Three-Year Outcomes of a US Pivotal Trial Substudy for Conformable Endoprosthesis in >=10 mm Non-Angulated Neck Anatomy.

OBJECTIVE: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). METHODS: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U.S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥ 10mm and proximal neck angulation of ≤ 60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. RESULTS: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (>=10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention. CONCLUSIONS: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Early Results From the Pivotal Trial Substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in Angulated Necks.

OBJECTIVE OR BACKGROUND: To report the investigational device exemption (IDE) study 1-year clinical outcomes of the high neck angulation (HNA) substudy of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) for treatment of infrarenal abdominal aortic aneurysms (AAA). METHODS: This study is a prospective, multicenter clinical trial conducted in the United States and included core laboratory assessment of imaging and independent event adjudication. Anatomic criteria for enrollment in the HNA substudy included infrarenal aortic neck angulation >60° and ≤90° with aortic neck length ≥10 mm. Primary safety endpoints included blood loss >1000 mL, death, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure, and thromboembolic events. Primary effectiveness endpoints included technical success, absence from Type I and III endoleak, migration (≥10 mm), sac enlargement (≥5 mm), sac rupture, and conversion to open repair. RESULTS: Between January 2018 and February 2022, 95 patients were enrolled in the HNA substudy across 35 sites. Of the 95 patients, 71 (74.7%) were male and the cohort average age was 74.4 years old. The mean infrarenal proximal aortic neck angle was 71.6° and mean AAA size was 62.9 mm. Overall technical success was achieved in 93 (97.9%) patients. Freedom from a primary safety endpoint through 30 days was 96.7%; 3 (3.3%) patients had blood loss >1000 mL. Freedom from the primary effectiveness at 12 months was achieved in 94.8%. Four (4.3%) patients had Type IA endoleak; intervention after the procedure was not required and no subsequent interventions or sac enlargement were noted in these patients. At 12 months, 29 (39.7%) patients experienced a Type II endoleak and 1 (1.3%) patient experienced AAA sac expansion ≥5mm. Through 12 months, 1 (1.3%) patient had a conversion to open surgical repair. There were no aneurysm-related deaths, ruptures, or migration through 12 months. CONCLUSIONS: The IDE study demonstrates safety and effectiveness of the EXCC device in AAA with highly angulated necks (>60° and ≤90°) are preserved at the 12-month follow-up.

Sex and outcomes after stenting and endarterectomy in asymptomatic severe carotid stenosis patients.

OBJECTIVES: To determine if sex was an effect modifier in a pooled analysis of asymptomatic patients from CREST and ACT I. MATERIALS AND METHODS: We analyzed data from 2544 patients aged <80 with ≥70 % asymptomatic carotid stenosis randomized to CAS or CEA (nCREST = 1091; nACT-1 = 1453). The pre-specified primary endpoint in both trials was any stroke, myocardial infarction or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. The secondary endpoint was any stroke or death during the peri-procedural period, or ipsilateral stroke within 4 years of randomization. RESULTS: There was no significant difference in the frequency of events for men or women between CAS and CEA for the primary or secondary endpoints. When assessing for an interaction of sex and risks between procedures, the treatment-by-sex interaction was not significant for either primary or secondary endpoints in the four-year period or the peri-procedural period. However, women had significantly fewer post-procedural events (ipsilateral stroke) with CAS than CEA (HR = 0.33, 95 % CI: 0.09-1.18) compared to men (HR = 2.09, 95 % CI: 0.78-5.61), p = 0.02 for interaction. CONCLUSIONS: In this large, pooled analysis of asymptomatic patients comparing CAS to CEA, sex did not act as an effect modifier of treatment differences in the four-year primary stroke-MI-or-death endpoint or the secondary stroke-or-death endpoint. However, during the post-procedural period men treated with CAS were at higher risk than their female counterparts.

Multicenter CT Image-Based Anatomic Assessment of Patients with Aortoiliac Aneurysm Undergoing Endovascular Repair with Iliac Branch Devices.

