Long-term clinical outcomes of arterial bypass, and the factors independently associated with the primary patency of arterial bypass in patients with suprainguinal arterial occlusion.

INTRODUCTION: Aortoiliac occlusive disease and iliofemoral occlusion are impact patient quality of life, cause limb loss and mortality. The aim of this study was to investigate the long-term clinical outcomes of arterial bypass, and the factors associated with the outcomes. METHOD: This retrospective chart/image review included all types of arterial bypass procedures performed for suprainguinal arterial occlusion during January 2004 to December 2017. The primary outcome was the primary patency. The secondary outcomes were the secondary patency, amputation-free survival, overall survival and the factors associated with the outcomes. RESULT: A total of 135 patients (107 males) were included. The median age was 65 years. The 1-year, 5-year, and 10-year primary patency rates were 74.3%, 65.7%, and 55.6%, respectively, with independent predictors of poor outcomes being underlying cerebrovascular disease (p = 0.003) and postoperative graft infection (p = 0.016). Secondary patency rates at 1-year, 5-year, and 10-year intervals were 90.1%, 87.1%, and 77.8%, respectively, with independent predictors of poor outcomes being underlying cardiovascular disease (p = 0.013) and postoperative acute kidney injury (p = 0.010). Amputation-free survival rates at 1-year, 5-year, and 10-year intervals were 77.1%, 71.6%, and 66.0%, respectively, with the independent predictor of poor outcome being preoperative foot infection (p = 0.013). Overall survival rates at 1-year, 5-year, and 10-year intervals were 84.4%, 58.6%, and 35.3%, respectively, with independent predictors of poor outcomes being chronic kidney disease (p = 0.030) and postoperative myocardial infarction (p = 0.018). However, antiplatelet therapy emerged as an independent predictor of favorable overall survival outcomes (p = 0.034). CONCLUSION: Our results showed the primary patency rates of arterial bypass to be relatively low at our center; however, most grafts could be saved with high secondary patency. Both disease-associated factors and patient condition-associated factors were found to influence the outcomes of this fragile patient population.

Navigating Challenges in the Endovascular Treatment of Asymptomatic Aortoiliac Aneurysms: A 10-Year Comparative Analysis.

BACKGROUND: Treating an abdominal aortoiliac aneurysm (AAIA) with endovascular methods can be challenging when the internal iliac artery (IIA) is involved. Embolizing the IIA and extending the limb to the external iliac artery (IIAE + EE) to prevent a type 2 endoleak may lead to pelvic ischemic complications. To avoid these complications, strategies that preserve the IIA, such as the bell-bottom technique (BBT) and the iliac branch device (IBD), have been proposed. This study aims to compare the outcomes of these three endovascular approaches for AAIA. METHODS: Between January 2010 and December 2019, 174 patients with asymptomatic AAIA were enrolled in this retrospective analysis. They were divided into two groups: 81 patients underwent non-IIAE procedures, and 93 patients underwent IIAE procedures. The iliac limb study group consisted of 106 limbs treated with the BBT, 113 limbs treated with the IIAE + EE, and 32 limbs treated with the IBD. The primary outcomes included the 30-day mortality rate and intraoperative limb complications. The secondary outcomes included postoperative pelvic ischemia, freedom from reintervention, and the overall 10-year survival rate. RESULTS: There was no significant difference in the perioperative mortality rate between the non-IIAE group (0%) and the IIAE group (2.1%), p = 0.500. The intraoperative limb complications did not differ significantly between the BBT limbs (7.5%), the IIAE + EE limbs (3.5%), and the IBD limbs (3.1%) groups, p = 0.349. The incidence of buttock claudication was significantly greater in the bilateral IIAE + EE group compared to the unilateral IIAE + EE and non-IIAE groups (25%, 11%, and 2.5%, p-value < 0.004), and was similar to the incidence of buttock rest pain with skin necrosis (15%, 0%, and 0%, p < 0.001). During the 10-year follow-up, the BBT limbs group had a significantly lower rate of iliac limb reintervention free time than the IIAE + EE limbs and the IBD limbs groups (88.7%, 98.2%, and 93.8%, p = 0.016). There was no significant difference in the overall 10-year survival rate between the non-IIAE and IIAE groups (51.4% vs. 55.9%, p = 0.703). CONCLUSIONS: The early and late mortality rates were similar between the non-IIAE and IIAE groups. Preserving the IIA is recommended to avoid pelvic ischemic complications. Considering the higher rate of reintervention in the BBT group, the IBD strategy may be preferred for AAIA.

The Correlation of Aortic Neck Angle and Length in Abdominal Aortic Aneurysm with Severe Neck Angulation for Prediction of Intraoperative Neck Complications and Postoperative Outcomes after Endovascular Aneurysm Repair.

