Antithrombotic Therapy and Freedom From Bridging Stent Occlusion After Elective Branched Endovascular Repair: A Multicenter International Cohort Study.

CLINICAL IMPACT: Based on our study, no antithrombotic therapy is significantly associated with bridging stent occlusion, and no evidence of the superiority of other antithrombotic therapy exists. Nevertehless, due to the low number of bridging stent occlusions, this study can neither support nor reject the PRINCE2SS recommendations. Further studies with larger cohorts are needed to determine clear guideliness of the best antithrombotic treatment regimen after complex enfovascular aortic repair.

REINTERVENTION RATE AFTER TREATMENT WITH THE INCRAFT AAA ULTRA-LOW-PROFILE STENT GRAFT SYSTEM.

OBJECTIVE: The INCRAFT stent graft system is an ultra-low profile endograft for the exclusion of infrarenal aortic aneurysms. In the market approval studies, an increased rate of device-related complications was observed and the endograft was approved with mandated postmarketing investigations. Our aim was to analyze midterm outcomes of a real-world patient cohort treated with the INCRAFT endograft. METHODS: Consecutive patients treated with the INCRAFT endograft between February 2015 and December 2022 at a single institution were included. In accordance with the Society for Vascular Surgery reporting standards, safety endpoints were reported and outcome endpoints included reinterventions, technical success, aortic-related and overall-mortality, endoleak, stent fracture, and endograft migration >5 mm. RESULTS: Eighty patients (85% male) with a mean age of 76 ± 7 years were included. Fifty-two patients (65%) were treated within the endograft's instruction for use (IFU). Mean aortic diameter was 59 ± 10 mm and 91% of the procedures were performed percutaneously. Mean follow-up was 37 ± 25 months and there was no aortic- or procedure-related mortality. Reinterventions occurred in 25 patients (31%) with a freedom from reintervention at 1, 3 and 5 years of 84%, 66% and 55%. The most frequent reinterventions were limb graft stenting (23%) and type II endoleak embolization (14%). Limb occlusion rate was 9% and in three patients (4%) distal endograft migrations >5 mm occurred. Persisting type II endoleaks were observed in 29% and aneurysm diameter was stable in 41% and had shrunk in 38%. Three type III endoleaks (4%) developed during follow-up and four open conversions (5%) were necessary. No known risk factors, including treatment outside IFU, were predictive for reinterventions. CONCLUSION: Treatment of infrarenal aortic aneurysms with the INCRAFT stent graft system was safe and successful. Nevertheless, a substantial rate of reinterventions was necessary during follow-up to maintain endograft patency and prevent aneurysm growth.

Indication and Outcome of Late Open Conversion after Abdominal Endovascular Aortic Repair.

BACKGROUND: Endovascular aortic repair (EVAR) has become the standard of care for patients with infrarenal aortic aneurysms over the last 2 decades. Endograft technology and treatment of complications like endoleaks, graft migration, or graft occlusion developed over time. However, sometimes open surgical conversion maybe required. Our aim was to analyze the indications, the technical aspects and outcomes in patients who underwent open conversion after EVAR with different types and generations of endografts. METHODS: This retrospective single-center study reviewed all patients who underwent EVAR from 2004 to 2020. Open surgical conversions >1 month post EVAR were identified. Conversions for graft infection were excluded. Indications for conversion and operative technique were analyzed. Primary endpoint of the study was 30-day mortality. Secondary endpoints were re-interventions and follow-up mortality. RESULTS: During 2004 and 2020, 443 consecutive EVARs were performed, and 28 patients required open surgical conversion, with an additional 3 referred from other hospitals (N = 31). The median age was 75 (range 58-93); 94% were male. Conversion was performed after a median time of 55 months (range 16-209). Twenty patients underwent elective and 11 emergency conversion. Indications for open conversion were graft migration, respectively, disease progression with endoleak type Ia and/or Ib in 52% (16/31) and sac expansion due to endoleak type II in 26% (8/31). Of the 31 patients, 17 (55%) had at least one previous endovascular re-intervention. All patients met the device-specific instructions for use for each implanted endograft. In-hospital intervention rate was 16% (5/31). Thirty-day mortality rate was 3% (1/31) with one patient died due to multiorgan failure after rupture with complete endograft replacement. Five patients (16%) died during follow-up. Mid-term follow-up was 47.5 months (range 24-203) with estimated cumulative survival rates of 97%, 89%, and 84%, at 1, 3, and 5 years, respectively. CONCLUSIONS: Late open conversion remains a valuable treatment option and can be performed safely in elective and emergency setting with a low early mortality. Lifelong surveillance and prompt intervention when necessary are essential in ensuring optimal outcomes after EVAR and preventing the need for emergent conversions.

Novel Surgeon-Modified Fenestrated Iliac Stent Graft.