BACKGROUND: The Global Iliac Branch Study (NCT05607277) is an international, multicenter, retrospective cohort study of anatomic predictors of adverse iliac events (AIEs) in aortoiliac aneurysms treated with iliac branch devices (IBDs). METHODS: Patients with pre-IBD and post-IBD computed tomography imaging were included. We measured arterial diameters, stenosis, calcification, bifurcation angles, and tortuosity indices using a standardized, validated protocol. A composite of ipsilateral AIE was defined, a priori, as occlusion, type I or III endoleak, device constriction, or clinical event requiring reintervention. Paired t-test compared tortuosity indices and splay angles pretreatment and post-treatment for all IBDs and by device material (stainless steel and nitinol). Two-sample t-test compared anatomical changes from pretreatment to post-treatment by device material. Logistic regression assessed associations between AIE and anatomic measurements. Analysis was performed by IBD. RESULTS: We analyzed 297 patients (286 males, 11 females) with 331 IBDs (227 stainless steel, 104 nitinol). Median clinical follow-up was 3.8 years. Iliac anatomy was significantly straightened with all IBD treatment, though stainless steel IBDs had a greater reduction in total iliac artery tortuosity index and aortic splay angle compared to nitinol IBDs (absolute reduction -0.20 [-0.22 to -0.18] vs. -0.09 [-0.12 to -0.06], P < 0.0001 and -19.6° [-22.4° to -16.9°] vs. -11.2° [-15.3° to -7.0°], P = 0.001, respectively). There were 54 AIEs in 44 IBDs in 42 patients (AIE in 13.3% of IBD systems), requiring 35 reinterventions (median time to event 41 days; median time to reintervention 153 days). There were 18 endoleaks, 29 occlusions, and 5 device constrictions. There were no strong associations between anatomic measurements and AIE overall, though internal iliac diameter was inversely associated with AIE in nitinol devices (nAIE, nitinol = 8). CONCLUSIONS: Purpose-built IBDs effectively treat aortoiliac disease, including that with tortuous anatomy, with a high patency rate (91.5%) and low reintervention rate (9.1%) at 4 years. Anatomic predictors of AIE are limited.

Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the 30-day outcomes of the primary arm of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. METHODS: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the primary study arm of extent IV thoracoabdominal aortic aneurysms and pararenal aneurysms. Technical success and major adverse events were analyzed per the Society for Vascular Surgery guidelines. RESULTS: The 102 patients of the primary arm who underwent endovascular repair using the TAMBE device were a mean age of 73 ± 6.4 years (range, 58-82 years) and 84 (84.2%) were male. The mean body mass index was 28.3 ± 5.0 kg/m2. Fifty-nine patients (57.8%) were treated for extent IV and 43 (42.2%) pararenal aneurysms; the mean maximum diameter of the aneurysms was 59.4 ± 7.8 mm. A prophylactic cerebral spinal fluid drain was used in 10 patients (9.8%). Technical success was achieved in 99% of patients, with the single failure owing to unsuccessful cannulation of the left renal artery. Mean procedure time was 315 ± 103 minutes (range, 163-944 minutes), estimated blood loss was 300 ± 296 mL (range, 10-2000 mL), and contrast administration was 153.6 ± 73.5 mL (range, 16-420 mL). The intensive care unit length of stay was 58.7 ± 52.7 hours (range, 1-288 mL). In 28 patients (27.5%), a total of 32 additional endovascular components were deployed to manage procedural complications including aortic and target vessel dissections and injuries not related to access. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). Postoperative transfusion was required in 14 patients (13.7%). Major adverse events occurred in seven patients (6.9%) through 30 days. Events included respiratory failure (n = 2), disabling stroke (n = 1), new-onset renal failure requiring dialysis (n = 2), and paraplegia (n = 2). At 30 days, there was one patient with intraoperative rupture; no severe bowel ischemia or lesion-related/all-cause mortality were reported. The Core lab-reported patency was 100% in the aortic component, superior mesenteric artery, and celiac artery, and 95.9% in the left renal and 99.0% in the right renal branch components through 30 days of follow-up. Reinterventions through 30 days were performed in 9 of 96 patients (9.4%) and were all minor. CONCLUSIONS: Early TAMBE device outcomes demonstrate a high technical success rate, no 30-day lesion-related mortality, and a low rate of safety events within 30 days of the index procedure.

Risk Factors for Development of Incisional Hernia after Aortic Aneurysm Repair: Secondary Analysis of the OVER Randomized Controlled Trial.

