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Major Elective Surgery for Vascular Disease in Patients Aged 80 or More: Perioperative (30-Day) Outcomes
Major Elective Surgery for Vascular Disease in Patients Aged 80 or More: Perioperative (30-Day) Outcomes Enzo Ballotta,1 Giuseppe Da Giau,1 Carmelo Militello,2 Oreste Terranova,2 and Antonio Piccoli,3 Padua, Italy
Although major vascular surgery is performed with increasing frequency in elderly people, the impact of age on outcomes is uncertain. We evaluated the perioperative (30-day) outcomes for patients who underwent major elective vascular operations under general or peripheral anesthesia in their eighties and nineties in a 14-year period. Data for all consecutive 3,060 patients (456 of them 80 years old) who underwent 3,314 elective vascular surgery procedures were prospectively entered into a computerized vascular registry. Detailed information was collected on patients’ preoperative status, type of procedure and anesthesia, perioperative outcomes, and predictors of perioperative outcomes. The end points of the study were perioperative death and main surgical complications. Perioperative all-cause mortality rates varied across operations and were higher in elderly than in younger patients (1.4% vs. 0.2%, P ¼ 0.014) after abdominal surgery (2.4% vs. 0.1%, P ¼ 0.006) and especially after abdominal aortic aneurysm repair (2.8% vs. 0%, P ¼ 0.035). In the elderly cohort, the mortality rate was <1% for almost 60% of all operations. In logistic regression analysis, only preoperative hypertension (odds ratio [OR] ¼ 72.5, 95% confidence interval [CI] 9.4-557.6), congestive heart failure (OR ¼ 16.5, 95% CI 2.3115.9), and perioperative cardiac (OR ¼ 20.7, 95% CI 1.6-273.8) and pulmonary (OR ¼ 41.7, 95% CI 7.9-218.9) complications were associated with a higher 30-day death risk. In this series, perioperative outcomes were not influenced by the type of elective surgical procedure. Though overall mortality after major vascular surgery was higher in patients 80 years old, age per se was not an independent factor of a higher perioperative mortality risk or fatal and nonfatal complications.
INTRODUCTION Longevity has increased in the last century, and survival to over 80 years old is now common in all 1 Vascular Surgery Section, Geriatric Surgical Clinic, Department of Surgical and Gastroenterological Sciences, University of Padua, School of Medicine, Padua, Italy. 2 Geriatric Surgical Clinic, Department of Surgical and Gastroenterological Sciences, University of Padua, School of Medicine, Padua, Italy. 3 Division of Nephrology, Department of Medical and Surgical Sciences, University of Padua, School of Medicine, Padua, Italy.
Correspondence to: Enzo Ballotta, MD, Vascular Surgery Section, Geriatric Surgical Clinic, Department of Surgical and Gastroenterological Sciences, University of Padua, School of Medicine, 2nd Floor, Ospedale Giustinianeo, Via N. Giustiniani 2, 35128 Padua, Italy, E-mail: [email protected] Ann Vasc Surg 2007; 21: 772-779 DOI: 10.1016/j.avsg.2007.04.005 Ó Annals of Vascular Surgery Inc. Published online: May 29, 2007
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industrialized countries: individuals reaching the age of 80 have a life expectancy of 7 and 9 years for men and women, respectively.1 The aging of the population has led to an increased number of elderly patients with various diseases undergoing surgery and anesthesia, but when it comes to major surgery for the very elderly, decision making is difficult and complicated by the perception that the risks are high. Although the risks of surgery do increase with age,2 severity of illness and comorbidity are more important predictors of complications than age itself.3,4 Patients undergoing vascular surgery for an expanding abdominal aortic aneurysm (AAA), aortoiliofemoral occlusive disease, or severe carotid disease are at risk of serious perioperative cardiac complications, such as myocardial infarction (MI), arrhythmia, and death because of the high incidence of coronary artery disease (CAD) and the
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hemodynamic stresses associated with vascular procedures. This risk is expected to be higher in elderly patients undergoing major vascular surgery because cardiovascular disease is commonly the leading cause of mortality and morbidity in such people.5,6 Previous observational studies investigating perioperative outcome after vascular surgery in the elderly have focused on specific types of surgery, e.g., AAA repair7,8 or carotid endarterectomy (CEA) for symptomatic and asymptomatic disease9-11 or lower extremity revascularization,12,13 or they have considered several vascular procedures within a wider ‘‘scenario’’ of major noncardiac surgery,14-16 reporting various mortality and morbidity rates that reflect small sample sizes and divergent experiences at single institutions. No investigators have so far considered the overall perioperative outcome of different types of surgery for vascular disease in the very elderly. This study was designed to analyze the perioperative outcomes of patients aged 80 years who underwent major elective vascular surgery at our institution, comparing the results with findings for major elective vascular surgery performed in patients under 80 years old.
