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Ann Thorac Surg 2007;84:1180-1185
© 2007 The Society of Thoracic Surgeons

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Original Articles: Cardiovascular

Safety of Thoracic Aortic Surgery in the Present Era

^a Departments of Preventive Medicine and Economics, State University of New York, Stony Brook, Stony Brook, New York
^b Section of Cardiothoracic Surgery, Yale University School of Medicine, New Haven, Connecticut

Accepted for publication May 11, 2007.

^_* Address correspondence to Dr Elefteriades, Section of Cardiothoracic Surgery, Yale University School of Medicine, 121 FMB, 333 Cedar St, New Haven, CT 06510 (Email: john.elefteriades{at}yale.edu).

Presented at the Forty-third Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 29–31, 2007.

	Abstract

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
Background: Advances in graft materials, hemostasis, and surgical techniques have facilitated surgery on the thoracic aorta. We investigate the current safety level of these operations—for the purposes of enabling risk/benefit decisions for surgery and also to serve as a benchmark for comparison with emerging endovascular approaches.

Methods: Five hundred six consecutive patients (315 male, 191 female; aged 14 to 91 years [mean, 61]) underwent surgery on the thoracic aorta at one institution from 1995 to 2004. In all, 360 operations involved the ascending and arch (71.1%) and 130 (25.7%) involved the descending or thoracoabdominal aorta, or both, and 16 (3.2%) were classified as miscellaneous aortic operations. Clinical data collected prospectively were analyzed retrospectively using ² and multivariable logistic regression statistics for the outcomes reoperation for bleeding, perioperative (hospital or 30-day) mortality and stroke. Midterm survival was assessed by Kaplan-Meier methodology.

Results: Mortality for elective operations on the ascending/arch was 3.0%; mortality for elective operations on the descending aorta was 2.9%. Mortality for elective thoracoabdominal operations was 11.9%. Mortality for all operations was 8.6%. Probability of stroke was 3.0% for ascending/arch, 4.2% for descending, and 2.1% for thoracoabdominal operations. The paraplegia rate was 7.3% for all descending and thoracoabdominal operations. Age and emergency operation predicted increased risk of death, stroke, and reoperation for bleeding. For young patients (less than 55 years old) having elective ascending/arch operations, freedom from permanent complications of operation (death, stroke, paraplegia) was 98%. Overall survival at 1, 3, and 5 years was 84.7%, 78.3%, and 72.5%, respectively.

Conclusions: Aortic surgery is quite safe in the current era and leads to good long-term survival for this patient group. These data support prophylactic replacement of the thoracic aorta in patients with poor expected natural history (based on aneurysm size or symptoms). As catheter-based therapies proliferate, surgical data provide a benchmark that must be equaled or exceeded by newer endovascular approaches.

	Introduction

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
The most serious complications of aortic aneurysms are aortic dissection and rupture, which often result in the death of the patient. To decide when to preemptively extirpate an aortic aneurysm, the risk of dissection and rupture has to be weighed against the risk of an adverse surgical outcome. A great deal of information has been obtained in recent years about the natural history of aortic aneurysms. It is now well established that the risk of dissection or rupture increases with aortic diameter. The aneurysmal thoracic aorta grows at an average rate of 0.10 cm per year (0.07 for the ascending aorta and 0.19 for the descending) [1]. By the time the thoracic aorta has reached a size of more than 6 cm, 31% of patients will have suffered rupture or dissection. Similarly, for the descending thoracic aorta, 43% of patients will have suffered this devastating outcome once the aorta has reached a size of 7.0 cm [2]. The annual risk of rupture, dissection or death for patients with thoracic aortic sizes greater than 4 cm, 5 cm, or 6 cm, is 5.3%, 6.5%, and 14.1%, respectively [2].

In 1989, Crawford and colleagues [3] found the 30-day surgical mortality rate in a series of 717 patients who had undergone surgery of the thoracic aorta to range from 9% to 26% among patients with multiple comorbidities. Since then, multiple advances in graft materials and surgical technique have been made. More specifically, these include the advent collagen-impregnated Dacron grafts, control of heparin effect with measurement of the activated clotting time, advent of and familiarity with antifibrinolytic agents (Amicar and aprotinin) [4], increased surgical experience with the button technique in the reanastomosis of coronary arteries, and advances in techniques for paraplegia prevention (including left atrial-to-femoral artery bypass, intercostal artery reimplantation, cerebrospinal fluid drainage, and emphasis on maintaining high postoperative blood pressures).

