Center-level outcomes following elective fenestrated endovascular aortic aneurysm repair in the Vascular Quality Initiative database.

OBJECTIVE: Hospital volume is associated with mortality after open aortic aneurysm repair. Fenestrated and branched endovascular aortic repair (B-FEVAR) has been increasingly used for repair of complex thoracoabdominal and juxtarenal aneurysms, but evidence of a center-volume relationship is limited. We aimed to measure the association of center volume with in-hospital mortality, postoperative outcomes, and 1-year survival following B-FEVAR. METHODS: Patients undergoing elective endovascular thoracoabdominal and complex abdominal aneurysm repair with branch intervention (2014-2021) listed within the national Vascular Quality Initiative Thoracic Endovascular Aortic Repair/Complex EVAR database were analyzed. Centers were grouped into quartiles by mean annual procedure volume. Multivariable regression was used to evaluate the effect of center volume on in-hospital mortality adjusting for baseline and procedural characteristics. Kaplan-Meier estimation, log rank test, and mixed effects Cox regression were used to evaluate 1-year survival. RESULTS: A total of 4302 adult elective F-BEVAR procedures were identified at a total of 163 centers. In-hospital mortality did not differ by hospital volume (quartile [Q]1 = 35/1059 [3.3%]; Q2 = 30/1063 [2.8%]; Q3 = 33/1120 [2.9%]; and Q4 = 44/1060 [4.2%]; P = .308). The high volume group had a higher rate of major complication (Q1 = 14.9%; Q2 = 12.8%; Q3 = 13.3%; and Q4 = 20.1%; adjusted P < .001). Physician-modified grafts were more frequently employed in high-volume centers (Q1 = 4.5%; Q2 = 18.7%; Q3 = 11.3%; and Q4 = 19.2%; P < .001), with a decreased incidence of any endoleak noted at the end of the procedure (Q1 = 34.9%; Q2 = 32.8%; Q3 = 30.0%; and Q4 = 29.0%; P = .003). In the multivariable analysis, in-hospital mortality was not associated with center volume, comparing very low volume to medium- and high-volume centers (odds ratio [95% confidence interval] vs Q4: Q1 = 1.1 [0.6-1.9], Q2 = 0.6 [0.4-1.1], and Q3 = 0.9 [0.5-1.5]; all P > .05). No significant difference was found in 1-year survival between center volume groups. CONCLUSIONS: In-hospital mortality is not associated with procedure volume within centers performing complex endovascular aortic repair. However, complication rates and endoleak may be associated with procedure volume. Long-term outcomes by annualized procedure volume, specifically graft durability and sac expansion, should be investigated.

Paradoxical Changes: EMMPRIN Tissue and Plasma Levels in Marfan Syndrome-Related Thoracic Aortic Aneurysms.

Background: Thoracic aortic aneurysms (TAAs) associated with Marfan syndrome (MFS) are unique in that extracellular matrix metalloproteinase inducer (EMMPRIN) levels do not behave the way they do in other cardiovascular pathologies. EMMPRIN is shed into the circulation through the secretion of extracellular vesicles. This has been demonstrated to be dependent upon the Membrane Type-1 MMP (MT1-MMP). We investigated this relationship in MFS TAA tissue and plasma to discern why unique profiles may exist. Methods: Protein targets were measured in aortic tissue and plasma from MFS patients with TAAs and were compared to healthy controls. The abundance and location of MT1-MMP was modified in aortic fibroblasts and secreted EMMPRIN was measured in conditioned culture media. Results: EMMPRIN levels were elevated in MFS TAA tissue but reduced in plasma, compared to the controls. Tissue EMMPRIN elevation did not induce MMP-3, MMP-8, or TIMP-1 expression, while MT1-MMP and TIMP-2 were elevated. MMP-2 and MMP-9 were reduced in TAA tissue but increased in plasma. In aortic fibroblasts, EMMPRIN secretion required the internalization of MT1-MMP. Conclusions: In MFS, impaired EMMPRIN secretion likely contributes to higher tissue levels, influenced by MT1-MMP cellular localization. Low EMMPRIN levels, in conjunction with other MMP analytes, distinguished MFS TAAs from controls, suggesting diagnostic potential.

