, 1190 Fifth Avenue, Box 1028, New York, NY 10029, USA. Tel: +1-212-659-6813; Fax: +1-212-659-6818; E-mail: Farzan.filsoufi{at}mountsinai.org



   Abstract
Top
 Abstract
Introduction
 Subjects and methods
 Results
 Hospital mortality
 Discussion
 References
 
Background. Few previous studies have reported on the outcome of patients with renal failure (RF) undergoing valvular surgery, particularly with regard to choice of valve prosthesis.

Methods. We retrospectively analyzed prospectively collected data from 155 patients with RF (mean age 62 ± 14, 42% female) who underwent left-sided valve surgery from January 1998 to December 2006. Patients were divided into two groups: Group 1 (non-dialysis-dependent renal failure (NDRF); creatinine >2.5 mg/dl; n = 47, 40%) and Group 2 (renal failure dialysis (DRF); n = 108, 60%). Mechanical valves were implanted in 50 (32%) patients and bioprostheses in 63 (41%). Isolated mitral valve reconstruction was performed in 27% (n = 42) of patients. Outcome measures included hospital mortality, major postoperative complications, length of hospital stay, discharge planning and late survival.

Results. The overall hospital mortality was 19.3% (n = 30) and was not different between Groups 1 (23%) and 2 (18%). Ejection fraction, peripheral vascular disease, aortic valve replacement and reoperation were independent predictors of hospital mortality. One- and five-year survival rates were 74.4 ± 7.8% and 53.1 ± 10.1% in Group 1 and 75.8 ± 4.6% and 49.1 ± 7.1% in Group 2 (P = ns), respectively. According to the type of prostheses, hospital mortality and freedom from reoperation were similar in patients with mechanical and biological valves. Five-year survival rate was 51 ± 10.7 for biological valves versus 55 ± 8.4 for mechanical valves (P = ns).

Conclusions. Hospital mortality and morbidity remain high in patients with RF undergoing valvular surgery and it is not different in NDRF and DRF patients. This study suggests that the type of valve prosthesis does not appear to have an impact on early and late survival but is limited by sample size. It may be that bioprostheses should be more widely used in patients with RF requiring valve replacement.

Keywords: mortality; prosthesis; renal failure; survival



   Introduction
Top
 Abstract
 Introduction
Subjects and methods
 Results
 Hospital mortality
 Discussion
 References
 
Chronic renal dysfunction is currently estimated to affect over 20 million people in the United States alone and its prevalence is increasing [11]. This has been reflected in changing referral patterns for cardiac surgery over the last decade, during which time the percentage of patients with impaired renal function undergoing cardiac surgery has steadily increased [9]. Although several studies have shown that renal failure (RF) requiring dialysis negatively impacts early and late outcomes of patients undergoing coronary artery bypass grafting (CABG) [6,16], few studies have focused on the surgical outcome of patients with RF undergoing valvular heart surgery [8]. Furthermore, data with respect to patients with non-dialysis-dependent renal failure (NDRF) are even more limited. Finally, data regarding the optimum choice of prosthesis in these patients are limited to a handful of small series [3,5,14] and a registry analysis including prostheses from the 1970s and 1980s [12]. The purpose of our investigation was, therefore, to determine the early and late outcomes of patients with moderate to end-stage RF undergoing valve surgery and the impact of biological versus mechanical prostheses on late survival.



   Subjects and methods
Top
 Abstract
 Introduction
 Subjects and methods
Results
 Hospital mortality
 Discussion
 References
 
Study population
From January 1998 to December 2006, 155 patients with chronic moderate to end-stage RF underwent left-sided valvular surgery at our institution. Patients who required concomitant CABG or re-operative surgery were included in the study. Clinical variables analyzed were obtained from an electronic database based on the New York State Department of Health (NYSDH, State Cardiac Advisory Committee) data registry. The NYSDH data registry represents a mandatory verified peer-reviewed data collection system that includes all cardiac surgery procedures in the New York State. Patient characteristics, operative information and postoperative data were retrospectively analyzed. Medical chart review was performed to obtain additional information when necessary. In addition, the logistic European system for cardiac operative risk evaluation (EuroSCORE) was used for risk stratification [18]. The EuroSCORE is a risk stratification system using multiple preoperative risk factors to predict operative mortality. Table 1 summarizes preoperative variables and their definition.


