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Robert W. Stewart
John H. Arnold
Floyd D. Loop
Delos M. Cosgrove, III
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Ann Thorac Surg 1998;66:699-706
© 1998 The Society of Thoracic Surgeons


Original articles: Cardiovascular

Aortic valve replacement for octogenarians: are small valves bad?

Benjamin Medalion, MDa,b, Bruce W. Lytle, MDa,b, Patrick M. McCarthy, MDa,b, Robert W. Stewart, MDa,b, Kristopher L. Arheart, EdDb, John H. Arnold, MDa,b, Floyd D. Loop, MDa,b, Delos M. Cosgrove, III, MDa,b

a Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
b Department of Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA

Address reprint requests to Dr Lytle, Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, 9500 Euclid Ave, F25, Cleveland, OH 44195

Presented at the Thirty-fourth Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 26–28, 1998.


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
Background. As the population ages, more octogenarians become candidates for aortic valve replacement. Many octogenarians, particularly women, have a small aortic annulus and there is uncertainty as to the optimal management of this situation in that age group.

Method. To examine this issue, we reviewed 248 octogenarians (mean age, 82.6 ± 2.3 years; 58% men) who underwent primary isolated aortic valve replacement (n = 99), or aortic valve replacement and coronary revascularization (n = 149), between 1980 and 1995. Nineteen-millimeter valves were used in 26% of the patients.

Results. In-hospital mortality was 8.9%, 5% for aortic valve replacement alone and 11.4% for aortic valve replacement and coronary revascularization. It was 12.5% for the 19-mm size valves compared with 7.7% for the bigger size valves (p = 0.24). Follow-up (mean interval, 4.4 years) demonstrated survival for all patients of 85%, 60%, and 30% and survival free from cardiovascular events of 80%, 45%, and 21% at 1, 5, and 10 postoperative years, respectively. Multivariate analysis identified triple-vessel disease and preoperative congestive heart failure as associated with increased risk for both in-hospital and late mortality (p < 0.05). Valve size did not influence late survival or event-free survival regardless of body surface area.

Conclusions. The use of small aortic valve prostheses in octogenarians does not adversely affect the incidence of early or late mortality or cardiac events.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
As the population ages, more octogenarians become candidates for aortic valve replacement (AVR) [1]. Many octogenarians, particularly women, have a small aortic annulus and there is uncertainty as to the optimal management of this situation in that age group. Small aortic prostheses may leave a residual gradient. On the other hand, aortic root enlargement may complicate an already complex procedure that usually includes bypass grafting [210]. Furthermore, many octogenarians with small annular size are small individuals and have a peak exercise capacity that is more limited than that of younger individuals. The purpose of this study was to examine the short- and long-term outcomes for patients 80 years of age after AVR and to see whether small valve sizes have an association with a bad late clinical outcome.


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
Between 1980 and 1995, 248 octogenarians underwent primary AVR, 99 (40%) having isolated AVR and 149 (60%) AVR with coronary artery bypass grafting (AVR+ CABG). We excluded patients undergoing cardiac reoperations or simultaneous cardiac or noncardiac procedures other than AVR or AVR+CABG.

Preoperative symptoms were classified according to New York Heart Association (NYHA) criteria. All patients underwent preoperative left heart catheterization with coronary arteriography. Categorization of the extent of coronary artery disease into single-vessel, double-vessel, triple-vessel, or left main coronary artery disease was based on a 50% or greater narrowing of a major coronary vessel or a first branch of a major vessel. Patients without coronary narrowing of 50% or greater were not considered to have coronary artery disease. Left ventricular function was evaluated by echocardiography and by the left ventriculogram, when available, and grouped by function as being normal or as having mild, moderate, or severe impairment.

Aortic valve lesions were classified as stenosis (1/4+ insufficiency), insufficiency (20 mm Hg aortic gradient), and mixed (a combination of at least 1/4+ insufficiency and 20 mm Hg aortic gradient). Fourteen patients (5.6%) had isolated aortic insufficiency.

Prosthesis selection was according to surgeon preference. Most patients (92%) received bioprostheses (Carpentier-Edwards bovine pericardium valve, 121 patients; Carpentier-Edwards porcine valve, 95 patients; Hancock porcine valve, 3 patients; Ionescu-Shiley bovine pericardium valve, 8 patients). In 21 patients we used St. Jude mechanical valve. In 64 (26%) patients we used 19-mm valves; larger valve sizes were used in the rest of the patients. In the mechanical valves subgroup, 12 (57%) patients received a 19-mm valve and 9 (43%) patients received a 21-mm valve.

