Quality of Life After Aortic Valve Replacement at the Age of >80 Years Thoralf M. Sundt, MD; Marci S. Bailey, RN; Marc R. Moon, MD; Eric N. Mendeloff, MD; Charles B. Huddleston, MD; Michael K. Pasque, MD; Hendrick B. Barner, MD; William A. Gay, Jr, MD Downloaded from http://circ.ahajournals.org/ by guest on June 14, 2017 Background—The optimal management of aortic valve disease in patients ⬎80 years old depends on functional outcome as well as operative risks and late survival. Methods and Results—We retrospectively identified 133 patients (62 men, 71 women) aged 80 to 91 years (mean 84⫾3 years) who underwent aortic valve replacement alone or in combination with another procedure between January 1, 1993, and April 31, 1998. Demographics included hypertension 68%, diabetes mellitus 17%, and history of stroke 11%. Operative (30 day) mortality rate was 11%. Urgent or emergent surgery, aortic insufficiency, and perioperative stroke or renal dysfunction were risk factors for operative death by multivariable analysis. Intensive care unit and total hospital length of stay were prolonged at 6.2 and 14.7 days, respectively. Late follow-up between July 1, 1998, and November 1, 1999, was 98% complete. Actuarial survival at 1 and 5 years was 80% and 55%, respectively. Predictors of late mortality were preoperative or perioperative stroke, chronic obstructive pulmonary disease, aortic stenosis, and postoperative renal dysfunction. The mean New York Heart Association functional class for 65 long-term survivors improved from 3.1 to 1.7. Quality of life assessed with the Medical Outcomes Study Short Form-36 was comparable to that predicted for the general population ⬎75 years old. Conclusions—Functional outcome after aortic valve replacement in patients ⬎80 years old is excellent, the operative risk is acceptable, and the late survival rate is good. Surgery should not be withheld from the elderly on the basis of age alone. (Circulation. 2000;102[suppl III]:III-70-III-74.) Key Words: valves 䡲 surgery 䡲 aging 䡲 cost-benefit analysis T he decision between continued medical management and surgical intervention for aortic valve disease in patients ⬎80 years old may be difficult for both the physician and the patient. Despite a number of recent studies that demonstrate acceptable operative risk as well as satisfactory long-term survival rates,1– 6 there remains significant reluctance to recommend aortic valve replacement (AVR) in this age group. This likely relates in part to uncertainty over the long-term functional results that can be expected. In some settings, the potential for increased resource utilization may enter into decision making as well. The advancing age of the general population makes this an increasingly frequently encountered dilemma. With these issues in mind, we sought to examine our results with AVR in patients ⬎80 years old. Perioperative mortality and morbidity rates, as well as late survival and functional outcome, including measures of the quality of life, were assessed. perioperative events were retrieved from our computerized database. Late follow-up information was obtained through postal questionnaire or telephone interview between July 1, 1998, and November 1, 1999. Follow-up was 98% complete. Functional status was determined in 65 late survivors. New York Heart Association (NYHA) functional class was assessed, as was quality of life with the Medical Outcomes Study (MOS) Short Form-36 (SF-36) tool.7 Eight dimensions of health were investigated: physical functioning, physical health related to age- and role-specific activities (“Role-Physical”), bodily pain, general health, vitality, social functioning, personal feelings of performance in age- and role-specific activities (“RoleEmotional”), and mental health. Scores were compared with those expected for the general population of a similar age. Members of the Division of Cardiothoracic Surgery carried out surgical procedures at Barnes and Jewish Hospitals. Although approaches varied somewhat among surgeons, all procedures