OBJECTIVES: Endovascular aneurysm repair (EVAR) in a hostile neck has been associated with adverse outcomes. We aimed to determine the association of infrarenal aortic neck angle and length and establish an optimal cutoff value to predict intraoperative neck complications and postoperative outcomes. METHODS: This was a retrospective review of patients with an intact infrarenal abdominal aortic aneurysm (AAA) with severe neck angulation (>60 degrees) who underwent EVAR from October 2010 to October 2018. Demographic data, aneurysm morphology, and operative details were collected. The ratio of neck angle and length was calculated as the optimal cutoff value of the aortic neck angle-length index. The patients were categorized into two distinct groups using latent profile analysis, a statistical technique employed to identify concealed subgroups within a larger population by examining a predetermined set of variables. Intraoperative neck complications, adjunct neck procedures, and early and late outcomes were compared. RESULTS: 115 patients were included. Group 1 (G1) had 95 patients with an aortic neck angle-length index ≤ 4.8, and Group 2 (G2) had 20 patients with an aortic neck angle-length index > 4.8. Demographic data and aneurysm morphology were not significantly different between groups except for neck length (p < 0.001). G2 had more intraoperative neck complications than G1 (21.1% vs. 55%, p = 0.005). Adjunctive neck procedures were more common in G2 (18.9% vs. 60%, p < 0.001). The thirty-day mortality rate was not statistically different. G1 patients had a 5-year proximal neck re-intervention-free rate comparable to G2 patients (93.7% G1 vs. 87.5% G2, p = 0.785). The 5-year overall survival rate was not statistically different (59.9% G1 vs. 69.2% G2, p = 0.891). CONCLUSIONS: Patients with an aortic neck angle-length index > 4.8 are at greater risk of intraoperative neck complications and adjunctive neck procedures than patients with an aortic neck angle-length index ≤ 4.8. The 5-year proximal neck re-intervention-free rate and the 5-year survival rate were not statistically different. Based on our findings, this study suggests that the aortic neck angle-length index is a reliable predictor of intraoperative neck complications during EVAR in AAA with severe neck angulation.

Prevalence and predictors of combined >50% iliocaval venous obstruction and superficial venous reflux in chronic venous insufficiency patients with healed or active venous leg ulcer.

OBJECTIVE: The aim of the present study was to investigate the prevalence and predictors of combined >50% iliocaval venous obstruction (ICVO) and superficial venous reflux (SVR) in patients with chronic venous insufficiency (CVI) with a healed (C5) or an active (C6) venous leg ulcer (VLU). METHODS: We conducted a retrospective review of prospectively collected data from patients with CVI with CEAP (Clinical, Etiology, Anatomy, Pathophysiology) class C5 (healed ulcer) or C6 (active ulcer) with SVR who had been treated at our institution from February 2017 to January 2018. The demographic, clinical, and surgical data and duplex ultrasound and computed tomography venography findings were collected. We used OsiriX MD, version 2.9, software (Pixmeo SARL, Bernex, Switzerland) to measure the vein diameter via multiplanar reconstruction. The prevalence of combined >50% ICVO and SVR was evaluated, and univariate and multivariate analyses were performed to identify the independent predictors of >50% ICVO in patients with CVI and SVR. RESULTS: A total of 79 limbs from 67 patients were enrolled. The mean age was 59.82 ± 12.86 years, the mean body mass index was 28.68 ± 6.41 kg/m2, and 41.8% were men. The prevalence of >50% ICVO in the patients with SVR was 31.6%. Univariate analysis showed a history of deep vein thrombosis (DVT) in the affected leg (P = .001), a VLU in the left leg (P = .033), a history of a recurrent VLU (P = .038), and reversed flow in the superficial epigastric vein (P = .004) were significantly associated with >50% ICVO in patients with CVI and SVR. Multivariate analysis revealed a history of DVT in the affected leg (adjusted odds ratio [aOR], 8.31; 95% confidence interval [CI], 2.29-30.19; P = .001), a VLU in the left leg (aOR, 3.95; 95% CI, 1.18-13.19; P = .026), and a history of a recurrent VLU (aOR, 3.08; 95% CI, 1.02-9.32; P = .047) to be independently associated with combined >50% ICVO and SVR in patients with CVI. CONCLUSIONS: The prevalence of combined >50% ICVO and SVR in patients with CVI and CEAP C5 or C6 was 31.6%. The independent predictors of combined >50% ICVO and SVR in those with CVI were a history of DVT in the affected leg, a VLU in the left leg, and recurrent VLUs.

The Geriatric Nutritional Risk Index predicts amputation after infrapopliteal angioplasty in critical limb ischemia patients.

OBJECTIVE: To validate the Critical Limb Ischemia Frailty Index (CLIFI), and to identify independent predictors of 2-year amputation-free survival after infrapopliteal endovascular treatment for chronic limb-threatening ischemia (CLTI) in Thai patients. METHODS: This retrospective study was conducted during the June 2014 to February 2017 study period. CLTI patients treated with infrapopliteal angioplasty were enrolled and analyzed. A patient was defined as CLIFI positive if two or more of the following criteria were present: Geriatric Nutritional Risk Index (GNRI) < 89.8, low skeletal muscle mass index (<6.87 kg/m2 in males, and <5.46 kg/m2 in females), and/or non-ambulatory status. Kaplan-Meier survival analysis was used to assess 2-year amputation-free survival (AFS), and comparisons were performed using log-rank test. Univariate and multivariate Cox proportional hazards models were used to analyze for significant and independent association, respectively, between preoperative characteristics and AFS. RESULTS: A total of 266 patients and 286 limbs were included. Forty (15.0%) patients were CLIFI positive, and 226 (85.0%) patients were CLIFI negative. The 2-year amputation-free survival rate was 90.3% in the CLIFI positive group, and 86.6% in the CLIFI negative group (p = 0.59). Multivariate analysis revealed the GNRI to be an independent risk factor for amputation within two years after infrapopliteal revascularization (adjusted hazard ratio: 4.87, 95% confidence interval: 1.20-19.70; p = 0.02). CONCLUSIONS: The GNRI was found to independently predict 2-year amputation after infrapopliteal angioplasty in Thai CLTI patients; however, the CLIFI was not found to significantly predict 2-year amputation in this patient population.

Early and Late Outcomes of Endovascular Aneurysm Repair for Infected Abdominal Aortic and/or Iliac Aneurysms.