BACKGROUND: Since the risk of mortality from rupture is elevated, elective repair of abdominal aortic aneurysms (AAAs) is often recommended. Currently, over 80% of elective repairs are carried out using an endovascular approach. While open repair has similar late survival and fewer reintervention outcomes when compared to endovascular repair, incisional hernia is a frequent complication with morbidity and cost implications. The Open versus Endovascular Repair (OVER) trial was the largest randomized trial of endovascular versus open repair of AAA in the United States. The purpose of this study was to determine risk factors associated with incisional hernia development following AAA repair via secondary analysis of the OVER data. METHODS: This was a multisite trial conducted within the Veterans Affairs health-care system. Study participants (N = 881) were enrolled from 2002 to 2008 and followed until 2011 with additional administrative data collection until 2016. Eligible patients had AAA for which elective repair was planned and randomized 1:1 to either open or endovascular repair. Incisional hernia was a prespecified end point in the OVER protocol, specifically assessed at each protocol follow-up visit. Technical details were extracted from each operative report, repair case report form(s), and adverse event form(s). Patient demographics, comorbid conditions, reported preoperative activity level, and operative details including initial approach, blood loss, and closure methods were analyzed using Bayesian hierarchical Weibull survival regression modeling. RESULTS: Incisional hernias were recorded among 46 participants (5.2%). The average time to hernia diagnosis was 3.5 years. Of the 437 participants randomized to open treatment, 427 received an open repair including crossovers from endovascular treatment assignment. Transperitoneal repair was performed in 81%, running suture in 96%, and absorbable suture in 71% of cases. Randomization to endovascular repair was associated with reduced risk of hernia (hazard ratio [HR] 0.70, 95% credible interval [CI] 0.49-0.94). Higher activity level was associated with increased hernia risk (HR 1.39, 95% CI 1.06-1.84). Approach, suture closure techniques, body mass index, diabetes, and smoking status were not associated with increased risk of hernia development. CONCLUSIONS: Incisional hernia is a frequent complication associated with open repair of abdominal aortic aneurysm and commonly required reintervention. Endovascular repair was associated with reduced risk of hernia. Patients with increased activity experienced a higher incidence of hernia. However, no other modifiable patient, operative, or technical factors were found to be associated with hernia development.

Image-based assessment of aortoiliac aneurysm anatomical characteristics in patients from the global iliac branch study.

OBJECTIVE: Endovascular repair is the preferred treatment for aortoiliac aneurysm, with preservation of at least one internal iliac artery recommended. This study aimed to assess pre-endovascular repair anatomical characteristics of aortoiliac aneurysm in patients from the Global Iliac Branch Study (GIBS, NCT05607277) to enhance selection criteria for iliac branch devices (IBD) and improve long-term outcomes. METHODS: Pre-treatment CT scans of 297 GIBS patients undergoing endovascular aneurysm repair were analyzed. Measurements included total iliac artery length, common iliac artery length, tortuosity index, common iliac artery splay angle, internal iliac artery stenosis, calcification score, and diameters in the device's landing zone. Statistical tests assessed differences in anatomical measurements and IBD-mediated internal iliac artery preservation. RESULTS: Left total iliac artery length was shorter than right (6.7 mm, P = .0019); right common iliac artery less tortuous (P = .0145). Males exhibited greater tortuosity in the left total iliac artery (P = .0475) and larger diameter in left internal iliac artery's landing zone (P = .0453). Preservation was more common on right (158 unilateral, 34 bilateral) than left (105 unilateral, 34 bilateral). There were 192 right-sided and 139 left-sided IBDs, with 318 IBDs in males and 13 in females. CONCLUSION: This study provides comprehensive pre-treatment iliac anatomy analysis in patients undergoing endovascular repair with IBDs, highlighting differences between sides and sexes. These findings could refine patient selection for IBD placement, potentially enhancing outcomes in aortoiliac aneurysm treatment. However, the limited number of females in the study underscores the need for further research to generalize findings across genders.

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Acute ischemia secondary to popliteal artery stent fracture and embolization.

Femoropopliteal disease comprises more than one half of lesions in peripheral vascular disease. The treatment modalities for stenosis or occlusion of this anatomic region include femoropopliteal bypass and percutaneous transluminal angioplasty with or without stenting. Our patient developed acute leg ischemia 3 years after stenting, secondary to stent fracture, with distal embolization of stent fragments. Using mechanical thromboembolectomy and superficial femoral artery to below-the-knee popliteal in situ saphenous vein bypass, we were able to restore perfusion to the limb and retrieve fragments of the fractured stent.

