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Ann Thorac Surg 2009;87:1360-1365. doi:10.1016/j.athoracsur.2009.02.050
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Endovascular Treatment of Type B Aortic Dissection: The Challenge of Late Success

Claudia Maria Rodrigues Alves, MD, PhDb,c,*, José Honório Palma da Fonseca, MD, PhDa,c, José Augusto Marcondes de Souza, MD, PhDb,c, Hyung Chun Kim, MDa,c, Guilherme Esher, MDb,c, Ênio Buffolo, MD, PhDa,c

a Department of Cardiothoracic Surgery, Federal University of São Paulo, Paulista School of Medicine, São Paulo, Brazil
b Department of Cardiology, Federal University of São Paulo, Paulista School of Medicine, São Paulo, Brazil
c Hospital do Coração da Associação do Sanatório Sírio, São Paulo, Brazil

Accepted for publication February 18, 2009.

* Address correspondence to Dr Rodrigues Alves, Rua Simão Álvares, no 527, Apto 63, São Paulo-SP, CEP-05417-030, Brazil (Email: cmralves{at}uol.com.br).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background: Thoracic endovascular aortic repair of type B aortic dissection is a therapeutic option for selected patients. However, late outcomes of this intervention are virtually unknown, and the series already published are heterogenous regarding demographics, indications, and type of devices.

Methods: From 1997 to 2004, 106 patients exclusively with classic complicated or symptomatic type B aortic dissection were treated with thoracic endovascular aortic repair, using the same device. We present in-hospital outcomes and late follow-up for 73 patients.

Results: Technical success was achieved for 99% of patients, and the clinical success rate was 83% (exclusion of the false lumen, no early death or surgical conversion). In-hospital death occurred in 5 patients, 2 of them after surgical conversion. Three patients required urgent surgical conversion. Neurologic complications occurred in 5 patients (1 case of paraplegia). The average time of follow-up was 35.9 ± 28.5 months. During follow-up, 37% of patients initially successfully treated reached a failure criterion (new endovascular or surgical intervention in the same aortic segment or death due to aortic or unknown cause). Kaplan-Meier curve showed late survival rates higher than 80% in 2 years.

Conclusions: Patients with both acute and chronic type B aortic dissection had excellent initial results with thoracic endovascular aortic repair. Although event-free survival rates decreased gradually with time owing to the frequent need for new interventions, survival curves were comparable to those for less complex patients undergoing clinical or surgical treatment. Randomized studies are required to establish the actual benefit of this new approach.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
The endovascular treatment of type B aortic dissection (TBAD) is an acceptable therapeutic procedure for patients who have favorable anatomy, in the acute and in the chronic stages of the disease; initial success rates are high regarding exclusion and thrombosis of the false lumen [1–3]. Compared to the classic surgical treatment [4], the reduction of mortality and paraplegia rates with thoracic endovascular aortic repair (TEVAR) has encouraged its use, often indiscriminately. However, encouraging initial results do not allow a solid conclusion to be reached about the procedure for this group of patients, as late follow-up reports have still included only a few patients or short periods of time. Typically, patients with TBAD are younger than patients who have atherosclerotic aneurysms and have a more fragile arterial structure, compatible with the predominant histopathology of the disease (severe elastic fiber degeneration, necrosis of muscle cells, and cystic spaces filled with mucoid material). The inclusion of patients with dissection variants in other series is also a confounding factor in the analysis because these patients have different demographic and anatomical characteristics [5].

To evaluate this high-risk group and its response to TEVAR, we report the in-hospital outcomes and follow-up of patients exclusively having complicated classic type B aortic dissection.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
From January 1997 to December 2004, a consecutive series of 187 patients underwent a first endovascular stenting procedure for several descending aortic diseases, after approval by the Research Ethics Committee and having signed the informed consent form. Procedures were performed at two institutions (Hospital São Paulo–UNIFESP and Hospital do Coração da Associação do Sanatório Sírio). Patients diagnosed with true aneurysm (n = 59), penetrating ulcer of the aorta and intramural hematoma (n = 16), and postoperative and traumatic pseudoaneurysm (n = 6) were excluded from the analysis. The remaining 106 patients were considered to have "classic type B aortic dissection," which means that we included only patients with tomographic or angiographic images consistent with a clear intimal tear and the "double barrel" appearance. Of those, 45 patients were treated for acute dissection and 61 for chronic dissection; the results of the in-hospital period have already been partially reported [6, 7] in mixed series.