Current Transthoracic Supra-Aortic Trunk Surgical Reconstruction Has Similar 30-Day Cardiovascular Outcomes Compared to Extra-Anatomic Revascularization but With Higher Morbidity Burden.

BACKGROUND: Operative risk for supra-aortic trunk (SAT) surgical revascularization for occlusive disease, particularly transthoracic reconstruction (TR), remains ill-defined. This study sought to describe and compare 30-day outcomes of TR and extra-anatomic (ER) SAT surgical reconstruction for an occlusive indication across the United States over a contemporary 15-year period. METHODS: Using the National Surgical Quality Improvement Program, TR and ER performed during 2005-2019 were identified. Procedures performed for nonocclusive indications and those concomitant with coronary or valve operations were excluded. Rates of stroke, death, myocardial infarction (MI) and these as composite outcome (S/D/M) were compared. Logistic regression with stabilized inverse probability weighting (IPW) was used to compare groups via average treatment effect (ATE) while adjusting for covariate imbalances. RESULTS: Over the 15-year period, 166 TR and 1,900 ER patients were identified. The majority of ERs were carotid-subclavian bypass (n = 1,344; 70.7%) followed by carotid-carotid bypass (n = 261; 13.7%) and subclavian/carotid transpositions (n = 123; 6.5%). TR consisted of aorto-SAT bypass (n = 120; 72.3%) and endarterectomy (n = 46; 27.7%). The median age was 64 years for TR and 65 years in ER (P = 0.039). Those undergoing TR were more often women (69.0% vs. 56.9%; P = 0.001) and less likely to have undergone previous cardiac surgery (9.2% vs. 20.8%; P = 0.006). TR were also less frequently hypertensive (68.1% vs. 75.4%; P = 0.038) and had statistically lower preoperative creatinine levels (0.86 vs 0.91; P = 0.002). Unadjusted rates of MI (0.6% vs. 1.3%; P = 0.72) and stroke (3.6% vs. 1.9%; P = 0.15) were similar between groups with mortality (3.6% vs. 1.5%; P = 0.05) and S/D/M (6.6% vs. 3.9%; P = 0.10) trending higher with TR. IPWs could be calculated for 1,754 patients (148 TR; 1,606 ER). The estimated probability of S/D/M was 3.8% in the ER group and 6.2% in TR; no difference was seen in ATE (2.4%; 95% confidence interval [CI]: -1.5 to 6.2; P = 0.23). No differences were seen in individual component ATEs (stroke: 3.0% vs. 1.7%; ATE = 1.3%; 95% CI: -3.9 to 1.3; P = 0.32; mortality: 3.8% vs. 1.4%; ATE = 2.4%; 95% CI: -5.6 to 0.7; P = 0.13). Secondary outcomes showed TR patients were more likely to have non-home discharge (18.7% vs. 6.6%; ATE = 12.1%; 95% CI: 5.0-19.2; P < 0.001) and longer lengths of stay (6.1 vs. 4.0; ATE = 2.2 days; 95% CI: 0.9-3.4; P < 0.001). Moreover, TR patients were more likely to require transfusion (22.7% vs. 5.0%; ATE = 17.7%; 95% CI: 10.2-25.2; P < 0.001) and develop sepsis (2.7% vs. 0.2%; ATE = 2.5%; 95% CI: 0.1-5.0; P = 0.04). CONCLUSIONS: Transthoracic and extra-anatomic surgical reconstruction of the SATs for occlusive disease have similar operative cardiovascular risk. However, morbidity tends to be higher with TR due to higher transfusion requirements, sepsis risk, and need for facility stay. These results suggest ER as a first-line approach in those with proper disease anatomy is reasonable with lower morbidity, while TR remains justified in appropriate patients.

Long-Term Outcomes of Exercise Therapy Versus Revascularization in Patients With Intermittent Claudication.