Effect of Two Years of Doxycycline Treatment on Infrarenal Aortic Neck Diameter.

Objective: Endovascular aneurysm repair (EVAR) is a widely used option for patients with suitable vascular anatomy who have a large infrarenal abdominal aortic aneurysm (AAA). Neck diameter is the primary anatomical determinant of EVAR eligibility and device durability. Doxycycline has been proposed to stabilise the proximal neck after EVAR. This study explored doxycycline mediated aortic neck stabilisation in patients with small AAA, monitored by computed tomography over two years. Methods: This was a multicentre prospective randomised clinical trial. Subjects from the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT, NCT01756833) were included in this secondary a priori analysis. Female baseline AAA maximum transverse diameter was between 3.5 and 4.5 cm, and male was between 3.5 and 5.0 cm. Subjects were included if they completed pre-enrolment and two year follow up computed tomography (CT) imaging. Proximal aortic neck diameter was measured at the lowest renal artery, and 5, 10, and 15 mm caudal to this point; mean neck diameter was calculated from these values. Unpaired, two tailed parametric t test analysis with post hoc Bonferroni correction was used to detect differences between neck diameters in subjects treated with placebo vs. doxycycline at baseline and two years. Results: One hundred and ninety-seven subjects (171 male, 26 female) were included in the analysis. All patients, regardless of treatment arm, demonstrated larger neck diameter caudally, a slight increase in diameter at all anatomical levels over time, and greater growth caudally. There was no statistically significant difference in infrarenal neck diameter between treatment arms at any anatomical level at any time point, nor mean change in neck diameter over two years. Conclusion: Doxycycline does not demonstrate infrarenal aortic neck growth stabilisation in small AAA followed for two years by thin cut CT imaging using a standardised acquisition protocol and cannot be recommended for mitigation of growth of the aortic neck in patients with untreated small abdominal aortic aneurysms.

Effect of Doxycycline on Progression of Arterial Calcification in the Noninvasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA(3)CT).

BACKGROUND: Doxycycline has been shown to prevent arterial calcification via attenuation of matrix metalloproteinases (MMP) in preclinical models. We assessed the effects of doxycycline on progression of arterial calcification in patients enrolled in the Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT). METHODS: Two hundred and sixty-one patients were randomized to 100 mg doxycycline twice daily or placebo. Arterial calcification was measured in abdominal vessels on noncontrast computed tomography scans. Patients with baseline computed tomography scan and 1 or more follow-up scans within the 2-year study were included for analysis. For individual arteries, mean change in iliofemoral artery calcification over time was calculated via linear regression. Serum MMP-3 and MMP-9 levels were measured at baseline and 6 months. RESULTS: Sixty-five patients in the doxycycline and 66 in the placebo arm were included in this analysis. Baseline characteristics between the groups were similar. The unadjusted mean change in iliofemoral calcium score per year trended toward higher values in patients treated with doxycycline compared with placebo (322 ± 399 units/year vs. 217 ± 307 units/year, P = 0.09). After 6 months, changes in serum MMP-3 and MMP-9 levels were not significantly different between study arms. CONCLUSIONS: In patients with small aortic aneurysm, treatment with doxycycline 100 mg twice daily did not decrease circulating levels of the matrix degrading enzymes MMP-3 and 9 or alter the progression of arterial calcification.

Analysis of Repair Type and Hypogastric Artery Antegrade Perfusion and Erectile Function following Repair of Abdominal Aortic Aneurysms.