BACKGROUND: Infected abdominal aortic and/or iliac aneurysm (AAIA) is a rare condition with a high mortality rate when treated with open surgery. In the past decade, the condition has increasingly been treated with endovascular aneurysm repair (EVAR). However, early and late outcomes, including the continued need for antibiotic treatments and predictors of persistent infection, are poorly understood. METHODS: We evaluated the outcomes of patients who underwent EVAR for infected AAIA from January 2010 to October 2017. We collected data including patient age, gender, clinical presentation, aneurysm location, culture results, intraoperative details, postoperative complications, 30-day mortality, in-hospital mortality, persistent infection, reintervention, and survival. RESULTS: Among 792 patients diagnosed with AAIA, 64 were diagnosed with primary infected aneurysm, underwent EVAR, and were included in this study (81.3% male; median age, 72 years; range, 18-94 years). The most commonly isolated organisms were Salmonella species (34%), followed by Streptococcus (21%), and Staphylococcus species (21%). Aneurysms were intact in 48 patients (75%) and were ruptured in 16 (25%). The perioperative mortality was 4.7% (3 patients) of whom one was diagnosed with ruptured infected AAIA. Six (9.4%) patients died during hospitalization, 5 of severe sepsis with multiorgan failure and one of myocardial infarction. Among the 58 surviving patients, 34 (58.6%) had persistent infection, of whom 13 (22.4%) required early and late reintervention, including 2 with endograft infection, 8 with primary and secondary aortoenteric fistula, 2 with recurrent new aortic infection, and one with graft limb occlusion. The remaining 24 patients were able to discontinue antibiotics and had no recurrence or need for reintervention. Overall survival rates at 1, 3, and 5 years in the antibiotic-discontinuation group were 91.7%, 87.5%, and 68.0%, respectively, and 82.4%, 52.6%, and 32.9%, respectively, in the persistent-infection group (P = 0.009). In multivariable analysis, primary aortoenteric fistula (Adjusted OR [aOR], 20.469; 95% confidence interval (CI), 1.265-331.320; P = 0.034) and preoperative serum albumin level <3 g/dL (aOR, 7.399; 95% CI, 1.176-46.558; P = 0.033) were preoperative parameter that predicted persistent infection. A C-reactive protein level more than 5 mg/L (aOR, 34.378; 95% CI, 4.888-241.788; P < 0.001) was observed in patients with persistent infection. CONCLUSIONS: EVAR is a feasible treatment with acceptable perioperative mortality for infected AAIA. Patients able to discontinue antibiotics have better survival and lower reintervention rates than those with persistent infection. A preoperative albumin level below 3 g/dL and primary aortoenteric fistula predicted persistent infection in this population.

Low Psoas Muscle Area is Associated with Increased Mortality and Spinal Cord Injury After Complex Endovascular Aortic Aneurysm Repair.

BACKGROUND: Low psoas muscle area (PMA) is associated with worse post-operative outcomes. Our objective was to evaluate the association of PMA and postoperative outcomes in patients undergoing fenestrated/branched endovascular aneurysm repair (F/BEVAR). METHODS: Patient characteristics, anatomical and clinical information, and post-operative outcomes were collected from patients undergoing F/BEVAR between 2005-February 2019 who were deemed too high-risk for open repair. PMA was measured using a validated web-based software (coreslicer.com). Post-operative outcomes were compared between patients with low PMA (lowest quartiles) and high PMA (highest quartiles). RESULTS: We included 129 patients with a mean age of 74.6 ± 8.1, 81.4% male, and a mean follow-up of 29.4 ± 32.2 months. Patients in the low PMA group were more likely to be female (33.8% vs. 3.1%, P < 0.0001), less likely to have hypertension (72.3% vs. 87.5%, P = 0.03), dyslipidemia (63.1% vs. 78.1%, P = 0.06), and a trend towards a greater history of endovascular aneurysm repair (4.6% vs. 0%, P = 0.08). There were no significant differences in aneurysm or device characteristics between groups. In a multivariate model including age, sex, aneurysm type, and presence of prophylactic spinal drain, the low PMA group had a significantly increased risk of spinal cord injury (odds ratio 12.7, 95% CI 1.1-143.6). There were no significant differences in other 30-day outcomes. When compared to the highest quartile, the lowest PMA quartile patients had a hazard ratio of 4.6 (95% CI 1.2-17.6) for mortality during follow-up in a model with age, sex, and aneurysm type. For each 1 cm2 increase in PMA, the HR was 0.90 (95% CI 0.82-0.99) for mortality during follow-up. CONCLUSIONS: In high-risk patients undergoing F/BEVAR low PMA is associated with spinal cord injury and mortality during follow-up. We found no association between PMA and 30-day mortality. PMA measurement is a simple method to assess for sarcopenia and frailty and may be useful for risk stratification pre-operatively.

Thrombus extension after cyanoacrylate closure of incompetent saphenous veins.

BACKGROUND: Cyanoacrylate closure (CAC) is a minimally invasive surgery to treat incompetent saphenous veins. This study aimed to investigate the incidence, the risk factors for, and the management of thrombus extension after cyanoacrylate closure (TEACAC) of incompetent saphenous veins in patients with chronic venous disease. METHODS: This retrospective study included patients aged >18 years who were diagnosed with chronic venous disease with superficial venous reflux in the great saphenous vein, anterior accessory saphenous vein, or small saphenous vein, and who were treated with CAC at Siriraj Hospital (Bangkok, Thailand) during January 2017 to December 2018. RESULTS: A total of 126 saphenous veins of 101 patients were included. TEACAC occurred in 5 of 101 (4.9%) patients, and in 5 of 126 (3.9%) treated saphenous veins. The mean follow-up time was 285±12 days. Based on Kabnick classification of endovenous heat-induced thrombosis (EHIT), the following TEACAC grades were observed: grade I (N.=2), grade II (N.=1), grade III (N.=2), and grade IV (N.=0). No patient or procedural predictive factors for TEACAC were identified. In patients with TEACAC-1 or TEACAC-2, the thrombus spontaneously disappeared by the 2-week follow-up. Patients with TEACAC-3 received therapeutic rivaroxaban or dabigatran, which resolved the thrombus within 2-4 weeks. No deep vein thrombosis or symptomatic pulmonary embolism was found. CONCLUSIONS: TEACAC was found not to be a rare complication after CAC. All patients should be informed of the risk of TEACAC prior to treatment. Treatment of TEACAC class 1-3 following EHIT guideline seems to be both safe and effective.