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  		Table 1 Variables used in this study and their definitions

 
Definition of patient population
Patients with both preoperative dialysis and non-dialysis-dependent RF were included in the study population. RF was defined according to the NYSDH registry as moderate to severe RF (creatinine level > 2.5 mg/dl) without any need for dialysis (NDRF, Group 1) or as end-stage RF requiring dialysis (DRF, Group 2).

Postoperative variables measured included hospital mortality, major postoperative complications (respiratory failure, deep sternal wound infection, bleeding requiring reoperation, unplanned reoperation, gastrointestinal complication and stroke), length of hospital stay, discharge planning and late survival. The definition of outcome variables used in this study is reported in Table 1. Comparison of outcomes between Groups 1 and 2 was performed, followed by an analysis of outcome by type and site of valve prosthesis with particular regard to long-term survival.

The protocol was approved by our local institutional review board and compliant to the Health Insurance Portability and Accountability Act (HIPAA) regulations and the ethical guidelines of the 1975 declaration of Helsinki, as revised in 2000. The approval included a waiver of informed consent.

Surgical management
All procedures were performed through a median (full or partial) sternotomy. Cardiopulmonary bypass was established between the ascending aorta and either the right atrium using a two-stage cannula or both venae cavae, and myocardial protection was achieved using high potassium cold blood cardioplegia in an antegrade and/or retrograde fashion. Additional myocardial protection was obtained with mild-to-moderate systemic cooling (28–30°C). During cardiopulmonary bypass, a perfusion pressure of > 60 mmHg and a minimum flow of 2.2 l/min/m2 were maintained in all patients. Following surgery, all patients were transferred to the intensive care unit (ICU). Patients were weaned from ventilator when haemodynamic stability was achieved, no postoperative bleeding occurred and adequate consciousness was obtained.

Statistical analysis
Normally distributed continuous variables are presented as mean ± standard deviation (SD) and otherwise as median ± interquartile range (IQR). Categorical variables are shown as the percentage of the sample. A P-value <0.05 was considered statistically significant for all used tests. The chi-square test was used to evaluate potential confounders of the relationship between preoperative renal dysfunction with a creatinine >2.5 mg/dl or dialysis and hospital mortality and morbidities in the entire patient population. Stepwise multivariate logistic regression was then performed to assess the influence of the two degrees of renal dysfunction as independent risk factors for hospital mortality and postoperative morbidities. The potential confounders included age, gender, obesity (body mass index >30 kg/m2), ejection fraction, congestive heart failure, previous cardiac procedure, history of diabetes mellitus, hypertension, history of myocardial infarction, acute myocardial infarction, chronic obstructive pulmonary disease, PVD, haemodynamic instability and type of operative procedure. Long-term survival was analyzed using Kaplan–Meier survival curves. Differences in patient characteristics were controlled by Cox proportional hazard analysis. The statistical analyses were performed with the use of SPSS 15 (SPSS Inc., Chicago, IL, USA).



   Results
Top
 Abstract
 Introduction
 Subjects and methods
 Results
Hospital mortality
 Discussion
 References
 
Demographic data
A total of 155 patients were included in this study. Among those, 47 (30%) patients had an elevated creatinine >2.5 mg/dl (Group 1) and 108 (70%) patients required chronic dialysis (Group 2). Evidence of congestive cardiac failure was present in 73% (n = 113) patients, endocarditis in 22% (n = 34), severely depressed left ventricular function in 18% (n = 22), previous stroke in 16% (n = 27) and coronary artery disease in 51% (n = 77). The mean predicted preoperative risk by logistic EuroSCORE was 30 ± 22. Group 1 patients were significantly older and were more likely to present with previous myocardial infarction or preoperative low ejection fraction (<30%) than patients in Group 2 (Table 2). Patients undergoing reoperation constituted 22% (n = 34) of the cohort, of whom 13 required first time valve surgery after previous coronary artery bypass grafting and 21 required repeat valvular surgery. Of the 21 patients undergoing reoperation, 8 (38%) patients had prosthetic valve endocarditis, and 7 (33%) had a perivalvular leak and 6 (29%) presented with structural valve deterioration at a mean follow-up of 7 years. The mean predicted mortality by EuroSCORE was higher in Group 1 (Group 1, 34 ± 23% versus Group 2, 28 ± 22%, P = 0.127).