Definitions and Indication Criteria
Indications for treatment were symptomatic or complicated acute TBAD (defined by persistent pain, diagnosed or imminent rupture, and organ or limb ischemia), total aortic diameter greater than 40 mm, or high flow in the false lumen [8]. Patients with chronic TBAD with persistent symptoms or total aortic diameter greater than 55 mm were also included [9]. In all patients, Braile stent grafts (Braile Biomédica, São José do Rio Preto, São Paulo, Brazil) were implanted, and the procedures were performed at the catheterization laboratory under general anesthesia, as previously reported [6, 7].

Classic type B aortic dissection was defined as patients with tomographic or angiographic images consistent with a clear intimal tear in the descending aorta and the "double barrel" appearance or double channel of different lengths, and excluding patients with ulcers and intramural hematomas. Acute TBAD included patients treated within 14 days of acute pain judged responsible for the dissection. Chronic TBAD included patients treated beyond that period. Technical success was obtained whenever the stent was deployed at the planned site with adequate angiographic result. Clinical success was defined as the sustained technical success that was confirmed by tomography or transesophageal echocardiogram, and without death or surgical conversion for as long as 30 days of hospitalization. Urgent treatment was considered for those patients either with chronic or acute TBAD, who had sudden or imminent rupture or required immediate action to prevent rupture because of failed medical therapy as judged by clinical evaluation. Renal failure was considered in patients with creatinine levels greater than 1.5 mg/dL.

Because of a strategical decision, previous surgical preparation of the proximal landing zone is seldom performed by our group; and in patients with proximal aortic necks smaller than 2 cm and proximal endovascular leak after stenting, the stent was fixed proximally by elective open surgery without extracorporeal circulation. These cases were considered as secondary success and excluded from the analysis of late follow-up (n = 4). The late prospective follow-up was carried out either by personal evaluation, phone calls to the patients, or medical charts review.

Reintervention was defined as a new endovascular procedure performed on the same aortic segment. Surgical conversion refers to open surgery performed on the same aortic segment or the treatment of complications from TEVAR. Time of follow-up continued until the last visit or telephone call to patients who were alive and without new events, whereas for patients who experienced events, it lasted until the date of the first event (reintervention, open surgical conversion, or death). Late failure was defined as the occurrence of sudden death, aortic death, surgical conversion, or reintervention. All patients without new events at late follow-up had false lumen thrombosis at thoracic level in the last tomographic review.

Statistical Analysis
Qualitative variables were represented by absolute (n) and relative frequency (%) and quantitative variables were represented by their means and standard deviations. Correlations between qualitative variables were tested with the {chi}2 or Fisher exact test. Student's t or Mann-Whitney U tests were used for comparing quantitative variables. A p value less than 0.05 was considered statistically significant. The Kaplan-Meier nonparametric method was used to generate estimates of survival, and the log-rank test was used when comparing subgroups.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
The mean age of these patients was 56.4 ± 10.8 years, and 77% of them were men. Only 1 patient with Marfan syndrome was included in the group. Thirty-seven percent of the patients had arterial hypertension, 4% had diabetes mellitus, and 15% had chronic renal failure. The procedure was performed on an urgent basis in 16 patients, 14 of them for aortic rupture during acute dissection. Twenty-six patients with acute TBAD and 46 patients with chronic TBAD had indication for treatment based only on tomographic or angiographic criteria, without additional symptoms. Six patients had previous thoracotomy for myocardial revascularization or treatment of ascending aortic disease. Mean aortic diameter before treatment was 59 ± 12 mm.