were carried out with cardiopulmonary bypass and at least mild systemic hypothermia. Cardiac arrest was achieved with cold crystalloid or blood cardioplegia. All procedures were performed via the standard median sternotomy approach. The selection of prosthesis type was at the discretion of the operating surgeon. There is a strong institutional preference for biologic valves in this age group regardless of the preoperative presence of atrial fibrillation. Coronary bypass was performed whenever occlusive disease involved major epicardial vessels. All continuous data were expressed as mean⫾SD or as a percentage as indicated. The survival analysis was made with the Methods Between January 1, 1993, and April 31, 1998, 133 patients ⬎80 years old underwent AVR with or without concomitant procedures at Washington University. Preoperative demographic information and From the Division of Cardiothoracic Surgery, Department of Surgery, Washington University School of Medicine, St Louis, Mo. Reprint requests to Thoralf M. Sundt, MD, Suite 3106, Queeny Tower, One Barnes Hospital Plaza, St Louis, MO 63110. E-mail [email protected] © 2000 American Heart Association, Inc. Circulation is available at http://www.circulationaha.org III-70 Sundt et al TABLE 1. Demographic Characteristics of the Study Population Characteristic Quality of Life After AVR at >80 Years TABLE 2. III-71 Operative Characteristics Characteristic Operative priority Age, mean (range) 83.5⫾2.6 (80.1–90.6) Elective 112 (84.2) Female sex, n (%) 71 (53.4) Urgent 14 (10.5) Hypertension, n (%) 90 (67.7) Diabetes mellitus, n (%) 23 (17.3) Tobacco abuse, n (%) Active 3 (2.3) Inactive 47 (35.3) COPD, n (%) 16 (12) Emergent CABG 89 (66.9) Mitral valve replacement 12 (9.0) Mitral valve repair 3 (2.3) CPB time, min (range) 158.6⫾57.91 (55–326) Cross-clamp time, min (range) 109.7⫾42.1 (32–234) Chronic renal insufficiency, n (%)* 7 (5.3) Peripheral vascular disease, n (%) 17 (12.8) Valve prosthesis Previous stroke, n (%) 15 (11.3) Biological Valve pathology, n (%) Mechanical Stenosis 7 (5.3) Associated procedures 126 (94.7) 7 (5.3) Downloaded from http://circ.ahajournals.org/ by guest on June 14, 2017 104 (78.2) 19 mm 17 (12.8) Regurgitation 10 (7.5) 21 mm 49 (36.8) Mixed 19 (14.3) ⬎21 mm 67 (50.4) Peak gradient, mm Hg† 54⫾22 Aortic valve area, cm2† 0.6⫾0.2 Preoperative atrial fibrillation, n (%) 28 (21.1) Previous myocardial infarction, n (%) 23 (17.3) Angina pectoris, n (%) 79 (59.4) Previous cardiac surgery, n (%) AVR 5 (3.8) CABG 8 (6.0) Pacemaker 7 (5.3) Other 11 (8.3) Ejection fraction ⬍0.35, n (%) 19 (14.3) Preoperative NYHA class, n (%) I 5 (3.8) II 20 (15.0) III 69 (51.9) IV 39 (29.3) COPD indicates chronic obstructive pulmonary disease. *Chronic renal insufficiency is defined as serum creatinine ⬎2.0 g/dL. †For patients with predominant functional stenosis. Kaplan-Meier estimator. Univariable analysis of risk factors for early and late death was performed, and factors found to trend toward significance (P⬍0.15) were entered into multivariable analysis. A stepwise multivariable Cox regression model was then constructed with those factors to determine independent predictors of early and late death (P⬍0.05). The Friedman nonparametric t test was used to compare the preoperative and postoperative NYHA functional class. A value of P⬍0.05 was considered significant for all statistical calculations. The SYSTAT system for statistics was used for all data analyses (Version 6.0 for Windows; SPSS). Results Demographics of the Study Population As shown in Table 1, men and women were approximately equally represented. Two thirds of patients had a history of hypertension but less than one fifth had diabetes mellitus. Chronic obstructive pulmonary disease, peripheral vascular disease, and cerebrovascular disease were less common. The Values are n (%) or mean⫾SD (range). CPB indicates cardiopulmonary bypass. n⫽133. majority of patients had predominant functional stenosis, with a mean peak gradient of 54⫾22 mm Hg and a calculated valve area