OBJECTIVE: The aim was to analyze the risk of progression to chronic limb-threatening ischemia (CLTI), amputation and subsequent interventions after revascularization versus noninvasive therapy in patients with intermittent claudication (IC). BACKGROUND: Conflicting evidence exists regarding adverse limb outcomes after each treatment strategy. METHODS: Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. MEDLINE, Web of Science, and Google Scholar were searched aided by a health sciences librarian through August 16, 2022. Randomized control trials (RCTs) comparing invasive (endovascular or surgical revascularization) and noninvasive treatment (exercise and/or medical treatment) were included. PROSPERO registration was completed (CRD42022352831). RESULTS: A total of 9 RCTs comprising 1477 patients (invasive, 765 patients; noninvasive, 712 patients) were eligible. During a mean of 3.6-year follow-up, progression to CLTI after invasive [5 (2-8) per 1000 person-years] and noninvasive treatment [6 (3-10) per 1000 person-years] were not statistically different [rate ratio (RR): 0.77; 95% CI, 0.35-1.69; P =0.51, I2 =0%]. Incidence of amputation (RR: 1.69; 95% CI, 0.54-5.26; P =0.36, I2 =0%) and all-cause mortality (hazard ratio: 1.26; 95% CI, 0.91-1.74; P =0.16, I2 =0%) also did not differ between the groups. However, the invasive treatment group underwent significantly more revascularizations (RR: 4.15; 95% CI, 2.80-6.16; P <0.00001, I2 =83%). The results were not changed by fixed effect or random-effects models, nor by sensitivity analysis. CONCLUSIONS: Although there is equivalent risk of progression to CLTI, major amputation and all-cause mortality compared with noninvasive treatment, invasive treatment for patients with IC led to significantly more revascularization procedures and should be used selectively in patients with major lifestyle limitation. Guideline recommendation of noninvasive treatment for first-line IC therapy is supported.

Operative and long-term outcomes of combined and staged carotid endarterectomy and coronary bypass.

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.54-1.36; P = .51) and mortality (HR, 1.02; 95% CI, 0.76-1.36; P=.91) were similar between groups, but higher risk of MI long-term was seen in those staged (HR, 1.49; 95% CI, 1.07-2.08; P = .02). CONCLUSIONS: In patients undergoing CCAB or staged open revascularization for carotid stenosis and coronary artery disease, the staged approach had an increased risk of postoperative cardiac event, but the short- and long-term rates of stroke and mortality seem to be comparable. Adverse cardiovascular event risk is high between operations when staged and should be a consideration when selecting an approach. Although factors leading to staged sequencing performance need further clarity, CCAB seems to be safe and should be considered an equally reasonable option.

Long Term Monitoring of Thoracic Endovascular Aortic Aneurysm Repair Using Transcaval Aortic Access.

Thoracic endovascular aortic repair (TEVAR) has reduced the morbidity and mortality associated with the treatment of thoracic aortic pathologies. However, TEVAR's use is often predicated on sufficiently large femoral access for the delivery of the endograft device. Transcaval access, or the delivery of endovascular device via the vena cava before crossing into the aorta, has been used successfully for the deployment of transcatheter aortic valves. Our institution previously reported on a case of TEVAR using transcaval access. We now report on the long-term follow-up outcome of this case. At 6 years post-surgery, computed tomography angiography (CTA) indicates stable aortic repair without any concerning findings associated with the site of transcaval access into the aorta. The patient is clinically without signs of lower extremity vascular or cardiopulmonary compromise. Overall, transcaval access for TEVAR is a promising alternative to traditional femoral artery access in highly-select patients with the appropriate anatomical and pathological indications.

Editor's Choice - Risk of Rupture and All Cause Mortality of Abdominal Aortic Ectasia: A Systematic Review and Meta-Analysis.