PURPOSE: We describe the feasibility and early results of a novel endovascular approach with a surgeon-modified fenestrated iliac stent graft to preserve pelvic perfusion in patients with iliac aneurysms not suitable for iliac branch devices (IBDs). TECHNIQUE: Seven high-risk patients, median age 76 years (range 63-83), with a complex aortoiliac anatomy with contraindications for commercially available IBDs were treated with a novel surgeon-modified fenestrated iliac stent graft between August 2020 and November 2021. The modified device was built using an iliac limb stent graft (Endurant II Stent Graft; Medtronic), which was partially deployed, surgically fenestrated with a scalpel, reinforced, re-sheathed, and inserted via femoral access. The internal iliac artery was cannulated and bridged with a covered stent. Technical success rate was 100%. After a median follow-up period of 10 months, there was 1 type II endoleak and no migrations, stent fractures, or loss of device integrity. One iliac limb occlusion occurred after 7 months, which needed a secondary endovascular intervention, restoring patency. CONCLUSION: Surgeon-modified fenestrated iliac stent graft is feasible and might be used as an alternative in patients with a complex iliac anatomy not suitable to commercially available IBDs. Long-term follow-up is needed to evaluate stent graft patency and potential complications. CLINICAL IMPACT: Surgeon modified fenetrated iliac stent grafts might be a promising alternative to iliac branch devices, extending endovascular solutions to a broader patient population with complex aorto-iliac anatomies preserving antegrade internal iliac artery perfusion. It is possible to treat small iliac bifurcations and large angulations of the iliac bifurcation safely and there is no need for a contralateral or upper-extremity access.

External Validation of a Prognostic Model for Survival of Patients With Abdominal Aortic Aneurysms Treated by Endovascular Aneurysm Repair.

OBJECTIVE: Current guidelines recommend diameter monitoring of small and asymptomatic abdominal aortic aneurysms (AAAs) due to the low risk of rupture. Elective AAA repair is recommended for diameters ≥ 5.5 cm in men and ≥ 5.0 cm in women. However, data supporting the efficacy of elective treatment for all patients above these thresholds are diverging. For a subgroup of patients, life expectancy might be very short, and elective AAA repair at the current threshold may not be justified. This study aimed to externally validate a predictive model for survival of patients with an asymptomatic AAA treated by endovascular aneurysm repair (EVAR). METHODS: This was a multicentre international retrospective observational cohort study. Data were collected from four European aortic centres treating patients between 2001 and 2021. The initial model included age, estimated glomerular filtration rate (eGFR), and chronic obstructive pulmonary disease (COPD) as independent predictors for survival. Model performance was measured by discrimination and calibration. RESULTS: The validation cohort included 1 500 patients with a median follow up of 65 months, during which 54.6% of the patients died. The external validation showed slightly decreased discrimination ability and signs of overfitting in model calibration. However, a high risk subgroup of patients with impaired survival rates was identified: octogenarians with eGFR < 60 OR COPD, septuagenarians with eGFR < 30, and septuagenarians with eGFR < 60 and COPD having survival rates of only 55.2% and 15.5% at five and 10 years, respectively. CONCLUSION: EVAR is a valuable treatment option for AAA, especially for patients unsuitable for open repair. Nonetheless, not all these patients will benefit from EVAR, and an individualised treatment recommendation should include considerations on life expectancy. This study provides a risk stratification to identify patients who may not benefit from EVAR using the present diameter thresholds.

One-Year Outcome of Postoperative Stroke and Nerve Injury After Supraclavicular Revascularization of The Left Subclavian Artery for Proximal Landing Zone Extension in Thoracic Endovascular Aortic Repair.

OBJECTIVE: To assess the outcome of stroke and nerve injury after supraclavicular revascularization of the left subclavian artery for proximal landing zone extension in thoracic endovascular aortic repair (TEVAR). METHODS: Retrospective analysis of all patients undergoing left-sided carotid-subclavian bypass (CSB) and subclavian-carotid transposition (SCT) with simultaneous or staged TEVAR between January 2010 and June 2019. Endpoints were perioperative cerebrovascular events and nerve injuries, patency and re-intervention due to the debranching, and mortality at 30 days and during follow-up. RESULTS: Forty-eight patients (median age 66 years, 81 % male) had 25 (52%) CSB and 23 (48%) SCT. TEVAR was performed simultaneously in 39 (81%) patients, 11 (23%) of them in an emergent setting. There were 7 (15%) re-interventions within 30 days: 3 due to local hematoma, one for bypass occlusion, 2 for stenosis (of which one was not confirmed intraoperatively), and one after initially abandoned SCT with subsequent CSB on the next day. 30-day mortality was 2%; 1 patient died on the first postoperative day after emergency coronary artery bypass surgery and multiorgan failure. 4 (8%) patients suffered postoperative strokes; 3 occurred after simultaneous emergency procedures and none was fatal. There were 9 (19%) left neck nerve injuries in 8 patients, 5 patients had SCT and 3 CSB. During a median follow-up of 37.5 months (IQR 23-83) with a Follow-up Index of 0.77, there were no reinterventions or occlusions, and no graft infections. Primary patency was 90% and primary assisted patency 98% during follow-up. 8 patients died during follow-up, all of them with patent cervical debranching. CONCLUSION: Supraclavicular LSA revascularization for proximal landing zone extension in TEVAR is safe with an acceptable rate of early re-interventions. There is higher risk for perioperative stroke during concomitant emergency LSA revascularization and TEVAR. Left neck nerve injuries are common complications but resolve completely in vast majority of the cases during first postoperative year. During follow-up, excellent patency could be expected.

