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J Thorac Cardiovasc Surg 2005;129:112-122
© 2005 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
Read at the Eighty-fourth Annual Meeting of The American Association for Thoracic Surgery, Toronto, Ontario, Canada, April 25-28, 2004.
Received for publication January 16, 2004; revisions received August 4, 2004; accepted for publication September 3, 2004. * Address for reprints: Santi Trimarchi, MD, Istituto Policlinico S Donato, via Morandi 30, 20097 S Donato Milanese, Italy (E-mail: satrimarchi{at}yahoo.it).
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Abstract |
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 Top Abstract MethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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METHODS: A comprehensive analysis was completed of 290 clinical variables and their relationship to surgical outcomes in 526 of 1032 patients enrolled in the International Registry of Acute Aortic Dissection from 1996 through 2001. Extracted cases, categorized according to risk profile, were defined as unstable (group I) in the presence of cardiac tamponade; shock; congestive heart failure; cerebrovascular accident; stroke; coma; myocardial ischemia, infarction, or both; electrocardiograms with new Q waves or ST elevation; acute renal failure; or mesenteric ischemia-infarction at the time of the operation. Outside of an unstable condition, patients were categorized as stable (group II).
RESULTS: The overall in-hospital mortality was 25.1%. Mortality in group I was 31.4% compared with 16.7% in group II (P < .001). Independent preoperative predictors of operative mortality were history of aortic valve replacement (odds ratio = 3.12), migrating chest pain (odds ratio = 2.77), hypotension as sign of acute type A aortic dissection (odds ratio = 1.95), shock or tamponade (odds ratio = 2.69), preoperative cardiac tamponade (odds ratio = 2.22), and preoperative limb ischemia (odds ratio = 2.10).
CONCLUSIONS: The International Registry of Acute Aortic Dissection experience confirms that patient selection plays an important role in determining surgical outcomes in patients with acute type A aortic dissection. Knowledge of significant risk factors for operative mortality can contribute to better management and a more defined risk assessment in patients affected by acute type A aortic dissection.
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Methods |
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TopAbstractMethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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Data analysis
Summary statistics were presented as frequencies and percentages, means ± SD, or medians and interquartile ranges. Missing data were not defaulted to negative, and denominators reflect only actual reported cases. Associations of death among nominal variables were compared by using the 
2 test or the 2-sided Fisher exact test. Bivariate comparisons of continuous variables were compared with the Student t test or the Wilcoxon rank sum test. Iterative logistic modeling was performed for in-hospital mortality by using the likelihood ratio test for model selection. Initial modeling implemented elements marginally suggestive of an unadjusted association to in-hospital mortality (P < .20). Variables were reviewed for clinical significance before testing. Diagnostic routines (Hosmer-Lemeshow test for lack of fit, change in deviance and residuals, and leverage indicators) were used on final model selection.
Extracted cases were also categorized according to risk profile; very high-risk patients were defined as preoperatively showing and/or presenting to surgical intervention with cardiac tamponade; shock; congestive heart failure; cerebrovascular accident; stroke; coma; myocardial ischemia, infarction, or both; electrocardiograms (ECGs) with new Q waves or ST elevation; acute renal failure; or mesenteric ischemia-infarction and were considered unstable (group I). Outside of an unstable setting, patients were categorized as stable and at moderate risk (group II). We compared presenting features and outcomes for group I (unstable) versus group II (stable) by using the 2 test or the Student t test. SAS 8.2 (SAS Institute, Cary, NC) and SPSS 11.5 (SPSS Inc, Chicago, Ill) were used for the analyses.
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Results |
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TopAbstractMethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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2 statistic of 1.13, a degree of freedom of 6, and a P value of .98, and deviance was 65.12 with a degree of freedom of 59 and a P value of .27.
