Hypogastric artery bypass to preserve pelvic circulation: improved outcome after endovascular abdominal aortic aneurysm repair

AbstractObjectiveThis study was carried out to compare the functional outcomes after hypogastric artery bypass and coil embolization for management of common iliac artery aneurysms in the endovascular repair of aortoiliac aneurysms (EVAR).MethodsBetween 1996 and 2002, 265 patients underwent elective or emergent EVAR. Data were retrospectively reviewed for 21 (8%) patients with iliac artery aneurysms 25 mm or larger that involved the iliac bifurcation. Patients underwent hypogastric artery bypass (n = 9) or coil embolization (n = 12). Interviews about past and current levels of activity were conducted. A disability score (DS) was quantitatively graded on a discrete scale ranging from 0 to 10, corresponding to “virtually bed-bound” to exercise tolerance “greater than a mile.” Worsening or improvement of symptoms was expressed as a difference in DS between two time points (-, worsening; +, improvement).ResultsThere was no difference in age (72.6 ± 7.3 years vs 73.1 ± 6.4 years), sex (male-female ratio, 8:1 vs 11:1), abdominal aortic aneurysm size (60.1 ± 5.9 mm vs 59.3 ± 7.0 mm), or number of preoperative comorbid conditions (1.9 ± 0.8 vs 2.1 ± 0.8) between hypogastric bypass and coil embolization groups, respectively. Mean follow-up was shorter after hypogastric bypass (14.8 vs 20.5 months; P < .05). There was no difference in the mean overall baseline DS between the bypass and the embolization groups (8.0 vs 7.8). Six (50%) of the 12 patients with coil embolization reported symptoms of buttock claudication ipsilateral to the occluded hypogastric artery. No symptoms of buttock claudication were reported after hypogastric bypass (P < .05). There was a decrease in the DS after both procedures; however, coil embolization was associated with a significantly worse DS compared with hypogastric artery bypass (4.5 vs 7.3; P < .001). In 4 (67%) of 6 patients with claudication after coil embolization symptoms improved, with a DS of 5.4 at last follow-up. This was significantly worse than in patients undergoing hypogastric artery bypass, with a DS of 7.8 at last follow-up (P < .001). There was no difference between the groups in duration of procedure, blood loss, length of hospital stay, morbidity, or mortality (0%).ConclusionsHypogastric artery bypass to preserve pelvic circulation is safe, and significantly decreases the risk for buttock claudication. Preservation of pelvic circulation results in significant improvement in the ambulatory status of patients with common iliac artery aneurysms, compared with coil embolization

Defining the type of surgeon volume that influences the outcomes for open abdominal aortic aneurysm repair

ObjectivePrior studies have reported improved clinical outcomes with higher surgeon volume, which is assumed to be a product of the surgeon's experience with the index operation. We hypothesized that composite surgeon volume is an important determinant of outcome. We tested this hypothesis by comparing the impact of operation-specific surgeon volume versus composite surgeon volume on surgical outcomes, using open abdominal aortic aneurysm (AAA) repair as the index operation.MethodsThe Nationwide Inpatient Sample was analyzed to identify patients undergoing open AAA repairs for 2000 to 2008. Surgeons were stratified into deciles based on annual volume of open AAA repairs (“operation-specific volume”) and overall volume of open vascular operations (“composite volume”). Composite volume was defined by the sum of several open vascular operations: carotid endarterectomy, aortobifemoral bypass, femoral-popliteal bypass, and femoral-tibial bypass. Multiple logistic regression analyses were used to examine the relationship between surgeon volume and in-hospital mortality for open AAA repair, adjusting for both patient and hospital characteristics.ResultsBetween 2000 and 2008, an estimated 111,533 (95% confidence interval [CI], 102,296-121,232) elective open AAA repairs were performed nationwide by 6,857 surgeons. The crude in-hospital mortality rate over the study period was 6.1% (95% CI, 5.6%-6.5%). The mean number of open AAA repairs performed annually was 2.4 operations per surgeon. The mean composite volume was 5.3 operations annually. As expected, in-hospital mortality for open AAA repair decreased with increasing volume of open AAA repairs performed by a surgeon. Mortality rates for the lowest and highest deciles of surgeon volume were 10.2% and 4.5%, respectively (P < .0001). A similar pattern was observed for composite surgeon volume, as the mortality rates for the lowest and highest deciles of composite volume were 9.8% and 4.8%, respectively (P < .0001). After adjusting for patient and hospital characteristics, increasing composite surgeon volume remained a significant predictor of lower in-hospital mortality for open AAA repair (odds ratio, 0.994; 95% CI, .992-.996; P < .0001), whereas increasing volume of AAA repairs per surgeon did not predict in-hospital deaths.ConclusionsThe current study suggests that composite surgeon volume—not operation-specific volume—is a key determinant of in-hospital mortality for open AAA repair. This finding needs to be considered for future credentialing of surgeons