Peripheral Artery Disease Leading to Major Amputation: Trends in Revascularization and Mortality Over 18 Years.

BACKGROUND: Patients with peripheral artery disease (PAD) are at risk for amputation. The aim of this study was to assess the type of revascularization prior to and the 30-day mortality rate after major amputation due to PAD. METHODS: Retrospective analysis of consecutive patients undergoing major amputation for PAD between 01/2000 and 12/2017 at a tertiary referral center. The number and target level of ipsilateral revascularizations prior to amputation were analyzed per patient and over the years. There were 3 types of revascularization (open, endovascular and combined treatment) at 3 levels: aortoiliac, femoropopliteal and infrapopliteal. Univariate and multivariate logistic regression models were used to assess the association of level of amputation and patient characteristics with 30-day mortality. RESULTS: A total of 312 patients (65.7% male) with a mean age of 73.3 ± 11 years underwent 338 major amputations: 70 (21%) above/through knee and 268 (79%) below knee. A median of 2 (interquartile range, IQR 1-4) revascularizations were performed prior to amputation, with a slight decrease of 1.4% per year from 2000-2017 (incidence rate ratio of 0.986 0.974-0.998; Poisson regression analysis, P = 0.021). 16% (53/338) of patients underwent primary amputation without revascularization; this number remained relatively stable throughout the study period. The proportion of exclusively open treatment before amputation decreased substantially from 35% in 2006 to none in 2016, while exclusively endovascular revascularizations were performed increasingly from 17% in 2002 to 64% in 2016. Amputation occurred after a median of 9.5 months (IQR 0.9-67.6 months) if the first revascularization was aortoiliac or femoropopliteal and after 2.1 months (IQR 0.5-13.8 months) if the first intervention was infrapopliteal (P < 0.001) with no significant change over the years (normal linear regression, P= 0.887). Thirty-day mortality was 8.9% (22/247) after below knee and 27.7% (18/65) after above/through knee amputation (adjusted OR 3.84, 95% CI 1.74-8.54, P= 0.001) with a slight increase of mortality over the study period (adjusted OR 1.09, 95% CI 1.018-1.159, Poisson regression analysis, P= 0.021). The uni- and multivariate analysis of patient characteristics did not show an association with mortality, except higher ASA classification (adjusted OR 2.65, 95% CI 1.23-5.72, P= 0.012). CONCLUSIONS: Mortality, especially after above/through knee amputation, remains high over the past 2 decades. There is a clear shift towards endovascular treatment of patients with PAD prior to major amputation. In patients needing infrapopliteal revascularizations, amputation was performed much sooner than in those with aortoiliac or femoropopliteal interventions, with no improvement over the years. Strategies to extend limb salvage in these patients should be the focus of further research.

Long-term results of cryopreserved allografts in aortoiliac graft infections.

OBJECTIVE: Different graft materials have been proposed for in situ reconstruction in the setting of vascular graft infection (VGI). We analyzed the long-term outcomes after in situ aortoiliac reconstruction with cryopreserved allografts. METHODS: We performed a retrospective analysis of patients who had undergone in situ aortoiliac reconstruction with cryopreserved arterial allografts for VGI from 2000 to 2015. The end points were the perioperative and long-term mortality and graft-related complications, including stenosis, occlusion, pseudoaneurysm, and reinfection. RESULTS: A total of 33 patients (91% male) with a median age of 67 years (range, 53-83 years) had undergone in situ aortoiliac reconstruction with cryopreserved allografts. The 30-day mortality was 6% (n = 2); both deaths were related to the allograft (one early allograft-enteric fistula and one graft rupture). Another two patients had experienced early (≤30 days) graft-related events (one allograft-enteric fistula and one graft limb occlusion), for an early graft-related complication rate of 12% (n = 4). Of the 31 discharged patients, 13 (42%) had died after a median of 47 months (range, 2-97 months). The median follow-up for the 18 remaining patients was 96 months (range, 10-146 months). The estimated survival at 1, 3, and 5 years was 88%, 81%, and 66%, respectively. Nine patients (29%) had experienced at least one of the following graft-related events during follow-up, including graft stenosis requiring intervention in five (16%), graft occlusion in four (13%), pseudoaneurysm in three (10%), and reinfection in two patients (6%). The estimated freedom from any first graft-related event at 1, 3, and 5 years was 78%, 71%, and 62%, respectively. The estimated primary patency and primary assisted patency at 1 and 3 years was 87% and 79%, and 90% and 83%, respectively. CONCLUSIONS: In situ aortoiliac reconstruction with cryopreserved allografts to treat VGI was associated with relevant perioperative graft-related complications. Although the reinfection rate was acceptable, other graft-related complications were frequent in the long term, in particular, graft occlusion and stenosis.