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Discussion |
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TopAbstractMethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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The IRAD includes surgical results of 18 aortic centers present in 8 different countries, and it is an initial experience in creating such types of registries. The difficulties to project a prospective randomized study associated with the different policies regarding these emergencies in the varying participating centers clearly determines some bias in terms of surgical results. The registry included patients who were medically treated and not operated on for different reasons, such as advanced age and severe comorbid illness, which might not be identical throughout all of the centers. Potentially 121 (18.7%) patients deselected for surgical intervention are enough to influence the overall results, but in IRAD centers the percentage of unstable patients submitted to surgical intervention was higher than the percentage of stable patients undergoing operations (53.5% vs 46.5%), evidencing that not only the lower-risk patients were subjected to operations.
Medical treatment has been previously analyzed in the IRAD,22 particularly in elderly patients. In this group the in-hospital surgical mortality rate was 45.5% among patients age 80 to 84 years, and it was 50% for patients' 85 years of age or older. These data, although they should not represent per se a criterion to exclude patients from undergoing surgical treatment, help physicians in choosing ethical medical treatment in these cases.
The outcome of IRAD patients with type A aortic dissection is the result of operations performed by many surgeons of different ages with varying experience, preferences with regard to operative techniques, variable policies concerning the timing of the operation, and differences in health organizations and hospital structures. Similarly, a mortality of 30% for acute type A dissection was reported in a 16-center trial in which 180 surgeons were involved.23
The nonhomogeneous approach to patients affected by proximal acute aortic dissection explains the difficulties of gathering complete information from 18 international centers. Even if it is possible to analyze 290 clinical variables and their relationship to surgical outcomes, the IRAD has obvious shortcomings in technical surgical data and cannot provide many details, such as site of arterial cannulation, reperfusion after open distal anastomosis, and adjuncts used to reinforce the sutures and possibly obliterate the false channel. Those are of major importance as key factors for good results, as reported by single principal institutions showing a lower mortality rate.21,24
IRAD surgical results could be influenced not only by the variability mentioned above but also by the fact that, as already observed, moribund patients admitted at night or on weekends, patients in shock, or patients in extreme conditions are likely to be more frequently operated on by younger surgeons.20
In association with technical problems, the operative result is also known to be largely related to the preoperative condition. Preoperative conditions are often the primary cause of postsurgical death1,7,8,25 that might even be predicted from presurgical assessment of individual risk conditions.26 Differentiation between stable and unstable patients from the IRAD registry demonstrated a significantly higher surgical mortality in unstable than in stable patients (group I: 31.4% vs group II: 16.7%, P < .001), regardless of the type of surgical procedure.
It has commonly been accepted that the interval between onset of symptoms and surgical treatment is closely tied to outcome. The mean time interval from onset of symptoms to surgical intervention for all IRAD patients operated on showed an average of 93 hours for survivors and 37.9 hours for those who died (P < .001). Not surprisingly, this time period was shorter in unstable patients (group I) than in stable patients (group II; 62.9 vs 105.1 hours, P = .05). Accordingly, the median time interval between confirmed diagnosis and surgical intervention was shorter in group I (unstable patients; 3.4 vs 5.0 hours, P = .02). A difference from the onset of symptoms to confirmed diagnosis and then to surgical intervention could be associated with a delay in diagnosis or the initiation of medical therapy or, more likely, could be related to comorbid conditions, such as myocardial disorders. In fact, when comparing patients within group I undergoing early aortic repair (<24 hours from symptom onset, group Ia) with those having late operations (>24 hours, group Ib), we observed a higher presence of cardiac complications in group Ib, such as myocardial infarction (11.2% vs 3%, P = .02) and ECG evidence of new Q waves and ST elevations (15.3% vs 8%, P = .12). Conversely, unstable patients submitted to surgical intervention within 24 hours (group Ia) presented with more severe preoperative conditions than group Ib, such as pulse deficit (39.8% vs 28.2%, P = .10), shock (31.3% vs 19.8%, P = .07), preoperative cardiac tamponade (41.2% vs 26.1%, P = .03), and more coma and altered consciousness (34.0% vs 14.6%, P = .002). The comparison of log rank scores for groups Ia and Ib was not significant (P = .13), whereas the comparison for groups Ia and IIa and groups Ia and IIb was statistically positive (P = .06 and P = .02, respectively), showing a trend in higher mortality for group Ia versus the other 3 risk groups Ib, IIa, and IIb (Figure 1). The presence of major risk factors of mortality will affect outcomes negatively, but this remains, of course, a clear indication for surgical intervention and requires the efforts of undelayed surgical intervention. We also observed a shorter interval time between the onset of symptoms and surgical intervention (
