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Ann Thorac Surg 2005;80:857-863
© 2005 The Society of Thoracic Surgeons
Center for Vascular Intervention and Division of Vascular Surgery, Union Memorial Hospital/MedStar Health, Baltimore, Maryland
Accepted for publication March 16, 2005.
* Address reprint requests to Dr Criado, 3333 N. Calvert Street, Suite 570, Baltimore, MD 21218 (Email: frank.criado{at}medstar.net).
Presented at the Fortieth Annual Meeting of The Society of Thoracic Surgeons, San Antonio, TX, Jan 26–28, 2004.
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Abstract |
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 Top Abstract IntroductionPatients and MethodsResultsCommentDiscussionReferences |
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METHODS: A retrospective chart review of 186 patients undergoing stent-graft repair of thoracic aortic lesions at our institution during the 92-month period ending on December 31, 2004 was performed. Patients were divided into two groups based on the indication for treatment; group A had thoracic aortic aneurysms (TAA) and group B had type B aortic dissections (TBAD). Both groups were analyzed for outcome variables including technical success, mortality, major morbidity, endoleak rate and type, secondary endovascular interventions, and long-term survival. Mean follow-up was 40 months (range, 1 to 92 months).
RESULTS: Compared to group B, group A patients were older and had a higher incidence of peripheral vascular disease and chronic obstructive pulmonary disease. Sixty percent of all patients were American Society of Anesthesiologists class III and the remainder were class IV (38.3%) and V (1.7%). The procedure was completed in 180 patients (96.7%), with all 6 failures being access-related. The average procedure time was 149 minutes (range, 72 to 405). The 30-day mortality was 4.7% (9 patients), and serious morbidity was 19.9% (37 patients). Eight patients (4.3%) developed spinal cord ischemia, 4 immediately after the procedure and 4 delayed (1 to 3 days). Total hospital length of stay averaged 6.7 days. Secondary endovascular interventions were successful in 17 patients with angiographically confirmed endoleaks (type I and III). At an average follow-up of 40 months, freedom from all-cause mortality was 62.5% in group A and 58.1% in group B.
CONCLUSIONS: Stent-graft repair for TAA and TBAD can be achieved with high technical success and comparatively low rates of morbidity and mortality. Midterm survival appears to be favorable. Further refinements in device technology and procedural techniques are needed.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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| Dr Criado discloses that he has a financial relationship with Medtronic Vascular.
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Stent-graft intervention for treatment of thoracic aortic diseases is an exciting new frontier in endovascular therapy. Beyond the initial report by Volodos and colleagues [1], Dake and colleagues’ [2, 3] and Fann and Miller’s [4] pioneering works at Stanford did the most to stimulate the evolutionary developments and growing interest that have taken place over the past several years. The availability of commercial devices and improvements in procedural capabilities catapulted all such procedures to the forefront of the endovascular specialty. Thoracic aortic aneurysms (TAA) and type B aortic dissection (TBAD) constitute the two most common indications for repair. Data are beginning to accumulate on best interventional strategies, technical results, and early and midterm clinical outcome [5–12], but much remains unclear or unknown. We sought to gain a better understanding of these issues through a retrospective review of our 8-year clinical experience with endovascular treatment of TAA and TBAD.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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2 analysis was used to compare categorical comorbidity data. Age comparisons were analyzed by the Student t test.
Indications for Intervention
Group A patients were considered for endovascular repair when one or more of the following were present: symptoms (pain), maximum diameter of the sac greater than 5.0 cm, or more than twice the diameter of an adjacent nonaneurysmal segment of the thoracic aorta, or documented sac growth of greater than 0.5 cm over a recent 6-month period.
Indications for repair in group B patients included imperatives for intervention in 64 (85.3%): acute expansion of the false lumen (> 4.5 cm), organ or limb malperfusion, progressive or persistent pain. Eleven patients (14.7%) undergoing stent-graft procedures had uncomplicated acute aortic dissection.