Criteria for classifying the postoperative events and death were according to reporting guidelines of The Society of Thoracic Surgeons [11], except for late episodes of bleeding which we defined, rather than anticoagulant-related bleeding, as late bleeding occurring either in the presence or absence of anticoagulation. In addition, postoperative myocardial infarction was defined as new q waves in an electrocardiogram or elevation of myocardial enzymes. Postoperative bleeding refers to patients who needed reexploration of the chest because of excessive bleeding. Renal failure was defined as renal failure requiring at least temporary dialysis. Respiratory failure was defined as mechanical ventilation of more than 48 hours or readmission to the intensive care unit because of respiratory problems, reintubation, or respiratory arrest. Sternal wound infection was defined as deep wound infection involving the sternum. Postoperative gastrointestinal complication was defined as gastrointestinal complication that necessitated intervention, either surgical or by endoscopy. The period of time between the patient’s arrival to the intensive care unit (ICU) and the time the patient left the ICU is the ICU stay. The period of time from the operation until discharge from the hospital is the hospital stay.

Follow-up data were obtained by mail questionnaires and telephone contact by trained personnel. Patients were contacted at a mean follow-up interval of 4.4 years; follow-up was 100% complete.

A list of the variables analyzed for early and late events is presented in Appendix 1. Data were assessed by univariate analysis (t test, {chi}2, or Fisher’s exact test when appropriate). All variables that achieved p less than 0.2 in the univariate analysis were included in a multivariate model and examined by actuarial analysis, logistic regression for early events, and Cox multivariate analysis method for late events. Deaths from all causes were considered in the actuarial analyses except when indicated. Annualized rates for events are calculated and presented for descriptive purposes. Because rates can include multiple events for a patient, no statistical comparison between annualized rates was done. Statistical significance was defined as p less than 0.05.


    Results
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
Patient population
For examination of valve size, the patients were divided into two groups. One group included patients with small valve size (SVS), defined here as patients who received a 19-mm valve. The second group included patients with bigger than 19-mm valve sizes (BVS). Patients with SVS were associated with female sex, older age, smaller body surface area (BSA), smaller aortic valve area, higher preoperative gradient across the valve, less smoking history, less circumflex coronary artery disease, and more degenerative calcified aortic stenosis, as presented in Table 1.


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Table 1. Characteristics of Patients

 
Mortality
There were 22 (8.9%) in-hospital deaths of 248 patients. Of those who had only AVR, 5 (5%) of 99 died, compared with 17 of 149 (11.4%) of those who underwent AVR+CABG (p = 0.09). In the SVS patients, 8 of 64 died (12.5%) compared with 14 of 184 (7.7%) for the BVS patients (p = 0.24). Selected characteristics of the patients with the related mortality rate are presented in Table 2. The cause of death was infection in 9 (41%), cardiac in 8 (36%), and stroke in 5 (23%) patients. The cause of death for patients with SVS or BVS was not different (p = 0.6).


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Table 2. In-Hospital Mortality According to Selected Characteristics of Patients

 
A multivariate logistic regression analysis of the preoperative variables revealed that triple-vessel disease (TVD) and congestive heart failure (CHF) were the only variables associated with higher in-hospital mortality. Of postoperative complications, respiratory failure and sepsis were found to increase in-hospital mortality (Table 3).


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Table 3. Multivariate Analysis of In-Hospital Mortality

 
Analysis of early and late survival did not demonstrate that the specific valve prosthesis or type of valve (mechanical or tissue) correlated with survival.

Morbidity
Thirty-five percent of patients experienced at least one complication after the operation. The most common complications were respiratory failure (21%) and reexploration for bleeding (10.5%). The rate of postoperative new-onset atrial fibrillation was 58%. The SVS patients had more complications (42.2%) compared with the BVS patients (31.7%), but this did not achieve statistical significance (p = 0.13) (Table 4). We performed multivariate logistic regression analysis of the preoperative variables for each postoperative complication. The isolated risk factors for each postoperative complication, as identified by multivariate analysis, are presented in Table 5. Preoperative CHF and smaller BSA were found to be associated with a higher likelihood of developing any postoperative complication, excluding atrial fibrillation.


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Table 4. In-Hospital Outcome

 

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Table 5. Multivariate Analysis of Postoperative Complications

 
Length of stay
The mean ICU stay was 6.1 ± 12 days (median, 2.2 days), and mean hospital length of stay was 17.7 ± 21 days (median, 11.1 days). There was no difference in the length of stay for SVS and BVS groups (Table 4). The longer the patient stayed in the ICU, the higher the in-hospital mortality was. Of the 27 patients who stayed at least 7 days in the ICU, 9 (33%) died, and of the 16 patients who stayed at least 14 days, 7 (43.7%) died. Creatinine level greater than 1.6 mg/dL and earlier year of operation were found to be independent preoperative risk factors for longer ICU and hospital stay. In addition, ICU stay was also affected by chronic obstructive lung disease and unstable angina. Respiratory failure, sepsis, and renal failure were complications associated with longer ICU and hospital stays. Stroke was associated with longer ICU stay only (Table 6).


