|
|
||||||||
a Division of Cardiothoracic Surgery, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas
b Division of Cardiology, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas
c Section of Adult Cardiac Surgery, The Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas
d San Francisco Veterans Affairs Medical Center and the University of California–San Francisco, San Francisco, California
Accepted for publication October 13, 2009.
* Address correspondence to Dr Bakaeen, Department of Cardiothoracic Surgery, Michael E. DeBakey VAMC, OCL 112, 2002 Holcombe Blvd, Houston, TX 77030 (Email: fbakaeen{at}bcm.edu).
| Abstract |
|---|
|
|
|---|
Methods: We retrospectively reviewed data from all patients diagnosed with severe aortic stenosis at a Veterans Affairs medical facility between January 1997 and April 2008.
Results: Of 345 patients with severe aortic stenosis, 260 (75%) underwent surgical evaluation, and 205 (59%) underwent aortic valve replacement (AVR). The patient's decision to decline surgical referral or AVR (n = 47) and severe comorbidities (n = 34) were the top two reasons for medical treatment rather than AVR. The AVR group was younger (69.5 ± 9.6 years versus 75.7 ± 8.6 years; p < 0.001) and had a higher prevalence of symptoms (96% versus 71%; p < 0.001) than the medical group. The medical group had a lower cardiac ejection fraction (0.42 ± 0.15 versus 0.50 ± 0.12; p < 0.001) and was less likely to be independent in activities of daily living (64% versus 74%). The AVR group had higher survival rates than the medical patients at 1 year (92% versus 65%), 3 years (85% versus 29%), and 5 years (73% versus 16%; log-rank test p < 0.0001). Valve replacement was independently associated with decreased mortality (hazard ratio, 0.17; 95% confidence interval, 0.10 to 0.27; p < 0.0001).
Conclusions: The management of severe aortic stenosis in veterans is sometimes limited to medical evaluation and treatment. Surgeons should be involved in the complex process of risk assessment, to select patients with severe aortic stenosis who would benefit from the survival advantage associated with AVR.
| Introduction |
|---|
|
|
|---|
The aging of the US population [2] may change the number and type of AS cases that US physicians treat. Because calcific AS is the predominant valve disease in the elderly [3], we are likely to witness a sharp rise in the number of patients with severe AS. The medical and surgical communities should anticipate this increase and set guidelines and allocate resources accordingly.
Recent advancements in medical and surgical care may change the stage of development at which AS cases are treated. Because symptom development is associated with poor survival [4], patients with asymptomatic AS have traditionally been treated expectantly, and surgery has been reserved until symptoms develop or until concomitant coronary artery bypass grafting surgery is indicated. However, recent advancements in cardiac surgery, improvements in myocardial protection, and the increased longevity of bioprosthetic valves favor earlier surgical intervention and placing less emphasis on symptoms in surgical decision making [5–9].
The advent of minimally invasive transcatheter technologies for treating valve disease [10, 11] may lead to a paradigm shift in the treatment of patients with severe AS. Although we are at a very early stage of its development, transcatheter valve implantation has generated a lot of interest and prompted a recent collaborative professional position statement [12].
Against this background, little is known about the care path of contemporary patients after they are diagnosed with severe AS. We hypothesized that surgically treated AS patients are only one part of a much larger pool of patients with severe AS. Therefore, we reviewed the treatment of all patients who were diagnosed with severe AS at our institution, and we focused specifically on the factors that influenced the choice of treatment modality (surgical versus medical). In addition, we analyzed the differences in survival between patients who underwent AVR and those who were treated medically.
| Patients and Methods |
|---|
|
|
|---|
A total of 345 patients who fit our criteria were identified, and a detailed chart review was conducted to extract relevant demographic, clinical, echocardiographic, surgical, and follow-up data. A total of 205 patients underwent AVR surgery, whereas 140 patients were medically treated. The reasons behind the choice of treatment (surgical versus medical) were identified and recorded. At our institution, the decision regarding management of severe AS typically involves close collaboration between the cardiologists and cardiac surgeons. Patient-related factors, including patient preference, are important considerations.
