Type Ia endoleaks after fenestrated and branched endografts may lead to component instability and increased aortic mortality.

OBJECTIVES: Fenestrated and branched endografts allow for proximal sealing zone extension into or above the visceral aorta to optimize landing in healthy aorta. We describe the incidence, causes, and implications of proximal endoleak development in patients undergoing complex endovascular aortic aneurysm repair. METHODS: All patients undergoing a fenestrated/branched repair were entered onto a prospective database, and this analysis included all those with at least one postoperative contrast computed tomography scan. Preoperative and postoperative three-dimensional imaging was reanalyzed to characterize morphology and identify endoleak. A blinded assessor used the preoperative imaging to resize the repairs in the endoleak group and a matched cohort of patients without endoleak. The outcome measures were proximal endoleak development, mortality, and component stability, and a comparison was made with all patients undergoing complex aortic repair. RESULTS: From 2001 to July 2013, 969 patients underwent repair in a physician-sponsored investigational device exemption trial. Excluded were 24 emergency patients and 21 patients without requisite imaging, leaving 924 available for analysis. A proximal type Ia endoleak developed in 26 patients (2.8%). Poor choice of landing zone was implicated in most cases, with an area of sealing in the visceral aorta, compared with the thoracic aorta, being significantly associated with endoleak development (P < .01). Aortic-related mortality was significantly higher in the endoleak group (26.9%) than in the group without endoleak (6.2%; P = .001). These patients also experienced a higher incidence of component instability of 30.8% compared with 9.6% in patients without type Ia endoleak (P < .01). CONCLUSIONS: Fenestrated/branched endovascular repair has a low incidence of sealing zone failure despite the increased complexity. However, development of a proximal endoleak destabilizes the repair and leads to increased mortality. Increasing complexity of design seems to improve the long-term outcome for patients requiring complex aortic repair.

The effect of chemotherapy for malignancy on the natural history of aortic aneurysm.

OBJECTIVE: Surgical dogma holds that chemotherapy increases the risk of aneurysm growth and rupture. We sought to determine the effect of cytotoxic chemotherapy on the growth of aortic aneurysms. METHODS: All patients undergoing chemotherapy for malignancy with coexisting aortic aneurysms at our institution between 2000 and 2011 were identified. Review of electronic medical records and rereview of serial cross-sectional imaging was performed. An additional cohort of patients undergoing aneurysm surveillance during the same period was identified, and demographic and anatomic variables were collected. Planned analysis included descriptive analysis, change in aneurysm diameter over time, and association of growth or need for intervention with type of chemotherapy and type of malignancy. RESULTS: Between 2000 and 2011, 125 patients at our institution had a concurrent diagnosis of aortic aneurysm and malignancy requiring cytotoxic chemotherapy. Cross-sectional imaging was available for 91 patients. The predominant malignancy type was lung cancer (34 of 91 [38%]), followed by lymphoma (21 of 91 [23%]) and colorectal cancer (10 of 91 [11%]). Most aneurysms were infrarenal (53 of 91 [58%]). Most patients were treated with more than one class of chemotherapeutic agent over 267 days (interquartile range [IQR], 144-469 days), and most had at least one cycle of alkylating agents (73 of 91), in addition to antimetabolites (42 of 91) and plant alkaloids/terpenoids (40 of 92). Chemotherapy regimens included steroids in 84 patients (92%). The baseline aneurysm diameter was 41.4 mm (IQR, 34.9-51.3 mm) for patients who received chemotherapeutic agents and 46.0 mm (IQR, 40-52 mm) for those who did not. Eight of the 91 patients (9%) underwent aneurysm repair during chemotherapy, but only two required urgent repair due to aneurysm rupture. The rate of aneurysm growth per year for patients who did and did not receive chemotherapy was similar at 2.3 mm vs 2.4 mm (P = .69). CONCLUSIONS: In 91 patients over 10 years at our institution, chemotherapy did not increase aneurysm growth compared with patients not undergoing treatment for malignancy.

Endovascular stent grafting for ascending aorta repair in high-risk patients.