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  		Table 2 Demographic data

 
Operative details
Details with respect to the operative procedure are shown in Table 3, and the overall numbers of procedures are shown in Figure 1. There were no differences in terms of CPB and cross-clamp times between the two groups. Mechanical valves were implanted in 44% (n = 50) cases and bioprostheses in 56% (n = 56) (Table 3). There was no significant difference in the type of prosthesis implanted when analyzed by dependence on dialysis. Isolated mitral valve reconstruction was performed in 27.1% (n = 42) of patients.


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  		Table 3 Operative data

 

Figure 1
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  		Fig. 1 Distribution of surgical procedures among patients with preoperative renal failure. AVR, aortic valve replacement; MVP, mitral valve repair; MVR, mitral valve replacement.

 


   Hospital mortality
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Hospital mortality
Discussion
 References
 
The overall hospital mortality was 19.3% (n = 30). Patients with preoperative creatinine >2.5 mg/dl failure had an increased mortality (23.3%, n = 10) compared to the patients with end-stage RF (18%, n = 20) (P = ns) (Table 4). Causes of death included multi-organ failure (n = 11), ventricular arrhythmia (n = 3), low cardiac output syndrome (n = 11), intractable sepsis (n = 2) and ischaemic gastrointestinal complications (n = 3). Multivariate analysis revealed low ejection fraction (<30%) (OR = 3.26), peripheral vascular disease (OR = 3.27), aortic valve replacement (OR = 3.44) and prior cardiac surgery (OR = 3.94) as independent predictors of hospital mortality (Table 5).


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  		Table 4 Mortality and morbidities

 

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  		Table 5 Predictors of hospital mortality in multivariate analysis

 
Morbidity
Postoperative complications are shown in Table 4. The most common complications were respiratory failure, sepsis and GI complications, and there was no significant difference between the groups in the overall rate of complications. Patients of Group 1, however, presented significantly more often with sternal wound infection (P = 0.037). The overall rate of reoperation for bleeding was 5.1% and not significantly different between the groups. Finally, among patients with NDRF (Group 1), 20 (42%) required postoperative dialysis.

The median length of stay in hospital among surviving patients was 14 (IQR 7–25) days. The median length of stay among patients of Groups 1 and 2 was 10 (IQR 6–22) and 17 (IQR 8–35) days, respectively. Twenty-five percent of patients of Group 1 and 30% of patients of Group 2 were discharged to rehabilitation facilities, skilled nursing homes and acute care facilities.

Late survival
Follow-up was completed for all patients. The overall mean follow-up was 3.9 ± 2.5 years. There were 47 (37.6%) deaths during the total follow-up of 125 patients who survived to hospital discharge. When patients were compared, it appeared that dialysis patients did not have significantly higher mortality compared to NDRF patients (n = 34/92, 39% versus n = 13/33, 37%, P = ns). Multivariate analysis revealed dialysis-dependent RF (OR = 5.1) to be an independent predictor of late mortality following cardiac surgery (Table 6). Survival at 1 and 5 years was 74.4 ± 7.8% and 53.1 ± 10.1% in Group 1 and 75.8 ± 4.6% and 49.1 ± 7.1% in Group 2 (P = ns). Figure 2 shows Kaplan–Meier survival curves for the entire patient population stratified by study groups.


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  		Table 6 Demographic data according to the type of prostheses

 

Figure 2
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  		Fig. 2 Kaplan–Meier survival curves for patients with preoperative renal failure.

 
Outcome analysis according to the type of prosthesis
Patients analyzed were divided into groups according to whether a mechanical (n = 50, 44%) or biological prosthesis (n = 63, 56%) was implanted (Table 6). Patients undergoing isolated mitral valve repair were not included. The groups were similar although patients receiving bioprostheses were on average older (67 ± 12 versus 55 ± 14, P < 0.001) and more likely to have severely depressed LV function (19% versus 14%, P = 0.039). No significant difference was identified between the two groups in terms of freedom from reoperation or 5-year survival (51 ± 10.7 versus 55 ± 8.4, P = 0.44) (Figure 3). Only four patients required reoperation. Three patients presented with late mechanical valve endocarditis and one patient with mechanical valve underwent reoperation for a perivalvular leak. There were no reoperations for structural valve deterioration in patients with bioprosthetic valves during the follow-up.