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Table 6. Multivariate Analysis of Length of Stay

 
Late death
The overall survival for all study patients, including in-hospital and late death, was 85%, 60%, and 30% at 1, 5, and 10 years, respectively (Fig 1). The survival of patients in this study was not found to be different from the expected survival for octogenarians in the general population matched by age and sex (standardized mortality ratio, 0.82; 95% confidence interval, 0.75 to 1) [12]. Patients who had isolated AVR or AVR+CABG had a similar overall survival (Fig 2). The longest follow-up for a patient with SVS in our study is 9 years. Up to 9 years of follow-up, the late overall survival of both SVS and BVS was not found to be different (Fig 3), even when studied for patients with BSA more than 1.7 m2 (Fig 4).



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Fig 1. Overall survival and event-free survival for all study groups.

 


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Fig 2. Overall survival and event-free survival according to type of operation. (AVR = aortic valve replacement; AVR+CABG = AVR and coronary artery bypass grafting; NS = not significant.)

 


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Fig 3. Overall survival and event-free survival according to valve size. (NS = not significant.)

 


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Fig 4. Overall survival and event-free survival according to valve size for patients with body surface area (BSA) greater than 1.7 m2. (NS = not significant.)

 
Multivariate analysis of the preoperative variables revealed that TVD and preoperative signs of CHF were predictors of late death (Table 7). Overall survival according to these risk factors is presented in Fig 5. Eleven percent of patients had both TVD and CHF. They had significantly worse outcome compared with 33% of patients who did not have these risk factors with 1-, 5-, and 10-year survival of 63%, 44%, and 0% compared with 95%, 81%, and 45%, respectively (p < 0.001).


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Table 7. Multivariate Analysis of Late Events

 


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Fig 5. Overall survival according to risk factors. (CHF = presence of CHF but not TVD; TVD = presence of TVD but not CHF; -TVD-CHF = no triple-vessel disease [TVD] and no congestive heart failure [CHF]; +TVD+CHF = presence of both TVD and CHF.)

 
Event-free survival
Annualized rates for major cardiac events are presented in Table 8. Because rates can include multiple events for a patient, no statistical comparison between annualized rates was done. Late event-free survival of major cardiac events, including death, was 80%, 45%, and 21% at 1, 5, and 10 years, respectively, for all patients (Fig 1). Patients with isolated AVR and AVR+CABG had similar event-free survival (Fig 2). As well, the event-free survival in SVS and BVS groups did not differ, regardless of BSA (Figs 3, 4). Multivariate analysis revealed that preoperative chronic lung disease, NYHA functional class III or IV, and aortic valve gradient less than 70 mm Hg were associated with more events during follow-up (Table 7).


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Table 8. Annualized Rate of Late Events

 
Functional class
At time of follow-up, 98% of the patients were in NYHA class I or II, regardless of valve size.


    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
Even for relatively elderly patients, aortic valve disease can have a major negative effect on life expectancy if left untreated. A study of 50 patients with a mean age of 77 years found that only 25% survived 3 years after they were found to have significant aortic stenosis [13]. Balloon dilation of the aortic valve, initially considered to be an attractive alternative treatment for elderly patients with aortic stenosis, proved to produce poor medium- and long-term results [14, 15]. Despite some increase in the surgical risk for these elderly patients, our results here support previous data from other groups demonstrating that octogenarians may benefit from AVR [1622].

The octogenarian patients in this series who underwent AVR had an overall in-hospital mortality of 8.9% and a 1-, 5-, and 10-year total survival of 85%, 60%, and 30%, respectively. The survival of these patients was not different from the expected survival for octogenarians in the general population matched by age and sex. Furthermore, the quality of life of the long-term survivors measured by event-free survival and functional class was also extremely good.

For patients with coronary artery disease who also underwent bypass grafting in addition to AVR there was a trend toward an increased in-hospital mortality rate (11.4%). But this was not a statistically significant increase, and overall, the presence of coronary artery disease did not affect long-term outcome. The subset of patients with coronary artery disease who had TVD did have increased early and late mortality rates, and the presence of CHF also increased the risk of death. However, it is striking that for patients who did not have either TVD or CHF at the time of their operation, their 5-year survival rate was 81%, a remarkable figure for patients who by the end of 5 postoperative years were at least 85 years old.