OBJECTIVES: Standard treatment of ascending aortic pathology is open repair, but some patients are too high risk. Thoracic endovascular aortic repair (TEVAR) of the ascending aorta has been used as an alternative. Our objectives were to characterize patients, describe repair methods, and assess outcomes. METHODS: From 2006 to 2014, 22 patients underwent supracoronary ascending TEVAR for acute Type A dissection (n = 9), intramural hematoma (n = 2), pseudoaneurysm (n = 9), chronic dissection (n = 2), or aorta-cardiac fistula (n = 2). Mean age was 71 ± 13 years and the maximum proximal aortic diameter was 6 ± 1 cm. Devices were delivered via a transfemoral (n = 10), transapical (n = 7), or axillary (n = 5) artery approach. The proximal landing zone was at the sinotubular junction in 14 patients, mid to distal ascending aorta in 3 patients, and surgical graft from previous ascending repair in 5 patients. More than 1 device was used in 15 patients. Imaging and engineering analysis was performed for all patients. RESULTS: There were 3 hospital deaths (13.6%) (tamponade in 1 patient, bleed from left atrial fistula in another patient). One patient had partial occlusion of the left coronary artery requiring open conversion and died later from multiorgan failure. One patient required early open conversion for retained delivery system. There were 3 strokes, 2 myocardial infarctions, and 2 tracheostomies, but there was no new-onset renal failure. Median follow-up was 12 months. Six patients developed type 1 endoleak: 2 were treated endovascularly, 1 with open repair, 1 resolved, 1 refused treatment, and 1 is being watched. In 2 patients, initial TEVAR was performed as a bridge for ruptured high-risk dissection and were later converted to open repair. Reoperations also included removal of stent graft due to distal migration and repair of left ventricular pseudoaneurysm. There were 3 late deaths. Actual survival at 30 days, 1 year, and 5 years was 86%, 80%, and 75%, respectively. CONCLUSIONS: Ascending TEVAR is a feasible alternative to medical therapy for repair of acute and chronic ascending disease in high-risk patients. Development of devices dedicated to treat ascending aortic pathology is needed to improve outcomes.

Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms.

OBJECTIVE: This study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, Ind) for treatment of juxtarenal abdominal aortic aneurysms (AAAs). METHODS: Sixty-seven patients with juxtarenal AAAs were prospectively enrolled in 14 centers in the United States from 2005 to 2012. Custom-made fenestrated stent grafts were designed with one to three fenestrations on the basis of analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents. Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography imaging at hospital discharge and at 1 month, 6 months, and 12 months and yearly thereafter up to 5 years. RESULTS: There were 54 male and 13 female patients with a mean age of 74 ± 8 years enrolled. Mean aneurysm diameter was 60 ± 10 mm. A total of 178 visceral arteries required incorporation with small fenestrations in 118, scallops in 51, and large fenestrations in nine. Of these, all 118 small fenestrations (100%), eight of the scallops (16%), and one of the large fenestrations (11%) were aligned by stents. Technical success was 100%. There was one postoperative death within 30 days (1.5%). Mean length of hospital stay was 3.3 ± 2.1 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 37 ± 17 months (range, 3-65 months). Two patients (3%) had migration ≥ 10 mm with no endoleak, both due to cranial progression of aortic disease. Of a total of 129 renal arteries targeted by a fenestration, there were four (3%) renal artery occlusions and 12 (9%) stenoses. Fifteen patients (22%) required secondary interventions for renal artery stenosis/occlusion in 11 patients, type II endoleak in three patients, and type I endoleak in one patient. At 5 years, patient survival was 91% ± 4%, and freedom from major adverse events was 79% ± 6%; primary and secondary patency of targeted renal arteries was 81% ± 5% and 97% ± 2%, freedom from renal function deterioration was 91% ± 5%, and freedom from secondary interventions was 63% ± 9%. CONCLUSIONS: This prospective study demonstrates that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft is safe and effective. Mortality and morbidity are low in properly selected patients treated in centers with experience in these procedures.

Outcomes for supra-aortic branch vessel stenting in the treatment of thoracic aortic disease.

OBJECTIVE: Endovascular options for the treatment of proximal thoracic and arch disease have evolved over the years. In this manuscript, we review the midterm results of fenestrated compared with chimney configurations for proximal aortic aneurysm disease. METHODS: We performed an analysis of all patients with chimney grafts or custom fenestrated endografts used for treatment of proximal thoracic aneurysm disease (involving the supra-aortic trunk vessels) presenting to our institution between 2004 and 2013. Patients were identified by retrospective chart review and through the prospective database (National Institutes of Health study number NCT00583050). Details of devices placed, intraoperative details, and measurements from postoperative imaging were included in the analysis. The primary outcomes of interest were long-term freedom from branch stent complications and freedom from proximal endoleak, but we also included perioperative events, in-hospital mortality, and requirement for secondary interventions in our review. The log-rank test (Mantel-Cox) was used to compare survival data. Student t-test (two tailed) and Fisher exact test (two tailed) were used for continuous and categorical data, respectively. RESULTS: Of 767 patients who underwent thoracic endovascular repair from January 2004 to February 2013, 33 satisfied the inclusion criteria (4%): 18 of 33 noncustom and 15 of 33 custom graft designs. Overall, the rate of technical success was 97%. There were four branch stent-related problems in the follow-up period, one of 15 (7%) in the custom group and three of 18 (17%) in the noncustom group. There were three proximal sealing failures in the immediate postoperative and follow-up period, one of 15 (7%) in the custom group and two of 18 (11%) in the noncustom group. Overall, 10 patients underwent secondary procedures, four of 15 (27%) in the custom group and six of 18 (33%) in the noncustom group. CONCLUSIONS: Although they are technically feasible, both custom fenestrated endografts and chimney repairs for proximal thoracic disease involving the supra-aortic trunk vessels suffer from failures in intermediate follow-up, with a trend toward better long-term outcomes for custom devices. More work is needed to develop durable devices for this anatomic territory in the future.