In-Hospital Stage
Technical success was obtained for 105 patients (99%) and clinical success for 88 patients (83%), 4 of them after proximal fixation of the stent graft (secondary success). On average, 1.7 ± 0.8 stents per patient were used. Intentional occlusion of the left subclavian artery was performed whenever necessary to extend stent landing zone (24 patients), and ischemic symptoms were rare afterward (2 cases of elective revascularization). Six patients had to undergo early surgical conversion within the first 30 days. In 3 patients, conversion was performed on an urgent basis (1 case of iatrogenic retrograde dissection of the ascending aorta, 1 case of iatrogenic dissection of the aorta distal to the stent, and 1 case of persistent severe lower limb ischemia). One patient awaiting surgical repair because of TEVAR failure had rupture of the aneurysm and death occurred during hospitalization.

Five patients (4.7%) died within the first 30 days of TEVAR. Two of them died of postoperative complications (surgical conversion after unsuccessful TEVAR), 2 experienced aortic ruptures (1 technical success and 1 failure awaiting surgery), and 1 died after an extensive cerebrovascular accident. The in-hospital mortality rate was higher among patients treated for urgent conditions (18.7% versus 2.2%, p = 0.02; Fig 1).


Figure 1
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  		Fig 1. Comparison of in-hospital mortality rates of patients treated on an urgent basis or as elective procedures and patients treated during the acute or chronic stages of aortic dissection.

 
Five patients had neurologic complications, mostly cerebrovascular accidents (3 patients). Only 1 patient had paraplegia, which occurred after proximal fixation of the stent, and in 1 patient, paraparesis developed and was totally reversed after liquor drainage and corticotherapy. Moreover, 3 patients had peripheral vascular complications, and 4 experienced acute renal failure after TEVAR.

When patients were considered separately, treated for either acute (n = 45) or chronic (n = 61) TBAD, no clinical differences were observed (demographic data, frequency of procedures performed on an urgent basis, and occlusion of the left subclavian artery). Patients with acute TBAD were treated on average within 6 ± 4.5 days of dissection, whereas for chronic patients, the time interval between dissection and treatment could be determined in only one third of them (mean, 10.5 ± 18 months; median, 4). The clinical success (75.5% versus 82%, p = 0.47), surgical conversion (8.8% versus 3.3%, p = 0.39), and mortality (6.6% versus 3.3%, p = 0.64) rates were also similar (Fig 1, Table 1).


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  		Table 1 Event Rates in the Initial 30-Day Period and Late Follow-Up for Patients Treated in the Acute (≤ 14 Days of Presentation) or Chronic (> 14 Days) Period of Dissection
 
Late Follow-Up
Of the 84 patients who were discharged with clinical success (excluding the 4 patients with proximal surgical fixation of the stent graft), late follow-up was obtained for 73 (86%). The average duration of follow-up was 35.9 ± 28.5 months.

The comparison of the groups with (n = 27) and without (n = 46) events showed no differences as to demographic data, presence of chronic renal failure or previous thoracotomy, frequency of occlusion of the left subclavian artery, and procedure performed on an urgent basis. Similarly, when groups were stratified by sex or age, no differences were found at follow-up.

Late failure was observed in 27 patients (27 of 73 = 37%). The mean time to first event was 29 ± 17.4 months. The first event was reintervention in 16 patients, late surgical conversion in 3 patients, and 8 deaths due to aortic causes (including 2 patients in their postoperative period for open surgery of an aortic segment other than that initially treated). Only 1 patient had a type A dissection during follow-up and had to undergo open surgical repair (Tables 2 and 3). Go


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  		Table 2 Discrimination of Causes and Number of Patients With New Thoracic Endovascular Aortic Repair as First Late Event and Time to Development of Event
 

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  		Table 3 Discrimination of Causes and Number of Patients With Surgical Conversion or Death as First Late Event and Time to Development of Event
 
When patients were stratified as those treated in the acute or in the chronic stage of dissection, late mortality (18% versus 6%, p = 0.2), reintervention (21% versus 22%, p = 0.7), and total event (43% versus 33%, p = 0.4) rates were similar between both groups (Table 1). Figure 2 shows Kaplan-Meier curves for survival free from aortic-related death and event-free survival.