METHODS Data Collection Since 1990, pertinent clinical data for all consecutive patients undergoing vascular surgery at our institution have been prospectively entered into a computerized vascular registry. For this study, the database was queried to identify patients aged 80 and <80 years who had major elective vascular surgery (e.g., open infra- or juxtarenal abdominal surgery for AAA or occlusive disease, CEA or supra-aortic trunk surgery, femoral and lower extremity artery reconstruction, extra-anatomical revascularization for aortoiliac disease) under general, spinal, or epidural anesthesia up until December 2003. Emergency surgical procedures (ruptured AAA repair, acute upper and lower extremity ischemia, or vascular trauma), procedures for lower extremity amputations or redo surgery, and endovascular procedures were not considered. The database, which is updated regularly with patient follow-up data, was queried retrospectively, and the clinical charts were reviewed. Preoperative Health Status Preoperative demographic information included the patient’s age and gender. Other potential
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preoperative risk factors measured included a history of smoking (defined as past or current cigarette smoking) and diseases related to the cardiovascular, pulmonary, neurological, or renal/urinary systems. Diabetes mellitus, hyperlipidemia, and hypertension were considered to be present if clinically diagnosed and documented in the medical records. Cardiac disease included any of the following: a history of MI, atrial fibrillation, congestive heart failure (CHF), coronary artery angioplasty/stenting or bypass grafting, surgery for valve disease or signs of ischemia on electrocardiogram (ECG), and nitrate therapy. Pulmonary disease was defined as a history of chronic restrictive or obstructive disease based on pulmonary function tests, pulmonary embolism, and prior lobectomy or pneumonectomy. Cerebrovascular disease was defined as a history of transient ischemic attacks or stroke. Chronic kidney disease (CKD) was defined as a serum creatinine level >1.5 mg/dL in either conservative or dialysis treatment. Perioperative Variables Potential variables predictive of adverse events included American Society of Anesthesiologists (ASA) classification and type of anesthesia. The ASA classification rates patients as follows: 1, healthy; 2, mild to moderate systemic disease; 3, severe disease that limits activity; 4, severe, incapacitating disease that is a constant threat to life. This rating was drawn from the patient’s preoperative evaluation by the anesthesiologists. End Points The end points of the study were (1) mortality at 30 days or at discharge and (2) adverse outcomes within 30 days after surgery, including cardiac, pulmonary, renal/urinary tract, gastrointestinal, wound, nervous system, and other complications. Cardiac complications were classified by a single cardiologist and included (1) MI with a diagnosis on the basis of creatinine kinase isoenzyme with muscle and brain subunits (CK-MB) levels and ECG findings, (2) pulmonary edema confirmed by chest radiography, (3) documented ventricular fibrillation or primary cardiac arrest, and (4) new complete heart failure requiring a pacemaker. A postoperative ECG was routinely obtained in all patients who had a history of CAD, CHF, or arrhythmia (rhythm other than sinus); and cardiac isoenzymes were obtained in all patients who had new findings at postoperative ECG. Pulmonary adverse events were defined as respiratory failure requiring intubation for more than 2 days or reintubation;
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noncardiogenic pulmonary edema; lobar pneumonia confirmed by chest radiography and requiring antibiotic therapy; and pulmonary embolism documented by autopsy, angiography or a high-probability ventilation-perfusion scan. A renal adverse event was defined as acute renal failure requiring dialysis, and neurological complications were defined as cerebrovascular accidents with new neurological deficits. Outcomes requiring therapy, such as medication, further workup, or transfer to a higher-acuity ward, were also recorded. Statistical Analysis Statistical analysis was performed with Student’s ttest for continuous data and chi-squared analysis for categorical data. All tests were two-tailed, and statistical significance was inferred at P < 0.05. Thirty-day and in-hospital mortality rates were determined for all operations in each category. Morbidity rates for patients aged 80 and <80 years were tabulated and compared, reporting the occurrence of one or more complications. Thirty-day and in-hospital mortality rates were also calculated for patients who experienced each type of complication. Since perioperative outcome depended on the surgical procedure and patients who had more than one operation were exposed to the compounded death or complication risk, several data items were analyzed vis-a`-vis surgical procedures instead of patients. Significant predictors of outcome were investigated by examining the frequency distribution of various pre- and perioperative variables, followed by a logistic regression analysis on sets of predictors with statistical or marginal significance to determine the independent predictors of death and fatal and nonfatal perioperative complications (Wald’s test). Results are presented as odds ratios (ORs) and two-sided 95% confidence intervals (CIs).
RESULTS Demographic Characteristics In the Vascular Surgery Registry at our institution (University Medical Center), we identified 3,081 consecutive patients who had undergone elective surgery for vascular diseases from January 1, 1990, to December 31, 2003; 21 medical records had been lost, bringing our total down to 3,060 patients. In all, 3,314 surgical procedures were performed by the same surgeon in 3,060 patients, 456 of them aged 80 years (15%, 491 operations), while the other 2,604 patients (85%, 2,823 operations) were younger. The difference between the number of