Global experience with an inner branched arch endograft.

BACKGROUND: Branched endografts are a new option to treat arch aneurysm in high-risk patients. METHODS AND RESULTS: We performed a retrospective multicenter analysis of all patients with arch aneurysms treated with a new branched endograft designed with 2 inner branches to perfuse the supra aortic trunks. Thirty-eight patients were included. The median age was 71 years (range, 64-74 years). An American Society of Anesthesiologists score of 3 or 4 was reported in 89.5% (95% confidence interval [CI], 79.7-99.3) of patients. The 30-day mortality rate was 13.2% (95% CI, 2.2-24.2). Technical success was obtained in 32 patients (84.2% [95% CI, 72.4-95.9]). Early secondary procedures were performed in 4 patients (10.5% [95% CI, 0.7-20.3]). Early cerebrovascular complications were diagnosed in 6 patients (15.8% [95% CI, 4.0-27.6]), including 4 transient ischemic attacks, 1 stroke, and 1 subarachnoid hemorrhage. The median follow-up was 12 months (range, 6-12 months). During follow-up, no aneurysm-related death was detected. Secondary procedures during follow-up were performed in 3 patients (9.1% [95% CI, 0.0-19.1]), including 1 conversion to open surgery. We compared the first 10 patients (early experience group) with the subsequent 28 patients. Intraoperative complications and secondary procedures were significantly higher in the early experience group. Although not statistically significant, the early mortality was higher in the early experience group (30% [95% CI, 0.0-60.0]) versus the remainder (7.1% [95% CI, 0.0-16.9]; P=.066). Being part of the early experience group and ascending aortic diameter≥38 mm were found to be associated to higher rates of combined early mortality and neurologic complications. CONCLUSIONS: Our preliminary study confirms the feasibility and safety of the endovascular repair of arch aneurysms in selected patients who may not have other conventional options. CLINICAL TRIAL REGISTRATION INFORMATION: Thoracic IDE NCT00583817, FDA IDE# 000101.

Late rescue of proximal endograft failure using fenestrated and branched devices.

OBJECTIVE: Endovascular aneurysm repair (EVAR) will fail over time in a percentage of patients. Mechanical failure of the device, progression of aortic disease, or interface complications between the device and the native vasculature may contribute. Our aim was to evaluate the role of fenestrated and branched endografts as treatment options for failed devices. METHODS: Between January 2001 and June 2013, 970 patients were enrolled into a physician-sponsored investigational device exemption (PSIDE) study and treated with a fenestrated/branched endograft. All patients treated for nonurgent proximal neck failure of an infrarenal endoprosthesis previously implanted during EVAR comprised the study group. Patients treated for a primary aneurysm within the PSIDE were evaluated as a comparison group to identify preoperative risk factors for failure. A retrospective review was undertaken to determine the details of the initial EVAR, whereas the prospective PSIDE database was used to assess outcomes of secondary treatment. Three-dimensional imaging techniques were used to define all morphologic measurements. Statistical analysis included comparisons between categoric variables with the χ(2) test and between continuous variables with the Wilcoxon rank sum test between patients with late failures and those with native aortic repair. Kaplan-Meier curves were used to analyze overall survival. RESULTS: Of 970 patients enrolled in the PSIDE, 54 (5.6%) had late failure of a prior endograft. Fenestrated/branched devices were used to address the failure in each patient. The etiology of failure was related to a proximal neck issue in all patients: type Ia endoleak in 38, stent migration in 18, neck degeneration in 28, or some combination of these factors. The endovascular rescue procedure took place a mean of 61 months after the primary procedure. The mean aneurysm diameter at reintervention was 67 mm. Patients requiring a secondary fenestrated procedure were younger at the time of their primary intervention (P = .039) and were more likely to have a history of chronic renal insufficiency (P = .05) compared with other patients in the PSIDE. Technical success rate in the study group was 85% (44 of 52). Successful stenting was achieved in 71 of 77 (92%) target vessels. Thirty-day mortality was 3.8% (two of 52). Fluoroscopy dose and operating time were longer in the rescue group (P = .07) than in the control group (P = .008). Secondary interventions were required in 36.5% (19 of 52) of patients. CONCLUSIONS: Our series demonstrates the risk for late failure after EVAR is greater in patients who are younger and have chronic renal impairment at the time of implantation. Branched and fenestrated repair after failed EVAR is more complex than repair in the native aorta. More research is needed to identify patients at higher risk of failure after EVAR to prevent the need for rescue in the future.