OBJECTIVE: To clarify the natural history of abdominal aortic ectasia (AAE) measuring 25 - 29 mm in maximum diameter, and to determine the optimal follow up based on the growth, risk of rupture, and overall mortality of AAE. DATA SOURCES: MEDLINE, Web of Science Core Collection, and Google Scholar. REVIEW METHODS: This was a systematic review and meta-analysis of AAE in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE, Web of Science Core Collection, and Google Scholar were searched, with the help of a health sciences librarian, up to 11 August 2021. Studies with longitudinal outcomes of AAE (prevalence, annual growth rate, aneurysmal enlargement, rupture, aneurysm related death, and all cause mortality) were included. Meta-analyses were conducted with a random effects model RESULTS: Twelve studies describing a total of 8 369 patients were eligible. The prevalence at population based settings was 3.2% (95% confidence interval [CI] 2.4 - 4.0); annual growth rate was 0.82 mm/year (95% CI 0.20 - 1.45). The estimated risks of aortic diameters exceeding 30 mm and 55 mm in five years were 45.0% (95% CI 28.5 - 61.5) and 0.3% (95% CI 0 - 0.6) respectively, while those beyond five years were 70.2% (95% CI 46.9 - 93.6) and 5.2% (95% CI 2.2 - 8.2). The rates of rupture and aneurysm related death were minimal until five years (0.1% and 0.1%, respectively) and beyond (0.4% and 0.2%, respectively). Overall mortality was 7.5% (95% CI 3.9 - 11.0) and 17.3% (95% CI 9.5 - 25.1) up to and beyond five years. Overall mortality from three studies showed no statistical difference between AAE and aneurysms (hazard ratio 0.62, 95% CI 0.32 - 1.21; p = .16). Cancer (35.0%) and cardiovascular diseases (31.9%) were major causes of death. CONCLUSION: AAE carries minimal risk of aneurysm related lethal events during the first five years, but a similar overall mortality risk as abdominal aortic aneurysm. Cancer and cardiovascular diseases are leading causes of death in patients with AAE.

Contemporary management and natural history of aberrant right subclavian artery.

OBJECTIVE: An aberrant right subclavian artery (ARSA) is the most common congenital anomaly of the aortic arch. A paucity of reported studies is available regarding the treatment of these patients. The purpose of the present study was to evaluate the contemporary management strategies and natural history of ARSA in these patients. METHODS: A single-center retrospective review of patients with a diagnosis of ARSA from 2009 to 2019 was performed. Computed tomography scans were analyzed, and the aortic and ARSA diameters were measured at 10 different segments. The demographic data, comorbidities, and operative interventions were collected. The patients were categorized into those who had undergone intervention and those who had undergone expectant management. Linear mixed effect models were used to estimate the annual ARSA diameter changes. RESULTS: A total of 30 patients with ARSA were identified, 17 (57%) of whom were women. The average age for the cohort was 54.5 ± 14.6 years. Of the 30 patients, 20 (67%) had undergone operative repair at presentation and 10 (33%) were initially observed. The most common presenting symptom was dysphagia (30%). Of the 10 patients who had been initially treated expectantly, 4 had subsequently required intervention. Of the 24 operative interventions, 13 (54%) were hybrid procedures involving right carotid-subclavian bypass or transposition and thoracic endovascular aortic repair. The mean diameter of ARSA at its origin was 20.4 ± 5.7 mm, and the mean cross-sectional aortic diameter at the level of the ARSA was 31.8 ± 8.5 mm for the entire cohort. For the patients who had initially been observed and had subsequently required intervention, the largest change in the ARSA cross-sectional diameter was observed 1 cm distally to the vessel ostium at a rate of 3.05 mm annually (95% confidence interval, 1.54-4.56; P < .001). No statistically significant changes in the annual growth rate of the aortic segments were observed in the entire cohort or for those patients who had undergone intervention (P > .05). CONCLUSIONS: The decision to intervene on an ARSA should be individualized by the presence of symptoms (eg, dysphagia lusoria) or complications (eg, dissection, concomitant aortic aneurysmal disease, enlarging Kommerell diverticulum). Asymptomatic patients with nonaneurysmal ARSA might not require any intervention and can be safely observed. Measurement of the cross-sectional ARSA diameter 1 cm distally to the ostium of the vessel might aid in the surveillance of vessel diameter changes. Additional studies are required to determine the specific size criteria as an indication for operative repair of asymptomatic Kommerell diverticulum.

Outcomes and role of peripheral revascularization in type A aortic dissection presenting with acute lower extremity ischemia.