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patients and operations lies in that 254 surgical procedures (35 in the elderly group and 219 in the younger group) were either bilateral or of more than one type in the same patient. The preoperative demographic data for the two groups considered are shown in Table I. The median age was 82 in the older group and 62 in the younger group. Older patients were significantly more likely to have arterial hypertension (51.3% vs. 36.7%, P < 0.001), CHF (6% vs. 3.5%, P ¼ 0.021), pulmonary disease (36% vs. 30.8%, P ¼ 0.031), and CKD (23.7% vs. 19.3%, P ¼ 0.034). Most patients aged 80 had higher ASA scores, indicating higher-risk patients (ASA class 3 60.7% vs. 52.8%, P ¼ 0.002, and ASA class 4 12.5% vs. 7.7%, P ¼ 0.001), whereas the proportion of healthy (ASA class 1 10.7% vs. 5.5%, P < 0.001) or low-risk (ASA class 2 28.7% vs. 21.3%, P ¼ 0.001) patients was higher in the younger group. The type of surgical procedure varied between and within the two groups. Lower extremity artery reconstruction (32.4%) and CEA (27.5%) were the most common operations performed in octogenarians. Perioperative Mortality and Morbidity The 30-day and in-hospital mortality rates coincided in this study (Table II). There were 11 perioperative deaths, representing an overall 30-day mortality rate of 0.3%. Overall, the perioperative mortality rate was higher for the elderly patients (1.4% vs. 0.2%, P ¼ 0.014) after abdominal surgery (2.4% vs. 0.1%, P ¼ 0.006) and particularly after AAA repair (2.8% vs. 0%, P ¼ 0.035). In the frequency distribution of 30-day death, only older age (P ¼ 0.015) and hypertension (P ¼ 0.045) were correlated with a significantly higher risk, whereas cardiac disease (P ¼ 0.069) and CHF (P ¼ 0.093) showed marginal significance. Sex, smoking, hyperlipidemia, diabetes mellitus, pulmonary and cerebrovascular diseases, CKD, ASA scores, and type of surgery were not significant predictors of perioperative mortality. In the logistic regression analysis for perioperative mortality, including all the above factors, only hypertension (OR ¼ 72.5, 95% CI 9.4-557.6) and CHF (OR ¼ 16.5, 95% CI 2.3-115.9) increased the 30-day death odds. The overall morbidity rate was 15.2% (507 of 3,314) (Table III). The rate of pneumonia was significantly higher in the elderly (2.4% vs. 0.7%, P < 0.001), however, although the incidence of pulmonary complications was comparable in the two groups. Cardiac complications occurred in 14
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Table I. Baseline patient characteristics and type of vascular procedure Age (years) Patient characteristics
<80 (n ¼ 2,604)
80 (n ¼ 456)
Age, median (25th, 75th) Male, n (%) Diabetes mellitus, n (%) Hypertension, n (%) Hyperlipidemia, n (%) Current or past history of smoking, n (%) Cardiac disease, n (%) CHF, n (%) Pulmonary disease, n (%) Cerebrovascular disease, n (%) CKD (creatinine level >1.5 mg/dL), n (%) Dialysis-dependent Non-dialysisedependent ASA class, n (%) 1 2 3 4 All operations/all patients, n Open infrarenal or juxtarenal abdominal surgery, n (%) Aneurysmal disease, n (%) Occlusive disease, n (%) CEA and supra-aortic trunk surgery, n (%) Lower extremity artery reconstruction, n (%) Extra-anatomical surgery for aortoiliac disease (axillo- or femorofemoral bypass), n (%)
62 1,789 852 954 415 1692 859 92 801 827 502 35 467
82 305 155 234 82 313 161 27 164 126 108 2 106
(46, 70) (68.7) (32.7) (36.7) (15.9) (64.9) (33.0) (3.5) (30.8) (31.7) (19.3) (1.3) (18)
(81, 84) (66.9) (34.0) (51.3) (18.0) (68.6) (35.3) (6.0) (36.0) (27.6) (23.7) (0.5) (23.2)
279 (10.7) 747 (28.7) 1,376 (52.8) 202 (7.7) 2,823/2604 750 (26.6)
25 (5.5) 97 (21.3) 277 (60.7) 57 (12.5) 491/456 126 (25.7)
327 423 1,332 714 27
72 54 135 159 71
patients (2.8%) in the elderly group, noncardiac complications in 70 (14.2%), and both in 8 (1.6%). Patients experienced cardiac complications more often on postoperative days 1-3, whereas noncardiac complications were spread from the day of
(11.6) (15.0) (47.2) (25.3) (0.9)
P
0.474 0.631 <0.001 0.306 0.142 0.360 0.021 0.031 0.089 0.034
<0.001 0.001 0.002 0.001
(14.6) (11.0) (27.5) (32.4) (14.5)
surgery to postoperative day 6. Neurological complications only occurred in patients who underwent carotid revascularizations. A logistic regression model was constructed for cardiac and noncardiac complications, including
Table II. Perioperative (30-day) mortality by type of operation Age (years) Operation
<80 (n ¼ 2,823)
80 (n ¼ 491)
Total (n ¼ 3,314)
P
All operations, (n/N ) % Open infrarenal or juxtarenal abdominal surgery, (n/N ) % Aortic aneurysm repair Aortoilio/femoral bypass/ endarterectomy CEA and supra-aortic trunk surgery, (n/N ) % Infrainguinal arterial reconstruction, (n/N ) % Extra-anatomical surgery for aortoiliac disease (axillo- or femorofemoral bypass), (n/N ) %
(6/2,823) 0.2 (1/750) 0.1
(5/491) 1.4 (3/126) 2.4
(11/3,314) 0.3 (4/876) 0.4
0.014 0.006
(0/327) 0 (1/423) 0.2
(2/72) 2.8 (1/54) 1.8
(2/399) 0.5 (2/477) 0.4
0.035 0.540
(4/1,332) 0.3
(0/135) 0
(4/1,467) 0.2
0.819
(1/714) 0.1
(1/159) 0.6
(2/873) 0.2
0.803
(0/27) 0
(1/71) 1.4
(1/98) 1.0
0.613
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Table III. Overall 30-day morbidity Age (years) Complications
<80 (n ¼ 2,823)
80 (n ¼ 491)
Total (n ¼ 3,314)
>1 complication, n (%) Cardiac (MI, arrhythmia, pulmonary edema, cardiac arrest), n (%) Pulmonary, n (%) Pneumonia Other Renal/urinary tract, n (%) Urinary tract infection Other Gastrointestinal (small bowel obstruction, ileus, bleeding, gastritis), n (%) Wound (deep or superficial wound infection, dehiscence, lymph leak), n (%) Nervous system (stroke, peripheral nerve injury), n (%) Other (bleeding requiring >4 units blood, multiorgan failure, deep-vein thrombosis, graft or prosthesis failure), n (%) Overall, n (%)
133 (4.7) 72 (2.5)
36 (7.3) 14 (2.8)
169 (5.1) 86 (2.6)
22 12 10 21 21 0 5
104 32 72 98 88 10 23
82 20 62 77 67 10 18
(2.9) (<1) (2.2) (2.7) (2.4) (<1) (<1)
(4.5) (2.4) (2.0) (4.3) (4.3) (1.0)
P
0.020 0.815
(3.1) (1.0) (2.1) (2.9) (2.6) (<1) (<1)
0.087 <0.001 0.084 0.023 0.520
52 (1.8)
11 (2.2)
63 (1.9)
0.676
71 (2.5)
6 (1.2)
77 (2.3)
0.111
51 (1.8)
5 (1.0)
56 (1.7)
0.288
423 (15.0)
84 (17.1)
507 (15.2)
0.254
age, sex, comorbidities, ASA scores, and surgical procedures. The model indicated that male sex (OR ¼ 1.8, 95% CI 1.1-3.0) and ASA score (OR ¼ 1.7, 95% CI 1.2-2.3) increased the odds of cardiac complications and that smoking (OR ¼ 3.3, 95% CI 1.8-6.1) and pulmonary disease (OR ¼ 6.9, 95% CI 4.0-11.7) increased the odds of pulmonary complications. In a second logistic regression model for the outcome of perioperative death, including all perioperative complications considered, only cardiac (OR ¼ 20.7, 95% CI 1.6-273.8) and pulmonary (OR ¼ 41.7, 95% CI 7.9-218.9) complications increased the odds of perioperative mortality.
DISCUSSION Although cardiovascular disease is primarily a disorder of the elderly, the surgical management of vascular disease in the elderly patient has often been approached more hesitantly than in the case of younger patients. This bias stems from the perception of a greater operative risk due to the presence of comorbidities. The present study statistically confirms the impression of higher operative risk but refutes the contention that this is entirely due to age.