Mortality and Major Adverse Events Improve With Increased Institutional Experience for Fenestrated and Branched Endovascular Aortic Repair.

OBJECTIVE: Our objective was to evaluate temporal trends in outcomes at our institution in the context a more heterogenous application of fenestrated/branched endovascular aneurysm repair (F/BEVAR). METHODS: Patient and aneurysm characteristics, procedure details, and postoperative outcomes were collected for consecutive patients undergoing F/BEVAR between 2002 and February 2019 at our institution. Outcomes were compared between tertile 1 (T1, 2002-2010, n=47), T2 (2011-2014, n=47), and T3 (2015-February 2019, n=47). RESULTS: We included 141 patients (74.8 ± 8.1 years, 83% male) with a mean follow-up of 28.0 ± 31.6 months. Proportion of patients with hypertension (63.8% T1, 85.1% T3, p=0.009), diabetes (6.4% T1, 29.7% T3, p=0.005), chronic obstructive pulmonary disease (COPD; 27.6% T1, 42.5% T3, p=0.07), and history of stroke (4.2% T1, 17% T3, p=0.07) increased over time. Aneurysm diameter (65.3±11.4mm) and extent (56.0% juxtarenal/pararenal, 22.0% type IV, 22.0% type I-III) did not differ between groups. Custom made devices were implanted in 96.5% of cases with 3.4 ± 0.7 vessels reimplanted/case. There was a trend toward increased history of aortic surgery (p=0.008) and less custom made devices (p=0.007) in T3.Total procedure time (383.5±119.2 minutes T1, 316.2±88.4 T3, p=0.02), contrast volume (222.8±109.1 mL T1, 139.2±62.7ml T3, p<0.0001), and estimated blood loss (601.3±458.1 mL T1, 413.3±317.7 mL T3, p=0.02) decreased over time. Overall 30-day mortality was 6.3%, 10.6%-T1, 6.3%-T2, and 2.1%-T3 (p=0.09). We noted significant improvement in survival over time; 1- and 3-year survival was 79% and 56%, 89% and 83%, and 90% and 90%, for T1, T2, and T3, respectively (p=0.007). In all, 467 of 480 target vessels were revascularized (97.3% success). Reintervention rate (30-day: 13.5%, follow-up: 34.7%) and reintervention free survival was not significantly different between groups. Any major adverse event (MAE) occurred in 36.9% of patients overall with a significant decrease from early (51.1%), mid (34.9%), to late in our experience (25.5%, p=0.03). In multivariate analyses, increasing institutional experience (T3), procedure time, age, and sex were independent predictors of major adverse events. CONCLUSION: We have shown improvement in F/BEVAR outcomes including mortality, MAEs, and procedural metrics with increasing institutional experience. We postulate that a combination of advancements in technique, surgical team and postoperative care experience, graft design and stent technologies, and patient selection contributed to improvement in outcomes.

Novel culture media enhances mononuclear cells from patients with chronic limb-threatening ischemia to increase vasculogenesis and anti-inflammatory effect.

BACKGROUND: Quality and Quantity culture media (QQ culture media) was reported to enhance vasculogenesis and angiogenesis function of mononuclear cells (MNCs) from healthy volunteers. In this study, MNCs from chronic limb-threatening ischemia (CLTI) patients were cultured in QQ culture media, and then investigated for angiogenesis-related phenotype and function. METHODS: Patients aged ≥ 18 years with CLTI caused by atherosclerosis of the lower extremities were prospectively recruited at Siriraj Hospital (Bangkok, Thailand) during July 2017-December 2018. Peripheral blood mononuclear cells (PBMNCs) were isolated from peripheral blood. PBMNCs were cultured in either QQ culture media or standard culture media. The number of CD34+CD133+ cells, CD206+ cells, CD4+CD25+CD127+ cells, colony formation assay, and human umbilical vein endothelial cell (HUVEC) tube formation assay in MNCs were compared between those cultured in QQ culture media and those cultured in standard culture media. RESULTS: Thirty-nine patients were included with a mean age of 69 ± 11 years. Diabetes mellitus was found in 25 (64%) patients. The percentage of CD34+CD133+ progenitor cells in MNCs cultured in QQ culture media and in MNCs cultured in standard culture media was 4.91 ± 5.30% and 0.40 ± 0.46%, respectively (p < 0.0001). The percentage of CD206+ cells in MNCs cultured in QQ culture media and in MNCs cultured in standard culture media was 19.31 ± 11.42% and 4.40 ± 2.54%, respectively (p < 0.0001). The percentage of inactive population of T regulatory cells (CD4+CD25+CD127+ cells) in MNCs cultured in standard culture media and in MNCs cultured in QQ culture media was 14.5 ± 10.68% and 1.84 ± 1.37%, respectively (p < 0.0001). The total number of colony-forming units from MNCs cultured in QQ culture media and in MNCs cultured in standard culture media was 8.86 ± 8.35 of 2 × 105 cells/dish, and 0.58 ± 1.05 of 2 × 105 cells/dish, respectively (p < 0.0001). The mean intensity of Dil-Ac-LDL uptake that incorporated into the HUVEC forming tube was 1.37 ± 0.88 in MNCs cultured in QQ culture media, and 0.78 ± 0.41 in MNCs cultured in standard culture media. (p < 0.0003). CONCLUSIONS: MNCs from CLTI patients that were cultured in QQ culture media had a significantly higher number of CD34+CD133+ cells and anti-inflammatory cells, and higher angiogenesis-related function compared to MNCs cultured in standard culture media.