Figure 2
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  		Fig 2. Kaplan-Meier curves (expressed in months) depicting (A) survival among patients with acute (solid line) and chronic (dashed line) dissection; (B) global survival, and (C) event-free survival (C).

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
The knowledge about TEVAR for aortic disease has deepened in the past few years, providing better definition of early indications and outcomes [8]. However, initial reports excluded a group of patients who probably represent a significant portion of the clinical practice, characterized by severe comorbidities and imperfect anatomy for stenting. Additionally, little is known about the late follow-up of TBAD patients who underwent stent graft implantation. In a disease characterized by diffuse fragility of the aortic wall, the impact of a noncompliant device applying constant radial force to the wall at the treatment site, the frequency of severe complications, and the time they occur are unknown. In our series, consisting of a large group of consecutive patients exclusively with the classic form of TBAD and using a single device, a few interesting data on the subject were disclosed.

The decision to exclude variants of aortic dissection seems justified to us because demographic differences, uncertainty as to whether TEVAR for intramural hematoma was adequate or not, and the focal presentation of the disease in patients with penetrating ulcer distinguish them from the classic type of dissection [5, 10]. Here, we have collected results from severely affected patients, who were frequently excluded from other series, but who may represent those receiving the highest benefit from a less invasive treatment. Although ours is a younger population when compared to patients with true aneurysms, we could argue that the most common histologic pattern of cystic medial necrosis may negatively impact late results, as already observed in surgical series [11], and results should be viewed in this particular way.

Our in-hospital results are similar to those of other series and are characterized by high rates of technical and clinical success, low mortality, and rare incidence of spinal cord ischemia, which are the great benefits obtained compared with the classic surgery [12–16]. Overall mortality rates are approximately 5%, occurring mainly among patients treated for acute dissection. These rates are significantly lower than the historical numbers among patients with complicated dissection treated surgically that range from 17% to 30% [4]. Regarding time of treatment, acute and chronic dissections pose different challenges: with acute dissection, clinical instability is what mostly impacts prognosis, whereas with the chronic form of the disease, that is due to frequent anatomical distortion. In our series, the lack of statistical difference between mortality in the acute and in the chronic stage (6.6% and 3.3%, respectively) is probably due to the small sample size, and is a frequent finding in many series [3]. Conversely, our high rate of surgical conversion is due to the strategy of using liberal anatomical criteria selection, and it does not reflect complications from the procedure. Scarcely discussed, the incidence of cerebrovascular accidents is far from negligible, but hopefully it will be further improved by technological advances in device manufacturing and greater team experience. The possibility of using carotid/subclavian bypass to enlarge the landing zone, rarely used in this series, has also its own risks; and the option to perform it only after stent deployment resulted in acute failures that probably would have not occurred with previous preparation. It is very unlikely that patients with TBAD will need this type of procedure very often, owing to the smaller aortic distortion in the acute stage of the disease, despite the close proximity to the left subclavian artery origin. In other series, the incidence of previous arch artery bypass ranges from 10% to 28% [14, 17]. However, the possibility of performing proximal fixation of the stent through a small incision seems rather interesting for those cases in which no effective proximal sealing was reached, and that may result in a lower incidence of neurologic complications.