In-hospital complications were relatively common for these elderly patients. Especially of note was the high rate of postoperative atrial fibrillation (58%). However, atrial fibrillation did not appear to be associated with increased hospital stay or increased risk. Respiratory failure, either primary or secondary to the occurrence of pneumonia, was also relatively common (21%), and multivariate analysis did identify the presence of respiratory failure after operation as a factor associated with increased in-hospital mortality rate. Sepsis, although not as common, was also found to be a risk factor for in-hospital death. The lengths of stay both in the ICU and in-hospital to discharge were long but were heavily affected by the very long stays of a few complicated patients, accounting for the large difference between the mean ICU stay (6.1 days) and the median stay (2.2 days). Preoperative renal dysfunction (creatinine > 1.6 mg/dL), unstable angina, and chronic obstructive lung disease were risk factors for longer in-hospital stay.

Small aortic annulus
Because it is currently unclear whether elderly patients with a small aortic annulus should undergo AVR with a 19-mm valve [2, 5, 6, 9, 23] or a more complicated procedure including aortic root enlargement to allow the insertion of a bigger valve [3, 4, 8, 10], a focus of this study was to see whether placement of a 19-mm prosthesis compromised outcomes.

Twenty-six percent of the patients in this study (SVS group) received a 19-mm valve. There was a clear association of 19-mm valve size with female sex and a small BSA. The SVS patients did exhibit trends toward a higher in-hospital mortality rate and a higher incidence of in-hospital complications when compared with patients who received larger valves, but those differences were not significant with either univariate or multivariate testing. Also, there was no difference in the length of hospital stay based on valve size. Most importantly, with up to 9 years of follow-up, survival, event-free survival, and NYHA functional class were not related to valve size.

We also specifically examined valve size in relationship to BSA. It has been suggested by Kratz and associates [3] that patients with BSA greater than 1.9 m2 or even patients with BSA greater than 1.7 m2 who receive small size St. Jude valves are more likely to experience late sudden death. He and coworkers [6] have suggested that BSA greater than 1.7 m2 is a predictor of late death for patients who require concomitant CABG in addition to receiving small valves. On the other hand, Sawant and colleagues [24] did not find BSA greater than 1.7 m2 to be a risk factor for long-term survival in patients who received 19-mm St. Jude valves. In our study 19 patients received 19-mm valves and had a BSA greater than 1.7 m2 (1.8 ± 0.08; range, 1.72 to 1.98 m2). There was no in-hospital mortality among these patients, and the long-term survival and event-free survival were similar to those who had larger valves and a BSA greater than 1.7 mm2 (p = 0.98 and p = 0.86, respectively).

Our previous studies concerning AVR and AVR + CABG for patients in all age groups have convinced us that older patients have a lower late death rate if they receive tissue valves [25, 26]. In this study, the type of valve that was used (mechanical versus tissue) did not appear to affect survival, but very few patients received mechanical prostheses, making conclusions on this issue invalid. To avoid the risks of anticoagulation we prefer to use tissue valves for octogenarians, and based on the findings of this study we are comfortable using 19-mm pericardial valves as aortic valve prostheses except for patients with an extremely large BSA.

Conclusions
We conclude that AVR can favorably be performed in octogenarians. The addition of CABG operation is associated with a trend toward an increased in-hospital mortality but does not seem to affect the long-term outcome. Patients without preoperative CHF and TVD who undergo isolated AVR are the most favorable subgroup of patients for both short- and long-term outcome. Octogenarians with a small aortic annulus can safely undergo AVR with a 19-mm tissue valve.


    Acknowledgments
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
We gratefully thank Maura Schnauffer for her assistance with the preparation of the manuscript.


    Appendix 1. Variables studied
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 
Preoperative variables studied

Age
Sex
Body surface area
Blood urea nitrogen
Blood creatinine
Hypertension
Diabetes
Smoking history
History of myocardial infarction
Electrocardiographic signs of myocardial infarction
Peripheral vascular disease
Chronic obstructive lung disease
Unstable angina
Emergency operation
Syncope
Stroke
Congestive heart failure
Enlarged cardiothoracic ratio by chest x-ray films
New York Heart Association functional class
Aortic valve area
Aortic valve gradient
Aortic insufficiency
Extent of coronary disease (single-, double-, or triple-vessel disease)
Left main coronary artery disease
Left anterior descending coronary artery disease
Circumflex coronary artery disease
Right coronary artery disease
Left ventricular function
Intraaortic balloon pump
Emergency operation

Intraoperative variables studied

Type of operation
Valve pathology
Type of valve inserted
Prosthetic valve size
Aortic cross-clamp time
Cardiopulmonary bypass time
Type of myocardial protection
Systemic temperature on cardiopulmonary bypass
Year of operation

Postoperative variables studied

Intensive care unit length of stay
Hospital length of stay
Blood urea nitrogen
Blood creatinine


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Appendix 1. Variables studied
 References
 

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