of 0.6⫾0.2 cm2 in this subgroup. Atrial fibrillation was present preoperatively in one fifth of patients. Angina pectoris was a presenting complaint in the majority of patients, and ⬎80% had NYHA functional class III or IV symptoms of heart failure. Few had undergone previous cardiac surgery or had a history of myocardial infarction. Less than 15% of patients had ejection fractions of ⬍0.35. Operative Characteristics Details of the operative procedures are presented in Table 2. A significant percentage of procedures were performed urgently or emergently. Concomitant CABG was performed frequently. Biological prostheses predominated, and ⬇50% of valves used were ⱕ21 mm. Of the 52 patients who received small valves, 40 (77%) were women. Perioperative Events The operative (30-day) mortality rate was 11.1% (Table 3). Stepwise logistic regression analysis yielded urgent or emergent surgical status (P⫽0.005) as a strong predictor of operative death. The mortality rate for urgently operated patients was 21.4%, whereas that for emergently operated patients was 43%. Aortic insufficiency also was a predictor of operative risk (P⬍0.05). Among perioperative complications, perioperative renal dysfunction (P⬍0.05) and stroke (P⬍0.05) were risk factors for death within 30 days of surgery. Concomitant CABG was not a risk factor. As shown in Table 4, the operative mortality rate was actually higher in those who underwent isolated AVR than in those who underwent concomitant CABG, although this difference did not reach statistical significance. Operative risk was not related to preoperative NYHA functional class, with similar III-72 Circulation TABLE 3. November 7, 2000 30-Day Mortality and Morbidity Incidence Event Death 15 (11.1) Myocardial infarction* 1 (0.75) Intraoperative/postoperative use of IABP 6 (4.5) Low-output syndrome† 22 (16.5) Renal dysfunction‡ 15 (11.3) Renal dialysis 5 (3.8) Stroke permanent 5 (3.8) Respiratory failure§ 35 (26.3) Ventricular arrhythmia 18 (13.5) Atrial arrhythmia 53 (39.8) Figure 1. Actuarial survival of study group with Kaplan-Meier method. Mean follow-up is 2.6 years. Although cost data are notoriously inaccurate, length of stay may be considered a surrogate for resource use. The postoperative length of stay in the intensive care unit was prolonged at a mean of 6.2 days (range 1 to 41 days). Forty-seven percent of patients spent ⬎4 days in the intensive care unit. The overall postoperative hospital stay ranged from 4 to 92 days (mean of 14.7 days). Sternal infection Deep 0 (0) Superficial 2 (1.5) Reoperation for bleeding 14 (10.5) Downloaded from http://circ.ahajournals.org/ by guest on June 14, 2017 Values are n (%). IABP indicates intra-aortic balloon pump. *Myocardial infarction defined as a new Q wave. †Low output defined as cardiac index ⬍2.0 or intra-aortic balloon support. ‡Renal dysfunction defined as serum creatine ⬎2.0 g/dL. §Respiratory failure defined as intubation ⬎24 hours or reintubation. n⫽133. Late Results The actuarial survival rate was ⬇80% at 1 year and ⬇55% at 5 years (Figure 1). Stepwise logistic regression analysis revealed preoperative history of stroke (P⫽0.01), chronic obstructive pulmonary disease (P⬍0.001), and aortic stenosis (P⬍0.001) as preoperative predictors of late death. Perioperative renal dysfunction (P⫽0.001) and perioperative stroke (P⬍0.001) were also predictive of late death. Late survival was not worse for those in an advanced NYHA functional class before surgery. Those in NYHA functional class I or II who underwent isolated AVR actually had a worse late survival rate than those in class III or IV (Table 4), which reached statistical significance, likely due to the small number of individuals in this group. Sixty-five long-term survivors responded to postal questionnaires or telephone interviews regarding their functional operative mortality rates observed for individuals in NYHA functional class I or II as for those in class III or IV (Table 4). The morbidity rate was significant. More than 10% of patients experienced