Hypersensitivity reaction after cyanoacrylate closure of incompetent saphenous veins in patients with chronic venous disease: A retrospective study.

PURPOSE: The objective of this study was to evaluate the incidence of, the risk factors for, the nature of the disease, and the management of hypersensitivity reaction (HSR) after cyanoacrylate closure (CAC) of incompetent saphenous veins in patients with chronic venous disease. METHODS: Data consisting of all incompetent saphenous veins, including great saphenous veins, anterior accessory saphenous veins, and small saphenous veins, treated with CAC at Siriraj Hospital (Bangkok, Thailand) from January 2017 to December 2018 were retrospectively evaluated. RESULTS: A total of 126 saphenous veins, including 106 great saphenous veins (84.1%), 7 anterior accessory saphenous veins (5.6%), and 13 small saphenous veins (10.3%) of 126 limbs from 101 patients were included. A HSR occurred in 16 of 101 patients (15.8%), in 19 of 126 limbs (15.0%), and in 19 of 126 treated saphenous veins (15.0%). HSR-related erythema, itching, swelling, and pain occurred in 100.0%, 95.0%, 68.4%, and 52.6%, of HSR patients, respectively. HSR occurred 1 week after CAC. All HSR symptoms were mild, could be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antihistamine, and were resolved within 1 week. The risk factors for HSR were suprafascial saphenous vein with a depth <1 cm from the skin, and saphenous vein diameter of ≥8 mm. CONCLUSIONS: A HSR occurred in 15.8% of patients and in 15.0% of limbs after CAC. Risk factors for HSR were a suprafascial saphenous vein located close to the skin and a large saphenous vein. All HSR symptoms were mild in severity, occurred at 1 week after CAC, and were resolved within 1 week after treatment with nonsteroidal anti-inflammatory drugs and antihistamines. To prevent HSR, CAC should be avoided in suprafascial saphenous veins that are located close to the skin, and CAC in saphenous veins with a size of ≥8 mm should be performed with caution.

Early and late outcomes of endovascular aneurysm repair to treat abdominal aortic aneurysm compared between severe and non-severe infrarenal neck angulation.

BACKGROUND: Abdominal aortic aneurysm with severe infrarenal neck angle (>60°) has long been thought to be an obstacle to endovascular aneurysm repair. However, some previous studies reported endovascular aneurysm repair to be safe and efficacious for treating abdominal aortic aneurysm in patients with severe neck angulation. The aim of this study was to investigate the early and late outcomes of endovascular aneurysm repair to treat abdominal aortic aneurysm compared between patients with severe and non-severe infrarenal neck angulation. METHODS: Fifty-four severe and 144 non-severe neck angulation patients who were treated at Siriraj Hospital (Bangkok, Thailand) during January 2010-October 2013 were recruited. The primary endpoints were intraoperative neck complications (e.g., type 1A endoleak or proximal graft migration) and immediate adjunct aortic neck procedures. The secondary endpoints included perioperative mortality, overall survival, and the proportion of patients that were reintervention-free at five years compared between the severe and non-severe groups. RESULTS: Severe angulation patients were significantly older than non-severe angulation patients (77 ± 6.3 vs. 74 ± 7.9 years; p = 0.021). The median proximal angle was significantly greater in the severe group (82° vs. 13.5°; p < 0.001). Intraoperative proximal neck complications developed in 29.6% of patients in the severe angulation group compared with 9.0% in the non-severe group (p < 0.001). Significantly more patients in the severe group required intraoperative adjunct procedures (29.6% vs. 7.6%; p < 0.001). There was no significant difference in perioperative mortality between groups. At the five-year follow-up, there was no significant difference between groups for overall survival or the proportion of patients that remained reintervention-free. CONCLUSIONS: Endovascular aneurysm repair to treat abdominal aortic aneurysm in patients with severe proximal neck angulation is technically feasible and safe Although the severe angulation group had a higher rate of intraoperative neck complications and immediate adjunct neck procedures than the non-severe group, there was no significant difference between groups for 30-day mortality, overall survival or the proportion of patients who remained reintervention-free at five years.

Validation of a New Method for 2D Fusion Imaging Registration in a System Prepared Only for 3D.

Purpose: To validate a new 2D-3D registration method of fusion imaging during aortic repair in a system prepared only for 3D-3D registration and to compare radiation doses and accuracy. Materials and Methods: The study involved 189 patients, including 94 patients (median age 70 years; 85 men) who underwent abdominal endovascular aneurysm repair (EVAR) with 2D-3D fusion on an Artis zee imaging system and 95 EVAR patients (median age 70 years; 81 men) from a prior study who had 3D-3D registration done using cone beam computed tomography (CBCT). For the 2D-3D registration, an offline CBCT of the empty operating table was imported into the intraoperative dataset and superimposed on the preoperative computed tomography angiogram (CTA). Then 2 intraoperative single-frame 2D images of the skeleton were aligned with the patient's skeleton on the preoperative CTA to complete the registration process. A digital subtraction angiogram was done to correct any misalignment of the aortic CTA volume. Values are given as the median [interquartile range (IQR) Q1, Q3]. Results: The 2D-3D registration had an accuracy of 4.0 mm (IQR 3.0, 5.0) after bone matching compared with the final correction with DSA (78% within 5 mm). By applying the 2D-3D protocol the radiation exposure (dose area product) from the registration of the fusion image was significantly reduced compared with the 3D-3D registration [1.12 Gy∙cm2 (IQR 0.41, 2.14) vs 43.4 Gy∙cm2 (IQR 37.1, 49.0), respectively; p<0.001). Conclusion: The new 2D-3D registration protocol based on 2 single-frame images avoids an intraoperative CBCT and can be used for fusion imaging registration in a system originally designed for 3D-3D only. This 2D-3D registration protocol is accurate and leads to a significant reduction in radiation exposure.