12 hours) in IRAD patients presenting with one or more preoperative independent risk factors of mortality (migrating pain, hypotension, shock, or tamponade at admission or history of aortic valve replacement; P < .05). Moreover, higher significant death rates of group I versus group II were evidenced only within 24 hours from symptoms to surgery (Figure 2). In summary, death differentials for unstable (vs stable) patients in shorter time intervals appear to be caused by defining criteria for clinical instability. The IRAD also reported that normotension at the time of the operation seems to protect from adverse outcomes (P < .001), as does delay to surgical intervention beyond the day of presentation (P = .05). The mortality in patients with surgical treatment delayed beyond 24 hours was much similar to that observed in stable patients (17.1% vs 16.7%), and concomitantly, a preoperative cardiac catheterization, which was performed in 19% of cases, was associated with positive outcome (P = .04). It would appear that delaying surgical intervention for any reason improves surgical results. This could be a bias related to the natural selection of the disease but supports the theory that during the management of stabilized patients it can be correct and useful to transfer the patient to a specialist center or avoid operating on him or her during the night or without enough surgical experience. By the way, according to preoperative clinical status, IRAD data show that early surgical intervention is attempted in unstable patients and is associated with a high mortality. The evaluation of the hemodynamic status at the time of the operation reveals a relationship between unstable conditions and a perioperative death rate. Patients with severe hypotension both at admission and surgical intervention have the worst prognosis, with a mortality of 42.3% (P < .0001).
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Prior elective cardiac surgery was previously considered a suspected risk factor of dissection19,20 and was observed in 17.2% of IRAD patients. In particular, a history of prior aortic valve replacement was an independent preoperative predictor of operative mortality. In such patients the high mortality is related to specific difficulties of redo operations with total replacement of the sinotubular junction. Creation of a coronary button for coronary reimplantation can be difficult because of the lack of tissue after aortic valve prosthesis removal and the presence of calcifications and scar tissue. Although the primary surgical choice seems to be the Bentall-DeBono approach,27 sometimes the Cabrol technique28 or bridging bypasses are required. The need to perform coronary revascularization is associated with even higher mortality (P = .007). Surgical maneuvers around aortic valve prostheses can also damage the conducting system with the risk of atrioventricular block. Reoperation implies both longer pump and ischemic times. Conversely, in patients with previous cardiac operations, cardiac tamponade and hemodynamic collapse might occur less frequently, probably because of the pericardial adhesions.29,30 In patients with relative hemodynamic stability and prior cardiac operations, preoperative angiography might only be appropriate with known coronary artery disease or bypass grafts.
As univariate analysis showed, any pulse deficit and presence of limb ischemia were predictors of increased mortality in all patients (P = .001 and P = .009, respectively) and in unstable patients (P = .003 and P = .03, respectively), indicating that ischemic metabolic alterations expose patients to a higher risk of postoperative complications.31
Study limitations
There is inherent study bias because of the study design of an observational study based mainly on data of tertiary referral centers that might not necessarily be applicable to the total population. Because IRAD is a collection of several participating institutions, the results should not be generalized to all patients submitted to surgical intervention in a single principal institution. In-hospital death was the outcome parameter that was assessed in this registry analysis. Although assessment of mortality is necessary and important to patients, it is not sufficient for full evaluation of patients with type A aortic dissection. One should also take into consideration factors such as surgical technical details, nonfatal adverse events, patient functional status, and resource use. Further studies are needed to address the best surgical approach for evaluating the predictors of long-term survival.
Discussion
Dr Joseph E. Bavaria (Philadelphia, Pa). Dr Trimarchi presents this relatively current report from the International Registry of Acute Dissections, known as IRAD, which analyzes 647 patients with type A dissections. Five hundred twenty-six of these 647 patients had surgical repair of acute type A dissection from 1996 through 2001 at 18 centers worldwide, and these patients form the basis of this report. This is a registry experience and is observational. There is no prospective randomized attempt to compare outcomes on the basis of a change in therapeutics.