OBJECTIVE: Limited data exists on management and outcomes of patients presenting with type A aortic dissection (TAAD) and acute lower extremity ischemia (ALI). The role of limb-related revascularization and optimal treatment strategy remains undefined. The objective of this study was to analyze dissection characteristics, treatment modalities, and outcomes of patients undergoing proximal aortic repair for TAAD with ALI. METHODS: Consecutive patients who underwent proximal aortic repair for TAAD were identified from a prospectively maintained database. Clinical data, imaging, operative details, and outcomes of patients with TAAD and ALI were retrospectively analyzed. Kaplan-Meier methodology was used to estimate overall and amputation-free survival. Log-rank tests were used to compare overall curves. Predictors of revascularization and in-hospital mortality were determined using multivariable logistic regression analysis. RESULTS: From 2010 to 2018, 463 patients with TAAD underwent proximal aortic repair. A total of 81 patients (17%) presented with ALI; 48% (39/81) with isolated ALI, and 52% (42/81) with ALI and renovisceral malperfusion. Thirty percent (24/81) required revascularization in addition to proximal aortic repair. Revascularization strategies involved endovascular (46%; 11/24), open (33%; 8/24), and hybrid (21%; 5/24) interventions. The major amputation rate was 4% (3/81), and in-hospital mortality was 21% (17/81). Amputation-free survival was significantly lower in patients requiring revascularization compared with those who did not (log-rank P = .023). Overall survival did not significantly differ between the two groups (log-rank P = .095). Overall survival was significantly lower in patients with concomitant ALI and renovisceral malperfusion compared with those with isolated ALI (log-rank P = .0017). Distal extent of dissection flap into zone 11 (odds ratio [OR], 5.65; 95% confidence interval [CI], 1.58-20.2; P = .008) and partial/complete thrombosis of any iliac artery (OR, 3.94; 95% CI, 1.23-12.6; P = .021) were associated with increased risk of requiring an additional revascularization procedure. True lumen collapse at level of renovisceral aorta (OR, 8.84; 95% CI, 1.74-44.9; P = .0086) was associated with increased risk of in-hospital mortality. CONCLUSIONS: ALI resolves after proximal aortic repair of TAAD in most cases. Distal extent of aortic dissection into zone 11 and iliac thrombosis are risk factors for additional peripheral revascularization. True lumen collapse at the renovisceral aorta and TAAD with concomitant ALI and renovisceral malperfusion portends a poor prognosis. A multi-disciplinary team approach to manage these patients who present with ascending aortic dissection and distal malperfusion may improve outcomes in this complex population.

Secondary Interventions After TEVAR for Aortic Dissection.

The goal of thoracic endograft placement in type B aortic dissection is to prevent aneurysmal degeneration and other complications. Although TEVAR is a highly effective tool for managing type B aortic dissection, many patients will require additional interventions. In this article, we present a case-based review of techniques for the management of persistent false lumen perfusion and stent-graft induced new entry tears after TEVAR for aortic dissection.

Three-Dimensional Holographic Guidance, Navigation, and Control (3D-GNC) for Endograft Positioning in Porcine Aorta: Feasibility Comparison With 2-Dimensional X-Ray Fluoroscopy.

OBJECTIVES: Intraprocedural deployment of endovascular devices during complex aortic repair with 2-dimensional (2D) x-ray fluoroscopic guidance poses challenges in terms of accurate delivery system positioning and increased risk of x-ray radiation exposure with prolonged fluoroscopy times, particularly in unfavorable anatomy. The objective of this study was to assess feasibility of using an augmented reality (AR) system to position and orient a modified aortic endograft delivery system in comparison with standard fluoroscopy. MATERIALS AND METHODS: The 3-dimensional guidance, navigation, and control (3D-GNC) prototype system was developed for eventual integration with the Intra-Operative Positioning System (IOPS, Centerline Biomedical, Cleveland, OH) to project spatially registered 3D holographic representations of the subject-specific aorta for intraoperative guidance and coupled with an electromagnetically (EM) tracked delivery system for intravascular navigation. Numerical feedback for controlling the endograft landing zone distance and ostial alignment was holographically projected on the operative field. Visualization of the holograms was provided via a commercially available AR headset. A Zenith Spiral-Z AAA limb stent-graft was modified with a scallop, 6 degree-of-freedom EM sensor for tracking, and radiopaque markers for fluoroscopic visualization. In vivo, 10 interventionalists independently positioned and oriented the delivery system to the ostia of renal or visceral branch vessels in anesthetized swine via open femoral artery access using 3D-GNC and standard fluoroscopic guidance. Procedure time, fluoroscopy time, cumulative air kerma, and contrast material volume were recorded for each technique. Positioning and orientation accuracy was determined by measuring the target landing-zone distance error (δLZE) and the scallop-ostium angular alignment error (θSOE) using contrast-enhanced cone beam computed tomography imaging after each positioning for each technique. Mean, standard deviation, and standard error are reported for the performance variables, and Student's t tests were used to evaluate statistically significant differences in performance mean values of 3D-GNC and fluoroscopy. RESULTS: Technical success for the use of 3D-GNC to orient and position the endovascular device at each renal-visceral branch ostium was 100%. 3D-GNC resulted in 56% decrease in procedure time in comparison with standard fluoroscopic guidance (p<0.001). The 3D-GNC system was used without fluoroscopy or contrast-dye administration. Positioning accuracy was comparable for both techniques (p=0.86), while overall orientation accuracy was improved with the 3D-GNC system by 41.5% (p=0.008). CONCLUSIONS: The holographic 3D-GNC system demonstrated improved accuracy of aortic stent-graft positioning with significant reductions in fluoroscopy time, contrast-dye administration, and procedure time.