Multicenter Experience With Large Diameter Balloon-Expandable Stent-Grafts for the Treatment of Infrarenal Penetrating Aortic Ulcers.

PURPOSE: To describe the use of large-diameter balloon-expandable stent-grafts (BeGraft aortic stent-graft, Bentley InnoMed GmbH, Hechingen, Germany) in the treatment of infrarenal penetrating aortic ulcer (iPAU). MATERIALS AND METHODS: Retrospective analysis of patients undergoing endovascular treatment with the BeGraft aortic stent-graft in 8 European centers from January 2017 to October 2020. Demographics, perioperative data, and midterm outcomes were collected. Endpoints of the study were technical feasibility, early mortality, and morbidity. RESULTS: A total of 40 patients were included. The mean age was 73.9±7.05 years and 63.2% were male. Indications for treatment included size and morphology (65%), presence of symptoms (29.5%), and contained ruptures (5.5%). Urgent treatment was performed in 5% of cases. Technical success was 97.5%. Median operation time was 58 minutes (19-170 minutes), with 27.5% of patients having additional procedures during the main intervention (1 additional repair with a C-TAG (W.L. Gore & Associates, Inc, Flagstaff, AZ, USA) thoracic endoprosthesis, 5 covered endovascular reconstruction of aortic bifurcation procedures, 3 extensions with proximal cuffs, and 2 percutaneous angioplasties of the common iliac arteries). Percutaneous femoral access was used in 72.5%, while groin cut-down was performed in 27.5%. Repair was successful with only 1 stent in 45% of cases, while 37.5% required 2 stents and nearly 17.5% required 3/4 stent-grafts. The 30-day mortality was 0%, with a 2.5% reintervention rate (1 patient required evacuation of an intra-abdominal hematoma). Median follow-up was 13.9 months (2-39 months), during which no vascular-related reinterventions or deaths were reported. In 4 patients, a type II endoleak was observed. No cases of graft migration, thrombosis, or stent-fracture were observed. CONCLUSIONS: The treatment of iPAU with the BeGraft aortic stent-graft in a selective patient group is feasible with low rate of perioperative morbidity and mortality. Balloon-expandable stent-grafts offer the option to repair iPAUs with a shorter coverage of the aorta using low-profile sheath, that enables treatment in the presence of calcified access vessels and small diameter aortic bifurcations.

Efficacy and Safety of Heparinization before Deployment of Endograft for Blunt Traumatic Aortic Injury in Severely Injured Patients.

BACKGROUND: The administration of unfractionated heparin (UFH) during endovascular repair of blunt traumatic aortic injury (BTAI) is controversial. The aim of the study is to report the early outcomes of patients undergoing thoracic endovascular aortic repair (TEVAR) for BTAI, and to assess the individualized intraoperative use and dose of UFH. METHODS: This is a retrospective analysis including consecutive patients treated with TEVAR for BTAI of the descending aorta between January 1st, 2005 and December 31st, 2018. Intraoperative use and doses of UFH were analyzed. Primary outcome included a reintervention because of new onset bleeding and/or thromboembolic complication and 30-day mortality. Technical success, injury severity score (ISS), timing of treatment, and neurologic deterioration were secondary outcome. RESULTS: Thirty-six patients with a mean age of 47 ± 18 years, 30 males (83%), were included. Intraoperative administration of UFH was recorded in 30/36 patients (83%) with a mean dose of 4750 ± 2180 IU. Two patients had no UFH because of extensive intracranial hemorrhage or suspected relevant liver laceration, respectively; 1 died in theatre, 1 was already anticoagulated having a mechanical aortic valve, and in 2 no information about heparin use was found. During 30 days of follow-up, 3 patients died (8%; 3/36): 1 patient with completely transected aorta died on-table and 2 on the fifth postoperative day, 1 from trauma-associated brain injury and 1 with multi organ failure. No bleeding or thromboembolic complication requiring reintervention occurred in any patient during 30 days follow-up. In 3 patients partial unintentional coverage of the left common carotid artery occurred, resulting in technical success of 89% (32/36). Mean ISS was 43 ± 15. Thirty-five patients (97%) were severely injured having an ISS ≥ 25. Twenty-nine patients (81%) were treated within 24 hr and 6 patients (17%) within 1 week. No stroke or spinal cord ischemia was observed. CONCLUSIONS: Systemic heparinization in different doses during TEVAR for BTAI can be safe with no intraoperative bleeding or thromboembolic complications in early postoperative period.

