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Ann Thorac Surg 2010;89:65-70. doi:10.1016/j.athoracsur.2009.10.026
© 2010 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Early and Late Outcomes of Aortic Valve Replacement in Dialysis Patients

Keisuke Tanaka, MDa,*, Kazuyoshi Tajima, MDb, Yoshiyuki Takami, MDb, Noritaka Okada, MDb, Sachie Terazawa, MDa, Akihiko Usui, MD, PhDa, Yuichi Ueda, MD, PhDa

a Department of Cardiac Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan
b Department of Cardiovascular Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan

Accepted for publication October 12, 2009.

Abbreviations and Acronyms ACC/AHA = American College of Cardiology/American Heart Association; AMI = acute myocardial infarction; AS = aortic stenosis; ASI = aortic stenosis with insufficiency; AVR = aortic valve replacement; CABG = coronary artery bypass grafting; CHF = congestive heart failure; EOAI = effective orifice area index; ESRD = end-stage renal disease; INR = international normalized ratio; LMT = left main tract; PV = pulmonary vein; PVE = prosthetic valve endocarditis

* Address correspondence to Dr Tanaka, Department of Cardiac Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan (Email: ktanaka{at}med.nagoya-u.ac.jp).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Background: Few data are available on the outcomes of aortic valve replacement (AVR) in dialysis patients. Valve selection has been controversial, and systemic calcification in these patients has been an important concern. This study reports our experiences and evaluates whether dialysis patients can be treated in a way that is similar to nondialysis patients.

Methods: A retrospective review was performed on 73 AVRs (43 men, 29 women), including one redo operation, for dialysis patients between 1995 and 2007. Mean age was 65.0 ± 8.3 years. The bioprosthesis was basically selected for elderly patients as for nondialysis patients.

Results: For a severely calcified ascending aorta, the femoral or subclavian artery was selected for arterial cannulation in 9 patients (12.3%), and aortic cross-clamping under temporary circulatory arrest with moderate hypothermia was applied in 17 (23.3%). Implanted were 51 mechanical and 22 bioprosthetic valves. Four elderly patients in poor general condition received high-performance mechanical valves instead of bioprosthesis to avoid aortic root enlargement. There was no stroke during the perioperative period. Hospital mortality was 6.8%. The overall actuarial survival rate was 74.6% ± 5.6%, 55.7% ± 7.6%, and 39.9% ± 9.7% at 3, 5, and 10 years, respectively.

Conclusions: The results for the dialysis patients after AVR were satisfactory. Dialysis patients can be treated in AVR just like nondialysis patients. Valve selection and surgical strategy on a case-by-case basis are important to improve the clinical outcomes in dialysis patients.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
The number of patients with end-stage renal disease (ESRD) requiring dialysis has been gradually increasing. In 2007 the prevalence of dialysis patients was 275,119 in Japan, and the population ratio has been boosted to more than 2000 per million since 2005 [1]. Dialysis patients are associated with a higher risk for the development of cardiovascular diseases, especially calcified degeneration of cardiac valves [2, 3]. In particular, aortic valve stenosis is common in patients who experience long-term dialysis. Therefore, it is expected that incidence of aortic valve stenosis or insufficiency requiring surgical intervention increases as the life expectancy of dialysis patients is extended.

The surgical management of dialysis patients is associated with specific problems, however. The aortic wall is easily calcified, as are the cardiac valves. Therefore, ascending aortic perfusion and cross-clamping are sometimes hazardous. Perioperative dialysis management is also a major concern. These difficulties in surgical management have increased the mortality and morbidity rates after operations. Surgical indications are generally determined based on a balance between the surgical benefit and early outcomes. Therefore, the surgical indications for aortic valve replacement (AVR) are one of the major concerns for dialysis patients.

The selection of the type of prosthetic valve is another major subject to debate. Although there have been several recommendations of mechanical or bioprosthetic valves, the protocol for valve selection for dialysis patients has not been clarified, as the description of the valve selection for dialysis patients disappeared from the current American College of Cardiology/American Heart Association (ACC/AHA) Task Force on 2006 practice guidelines [4].

Few data are available for the surgical indications, the prosthetic valve selection, and the clinical outcomes regarding AVR in dialysis patients. The purpose of this study is to report the clinical experience of a series of dialysis patients who underwent AVR at a single institution, to assess the early and late outcomes, and to evaluate whether dialysis patients could be treated like nondialysis patients, especially from the viewpoint of valve selection.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
This retrospective review of the clinical records has been approved by the appropriate Ethics Committee of Nagoya Daini Red Cross Hospital, and informed consent was provided by each patient.

