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Ann Thorac Surg 1999;67:1971-1974
© 1999 The Society of Thoracic Surgeons

Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation"

^a Department of Cardiovascular and Thoracic Surgery, and Division of Cardiovascular and Interventional Radiology, Stanford University School of Medicine, Stanford, California, USA

Address reprint requests to Dr Mitchell, Dept of Cardiovascular and Thoracic Surgery, Falk Cardiovascular Research Building, Stanford University Medical Center, Stanford, CA 94305
e-mail: rsmitch{at}leland.stanford.edu

Presented at the Aortic Surgery Symposium VI, April 30–May 1, 1998, New York, NY.

	Abstract

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Objective. The feasibility and efficacy trial of an endovascular stent-grafting system for the treatment of aneurysms of the descending thoracic aorta was investigated.

Methods. After Institutional Review Board approval, 103 patients (mean age 69 years) underwent stent graft repair of a descending thoracic aortic aneurysm between July 1992 and November 1997. The stent graft was fabricated using self-expanding "Z" stents covered by a woven Dacron tube graft. Follow-up, which averaged 22 months, was 100% complete. Simultaneous open abdominal aortic aneurysm repair was performed in 19 patients.

Results. Complete aneurysm thrombosis was achieved in 86 patients (83%). Early mortality, defined as a death during the same hospitalization or in less than 30 days, was 9 ± 3%, and was significantly associated with preoperative cerebrovascular accident (CVA) or myocardial infarction. Major perioperative morbidity occurred in 31 patients, and included paraplegia in 3, CVA in 7, and respiratory insufficiency in 12 patients each. Actuarial survival was 81 ± 4% at 1 year, and 73 ± 5% at 2 years. Treatment failure (including all late, sudden, unexplained deaths) occurred in 38 patients, and only 53 ± 10% of patients were free of treatment failure at 3.7 years. Five patients required late operative therapy for endoleaks associated with aneurysm enlargement.

Conclusions. Satisfactory results were achieved using this "first-generation" homemade stent graft device. Mortality and morbidity occurred frequently, but may have been associated with the high-risk character of this patient population. Medium-term results were acceptable, but continued aortic enlargement, with the late development of endoleaks, is a significant concern. Second-generation devices with commercial development, coupled with this initial experience, should allow improved clinical results in the future. Longer term follow-up is still necessary to fully define the efficacy of this endovascular approach.

	Introduction

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The traditional surgical therapy for the treatment of descending thoracic aortic aneurysms, namely graft interposition, has been associated with high mortality and morbidity rates in a population that is frequently elderly and debilitated [1]. Endoluminal placement of covered stent grafts has developed as an alternative treatment modality that may be associated with decreased morbidity and mortality [2–8]. In an effort to determine the feasibility and efficacy of such an approach, approval was obtained from our Institutional Review Board, and a prospective nonrandomized trial was commenced in July 1992.

	Material and methods

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Between July 1992 and November 1997, 103 patients underwent an endovascular repair of their thoracic aortic aneurysm utilizing self-expanding "Z" stents covered by a woven Dacron tube graft (Meadox-Boston Scientific, Boston, MA). Patients were evaluated preoperatively with chest radiographs, contrast-enhanced spiral computed tomography (CT), and angiography to identify proximal and distal "landing zones," as well as to define anatomic relationships with critical adjacent aortic branch vessels. Pelvic angiography was used to determine the size and tortuosity of femoral and iliac vessels necessary for endoluminal delivery.

In the operating room, with the patients under general anesthesia, a team of cardiovascular surgeons and interventional radiologists, acting in concert, carefully positioned and deployed the stent graft. Access was gained either through the femoral or external iliac arteries, or via the abdominal aorta, and a 28 Fr (OD) sheath was positioned under both fluoroscopic and transesophageal echocardiographic guidance. A custom-fabricated stent graft, oversized by 10%–15% compared with CT-determined diameters, was then positioned optimally and deployed utilizing procedures previously detailed [9, 10].