Perioperative Outcome of Fenestrated and Branched Stent Grafting after Previous Open or Endovascular Abdominal Aortic Repair.

BACKGROUND: To compare the perioperative outcome of patients treated with elective or urgent fenestrated and branched stent grafting (fbEVAR) for pararenal (pAAA) and thoracoabdominal aortic aneurysm (TAAA) after previous open with previous endovascular abdominal aortic repair. METHODS: Single center retrospective analysis of all patients undergoing fbEVAR after previous open (post-open fbEVAR group) or endovascular abdominal aortic repair (post-endo fbEVAR group) between January 2015 and December 2017. Primary outcomes were technical success and in-hospital all-cause mortality. RESULTS: We identified 42 patients undergoing fbEVAR after previous open or endovascular abdominal aortic repair during this period. Twenty-one patients (post-open fbEVAR group) had previous open abdominal aortic repair, 13 with a bifurcated and 8 with a tube graft. Of these, 2 patients presented with pAAA and 19 with TAAA. Twenty-one patients (post-endo fbEVAR group) had previous EVAR. Thirteen patients presented with pAAA, 3 of them with additional type Ia endoleak, 2 with stent-graft migration and 2 with previously failed fEVAR. Eight presented with TAAA. Median interval between previous repair and fbEVAR was 84 months (IQR 60-156) for the post-open fbEVAR group and 72 months (IQR 36-96) for the post-endo fbEVAR group (P = 0.746). Eighteen patients (86%) had branched stent grafting in the post-open versus 11 (52%) in the post-endo group (P < 0.01). In 2 patients in the post-open group, 3 renal arteries were not catheterized due to severe ostial stenosis, resulting in technical success of 91% in the post-open and 100% in the post-endo fbEVAR group. Four patients (19%) in the post-open fbEVAR group died in hospital, 2 due to cerebral hemorrhage and 2 due to pneumonia, and none in the post-endo fbEVAR group (P = 0.101). There were 5 nonstent-graft-related reinterventions, 2 (10%) in the post-open fbEVAR group and 3 (14%) in the post-endo fbEVAR group (P = 0.844). After 12 months there were 4 events in the post-endo fbEVAR group: one renal artery stent occluded, one renal artery stent required relining because of disconnection and 2 type II endoleaks were embolized with coils. There were no reinterventions in the post-open fbEVAR group during 12 months. CONCLUSIONS: Fenestrated and branched repair after previous open or endovascular abdominal aortic repair appears safe with high technical success rate. There is no difference in the technical success and in-hospital all-cause mortality rates between fbEVAR after previous open or endovascular abdominal aortic repair.

Development and internal validation of a prognostic model for mortality of patients with abdominal aortic aneurysms treated with endovascular aneurysm repair.

Background: Morbidity and mortality associated with elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAA) must be balanced against the impending risk of aneurysm rupture and the estimated remaining lifetime. The aim of this study is to develop and validate a prognostic model for mortality of patients with AAA treated with EVAR. Methods: This retrospective observational study included 251 consecutive patients treated with EVAR for asymptomatic AAA between January 2001 and December 2012 at the University Hospital in Bern, Switzerland. Pre-selection of variables was based on a literature review; least absolute shrinkage and selection operator technique was used for the final variable selection. A Firth's bias reduced Cox proportional hazard model was developed and validated using 10,000 bootstrap samples to predict survival after EVAR. Results: The median follow-up time was 5.3 years (range 0.1 to 15.9). At the study closing date 95% of follow-up information was available. The mortality rates were 31.9% at 5 years and 50.5% at the study closing date, respectively. Identified predictors for overall mortality after EVAR were age, hazard ratio (HR) = 2.24 per 10-year increase (95% CI 1.64 to 3.09), the presence of chronic obstructive pulmonary disease (COPD), HR = 2.22 (95% CI 1.48 to 3.31), and lower estimated glomerular filtration rate, HR = 1.24 per 10 ml/min/1.73 m2 decrease (95% CI 1.12 to 1.39). The model showed good discrimination ability, Harrell's C = 0.722 (95% CI 0.667 to 0.778) and was very robust in the bootstrap in-sample validation Harrell's C = 0.726 (95% CI 0.662 to 0.788). Conclusion: Higher age, the presence of COPD and impaired kidney function are independent predictors for impaired survival after EVAR. The expected remaining lifetime should be considered in patients with AAA. This prognostic model can help improving patient care; however, external validation is needed prior to clinical implementation.