We found a relatively low 30-day mortality rate (1.4%) for more than 450 patients aged 80 years who had major elective vascular surgery at our institution between 1990 and 2003. Although the 30day mortality rate among our elderly patients was <1% for almost 60% of the operations performed, the overall incidence was nonetheless significantly higher than in the younger patients, especially when abdominal surgery for AAA repair was considered. An early mortality after AAA repair of almost 3% might be seen as high for a prophylactic procedure, but this figure is lower than the one recommended for high-risk patients in a recent article.17 Paty et al.7 reported comparable results but noted no difference in perioperative mortality rates (3% vs. 2%) in a retrospective study comparing 77 patients aged 80 with 622 younger patients undergoing elective AAA repair. Likewise, in a retrospective analysis of 856 patients who underwent elective AAA repair, among the 49 of them who were 80, Berry et al.18 reported an in-hospital mortality rate of 2% and an incidence of major complications of 23%, reflecting the favorable results achieved in previous series, which included both in-hospital and 30-day mortality data.8,19 There were no perioperative deaths or strokes in our subgroup of elderly patients who underwent
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CEA, all performed under deep general anesthesia in a mainly symptomatic patient population (66%) and with an occluded contralateral carotid artery in >50% of cases. This is consistent with and adds to the data from our previous investigations focusing on early and late outcomes of CEA in the elderly11,20 and correlates well with numerous other reports of excellent results in such patients,9,10,21-23 demonstrating that the very elderly may benefit from CEA even more than younger people. There were relatively few perioperative deaths in our series, and this may explain why the logistic regression analysis identified only two comorbidities (i.e., hypertension and CHF) and two postoperative adverse events (i.e., cardiac and respiratory complications) with an independent significant effect on the 30-day mortality rate. Numerous reports have identified hypertension, in addition to other variables, as a risk factor for perioperative death after vascular surgery, especially AAA repair,24-26 while other studies have found that hypertension was not an independent risk for any perioperative adverse events after noncardiac surgery.27,28 The agreement found in our analysis between CHF and perioperative mortality correlates well with data from other investigations.29 The clinical diagnosis of CHF in older patients may be complicated by the lack of typical symptoms and physical findings,30 and as many as one-third of patients with a history of CHF may have a normal systolic function,31 suggesting that CHF can result from left ventricular diastolic dysfunction despite left ventricular systolic function being preserved. The adequacy and accuracy of preoperative heart function assessment in candidates for elective vascular surgery are therefore a critical field of further investigation. This study found that the independent effect of the type of surgery had no influence on perioperative death and complications and that older age and cardiac disease (variables that were predictors of perioperative death in the frequency distribution) failed to appear in the logistic regression model. Although the lack of previously published studies considering all major vascular operations and their perioperative outcomes prevents us from drawing any useful comparisons, the patient’s age was reportedly not a predictor of perioperative death in many other studies either, which (though they only focused on a specific type of vascular surgery) found that other factors were strongly associated with perioperative mortality in elderly patients, factors proving stronger determinants of death than age.3,4,7-10,13,18 Unlike other studies that identified
Surgery for vascular disease in patients aged 80 or more 777
CAD as an independent risk factor for perioperative mortality after various types of vascular surgery,14,18,32-34 in our analysis cardiac disease was not a comorbidity significantly associated with perioperative death. This is probably due to the fact that all our patients were examined preoperatively by a cardiologist and significant CAD was treated by coronary artery angioplasty/stenting or bypass grafting, reflecting better surgical and perioperative techniques and monitoring rather than a lower-risk cohort. This impression correlates well with the analysis by Eagle et al.35 on the 24,959 participants with known CAD in the Coronary Artery Surgery Study database, in which the cardiac risk associated with noncardiac operations involving the chest, abdomen, vasculature, and head and neck was significantly lower in patients who had undergone prior coronary artery bypass grafting (postoperative death 1.7% vs. 3.3%, MIs 0.8% vs. 2.7%). Conversely, in a recently published randomized clinical trial that specifically addresses the influence of coronary revascularization on mortality rates before major vascular surgery, the Coronary Artery Revascularization Prophylaxis trial, McFalls et al.36 found that elective coronary revascularization does not appear to provide an additional benefit in reducing the incidence of perioperative death or MI. Almost one in six patients suffered at least one perioperative complication. Although the incidence of pneumonia was significantly higher in the older group, the overall incidence of perioperative complications was comparable for the older and younger patient groups. At logistic regression, older age and many of the conditions associated with aging (e.g., hypertension and cardiac disease) did not increase the risk of early cardiac complications, and older age as such did not increase the risk of other noncardiac, particularly respiratory, complications that, along with cardiac adverse events, emerged as independent predictors of perioperative death. This goes to show that major elective vascular surgery in elderly patients is not associated with an increase in surgery-related complications and that age in itself is not a predictor of fatal perioperative complications. Our findings should be interpreted in the light of the study’s limitations. Though our data were collected prospectively, the analysis is retrospective in nature. The inclusion of patients undergoing only elective surgery may explain the low mortality and morbidity rates observed. The small number of deaths also led to larger standard errors and wider confidence limits in the model used to assess the association between independent predictors and mortality rate. The unbalanced distribution of the
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surgical procedures in both groups has complicated the interpretation of the results, particularly because of the very low mortality and morbidity rates associated with CEA procedures compared with the other major vascular operations. Stratified analyses could have been used to address this limitation, but given the very small number of 30-day adverse events, these were not feasible. Moreover, all patients were treated at a single institution and all surgical procedures were performed by the same surgeon, so the surgical outcomes may be different at other centers or when more surgeons are involved. In conclusion, the overall results of this study indicate that the type of elective surgical procedure does not influence perioperative outcome. Although the overall mortality rate after major vascular surgery is higher in patients in their eighties, age per se is not an independent factor of any greater risk of perioperative mortality or fatal and nonfatal complications.
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14.