Open aortic repair after prior thoracic endovascular aortic repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has been applied to increasingly complex aortic pathology, resulting in an increase in late complications. We characterized patients undergoing open repair after prior TEVAR including indications, operative techniques, and outcomes. METHODS: Chart review and query of a prospectively collected database identified 50 patients who underwent thoracic aortic operation after prior TEVAR. Active follow-up was supplemented by Social Security information for vital status. RESULTS: From July 2001 to January 2012 open arch (n = 25), descending (n = 6), thoracoabdominal (n = 17), or extra-anatomic bypass (n = 2) operations were performed after previous TEVAR (median interval from TEVAR to open surgical procedure: 13.9 months; interquartile range, 0.5 to 24 months). Indications for open operation included type 1 endoleaks (n = 19), retrograde aortic dissection (n = 9), chronic aortic dissection with persistent growth of the false lumen (n = 16), and graft infection (n = 6). Sixty percent had prior cardiovascular surgical procedures and 18% were done as emergencies. Circulatory support was required in 78% and hypothermic arrest in 48%. Hospital mortality occurred in 3 (6%) patients with no strokes and 1 patient with myocardial infarction; 5 (10%) patients required tracheostomy and 1 required dialysis. Survival was 67% at a median follow-up of 2.9 years. CONCLUSIONS: Conversion to open repair after thoracic stent-grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent-graft in most cases. Late outcomes are consistent with the chronic disease state of these patients.

Hypogastric and subclavian artery patency affects onset and recovery of spinal cord ischemia associated with aortic endografting.

OBJECTIVE: Spinal cord ischemia (SCI) is a devastating complication associated with aortic aneurysm repair. The aim of the current study was to evaluate factors affecting outcomes from SCI associated with endovascular aortic aneurysm repair. METHODS: A total of 1251 patients underwent endovascular repair of aortic aneurysm as part of a device trial between 1998 and 2010 utilizing endovascular abdominal aortic aneurysm repair (n = 351), thoracic endovascular aortic aneurysm repair (n = 201), fenestrated endovascular aortic aneurysm repair (n = 227), and visceral branched endografts (n = 472). Records and imaging studies were reviewed to supplement prospective outcome data. Demographics, type of repair, collateral bed (hypogastric/subclavian) patency, clinical presentation, and outcomes were evaluated on patients with SCI. Survival was calculated using life-table analysis. RESULTS: SCI occurred in 2.8% (n = 36) of patients: abdominal aortic aneurysm, 0.3%, juxtarenal, 0.4%, thoracic aortic aneurysm, 4.6%, and thoracoabdominal aortic aneurysm, 4.8%). Four (11%) required carotid-subclavian bypass prior to endografting, and two underwent coverage of the left subclavian artery. Unilateral hypogastric artery occlusion was present in 11 (31%) patients prior to endograft placement, and three had bilateral occlusions. An additional seven patients had occlusion of at least one hypogastric artery during surgery. SCI was apparent immediately in 15 (42%) patients. Immediate onset of symptoms was observed in 73% of patients with at least one occluded collateral bed but in only 24% of those with patent collateral beds (P = .021). Of those presenting in a delayed fashion, nine (43%) had a clear precipitating event prior to onset of SCI (hypotension, n = 6, and segmental artery drain removal, n = 3). Recovery occurred in 24 (67%) patients, most within 7 days. Immediate presentation was a negative predictor of recovery (P = .025), as was occlusion of at least one collateral bed (P = .035). Mean follow-up was 22 ± 4 months with 30-day and 1-year survival of 92 ± 4.6% and 56 ± 8.3%. Survival was only 36% at 3 months in those with permanent SCI compared with 92% (P < .001) in those with temporary symptoms. CONCLUSIONS: SCI continues to complicate aortic surgery despite the advent of endovascular therapy. Occlusion of a single collateral bed is associated with an increased risk for immediate onset of SCI and lack of recovery. These factors are harbingers of poor outcomes and increased short-term mortality. This may be prevented by preserving collateral bed patency in patients undergoing extensive endovascular procedures.

Endovascular versus open elephant trunk completion for extensive aortic disease.

OBJECTIVES: To compare the outcomes between patients undergoing endovascular (EEC) or open (OEC) approaches to second-stage elephant trunk completion (EC). METHODS: From 1993 to 2010, 225 patients underwent second-stage EC (EEC, n = 92; OEC, n = 133). Propensity matching was performed for a fair comparison. RESULTS: The EEC patients were older, more likely to have atrial fibrillation, and had a smaller proximal aorta. The 30-day mortality was 6.2% (6.5% EEC vs 6% OEC, P = .88). No difference was found in bleeding (8.8%), stroke (3%), renal failure (4%), or spinal cord injury (4%); however, the OEC patients required tracheostomy more often (10 vs 1, P = .014). Survival after second-stage EC at 6 months and 1 and 5 years was 91%, 90%, and 77%, respectively. Survival and major morbidity did not differ after matching (44 pairs). However, the EEC group had shorter stays (9.9 ± 13 vs 13 ± 9 days, P < .0001) and received less blood (3 ± 8 vs 6 ± 8 U, P = .0001) than did the OEC group. This was maintained after matching. During follow-up, 32 endoleaks (3 type I, 27 type II, 2 type III) occurred; 26 (28%) EEC and 13 of 76 (17%) OEC patients underwent reoperation. The approach was not related to the risk of death in either hazard phase, but a larger descending diameter predicted a greater risk in the early phase. CONCLUSIONS: Death and complications occur similarly after OEC or EEC. The early toll might be greater after OEC, at the cost of reintervention for EEC. EEC expands the options to older patients and allows for earlier completion. Second-stage repair should not be delayed, and all patients require lifelong imaging surveillance.