Device Strategy and Procedural Techniques
Endograft sizing and design, and implant strategy, were based on evaluation of morphology by angiography, intravascular ultrasound (IVUS), and 3-mm slice contrast-enhanced spiral computed tomography (CT) with or without three-dimensional (3D) reconstructions. The procedures were performed in the operating room under fluoroscopic and angiographic guidance (40 degree left anterior oblique projection). Anesthesia used was general endotracheal in 124 (66.7%), spinal in 52 (27.9%), and local with intravenous sedation in 10 (5.4%) patients. The anesthesiologist was asked to maintain the mean blood pressure at 80 mm Hg or lower during deployment of the proximal-most endograft segment and ballooning. In TAA cases, the stent-graft device was placed to cover the length of the aneurysm and extend (if possible) a minimum of 20 mm proximally and distally. Endovascular strategy for TBAD patients, on the other hand, consisted of endograft placement from the origin (or just above) of the left subclavian artery (LSA) down to the proximal abdominal aorta, covering the full length of the descending thoracic aorta (DTA). An extra stiff (Lunderquist) guidewire was inserted retrograde into the proximal ascending aorta using a catheter exchange technique under fluoroscopy. Such stiff wire provided the necessary support for advancement and delivery of the endograft system. The device used in all instances was the Talent self-expanding thoracic stent graft (Medtronic Vascular, Santa Rosa, CA), with a 4 to 6 mm diameter oversize, and an uncovered proximal stent (bare spring) allowing for transostial placement with preservation of branch-artery patency (Fig 1).
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Results |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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Six procedures (2.6%) were aborted because of access failure; all but one in female patients. Among the 180 patients actually receiving an implant, proximal endograft attachment was in the DTA more than 2 cm distal to the origin of the LSA in 34, within 2.0 cm of the LSA (parasubclavian) in 69, and proximal to the LSA in 77 (Fig 2). The endograft was placed across the origin of the LSA (occluding the vessel) in 62 (34.4%). Eighteen patients (9.7%) had preliminary adjunctive cervical operations designed to transpose and/or bypass the LSA and/or the left common carotid artery to enable more proximal stent-graft attachment within the aortic arch. Distal stent-graft attachment was at the level of T12 or lower in 123 (68.3%). Among these, the celiac artery origin was crossed with the uncovered stent in 9, and intentionally occluded (covered) by the endograft in 3. Nine patients with history of prior infrarenal aortic aneurysm repair had adjunctive placement of a cerebrospinal fluid drainage (CSFD) catheter in an effort to minimize or prevent risks of spinal cord ischemia (SCI). The average procedure time was 149 minutes (range, 72 to 405).
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Within 30 days of the procedure, nonfatal serious adverse events (SAE) occurred in 37 patients (19.9%). Eight patients (4.3 %) developed SCI: it was immediately apparent postoperatively in 4, but delayed in onset (1 to 3 days) in the other 4. Predisposing or precipitating conditions for this complication included prior abdominal aortic aneurysm (AAA) repair in 2, extensive aortic coverage (LSA to celiac artery) in 2, shaggy aorta in 1, hypotension in the setting of rupture in 1, and unclear in 2. The ischemic syndrome consisted of paraplegia in 3 patients (1 improved dramatically after CSFD), paraparesis in 2, and monoparesis in 3. Four of the five patients with monoparesis or paraparesis had complete resolution of their symptoms and one had dramatic improvement (4 received CSFD after the onset of symptoms). Three other patients (1.6%) sustained carotid (n = 2) or vertebro-basilar (n = 1) ischemic strokes that were felt to represent embolic phenomena, likely induced by catheter and guidewire manipulations in the aortic arch region. One patient recovered fully and the other 2 had significant improvement.
The remaining nonfatal SAEs were in order of decreasing frequency: respiratory complications prolonging hospitalization (n = 9), access vessel thrombosis, bleeding or rupture (n = 8), "post-implant syndrome" with severe back pain, fever, and leukocytosis lasting several days (n = 6), acute renal failure (n = 2), and lymph leakage from a cervical incision after a preliminary subclavian-to-carotid transposition (n = 1). The average hospital length of stay was 6.7 days (range, 1 to 45 days; median of 2 days).