The 103 selected patients who received a stent graft comprised a heterogeneous mix of etiologies and risk factors as listed in Table 1. During this same time interval, 186 other patients underwent conventional open surgical repair of their descending thoracic aneurysms on our service. Twenty-one additional patients who had stent graft repairs performed by other surgeons at our institution, or at other institutions by one of us (M.D.D.), were excluded. The average interval from stent graft implantation until hospital discharge was 8 ± 6.6 days (range 0–42), and one-quarter of patients were discharged on or before the fourth hospital day. Some of this hospital time was consumed by completion of protocol-mandated postprocedure imaging studies.

SPSS for Windows (version 6.1; SPSS Inc., Chicago, Ill) was employed for all statistics. Continuous data are reported as the mean ± 1 standard deviation (SD). Important analyses are reported with 70% confidence limits (± 70% CL).

	Results

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Early mortality
Operative mortality was 9 ± 3%. The causes of death, often unassociated with the stent-graft procedure, were quite varied, and included intracerebral hemorrhage, sepsis, multisystem organ failure, respiratory insufficiency, malignancy, and pulmonary embolism. The presence preoperatively of either a myocardial infarction (MI) or a CVA increased the risk of death eight- to ninefold. Aneurysm etiology other than atherosclerosis, dissection, or trauma also increased the risk two- to threefold.

Early morbidity
Morbid complications occurred frequently in these patients, with 12 patients experiencing respiratory insufficiency, 7 patients sustaining a CVA, paraplegia occurring in 3 patients, and MI in 2 (Table 3). In only 1 case, with a failed connection to a previously placed elephant trunk, was a surgical conversion necessary. No multivariate predictors of stroke were revealed. Myocardial infarction was associated with the presence of coronary artery disease. Paraplegia occurred more commonly when arterial access was gained via the abdominal aorta. Two cases of paraplegia occurred in patients undergoing simultaneous repair of abdominal and thoracic aneurysms, and the third in a patient who had undergone abdominal aortic aneurysm repair some years earlier. Classification of a patient as a nonsurgical candidate increased the risk of respiratory insufficiency sixfold; severe chronic obstructive pulmonary disease was the most common reason for disqualifying a patient from consideration for surgery.

Primary success
Initial success was achieved in 73 ± 5% of patients, with secondary success in another 12%. The majority of endoleak failures occurred during the first year of our experience, with only a small incidence thereafter. An early or late endoleak was not treated in 7 patients, and persisted after treatment in 2 others. Three early endoleaks thrombosed spontaneously. Late leaks appeared more commonly in patients with diffuse aortic involvement, with continued aortic enlargement causing a major distal leak in 3 patients.

Survival
Actuarial survival was 86 ± 4% at 6 months, 81 ± 4% at 1 year, and 73 ± 5% at 2 years (Figure 1A). Only classification as a nonsurgical candidate was an independent predictor for all deaths (5-fold increase). For nonsurgical candidates, survival at 2 years was estimated to be 60 ± 7%, versus 91 ± 5% for surgical candidates (Figure 1B).

View larger version (23K): [in this window] [in a new window]   Fig 1. A) Actuarial survival curve depicting overall survival estimates for all patients. B) Actuarial survival curve for subgroups of surgical and nonsurgical candidates (SE = standard error of the mean).

Late complications
Forty-nine stent graft complications occurred in 39 patients, with an early endoleak being the most common problem. A multitude of other complications also occurred, including stent graft misdeployment (3), paraplegia (3), and the need for other aortic procedures (3) or catheter-based interventions (4). New aortic dissections (1), arterial injury/replacement (2), stroke (2), distal thromboembolism (1), and gut ischemia (1) also occurred, but less frequently. No patient experienced stent graft migration or infection.

Complications were associated with more proximal implantation sites and the necessity for bypassing the left subclavian artery, reflecting in part the inability of this first-generation graft to conform to the distal arch. The necessity for procedures on the left subclavian artery markedly increased the risk for late stent graft complications, as did the history of a prior MI. Fatal stent graft complications occurred in 4 patients, and included aneurysm expansion and erosion into the esophagus, aneurysm rupture, and 2 instances of arterial injury requiring graft replacement.