Radiation exposure to operating room personnel and patients during endovascular procedures.

OBJECTIVE: To characterize radiation exposure to patients and operating room personnel during fluoroscopic procedures. METHODS: Patient dose information was collected from the imaging equipment. Real-time dosimetry was used to measure doses to the operators, scrub nurse, radiologic technologist (RT), and anesthesiologist in 39 cases of endovascular thoracoabdominal aortic aneurysm repair using fenestrated endografts. Overall equivalent doses and dose rates at time points of interest were noted and compared with the corresponding patient doses. RESULTS: The dosimeter on the anesthesia equipment received 143 µSv (38-247) more radiation per case than the average operator, and the scrub nurse and RT received 106 µSv (66-146) and 100 µSv (55-145) less, respectively. Adjusting for protective lead aprons by the Webster methodology, the average operator received an effective dose of 38 µSv. Except for the RT, personnel doses were well correlated with patient dose as measured by kerma area product (KAP) (r = .82 for average operator, r = .85 for scrub nurse, and r = .86 for anesthesia; all P < .001) but less well correlated with fluoroscopy time or cumulative air kerma (CAK). When preoperative cone beam computed tomography was performed, the equivalent dose to the RT was 1.1 µSv (0.6-1.5) when using shielding and 37 µSv (22-53) when unshielded. Digital subtraction acquisitions accounted for a large fraction of all individuals' doses. Decreasing field size (and thus, increasing magnification) was associated with decreased KAP (r = .47; P < .001) and increased CAK (r = -.56; P < .001). The square of the field size correlated strongly with the KAP/CAK ratio (r = .99; P < .001). Increased lateral angulation of the C-arm increased both CAK and KAP (at field size, 22 cm; r = .54 and r = .44; both P < .001) and the average dose rate to an operator was 1.78 (1.37-2.31) times as high in a lateral projection as in a posterior-anterior projection. CONCLUSIONS: Personnel doses were best correlated with KAP and less well correlated with fluoroscopy time or CAK. The dosimeter on the anesthesia equipment recorded the highest doses attributable to ineffective shielding. Operators can reduce the effective dose to themselves, the patient, and other personnel by minimizing the use of digital subtraction acquisitions, avoiding lateral angulation, using higher magnification levels when possible, and being diligent about the use of shielding during fluoroscopy cases.

Family history of aortic disease predicts disease patterns and progression and is a significant influence on management strategies for patients and their relatives.

BACKGROUND: While a positive family history (FH) is a known risk factor for developing an aneurysm, its association with the extent of disease has not been established. We evaluated the influence of a FH of aortic disease with respect to the pattern and distribution of aortic aneurysms in a given patient. METHODS AND RESULTS: From November 1999 to November 2011, 1263 patients were enrolled in physician-sponsored endovascular device trials to treat aortic aneurysms. Of the 555 patients who were alive and returning for follow-up, we obtained 426 (77%) family histories. Three-dimensional imaging studies were used to identify the presence of aneurysms; 36% (155/426) of patients had a FH of aortic aneurysms and 5% (21/155) had isolated intracranial aneurysms. A logistic regression model was used to compare aortic morphology between patients with a positive or negative FH for aneurysms. Patients with a positive FH of aortic aneurysms were younger at their initial aneurysm (63 vs 70 years; P < .0001), more frequently had proximal aortic involvement (root: odds ratio [OR], 5.4; P < .0001; ascending: OR, 2.9; P < .001; thoracic: OR, 2.2; P = .01) with over 50% of FH patients ultimately developing suprarenal aortic involvement (P = .0001) and had a greater incidence of bilateral iliac artery aneurysm (OR, 1.8; P = .03). CONCLUSIONS: FH is an important tool that provides insight into the expected behavior of the untreated aorta and has significant implications for the development of treatment strategies. These findings should be used to guide patient's management with regard to treatment, follow-up paradigms, genetic testing, and screening of other family members.

Endovascular repair of aortoiliac aneurysmal disease with the helical iliac bifurcation device and the bifurcated-bifurcated iliac bifurcation device.

