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a Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia
b Department of Biostatistics, Rollins School of Public Health, Emory University School of Medicine, Atlanta, Georgia
Accepted for publication June 10, 2008.
* Address correspondence to Dr Thourani, 550 Peachtree Street, Crawford Long Hospital, 6th Floor, Medical Office Tower, Cardiothoracic Surgery, Atlanta, GA 30308 (Email: vinod.thourani{at}emoryhealthcare.org).
Presented at the Forty-fourth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2008. Winner of the Geriatric Patient Care Award.
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Abstract |
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Methods: A retrospective review was performed on patients who underwent isolated, primary AVR from 1996 to 2006 at the Emory Healthcare Hospitals. Five-hundred fifteen patients were divided into three age groups: 60 to 69 (n = 206), 70 to 79 (n = 221), and 80 to 89 years of age (n = 88). Outcomes were compared among the age groups using logistic regression and analysis of variance techniques. Long-term survival between age groups was compared using the Cox proportional hazards model. Kaplan-Meier plots were used to determine survival rates.
Results: The groups were similar with respect to in-hospital mortality (p = 0.66) and hospital length of stay (p = 0.08). Preoperative predictors of in-hospital mortality included stroke (odds ratio [OR] 5.36), chronic lung disease (OR 4.51), and renal failure (OR 1.39). As expected, age significantly impacted long-term survival (hazard ratio [HR] 1.06). Other predictors of long-term survival included stroke (HR 2.15), current smoker (HR 2.03), diabetes (HR 1.53), and renal failure (HR 1.4). The Kaplan-Meier estimate of median survival for octogenarians was 7.4 years.
Conclusions: In the modern era, octogenarians have acceptable short- and long-term results after open AVR. Comparisons of less invasive techniques for AVR should rely on outcomes based in the modern era and decisions regarding surgical intervention in patients requiring AVR should not be based on age alone.
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Introduction |
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TopAbstractIntroductionMaterial and MethodsResultsCommentDiscussionAcknowledgmentsReferences |
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The purpose of the current study was to evaluate 515 consecutive patients undergoing isolated, primary AVR over a 10-year period at the Emory Healthcare Hospitals. Specifically, we wanted to evaluate whether patients older than 80 years of age had a higher risk of developing in-hospital postoperative morbidity and (or) mortality compared with their younger counterparts (ages 60 to 69 and 70 to 79). Furthermore, we assessed the long-term all-cause survival of patients undergoing AVR among varying age groups.
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Material and Methods |
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Surgical Technique
The selection of candidates for cardiac operations at Emory Healthcare was at the discretion of individual referring physicians, cardiologists, and cardiac surgeons. Meticulous preoperative and postoperative care, including aggressive early mobilization, is mandatory to minimize complications and shorten postoperative stay. Nephrotoxic drugs are avoided when selecting prophylactic antibiotics. Central venous catheters are removed as soon as possible to avoid sepsis and enteral feeding is begun early in the postoperative period.
Specific details of surgical technique and valve selection and implantation were determined by the individual cardiac surgeon. Generally, all patients were performed with standard cardiopulmonary bypass techniques utilizing roller head pumps, membrane oxygenator, cardiotomy suction, arterial filters, cold antegrade and retrograde blood cardioplegia, and moderate systemic hypothermia (
32°C). Direct aortic clamping was utilized in all patients. Antifibrinolytics were administered at the discretion of the attending cardiac surgeon.
Demographic and Preoperative Data
Prior to analysis, 22 preoperative risk factors for short-term and long-term survival were identified and harvested from the Society of Thoracic Surgeons National Database (www.sts.org) (see Table 1). The definitions of each risk factor are specified by the STS and reflect standardized and generally recognized symptoms and qualifications of disease. Status was dichotomized as either elective or nonelective (urgent-emergent). Race was dichotomized to either Caucasian or non-Caucasian. Chronic lung disease, which was ordinal (none, mild, moderate, severe) for some of the study years, was recategorized dichotomously as either present or absent. Postoperative definitions and outcomes were also determined according to the Society of Thoracic Surgeons National Database criteria. Data were complete for the critical risk factor of interest (age) as well as for each postoperative hospital outcome and long-term survival.