The study analyzed 290 clinical variables and related them to outcomes in the 526 surgically treated patients. They defined an unstable group and a stable group fundamentally based on hemodynamics, the presence of malperfusion syndromes, and neurologic presentation. Overall, surgical mortality was 25.1%, 31.4% in the unstable population and 16.7% in the stable population. Not surprisingly, they identified malperfusion, tamponade, and stroke, with high odds ratios for perioperative mortality rate. Interestingly, they identified prior aortic valve replacement as a serious risk factor but not prior CABG, which might relate to preoperative treatment with warfarin.
So what does this study tell us? Well, it obviously tells us that acute type A dissection is a very serious vascular presentation with a worldwide surgical mortality of more than 25%. This corroborates the public US Food and Drug Administration submission by CryoLife (Marietta, Ga) of their prospective randomized trial in the United States of acute type A dissection, with 174 patients at 20 sites and 56 operating surgeons. The mortality rate of that study was 21% when presented to the US Food and Drug Administration. It could be argued that this was a stable group in the sense that informed consent had to be obtained from all participants. Dr Trimarchi does not tell us how we can necessarily improve on the overall survival of acute dissection.
In 2002, Dr Jean Bachet asked the following question: Can we dramatically reduce surgical mortality? We might be able to improve results a bit with continually advanced surgical techniques, and recent data suggest we can decrease late reoperations with better technical procedures the first time around. However, Dr Trimarchi's report suggests that we really need to develop more rapid disease recognition, more rapid confirmatory diagnosis, and more rapid transfer. Most importantly, this study might be able to help us understand who not to operate on by defining subsets of patients who have extraordinarily high perioperative mortality rates. Therefore I have 3 questions for Dr Trimarchi.
First, in your study no single independent risk factor would suggest that surgical intervention is either futile or inappropriate. Can you tell us of any combination—I repeat, combination—of risk factors that would result in an odds ratio that would prohibit surgical intervention?
Dr Trimarchi. Thank you for your question, Dr Bavaria. About this issue, up to now we did not analyze the combination of the different risk factors.
Dr Bavaria. That is interesting. That is what we really need to be able to say as to whether we should treat very sick patients with multiple combinations medically or not operate.
Second, should we ever delay surgical intervention?
Dr Trimarchi. This is a very important question. In this study we observed that all patients who had a delay in surgical intervention of more than 24 hours showed surgical results similar to those patients categorized as stable (17.9% vs 16.7%). In a perverse way we can say that if we delay surgical intervention, we have a better result. Concerning this topic, we conclude that it is related to the natural selection of the disease.
Dr Bavaria. Finally, is there an age, say, 80 or 85 years, at which the outcomes of medical treatment of type A dissection converge with surgical repair?
Thank you very much. This is an excellent article by the IRAD group.
Dr Trimarchi. We already had the opportunity to evaluate patients with advanced age. We had an article that was published in Circulation by Dr Mehta and coauthors that showed that the in-hospital surgical mortality rate among patients aged 80 to 84 years was 45.5%, and for patients with age greater than 85 years, it was 50%. After these indications, we could treat medically all stable patients older than 80 years.
Dr G. Hossein Almassi (Milwaukee, Wis). In your presentation it appeared that the need for coronary bypass is a risk factor.
The question is, are these patients having dissection of their coronary arteries in the setting of an acute myocardial infarction coming to you with dissection, or are these the patients who have native coronary disease to begin with, in which case you are obligated or you might decide to do a couple of extra coronary artery bypasses? I think that makes a difference.
Dr Trimarchi. In these patients we do not know whether CABG was performed for the presence of native coronary atherosclerotic lesions or because of involvement of the coronary arteries in the aortic dissection. Therefore we do not have the right variable regarding the indication to perform a coronary revascularization, and this is a limitation of the registry, even if the necessity of performing a CABG during surgical treatment of acute type A aortic dissection appeared as the unique surgical risk factor.