BACKGROUND: Published reports suggest that exclusion of antegrade hypogastric artery flow may have deleterious effects on erectile function after abdominal aortic aneurysm (AAA) repair. Off-label and open surgical hybrid procedures and, more recently, purpose-built branched devices have been developed to maintain antegrade pelvic perfusion in patients undergoing endovascular repair. Maintaining antegrade perfusion may reduce a spectrum of risks, including buttock claudication, colorectal ischemia, and spinal cord ischemia when patients undergo subsequent thoracic aortic procedures, as well as erectile dysfunction (ED). This project specifically focuses on erectile function, and analyzes baseline associations and relationships of hypogastric artery exclusion on changes in erectile function following aneurysm repair. METHODS: Male patients in the Veterans Affairs Open Versus Endovascular Repair (CSP#498; OVER) Trial had erectile function assessed preoperatively and postoperatively by administration of the International Index of Erectile Function-5 questionnaire. Bayesian mixed-effects regression models were created with the outcome variable (erectile function) treated as a latent variable. Primary effects of differences in erectile function between groups with and without preservation of bilateral antegrade hypogastric flow were compared. RESULTS: 876 men (442 randomized to endovascular repair) were enrolled in the trial and included in the analysis comparing treatment assignment. There is significant ED in elderly men with aortic aneurysm at baseline. Over 5 years of follow-up, there is modest decrease in erectile function and the endovascular group has improved function compared to open repair (0.082; 95% credible interval (CI) 0.008 and 0.155). A fifth of patients did not have bilateral preservation of antegrade hypogastric artery perfusion, with no difference in erectile function by univariate analysis. A more detailed regression analysis was applied--and after adjustment for baseline score, age, beta blocker use, diabetes, activity level, ejection fraction, preoperative ankle-brachial indices and time--preservation of both antegrade hypogastric arteries' perfusion showed transient improvement in survey scores compared to occlusion of at least 1 hypogastric artery at 6 months and 12 months after treatment, although this was not sustained at 60 months (score change: 0.046; 95% CI: -0.123, 0.215). Retesting this model in the cohort with complete data as a sensitivity analysis did not meaningfully change the conclusions. CONCLUSIONS: In this large prospective aneurysm treatment trial with systematic measurement of erectile function with a validated instrument, endovascular repair is associated with improved erectile function. Preservation of antegrade hypogastric flow with any repair is associated with early improved erectile function; however, it is not a sustained benefit. There is limited benefit of maintaining bilateral hypogastric artery perfusion for this specific indication in unselected men undergoing AAA repair.

Reengaging patients with forgotten filters through an institutional multidisciplinary approach.

OBJECTIVE: The aim of the present study was to evaluate the outcomes of a hospital-wide multidisciplinary initiative to reengage and manage patients with unretrieved chronic indwelling inferior vena cava (IVC) filters placed at a large tertiary care center, who had been lost to follow-up. METHODS: We performed a retrospective review of outcomes from a completed multidisciplinary quality improvement project. The quality improvement project identified and contacted (via letter) patients with chronic indwelling IVC filters placed at a single tertiary care center from 2008 to 2016 who were alive and without evidence of filter retrieval in the medical records. A total of 316 eligible patients were mailed a letter regarding their chronic indwelling IVC filter and the updated recommendations regarding IVC filter removal. The letter included institutional contact information, and all the patients who responded were offered a clinic visit to discuss potential filter retrieval. In the retrospective review, we assessed the outcomes of the quality improvement project, including the patient response rate, follow-up clinic visits, new imaging studies generated, retrieval rate, procedural success, and complications. The patient demographics and filter characteristics were collected and evaluated for correlations with the response and retrieval rates. RESULTS: The patient response rate to the letter was 32% (101 of 316). Of the 101 patients who responded, 72 (71%) were seen in clinic and 59 (82%) underwent new imaging studies. Using standard and advanced techniques, 34 of 36 filters after a median dwell time of 9.4 years (range, 3.3-13.3 years) were successfully retrieved (94% success rate). The patients with a documented IVC filter complication were more likely to respond to the letter (odds ratio, 4.34) and undergo IVC filter retrieval (odds ratio, 6.04). No moderate or severe procedural complications occurred during filter retrieval. CONCLUSIONS: An institutional, multidisciplinary quality initiative successfully identified and reengaged patients with chronic indwelling IVC filters who had been lost to follow-up. The filter retrieval success rate was high and procedural morbidity low. Institution-wide efforts to identify and retrieve chronic indwelling filters are feasible.

Excess Mortality for Abdominal Aortic Aneurysms and the Potential of Strict Implementation of Cardiovascular Risk Management: A Multifaceted Study Integrating Meta-Analysis, National Registry, and PHAST and TEDY Trial Data.