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Data Management and Statistical Analysis
All data for consecutive patients were entered into a computerized cardiac surgical database, utilizing the data fields of the STS National Adult Cardiac Database. Patients were primarily classified according to their age into three different decade age ranges (60 to 69, 70 to 79, and 80 to 89 years). A multivariable logistic regression model was constructed to evaluate whether in-hospital mortality differed among the age groups, adjusted for the aforementioned 22 risk factors (see Table 1). Further, a general linear model (GLM) was constructed to compare hospital length of stay (in days) and ICU length of stay (in hours) among age groups, adjusted for the 22 covariates. Similarly, observed-to-expected (O/E) mortality was measured across age groups using in-hospital observed mortality and the STS predicted risk of mortality measure.
Long-term survival was evaluated using Kaplan-Meier product-limit estimates to measure 1-, 3-, 5-, and 10-year survival along with 95% confidence intervals. Secondarily, by a process of backward elimination, a proportional hazards regression survival model was determined that started with each risk factor listed in Table 1 and eliminated risk factors until every risk factor remaining in the model was significant at the 0.05 alpha level. Hazard ratios and 95% confidence intervals were reported. The data were managed and analyzed using SAS Version 9.1 (SAS, Cary, NC). All statistical tests were two-sided using an p = 0.05 level of significance.
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Results |
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Table 2 represents the operative characteristics for all patients. As expected, more bioprosthetic valves were implanted in the older patient populations. The most common valve size was 23 mm in the 60 to 69 and 70 to 79 age groups, while 21 mm was the most common in the 80 to 89 age group. An intraoperative intraaortic balloon pump was rarely required and octogenarians had a significantly lower body mass index (BMI) compared with the younger age groups. While the cardiopulmonary bypass (CPB) time was not different among groups, the mean aortic cross-clamp time was significantly less in the older age groups.
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Comment |
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The results of the current study add to the increasing weight of evidence that suggest open, traditional AVR can be performed safely in octogenarians with acceptable morbidity and short-term mortality. In this study, the overall in-hospital mortality rate of 5.7% in the 88 octogenarians compares favorably with 60 to 69 year old patients (3.4%), but also with those patients in their 70s (4.1%). Although the purpose of this study was not to compare the results of AVR between two eras of cardiac surgery, mortality appears to be improving comparing these results with earlier series. In patients undergoing AVR in the early to mid 1990s and earlier, mortality has been reported to be 5.6% to 16.7% [7, 15–18]. More recently in this patient population, short-term mortality has been reported to be 5.2% to 10% [4, 9, 19–21]. Although the reasons for such a decline are likely multifactorial, continued refinements in cardiac anesthesia, surgical technique, myocardial protection, and postoperative management may be determinants leading to improved hospital survival. Another plausible explanation remains surgeon and cardiologist variability in patient selection. Unfortunately, data regarding patients evaluated, but not offered surgery, are not readily available.
In patients undergoing coronary surgery, octogenarians have been shown to have significantly higher rates of major adverse events such as stroke, reoperation for bleeding, sepsis, and renal and respiratory failure than younger patients [22]. In the current series of patients undergoing isolated aortic valve surgery, we have not shown a statistically significant increase in major adverse events in octogenarians compared with younger patient populations. However, we have shown trends toward prolonged ventilator dependence, intensive care unit stay, and postoperative hospital length of stay. Similarly, Filsoufi and colleagues [9] and Chukwuemeka and colleagues [23] have shown similar morbidity outcomes in octogenarians undergoing aortic valve replacement compared to younger patients. However, the increased resource utilization of octogenarians may translate into increased overall costs and may be an important consideration when projecting health care expenditures.
In the current study, survival estimates for the octogenarian group at 1 year were 87%, 68% at 3 years, 61% at 5 years, and 30% at 10 years (Table 5). This compares well with previously reported long-term survival in this population [4, 19, 20, 23]. Sundt and colleagues [4] from the Mayo Clinic noted a 1-year survival of 80% and a 5-year survival of 55% in octogenarians undergoing AVR with or without concomitant coronary artery bypass grafting. Chiappini and colleagues [20] reported an 86.4% actuarial survival rate at 1 year and 69.4% at 5 years, while Melby and colleagues [19] noted an 82% survival at 1 year and 56% at 5 years. Stoica and colleagues [24] recently published long-term survival for octogenarian patients undergoing cardiac surgery to far exceed the life expectancy of their peers. In this study, long-term survival was significantly better in the patients having undergone cardiac surgery than the general population with the same age-sex distribution (5-year survival 82% vs 56%, p < 0.001). We agree with this notion as a Kaplan-Meier estimate of median survival for octogenarians remains an impressive 7.4 years.