We extracted the Department of Veterans Affairs Continuous Improvement in Cardiac Surgery Program's (CICSP) risk covariates (and used their associated definitions), including age, serum creatinine level, history of endocarditis, chronic obstructive pulmonary disease, current smoking status, cerebrovascular disease, diabetes, New York Heart Association heart failure class, functional status, peripheral vascular disease, and ejection fraction [13]. For the purposes of this study, we used comorbidities as an umbrella term to cover a range of noncardiac disease entities, including cancer, liver disease, renal disease, pulmonary disease, and central and peripheral vascular disease. Data on prescribed medications, including β-blockers, statins, and antiplatelet drugs, were not complete and could not be evaluated in this study.
Follow-up data were available for all patients and started from the date of the first echocardiogram that indicated an aortic valve area less than 1.0 cm2. The study end point, namely all-cause mortality, was determined from the Veterans Affairs Computerized Patient Record System, which contains pertinent information on the vital status of each patient. The National Social Security Death Index was used as a supplementary source of mortality data.
Statistical Methods
All data were analyzed with SAS version 9.1 (SAS Institute Inc, Cary, NC). All demographic and clinical variables were compared between the AVR group and the medical group by using Student's t tests for continuous variables and Fisher's exact test or
2 test for categorical variables. Overall survival at 1, 3, and 5 years was estimated by the Kaplan-Meier method and expressed as percentage ± 95% confidence interval (CI). Stepwise Cox regression was used to identify CICSP covariates that were significantly associated with survival.
| Results |
|---|
|
|
|---|
|
|
Surgery
In addition to AVR, 40.1% (83 of 205) of patients underwent coronary artery bypass grafting, and 4.9% (10 of 205) underwent aortic root or ascending aortic repair. Five patients underwent a concomitant left atrial ablation procedure for atrial fibrillation. There were no concomitant procedures involving other valves. There was mild or moderate mitral regurgitation in 60.5% (124 of 205) of patients but no mitral regurgitation severe enough to prompt surgical correction. The overall 30-day or in-hospital mortality rate was 6.3% (13 of 205).
Survival
Survival rates after diagnosis were significantly higher in the AVR group than in the medical group at 1 year (92%; 95% CI, 87% to 95%; versus 65%; 95% CI, 56% to 72%), 3 years (85%; 95% CI, 79% to 90%; versus 29%; 95% CI, 21% to 37%), and 5 years (73%; 95% CI, 65% to 80%; versus 16%; 95% CI, 9% to 23%; log-rank test p < 0.0001; Fig 2). Cox proportional hazard modeling, after adjusting for preexisting conditions, indicated that the AVR group had a hazard ratio for mortality of 0.17 (95% CI, 0.10 to 0.27; p < 0.0001) compared with the medical group. The predictors of mortality were older age, higher serum creatinine level, lower cardiac ejection fraction, the presence of chronic obstructive pulmonary disease, the presence of cerebrovascular disease, and, counterintuitively, the absence of peripheral vascular disease (Table 2).
|
|
| Comment |
|---|
|
|
|---|
Patients with severe AS who have a limited life expectancy owing to severe noncardiac disease are unlikely to benefit from AVR. Many of the comorbidities that influenced the choice of treatment (AVR versus medical) for our patients with severe AS are not captured by traditional cardiac risk models. Patients with terminal illness such as advanced incurable cancer, end-stage pulmonary disease, advanced liver cirrhosis, or ongoing uncontrollable sepsis (excluding surgical endocarditis) may be anatomically operable, but to subject such patients to surgery or any invasive procedure is clearly inappropriate. Severe irreversible pulmonary hypertension that is associated with primary pulmonary (rather than cardiac) disease also contraindicates AVR. Renal failure that is captured by cardiac risk models is particularly ominous in patients with severe AS, especially if the renal failure has an acute onset and is associated with other organ dysfunction. Consideration should be given to mechanically supporting the heart to reverse organ dysfunction before proceeding with AVR. In our opinion, patients with major debilitating stroke or with advanced dementia that renders them unable to care for themselves are best treated medically. Patients with severe and debilitating noncardiac disease are not only at higher risk for operative mortality but are also likely to have a limited life expectancy regardless of the treatment modality chosen. Severe AS becomes a secondary concern in those patients who are better treated with palliative medical measures.