Predictors of bleeding or anemia requiring transfusion in complex endovascular aortic repair and its impact on outcomes in health insurance claims.

OBJECTIVE: This study aimed to determine predictors and outcomes associated with bleeding or anemia requiring transfusion (BAT) after fenestrated or branched endovascular aneurysm repair (FB-EVAR). METHODS: Health insurance claims data of Germany's third largest insurance provider, DAK-Gesundheit, were used to investigate BAT in elective FB-EVAR performed between 2008 and 2017. International Classification of Diseases and German Operations and Procedure Key codes were used. RESULTS: A total of 959 patients (24.8% with BAT) matching the inclusion criteria were identified during the study period. Compared with patients without BAT, patients with BAT were older (74.4 vs 73.0 years; P = .015) and suffered more frequently from congestive heart failure (18.5% vs 9.4%), cardiac arrhythmias (26.9% vs 14.7%), and hereditary or acquired coagulopathy (31.9% vs 6.2%; all P < .001). Coagulopathy (odds ratio [OR], 3.65; 95% confidence interval [CI], 2.29-5.84), female sex (OR, 2.67; 95% CI, 1.78-4.00), and multiple comorbidities (OR, 1.10; 95% CI, 1.07-1.14) were independent predictors of BAT (all P < .001). BAT was associated with higher in-hospital (11.3% vs 2.6%), 30-day (12.2% vs 3.1%), and 90-day (18.5% vs 4.4%) mortality (all P < .001). Furthermore, myocardial infarction (23.9% vs 2.8%) and paraplegia (9.7% vs 0.7%) were more frequent in the BAT group (all P < .001). In multivariable analyses, BAT was associated with worse short-term (OR, 3.19; 95% CI, 1.63-6.33; P = .001) and long-term survival (hazard ratio, 1.62; 95% CI, 1.24-2.11; P < .001). CONCLUSIONS: Patients with hereditary or acquired coagulopathy, patients with multiple comorbidities, and women are at higher risk for development of BAT after FB-EVAR. The occurrence of this event was strongly associated with higher major complication rates and worse short-term and long-term survival. This emphasizes a need to further illuminate the value of patient blood management in FB-EVAR.

Fascial suture technique versus open femoral access for thoracic endovascular aortic repair.

BACKGROUND: Fascial suture technique (FST) has proved to be a safe and effective access closure technique after endovascular repair of the abdominal aorta. FST has not yet been investigated for closure of large-bore access after thoracic endovascular aortic repair (TEVAR). The aim of this study was to compare FST with open femoral access in terms of access safety, hemostasis efficacy, and reintervention rate after TEVAR. METHODS: A retrospective study including consecutive patients undergoing TEVAR with either FST or open femoral access between January 2010 and April 2016 was undertaken. Exclusion criteria included the use of closure devices. The composite primary end point was defined as any access-related complication (bleeding, femoral artery stenosis or occlusion, pseudoaneurysm, and wound infection) during 30 postoperative days. Preoperative and procedural variables were examined in a multiple logistic regression model as potential associated factors with access morbidity. All access vessels were postoperatively examined by clinical examination and computed tomography angiography before discharge as well as during the follow-up period. In case of suspected pseudoaneurysm, additional duplex ultrasound and computed tomography angiography confirmed the diagnosis. RESULTS: From a total of 206 patients undergoing TEVAR, 109 (53%) had FST, whereas 93 (45%) had an open femoral access. Four patients were excluded: closure device was used in one; one had primary conversion after percutaneous puncture without FST; and in two, no data were available about the femoral access. The access complication rate was higher in FST (FST, 14 [13%]; open access, 3 [3%]; P = .01). Five (4.6%) patients needed early reintervention, two for bleeding and three for vessel occlusion. Seven (6.4%) pseudoaneurysms were detected during the 30-day period in the FST group; three had successful exclusion with thrombin injection, one was treated with manual compression, one was treated with open repair, and two were managed conservatively. Four (3.6%) patients in the FST group and three (3%) patients in the open access group had wound complications. After multiple logistic regression, FST was the only independent factor for any access complication (odds ratio, 5.176; 95% confidence interval, 1.402-19.114; P = .014). During follow-up, neither new pseudoaneurysm nor stenosis or occlusion was detected. CONCLUSIONS: FST for large-hole closure had higher risk for any access complication compared with open access in TEVAR during the 30-day postoperative period. No other complications during 12 months of follow-up were observed in FST patients.

Fenestrated or branched endovascular aortic repair for postdissection thoracoabdominal aortic aneurysm.