renal dysfunction defined as an increase in serum creatinine to ⬎2.0 g/dL, and almost 4% of patients required hemodialysis after surgery. More than one fourth of patients required mechanical ventilation for ⬎24 hours. Permanent stroke, however, was observed in only 4% of patients. Atrial fibrillation was common, and a relatively high percentage of patients experienced bleeding complications. TABLE 4. Mortality Incidence by Subgroup Operative Procedure n Perioperative Deaths Early Plus Late Deaths Isolated AVR, n (%) 35 3 (8.6)* 12 (34.3)* 6 1 (16.7) 4 (66.7) NYHA class I or II NYHA class III or IV AVR⫹CABG, n (%) 29 2 (6.9)† 71 10 (14.1)* 8 (27.6)‡ 27 (38.0)* NYHA class I or II 15 2 (13.3) 6 (40) NYHA class III or IV 56 8 (14.3) 21 (37.5) AVR⫹MVR, n (%) 4 1 (25) AVR⫹MVR⫹CABG, n (%) 8 2 (25) 1 (25) AVR⫹MV repair⫹CABG, n (%) 3 0 AVR⫹CEA, n (%) 5 1 (20) 2 (40) AVR⫹CABG⫹CEA, n (%) 3 0 1 (33) AVR⫹ascending aortic replacement, n (%) 4 1 (25) 2 (50) AVR⫹CABG⫹ascending aortic replacement, n (%) 2 1 (50) 2 (100) AVR⫹other (tricuspid annuloplasty, ASD, atrial myxoma, septal myectomy), n (%) 4 0 0 2 (25) 2 (66.7) ASD indicates atrial septal defect; CEA, carotid endarterectomy; and MVR, mitral valve replacement. *P⫽NS for isolated AVR vs AVR⫹CABG. †P⫽NS for class I or II vs class III or IV. ‡P⫽0.001 for class I or II vs class III or IV. Sundt et al Figure 2. Improvement in NYHA class among 60 survivors who respond to postal questionnaire or telephone interview. Median class improved from 3 to 1, and mean class from 3.1 to 1.7. Downloaded from http://circ.ahajournals.org/ by guest on June 14, 2017 status. For this subgroup, the mean NYHA functional class improved from 3.1 to 1.7 (Figure 2) with ⬎80% of patients in class I or II (P⬍0.001). Scores on the SF-36 were comparable to those for the general population ⱖ75 years old (Figure 3). Subjects actually scored higher than the control population in 5 areas, including Bodily Pain, General Health, Social Functioning, Role-Emotional, and Mental Health. Unfortunately, matched preoperative data on subjects are unavailable. Discussion The results of the present study demonstrate that gratifying late results may be achieved with AVR in patients ⬎80 years old. Survival rates at 1 and 5 years postoperatively were satisfactory, and there was marked improvement in NYHA functional class among long-term survivors. Furthermore, the quality of life as assessed with the MOS SF-36 survey was comparable to that is expected among the general elderly population. This can be accomplished at an acceptable Figure 3. Results of MOS SF-36 for subjects compared with general population with definitions of 8 health concepts from Bungay and Ware.7 Quality of Life After AVR at >80 Years III-73 operative risk even among patients with advanced symptoms of heart failure. There are ample data in the literature that support the excellent late survival rates to be achieved in this age group. Remarkably, there have been multiple reports1– 6,8,9 of similar 5-year survival rates of 55% to 66%. Less attention has been paid to functional outcome, however. A clear improvement in NYHA functional class has been reported,4 as have measures such as autonomy8 and “satisfaction” with present quality of life8 or with the decision to proceed with surgery.2,9 In recent years, interest has increased in more sophisticated and standardized measurement of functional outcome, and several previous studies have been published. Khan et al4 evaluated 61 octogenarians (mean age 83.5 years) who underwent cardiac surgery and obtained Karnofski performance scores before and after surgery. Of these patients, 47 underwent isolated AVR. Functional improvement was significant, with an improvement in the Karnofski score of 50% by 1 month and a 2-class improvement in median NYHA status. Levin et al10 and Olsson et al11 also explored the measurement of quality of life with their own assessment tools, again with documented improvement. These studies share a significant strength in having both preoperative and