Length of follow-up ranged from 1 to 92 months, and averaged 40 months. Eleven additional deaths have occurred: TAA-related in 2, TBAD-related in 1, unrelated in 5, and unknown in 3. The 2 aneurysm-related deaths (at 2 and 4 months) occurred in the setting of extensive thoracoabdominal aortic aneurysm (TAAA) with distal type 1 endoleak and failed secondary intervention (cuff extensions); in both cases, the aneurysm extended to or beyond the origin of the celiac artery. One patient with known proximal endoleak after repair of chronic TBAD died presumably from rupture after a carotid-carotid bypass in preparation for planned proximal extension into the arch.
Nineteen TAA patients (17%) were found (by CT) to have an endoleak within 30 days. Only 1 of these was apparent on completion angiography at the time of implantation. Diagnostic angiography confirmed the presence of a type 1 (attachment site) or type 3 (modular disconnection) endoleak in 17 of 19 patients uncovered by CT. It was negative in the other 2. There were no confirmed type 2 (branch flow) endoleaks. Secondary intervention was undertaken in all 17 cases with angiographic confirmation. Eleven patients underwent placement of extension cuffs (proximal n = 5, distal n = 6) between 1 and 6 months after the initial stent-graft procedure. Five patients had relining of their previous repair with a new endoluminal stent-graft system that was deployed to seal a type 3 endoleak. Direct transcatheter (transbrachial) coil embolization of the endoleak nidus was performed in 1. Extension cuff placement and relining resulted in resolution of the endoleak in 13 of 15 (84%) patients, but failed in 2 whose thoracoabdominal aneurysm extended down to or beyond the celiac artery. They both died from aneurysm rupture (see above). Coil embolization of the endoleak nidus resulted in complete thrombosis in the one patient it was attempted. Finally, the 2 patients with negative angiogram (but positive evidence of endoleak on CT) have stable (nonenlarging) aneurysms; the endoleak persists in 1, but has resolved on the other.
The TBAD patients have been scrutinized in much the same manner as those with TAA after stent-graft repair. Among the 75 treated patients, 64 (85.3%) presented with an imperative for intervention (malperfusion, continuing pain, acute expansion of the false lumen, etc), but 11 (14.7%) had none. The dissection was acute (< 2 weeks from onset) in 56 (74.7%), and 10 patients (13.3%) had ruptured by the time the endovascular procedure was undertaken. Preoperatively, the false lumen was patent in 67 (89.3%) and thrombosed in 8 (10.7%). Endovascular repair resulted in thrombosis of the false lumen in the thoracic aorta (by CT at 1 to 3 months) in 70 of 75 (93%) patients. Continued patency of the false lumen in the abdominal segment, on the other hand, remained unchanged in the majority of cases where the dissection extended to the infrarenal segment or iliac arteries. Two patients underwent secondary intervention to extend endograft coverage of the true lumen to encompass the full length of the DTA. Both of these patients had been treated during the initial phase of our TBAD experience, before adopting the policy of endograft coverage of the entire DTA. In both cases, continued patency and pressurization of the false lumen had resulted in continued aneurysmal dilatation in the thoracic aorta.
Survival was analyzed by the life-table methodology using available long-term follow-up data (TAA, n = 99; dissection, n = 41). Kaplan-Meier curves were compared using a log-rank test. At the end of the study period, after an average follow-up of 40 months, 62.5% of group A and 58.1% of group B patients were still alive (p = 0.54) (Fig 3). The endoleak-free survival was 43% and 44.9% in groups A and B, respectively (p = 0.9) (Fig 4).
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Comment |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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Unlike abdominal aortic repair, where conventional surgical reconstruction is widely available and produces good results with relatively low mortality rates, open repair of the aortic arch and thoracic aorta is accompanied by very high (if not prohibitive) mortality and morbidity. Published mortality rates vary between 3% and nearly 30% for elective cases, and even higher in emergent situations [12, 18, 23–26]. Our own results, with an overall 30-day mortality of 4.7% and a low 2.9% rate in intact-nonruptured cases, are impressive examples of the advantages of the endovascular approach. The same cannot be said about stent-graft intervention for ruptured TAA and TBAD, where the overall mortality was 37%.