Figure 3
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  		Fig. 3 Kaplan–Meier survival curves for patients with preoperative renal failure stratified by the type of implanted prosthesis.

 
In the aortic position, 5-year survival was 59 ± 11.8 in patients with mechanical prosthesis and 43 ± 14.5 in patients who received biological prostheses (P = 0.836). In the mitral position, 5-year survival was 64 ± 13.2 and 42 ± 20.5 for mechanical and biological prostheses, respectively.



   Discussion
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Hospital mortality
 Discussion
References
 
Mortality and morbidity
The hospital mortality of 18% observed in dialysis-dependent RF patients in this cohort is similar to that reported previously: in two small retrospective series mortality ranged from 16 to 29% [3,5], and Horst et al. observed an overall mortality of 19.3% in a review of the literature that included 230 patients undergoing valve surgery over 30 years [13]. The mortality associated with valve surgery in a large registry analysis of renal dialysis patients was 20.7% [12], which is similar to that found in an analysis of the Society of Thoracic Surgeons database which reported operative mortality for isolated AVR and MVR as 17.1% and 22.5%, respectively, with significantly higher mortality associated with concomitant CABG [8]. Most of these studies provide no data with respect to the mortality of valve surgery in non-dialysis-dependent RF or predictors of operative mortality. Although it might be assumed that results of surgery in dialysis-dependent RF could safely be extrapolated to results of surgery in patients with non-dialysis failure who share many characteristics, this is the first study to document similar outcomes.

In this study, multivariate analysis revealed that patients with low ejection fraction, peripheral vascular disease, aortic valve replacement or a history of prior cardiac surgery were between three and four times as likely to die in hospital or within 30 days of surgery as patients without these risk factors. One potential explanation for these findings is that these risk factors are markers of diffuse, severe atherosclerotic disease, which is particularly prevalent in this population [11] and associated with significantly poorer outcomes [18]. This suggestion is supported by the observation that almost two-thirds of the deaths in our patient cohort could be attributed to pathology associated with advanced arteriopathy. Aggressive prevention, diagnosis and management of atherosclerotic disease in patients with RF may offer a key to improving future operative outcomes.

The overall incidence of post-operative morbidity was very high, with almost one-third of patients experiencing respiratory failure and almost 10% suffering major gastrointestinal complications. This is comparable to the incidence of major morbidity reported by two smaller single center series [3,7] and reflects the severity of valvular heart disease and polyarteriopathy widely prevalent in these patients. Dialysis-dependent RF was not associated with significantly higher hospital morbidity than non-dialysis-dependent RF in patients undergoing valve surgery, but the incidence of sternal wound infection was significantly higher in this group. There are two possible explanations for this finding. Firstly, the alterations in fluid balance and the effect of retained metabolites and toxins may be less critical in patients with severe RF that are undergoing regular dialysis than they are in patients with moderate to severe RF not receiving dialysis [19], predisposing patients to sepsis. Secondly, a proportion of the non-dialysis-dependent patients may have suffered an acute deterioration in RF associated with other comorbidity contributing to infectious complications, not accounted for in the multivariate analysis. The long average length of stay, and the fact that over a quarter of these patients could not be discharged home from hospital, requiring skilled nursing care in rehabilitation centers, reflects the substantial post-operative morbidity in both groups.

Long-term survival
There is limited data on the long-term survival of patients with non-dialysis-dependent moderate to severe RF following valve surgery. No significant difference was observed in late mortality between Groups 1 and 2, suggesting that, in this case, findings in patients with dialysis-dependent RF may be extrapolated to patients with non-dialysis-dependent moderate to severe RF. In the 125 patients discharged from hospital, three quarters were alive at 1 year, and almost half still alive 5 years after surgery. This is substantially better than the long-term survival observed after valve surgery in a large analysis of patients taken from the US Renal Data System database which reported 1- and 5-year survival of 54 ± 1.3% and 14.8 ± 1.3%, respectively [12]. This may reflect the fact that Herzog et al. only analyzed patients between 1978 and 1998, with one-fifth of patients undergoing surgery over 20 years previously, since when there has been a large number of incremental improvements to patient care that have contributed to an improved life expectancy. This appears to be supported by the fact that improved 5-year survivals of between 27 and 33% are reported by several small case series based on more contemporary patient cohorts [3,5,14].