The Midterm Results of Fenestrated and Branched Aneurysm Repair of Previous Failed Fenestrated EVAR.

BACKGROUND: The purpose of this study was to report the feasibility and midterm outcomes of a redo-fenestrated and/or branched endovascular aortic repair (re-F/BEVAR) to rescue failed previous FEVAR. METHODS: Consecutive patients undergoing re-F/BEVAR were reviewed retrospectively. Electronic databases, clinical data, all imaging studies, and initial stent-graft planning were reviewed to assess causes of initial stent-graft failure and outcomes of re-F/BEVAR. Data are presented as median and interquartile range. RESULTS: Five of 221 (2.2%) patients receiving an FEVAR between 2007 and 2015 underwent re-F/BEVAR between 2012 and 2016 (52 (34-80) months postoperatively). An unsuitable initial proximal sealing zone for the original FEVAR had been chosen in all patients. The failures motivating re-F/BEVAR became apparent as type Ia endoleaks (3 isolated and 1 combined with graft migration) and a graft migration associated with significant proximal aortic expansion (1 patient). The median operative time was 206 (202-378) minutes and technical success was achieved in all cases. Two patients received staged procedures. No perioperative death or spinal cord ischemia occurred. During a follow-up of 37 (22-56) months, 2 patients underwent late reinterventions, 1 patient required 1 reintervention, and 1 patient required 4 reinterventions including a type III endoleak with rupture. Secondary success could be achieved in all cases. There were 2 non-aneurysm-related deaths. CONCLUSIONS: Late FEVAR failure is rare and follows poor initial graft planning. Re-F/BEVAR is technically demanding but the midterm outcomes are acceptable even if reinterventions are needed in some patients. Re-F/BEVAR represents a valuable approach to rescue failed FEVAR but the findings need to be confirmed on a larger scale preferably with a multicenter contribution.

Thoracic endovascular aortic repair with stent grafts alone or with a composite device design in patients with acute type B aortic dissection in the setting of malperfusion.

OBJECTIVE: The objective of this study was to compare short-term outcomes in patients who underwent thoracic endovascular aortic repair (TEVAR) with stent grafts alone or with a composite device design (stent graft plus bare-metal aortic stent) for acute type B aortic dissection in the setting of malperfusion. METHODS: This retrospective analysis included patients with acute (≤14 days of symptom onset) complicated type B dissection in the setting of malperfusion who were treated with stent grafts alone (TEVAR cohort) at two European institutions vs those who underwent TEVAR with a composite device design (Cook Medical, Bloomington, Ind) in the investigational STABLE I feasibility study and STABLE II pivotal study (STABLE cohort). Preoperative characteristics and 30-day outcomes (including mortality, malperfusion-related mortality, morbidity, and secondary interventions) were compared between the two groups. RESULTS: The TEVAR cohort (41 patients; mean age, 58.8 ± 12.7 years; 78.0% male) and the STABLE cohort (84 patients; mean age, 57.8 ± 11.7 years; 71.4% male) were largely similar in preoperative medical characteristics, with more STABLE patients presenting with a history of hypertension (79.8% vs 58.5%; P = .018). The TEVAR and STABLE groups had similar lengths of dissection (451.8 ± 112.7 mm vs 411.8 ± 116.4 mm; P = .10) and similar proximal and distal extent of dissection. At presentation, the two groups exhibited comparable organ system involvement in malperfusion: renal (53.7% TEVAR, 57.1% STABLE), gastrointestinal (41.5% TEVAR, 44.0% STABLE), lower extremities (34.1% TEVAR, 52.4% STABLE), and spinal cord (9.8% TEVAR, 2.4% STABLE). The 30-day rate of all-cause mortality was 17.1% (7/41) in the TEVAR group and 8.3% (7/84) in the STABLE group (P = .22). The 30-day rate of malperfusion-related mortality (deaths from bowel/mesenteric ischemia or multiple organ failure) was 12% (5/41) in the TEVAR group and 2.4% (2/84) in the STABLE group (P = .038). The 30-day morbidity, for the TEVAR and STABLE groups, respectively, included bowel ischemia (9.8% [4/41] vs 2.4% [2/84]; P = .09), renal failure requiring dialysis (7.3% [3/41] vs 9.5% [8/84]; P > .99), paraplegia or paraparesis (4.9% [2/41] vs 3.6% [3/84]; P = .66), and stroke (2.4% [1/41] vs 10.7% [9/84]; P = .16). The occurrence of 30-day secondary intervention was similar in the TEVAR and STABLE groups (7.3% [3/41] vs 7.1% [6/84]; P > .99). True lumen expansion in the abdominal aorta was significantly greater in the STABLE group. CONCLUSIONS: In patients with acute type B aortic dissection in the setting of branch vessel malperfusion, the use of a composite device with proximal stent grafts and distal bare aortic stent appeared to result in lower malperfusion-related mortality than the use of stent grafts alone. The 30-day rates of morbidity and secondary interventions were similar between the groups.