Between 1995 and 2007, 73 AVRs with or without concomitant procedures were performed in 72 patients (43 men, 29 women) with ESRD requiring dialysis at Nagoya Daini Red Cross Hospital. The baseline patient clinical profiles are reported in Table 1. The mean age was 65.0 ± 8.3 years, and the average duration of dialysis was 12.0 ± 7.7 years. The predominant disease was aortic stenosis.


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  		Table 1 Patient Characteristics by Valve Type
 
Surgical Indication and Valve Selection
The surgical indications for dialysis patients were basically consistent with the ACC/AHA guidelines [4, 5]. We indicated AVR for any dialysis patients who were associated with certain symptoms due to severe aortic valve disease.

The standard of valve selection has changed over time. Only mechanical valves had been selected until 1997. After Lucke and associates [6] reported the availability of bioprostheses for ESRD patients in 1997, bioprostheses have been principally selected for patients aged 70 and older, regardless of a class III indication in the previous ACC/AHA 1998 guidelines [5]. With the recent revision of the ACC/AHA guidelines in 2006 [4], the lower age limit for bioprostheses was changed to patients aged 65 and older.

The target of effective orifice area index (EOAI) was set to achieve 0.80 cm2/m2 and higher, considering the limited activities of daily life of dialysis patients.

Surgical Procedures and Perioperative Management
Low potassium hemodialysis was routinely performed for the consecutive 2 days before the operation, except for emergencies, as we previously reported [7]. Standard anesthetic and surgical techniques were used for AVR. The quality of the ascending aorta was routinely evaluated by computed tomography imaging before the operation and by epiaortic echo scanning during the operation.

When a severely calcified aorta was detected, the femoral or subclavian artery was selected for arterial cannulation instead of the ascending aorta to reduce the risk of embolism. When the site of aortic cross-clamping was also thought to be highly associated with embolism due to fragmentation of severely calcified aorta, moderate hypothermic circulatory arrest was induced, and a cross-clamp was carefully applied after the inspection of the inside aorta and with or without a resection of calcification, as we previously reported [8]. An ultrasonic surgical aspirator (CUSA, Tyco Healthcare, Mansfield, MA) was used to remove calcification of the internal aortic wall and the aortic valve annulus.

Valves were implanted at the supraannular position by interrupted sutures. In the case of a mechanical valve, a high performance valve, including ATS AP Series (ATS Medical Inc, Minneapolis, MN), CarboMedics TopHat (CarboMedicus Inc, Austin, TX), Bicarbon Slimline (Sorin Biomedica, Saluggia, Italy) and St. Jude Medical Regent (St. Jude Medical Inc, St. Paul, MN), was implanted for a small annulus to achieve an EOAI exceeding 0.80 cm2/m2. Aortic root enlargement with the modified Nicks method was also performed to achieve an EOAI exceeding 0.80 cm2/m2.

A stentless valve was not used to avoid longer cardiac ischemic time. The extracorporeal ultrafiltration method was routinely performed, except for emergency cases requiring hemodialysis. Serum potassium levels of less than 4.0 mEq/L and blood hemoglobin levels exceeding 10.0 g/dL were always maintained at the end of cardiopulmonary bypass to prevent subsequent hyperkalemia [7].

Hemodialysis was resumed on the first postoperative day in most patients. Continuous hemofiltration was applied immediately after the operation only in those patients with hemodynamic instability, impaired pulmonary oxygenation, or advanced hyperkalemia. The patients with mechanical valves were postoperatively prescribed warfarin therapy at the level of the international normalized ratio (INR) of prothrombin time ranging from 2.0 to 2.5. Those who had bioprostheses were also given warfarin for the first 3 months after the AVR at the same level of INR, followed thereafter by cessation of warfarin.

Data Collection
Patient demographics and risk factors, surgical information, and postoperative outcome data were collected. Hospital mortality was defined as death for any reason occurring within 30 days after the operation or after 30 days occurring during the same hospitalization, regardless of the length. Neurologic morbidities were defined as stroke; a new neurologic dysfunction that persisted for 72 hours and transient neurologic dysfunction; and any neurologic dysfunction that recovered completely within 72 hours. Valve-related complications and deaths were defined according to the Guidelines for Reporting Mortality and Morbidity after Cardiac Valve Interventions [9]. Sudden, unexplained deaths of patients with a surgically treated valve were included as a valve-related death. The patient's recent status was determined through telephone interviews with the patient or his or her family. Any events were confirmed with the clinical records or inquiries to the follow-up institutions or physicians.