Other fatal complications occurred in 9 patients, including pulmonary failure in 4, stroke in 3, and pulmonary embolism, MI, renal failure, infection, and local hemorrhage in 1 patient each. Preoperative stroke was the only preoperative predictor of such events.

Only 5 patients ultimately required removal or exclusion of the stent graft, 2 of whom required a second operation when the aneurysm leaked or ruptured. The actuarial estimate of freedom from stent graft removal at 3.7 years was 86 ± 9%.

	Discussion

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Although relatively uncommon (6 cases per 100,000 person years) [11], the incidence of thoracic aortic aneurysms appears to be increasing, perhaps because of the aging of the population and our increased diagnostic capabilities. Because the natural history of aneurysms is one of continued expansion and rupture [12], 5-year survival rates are low, between 10% and 15% [11, 13]. Although elective surgical graft interposition is the treatment of choice for patients who are surgical candidates, frequent comorbidities in this elderly population substantially increase the risk of surgical intervention. Nevertheless, 5-year survival rates between 70% and 80% have been achieved in recent series [1, 4, 11, 13].

Endovascular repair of these aneurysms offers an alternative approach that may be less invasive and less morbid. Although the mortality rate in our series was not dramatically lower than that achieved with open procedures [1, 4, 14–16], we believe these results to be quite acceptable considering that fully 60% of our patients were judged not to be operative candidates. It was disappointing that endovascular repair did not appear to lower the risk for paraplegia overall, although, as previously stated, this complication occurred only in patients undergoing concurrent AAA repair, or who had undergone AAA repair earlier. Also alarming was the high incidence of stroke. Although different mechanisms were responsible (i.e., intracerebral hemorrhage and probable multiple emboli), clearly manipulation of a large and stiff delivery sheath in the transverse arch of these severely diseased aortas is not without risk. The availability of smaller, more flexible, over-the-wire systems should minimize these hazards in the future.

Endoleaks continue to be the "Achilles’ heel" for all stent graft therapies for aneurysmal disease. Indeed, in this series, endoleaks occurred in fully 24% of cases. Early in our experience, we did not fully appreciate the grave consequences of unrepaired endoleaks, and were not adequately aggressive in their early prevention and repair. The availability of a back-up stent graft, and the recognition of unfavorable anatomies for stent deployment have subsequently greatly reduced the incidence of endoleaks. Coil embolization was effective in eliminating the endoleak in 10 patients [17, 18], whereas balloon inflation to "mold" the stent was not. The recognition that the majority of our endoleaks were from proximal stent graft sites, particularly those adjacent to the left subclavian orifice, and probably resulted from use of a poorly malleable, semi-rigid device has prompted the development of a new more conformable stent graft for future use.

It is clear that the best candidates for these devices are those patients with localized disease in relatively straight portions of the aorta anatomically distant from the transverse arch. Additionally, this report documents only the early to mid-term results, and longer follow-up will be necessary before any statements as to the true efficacy of this modality are possible. Nevertheless, we believe that, with continued development, stent graft repairs will add significantly to the armamentarium of thoracic aortic surgeons.

	Acknowledgments

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We thank our surgical and radiological colleagues and our surgical residents for providing the care for these patients, and for their assistance in gathering and preparing this data, including Robert C. Robbins, MD, Philip E. Oyer, MD, PhD, James I. Fann, MD, G. Randall Green, MD, Paul Dagum, MD, PhD, Linda Campbell, RT, RN, Mahmood K. Razavi, MD, Stephen T. Kee, MD, Daniel Y. Sze, MD, PhD, Suzanne M. Slonim, MD, Shaun Samuels, MD, Noriyuki Kato, MD, Robert P. Liddell, MS, Tetsuhisas Yamada, MD, and Katina A. Woodman.

	References

Top Abstract Introduction Material and methods Results Discussion Acknowledgments References

 

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