BACKGROUND: Iliac branch device (IBD) treatment of common and internal iliac artery (CIA and IIA) aneurysms has been controversial in the context of available embolization techniques or off-label adjunctive procedures. Two devices exist, a straight IBD (S-IBD) and a helical IBD (H-IBD). We report our midterm results with the latter and present outcomes with a third device intended to treat disease in the presence of short CIAs termed the bifurcated-bifurcated IBD (BB-IBD). METHODS: Data were prospectively collected from IBD-treated patients with infrarenal aortoiliac or thoracoabdominal aortoiliac aneurysms. Preoperative aneurysmal characteristics were collected in accordance with the endovascular reporting standards document, including presence of IIA stenosis, CIA diameters, and the presence of an IIA aneurysm. Technical success was defined as IBD device placement, branch placement, and patency without type I or III endoleak at implantation in addition to 24 hours survival. Follow-up computed tomography scans at 1, 6 (optional), 12 months, and annually thereafter were performed and reinterventions, sac morphology changes, and endoleaks noted. Survival and patency were evaluated with life-table analyses, and differences among anatomic groups were compared with log-rank tests, whereas t-tests and Fisher exact tests were used to compare simple variables. RESULTS: Between 2003 and 2012, 138 IBD devices were placed into 130 patients (98 H-IBD and 40 BB-IBD). Median follow-up was 20.3 months (range, 1-72 months) with 30- day, 12-month, 3- and 5-year survival rates of 99%, 90%, 79%, and 62%, respectively. Technical success was 94%, and branch patency was 94.6% at 30 days and 81.8% at 5 years. Thirty-five percent (35%) of branches were placed into patients with IIA aneurysms (in addition to their proximal disease), 20% into stenotic IIAs, and 46% into iliac systems with narrow (<16 mm) CIAs. Technical success was significantly lower in patients with IIA stenosis (81.5 vs 96.4%; Fisher exact test, P = .015) but not affected by the presence of an IIA aneurysm or narrow CIA. Branch patency was similar in all groups throughout follow-up. No stent fractures or component separations were noted in the IBDs or mating devices throughout the study period. CONCLUSIONS: The H-IBD and BB-IBD configurations have high technical success and acceptable long-term patency for the treatment of CIA and IIA aneurysms, including those with challenging anatomy difficult to treat with the straight branch design.

Fenestrated and branched endovascular aortic repair for chronic type B aortic dissection with thoracoabdominal aneurysms.

OBJECTIVE: The treatment of patients with arch and thoracoabdominal aortic aneurysms (TAAAs) and chronic dissections is challenging. We report the results of fenestrated and branched endovascular aortic repair (FEVAR) of such aneurysms. METHODS: A single-center prospective FEVAR trial enrolled 356 patients (2006 to 2011), of whom 30 had chronic dissections with arch aneurysm or TAAAs, or both. Patients were divided into group A, 15 patients (mean age, 58 years) with extensive dissections extending from the arch through the visceral segment, and group B, 15 patients (mean age, 74 years old) with focal dissections and no extension into the thoracic aorta. Inclusion criterion was aneurysm size >5.5 cm in diameter. Customized grafts were implanted into the true lumen, and branches were extended into the true lumen of the supra-aortic trunk (arch branch devices) and visceral vessels. Patients were monitored annually with clinical, imaging, and laboratory studies. Outcome analyses included survival, rupture, spinal cord ischemia, endoleak, morbidity (cardiac, renal or pulmonary), reinterventions, dissection, and aneurysm growth. RESULTS: The mean time from the onset of dissection to the FEVAR performed in group A was 10.4 years. The mean maximum aneurysm diameter was 60 mm. Follow-up averaged 1.7 years. There were no perioperative deaths. One aortic-related death occurred at 87 days due to progression of a pre-existing untreated arch dissection. No ruptures, cardiac, renal, pulmonary, or spinal cord ischemia complications occurred. Despite the initially narrow true lumen dimensions, stent grafts expanded to their nominal diameters after implantation without any blood flow disturbance of branched visceral vessels and distal aorta. No graft compression occurred. Post-FEVAR growth was noted in two patients, related to type II endoleaks. Sac regression was similar (-6.8 vs -11.4 mm; P = .43), but early endovascular reinterventions were more common in group A (8 patients). Patients with extensive dissection were younger, and the dissection more likely to be associated with a defined connective tissue disease (Marfan syndrome or Loeys-Dietz mutations, 40% vs 0%; P = .006). CONCLUSIONS: FEVAR is feasible for patients with chronic dissections and TAAA. Concerns regarding visceral vessel access and graft compression resulting from narrow true lumen diameters were not relevant in our experience. Favorable sac and lumen morphologic changes, coupled with a low mortality and complication risk, makes this an attractive means of handling this clinical problem.

Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms.

OBJECTIVE: This article reports the early clinical outcomes and experiences of Zenith pivot branch device (p-branch) standard fenestrated endovascular graft (Cook, Bloomington, Ind) for treating juxtarenal abdominal aortic aneurysm (AAA) originating below the superior mesenteric artery (SMA). METHODS: A physician-sponsored investigational device exemption study was used to assess enrolled elective and emergency patients from August 2011 to September 2012 for treatment with an off-the-shelf Zenith p-branch device. Patients were included provided an anatomic seal could be established 4 mm below the SMA and the renal geometry fit the protocol based on reconstructed computed tomography data. The celiac artery was addressed with a scallop and the SMA with an 8-mm fenestration. The renal fenestrations were constructed as a modified design to allow a range of renal locations (7.5 mm radially from the center of the fenestration) to be acceptably treated with a single configuration. Two anatomic configurations were created for renal arteries (origins at the same level, or disparate renal arteries with left lower than right). Outcomes are reported in coherence with endovascular reporting standards documents. RESULTS: The study enrolled 16 patients (94% men; median age, 75 years [range, 59-87 years]) with a mean aneurysm size of 61 mm (range, 52-82 mm). Two were treated for aneurysm rupture. Technical success was achieved in all patients. The median fluoroscopy time was 62 minutes (range, 38-105 minutes), and the amount of contrast media was 69 mL (range, 31-121 mL). There were no aortic-related deaths, aneurysm ruptures, open surgical conversion, or type I/III endoleaks. One right renal artery occluded during follow-up in the setting of a conically shaped visceral aortic segment and was successfully treated with endovascular recanalization. CONCLUSIONS: The use of the p-branch device for aneurysms originating infra-SMA is associated with a high rate of technical success and minimal problems during the short follow-up duration. The off-the-shelf design allows for the treatment of ruptures and other urgent situations. Additional patients and more follow-up will be required to further define the risks and benefits of such a treatment strategy.