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34. L’Italien GJ, Cambria RP, Cutler BS, et al. Comparative early and late cardiac morbidity among patients requiring different vascular surgery procedures. J Vasc Surg 1995;21: 935-944. 35. Eagle KA, Rihal CS, Mickel MC, et al. Cardiac risk of noncardiac surgery: influence of coronary disease and type of surgery in 3368 operations. CASS Investigators and University of Michigan Heart Care Program. Coronary Artery Surgery Study. Circulation 1997;96:1882-1887. 36. McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. N Engl J Med 2004;351:2795-2804.
Although major vascular surgery is performed with increasing frequency in elderly people, the impact of age on outcomes is uncertain. We evaluated the perioperative (30-day) outcomes for patients who underwent major elective vascular operations under general or peripheral anesthesia in their eighties and nineties in a 14-year period. Data for all consecutive 3,060 patients (456 of them 80 years old) who underwent 3,314 elective vascular surgery procedures were prospectively entered into a computerized vascular registry. Detailed information was collected on patients’ preoperative status, type of procedure and anesthesia, perioperative outcomes, and predictors of perioperative outcomes. The end points of the study were perioperative death and main surgical complications. Perioperative all-cause mortality rates varied across operations and were higher in elderly than in younger patients (1.4% vs. 0.2%, P ¼ 0.014) after abdominal surgery (2.4% vs. 0.1%, P ¼ 0.006) and especially after abdominal aortic aneurysm repair (2.8% vs. 0%, P ¼ 0.035). In the elderly cohort, the mortality rate was <1% for almost 60% of all operations. In logistic regression analysis, only preoperative hypertension (odds ratio [OR] ¼ 72.5, 95% confidence interval [CI] 9.4-557.6), congestive heart failure (OR ¼ 16.5, 95% CI 2.3115.9), and perioperative cardiac (OR ¼ 20.7, 95% CI 1.6-273.8) and pulmonary (OR ¼ 41.7, 95% CI 7.9-218.9) complications were associated with a higher 30-day death risk. In this series, perioperative outcomes were not influenced by the type of elective surgical procedure. Though overall mortality after major vascular surgery was higher in patients 80 years old, age per se was not an independent factor of a higher perioperative mortality risk or fatal and nonfatal complications.
INTRODUCTION Longevity has increased in the last century, and survival to over 80 years old is now common in all 1 Vascular Surgery Section, Geriatric Surgical Clinic, Department of Surgical and Gastroenterological Sciences, University of Padua, School of Medicine, Padua, Italy. 2 Geriatric Surgical Clinic, Department of Surgical and Gastroenterological Sciences, University of Padua, School of Medicine, Padua, Italy. 3 Division of Nephrology, Department of Medical and Surgical Sciences, University of Padua, School of Medicine, Padua, Italy.
Correspondence to: Enzo Ballotta, MD, Vascular Surgery Section, Geriatric Surgical Clinic, Department of Surgical and Gastroenterological Sciences, University of Padua, School of Medicine, 2nd Floor, Ospedale Giustinianeo, Via N. Giustiniani 2, 35128 Padua, Italy, E-mail: [email protected] Ann Vasc Surg 2007; 21: 772-779 DOI: 10.1016/j.avsg.2007.04.005 Ó Annals of Vascular Surgery Inc. Published online: May 29, 2007
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industrialized countries: individuals reaching the age of 80 have a life expectancy of 7 and 9 years for men and women, respectively.1 The aging of the population has led to an increased number of elderly patients with various diseases undergoing surgery and anesthesia, but when it comes to major surgery for the very elderly, decision making is difficult and complicated by the perception that the risks are high. Although the risks of surgery do increase with age,2 severity of illness and comorbidity are more important predictors of complications than age itself.3,4 Patients undergoing vascular surgery for an expanding abdominal aortic aneurysm (AAA), aortoiliofemoral occlusive disease, or severe carotid disease are at risk of serious perioperative cardiac complications, such as myocardial infarction (MI), arrhythmia, and death because of the high incidence of coronary artery disease (CAD) and the
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hemodynamic stresses associated with vascular procedures. This risk is expected to be higher in elderly patients undergoing major vascular surgery because cardiovascular disease is commonly the leading cause of mortality and morbidity in such people.5,6 Previous observational studies investigating perioperative outcome after vascular surgery in the elderly have focused on specific types of surgery, e.g., AAA repair7,8 or carotid endarterectomy (CEA) for symptomatic and asymptomatic disease9-11 or lower extremity revascularization,12,13 or they have considered several vascular procedures within a wider ‘‘scenario’’ of major noncardiac surgery,14-16 reporting various mortality and morbidity rates that reflect small sample sizes and divergent experiences at single institutions. No investigators have so far considered the overall perioperative outcome of different types of surgery for vascular disease in the very elderly. This study was designed to analyze the perioperative outcomes of patients aged 80 years who underwent major elective vascular surgery at our institution, comparing the results with findings for major elective vascular surgery performed in patients under 80 years old.