Choice of valve prosthesis
Debate surrounds the optimum choice of valve prosthesis in patients with end-stage RF. Traditional teaching has been that patients with RF should receive mechanical valves because of concerns about the risk of accelerated calcification resulting in early structural prosthesis deterioration [1]. These concerns were raised by anecdotal reports of early prosthesis calcification in dialysis patients who received porcine valves in the late 1970's [10,15]. The AHA-ACC guidelines were changed in 2006 to reflect the findings of a series of observational studies which showed no significant difference in the freedom from valve-related events including reoperation and late mortality between patients with dialysis-dependent RF receiving a mechanical or a biological prosthesis [2]. Herzog et al.'s large registry analysis found that choice of valve was not associated with difference in long-term survival and concluded that dialysis should not be viewed as a contra-indication to implantation of a bioprosthesis, particularly in the light of relatively limited life expectancy in these patients. The results of three much smaller series, all containing less than 75 patients, also appear to support this conclusion [5,14,17]. Only one study has reported a survival advantage with mechanical valves [4]. This group did not exclude operative deaths from their long-term survival analysis and the substantially higher operative mortality in patients receiving bioprostheses (36.2%) compared to patients receiving mechanical valves (13.6%) may have contributed to difference identified in long-term survival. Furthermore, patients receiving bioprostheses were significantly more likely than patients receiving mechanical prostheses to be elderly and have ischaemic heart disease, both of which are associated with significantly reduced life expectancy in patients with renal dysfunction [11].

Our analysis showed no significant difference in life expectancy or rate of reoperation after a mean follow-up of ~4 years between patients receiving mechanical or biological prostheses, despite the greater proportion of elderly patients in the biological prosthesis group. In view of recent reports of increased risk of haemorrhagic complications with mechanical valves with a linearized rate of 1–2% risk of major bleeding complication per annum in the general population [2] and the challenges inherent in achieving therapeutic anticoagulation in patients with RF, it seems reasonable to suggest that biological valves could be more widely applied in this patient group.

Strengths and limitations section
In the revised 2006 guidelines, the American Heart Association did not make a specific recommendation for prosthesis choice in patients with RF because of insufficient data [2]. We have attempted to add to existing knowledge with what is currently the largest contemporary single center analysis of outcomes in patients with RF undergoing valve surgery. This study does, however, present certain limitations. Firstly, given that this is a retrospective observational study, conclusions are necessarily limited in their application. Secondly, clinical outcomes are limited to major post-operative morbidity and mortality with no information on late complications, quality of life, cause of death during follow-up or cost-analysis. Thirdly, the limited number of patients in each sub-group prevented more detailed analysis of outcomes by prosthesis according to position.

Summary
Although valve surgery in patients with renal dialysis is associated with substantial post-operative mortality and morbidity, long-term survival appears to have improved in recent years. The previous literature focuses on dialysis-dependent RF and we demonstrate for the first time that findings in this patient group in the context of valve surgery may be safely extrapolated to patients with moderate to severe non-dialysis-dependent RF. Markers of severe atherosclerotic disease including coronary artery bypass grafting, previous myocardial infarction and peripheral vascular disease increase the risk of operative mortality over threefold in this patient group. In addition to established criteria such as age, the choice of prosthesis in these patients should take into consideration additional factors such as limited life expectancy secondary to renal dysfunction, increased risk of haemorrhagic events and the relatively low potential risk of early structural valve deterioration. This study suggests that the choice of valve prosthesis does not appear to have an impact on long-term survival after surgery but is limited by sample sized. It may be that bioprostheses should be more widely used in patients with RF requiring valve replacement.

Conflict of interest statement. None declared.



   References
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Hospital mortality
 Discussion
 References
 

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Received for publication: 8. 1.08
Accepted in revised form: 22. 5.08


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