A Novel Solution to Concomitant Type Ia/Type IIIa Endoleak Using the Cook Zenith Fenestrated Device and Endologix AFX®2.

Failing EVAR is typically treated with open explant or conversion to fenestrated endovascular repair. Novel solutions for EVAR salvage may be required in patients unable to tolerate explant or travel to centers with custom-fenestrated capabilities. However, strategies utilizing commercially available devices are often limited by anatomic constraints such as short renal artery to endograft bifurcation length. We present a case of progressive sac expansion due to late, concomitant type Ia and type IIIa endoleaks. The patient was successfully treated by proximal extension into the visceral segment using a Cook Zenith Fenestrated device and graft relining using the Endologix AFX®2.

Impact of bridging stent design and configuration on branch vessel durability after fenestrated endovascular repair of complex aortic aneurysms.

OBJECTIVE: The ideal mating stent for target vessel revascularization in fenestrated endovascular aneurysm repair (FEVAR) of juxtarenal and thoracoabdominal aortic aneurysms remains unknown. The objective of this study was to assess the outcomes associated with use of different stent types and configurations mated with reinforced fenestrations during FEVAR. METHODS: Clinical data from patients undergoing FEVAR for juxtarenal and thoracoabdominal aortic aneurysms in a prospective physician-sponsored investigational device exemption trial were analyzed. Outcomes for two different balloon-expandable covered stents (BECSs) mated with reinforced fenestrations were assessed along with the impact of distal extension with a self-expanding stent (SES). Primary patency, branch-related endoleak, and reintervention rates were determined. Cox proportional hazards model was used for time-to-event analysis. RESULTS: From 2001 to 2016, there were 918 patients who underwent fenestrated or branched endograft repair of complex aortic aneurysms; 1604 renal arteries (RAs), 714 superior mesenteric arteries (SMAs), and 333 celiac arteries (CAs) were mated with reinforced fenestrations using JOMED (n = 2014; Abbott Vascular, Santa Clara, Calif) or iCAST (n = 637; Atrium Medical, Hudson, NH) BECSs. The type of BECS did not affect short-term or long-term patency, branch-related endoleaks, or reintervention rates in the RA, SMA, or CA. Twenty-five percent (402/1604) of RAs, 84% (598/714) of SMAs, and 8% (27/333) of CAs underwent distal SES extension at the index operation. RAs with a distal SES in addition to the BECS had a higher likelihood of an occlusion event (hazard ratio, 2.791; 95% confidence interval, 1.42-5.48; P = .003) and reinterventions (P = .036) compared with those without an SES. Addition of a distal SES to the BECS in the SMA or CA did not have an impact on patency or reintervention rates. CONCLUSIONS: BECS choice does not appear to have an impact on branch durability after FEVAR. Selective distal SES placement in RAs with high-risk anatomy does not appear to significantly protect against an occlusion event or to prevent secondary interventions. Routine addition of a distal SES does not improve SMA fenestration durability.

Midterm outcomes of subclavian artery revascularization in the setting of thoracic endovascular aortic repair.