Explant analysis of AneuRx stent grafts: relationship between structural findings and clinical outcome

AbstractObjectiveWe reviewed the structural findings of explanted AneuRx stent grafts used to treat abdominal aortic aneurysms, and relate the findings to clinical outcome measures.MethodsWe reviewed data for all bifurcated AneuRx stent grafts explanted at surgery or autopsy and returned to the manufacturer from the US clinical trial and worldwide experience of more than 33,000 implants from 1996 to 2003. Devices implanted for more than 1 month with structural analysis are included in this article. Explant results were analyzed in relation to cause of explantation and pre-explant evidence of endoleak, enlargement, or device migration.ResultsOne hundred twenty explanted stent grafts, including 37 from the US clinical trial, were analyzed. Mean implant duration was 22 ± 13 months (range, 1-61 months). Structural abnormalities included stent fatigue fractures, fabric abrasion holes, and suture breaks. The mean number of nitinol stent strut fractures per explanted device was 3 ± 4, which represents less than 0.2% of the total number of stent struts in each device. The mean number of fabric holes per explanted device was 2 ± 3, with a median hole size of 0.5 mm2. Suture breaks were seen in most explanted devices, but composed less than 1.5% of the total number of sutures per device. “For cause” explants (n = 104) had a 10-month longer implant duration (P = .007) compared with “incidental” explants (n = 16). “For cause” explants had more fractures (3 ± 5; P = .005) and fabric holes (2 ± 3; P = .008) per device compared with “incidental” explants, but these differences were not significant (P = .3) when adjusted for duration of device implantation. Among clinical trial explants the number of fabric holes in grafts in patients with endoleak (2 ± 3 per device) was no different from those without endoleak (3 ± 4 per device; P = NS). The number of fatigue fractures or fabric holes was no different in grafts in clinical trial patients with pre-explant aneurysm enlargement compared with those without enlargement. Pre-explant stent-graft migration was associated with a greater number of stent strut fractures (5 ± 7 per device; P = .04) and fabric holes (3 ± 3 per bifurcation; P = .03) compared with explants without migration. Serial imaging studies revealed inadequate proximal, distal, or junctional device fixation as the probable cause of rupture or need for conversion to open surgery in 86% of “for cause” explants. Structural device abnormalities were usually remote from fixation sites, and no causal relationship between device findings and clinical outcome could be established.ConclusionsNitinol stent fatigue fractures, fabric holes, and suture breaks found in explanted AneuRx stent grafts do not appear to be related to clinical outcome measures. Longer term studies are needed to confirm these observations

pivotal results for the valiant navion stent graft system in the valiant evo global clinical trial

Abstract Objective The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented. Methods The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a major device effect (MDE), including device-related secondary procedures, device-related mortality, conversion to open surgery, or thoracic aortic aneurysm rupture within 30 days of the index procedure. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported. Results Of the 87 consecutive patients undergoing thoracic endovascular aneurysm repair who were enrolled, 33 (37.9%) were female with 61 (70.9%) presenting with severe access artery tortuosity and 66 (85.7%) with high thoracic aortic tortuosity per core laboratory evaluation. The mean procedure duration was 88.7 ± 53.4 minutes and geographical differences existed such as percutaneous access (37/52 [71.2%]) in the United States and surgical cut down in the outside of the U.S. sites (28/35 [80.0%]). There were no access or deployment failures and only 2.3% of the patients (2/87; P Conclusions Access/deployment failures, MDEs, and endoleaks were rare in the first 30 days of the Valiant Evo clinical trial. The Valiant Navion thoracic stent graft system has shown encouraging 30-day results in this challenging cohort and trial patients will continue to be followed through 5 years

Intravascular ultrasound scanning improves long-term patency of iliac lesions treated with balloon angioplasty and primary stenting