Not only do these patients have an extended life expectancy, but they also enjoy an improved quality of life. Fruitman and colleagues [6] reported that approximately 83% of octogenarians undergoing cardiac surgery were living in their own home and 74% rating their current health as good or excellent. Similarly, in the current study, 90.1% of our octogenarians were discharged to home. Huber and colleagues [25] reported that 81% of octogenarians undergoing cardiac surgery had little disability in daily activities and 93% were free or significantly less symptomatic; Sundt and colleagues [4] noted that quality of life for octogenarians undergoing AVR as assessed with the Medical Outcomes Study Short Form-36 was comparable with that predicted for the general population greater than 75 years of age. Furthermore, they noted a mean New York Heart Association (NYHA) functional class improvement from 3.1 to 1.7 [4].
The results of the current study confirmed significant preoperative factors contributing to long-term survival. Advanced age, cerebrovascular accident, current smoker, diabetes mellitus, and renal failure portended a worse prognosis. Unlike some studies, preoperative NYHA classification, congestive cardiac failure, and urgent versus emergent status did not affect long-term survival outcomes in the current analysis [4, 23, 26]. A major discrepancy may be due to the lack of concomitant procedures and the primary nature of the AVR performed in patients of this report.
The current study by its retrospective single-center nature is limited to the weaknesses of this particular type of analysis. Specifically, this study is limited by the potential selection bias of patients due to the specific referral patterns to the institution and personal selection criteria of the individual cardiologist and surgeon. The selection of healthier appearing patients by the cardiologists for referral and the continued medical management of patients deemed to be "too sick" for surgery are factors difficult to account for in this study. Likewise, it is not known how many patients referred for surgery were ultimately denied for various reasons. However, because overall preoperative risk factors were similar in all groups, the selection bias is presumably equal across all age groups and not particularly dominant in the octogenarian group alone. This study is also limited by selecting only octogenarians undergoing isolated, primary AVR alone. Clearly, octogenarians undergoing combined or reoperative procedures are at higher risk and continue to be the subject of ongoing research at our institution.
Very important in selecting octogenarians for cardiac surgery is the surgeon's subjective impression after interviewing and examining the patient. Family history of longevity, intellectual function, and general level of fitness and activity are important predictors of outcome that cannot be easily quantified or reported. In summary, we believe that based on age alone, with minimal comorbidities, conventional primary, isolated AVR remains the standard of care and can be performed with low morbidity and in-hospital mortality and acceptable long-term survival. It is plausible that in patients with advanced age and additional comorbidities, percutaneous (transfemoral or transapical) AVR may provide potential benefits in postoperative morbidity and mortality.
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Discussion |
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DR THOURANI: Thank you, Dr Lahey. Those are very insightful comments. I do agree with you, we probably do need a different yard-stick to measure the success of aortic valve surgery in the elderly population. I agree with you that a lot of these patients are less worried about mortality, since they feel like they have lived their life. Sometimes, I think it their children who are more worried about the mortality, especially if they will be the caretakers postoperatively. Although this study did not specifically look at postoperative improvements in the quality of life or NYHA classifications, there have been studies from Mayo Clinic (by Dr Sundt and others) which have shown that quality of life does improve in this patient population. In that study, the NYHA classification significantly improved. We at Emory are very interested in this topic and hope to answer these questions in the future.
DR JOSEPH C. CLEVELAND (Denver, CO): Vinod, that is an outstanding series and I think clearly highlights again proof of concept, that with the outstanding care that you all give these patients they can do well. Very impressive, only 10% of them actually went to nursing homes. That is actually a lot lower than some of the other series would suggest. A couple of questions. One is, for the long-term survival, particularly for the older than 80 group, do you have age-matched controls? Stated differently, what is expected survival for an individual who is 80 years old? The second question is, as we all know, caring for these people is a challenge, essentially from the standpoint that one little thing derail their recovery. Do you have specific protocols, other things you follow, things you do differently with your population either in the OR or in the CVICU to keep them from aspirating or getting delirious? Again, an outstanding series. Congratulations.