It is the aim of this study to investigate the current level of safety of thoracic aortic surgery in a series of 506 consecutive operations performed between 1995 and 2004 (see Fig 1).

View larger version (15K): [in this window] [in a new window]   Fig 1. Number of procedures by year; only part of 2004 was included in the study. (Bars = case volume.)

	Patients and Methods

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
This study was approved by the Yale Human Investigation Committee (#27544).

Definition of Adverse Outcome
Five hundred six consecutive surgeries on the thoracic aorta performed at the Yale Center for Thoracic Diseases from 1995 to 2004 were analyzed retrospectively (data were collected prospectively) for the following outcomes: reexploration for bleeding; perioperative mortality (defined as death within 30 days of the original surgery, in-hospital death, or discharge to hospice); stroke (defined as new, fixed neurologic deficit secondary to the surgery and confirmed on computed tomography scan); paraplegia; and any permanent complication (including death, stroke, paraplegia).

Study Design
Long-term survival was assessed by determining the number of days alive after surgery by following the Social Security Death Index until the conclusion of patient enrollment on November 24, 2004.

The independent variables of this study are age, sex, type of surgery, and urgency of procedure.

Our study included 315 male and 191 female patients. Patient ages ranged from 14 to 91 years (mean age, 61) and were grouped into the following three categories: less than 55 years of age, 55 to 64 years, and 65 years and older.

All surgeries were performed for the treatment of aortic aneurysm or dissection (95 type A dissections and 17 Type B dissections, remainder aneurysms). All surgeries were grouped into the following four categories: ascending aortic aneurysm and arch repairs (360), descending thoracic aortic aneurysm repairs (95), thoracoabdominal aortic aneurysm repairs (35), and miscellaneous aortic surgeries (16). Among the ascending/arch group were 123 patients who were treated with implantation of a tube graft in the ascending aorta (usually with a hemiarch replacement), 80 patients who received a tube graft combined with aortic valve replacement, 132 who underwent a composite valved conduit procedure, and 25 who underwent a full aortic arch replacement (11 with the elephant trunk technique). The miscellaneous surgeries included 9 extra-anatomic grafts, 1 sinus of Valsalva repair, 3 aneurysmorrhaphies, 2 aortoplasties with aortic valve replacement, and 1 primary repair for type A dissection.

Of all 506 surgeries, 320 surgeries were performed on an elective basis, 111 urgently (within 24 hours after presentation to the hospital) and 75 emergently (within 12 hours after presentation to the emergency room).

Operative Technique
Our preferred technique for operations on the ascending aorta involves two-stage atrial/femoral artery cannulation and perfusion, arresting the heart through antegrade and retrograde cardioplegia, cross-clamping the aorta, and performing the proximal anastomosis. That is followed by unclamping the aorta under deep hypothermic circulatory arrest and proceeding with an open distal anastomosis. (We prefer to perform the proximal anastomosis first, as we believe exposure deep in the aortic root for the proximal anastomosis is more difficult after the distal end of the graft is attached.) Despite evidence in the literature regarding potential benefits of antegrade cerebral perfusion [5], no antegrade or retrograde cerebral perfusion is used during the deep hypothermic arrest time in this series. Brain hemisphere oxygen saturation was not monitored. Perfusion is resumed using the original femoral cannula. Various glues (French glue [home made], BioGlue [CryoLife, Atlanta, Geogia]), and fibrin glue) were used sparingly, especially in acute aortic dissection patients. (We have previously published on the safety of resuming perfusion through this route, even in aortic dissection [6].)

For operations on the descending aorta, the patient is intubated with a double-lumen endotracheal tube and brought into a right lateral decubitus position. A lumbar spinal drain is placed routinely, and the femoral artery and left inferior pulmonary vein are cannulated. Subsequently, the aorta is cross-clamped and perfusion is initiated. For stroke reduction, we follow the principle of clamping before initiating bypass and stopping bypass before unclamping [7].

All aortic surgeries are done with intraoperative transesophageal echocardiography. The surgical field is routinely flooded with CO₂. Suture lines are reinforced with Teflon strips (Impra, subsidiary of L. R. Bard, Tempe, Arizona).