In addition to its role in aneurysmal disease and related conditions, stent-graft repair is emerging as an attractive treatment choice for complicated acute type B aortic dissection, where open surgical repair has produced dismal results [12, 14, 26–28]. The principle of "simple" coverage of the entry tear, thereby redirecting flow exclusively down the true lumen and decompressing the false lumen, is sound and appealing. However, we have found that persistent flow in the false lumen and the need for secondary intervention can be minimized through more extensive endograft coverage during the initial endovascular procedure [27, 29]. The result has been the adoption of the new policy of covering essentially the whole length of the DTA with the endograft during endovascular repair of acute TBAD. While this may theoretically increase the risk of SCI and paraplegia, we have not had a single such occurrence. Stent-graft repair is particularly sound and effective for treatment of malperfusion, which is largely related to compression of the true lumen by the pressurized false channel. On the other hand, intervention for uncomplicated TBAD (14.7% in the current series) is controversial and cannot be based on available evidence. Randomized clinical trials will hopefully resolve this important issue in the near future. In the meantime, stent-graft repair should be used sparingly in the absence of clinical imperatives, although it is tempting to think that it should "logically" represent an improvement over the rather unfavorable natural history of untreated aortic dissection.
The incidence of SCI was 4.3% in this series, consistent with other published results [5, 6, 8, 30, 31]. Risk factors for this dreaded complication include concomitant or previous AAA repair, extensive endograft coverage of the aorta, and hypotension. Cerebrospinal fluid drainage has been shown to prevent SCI during open repair of TAAA (level I evidence) [32], which has prompted several investigators to do the same during endovascular repair [33, 34]. We adhere to this policy as well, and maintain CSF drainage intraoperatively and for 2 to 3 days postoperatively on all patients at risk, especially those who have had prior infrarenal replacement. A CSF catheter is also promptly inserted on any patient who develops SCI after repair.
Cerebral ischemia and strokes have also been reported as a complication of thoracic endovascular repair [25]. Three patients (1.6%) suffered such events in our series. They were likely caused by embolic phenomena from endovascular manipulation in the aortic arch. Advancement of the delivery system and actual graft deployment maneuvers may be implicated as well. It cannot be overemphasized that optimal interventional skills and gentle execution are paramount requirements for the safe conduct of these procedures. Further device refinements will also be helpful in this regard.
Not unexpectedly, endoleaks occur with a relatively high incidence. The rate in this series (17% of TAA patients) is consistent with other publications [17, 25]. It is noteworthy that all endoleaks were found to be type 1 (attachment site) or type 3 (modular disconnections). There were no instances of confirmed type 2 leaks. The latter, of course, are the most frequent type after stent-graft repair of AAA. Insufficient endograft coverage of the diseased aortic segment could be implicated in several of the cases, necessitating second intervention for placement of an extension cuff. More aggressive pursuit of good-quality completion angiography, including more frequent use of general endotracheal anesthesia that allows for respiratory cessation for better imaging, and more generous endograft coverage of the diseased aorta have emerged as important lessons learned from this experience. Type 3 leaks, on the other hand, may be related to insufficient overlap length between modular components. Relining the repair with a new endograft placed within it has worked well in such a scenario. Prevention of this problem can be achieved through the use of longer, single-segment endografts, and more generous (5.0 cm+) overlap of modular components when necessary.
Management of aortic arch branches ranks among the most significant unresolved and somewhat controversial issues [11, 13, 35]. In 34.4% of the cases in this series, the LSA origin was covered-occluded by the endograft device. By and large, we have found this maneuver to be very well-tolerated. Approximately 35% of the patients develop arm claudication, which tends to be self-limited and nonincapacitating. One patient died from bilateral cerebellar infarctions; he had preexistent occlusion or absence of the contralateral vertebral artery. At present, in all elective situations where coverage of the LSA is contemplated, patients are referred for magnetic resonance angiography studies where patency of the vertebral arteries and intactness of the circle of Willis are assessed. Preliminary performance of LSA transposition or bypass is reserved for patients with absent contralateral vertebral artery flow, or those with a history of coronary artery bypass graft using the left internal mammary artery. In all others, we prefer to maintain patency-continuity of the LSA, allowing placement of a transbrachial-LSA catheter that has been found to be so helpful for safe and precise placement of the stent-graft device in the aortic arch (Fig 5). Transcatheter coil embolization of the LSA (performed at the end of the procedure) can address issues related to possible backflow endoleak when proximity to or involvement by the TAA make such occurrence likely.