METHODS Data Collection Since 1990, pertinent clinical data for all consecutive patients undergoing vascular surgery at our institution have been prospectively entered into a computerized vascular registry. For this study, the database was queried to identify patients aged 80 and <80 years who had major elective vascular surgery (e.g., open infra- or juxtarenal abdominal surgery for AAA or occlusive disease, CEA or supra-aortic trunk surgery, femoral and lower extremity artery reconstruction, extra-anatomical revascularization for aortoiliac disease) under general, spinal, or epidural anesthesia up until December 2003. Emergency surgical procedures (ruptured AAA repair, acute upper and lower extremity ischemia, or vascular trauma), procedures for lower extremity amputations or redo surgery, and endovascular procedures were not considered. The database, which is updated regularly with patient follow-up data, was queried retrospectively, and the clinical charts were reviewed. Preoperative Health Status Preoperative demographic information included the patient’s age and gender. Other potential
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preoperative risk factors measured included a history of smoking (defined as past or current cigarette smoking) and diseases related to the cardiovascular, pulmonary, neurological, or renal/urinary systems. Diabetes mellitus, hyperlipidemia, and hypertension were considered to be present if clinically diagnosed and documented in the medical records. Cardiac disease included any of the following: a history of MI, atrial fibrillation, congestive heart failure (CHF), coronary artery angioplasty/stenting or bypass grafting, surgery for valve disease or signs of ischemia on electrocardiogram (ECG), and nitrate therapy. Pulmonary disease was defined as a history of chronic restrictive or obstructive disease based on pulmonary function tests, pulmonary embolism, and prior lobectomy or pneumonectomy. Cerebrovascular disease was defined as a history of transient ischemic attacks or stroke. Chronic kidney disease (CKD) was defined as a serum creatinine level >1.5 mg/dL in either conservative or dialysis treatment. Perioperative Variables Potential variables predictive of adverse events included American Society of Anesthesiologists (ASA) classification and type of anesthesia. The ASA classification rates patients as follows: 1, healthy; 2, mild to moderate systemic disease; 3, severe disease that limits activity; 4, severe, incapacitating disease that is a constant threat to life. This rating was drawn from the patient’s preoperative evaluation by the anesthesiologists. End Points The end points of the study were (1) mortality at 30 days or at discharge and (2) adverse outcomes within 30 days after surgery, including cardiac, pulmonary, renal/urinary tract, gastrointestinal, wound, nervous system, and other complications. Cardiac complications were classified by a single cardiologist and included (1) MI with a diagnosis on the basis of creatinine kinase isoenzyme with muscle and brain subunits (CK-MB) levels and ECG findings, (2) pulmonary edema confirmed by chest radiography, (3) documented ventricular fibrillation or primary cardiac arrest, and (4) new complete heart failure requiring a pacemaker. A postoperative ECG was routinely obtained in all patients who had a history of CAD, CHF, or arrhythmia (rhythm other than sinus); and cardiac isoenzymes were obtained in all patients who had new findings at postoperative ECG. Pulmonary adverse events were defined as respiratory failure requiring intubation for more than 2 days or reintubation;
774 Ballotta et al.
noncardiogenic pulmonary edema; lobar pneumonia confirmed by chest radiography and requiring antibiotic therapy; and pulmonary embolism documented by autopsy, angiography or a high-probability ventilation-perfusion scan. A renal adverse event was defined as acute renal failure requiring dialysis, and neurological complications were defined as cerebrovascular accidents with new neurological deficits. Outcomes requiring therapy, such as medication, further workup, or transfer to a higher-acuity ward, were also recorded. Statistical Analysis Statistical analysis was performed with Student’s ttest for continuous data and chi-squared analysis for categorical data. All tests were two-tailed, and statistical significance was inferred at P < 0.05. Thirty-day and in-hospital mortality rates were determined for all operations in each category. Morbidity rates for patients aged 80 and <80 years were tabulated and compared, reporting the occurrence of one or more complications. Thirty-day and in-hospital mortality rates were also calculated for patients who experienced each type of complication. Since perioperative outcome depended on the surgical procedure and patients who had more than one operation were exposed to the compounded death or complication risk, several data items were analyzed vis-a`-vis surgical procedures instead of patients. Significant predictors of outcome were investigated by examining the frequency distribution of various pre- and perioperative variables, followed by a logistic regression analysis on sets of predictors with statistical or marginal significance to determine the independent predictors of death and fatal and nonfatal perioperative complications (Wald’s test). Results are presented as odds ratios (ORs) and two-sided 95% confidence intervals (CIs).
RESULTS Demographic Characteristics In the Vascular Surgery Registry at our institution (University Medical Center), we identified 3,081 consecutive patients who had undergone elective surgery for vascular diseases from January 1, 1990, to December 31, 2003; 21 medical records had been lost, bringing our total down to 3,060 patients. In all, 3,314 surgical procedures were performed by the same surgeon in 3,060 patients, 456 of them aged 80 years (15%, 491 operations), while the other 2,604 patients (85%, 2,823 operations) were younger. The difference between the number of