Statistical Analysis
We used ² statistics and performed multivariable logistic regression analyses for the outcomes surgical mortality, postoperative stroke, reexploration for bleeding, and combined endpoint of death, stroke, or paraplegia (which we call permanent complications). The statistical software package (SAS, version 8.2; SAS Institute, Cary, North Carolina) was used for our calculations. The p values were two-tailed, and a p value of less than 0.05 was considered to be significant.

The following regressors were included as explanatory variables in our regression models: age (ages 55 to 64 years, 65 years and over, with age under 55 years as the reference group), male sex, type of surgery (descending, thoracoabdominal, other surgeries involving the aorta, with ascending/arch graft surgery as the reference location), and whether the operation was urgent or emergent (with elective surgery as the reference group).

We combined the variables urgent procedures and emergent procedures into one variable urgent/emergent to increase the power of the analysis. We chose not to create a separate variable for dissections as all type A dissections were urgent/emergent procedures and all patients with type B dissections underwent surgery on a nonurgent basis.

To determine the long-term prognosis of patients, the proportion surviving after 1, 3, and 5 years was calculated using the procedure Lifetest in SAS. This provided survival results using the Kaplan-Meier life table method.

	Results

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
Perioperative Morbidity and Mortality
Reexploration for bleeding
The average probability of hemorrhage requiring reexploration in elective surgery was 3.3% for ascending aneurysms, 3.4% for descending aneurysms, and 8.9% for thoracoabdominal aortic aneurysms (Table 1). For urgent/emergent procedures, the probabilities increased to 9.9%, 10.2%, and 23.6%, respectively. (Reexploration was generally undertaken in case of hemodynamic instability, high-volume blood loss, or persistent moderate bleeding after correction of coagulation factors using blood products.) Patients aged less than 55 years of age undergoing a scheduled operation on the ascending or descending aorta had the lowest bleeding risk, with only a 2.7% and 2.8% chance, respectively, of significant bleeding requiring reexploration.

Perioperative mortality
The surgical mortality for an elective ascending/arch or descending aortic aneurysm repair was 3.0% for ascending and arch and 2.9% for the descending aorta (Table 2). For patients aged less than 55 years of age, the risks were only 1.2% and 1.3%, respectively. Even in the 65 years and over age group, the mortality was only 4.5% for ascending aortic aneurysms and 4.2% for descending. However, the same operations performed urgently/emergently yielded a mortality of 19.7% and 20.9%, respectively, for ascending and descending aortas. Overall mortality for all patients was 8.6%.

Perioperative stroke
The average likelihood of having a stroke during a scheduled operation was 3.0% for surgery on the ascending aorta, 4.2% on the descending aorta, and 2.0% on the thoracoabdominal aorta (Table 3). The probabilities for the oldest age group (65 years and over) were very similar, with 3.2% for ascending aneurysms, 4.3% for descending, and 2.1% for thoracoabdominal aortic aneurysms. For urgent/emergent surgery, the average probability of stroke increased to 10.7%, 14.5%, and 7.8%, respectively. Among patients aged less than 55 years of age, the risk of stroke during an elective surgery is very low (only 0.6% to 1.2%).

Paraplegia
Of all descending and thoracoabdominal operations, the paraplegia rate was 10 of 130, or 7.6%. Five patients in the thoracoabdominal aortic aneurysm group and 5 in the descending aortic aneurysm group became paraplegic. The number of patients suffering paraplegia as a consequence of aortic surgery was too low to be amendable to subgroup statistical analysis. Only 2 of all 360 ascending aortic surgeries (0.55%) were complicated by paraplegia.

Any permanent complication (death, paraplegia, stroke)
When discussing an elective procedure such as an aortic aneurysm repair, patients are interested to know the chances of "coming out of surgery the way they were before," unaltered from their prior state of health. The likelihood of any permanent complication (death, paraplegia, or stroke) in elective surgery was 4.4% for ascending aortic surgery, 7.8% for descending aortic surgery, and 24.1% for thoracoabdominal aortic surgery (Table 4). This finding indicates that roughly 94% of all patients undergoing elective surgery on the ascending/arch or descending aorta will be free of any significant permanent complication. For elective surgery in the ascending or descending aorta among subjects aged less than 55 years, the probabilities of any permanent complication were just 1.9% and 3.5%, respectively.

