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J Thorac Cardiovasc Surg 2007;133:1474-1482
© 2007 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
a Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio
b Department of Vascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio.
Read at the Eighty-sixth Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pa, April 29-May 3, 2006.
Received for publication May 10, 2006; revisions received August 8, 2006; accepted for publication September 26, 2006. * Address for reprints: Roy Greenberg, MD, Cleveland Clinic, 9500 Euclid Avenue, Desk S40, Cleveland, OH 44195. (Email: greenbr{at}ccf.org).
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Abstract |
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 Top Abstract IntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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Methods: Between May 2004 and February 2006, patients with thoracoabdominal aneurysms considered high risk for conventional surgery were enrolled in a prospective trial to evaluate a novel endovascular grafting system. Devices were custom designed for each patient using high-resolution computed tomography. Patient data included mortality, morbidity, procedural details, and surrogate end points for endovascular repair. These were collected at hospital discharge and at 1, 6, and 12 months.
Results: Seventy-three patients underwent endovascular repair of thoracoabdominal aortic aneurysms for type I, II, or III (n = 28), or for type IV (n = 45) thoracoabdominal aneurysms. Mean aneurysm size was 7.1 cm (range 4.5–11.3 cm). General anesthesia was used in 47% of patients and regional anesthesia in 53%. There were no conversions to open surgery nor ruptures post-treatment. Technical success was achieved in 93% of patients (68/73). Thirty-day mortality was 5.5% (4/73). Major perioperative complications occurred in 11 (14%) patients and included paraplegia (2.7%, 2/73), new onset of dialysis (1.4%, 1/73), prolonged ventilator support (6.8%, 5/73), myocardial infarction (5.5%, 4/73), and minor hemorrhagic stroke (1.4%; 1/72). A majority of patients had no complications. Mean length of stay was 8.6 days. At follow-up, 6 deaths had occurred. There were no instances of stent migration nor aneurysmal growth.
Conclusions: Endovascular repair of aortic aneurysms involving the visceral segment in nonsurgical candidates is feasible. Known complications of repair are not eliminated, but morbidity and mortality appeared low relative to the high-risk population studied. Further refinement of device design, delivery technique, and patient selection is ongoing. Assessment of durability will require longer follow-up.
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Introduction |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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Standard surgical approach to the treatment of thoracoabdominal aneurysms requires a demanding operation. Surgical outcomes are complicated by the presence of multiple comorbid conditions in these patients. Use of improved techniques has lowered the risk of complications and testifies to the effectiveness of treatment evolution and surgical experience in improving outcomes. However, risk for morbidity and mortality in this challenging patient population is still substantial. Large single-center experiences have reported mortality ranging from 7.4% to 17%.1-6 A recently published population-based study reported 20% perioperative mortality and only 69% survival at 12 months.7 Cardiac, neurologic, respiratory, and renal complications limit the number of patients eligible for surgery. All of these factors have encouraged the development of an alternative approach.
Endovascular repairs of straightforward infrarenal and thoracic aortic aneurysms have been favorably compared with surgical controls.E1-E4 The application of this technology to segments of the aorta with visceral or brachiocephalic branches has required modifications of devices and procedures. Fenestrated devices have been developed to treat juxtarenal aneurysms, and the use of branched devices to treat aneurysms of the visceral and arch segments has been reported.8-13 We have explored a broadened indication for the use of endovascular procedures to treat aneurysms of the visceral segment. This article describes the techniques and reports the results of branched stent grafts to treat thoracoabdominal aortic aneurysms in select high-risk patients.
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Materials and Methods |
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Quantification of patients as poor candidates for conventional surgery is challenging, even for surgeons with extensive experience. The determination was made largely based upon the patient’s age, aneurysm morphology, and comorbid factors present.1-7 All patients enrolled were considered high risk for open surgery after surgeons’ assessment of all of these factors. Associated comorbidities are delineated in Table 1.
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Device Construct
The Zenith endograft (Cook Inc, Bloomington, Ind), previously studied for treatment of infrarenal abdominal aortic aneurysms, juxtarenal abdominal aortic aneurysms, and thoracic aneurysms, formed the basis of this device.E2,E3,8,10 Branches for the visceral segment were added to a tubular component that transcended the visceral segment in a manner similar to prior reports11,12 (Figure 1). Two types of branches were constructed depending upon the distance of the visceral ostia from the presumed location of the aortic prosthesis. The first involved a fenestration circumferentially reinforced with a nitinol ring (reinforced fenestrated design). This was mated with a balloon-expandable stent graft partially extending within the aortic stent-graft lumen. The aortic segment of the balloon-expandable stent graft was then flared using sequentially larger balloons (12-mm, then a compliant 32-mm balloon) to abut the stent graft to the aortic graft, achieving a seal around the nitinol ring. The second branch type, termed a directional branch, consisted of an 8-mm polyester graft sewn to the aortic prosthesis above the target vessel. The branch was wrapped in a helical fashion external to the aortic prosthesis, oriented in either an antegrade or retrograde fashion, and terminated proximal to the target vessel. Directional branches provide long regions (2 cm) of overlap, allowing for the mating of a self-expanding stent graft (Fluency, Bard Inc, Tempe, Ariz) sized to the visceral vessel. A given device may have incorporated both types of branches based on the patient’s anatomy.