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patients and operations lies in that 254 surgical procedures (35 in the elderly group and 219 in the younger group) were either bilateral or of more than one type in the same patient. The preoperative demographic data for the two groups considered are shown in Table I. The median age was 82 in the older group and 62 in the younger group. Older patients were significantly more likely to have arterial hypertension (51.3% vs. 36.7%, P < 0.001), CHF (6% vs. 3.5%, P ¼ 0.021), pulmonary disease (36% vs. 30.8%, P ¼ 0.031), and CKD (23.7% vs. 19.3%, P ¼ 0.034). Most patients aged 80 had higher ASA scores, indicating higher-risk patients (ASA class 3 60.7% vs. 52.8%, P ¼ 0.002, and ASA class 4 12.5% vs. 7.7%, P ¼ 0.001), whereas the proportion of healthy (ASA class 1 10.7% vs. 5.5%, P < 0.001) or low-risk (ASA class 2 28.7% vs. 21.3%, P ¼ 0.001) patients was higher in the younger group. The type of surgical procedure varied between and within the two groups. Lower extremity artery reconstruction (32.4%) and CEA (27.5%) were the most common operations performed in octogenarians. Perioperative Mortality and Morbidity The 30-day and in-hospital mortality rates coincided in this study (Table II). There were 11 perioperative deaths, representing an overall 30-day mortality rate of 0.3%. Overall, the perioperative mortality rate was higher for the elderly patients (1.4% vs. 0.2%, P ¼ 0.014) after abdominal surgery (2.4% vs. 0.1%, P ¼ 0.006) and particularly after AAA repair (2.8% vs. 0%, P ¼ 0.035). In the frequency distribution of 30-day death, only older age (P ¼ 0.015) and hypertension (P ¼ 0.045) were correlated with a significantly higher risk, whereas cardiac disease (P ¼ 0.069) and CHF (P ¼ 0.093) showed marginal significance. Sex, smoking, hyperlipidemia, diabetes mellitus, pulmonary and cerebrovascular diseases, CKD, ASA scores, and type of surgery were not significant predictors of perioperative mortality. In the logistic regression analysis for perioperative mortality, including all the above factors, only hypertension (OR ¼ 72.5, 95% CI 9.4-557.6) and CHF (OR ¼ 16.5, 95% CI 2.3-115.9) increased the 30-day death odds. The overall morbidity rate was 15.2% (507 of 3,314) (Table III). The rate of pneumonia was significantly higher in the elderly (2.4% vs. 0.7%, P < 0.001), however, although the incidence of pulmonary complications was comparable in the two groups. Cardiac complications occurred in 14
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Surgery for vascular disease in patients aged 80 or more 775
Table I. Baseline patient characteristics and type of vascular procedure Age (years) Patient characteristics
<80 (n ¼ 2,604)
80 (n ¼ 456)
Age, median (25th, 75th) Male, n (%) Diabetes mellitus, n (%) Hypertension, n (%) Hyperlipidemia, n (%) Current or past history of smoking, n (%) Cardiac disease, n (%) CHF, n (%) Pulmonary disease, n (%) Cerebrovascular disease, n (%) CKD (creatinine level >1.5 mg/dL), n (%) Dialysis-dependent Non-dialysisedependent ASA class, n (%) 1 2 3 4 All operations/all patients, n Open infrarenal or juxtarenal abdominal surgery, n (%) Aneurysmal disease, n (%) Occlusive disease, n (%) CEA and supra-aortic trunk surgery, n (%) Lower extremity artery reconstruction, n (%) Extra-anatomical surgery for aortoiliac disease (axillo- or femorofemoral bypass), n (%)
62 1,789 852 954 415 1692 859 92 801 827 502 35 467
82 305 155 234 82 313 161 27 164 126 108 2 106
(46, 70) (68.7) (32.7) (36.7) (15.9) (64.9) (33.0) (3.5) (30.8) (31.7) (19.3) (1.3) (18)
(81, 84) (66.9) (34.0) (51.3) (18.0) (68.6) (35.3) (6.0) (36.0) (27.6) (23.7) (0.5) (23.2)
279 (10.7) 747 (28.7) 1,376 (52.8) 202 (7.7) 2,823/2604 750 (26.6)
25 (5.5) 97 (21.3) 277 (60.7) 57 (12.5) 491/456 126 (25.7)
327 423 1,332 714 27
72 54 135 159 71
patients (2.8%) in the elderly group, noncardiac complications in 70 (14.2%), and both in 8 (1.6%). Patients experienced cardiac complications more often on postoperative days 1-3, whereas noncardiac complications were spread from the day of
(11.6) (15.0) (47.2) (25.3) (0.9)
P
0.474 0.631 <0.001 0.306 0.142 0.360 0.021 0.031 0.089 0.034
<0.001 0.001 0.002 0.001
(14.6) (11.0) (27.5) (32.4) (14.5)
surgery to postoperative day 6. Neurological complications only occurred in patients who underwent carotid revascularizations. A logistic regression model was constructed for cardiac and noncardiac complications, including
Table II. Perioperative (30-day) mortality by type of operation Age (years) Operation
<80 (n ¼ 2,823)
80 (n ¼ 491)
Total (n ¼ 3,314)
P
All operations, (n/N ) % Open infrarenal or juxtarenal abdominal surgery, (n/N ) % Aortic aneurysm repair Aortoilio/femoral bypass/ endarterectomy CEA and supra-aortic trunk surgery, (n/N ) % Infrainguinal arterial reconstruction, (n/N ) % Extra-anatomical surgery for aortoiliac disease (axillo- or femorofemoral bypass), (n/N ) %
(6/2,823) 0.2 (1/750) 0.1
(5/491) 1.4 (3/126) 2.4
(11/3,314) 0.3 (4/876) 0.4
0.014 0.006
(0/327) 0 (1/423) 0.2
(2/72) 2.8 (1/54) 1.8
(2/399) 0.5 (2/477) 0.4
0.035 0.540
(4/1,332) 0.3
(0/135) 0
(4/1,467) 0.2
0.819
(1/714) 0.1
(1/159) 0.6
(2/873) 0.2
0.803
(0/27) 0
(1/71) 1.4
(1/98) 1.0
0.613
776 Ballotta et al.
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Table III. Overall 30-day morbidity Age (years) Complications
<80 (n ¼ 2,823)
80 (n ¼ 491)
Total (n ¼ 3,314)
>1 complication, n (%) Cardiac (MI, arrhythmia, pulmonary edema, cardiac arrest), n (%) Pulmonary, n (%) Pneumonia Other Renal/urinary tract, n (%) Urinary tract infection Other Gastrointestinal (small bowel obstruction, ileus, bleeding, gastritis), n (%) Wound (deep or superficial wound infection, dehiscence, lymph leak), n (%) Nervous system (stroke, peripheral nerve injury), n (%) Other (bleeding requiring >4 units blood, multiorgan failure, deep-vein thrombosis, graft or prosthesis failure), n (%) Overall, n (%)
133 (4.7) 72 (2.5)
36 (7.3) 14 (2.8)
169 (5.1) 86 (2.6)
22 12 10 21 21 0 5
104 32 72 98 88 10 23
82 20 62 77 67 10 18
(2.9) (<1) (2.2) (2.7) (2.4) (<1) (<1)
(4.5) (2.4) (2.0) (4.3) (4.3) (1.0)
P
0.020 0.815
(3.1) (1.0) (2.1) (2.9) (2.6) (<1) (<1)
0.087 <0.001 0.084 0.023 0.520
52 (1.8)
11 (2.2)
63 (1.9)
0.676
71 (2.5)
6 (1.2)
77 (2.3)
0.111
51 (1.8)
5 (1.0)
56 (1.7)
0.288
423 (15.0)
84 (17.1)
507 (15.2)
0.254
age, sex, comorbidities, ASA scores, and surgical procedures. The model indicated that male sex (OR ¼ 1.8, 95% CI 1.1-3.0) and ASA score (OR ¼ 1.7, 95% CI 1.2-2.3) increased the odds of cardiac complications and that smoking (OR ¼ 3.3, 95% CI 1.8-6.1) and pulmonary disease (OR ¼ 6.9, 95% CI 4.0-11.7) increased the odds of pulmonary complications. In a second logistic regression model for the outcome of perioperative death, including all perioperative complications considered, only cardiac (OR ¼ 20.7, 95% CI 1.6-273.8) and pulmonary (OR ¼ 41.7, 95% CI 7.9-218.9) complications increased the odds of perioperative mortality.