OBJECTIVE: Previous studies imply a profound residual mortality risk following successful abdominal aorta aneurysm (AAA) repair. This excess mortality is generally attributed to increased cardiovascular risk. The aim of this study was (1) to quantify the excess residual mortality for patients with AAA, (2) to evaluate the cross sectional level of cardiovascular risk management, and (3) to estimate the potential of optimised cardiovascular risk management to reduce the excess mortality in these patients. METHODS: Excess mortality was estimated through a systematic review and meta-analysis, and through data from the Swedish National Health Registry. Cardiovascular risk profiles were individually assessed during eligibility screening of patients with AAA for two multicentre pharmaceutical AAA stabilisation trials. The potential of full implementation of cardiovascular risk management was estimated through the validated Second Manifestations of ARTerial disease (SMART) risk scores algorithm. RESULTS: The meta-analysis showed a similarly impaired survival for patients who received early repair (small AAA) or regular repair (≥ 55 mm), and a further impaired survival for patients under surveillance for a small AAA. Excess mortality was further quantified using Swedish population data. The data revealed a more than quadrupled and doubled five year mortality rate for women and men who had their AAA repaired, respectively. Evaluation of the level of risk management of 358 patients under surveillance in 16 Dutch hospitals showed that the majority of patients with AAA did not meet therapeutic targets set for risk management in high risk populations, and indicated a more pronounced prevention gap in women. Application of the SMART risk score algorithm predicted that optimal implementation of risk management guidelines would reduce the 10 year risk of major adverse cardiovascular events from 43% to 14%. CONCLUSION: Independent of the rupture risk, AAA is associated with a worryingly compromised life expectancy with a particularly poor prognosis for women. Optimal implementation of cardiovascular risk prevention guidelines is predicted to profoundly reduce cardiovascular risk.

Effect of preservation of antegrade hypogastric flow on development of claudication following aortoiliac aneurysm repair.

OBJECTIVE: The objective of this study was to compare the rate of development of buttock claudication in patients undergoing aortoiliac aneurysm repair with and without exclusion of antegrade hypogastric arterial flow. In the absence of convincing data, questions remain regarding the best management of hypogastric arterial flow to prevent the theoretical risk of buttock claudication. METHODS: The Veterans' Affairs Open Versus Endovascular Repair (OVER) Cooperative Study prospectively collected information on buttock claudication. Trial participants were specifically prompted both pre- and postoperatively to report the development of claudication symptoms at several anatomic levels. Of note, trial investigators were specifically trained to occlude the trunk hypogastric arterial, preserving the anterior and posterior divisions. Bayesian survival models were created to evaluate time to development of left, right, or bilateral buttock claudication according to the presence/absence of antegrade hypogastric perfusion. RESULTS: A total of 881 patients from the OVER trial with information regarding status of hypogastric flow were included in the analysis. Of these, 788 patients maintained bilateral antegrade hypogastric arterial perfusion, 63 had right hypogastric coverage/occlusion, and 27 had left hypogastric coverage/occlusion, whereas 3 patients had bilateral hypogastric coverage/occlusion. Just under 5% of all patients (n = 41) developed buttock claudication. After adjustment for smoking, chronic obstructive pulmonary disease, medications, study arm, preoperative activity level, body mass index, age, and diabetes, intervention-related changes to hypogastric perfusion had no effect on time to development of buttock claudication. A Maximum A Posteriori Kullback- Leibler misfit χ2 was 14.45 with 24 degrees of freedom, resulting in a goodness of fit P-value of P = .94, indicative of a good fit. CONCLUSIONS: OVER is the largest aneurysm treatment study to prospectively collect data related to the development of claudication as well as hypogastric preservation status. Despite this, we were unable to find evidence to support the assertion that preservation of antegrade hypogastric flow decreases the rate of development of buttock claudication symptoms. The low rate of development of buttock claudication overall and in the subgroups is striking.

Five-year outcomes from a prospective, multicenter study of endovascular repair of iliac artery aneurysms using an iliac branch device.