OBJECTIVE: The outcomes of subclavian artery revascularization (SAR) have been examined extensively in the setting of atherosclerotic occlusive disease but have been poorly characterized in the setting of thoracic endovascular aortic repair (TEVAR). As trials for branched thoracic endovascular stent grafts materialize, the outcomes of the subclavian artery branched prosthesis will need to be compared with TEVAR with SAR by carotid-subclavian bypass or subclavian transposition. METHODS: A database of 1516 patients undergoing TEVAR from 2000 to 2015 was queried. Of those undergoing TEVAR, 19% (282 patients) also underwent SAR. Patient demographics, TEVAR indication, 30-day morbidity and mortality, and midterm patency and survival were analyzed. RESULTS: During the study period, 282 patients underwent 288 SARs in the setting of TEVAR. A total of 269 (93%) carotid-subclavian bypasses and 19 (7%) subclavian artery transpositions were performed; 76% of the SARs occurred before TEVAR, 14% occurred concurrently with TEVAR, and 10% occurred after TEVAR. The most common indications for TEVAR was aortic aneurysm (56%), chronic aortic dissection with aneurysmal degeneration (23%), and aortic dissections (13%). The 30-day ipsilateral stroke rate was 3.5%. Eight patients (2.8%) underwent an unplanned return to the operating room (2.1% for hematoma evacuation and 0.7% for management of chyle leak). Six patients (2.1%) sustained a nerve injury. The mean follow-up was 4.2 years. All-cause 30-day mortality was 4.6%. The overall survival rates at 1 year, 5 years, and 10 years were 82%, 60%, and 42%, respectively. The median survival was 7.2 years. Four patients were found to have a failure in primary patency during follow-up. All four patients had undergone a carotid-subclavian bypass. The 1-, 2-, and 5-year primary patency rates were 99.5%, 98.9%, and 98.0%, respectively, for carotid-subclavian bypass and 100% for carotid-subclavian transposition. CONCLUSIONS: During our 16-year study, we found SAR in the setting of TEVAR to be associated with low morbidity, durable long-term patency, and infrequent need for reintervention.

Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers.

OBJECTIVE: Chronic venous leg ulcers (VLUs) affect up to 2% of the general population, resulting in a significant socioeconomic burden. Placental tissue that contains mesenchymal stem cells and active growth factors has been shown to be beneficial in healing of chronic wounds. We compared the efficacy of a human viable wound matrix (hVWM) of cryopreserved placental tissue for the treatment of refractory VLUs with standard therapy. METHODS: This prospective single-center open-label single-arm study enrolled patients with Clinical, Etiology, Anatomy, and Pathophysiology clinical class C6 VLUs. The ulcers of all enrolled patients had failed to heal after a trial of standard therapy of at least 12 weeks, which included weekly multilayer compression therapy along with local wound care. The same patients subsequently received application of hVWM (Grafix; Osiris Therapeutics, Columbia, Md) every 1 to 2 weeks in addition to standard therapy. Healing with hVWM therapy was then compared with standard therapy, with each patient serving as his own control. RESULTS: There were 30 VLUs in 21 consecutive eligible patients who were enrolled in the study. All patients were men with an average age of 67 years (standard deviation [SD], ±10.8 years), and the average area of venous ulcers before hVWM initiation was 12.2 cm2 (SD, ±14.6 cm2; range, 3.3-12.3 cm2). Duplex ultrasound confirmed superficial or deep system venous reflux in all patients. Complete ulcer healing was achieved in 53% (16/30) of VLUs refractory to standard therapy after application of hVWM. There was a mean reduction in wound surface area by 79% (SD, ±27.3%; P < .001 compared with standard therapy) after a mean treatment time of 10.9 weeks. Eighty percent of VLUs were reduced in size by half compared with 25% with standard therapy (P < .001). The mean rate of reduction in ulcer area after hVWM applications was 1.69% per day vs 0.73% per day with standard therapy (P = .01). CONCLUSIONS: Cryopreserved placental tissue (hVWM) improves healing processes to achieve complete wound closure in a significant proportion of chronic VLUs refractory to standard therapy. Adjunctive therapy with hVWM provides superior healing rates in refractory VLUs.

Management of failed endovascular aortic aneurysm repair with explantation or fenestrated-branched endovascular aortic aneurysm repair.