Our overall complication rate (death, paraplegia, or stroke) for all ascending aortic surgery (including elective, urgent, and emergent) was 10.5%. Relative to elective operations, the odds of any permanent complication are more than sixfold higher if the operation is performed nonelectively (OR 6.24, p <0.0001). Similarly, the odds are sevenfold higher when surgery is performed on thoracoabdominal aortic aneurysms (OR 7.10, p < 0.0001). Increasing age raised the chances of suffering an adverse event. As compared with the age group 55 years and younger, the age group 55 to 64 years had a threefold higher chance of complications (OR 3.00, p = 0.01), and among the 65 and older group, the odds were more than threefold higher (OR 3.27, p = 0.001).

Midterm Prognosis
The midterm survival was calculated based on how many days patients were alive after the date of surgery. The overall survival for all patients undergoing aortic surgery in our study was 84.7% after 1 year, 78.3% after 3 years, and 72.5% after 5 years (see Fig 2). Survival for patients free of hospital death was 93.4% at 1 year, 86.3% at 3 years, and 79.9% at 5 years (see Fig 2).

View larger version (14K): [in this window] [in a new window]   Fig 2. Kaplan-Meier survival estimate. Survival of all patients (light gray lower curve) and of patients discharged alive from the hospital (dark gray upper curve).

	Comment

Top Abstract Introduction Patients and Methods Results Comment Discussion References

The midterm survival of discharged patients was 93% at 1 year and 83% at 5 years in the Griepp series. We report a very similar survival: 93.4% at 1 year and 79.9% at 5 years, despite admixture in our series of descending and thoracoabdominal patients, whose midterm prognosis is notoriously poor. Pacini and coworkers [9] reported an actuarial survival rate of 77.7% at 5 years and 63% at 10 years, with an early mortality of 6.9% for patients treated with the Bentall operation.

For elective thoracoabdominal aortic aneurysm repairs, Coselli (LeMaire and associates [10]) reports 13.0% incidence of adverse outcome, defined as death within 30 days, death before discharge from the hospital, paraplegia, paraparesis, stroke, or acute renal failure. These results with thoracoabdominal aneurysms exceed the freedom from any permanent complication (death, stroke, or paralysis) realized in the relatively small number of patients in this subgroup in our series.

Recent Advances in Aortic Surgery
Whereas in the 1980s the operative mortality of ascending aortic aneurysm repair ranged somewhere between 13% [11] and 17.5% [12], a number of recent advances have substantially reduced the mortality and morbidity of aortic aneurysm resections [13]. The advent of collagen-impregnated Dacron grafts in the early 1990s allowed for a conduit that does not seep and thus decreased the risk of early bleeding [14, 15]. The control of heparin effect with measurement of activated clotting time improved hemostasis through better control of heparin reversal. Antifibrinolytic agents, such as aprotinin, further reduced bleeding and transfusion requirements in high-risk patients by limiting fibrinolysis and other beneficial effects such as inhibition of neutrophil activation, preservation of platelet membranes, and inhibition of kallikrein [4, 16]. Increased technical experience over the course of the last decade contributed to the enhanced safety of complicated aortic operations. Among the many technical innovations is the coronary button technique for reimplantation of the coronary arteries that decreased the risk of hemorrhage and pseudoaneurysm at the anastomosis site [17]. Increased familiarity with deep hypothermic circulatory arrest enables the surgeon to perform technically optimal aortic arch repairs [18].

Limitations of the Study
While the present study provides a detailed analysis of surgical risk from thoracic aortic surgery in a large group of patients, it has several limitations. First, these results are based on observational data. We have sought to mitigate possible bias in these observational analyses by specifying multivariable models to control for important confounders affecting outcomes following aortic surgery. As in any observational study, however, caution must be exercised in drawing causal inferences.

Second, our findings for surgical complications and mortality pertain to a wide cross section of subjects treated at a large tertiary care hospital with considerable expertise in performing aortic surgery. While this affords us a large sample size of 506 consecutive surgeries, it may nevertheless limit the generalizability of our findings. Both differences in patient characteristics and institutional variation in performing aortic surgery could affect the results. Results may vary for subgroups of patients who were not considered separately in this study, such as patients with Marfan syndrome, or for centers with less experience in performing aortic surgery.