DR THOURANI: Thank you Dr Cleveland for your comments and questions. We do not have age-matched controls for patients for our long-term survival. There is one study that has evaluated this aspect and they did note that compared to age-matched controls, patients undergoing AVR had comparable and parallel survival curves. I think is an excellent point.
We are fortunate, like other academic teaching institutions, to have an incredible support from our anesthesiology department, residents, perfusionists, and physician extenders in the care of these patients. Intraoperatively, we try to keep their mean pressures over 70 to 75 mm Hg. Furthermore, we attempt to provide an expeditious surgery with the short aortic cross-clamp and cardiopulmonary bypass time. Postoperatively, we are very careful with a couple specific aspects. We are very cognizant when prescribing and dosing of nephrotoxic drugs. We are more likely to get our pharmacokinetics team involved earlier with the management of these patients. I agree with you, we are worried about aspiration in this patient population. We are very aggressive about getting the swallowing team involved, and a lot of times they will see them in the ICU before we start feeding them. It, of course and as you know, depends on the individual patient. Lastly, in managing these patients' respiratory status, we commonly are quite aggressive about pulmonary toilet and early extubation. Much of the care is the same for all cardiac surgery patients; we are just cognizant that octogenarians have a narrower window of error.
DR HUGH E. SCULLY (Toronto, Ontario, Canada): I noticed that the sizes of the valves in the older patients are smaller, but you did make the case that more of them were women than men, in the first instance. And the other question has to do with how aggressive you are in the older patients, and we are all more aggressive with younger patients, in enlarging the annulus to put a larger valve in. Certainly our practice in Toronto is not to be so aggressive in the relatively less active octogenarians. So we won't be as aggressive about taking the time to enlarge the annulus. Is that one of the factors in your pump time and cross-clamp time?
DR THOURANI: Thank you, Dr Scully, for those questions. I do think that we are a little bit more conservative towards that also. Obviously as you know from your many decades of practice that these patients' tissues also are not optimal. Unless we really have a patient-prosthesis mismatch in a very active octogenarian, we try not to do Manougian or Nicks procedures in those patients. Moreover, in our study, octogenarians have a significantly lower body mass index and older patients were more likely to be females. Usually in these patients, a size 21 valve will suffice.
DR SCULLY: Agreed.
DR MARC MOON (St. Louis, MO): Do you find yourself also being less aggressive in regards to revascularization in an 80-year-old patient? For example, a 50% obtuse marginal lesion that you would consider repairing easily in a 60-year-old you may not do in an 80-year-old?
DR THOURANI: We have eight cardiac surgeons currently at Emory, and I think everybody is little bit different about that. Your own study that you have done just recently published in 2007 in the Annals of Thoracic Surgery shows that patients who had coronary bypass actually do better in the octogenarians compared to those who do not. I think that point is well taken, but it is individualized. If it is a 50 to 60% lesion or less, I probably wouldn't do anything to it; if it is 70%, I will.
DR ADIB H. SABBAGH (Tucson, AZ): We noticed in that age group we have more calcified ascending aorta, and sometimes you have to open and you close. Have you ever encountered such a complication?
DR THOURANI: Yes, we have. However, I can not give you an exact number of patients that we have encountered with this problem. The current series includes patients who actually underwent a valve replacement. I agree with you that this is a problem for us, and in fact in the last four to five months there are three patients that we have opened and closed, and consequently two of those have come back to us. Two of those patients have undergone off-pump apical-aortic conduits by Dr Robert Guyton and myself. Moreover, we now have the capability of performing transfemoral aortic valve replacement (Edwards LifeScience) with our cardiologists; I have a few patients who are referred to me for this exact problem.
In elderly patients, I carefully look at the PA/lateral chest X-ray for a calcified ascending aorta. If I am concerned, I order a non-contrast chest CT to confirm my suspicions.
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Acknowledgments |
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This study was internally funded solely by Emory Healthcare, through the Clinical Research Unit of the Division of Cardiothoracic Surgery, without contribution from any outside corporate entity.
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