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Procedures
Procedures included bilateral femoral artery exposure, anticoagulation to maintain activated clotting times greater than 300 seconds, and selective exposure of brachial access sites. The primary device was delivered over a stiff wire that terminated in the ascending aorta. Each branch component was introduced through the contralateral femoral or brachial artery.
Longitudinal positioning of the aortic component was assisted by small injections of contrast above the celiac artery or by selective access of branch arteries to mark their positions. The device was then unsheathed. A posterior tethering wire partially constrained the graft, allowing fine positioning adjustments during selective cannulation of each visceral branch from within the aortic prosthesis.
Antegrade helical branches were selectively accessed with a preloaded wire and catheter. Retrograde helical branches and reinforced fenestrations were catheterized from femoral access points. Curved 7F or 8F sheaths were placed into respective branches.
After access into each visceral vessel through the intended branch, the aortic component was completely expanded by removal of the posterior tethering wire. Release of the proximal fixation component allowed barbs to engage within the aortic wall. Balloon-expandable stent grafts (reinforced fenestrated branches) that were 17 to 38 mm in length (Jomed, Abbott Labs, Abbott Park, Ill) or self-expanding stent grafts (helical branches) that were 60 mm in length (Fluency, Bard, Tempe, Ariz) were delivered. Balloon-expandable stent grafts were flared. The aortic delivery system was removed and proximal thoracic, distal bifurcated iliac, or internal iliac components were added as required.
Perioperative Patient Management
Regional anesthesia was preferentially used in patients with significant comorbid pulmonary disease (Table 1). Patients were usually followed in an intensive care unit for a minimum of 12 hours (n = 53). Spinal drainage was selectively employed depending on extent of aortic coverage (type I, II, and III aneurysms) or in the setting of prior aortic repair (n = 37). Drainage was continued for 72 hours or until CT scan confirmed aneurysm exclusion. Hydration and N-acetyl cysteine were administered before and after procedures for patients with chronic renal insufficiency. Other than aspirin, no anticoagulation was prescribed as a result of the aortic procedure.
Follow-up
Imaging and clinical evaluations occurred at 1, 6, and 12 months postoperatively and annually thereafter. Mortality data were available for all patients, and 92% of patients were compliant with clinical and imaging follow-up. Studies included serum creatinine and blood urea nitrogen, CT, visceral duplex ultrasonography, and plain chest and abdominal radiographs. Image evaluation was conducted on a work station using 3-D techniques (Figure 2).
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aneurysm repair.
Data were entered into an Oracle database. Mortality was assessed using life table analyses. Branch patency during follow-up studies was defined by contrast CT or duplex ultrasound, and device migration was defined according to recent modifications.14
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Results |
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Mortality
Probability of freedom from all-cause mortality (94%, 85%, and 81%) and aneurysm-related mortality (94%, 89%, and 89%) at 1, 6, and 12 months, respectively, is shown in Figure 3.
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Late mortality
Six patients died more than 30 days after surgery. Two patients expired at extended care facilities from complications related to spinal cord injuries. One died at an outside hospital due to an upper gastrointestinal bleed 4 days following embolization of a type II endoleak from the inferior mesenteric artery. A fourth late death resulted from sepsis 6 months after the procedure. The fifth patient died on day 167 from an acute myocardial infarction documented by autopsy, which also provided the opportunity for device explantation and analysis. And a sixth death occurred on postoperative day 312 as a result of cardiac arrhythmia and renal failure.
Morbidity
Thirty-seven (52%) patients had no complications and were discharged after a mean of 4.9 ± 3.0 days. Death or major complications occurred in 15 patients (Table E1).
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Cardiovascular and respiratory complications
None of the 10 patients with ischemia on preoperative testing had cardiac events. Four patients had perioperative myocardial infarctions. Overall, 5 patients (6.8%) required prolonged intubation. Two of these who underwent tracheostomy are also the patients who had spinal cord injuries.