AbstractPurpose: Underdeployment of an intravascular stent has been identified as a cause of restenosis or occlusion of a treated arterial lesion. Intravascular ultrasound (IVUS) has been shown to initially improve the anatomic and clinical stenting. The purpose of this study was to determine whether the use of IVUS increased long-term patency of this intervention. Methods: Between March 1992 and October 1995, 71 limbs (52 patients) with symptomatic aortoiliac occlusive disease underwent balloon angioplasty with primary stenting. IVUS and arteriography were used in 49 limbs (36 patients) to evaluate stent deployment. Arteriography alone was used in 22 limbs (16 patients) to evaluate stent deployment. Patients were captured prospectively in a vascular registry and retrospectively reviewed. Results: Mean age of patients treated with IVUS was 61.1 ± 9.0 years (range, 38-85) versus 70.0 ± 10.1 years (range, 57-87) in patients treated without IVUS (P <.01). There was no difference between the groups with respect to preoperative comorbidities, ankle-brachial indices, or number of stents per limb. Mean follow-up for IVUS patients was 62.1 ± 7.3 months (range, 15-81) and 57.9 ± 8.7 months (range, 8-80) for patients treated without IVUS (P = not significant). In 40% (20/49) of limbs, IVUS demonstrated inadequate stent deployment at the time of the original procedure. Kaplan-Meier 3- and 6-year primary patency estimates were 100% and 100% in the IVUS group and 82% and 69%, respectively, in limbs treated without IVUS (P <.001). There have been no secondary procedures performed in limbs treated with IVUS and a 23% (5/22) secondary intervention rate in the non-IVUS group (P <.05). Overall Kaplan-Meier survival estimates at 3 and 6 years for all patients were 84% and 67%, respectively. Conclusion: Balloon angioplasty and primary stenting of symptomatic aortoiliac occlusive lesions is a durable treatment option. Long-term follow-up of treated patients shows outcomes that are comparable with direct surgical intervention. IVUS significantly improved the long-term patency of iliac arterial lesions treated with balloon angioplasty and stenting by defining the appropriate angioplasty diameter endpoint and adequacy of stent deployment. (J Vasc Surg 2002;35:316-23.

Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy

ObjectiveProximal attachment site complications continue to occur after endovascular repair of abdominal aortic aneurysms (EVAR), specifically type Ia endoleak and endograft migration. EndoAnchors (Aptus Endosystems, Sunnyvale, Calif) were designed to enhance endograft proximal fixation and sealing, and the current study was undertaken to evaluate the potential benefit of this treatment.MethodsDuring the 23-month period ending in December 2013, 319 subjects were enrolled at 43 sites in the United States and Europe. EndoAnchors were implanted in 242 patients (75.9%) at the time of an initial EVAR procedure (primary arm) and in 77 patients with an existing endograft and proximal aortic neck complications (revision arm). Technical success was defined as deployment of the desired number of EndoAnchors, adequate penetration of the vessel wall, and absence of EndoAnchor fracture. Procedural success was defined as technical success without a type Ia endoleak at completion angiography. Values are expressed as mean ± standard deviation and interquartile range.ResultsThe 238 male (74.6%) and 81 female (25.4%) subjects had a mean age of 74.1 ± 8.2 years. Aneurysms averaged 58 ± 13 (51-63) mm in diameter at the time of EndoAnchor implantation (core laboratory measurements). The proximal aortic neck averaged 16 ± 13 (7-23) mm in length (42.7% <10 mm and 42.7% conical) and 27 ± 4 mm (25-30 mm) in diameter; infrarenal neck angulation was 24 ± 15 (13-34) degrees. The number of EndoAnchors deployed was 5.8 ± 2.1 (4-7). Technical success was achieved in 303 patients (95.0%) and procedural success in 279 patients (87.5%), 217 of 240 (89.7%) and 62 of 77 (80.5%) in the primary and revision arms, respectively. There were 29 residual type Ia endoleaks (9.1%) at the end of the procedure. During mean follow-up of 9.3 ± 4.7 months, 301 patients (94.4%) were free from secondary procedures. Among the 18 secondary procedures, eight were performed for residual type Ia endoleaks and the others were unrelated to EndoAnchors. There were no open surgical conversions, there were no aneurysm-related deaths, and no aneurysm ruptured during follow-up.ConclusionsUse of EndoAnchors to treat existing and acute type Ia endoleaks and endograft migration was successful in most cases. Prophylactic use of EndoAnchors in patients with hostile aortic neck anatomy appears promising, but definitive conclusions must await longer term follow-up data