Statistical Analysis
Continuous data were expressed as means ± standard deviations and compared using the Mann-Whitney U test for analysis. Category variables were expressed as percentages and compared using the Fisher exact test for analysis. To compare the incidence of valve-related complications between the two valve groups, the incidence rate in each group was computed. The statistical test and the estimation of confidence interval for the incidence rate ratio were based on binomial distribution. Univariate logistic regression was performed to assess predictors for hospital mortality. Survival curves were generated using Kaplan-Meier methods and compared using a log-rank test. A value of p < 0.05 was considered significant. The statistical analysis was done with SPSS 16 software (SPSS Inc, Chicago, IL).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
Procedure and Valve Selection
Detailed information is provided in Table 1. Concomitant procedures were performed in 36 patients (49%). The femoral or right subclavian artery was selected for the arterial cannulation site in 9 patients (12%), and aortic cross-clamping was applied under temporary circulatory arrest in 17 (23%). The circulatory arrest times were all within 5 minutes at the lowest rectal temperature maintained between 28° and 32°C.

Implanted were 51 mechanical and 22 bioprosthetic valves. The rate of bioprosthesis use was 0% (0 of 34) in the patients aged 64 and younger, 28.6% (4 of 14) in the patients between 65 and 69, and 72.0% (18 of 25) in the patients aged 70 and older. The difference in the average age of patients between the mechanical and bioprosthetic valve group was significant (p < 0.001). The average EOAI was 1.03 ± 0.20 cm2/m2 (range 0.69 to 1.45 cm2/cm2). The average EOAI in the mechanical valve group was significantly larger than that in the bioprosthesis group (p < 0.001).

In 8 patients, the valve selections were different from our described policy. Although 4 valves were selected by the patient's request, the high-performance mechanical valve, instead of a bioprosthesis, was used to avoid aortic root enlargement in 4 elderly patients in poor general condition. In the mechanical valve group, the high performance models were selected for 64.7% of patients. Aortic root enlargement was performed in 5 patients; however, the EOAI was still less than 0.80 cm2/m2 in 2 who received mechanical valves.

Early Outcomes
Early complications and the causes of hospital death are listed in Table 2. No stroke occurred during perioperative period. Postoperatively, 5 patients (6.8%) died in-hospital at 9, 10, 10, 14, and 19 days. All other patients were discharged from the hospital self-reliantly. In the first term, between 1995 and 2001, the hospital mortality was high at 16.0% but improved to 2.1% in the second term between 2002 and 2007 (Table 2). The only significant predictor for hospital deaths based on univariate logistic regression was the need of aortic root enlargement (Table 3).


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  		Table 2 Early Outcomes by Valve Type
 

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  		Table 3 Predictors for Hospital Death by Univariate Analysis a
 
Late Outcomes
The mean follow-up period for 67 survivors was 42 ± 31 months (range, 2 to 147 months). The total follow-up period after discharge for 65 patients with reliable long-term data (97.0% complete) was 227.7 patient-years (mechanical valve, 176.5 patient-years; bioprosthesis, 51.2 patient-years). Valve related complications are summarized in Table 4. No structural valve deterioration of the bioprostheses was seen in this series. Valve-related complications were documented in 12 of 44 patients (7.61/100 patient-years) in the mechanical valve group and in 2 of 21 patients (3.90/100 patient-years) in the bioprosthesis group. However, the differences between the two valve groups were not significant (odds ratio, 1.95; 95% confidence interval, 0.44 to 8.71; p = 0.38). During the follow-up period, 21 patients in the survived group died. The causes of late death are summarized in Table 4. The overall actuarial survival rates were 74.6% ± 5.6%, 55.7% ± 7.6%, and 39.9% ± 9.7% at 3, 5, and 10 years, respectively (Fig 1). The all-cause survival rate of patients with bioprostheses was significantly worse than that of patients with mechanical valves (Fig 2). However, no significant difference was observed in the valve-related survival rate between the two groups (p = 0.202).


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  		Table 4 Late Outcomes by Valve Type
 

Figure 1
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  		Fig 1. Kaplan-Meier survival after operation in all patients.

 

Figure 2
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  		Fig 2. All-cause survival for patients with mechanical valves (MV; solid line) and bioprosthetic valves (BV; dash line).