Renal complications
Sustained elevations of serum creatinine greater than 30% over baseline levels were noted in only 11% (6/53) of patients at 1-month follow-up. Two of these 6 patients had evidence of renal insufficiency preoperatively. One, who had paraparesis, required hemodialysis and eventually died. The other developed postoperative renal artery stenosis, which was treated with repeat stenting, and his serum creatinine has remained stable at 3.1 mg/dL. Creatinine elevations in the other 4 patients have remained stable between 1.4 and 2.0 mg/dL at 6-month (n = 2) and 12-month (n = 2) follow-up.
Three patients had failed access into a single renal artery. At follow-up, 1 of these individuals had a reduced serum creatinine attributable to successful treatment of a tight stenosis in his dominant kidney. The second patient had a rise in serum creatinine, which has remained stable at 2.7 mg/dL. The third refused hemodialysis and died on postoperative day 30.
Radiographic Complications
Endoleaks and sac morphology
Overall incidence of endoleaks was 11% before hospital discharge. Incidence and categorization of endoleaks are depicted in Figure 4. All type I (n = 3) endoleaks and all but 1 type III (n = 5) endoleaks were treated with secondary interventions. The single exception, a type III endoleak from the joint between the visceral component and bifurcated iliac component, resolved within 1 month. Of the 7 patients with type II endoleaks, 2 underwent treatment with glue embolization, 2 resolved by 1-month follow up, and the remaining 2 will be followed.
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Secondary interventions
All secondary interventions were elective, and most occurred within the first month. Interventions for type I or III endoleaks occurred either before discharge (n = 3) or at 1-month follow-up (n = 4). Additional secondary procedures included groin complications (n = 2), internal iliac artery stenosis (n = 2), thrombosed iliac graft limb (n = 1), and a renal stent fracture (n = 1). Freedom from secondary interventions, by life table analysis, at 1, 6, and 12 months was 87%, 74%, and 71%, respectively.
Device integrity and branch patency
There have been no component separations, barb fractures, or device migrations. A single stent fracture was identified within a renal stent graft (Jomed) placed into a reinforced fenestration. This was not associated with any clinical event or endoleak and was treated with supplemental renal stent-graft placement. All renal and visceral branch vessels patent at hospital discharge remain patent at late follow-up imaging (Table E1).
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Discussion |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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Direct comparison between historic results of open surgery and the current study, however, is not accurate given that the patients in this series were deemed excessively high-risk candidates for an open repair. When compared with patients in other series, our patients were generally older; had more coronary artery disease, obstructive pulmonary disease, and chronic renal insufficiency; and had more frequently undergone prior abdominal aortic repair.1-7 Furthermore, these data were collected prospectively under an intensive clinical and imaging follow-up protocol that allowed for accurate charting of complications, a more reliable process than retrospective review.
An alternative hybrid approach to treating these patients combining open surgical extra-anatomic bypass with endovascular coverage of the visceral segment has been proposed as a potentially lower-risk procedure for these difficult-to-treat patients. In a recent review of our own experience with this technique, we found a 23% mortality rate and the need for additional open surgical procedures necessary in 6/13 patients.15 These results mirror those of others and have led us to reserve this approach to those with no other reasonable options, such as emergency cases or those with anatomy that would preclude branched device design (excessive tortuosity or compact branch vessel origins).
The decision to treat these patients with any invasive therapy must be weighed against the risk of aneurysm rupture. With the mean size exceeding 7 cm, it can be estimated from the data provided by Elefteriades16 that the lifetime risk of complications in these patients exceeds 43%. There have been no known ruptures or evidence of aneurysm growth after endovascular treatment in this series. Even with short-term follow-up, we have documented a decrease in aneurysm size in many patients, lending credence to the hypothesis that such a repair reverses the natural history of disease.
It is clear from these data that endografting has not eliminated the complications of spinal cord ischemia, renal dysfunction, and myocardial infarction associated with the treatment of thoracoabdominal aortic aneurysms; however, the occurrence of such events compares favorably with results from open surgical treatment. The paucity of pulmonary complications was particularly favorable. Ability to perform this procedure using regional anesthesia allowed for the treatment of patients with severe lung disease, a factor previously shown to be predictive of poor outcome.1,3,17 Avoidance of aortic crossclamping, obligatory end organ ischemia, and excessive fluid loss also potentially contributed to reduce risk.