Durability of branches in branched and fenestrated endografts.

OBJECTIVE: Branched and fenestrated repair has been shown to be effective for treatment of complex aortic aneurysms. However, the long-term durability of branches is not well reported. METHODS: Prospective data collected for all patients enrolled in a physician-sponsored investigational device exemption trial for branched and fenestrated endografts were analyzed. Retrospective review of imaging studies and electronic records was used to supplement the dataset. Incidences of branch stent secondary intervention, stent fracture, migration, branch-related rupture, and death were calculated. A time-to-event analysis was performed for secondary intervention for any branch. Univariable and multivariable analyses were performed to identify related variables. Branch instability, a composite outcome of any branch event, was reported as a function of exponential decay to capture the loss of freedom from complications over time. RESULTS: Between the years 2001 and 2010, 650 patients underwent endovascular aortic repair with branched or fenestrated devices. Over 9 years of follow-up (mean [standard deviation], 3 [2.3] years), secondary procedures were performed for 0.6% of celiac, 4% of superior mesenteric artery (SMA), 6% of right renal artery, and 5% of left renal artery stents. Mean time to reintervention was 237 (354) days. The 30-day, 1-year, and 5-year freedom from branch intervention was 98% (95% confidence interval [CI], 96%-99%), 94% (95% CI, 92%-96%), and 84% (95% CI, 78%-90%), respectively. Death from branch stent complications occurred in three patients, two related to SMA thrombosis and one due to an unstented SMA scallop. Multivariable analysis revealed no factors as independent predictors of need for branch reintervention. CONCLUSIONS: Branches, after branched or fenestrated aortic repair, appear to be durable and are rarely the cause of patient death. The absence of long-term data on branch patency in open repair precludes comparison, yet the lower morbidity and mortality risk coupled with longer-term durability data will further alter the balance of repair options.

Treatment of a patient with vertebral and subclavian aneurysms in the setting of a TGFBR2 mutation.

We present the case of a patient diagnosed with hypermobile Ehlers-Danlos syndrome with aneurysms of the subclavian and vertebral arteries. Molecular testing demonstrated transforming growth factor-beta receptor type 2 mutation. She was not a candidate for an open repair; therefore, a hybrid approach involving right vertebral ligation and bypass from the right common carotid to the vertebral C1-2 interface, endovascular exclusion of the left vertebral artery, and stent grafting of the left subclavian/axillary artery was used. The left vertebral embolization proved ineffective, requiring a right-to-left vertebral catheterization with glue occlusion. Based on her proper molecular diagnosis, she underwent prophylactic root and ascending aortic repair.

Patients with chronic obstructive pulmonary disease have shorter survival but superior endovascular outcomes after endovascular aneurysm repair.

OBJECTIVE: This study determined the effect of pulmonary disease on outcomes after endovascular abdominal (EVAR) and endovascular thoracoabdominal aortic aneurysm (eTAAA) repair. METHODS: A prospective study of high-risk patients undergoing EVAR and eTAAA repair between 1998 and 2009 was used to contrast clinical and endovascular outcomes between patients with (group 1) and without (group 2) chronic obstructive pulmonary disease (COPD). COPD patients were classified in accordance with the severity of their pulmonary disease using the Global Initiative for Chronic Obstructive Lung Disease criteria. Survival, morphologic changes, and complications were assessed using Cox models and life-table analyses. The cause and timing of deaths between the groups was compared. RESULTS: Of 905 patients analyzed, 289 (32%) had COPD (group 1) and the remaining patients (group 2) did not have COPD. EVAR was performed in 334 patients (37%), and fenestrated or branched devices were used in the remaining 571 (63%). Group 1 patients were younger (73.5 ± 6.7 vs 75.6 ± 8.2 years), had a better glomerular filtration rate (67.8 ± 25.8 vs 61.0 ± 23.3 mL/min/1.73 m(2)), had higher hematocrits (41.6 ± 5.0 vs 40.5 ± 4.6), and had more extensive aneurysms. Mean follow-up was 39.5 ± 30.9 months. Early (3% vs 3%) and late (2% vs 1%) aneurysm-related deaths were similar between the two groups. Survival in group 1 depended on the severity of disease. Survival in patients with Global Initiative for Chronic Obstructive Lung Disease classification I and II was similar to group 2. Those with classifications III and IV demonstrated lower survival rates. Relevant pulmonary function test variables included a lower forced expiratory volume in 1 second and forced expiratory flow in the middle 50%, which were associated with decreased survival. Surrogate endovascular outcome analyses demonstrated that group 1 patients had fewer endoleaks (20% vs 25%; P = .05) and more rapid sac shrinkage rate (1.66 mm/y difference; P < .001). CONCLUSIONS: The perioperative risk of death between COPD patients and non-COPD patients is eliminated when endovascular techniques are used. Long-term survival in COPD patients is most strongly related to the severity of their disease, and forced expiratory volume in 1 second and forced expiratory flow in the middle 50% are reasonable indicators of poor long-term outcomes. Morphologic changes after EVAR and eTAAA repair are more favorable in COPD patients, with a lower endoleak rate and faster sac shrinkage.