Long-term survival after endovascular and open repair in patients with anatomy outside instructions for use criteria for endovascular aneurysm repair.

BACKGROUND: Randomized controlled trials of long-term survival for infrarenal abdominal aortic aneurysms have compared open surgical repair (OSR) with endovascular aneurysm repair (EVAR) in patients with suitable aortic anatomy for EVAR. However, in clinical practice, patients who do not meet instructions for use (IFU) criteria are often still treated by EVAR despite that some studies show higher graft-related adverse events. The goal of this study was to compare the long-term survival of EVAR and OSR in patients with anatomy outside IFU criteria for EVAR. METHODS: This multicenter retrospective cohort study included patients with at least one anatomic IFU violation for EVAR undergoing either elective EVAR or elective OSR for abdominal aortic aneurysm. Demographics, anatomic data, and follow-up data of patients were collected from three academic centers from 2003 to 2016. Device-specific IFU were used for EVAR patients, whereas generic IFU for EVAR were applied to the OSR patients. The primary outcomes were 30-day mortality and long-term all-cause mortality. Secondary outcomes were aneurysm-related mortality and perioperative complications at 30 days. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Inverse propensity score weights were used to adjust for differences in treatment selection. RESULTS: The study population included 202 EVAR patients and 224 OSR patients with at least one anatomic IFU violation for EVAR. EVAR patients were older (78.1 ± 7.3 vs 70.9 ± 7.0 years; P < .001) and less likely to be hypertensive (69.3% vs 79.0%; P = .02) compared with OSR patients. OSR patients were more likely to have proximal aortic neck IFU violations (75.0% vs 47.1%; P < .001) and were less likely to have iliac IFU violations (65.2% vs 79.2%; P < .001). All-cause mortality was 37.6% in the EVAR group and 24.1% in the OSR group with a median follow-up time of 5.2 (3.5-7.2) and 5.4 (2.8-9.3) years, respectively (P < .002). Kaplan-Meier survival analysis revealed a significant association between patients undergoing OSR and increased long-term survival (log-rank P < .0001). When adjusted for possible confounders and weighted for propensity for treatment through Cox hazard modeling, the association remained significant (hazard ratio, 0.6; 95% confidence interval, 0.4-0.9). Aneurysm-related mortality was 3.5% in the EVAR group and 2.2% in the OSR group during long-term follow-up (P < .001). CONCLUSIONS: Our study identified that patients with IFU violations have higher overall long-term survival with open surgery compared with EVAR. Caution should be applied in considering standard EVAR for patients with anatomy outside of IFU.

Malperfusions in Acute Type B Aortic Dissection-Predictors of Outcomes.

BACKGROUND: Acute type B aortic dissection (AoD) with malperfusion is a rare and complex disease. In this specific setting, invasive treatment is generally required to improve aortic branch vessel flow. Thoracic aorta stent grafting (TEVAR) of the proximal descending thoracic aorta to cover/exclude the proximal intimal entry tear would promote resolution of the dynamic component (the most prevalent) of the malperfusion conflict by redirecting the flow within the true lumen. The aim was to study outcomes of patients undergoing TEVAR for acute (<14 days) type B AoD complicated with malperfusion and to depict any preoperative and intraoperative predictors that could affect the prognosis of those patients. METHODS: From March 2005 to January 2016, all patients treated with TEVAR for acute type B AoD with malperfusion in 2 European high-volume aortic centers were retrospectively studied. Preoperative, intraoperative, and postoperative details were collected. Preoperative computed tomography angiogram was reanalyzed on a dedicated 3D workstation (Aquarius iNtuition Viewer, TeraRecon). Thirty-day malperfusion-related complication and mortality rates were determined. Logistic regression model was used to assess preoperative and intraoperative factors affecting postoperative outcomes; in particular, details on the mechanisms of malperfusion and organ(s) involved were entered into the model and tested. RESULTS: A total of 41 patients (60 years old [interquartile range (IQR): 51-68.5]; 78% men) have been included in the analysis. Patients were mostly (68.3%) affected by only 1 malperfusion syndrome, with renal ischemia being the most frequent (53.6%). The median length of aortic coverage was 197 mm (IQR: 157-209). Additional visceral/renal/iliac stentings were performed after stent graft implantation for 25 branches in 17 patients (41%). The 30-day mortality rate was 17.1%. All but 2 early deaths were related to malperfusion. The number of malperfusion syndromes was the only independent factor associated to increasing 30-day malperfusion-related complications or deaths (3 vs 1, HR = 30.3 [P = 0.001]; 3 vs 2, HR = 9.9 [P = 0.004]). CONCLUSIONS: Prognosis of patients with acute type B AoD complicated initially with malperfusion syndrome(s) is severe, especially if several territories are ischemic. Early identification of those complications can be lifesaving but still lacks hard criteria.

Outcomes of Open Repair, Fenestrated Stent Grafting, and Chimney Grafting in Juxtarenal Abdominal Aortic Aneurysm: Is It Time for a Randomized Trial?