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
Valve Selection
Many studies have addressed prosthetic valve selection in dialysis patients; however, valve selection has been controversial and is still a major concern for AVR in these patients. In the late 1970s, concerns about the rapid calcification of bioprosthetic valves were raised initially by two reports of porcine valves implanted in dialysis patients [10, 11]. As a result of these reports, the use of bioprostheses for dialysis patients was classified as a class III indication by the previous ACC/AHA 1998 practice guidelines [5]. On the other hand, Lucke and associates [6] reported in 1997 that both older patients and patients with a relative short life expectancy in ESRD patients should be considered as candidates for bioprostheses. Moreover, Herzog and colleagues [12] reported in 2002 the adequacy of bioprostheses in survival from the epidemiologic data on 5825 dialysis patients. The Canadian Cardiovascular Society Consensus on Surgical Management of Valvular Heart Disease has also recommended bioprostheses for dialysis patients [13]. On the basis of these publications, we have selected bioprosthesis for elderly dialysis patients since 1998. As a result, our valve selection for AVR has been the same as in nondialysis patients.

Surgical management for small aortic root is another concern for AVR. Many studies have recommended an EOAI exceeding 0.85 cm2/m2 for the superiority of early and late results [14, 15]. However, we consider that an EOAI exceeding 0.85 cm2/m2 is not always required for dialysis patients with low activity of daily life and, therefore, have set an EOAI exceeding 0.80 cm2/m2 as the target. The EOAI in 2 of our patients did not reach 0.80 cm2/m2 regardless of aortic root enlargement with a high-performance mechanical valve, but they had no symptoms after the operation and their quality of life has been satisfactory. It is likely that lower EOAI levels may be acceptable for dialysis patients.

High-performance mechanical valves were selected instead of bioprosthesis, according to our policy, in 4 patients aged 70 and older to avoid aortic root enlargement requiring longer cardiac ischemic time. However, no harmful events have occurred in these patients after operation. A univariate logistic regression analysis showed aortic root enlargement was the only predictor for hospital deaths in this study. The result of this analysis may not always be valid, but aortic root enlargement should not be performed without careful consideration, and valve selection on a case-by-case basis is needed for dialysis patients.

Early Clinical Results
The hospital mortality rate in this study was 6.8%, which was better than that described in previous reports [6, 12, 16, 17]. There are some speculations to explain the better early results. One explanation is the surgical technique to prevent intraoperative stroke. There was no incidence of stroke in the present study. Our procedures implemented to treat calcified aorta may have contributed to the better results [8]. The second explanation is the patients' characteristics. The present study included fewer patients with diabetic nephropathy, peripheral vascular disease, or infectious endocarditis, which are well known risk factors for early death. The third possible explanation is our aggressive strategy of early surgical indication as in nondialysis patients. Delayed surgical intervention for dialysis patients allows the progression of valvular disease and might result in poorer surgical outcomes.

Early clinical results obviously improved in the second term compared with the first term. The reasons for hospital death in the first term included ischemic colitis and ventricular arrhythmia. The rapid correction of excess water was thought to be a cause of collapse of peripheral circulation that triggered ischemic colitis or abnormal blood levels of electrolytes, which might cause ventricular arrhythmia. Thereafter, we applied a gradual correction of excess water in postoperative management. The slow return to preoperative dry weight might be closely related to the improved results

Late Clinical Results
Chan and coworkers [18] reported no advantage of mechanical valves over bioprostheses in terms of freedom from valve-related complication in dialysis patients. Brinkman and colleagues [19] reported a sixfold higher incidence of bleeding events or stroke in dialysis patients with a mechanical valve compared with a bioprosthesis. These statistical inferences support the 2004 Canadian guidelines recommending the use of bioprostheses for dialysis patients [13]. The present study also indicated an approximately twofold higher incidence of valve-related complications in patients with a mechanical valve even without a significant difference. In addition, no incidence of calcified structural valve deterioration of a bioprosthesis was observed in this series. These observations also support the validity of the 2004 Canadian guidelines.

The overall survival rates of this series were quite satisfactory compared with the previous studies [6, 12, 16, 18, 20]. According to The Japanese Society for Dialysis Therapy, the survival rates of the general population of dialysis patients in Japan at 3, 5 and 10 years were 72.8%, 59.7%, and 36.3%, respectively, in 2007 [1]. The survival rates in our cohort of dialysis patients undergoing AVR were almost equivalent to those in the general population of dialysis patients in Japan. Although comparisons cannot be made between our current cohort and the general population, this observation may indicate that AVR is not associated with a reduction in the life expectancy of dialysis patients and may support the aggressive recommendation of AVR in dialysis patients with symptoms.