OBJECTIVE: Fenestrated or branched endovascular aortic repair (FB-EVAR) usually represents the last stage in endovascular treatment of postdissection aneurysm after thoracic endograft coverage of entry tear and false lumen embolization. METHODS: The study was a retrospective analysis of all patients with postdissection thoracoabdominal aneurysm treated with FB-EVAR in a single center. Short-term outcomes included technical success, operative mortality, and morbidities. Midterm outcomes included secondary intervention, false lumen thrombosis rate, aneurysm size regression, and subsequent survival. RESULTS: Twenty patients (95% male with a mean age of 64 ± 9 years) were treated between January 2014 and December 2017. The technical success was 100%. There was one death (5%) within 30 days. Postoperative complications included two patients with spinal cord ischemia (10%; one partial and one full). The median follow-up period was 12 months (range, 0-31 months). A secondary intervention was required in six patients, including thoracic stent graft relining for type III endoleak (n = 2), covered stent relining for junctional leak between main body and renal stent (n = 2), and iliac false lumen embolization (n = 2). Twelve patients completed the 1-year follow-up computed tomography angiogram, and their mean aneurysm diameters were 71 ± 18, 66 ± 19, and 62 ± 19 mm preoperatively, immediate postoperatively, and at 1 year, respectively; the corresponding false lumen thrombosis rates were 0% (0/20), 58% (7/12), and 92% (11/12), respectively. One more patient died during follow-up from a non-aneurysm-related cause. The estimated overall survival rates were 95 ± 5%, 88 ± 8%, and 88 ± 8% at 6, 12, and 18 months, respectively. CONCLUSIONS: FB-EVAR was feasible for postdissection thoracoabdominal aneurysm. Despite the associated perioperative risk and high probability of planned or unplanned reintervention, the procedure led to favorable aortic remodeling with false lumen thrombosis and aneurysm regression.

Distribution of Air Embolization During TEVAR Depends on Landing Zone: Insights From a Pulsatile Flow Model.

Purpose: To analyze the distribution of air bubbles in the supra-aortic vessels during thoracic stent-graft deployment in zones 2 and 3 in an aortic flow model. Materials and Methods: Ten identical, investigational, tubular, thoracic stent-grafts were deployed in a glass aortic flow model with a type I arch: 5 in zone 2 and 5 in zone 3. A pulsatile pump generated a flow of 5 L/min with systolic and diastolic pressures (±5%) of 105 and 70 mm Hg, respectively. The flow rates (±5%) were 300 mL/min in the subclavian arteries, 220 mL/min in the vertebral arteries, and 400 mL/min in the common carotid arteries (CCAs). The total amounts of air released in each supra-aortic branch and in the aorta were recorded. Results: The mean amounts of air measured were 0.82±0.23 mL in the zone-2 group and 0.94±0.28 mL in the zone-3 group (p=0.49). In the zone-2 group compared with zone 3, the amounts of released air were greater in the right subclavian artery (0.07±0.02 vs 0.02±0.02 mL, p<0.01) and right CCA (0.30±0.8 vs 0.18±07 mL, p=0.04). There were no differences between the groups concerning the mean amounts of air measured in the right vertebral and all left-side supra-aortic branches. The amount of air released in the descending aorta was significantly higher in the zone-3 group vs the zone-2 group (0.48±0.12 vs 0.13±0.08 mL, p<0.01). Small bubbles were observed continuously during deployment, whereas large bubbles appeared more commonly during deployment of the proximal stent-graft end and after proximal release of the stent-graft. Conclusion: Air is released into all supra-aortic branches and the descending aorta during deployment of tubular thoracic stent-grafts in zones 2 and 3 in an aortic flow model. Higher amounts of air were observed in right-side supra-aortic branches during deployment in zone 2, whereas significantly greater amounts of air were observed in the descending aorta during deployment in zone 3.

Through-and-Through Suture Technique to Stabilize a Sheath in Branched Endovascular Aortic Repair.

Purpose: To describe a technique to catheterize antegrade branches of a branched thoracoabdominal endograft from a femoral access with the help of standard sheaths and a vascular suture. Technique: The technique is demonstrated in a patient who underwent successful complex thoracoabdominal branched endovascular aortic repair. After the deployment of an aortic endograft with two antegrade branches for the targeted renovisceral vessels, a standard braided sheath was preloaded with a 3/0 polypropylene suture and introduced inside an additional sheath from the groin to the thoracic aorta. Simultaneous gentle traction on the suture as the preloaded sheath was advanced achieved a very stable 180° curve of the proximal end of the sheath. It was possible to selectively catheterize the antegrade branches and respective target vessels sequentially, as well as deploy the planned bridging stents for each branch. Conclusion: The through-and-through suture technique is a helpful tool in branched endovascular aortic repair. It saves time, radiation, and materials; no snare is needed, and it can be preloaded into a sheath.