OBJECTIVE: We have reported the 5-year results of a pivotal prospective, multicenter study conducted in the United States of a specifically designed iliac branch endoprosthesis (IBE; W.L. Gore & Associates, Flagstaff, AZ) for endovascular repair of aortoiliac aneurysms and common iliac artery aneurysms. METHODS: A total of 63 patients (98.4% male; mean age, 70 years) with aortoiliac or common iliac artery aneurysms had undergone implantation of a single IBE device and a bifurcated aortoiliac stent graft. Patients with bilateral common iliac artery aneurysms (n = 22; 34.9%) had undergone either staged occlusion or surgical revascularization of the contralateral internal iliac artery before study enrollment. At 5 years, 36 of the 63 patients had completed the final study follow-up examinations, including clinical examinations (n = 35) and computed tomography (n = 32), with the results evaluated by an independent core laboratory and adverse events adjudicated by a clinical events committee. RESULTS: At 5 years, freedom from all-cause mortality was 85.7% and freedom from aneurysm-related mortality was 100%. The nine deaths that had occurred (range, 132-1898 days) were adjudicated as unrelated to the aneurysm or procedure. Primary patency of the internal and external iliac artery IBE limbs was 95.1% and 100%, respectively. No patients had experienced new-onset buttock claudication on the IBE side or self-reported new-onset erectile dysfunction. The common iliac artery diameter on the IBE side was either unchanged or had decreased by ≥5 mm in 30 of the 31 patients (96.8%) with a baseline (1 month) and 5-year (range, 1641-2006 days) computed tomography scan available. Of the 31 evaluable patients, 9 (29.0%) had had an increase of ≥5 mm in the aortic diameter, 5 of whom had had a concurrent type II endoleak. No type I or type III endoleaks or device migration were identified by the core laboratory. Six patients had undergone eight secondary interventions, including five interventions for a type II endoleak. The freedom from secondary intervention was 90.5%. CONCLUSIONS: The 5-year results of our prospective, multicenter study have confirmed the safety, efficacy, and durability of the IBE device for the treatment of aortoiliac and iliac artery aneurysms. The device effectively prevented common iliac artery aneurysm rupture, maintained the patency of the internal iliac artery, and avoided the complications associated with internal iliac artery sacrifice. Although common iliac artery aneurysm enlargement was rare, abdominal aortic enlargement was more common, suggesting that the outcomes of endovascular aneurysm repair might be different for patients with or without associated common iliac artery aneurysms.

Midterm Outcomes of Endovascular Repair of Aortic Arch Aneurysms with the Gore Thoracic Branch Endoprosthesis.

OBJECTIVE: Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported. METHODS: This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported. RESULTS: The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement > 5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm. CONCLUSION: Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.

Outcomes of endovascular repair of aortic aneurysms with the GORE thoracic branch endoprosthesis for left subclavian artery preservation.

OBJECTIVE: Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA. METHODS: Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion. RESULTS: More than one-half of the patients were male (63%). Their average age was 70 ± 11 years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2 mm. The mean follow-up was 30 months (range, 2.6-50.7 months). Reported here are the patient outcomes at 1 and 12 months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n = 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12 months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6 months. Type I (n = 3) and III (n = 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention. CONCLUSIONS: Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12 months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.

Surgeon Learning Curve and Clinical Outcomes of Minimally Invasive Anterior Lumbar Interbody Fusion With Posterior Percutaneous Instrumentation.

OBJECTIVES: This study reports the learning phase of the minimally invasive anterior lumbar interbody fusion (mini-ALIF) approach with a vascular and orthopaedic spine surgeon team. METHODS: Adult patients who underwent primary mini-ALIF at the lowest two segments of the lumbar spine (i.e., L4/5, L5/S1) between January 2010 and December 2018 were analyzed. RESULTS: One hundred twenty-seven patients were included. There was no notable change in total surgical time over the study period. Estimated blood loss markedly decreased until stabilizing at case 30 and slowly declined thereafter. The mean estimated blood loss was 184 mL for L5/S1, 232 mL for L4/L5, and 458 mL for two-level mini-ALIF. There were 20 vascular issues requiring primary repair or packing. Vascular issues declined over time, with a rate of 32% in the first 25 cases and 0% in the last 25. The postoperative complication rate was highest in the first 25 cases (7 of 21 total complications). The odds ratio of vascular injury with body mass index (BMI) > 35 was 4.09 (1.4 to 11.7 confidence interval, P ≤ 0.008). Total surgical time and postoperative complications increased with increasing BMI. CONCLUSION: Performance of the mini-ALIF approach is associated with a learning curve of 25 to 30 cases before complications begin to decline. BMI > 35 is associated with increased surgical time and complications.