postoperative data on subjects. Their use of nonstandardized instruments, however, may make their methodology of limited applicability. We have chosen to explore the use of a widely accepted instrument for the assessment of quality of life, the MOS SF-36. Many such tools have been developed, and each may be more applicable to a specific disease state than to another; however, this instrument was previously used in a similar study of a somewhat younger patient population who underwent cardiac surgery at the Johns Hopkins School of Medicine. Tseng et al12 studied patients ⬎70 years old who underwent AVR. The mean age of their study group was 76.2 years. In comparison with the general population, as in the present study, excellent functional recovery was achieved. A shortcoming of their study, like ours, was the lack of preoperative data on the study subjects, an inherent limitation of retrospective analysis. In addition, for any such study, the completion of even a “short-form” questionnaire can be a challenge for elderly individuals whose vision or mental faculties may be compromised. The result is a likely selection bias among responders for those with the best functional outcome. Nonetheless, the present study confirms in this older population the finding that even in elderly persons, an excellent quality of life can be anticipated in a significant proportion of individuals. This improvement in functional status comes at some cost, however. In addition to the risk of perioperative death, the morbidity rate was considerable and the hospital length of stay was, for the current era, prolonged. This can be expected to translate into increased overall costs and should be taken into consideration when projecting health care expenditures. Among the risk factors for operative death that were identified in the present study, only surgical status is potentially modifiable. The marked increase in operative risk for urgent and emergent procedures suggests that surgical intervention should be considered before hemodynamic decompensation has oc- III-74 Circulation November 7, 2000 Downloaded from http://circ.ahajournals.org/ by guest on June 14, 2017 curred. We favor an aggressive approach once a patient has been deemed a surgical candidate. In contrast, patients who present in a decompensated state may benefit from the optimization of hemodynamics before surgery. The present study identified the presence of preoperative stroke and chronic obstructive pulmonary disease as predictors of late death. This finding also is consistent with previous studies2,9,12 and suggests that a less aggressive approach may be warranted in these individuals. Concomitant CABG was performed in a significant number of patients in our series. Early studies of AVR in elderly persons suggested that the mortality rate for the combined procedure was increased, with mortality rates for the combined procedure ranging from 12% to 37% compared with rates of 5% to 7% for AVR alone.2,13–15 Concomitant revascularization was not a predictor of death in our more contemporary series, possibly due to the neutralizing effect of improved myocardial protection. Several other recent series have shown similar results, with no effect of CABG,8 or an affect only in women who underwent the combined procedure.16 A significant number of patients in this series received valves of ⱕ21 mm. Although body surface area data were not available, the majority of these valves were placed in women. This also reflects our reluctance to embark on more extensive procedures, such as root enlargement, in the very old. This practice is supported in the literature,5 and small valve size did not fall out as a risk factor for early or late death. The present study was retrospective, and there are inherent weaknesses and limitations of any such analysis. Principal among these is the potential selection bias in favor of more robust patients imposed by the cardiologists who propose this intervention and the surgeons who accept the patients as candidates. This