The importance of cardiac symptoms in determining the timing of surgical referral of patients with severe AS is a subject of intense interest. In this era of advanced perioperative care and improved surgical outcomes, there is a growing body of literature that supports earlier surgical intervention and less emphasis on symptoms [5–9]. We believe that "asymptomatic" patients often inadvertently reduce their activity level and mask their symptoms. In our experience, many AS patients initially labeled as asymptomatic are found to be symptomatic on further evaluation and often have abnormal left ventricular echocardiographic manifestations. We adopt a more conservative but watchful approach for severe AS patients who are truly asymptomatic; this approach is characterized by optimal medical treatment and close follow-up with serial echocardiography. Surgery is considered as soon as symptoms develop or when adverse changes in cardiac function or dimensions are detected. We pay particular attention to the morphology and calcification of the leaflets. In our experience, patients with heavily calcified and restricted leaflets and those with bicuspid aortic valves are likely to experience a rapid progression in AS severity and symptom onset and warrant earlier intervention.
The deterioration of functional capacity is a tricky issue in terms of surgical decision making, because it may in fact be a subtle manifestation of cardiac symptoms, rather than the result of comorbid conditions that might contraindicate surgery. If the decline in functional status is simultaneous with worsening degree of aortic stenosis or worsening cardiac function, then doing the surgery can reverse the decline in function by correcting the underlying cardiac cause. To help us in treatment decision making in certain select instances, we have performed balloon aortic valvuloplasty to ascertain whether a brief window of improvement or optimization may be achieved, which would suggest a potential benefit of AVR for the patient.
Although advanced age (>80 years) was the primary reason for nonsurgical treatment in only a few cases (8 of 140), age probably played an indirect role in the choice of medical treatment over AVR through age-associated comorbidities and declining functional status. It is projected that by the year 2020, approximately 20 million Americans will be 80 years or older [2]. The prevalence of AS increases with age, and the lack of effective medical treatment to prevent aortic valve stenosis or halt its progression can only increase the health-care burden imposed by this condition [16, 17]. Most contemporary series of AVR operations in patients aged 80 years and older have shown good outcomes, including satisfactory long-term survival rates [18–20]. However, the medical community has been somewhat reluctant to refer very elderly patients for AVR. This reluctance persists despite recent evidence that the quality of life of octogenarians after AVR is comparable to that predicted for the age-matched general population [21]. Physicians should consider patient age in the context of the entire clinical picture, rather than assigning an arbitrary cutoff age for medical versus surgical intervention.
Also, there is no cutoff value for ejection fraction when it comes to offering or declining surgical intervention; instead, we consider evaluating the cardiac contractile reserve, especially in AS patients with low ejection fraction and low gradient, to refine the risk stratification process. A particularly challenging scenario is a small annulus in an AS patient with low ejection fraction or low gradient. Every effort should be made to use the largest possible valve, and consideration should be given to performing root enlargement at the time of AVR to minimize the transprosthetic gradient, which is poorly tolerated in these high-risk patients. Depending on other patient-related factors, including age and comorbidities, the risks imposed by surgery may be prohibitive.
Patients who are deemed high-risk for traditional AVR because of anatomic or technical surgical considerations (eg, porcelain aorta, multiple previous cardiac operations), with or without other medical risk factors, are particularly challenging to treat but may be candidates for alternative interventional modalities. Patients with less than moderate aortic regurgitation and a segment of the descending aorta that is suitable for clamping are considered for apical to descending valved conduit bypass.
Transcatheter aortic valve implantation is a new strategy in the armamentarium of AS treatments. However, currently, about half of the patients referred for transcatheter aortic valve intervention are either deemed unsuitable candidates or end up undergoing traditional AVR [22]. The technology is still in its infancy, and as more data become available to support the safety and efficacy of the procedure, carefully selected patients who are deemed high risk for traditional AVR may benefit from this procedure. Rigorous evaluation of transcatheter technology with adequate follow-up is needed before any major paradigm shift in the treatment of severe AS can take place.