DISCUSSION Although cardiovascular disease is primarily a disorder of the elderly, the surgical management of vascular disease in the elderly patient has often been approached more hesitantly than in the case of younger patients. This bias stems from the perception of a greater operative risk due to the presence of comorbidities. The present study statistically confirms the impression of higher operative risk but refutes the contention that this is entirely due to age.
We found a relatively low 30-day mortality rate (1.4%) for more than 450 patients aged 80 years who had major elective vascular surgery at our institution between 1990 and 2003. Although the 30day mortality rate among our elderly patients was <1% for almost 60% of the operations performed, the overall incidence was nonetheless significantly higher than in the younger patients, especially when abdominal surgery for AAA repair was considered. An early mortality after AAA repair of almost 3% might be seen as high for a prophylactic procedure, but this figure is lower than the one recommended for high-risk patients in a recent article.17 Paty et al.7 reported comparable results but noted no difference in perioperative mortality rates (3% vs. 2%) in a retrospective study comparing 77 patients aged 80 with 622 younger patients undergoing elective AAA repair. Likewise, in a retrospective analysis of 856 patients who underwent elective AAA repair, among the 49 of them who were 80, Berry et al.18 reported an in-hospital mortality rate of 2% and an incidence of major complications of 23%, reflecting the favorable results achieved in previous series, which included both in-hospital and 30-day mortality data.8,19 There were no perioperative deaths or strokes in our subgroup of elderly patients who underwent
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CEA, all performed under deep general anesthesia in a mainly symptomatic patient population (66%) and with an occluded contralateral carotid artery in >50% of cases. This is consistent with and adds to the data from our previous investigations focusing on early and late outcomes of CEA in the elderly11,20 and correlates well with numerous other reports of excellent results in such patients,9,10,21-23 demonstrating that the very elderly may benefit from CEA even more than younger people. There were relatively few perioperative deaths in our series, and this may explain why the logistic regression analysis identified only two comorbidities (i.e., hypertension and CHF) and two postoperative adverse events (i.e., cardiac and respiratory complications) with an independent significant effect on the 30-day mortality rate. Numerous reports have identified hypertension, in addition to other variables, as a risk factor for perioperative death after vascular surgery, especially AAA repair,24-26 while other studies have found that hypertension was not an independent risk for any perioperative adverse events after noncardiac surgery.27,28 The agreement found in our analysis between CHF and perioperative mortality correlates well with data from other investigations.29 The clinical diagnosis of CHF in older patients may be complicated by the lack of typical symptoms and physical findings,30 and as many as one-third of patients with a history of CHF may have a normal systolic function,31 suggesting that CHF can result from left ventricular diastolic dysfunction despite left ventricular systolic function being preserved. The adequacy and accuracy of preoperative heart function assessment in candidates for elective vascular surgery are therefore a critical field of further investigation. This study found that the independent effect of the type of surgery had no influence on perioperative death and complications and that older age and cardiac disease (variables that were predictors of perioperative death in the frequency distribution) failed to appear in the logistic regression model. Although the lack of previously published studies considering all major vascular operations and their perioperative outcomes prevents us from drawing any useful comparisons, the patient’s age was reportedly not a predictor of perioperative death in many other studies either, which (though they only focused on a specific type of vascular surgery) found that other factors were strongly associated with perioperative mortality in elderly patients, factors proving stronger determinants of death than age.3,4,7-10,13,18 Unlike other studies that identified
Surgery for vascular disease in patients aged 80 or more 777
CAD as an independent risk factor for perioperative mortality after various types of vascular surgery,14,18,32-34 in our analysis cardiac disease was not a comorbidity significantly associated with perioperative death. This is probably due to the fact that all our patients were examined preoperatively by a cardiologist and significant CAD was treated by coronary artery angioplasty/stenting or bypass grafting, reflecting better surgical and perioperative techniques and monitoring rather than a lower-risk cohort. This impression correlates well with the analysis by Eagle et al.35 on the 24,959 participants with known CAD in the Coronary Artery Surgery Study database, in which the cardiac risk associated with noncardiac operations involving the chest, abdomen, vasculature, and head and neck was significantly lower in patients who had undergone prior coronary artery bypass grafting (postoperative death 1.7% vs. 3.3%, MIs 0.8% vs. 2.7%). Conversely, in a recently published randomized clinical trial that specifically addresses the influence of coronary revascularization on mortality rates before major vascular surgery, the Coronary Artery Revascularization Prophylaxis trial, McFalls et al.36 found that elective coronary revascularization does not appear to provide an additional benefit in reducing the incidence of perioperative death or MI. Almost one in six patients suffered at least one perioperative complication. Although the incidence of pneumonia was significantly higher in the older group, the overall incidence of perioperative complications was comparable for the older and younger patient groups. At logistic regression, older age and many of the conditions associated with aging (e.g., hypertension and cardiac disease) did not increase the risk of early cardiac complications, and older age as such did not increase the risk of other noncardiac, particularly respiratory, complications that, along with cardiac adverse events, emerged as independent predictors of perioperative death. This goes to show that major elective vascular surgery in elderly patients is not associated with an increase in surgery-related complications and that age in itself is not a predictor of fatal perioperative complications. Our findings should be interpreted in the light of the study’s limitations. Though our data were collected prospectively, the analysis is retrospective in nature. The inclusion of patients undergoing only elective surgery may explain the low mortality and morbidity rates observed. The small number of deaths also led to larger standard errors and wider confidence limits in the model used to assess the association between independent predictors and mortality rate. The unbalanced distribution of the
778 Ballotta et al.
surgical procedures in both groups has complicated the interpretation of the results, particularly because of the very low mortality and morbidity rates associated with CEA procedures compared with the other major vascular operations. Stratified analyses could have been used to address this limitation, but given the very small number of 30-day adverse events, these were not feasible. Moreover, all patients were treated at a single institution and all surgical procedures were performed by the same surgeon, so the surgical outcomes may be different at other centers or when more surgeons are involved. In conclusion, the overall results of this study indicate that the type of elective surgical procedure does not influence perioperative outcome. Although the overall mortality rate after major vascular surgery is higher in patients in their eighties, age per se is not an independent factor of any greater risk of perioperative mortality or fatal and nonfatal complications.
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13.
14.
15.
16.
17.
18.
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