Dr Steven L. Lansman (New York, NY). I would be curious to know whether you have any data about the size of the ascending aorta or descending aorta at the time of dissection? Also, because previous aortic valve replacement was the most important preoperative risk factor in the multivariate analysis, do you have any information about what size the aorta was at the time of aortic valve replacement and perhaps the incidence of bicuspid aortic valve at that time?
Dr Trimarchi. Thank you, Dr Lansman. We observed that the mean diameter of the aortic annulus was 30 mm, the mean aortic root in all operated patients was 44 mm, the sinotubular junction was 41 mm, the mean ascending aorta was 52 mm, and the mean aortic arch of these patients was 37 mm.
About the bicuspid valve, the incidence of this disease and this pathology in this registry was 4.9% of cases, and it was not significant in terms of surgical results.
Dr R. Scott Mitchell (Stanford, Calif). Dr Trimarchi, that was a nice presentation. I am not that familiar, but do you include cannulation data in your database to see whether differences in surgical practice—cannulation of axillary arteries versus femoral versus whatever—make a difference?
Dr Trimarchi. Up to now, we do not have these data in this data form. Therefore we are planning to start with a new surgical data form in which we will also include the cannula arterial way perfusion.
Dr Marc Ruel (Ottawa, Ontario, Canada). I enjoyed your presentation. You showed an inverse relationship between time to operation and survival, which I think most people in the audience would agree is largely due to selection bias.
One question I had that I think is of interest concerns stable patients. What about the dissection about which you get called at 2 AM? Did you look at the relationship between time taken to operate and survival in stable patients?
Dr Trimarchi. Thank you for the question. This is a debated issue that I think is related with the experience of the surgeon on call. All patients that are enrolled, for example, in our institution immediately go to the operating room for surgical intervention. In the IRAD study different surgical results between stable and unstable patients have been shown only within 24 hours from the onset of symptoms, whereas no differential in death rates has been demonstrated after 24 hours. Therefore what we can say is that the natural history of the disease might be similar in the 2 groups, stable or not stable, after 1 day.
Dr Tirone E. David (Toronto, Ontario, Canada). Dr Trimarchi, you reported 526 patients operated on in 18 institutions. Was the mortality related to the number of cases per institution?
Dr Trimarchi. Dr David, we do not have the mortality for each institution. We can say that just in our institution, at the Istituto Policlinico San Donato, it is 16.8%, irrespective of the preoperative clinical conditions.
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Conclusions |
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TopAbstractMethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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Appendix 1. The IRAD investigators |
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TopAbstractMethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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Co-Investigators: Eduardo Bossone, MD, National Research Council, Lecce, Italy; Arturo Evangelista, MD, Hospital General Universitari Vall d'Hebron, Barcelona, Spain; Rosella Fattori, MD, University Hospital S. Orsola, Bologna, Italy; Dan Gilon, MD, Hadassah University Hospital, Jerusalem, Israel; Stuart Hutchison, MD, St Michael's Hospital, Toronto, Ontario, Canada; Alfredo Llovet, MD, Hospital Universitario "12 de Octubre," Madrid, Spain; Rajendra H. Mehta, MD, MS, University of Michigan, Ann Arbor, Mich; Truls Myrmel, MD, Tromsø University Hospital, Tromsø, Norway; Patrick O'Gara, MD, Brigham and Women's Hospital, Boston, Mass; Jae K. Oh, MD, Mayo Clinic, Rochester, Minn; Linda A. Pape, MD, University of Massachusetts Hospital, Worcester, Mass; Udo Sechtem, MD, Robert-Bosch Krankenhaus, Stuttgart, Germany; Toru Suzuki, MD, University of Tokyo, Tokyo, Japan; Santi Trimarchi, MD, Istituto Policlinico San Donato, San Donato Milanese, Italy.
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Footnotes |
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* International Registry of Acute Aortic Dissection investigators are listed in Appendix 1. 
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References |
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TopAbstractMethodsResultsDiscussionConclusionsAppendix 1. The IRAD...References |
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