Probably, the most incisive information herein is the high rate of late failure (37%, occurring within 29 ± 17.4 months). Many explanations can be provided for these results, among which we should stress the progressive nature of the disease and that physicians must keep in mind that the endovascular approach is a palliative treatment. The inclusion in this series (during our learning curve) of many patients who were treated with only a short stent graft in the acute stage and who required posterior complementation also caused our rate of late failure to increase. Today our approach, similar to that of other groups, is to do liberal coverage of the thoracic segment. Moreover, cases referred to surgery would also be easily complemented by endovascular treatment with more user-friendly, newer generation devices. In the endovascular reintervention group, 3 patients experienced disease progression with dilation of the segment located immediately below the stent graft. Although aortic wall alteration caused by the stent should not be dismissed, the continuous progression of the disease may reinforce the convenience of TEVAR compared with surgical treatment for young patients. Although mortality rate and the incidence of new endovascular procedures are still low in other published series of late follow-up, they reflect restricted clinical and anatomical selection. In our study, we observed a high frequency of inoperable patients with renal failure before the procedure, acute dissection, or obvious rupture. However, it will be difficult to justify that frequent reintervention is a fair price to pay to obtain reduced morbidity and mortality rates during treatment in the acute stage if it can not be proven that these patients will not progress to greater late mortality. Only one small series recorded rates for late failure similar to ours, with a 48-month follow-up [18]. Finally, it seems logical to assume that the longer the follow-up, the higher the number of reinterventions expected for patients with TBAD.

Although we have not found any differences in the rates of clinical success and late failure among patients treated on an urgent basis, their in-hospital mortality was significantly higher and their inclusion certainly means prognostic implications also in the late stage [13], as these patients have often more extensive disease and larger aortic diameters [19].

In a population at lower risk than that studied here, Winnerkvist and colleagues [10] showed an aortic event rate of 27.5% in a 79-month clinical follow-up among patients with uncomplicated classic dissection. In the late follow-up of uncomplicated TBAD patients followed by the International Registry of Acute Aortic Dissection [13] for a period of 2.3 years, the survival rate was 77.6% ± 6.6%. Treatment type (clinical, surgical, or endovascular) did not appear to have any influence on late mortality rates until the period analyzed; however, clinical factors observed in the initial hospitalization were predictive of late poor prognosis (e.g., renal failure, aneurysm rupture, history of previous aneurysm, or atherosclerosis), imposing a devastating effect on these late mortality rates. These last two reports show results comparable to the data presented here, showing a survival rate higher than 80% within 24 months but in a sicker population. On the one hand, event-free survival curves progressively deteriorate in several series; but on the other hand, global survival curves do not directly reflect this finding or maybe even the type of treatment. On the contrary, aortic survival curves show a less marked reduction than would be expected for such a sick population, which is similar to that of patients who have a much better prognosis maintained on clinical treatment, such as those previously mentioned. This result has been also observed in other endovascular [20] and surgical [21] series.

Although based on a small number of patients, late mortality seems greater for patients treated during the acute phase of TBAD. We could not find any anatomic or clinical reason other than the natural selection of less severely compromised patients in the chronic group. As already mentioned, the International Registry of Acute Aortic Dissection has reported that clinical factors demanding early treatment had also an impact on late survival [13].

In summary, we believe that reporting late outcomes of endovascular intervention for aortic dissection is critical for the understanding of which group will benefit from the procedure. Considering the severity of disease of these patients, the recognized clinical progression of the disease characterized by multiple events, and the reduction of early morbidity and mortality with TEVAR compared with the classic surgery, stenting seems to us an acceptable option for patients with acute or chronic TBAD. During follow-up, a better adherence to image and medical protocols, a clear definition of patients requiring bypass of arch arteries, the extensive coverage of the descending thoracic segment avoiding curvature or stress points and, finally, further technologic advancement of the devices may improve the results obtained so far. For young and low surgical risk patients, the difficulty of clearly predicting the occurrence of late events, especially after the 2 first years, can justify some restriction in its use, although initial results are still encouraging.

Limitations
In a country of continental size such as ours, follow-up completion is very difficult to achieve, especially in the public health network; therefore, our 86% rate, although far from optimum, seemed acceptable to us for reporting. Although it can not be dismissed that patients lost to follow-up may have experienced fatal events, a higher adherence to the service is typically observed among patients who are more severely ill and prone to complications. It is important to stress that the occurrence of a first manageable event (TEVAR and surgery) in 22% of the patients within 2 to 3 years obviously does not exclude the possibility of future and severe complications.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

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