Air Embolism During TEVAR: Liquid Perfluorocarbon Absorbs Carbon Dioxide in a Combined Flushing Technique and Decreases the Amount of Gas Released From Thoracic Stent-Grafts During Deployment in an Experimental Setting.

PURPOSE: To investigate the influence of flushing thoracic stent-grafts with carbon dioxide and perfluorocarbon on the amount of gas released during stent-graft deployment in thoracic endovascular aortic repair (TEVAR). MATERIALS AND METHODS: Ten TX2 ProForm thoracic stent-grafts were deployed into a water-filled container with a curved plastic pipe and flushed sequentially with carbon dioxide, 20 mL of liquid perfluorocarbon (PFC), and 60 mL of saline. Released gas was measured using a calibrated setup. The volume of released gas was compared with the results of an earlier published reference group, in which identical stent-grafts were flushed with 60 mL saline alone as recommended in the instructions for use. RESULTS: The average amount of gas released in the test group was 0.076 mL, significantly lower (p<0.001) than the mean 0.79 mL of gas released in the reference group. Big bubbles appearing at the tip of the sheath when deployment was started were seen in all grafts of the reference group but in only 2 of the test group stent-grafts. Small bubbles were less frequent in the test group. CONCLUSION: The amount of gas released from thoracic stent-grafts during deployment can be influenced by different flushing techniques. The use of PFC in addition to the carbon dioxide flushing technique reduces the volume of gas released during deployment of tubular thoracic stent-grafts to a few microliters. This significant effect is presumably based on the high solubility of carbon dioxide in perfluorocarbon and could be a potential future approach to lower the risk of cerebral injury and stroke from air embolism during TEVAR.

In situ Reconstruction of Infected Groin Pseudoaneurysms in Drug Abusers With Biological Grafts.

OBJECTIVES: The aim of this study was to evaluate outcomes after in situ reconstruction using biological grafts in infected groin pseudoaneurysms in drug abusers. METHODS: This was a single centre retrospective analysis of all patients undergoing in situ reconstruction with biological vascular grafts for infected groin pseudoaneurysms in drug abusers from 2000 to 2017. Outcome measures included wound healing problems, re-infection, graft patency, lower limb amputation, and mortality. RESULTS: Twenty-two patients (14 male) with a median age of 39 years (range 27-49) were identified. Fifteen patients (68%) underwent urgent in situ reconstruction with a xenograft, five patients (23%) with a homograft, and two patients (9%) with an autologous vein. There were no in hospital deaths, in hospital re-infections, or early major limb amputations. Four (18%) patients developed wound healing complications requiring re-operation. During a median follow up of 56 months (range 13-180 months), six patients (27%) developed re-infection requiring complete graft replacement with a new biological graft. Thereafter, three (14%) had re-re-infection. Seven patients (32%) had graft occlusions: two were treated endovascularly, two underwent re-operation, and three were treated conservatively. Two patients (9%) had patent grafts but significant stenosis: one had successful angioplasty and another one was left untreated. One patient required above knee amputation, resulting in an overall major amputation rate of 4%. Estimated primary patency was 87% after one year and 40% after five years. Six patients (27%) died during follow up from non-vascular causes. CONCLUSIONS: In situ reconstruction using biological grafts of infected groin pseudoaneurysms in drug abusers can be achieved with no peri-operative graft related complications, although rates of wound complications may be high. In the longer term, a significant number of patients develop re-infection, graft occlusion, or stenosis, although the amputation rate remains low. The management of this demanding group of patients remains a major challenge.

False Lumen Occlusion in Chronic Aortic Dissection: The New Generation Candy-Plug II.

BACKGROUND: To introduce the new generation Candy-Plug II with a self-closing channel construction inside the plug. METHODS: The technique of the Candy-Plug II was demonstrated in a 50-year-old patient with residual chronic aortic dissection and thoracic false lumen aneurysm with false lumen backflow after open surgical repair of the ascending aorta for acute type A aortic dissection. The Candy-Plug Technique was applied in addition to a branched arch procedure using a new generation Candy-Plug II for false lumen occlusion. The Candy-Plug II is a short tubular stent graft with a small open channel inside the graft to accommodate the central cannula and allow retrieval of the dilator tip, which closes itself as soon as the dilator tip is removed. The channel inside the graft is unsupported and will collapse and thereby close. This new design obviates additional placement of a plug to occlude the midsection of the first-generation Candy-Plug. After deployment of the Candy-Plug, distal false lumen occlusion was confirmed on final angiogram and postoperative computed tomography scans without any leakage through the Candy-Plug. CONCLUSIONS: The new generation Candy-Plug II is a useful refinement of the previously available model. It reduces the procedural steps and provides a longer sealing segment.