Open, hybrid, and endovascular treatment for aortic coarctation and postrepair aneurysm in adolescents and adults.

BACKGROUND: Open, hybrid, and endovascular procedures are used for grown-up patients with aortic coarctation and complications after repair, an expanding population. We sought to characterize patients and procedures, assess early and late outcomes, and describe indications to guide treatment of these complex patients. METHODS: Between May 1999 and January 2011, 110 patients underwent open (n=40), hybrid (n=11), or endovascular (n=59) repair of coarctation (n=43), recurrent aortic coarctation (n=42), or postrepair aneurysm (n=25). Mean age was 38±14 years. Sixty-eight had previous repairs (median 27 years earlier; range, 1 to 50). Twenty-two had prior cardiovascular operations other than coarctation and 50% had bicuspid valve. Fifty-nine concomitant procedures were performed in 45 patients (40%). Data were from the prospective database, chart review, and Social Security Death Index. RESULTS: Technical success was achieved in 100%, with no hospital deaths, no strokes, and no paraplegia. Complications were uncommon and included respiratory failure (n=2, 1.8%), and temporary renal failure (n=2, 1.8%). Twenty-two patients required reinterventions, but half of those were planned. There was no difference in occurrence of unplanned reintervention between approaches (endovascular 12%, hybrid 18%, open 12.5%). Length of stay was 4.8±4.8 days. Transcoarct gradient fell from 37.6±18 mm Hg preoperatively to 7.0±6.9 mm Hg in coarctation patients. Postrepair aneurysm patients had no late ruptures, and maximum diameter shrunk from 5.9±1.3 cm preoperatively to 4.8±1.3 cm. Estimated survival at 1, 5, and 8 years was 95%, 95%, and 90%, respectively. CONCLUSIONS: Coarctation, recurrent coarctation, and postrepair aneurysm/pseudoaneurysm in adolescent and adult patients can be safely and effectively managed with open, hybrid, or endovascular techniques. Optimal results are achievable in this complex population of patients with a multimodality approach tailored to surgical indication and anatomy. All survivors of coarctation repair require lifelong surveillance.

Open repair of chronic distal aortic dissection in the endovascular era: Implications for disease management.

OBJECTIVE: Controversy surrounds the treatment of chronic aortic dissection. Open surgical and endovascular experiences include mixed populations treated with evolving strategies and limited follow-up. We establish a standard against which endovascular repair can be compared by assessing outcomes after open repair of chronic distal aortic dissections anatomically suitable to stent-grafting. METHODS: From 2000 to 2008, 169 patients underwent open repair of the descending thoracic artery only (n = 88) or thoracoabdominal (n = 81) chronic aortic dissection (elective in 98, urgent/emergency in 71). Chart review and 3-dimensional assessment of computed tomography were performed. Poor outcome included all-cause mortality or vascular reintervention. RESULTS: Thirty-day mortality was 8% (n = 14). Serious complications included neurologic (n = 12 [spinal cord n = 4, 2.4%]), respiratory (n = 32), and renal failure (n = 1 descending thoracic artery only vs 17 thoracoabdominal, P < .001). Chronic obstructive pulmonary disease predicted early mortality (hazard ratio 8.0, P = .005). Survival at 1, 2, and 5 years was 76%, 69%, and 55%, respectively; 23 patients (14%) required reintervention. Event-free survival at 5 years was 51% and 47% after descending thoracic artery only or thoracoabdominal repair, respectively. Greater maximum aortic diameter (hazard ratio 1.9, P = .03) and greater diameter at the diaphragm (hazard ratio 3.7, P = .01) or renal segment (hazard ratio 4.3, P = .03) predicted poor outcome. CONCLUSIONS: Early outcomes are good and late outcomes are less than desirable after open repair of chronic distal aortic dissection, regardless of the extent of repair. High-risk and late-stage patients with larger and more extensive aneurysmal degeneration warrant further investigation, including the use of newer, less-invasive techniques. Select patients at risk for aneurysmal degeneration should undergo a more aggressive initial approach with aortic dissection repair.