With rising health-care costs and with AS being predominantly a senile disease, socioeconomic and ethical considerations come into play. Furthermore, quality of life is an important outcome that is often overlooked and that should be carefully evaluated as we consider different treatment modalities for AS. Offering surgical or percutaneous intervention that may extend the life of a patient with debilitating comorbidities or advanced dementia comes at a risk and price that is sometimes hard for the patient, the patient's family, and society to accept. Our job as responsible and caring professionals is to offer AVR or other interventions that extend functional and reasonably contented lives.
There are several limitations to our study. It is retrospective in nature and has a relatively small sample size; thus, it is vulnerable to all the weaknesses and biases associated with such a design. Although we reviewed the cardiac echocardiogram reports to verify the severity of AS, we did not independently review the echocardiogram images and verify the valve measurements. Follow-up echocardiographic data were limited because 65% of our patients were referred from remote hospitals. Once these patients are discharged, they are followed up by their local primary care physician or cardiologist; therefore, follow-up echocardiograms were not uniformly available. As a result, we could not study the effects of AVR on long-term ventricular remodeling.
Our risk model covariates were derived from the CICSP, which is generated from a national veterans cardiac surgical cohort and does not track variables that are rarely encountered in such a population (eg, dementia, cirrhosis) but are more common in medically managed patients. In addition, the only outcome we examined was all-cause mortality; we did not track adverse cardiovascular events. Our study is novel because it addresses a timely topic that has been inadequately studied: the patterns of referral and treatment of patients with severe AS. We examined factors that are often overlooked in reports on this subject, such as factors involved in patient selection for surgical intervention versus medical treatment.
In conclusion, despite medical advancements and newer treatment modalities, the management of patients with severe AS can be challenging and is best approached in a multidisciplinary setting with surgical expertise to navigate the complex process of risk assessment and to select patients who would benefit from the survival advantage associated with AVR.
| Acknowledgments |
|---|
|
|
|---|
| References |
|---|
|
|
|---|
This article has been cited by other articles:
![]() |
M. A. Clark, S. V. Arnold, F. G. Duhay, A. K. Thompson, M. J. Keyes, L. G. Svensson, R. O. Bonow, B. T. Stockwell, and D. J. Cohen Five-year Clinical and Economic Outcomes Among Patients With Medically Managed Severe Aortic Stenosis: Results From a Medicare Claims Analysis Circ Cardiovasc Qual Outcomes, September 1, 2012; 5(5): 697 - 704. [Abstract] [Full Text] [PDF] |
||||
![]() |
S. Chitsaz, N. Jaussaud, E. Chau, K. S. Yan, A. N. Azadani, M. B. Ratcliffe, and E. E. Tseng Operative Risks and Survival in Veterans With Severe Aortic Stenosis: Surgery Versus Medical Therapy Ann. Thorac. Surg., September 1, 2011; 92(3): 866 - 872. [Abstract] [Full Text] [PDF] |
||||
![]() |
M. Thomas, G. Schymik, T. Walther, D. Himbert, T. Lefevre, H. Treede, H. Eggebrecht, P. Rubino, A. Colombo, R. Lange, et al. One-Year Outcomes of Cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry: The European Registry of Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN Valve Circulation, July 26, 2011; 124(4): 425 - 433. [Abstract] [Full Text] [PDF] |
||||
![]() |
O. Wendler, T. Walther, H. Schroefel, R. Lange, H. Treede, M. Fusari, P. Rubino, and M. Thomas The SOURCE Registry: what is the learning curve in trans-apical aortic valve implantation? Eur J Cardiothorac Surg, June 1, 2011; 39(6): 853 - 860. [Abstract] [Full Text] [PDF] |
||||
![]() |
F. G. Bakaeen, D. Chu, J. Huh, and B. A. Carabello Is an Age of 80 Years or Greater an Important Predictor of Short-Term Outcomes of Isolated Aortic Valve Replacement in Veterans? Ann. Thorac. Surg., September 1, 2010; 90(3): 769 - 774. [Abstract] [Full Text] [PDF] |
||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
| ANN THORAC SURG | ASIAN CARDIOVASC THORAC ANN | EUR J CARDIOTHORAC SURG |
| J THORAC CARDIOVASC SURG | ICVTS | ALL CTSNet JOURNALS |