factor cannot be accounted for in any rigorous way, because there is no database of patients who were// refused surgery. A large number of surgeons and cardiologists were involved in the care of these patients, and there are no codified criteria for acceptance for surgery at our institution. Still the majority of patients were of advanced functional class, and many required concomitant bypass grafting suggesting that this is not a highly selected subgroup. References 1. Logeais Y, Roussin R, Langanay T, et al. Aortic valve replacement for aortic stenosis in 200 consecutive octogenarians. J Heart Valve Dis. 1995;4(suppl 1):S64 –S71. 2. Gehlot A, Mullany CJ, Ilstrup D, et al. Aortic valve replacement in patients aged eighty years and older: early and long-term results. J Thorac Cardiovasc Surg. 1996;111:1026 –1136. 3. Asimakopoulos G, Edwards MB, Taylor KM. Aortic valve replacement in patients 80 years of age and older: survival and cause of death based on 1100 cases: collective results from the UK Heart Valve Registry. Circulation. 1997;96:3403–3408. 4. Khan JH, McElhinney DB, Hall TS, et al. Cardiac valve surgery in octogenarians: improving quality of life and functional status. Arch Surg. 1998;133:887– 893. 5. Medalion B, Lytle BW, McCarthy PM, et al. Aortic valve replacement for octogenarians: are small valves bad? Ann Thorac Surg. 1998;66: 699 –705. 6. Craver JM, Puskas JD, Weintraub WW, et al. 601 octogenarians undergoing cardiac surgery: outcome and comparison with younger age groups. Ann Thorac Surg. 1999;67:1104 –1110. 7. Bungay KM, Ware JE. Measuring and Monitoring Health-Related Quality of Life: Current Concepts. Kalamazoo, Mich: The Upjohn Company, 1993. 8. Kirsch M, Guesnier L, LeBesnerais P, et al. Cardiac operations in octogenarians: perioperative risk factors for death and impaired autonomy. Ann Thorac Surg. 1998;66:60 – 67. 9. Akins CW, Daggett WM, Vlahakes GJ, et al. Cardiac operations in patients 80 years old and older. Ann Thorac Surg. 1997;64:606 – 614. 10. Levin IL, Olivecrona GK, Thulin LI, et al. Aortic valve replacement in patients older than 85 years: outcomes and the effect on their quality of life. Coron Artery Dis. 1998;9:373–380. 11. Olsson M, Janfjall H, Orth-Gomer K, et al. Quality of life in octogenarians after valve replacement due to aortic stenosis: a prospective comparison with younger patients. Eur Heart J. 1996;17:583–589. 12. Tseng EE, Lee CA, Cameron DE, et al. Aortic valve replacement in the elderly: risk factors and long-term results. Ann Surg 1997;225:793– 802; discussion 802– 804. 13. Tsai TP, Matloff JM, Chaux A, et al. Combined valve and coronary artery bypass procedures in septuagenarians and octogenarians: results in 120 patients. Ann Thorac Surg. 1986;42:681– 684. 14. Culliford AT, Galloway AC, Colvin SB, et al. Aortic valve replacement for aortic stenosis in persons aged 80 years and over. Am J Cardiol. 1991;67:1256 –1260. 15. Elayda MA, Hall RJ, Reul RM, et al. Aortic valve replacement in patients 80 years and older: operative risks and long-term results. Circulation. 1993;88(suppl II):II-11–II-6. 16. Aranki SF, Rizzo RJ, Couper GS, et al. Aortic valve replacement in the elderly: effect of gender and coronary artery disease on operative mortality. Circulation. 1993;88(suppl II):II-17–II-23. Quality of Life After Aortic Valve Replacement at the Age of >80 Years Thoralf M. Sundt, Marci S. Bailey, Marc R. Moon, Eric N. Mendeloff, Charles B. Huddleston, Michael K. Pasque, Hendrick B. Barner and William A. Gay, Jr Downloaded from http://circ.ahajournals.org/ by guest on June 14, 2017 Circulation. 2000;102:Iii-70-Iii-74 doi: 10.1161/01.CIR.102.suppl_3.III-70 Circulation is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2000 American Heart Association, Inc. All rights reserved. Print ISSN: 0009-7322. Online ISSN: 1524-4539 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circ.ahajournals.org/content/102/suppl_3/Iii-70 Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. 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