Limitations
The main limitation in this study was the short follow-up and the small numbers of patients in the bioprosthesis group. A further observation is necessary, because the nondiabetic dialysis patients generally have a relatively good prognosis. The use of bioprosthesis in those patients should be considered carefully. The Kaplan-Meier method and log-rank tests revealed an advantage in the all-cause survival in favor of the mechanical valve group. This survival advantage is difficult to interpret, however, because the patients in this study who received bioprosthesis were significantly older.

Conclusions
The early and late clinical results of AVR in dialysis patients have been improving and are satisfactory. AVR can be applied in dialysis patients as well as in nondialysis patients, with the selection of bioprostheses in elderly patients. Valve selection and surgical ingenuity on a case-by-case basis are important to improve the clinical results in dialysis patients.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
We gratefully acknowledge Dr Kenji Wakai, PhD, Associate Professor, Department of Preventive Medicine/Biostatistics and Medical Decision Making, Nagoya University Graduate School of Medicine, for his valuable advice on statistical analysis.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Japanese Society for Dialysis Therapy An overview of regular dialysis treatment in Japan as of Dec. 31, 2007http://docs.jsdt.or.jp/overview/pdf2008/2007all.pdfAccessed: May 15, 2009.
  2. Maher ER, Young G, Smyth-Walsh B, Pugh S, Curtis JR. Aortic and mitral valve calcification in patients with end-stage renal disease Lancet 1987;2:875-877.[Medline]
  3. Straumann E, Meyer B, Misteli M, Blumberg A, Jenzer HR. Aortic and mitral valve disease in patients with end stage renal failure on long-term haemodialysis Br Heart J 1992;67:236-239.[Abstract/Free Full Text]
  4. Carabello BA, Lytle BW, Chatterjee K, et al. ACC/AHA 2006 Guidelines for the management of patients with valvular heart disease: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines JACC 2006;48:e1-e148.[Free Full Text]
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  6. Lucke JC, Samy RN, Atkins BZ, et al. Results of valve replacement with mechanical and biological prostheses in chronic renal dialysis patients Ann Thorac Surg 1997;64:129-133.[Abstract/Free Full Text]
  7. Takami Y, Tajima K, Terazawa S, et al. Simplified management of hemodialysis dependent patients undergoing cardiac surgery Ann Thorac Surg 2009in press.
  8. Takami Y, Tajima K, Terazawa S, Okada N, Fujii K, Sakai Y. Safer aortic cross-clamping under short-time moderate hypothermic circulatory arrest for cardiac surgery in patients with a bad ascending aorta J Thorac Cardiovasc Surg 2009;137:875-880.[Abstract/Free Full Text]
  9. Akins CW, Miller DC, Kouchoukos NT, et al. Guidelines for reporting mortality and morbidity after cardiac valve interventions Ann Thorac Surg 2008;85:1490-1495.[Free Full Text]
  10. Fishbein MC, Gissen SA, Collins Jr JJ, Barsamian EM, Cohn LH. Pathologic findings after cardiac valve replacement with glutaraldehyde-fixed porcine valves Am J Cardiol 1977;40:331-337.[Medline]
  11. Lamberti JJ, Wainer BH, Fisher KA, Karunaratne HB, Al-Sadir J. Calcific stenosis of the porcine heterograft Ann Thorac Surg 1979;28:28-32.[Abstract/Free Full Text]
  12. Herzog CA, Ma JZ, Collins AJ. Long-term survival of dialysis patients in the United States with prosthetic heart valves: Should the ACC/AHA practice guidelines on valve selection be modified? Circulation 2002;105:1336-1341.[Abstract/Free Full Text]
  13. Jamieson WRE, Cartier PC, Burwash IG, et al. Canadian Cardiovascular Society Surgical management of valvular heart disease Can J Cardiol 2004;20E:1-120.
  14. Blais C, Dumesnil JG, Baillot R, et al. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement Circulation 2003;108:983-988.[Abstract/Free Full Text]
  15. Kohsaka S, Mohan S, Virani S, et al. Prosthesis-patient mismatch affects long-term survival after mechanical valve replacement J Thorac Cardiovasc Surg 2008;135:1076-1080.[Abstract/Free Full Text]
  16. Horst M, Mehlhorn U, Hoerstrup SP, Suedkamp M, de Vivie ER. Cardiac surgery in patients with end-stage renal disease: 10-year experience Ann Thorac Surg 2000;69:96-101.[Abstract/Free Full Text]
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