Risk of spinal cord ischemia was relatively low in this series (2.7% overall, 7.1% if all type IV thoracoabdominal aneurysms were excluded), despite the inability to reimplant intercostal arteries. This parallels the low incidence of spinal cord complications noted after endovascular repair of thoracic aneurysms and after extra-anatomic bypasses combined with total aortic coverage.10,11,18 However, the consequences of this complication are devastating, exemplified by the 2 patients in this series who ultimately died after a complicated postoperative course. Both patients had compromised internal iliac perfusion and extensive aortic coverage. Increased risk of spinal cord ischemia is an unavoidable situation when treating extensive continuous aneurysmal disease. This risk in endovascular repairs seems to be more attributable to anatomic factors related to the morphology of the disease than to the physiologic consequences inherent to aortic clamping and open surgery. Therefore, cerebrospinal fluid drainage is employed in all patients at anatomic risk for spinal cord injury: those with type I to III aneurysms and those who have had prior aortic surgery. Similar concerns have been raised about diminishing left subclavian and consequently antegrade vertebral artery flow with proximal placement of thoracic endovascular devices.10,19 These observations have caused us to temper our enthusiasm for extensive endovascular repair in the setting of compromised pelvic or subclavian perfusion. Subsequently, such patients have either been turned down for a repair, undergone initial carotid subclavian bypass procedures (n = 1), or had internal iliac branch device placement (n = 3) to maintain antegrade perfusion to these important collateral vascular beds. No patients had coverage of the left subclavian artery without a bypass procedure.
Although the stringent definition likely overestimates renal dysfunction in this series compared with other published series, the conclusions are similar: patients with thoracoabdominal aneurysms are at risk for renal impairment. The risk of renal failure in Godet’s6 series was 25%, with 8% of the patients requiring hemodialysis. Safi’s20 focused analysis demonstrated a 17.5% risk of worsening renal function, with 15% requiring hemodialysis; half of the patients ultimately died. After endovascular repair of juxtarenal aneurysms, the risk for needing hemodialysis was low, but preoperative renal dysfunction was shown to adversely effect survival and increase the risk for worsening renal dysfunction.21 Similar results were suggested by the present series, although it was not statistically powered to demonstrate an association. The advantage of avoiding renal ischemia with an endovascular approach may be offset by the use of nephrotoxic contrast agents and the risk of atheroembolization due to device manipulation within the aneurysm.
Myocardial complications are infrequent but not eliminated with an endovascular approach. Patients having open thoracoabdominal aneurysm repairs at our institution undergo coronary angiography followed by revascularization, if indicated, before aneurysm repair. However, when endovascular repairs are planned, only patients with symptoms or functional studies indicative of reversible ischemia are evaluated by cardiac catheterization. In the review of Svensson et al’s1 experience, an association between coronary artery disease and 30-day mortality was demonstrated. The finding that later surgical series have not shown coronary atherosclerosis to be a risk for mortality may be attributable to more aggressive screening and revascularization strategies.2-5 Whether all of the patients having endovascular repair of thoracoabdominal aneurysm should undergo cardiac catheterization remains to be seen.
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Technical Issues |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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The endovascular approach and the design of this device place limitations on patient selection. All patients in this series had aneurysms; none had chronic dissections. Accurate device deployment and rotational movement may be limited by the small true lumen in patients having dissection. Therefore, these patients are currently treated with conventional surgery at our institution. Additional anatomic constraints on patient selection included individuals whose visceral arteries arose within approximately a 10-mm arc length of each other. Such cases have been addressed using directional branches or hybrid approaches combined with extra-anatomic bypass, but these are more challenging.
Planning, device design, and manufacturing of custom devices create inherent delays in treatment. Therefore, patients requiring urgent or emergency repairs are relegated to open surgery. Potential for rupture in the intervening period should be considered in the overall mortality but certainly also occurs in patients awaiting elective open repair.
This technique will continue to undergo iterative improvements with respect to patient selection, device design, and delivery techniques. Adequate determination of long-term rupture protection or device durability will require longer follow-up of a stable design. Dissemination of this repair technique will also require widespread availability of adequate intraoperative imaging equipment and the mixed skill set for proper deliver. Once these issues have been addressed, a more accurate comparison of open versus endovascular treatment of thoracoabdominal aneurysms can be considered.
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Conclusions |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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Appendix E1 |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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Neurologic injury included stroke and spinal cord injury and was defined by typical findings on clinical exam and confirmation by imaging and consultation with a neurologist.
Myocardial infarction was determined by rise and fall in enzymes and associated characteristics.
Respiratory failure was defined as the need for mechanical ventilation after reintubation or tracheostomy.
Renal dysfunction was defined as a sustained increase in the serum creatinine by 30% or more, loss of renal branch patency, or the need for new onset of hemodialysis.
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Footnotes |
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References |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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Online References |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionTechnical IssuesConclusionsAppendix E1ReferencesOnline References |
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