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In conclusion, current advances with stent-graft thoracic intervention must be viewed as exciting new developments that offer hope to many patients with TAA, TBAD, and other serious conditions affecting the thoracic aorta. Techniques and technologies continue to evolve, and present-day concepts and results should be viewed within the context of work-in-progress. Most significantly, early and midterm results demonstrate a significant advantage over historic surgical outcomes. It is likely that these techniques will soon become first-line therapy for most cases with suitable anatomy. However, since little if any information is available on long-term results in terms of durability of the repair and device integrity, these procedures should probably be performed only within the confines of well-controlled clinical trials at present.
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Discussion |
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TopAbstractIntroductionPatients and MethodsResultsCommentDiscussionReferences |
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DR JOSEPH S. COSELLI (Houston, TX): I congratulate you on a wonderful presentation and your reporting upon both candid and sobering results. I must agree entirely that this is a wake-up call to all cardiac surgeons to embrace technology, future opportunities for new surgical interventions, and to continue to lead in stretching the envelope.
When we compare the endovascular treatment of aortic pathology against standard open surgical therapy, I believe it is helpful to remember that the latter is, as yet, the gold standard. Clearly, open surgical technique cannot compare with the shorter recovery time, reduced ICU time, abbreviated hospitalization, and possibly, with time, preferred economics. However, when I evaluated 469 descending thoracic aortic replacements, our 30-day mortality was 4%, the combined paraplegia and paraplegia rate was 2.6%, renal failure was 2.3%, and postoperative bleeding requiring return to the operating room was 2.6%. We, of course, encountered no endoleaks and none of our patients died of later rupture of their aneurysms.
I would like to pose the following questions. What would the authors’ recommendation be with regards to mycotic aneurysms employing current endovascular technology? What are the limits of what we are currently able to offer from an endovascular standpoint? Who would the authors not treat? In other words, who would they absolutely select for operative intervention at this point in time?
There are at least eight reports in the literature with retrograde extension into the ascending aorta and aortic root of endovascular therapy, in effect converting a DeBakey type III dissection into a DeBakey type I; ie, Stanford type A dissection. The authors refer to placing the uncovered portion of the stent graft into the anatomic transverse arch. Do they have any other recommendations to prevent this dreaded complication (retrograde extension), which requires urgent open surgical intervention? What other modifications do the authors offer regarding safety in this respect? Finally, what recommendations do the authors make regarding the training of thoracic residents in this important, if not critical, emerging technology?
I do believe that stent grafting will find a role in the treatment of thoracic aortic aneurysms; it is pioneering work such as this, which will help us define both its role and its limitations. Thank you.
DR CRIADO: I appreciate Dr Coselli’s remarks and certainly recognize his pioneering monumental work in this area. I agree that surgery continues to be the gold standard, but I would add that this is going to change rapidly in the near future, especially for treatment of lesion from the mid arch down.
He asked about mycotic thoracic aortic aneurysms. I would be very hesitant to place an endograft for that indication. On the other hand, my experience and view are that most cardiothoracic surgeons are unwilling to operate on such cases anyway. So sometimes we are forced to intervene, albeit reluctantly, but I would certainly remain concerned about the potential for development of a serious endograft infection.
In terms of the retrograde dissection issues, there are 19 reported cases of either retrograde dissection or perforation and ruptures, and the majority have been associated with the placement of an endograft with a proximal bare spring. Interestingly and intriguingly, we have not had a single such occurrence. It is my view that the insistence of securing proximal attachment within the mid or distal arch may have contributed to prevention of these complications. Ultimately, further technological refinements and new endograft designs will likely address all such issues in the near future.
The training issues are enormously important and difficult to sort out. I would like to emphasize the point that thoracic endovascular procedures can be extraordinarily difficult to perform, even for seasoned interventional specialists. The thoracic aorta is not the place to start one’s endovascular experience, same as repair of arch aneurysms is not where surgical trainees would begin. It would be very difficult to achieve minimum acceptable competency to perform these procedures without a previous overall endovascular background and training. Another potential pathway would be an association or collaboration with an interventional specialist.
I really appreciate the opportunity to present this information. Thank you very much.
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