Third, while we had an adequate series of patients to identify individual risk factors for mortality and complications after aortic surgery, we lacked sufficient statistical power to test for interaction effects between the explanatory variables. Interaction effects models would test whether risk factors have a synergistic effect in addition to the purely additive effect that we have been able to ascertain. These more complex, data-intensive interaction models could enhance and refine risks estimates for specific subgroups. This is an important direction for future work when sufficient data become available.

Conclusion
We conclude that surgery on the thoracic aorta has become a relatively safe procedure at high-volume centers owing to a variety of recent advances in surgical experience, technique, and materials. Our logistic regression analysis of 506 consecutive surgeries revealed an average perioperative mortality of only about 3% for elective surgeries on the ascending or descending aorta. In approximately 92% of descending and 96% of ascending/arch procedures, patients underwent the operation free of any complication (defined as stroke, paraplegia, or death). For those patients discharged from the hospital, the midterm survival was 93.4% at 1 year, 86.3 at 3 years, and 79.9% at 5 years. For young patients (< 55 years) having elective ascending/arch operations, freedom from permanent complications of operation (death, stroke, paraplegia) was 98%.

We recently analyzed the risk of aneurysm-related complications (rupture, dissection, or death) based on aortic size index (aortic size compared with body surface area) [19]. For the moderate-risk group (2.75 to 4.24 cm/m²), the yearly risk of adverse aortic events was 8%; and for the high-risk group ( 4.25 cm/m²), the yearly risk of adverse aortic events was 20%. In light of these data, the benefit of preemptive extirpation of thoracic aortic aneurysms at sizes greater than 5.5 cm for ascending aortic aneurysms and greater than 6.5 cm for descending aortic aneurysms clearly outweighs the surgical risk for most patients. The surgical risk amounts to a fraction of the risk for a single year of natural history of unresected aneurysm.

Also, in the current era of exuberant application of endovascular therapies (which we do apply sparingly at our institution), these data on the safety of conventional open aortic surgery provide a benchmark for future comparison of endovascular techniques. Given the proven long-term effectiveness of open aortic resection, it remains to be demonstrated that the safety and long-term durability of interventional techniques can equal or even surpass those of conventional open resection [20].

	Discussion

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 
DR RANDALL B. GRIEPP (New York, NY): I would like to congratulate you on a very nice study and ask one question. Have you done any comparison of your late survival with an age- and sex-matched population? We have found, for instance, in arch and in ascending aorta, there is quite a dichotomy: patients who survive an ascending aortic operation or root replacement have no excess deaths thereafter. They parallel exactly a normal population.

That is not true for patients with arch aneurysms, and I suspect is also not true for patients with thoracoabdominal aneurysms. But I think one way of allowing us to evaluate our results is to look at the survival of our operated patients compared with a normal population. If we can make those curves parallel, we are really accomplishing something. Can you say anything about your survival curves compared with normal populations?

DR ACHNECK: Thank you for this question, Dr Griepp. We have not compared survival with an age- and a sex-matched population that is not affected by thoracic aortic disease. The notion that the survival in the general population may be similar to patients who had ascending aortic aneurysm repair is something we have observed but not yet studied. We believe that, as you mentioned, the dichotomy is likely due to the difference in the natural history of the disease between ascending aneurysms versus those that are located further distally in the aorta. In this study, we combined all different types of aortic pathologies, namely, those of ascending, descending and, to some degree, thoracoabdominal, with the main aim of showing that, across the board, aortic surgery in this day and era is a fairly safe procedure as compared with the past. But I think finding out these exact differences and how they compare with the general population will be a great future study.

	References

Top Abstract Introduction Patients and Methods Results Comment Discussion References

 

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2. Davies RR, Goldstein LJ, Coady MA, et al. Yearly rupture or dissection rates for thoracic aortic aneurysms: simple prediction based on size Ann Thorac Surg 2002;73:17-28.[Abstract/Free Full Text]
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4. Sedrakyan A, Wu A, Sedrakyan G, Diener-West M, Tranquilli M, Elefteriades J. Aprotinin use in thoracic aortic surgery: safety and outcomes J Thorac Cardiovasc Surg 2006;132:909-917.[Abstract/Free Full Text]
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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): John A. Elefteriades Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Achneck, H. E. Articles by Elefteriades, J. A. Search for Related Content PubMed PubMed Citation Articles by Achneck, H. E. Articles by Elefteriades, J. A. Related Collections Great vessels