OBJECTIVE: The incidence of failed endovascular aneurysm repair (EVAR) is increasing, and understanding the different methods of management and repair is paramount. The objective of this study was to evaluate the clinical management and rescue of failed EVAR by either explantation or fenestrated-branched EVAR (F/B-EVAR). METHODS: A retrospective analysis (1999-2016) of 247 patients who underwent either explantation (n = 162) or F/B-EVAR (n = 85) for failed EVAR was performed. F/B-EVAR was performed under a physician-sponsored investigational device exemption. Demographics of the patients, clinical presentation and failure etiology, perioperative management, rate of reinterventions, morbidity, and mortality were analyzed. Those undergoing surgical explantation were compared with those undergoing F/B-EVAR conversion. Statistical analysis included multivariable logistic regressions, Fisher exact test, and χ2 test. RESULTS: The majority of patients were male (n = 216 [87%]), with a mean age of 75 years (range, 50-93 years). The mean time from primary EVAR was higher in F/B-EVAR (46 ± 7 months vs 69 ± 41 months; P < .001). Graft manufacturer did not differ between those requiring explantation and those having endovascular rescue (P = .170). All emergencies (n = 24 [10%]) and infections (n = 28 [11%]) were treated with open conversion. Endoleak was the most common reason for failure in both explantation and F/B-EVAR groups (75% vs 64%, respectively; P = .052). Type I endoleak was the most common endoleak reported in both groups, occurring more frequently in F/B-EVAR (64% vs 40%; P < .001); type II endoleak was more common in those undergoing open repair (28% vs 2%; P < .001). Graft migration (12% vs 26%; P = .005) and neck degeneration/disease progression (14% vs 59%; P < .001) were more prevalent in F/B-EVAR, but aneurysm enlargement was more common in explantation (68% vs 33%; P < .001). Thirty-day reintervention rates did not differ between F/B-EVAR and explantation (odds ratio, 0.6258; 95% confidence interval, 0.2-1.86; P = .4115); however, 30-day mortality was lower in the F/B-EVAR group (5% vs 10%; P = .0192). Similarly, aneurysm-related mortality was also lower in the F/B-EVAR group (hazard ratio, 0.0683; 95% confidence interval, 0.01-0.44; P = .0048). A subset analysis excluding emergencies and infections did not alter the lack of difference in terms of freedom from reinterventions (P = .1175), 30-day mortality (P = .6329), or aneurysm-related mortality (P = .7849). CONCLUSIONS: Explantation and F/B-EVAR are necessary options in treating patients with failed EVAR, and both techniques have competitive results. Different modes of failure may point to a preferred method of treatment; consequently, rescue of failed EVAR should be individualized according to each patient's presentation and resources available.

Durability of iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms.

OBJECTIVE: This study evaluated and compared the long-term clinical outcomes of endovascular repair of infrarenal aortoiliac aneurysms (EVAR) vs EVAR with preservation of antegrade internal iliac artery (IIA) perfusion using iliac branched devices (EVAR-IBDs). METHODS: From October 1998 to August 2015, patients with infrarenal aortoiliac aneurysmal (AIA) disease at high risk for conventional open surgery were enrolled in a prospective physician-sponsored investigational device exemption trial. Clinical data of 75 patients treated with EVAR-IBD and 255 with standard EVAR were analyzed. Technical success, perioperative outcomes, mortality, device patency, endoleak rates, and reinterventions during a follow-up of 10 years were analyzed. RESULTS: There were 87 IBDs deployed in 75 patients. Technical success rate was 97%. Mortality at 30 days was 1.3%. Freedom from aneurysm-related mortality at 3, 5, and 10 years was 99%. Freedom from a type I or III endoleak at 3, 5, and 10 years was 99%. Freedom from secondary reinterventions at 3, 5, and 10 years was 86%, 81%, and 81%, respectively. Primary patency of the IBDs at 3, 5, and 10 years was 94%, 94%, and 77%, respectively. Twenty-four percent of patients underwent EVAR for concomitant AIA disease (EVAR-AIA), and 78% were managed by staged IIA embolization before EVAR. No statistically significant difference in freedom from aneurysm-related mortality, limb occlusions, or endoleak rates was identified in patients with EVAR-AIA vs EVAR-IBD (P > .05). There were significantly more secondary reinterventions in the EVAR-AIA group compared with the EVAR-IBD group (hazard ratio, 0.476, 95% confidence interval, 0.226-1.001; P = .045). CONCLUSIONS: EVAR of infrarenal AIAs with preservation of antegrade flow to the IIA using IBDs is feasible with long-term sustained durability. Serious considerations should be given to the use of IBDs in patients with infrarenal AIAs meeting appropriate anatomic criteria.