BACKGROUND: The well-established, gold standard treatment for juxtarenal abdominal aortic aneurysms (JAAAs) is open repair (OR). However, endovascular treatment with fenestrated or chimney grafts has been increasingly performed in the past decade. This study compared the outcomes of OR with 2 endovascular methods in JAAA. METHODS: We retrospectively reviewed consecutive patients with JAAA who underwent OR (n = 32), repair with fenestrated stent grafts (fenestrated endovascular aortic aneurysm repair [FEVAR], n = 20), or chimney grafts (Ch-EVAR, n = 23) during the period from January 2011 to December 2016 at a single center. Our primary end point was perioperative mortality. Secondary end points included renal function impairment, new-onset dialysis, procedural details, and postoperative complications. Kaplan-Meier analysis was used to estimate freedom from late reintervention, primary patency of target vessel stent grafts, and overall survival. RESULTS: There were no significant differences between groups in baseline characteristics. Perioperative mortality was similar in all the 3 groups (3.1% (1/32) in the OR group, 0% in the FEVAR group, and 4.3% (1/23) in the Ch-EVAR group. Mean follow-up duration was 36.7 months (range 1-75 months). There were no significant differences between groups regarding any of the secondary end points, except for blood loss (which was significantly greatest in the OR group), and there was no significant difference in overall survival. Estimated target vessel stent patency at 1 and 4 years was 93.8% and 93.8% in the FEVAR group, and 89.5% and 89.5% in the Ch-EVAR group. There was no significant difference between groups in estimated freedom from late reintervention (96.4% in the OR group, 77.2% in the FEVAR group, and 82.3% in the Ch-EVAR group). CONCLUSIONS: Open surgery is an acceptable and effective treatment for JAAA. However, FEVAR and Ch-EVAR also showed high technical success rates and low perioperative mortality, with acceptable reintervention rates during follow-up.

Mid-term Outcomes of Endovascular Repair of Ruptured Thoraco-abdominal Aortic Aneurysms with Off the Shelf Branched Stent Grafts.

OBJECTIVE: To assess the mid-term outcomes and feasibility of branched endovascular repair (b-EVAR) of ruptured thoracoabdominal aortic aneurysms (rTAAAs). METHODS: All patients undergoing b-EVAR of rTAAAs between 2011 and 2016 were included. Pre-, intra and postoperative imaging was reviewed to assess technical success, outcomes, and feasibility of b-EVAR in the emergent setting. RESULTS: Eleven emergency b-EVAR of rTAAAs (10 aneurysms and 1 chronic dissection) were performed using off-the-shelf (OTS) branched stentgrafts. Only 18% of patients complied to the anatomical instruction-for-use of the OTS device; a small aortic lumen and occluded target vessels were the main violations. Median operative time was 430 (IQR 395-629) minutes. Technical failure was 36% including one intraoperative death, one target vessel catheterization failure, one type Ia and one type III endoleak. Thirty-day mortality was 27%. Only early re-intervention was for the type Ia endoleak. Spinal cord ischemia occurred in 4 patients (30%), of which 2 recovered completely. Median clinical follow-up were 15 (IQR 7-39) months respectively. The median clinical follow-up index (FUI) was 0.65 (0.32-0.95). Overall survival was 75 ± 21.7% at 18 months. Four branch occlusions occurred; one renal stent occlusion led to permanent hemodialysis. Branch patency was 87.5 ± 8.3% and 72.2 ± 12% at 1 and 2 years, respectively. One stentgraft migrated but no late major endoleak occurred. CONCLUSION: Emergency b-EVAR of rTAAA with OTS device is feasible despite a low anatomical suitability. With proper adjunctive procedures, it can be offered to most hemodynamically stable patients. These time-consuming complex procedures are not suitable for unstable patients. Often the procedure is done as life-saving in the emergency setting and reinterventions may be needed later. Consequently, the success rates are lower than in the elective setting. These results need to be confirmed by larger studies and longer follow-up.

Any nonadherence to instructions for use predicts graft-related adverse events in patients undergoing elective endovascular aneurysm repair.

BACKGROUND: A variety of devices exist for endovascular aneurysm repair (EVAR). Device-specific instructions for use (IFU) detail anatomic constraints to application and deployment of devices and are developed from rigorous bench testing. Nonadherence to IFU occurs frequently to avoid open surgery. The purpose of this study was to determine if IFU violations are associated with increased risk of graft-related adverse events (GRAEs) during follow-up. METHODS: This multicenter retrospective observational study included patients undergoing elective endovascular repair for abdominal aneurysmal disease with three different devices. Demographics, anatomic data, and follow-up data were collected on patients from 2005 to 2014. IFU violations were device specific and included neck diameter, length, and angulation and iliac artery diameter and length. GRAEs included a composite outcome of reintervention, migration, endoleak (type II excluded), rupture, limb occlusion, sac growth, and aneurysm-related mortality during the follow-up period. Kaplan-Meier survival and Cox proportional hazards modeling were performed. Any IFU violations as well as neck-specific IFU violations were analyzed. RESULTS: In 461 patients undergoing EVAR, 43.8% had at least one IFU violation. Patients with IFU violations were more likely to have peripheral vascular disease (12.4% vs 7.3%) and were less likely to be male (78.7% vs 90.3%). The most frequent IFU violations included diameter deviations of the neck (15.2%) and of the iliac artery (21.4%). Overall, the GRAE rate was 12.8%. Median follow-up time was 1.9 and 2.1 years for patients with and without an IFU violation, respectively. Kaplan-Meier survival revealed a significant association between the presence of an IFU violation and GRAEs (log-rank, P = .031). When adjusted for clinical variable through Cox hazard modeling, the association remained significant (hazard ratio 1.8; 95% confidence interval, 1.05-3.1). When neck-specific violations were considered independently, Kaplan-Meier survival (log-rank, P = .003) and Cox modeling (hazard ratio, 2.2; 95% confidence interval, 1.2-4.0) revealed a significant association between neck-specific IFU violation and GRAEs. CONCLUSIONS: A total of 43.8% of patients undergoing EVAR had a device-specific IFU violation, indicating that implanters are pushing the boundaries of device capabilities. Our study identified that any IFU violation was significantly associated with GRAEs over time. Caution should be applied to patients being considered for EVAR when IFU deviations exist.