Search

Objective: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). Methods: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6–67.0) and was completed in 91.2% (177/194) of patients. Results: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76–0.70]) and 56.6% (95% CI = [0.57–0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07–0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21–0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004–0.05]) and 3.9% (95% CI = [0.007–0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. Conclusions: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.

Purpose: To systematically review existing evidence on outcomes of endovascular repair of abdominal atherosclerotic penetrating aortic ulcers (PAUs). Material and Methods: Cochrane Central Registry of Registered Trials (CENTRAL), MEDLINE (via PubMed), and Web of Science databases were systematically searched. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol (PRISMA-P 2020). The protocol was registered in the international registry of systematic reviews (PROSPERO CRD42022313404). Studies reporting on technical and clinical outcomes of endovascular PAU repair in 3 or more patients were included. Random effects modeling was used to estimate pooled technical success, survival, reinterventions, and type 1 and type 3 endoleaks. Statistical heterogeneity was assessed using the I2 statistic. Pooled results are reported with 95% confidence intervals (CIs). Study quality was assessed using an adapted version of the Modified Coleman Methodology Score. Results: Sixteen studies including 165 patients with a mean/median age ranging from 64 to 78 years receiving endovascular therapy for PAU between 1997 and 2020 were identified. Pooled technical success was 99.0% (CI: 96.0%-100%). In all, 30-day mortality was 1.0% (CI: 0%-6.0%) with an in-hospital mortality of 1.0% (CI: 0.0%-13.0%). There were no reinterventions, type 1, or type 3 endoleaks at 30 days. Median/mean follow-up ranged from 1 to 33 months. Overall, there were 16 deaths (9.7%), 5 reinterventions (3.3%), 3 type 1 (1.8%), and 1 type 3 endoleak (0.6%) during follow-up. The quality of studies was rated low according to the Modified Coleman score at 43.4 (+/- 8.5) of 85 points. Conclusion: There is low-level evidence on outcomes of endovascular PAU repair. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. Recommendations with regard to treatment indications and techniques in asymptomatic PAU should be made cautiously. Clinical Impact This systematic review demonstrated that evidence on outcomes of endovascular abdominal PAU repair is limited. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. In the context of a benign prognosis of asymptomatic PAU and lacking standardization in current reporting, recommendations with regard to treatment indications and techniques in asymptomatic PAUs should be made cautiously.

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.

To report a randomized trial comparing the Legflow paclitaxel-eluting balloon (PEB) + Supera stenting to Supera stenting alone in patients with intermediate to long superficial femoral artery (SFA) lesions.The multicenter RAPID trial ( controlled-trials.com ; identifier ISRCTN47846578) randomized (1:1) 160 patients (mean age 67 years; 102 men) with Rutherford category 2-6 ischemia to treatment with Legflow PEB + Supera stent or Supera stent alone in intermediate to long SFA lesions (mean lesion length 15.8±7.4 vs 15.8±7.6 cm, respectively). The efficacy outcome was primary patency, defined as freedom from restenosis on duplex ultrasound or angiography.Baseline characteristics including the percentage of occlusions were similar between groups. In the intention-to-treat analysis, the estimated primary patency at 1 year was 68.3% (95% CI 56.7% to 79.9%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the Supera group (p=0.900). Per-protocol analysis showed a 12-month primary patency estimate of 74.7% (95% CI 63.1% to 86.3%) in the PEB + Supera group vs 62.0% (95% CI 49.1% to 74.9%) in the control group (p=0.273). Secondary patency estimates at 12 months (per-protocol analysis) were 89.0% (95% CI 80.6% to 97.4%) vs 98.0% (95% CI 94.1% to 100%; p=0.484); the estimates for freedom from clinically driven target lesion revascularization (CD-TLR) were 83.0% (95% CI 72.8% to 93.2%) and 77.8% (95% CI 66.6% to 89.0%; p=0.277), respectively.The short-term results from the multicenter RAPID randomized controlled trial indicate that the Legflow PEB is safe and feasible for the treatment of intermediate to long SFA lesions. In this trial, at least 70% of the patients suffered an occlusion. The PEB group had higher rates of primary patency and freedom from CD-TLR, although there were no statistically significant differences vs controls.

Purpose: To evaluate the feasibility and accuracy of fusion imaging (FI) during endovascular aneurysm repair (EVAR). Methods: FI was performed in 101 consecutive EVAR patients (median age 72 years; 93 men) using automatic registration of the preoperative computed tomography angiography (CTA) with an intraoperative noncontrast cone beam CT (nCBCT; 3D-3D registration). Operative landmarks defined on the CTA were then overlaid in 3 dimensions on fluoroscopy images. Accuracy was measured as the deviation of the position of the lowest renal artery between the FI and angiography. Factors potentially influencing accuracy (α angle, β angle, anesthesia, tortuosity index, neck calcification, neck length, CTA slice thickness, and conventional or sac sealing stent-graft) were analyzed in a multivariate linear regression model. Results: Median procedure time for nCBCT was 3 minutes (range 2–20), with 4 minutes (range 0.4–15) for registration. An automatic registration tool was used successfully in 90 (89%) patients. Median craniocaudal deviation of the FI was 3 mm (range 0–15). Full accuracy (5-mm deviation in 33 (33%). Caudal deviation potentially resulting in renal coverage was seen in 9 (9%). Lateral plus craniocaudal deviation was a median 5.8 mm (range 0–22). The position of the lowest renal artery compared to the FI was left and cranial in 62 (61%). Aneurysm morphology (β angle, p=0.04), CTA slice thickness (p=0.02), and the use of 2 stiff guidewires in endovascular aneurysm sealing (p=0.01) influenced the overlay accuracy. Conclusion: Fusion imaging can be integrated into a daily workflow adding little to the procedure time. Craniocaudal accuracy (

The aims of the present study were to examine the influence of a low-dose unfractionated heparin regime on platelet aggregation and to additionally assess the prevalence of primary aspirin resistance in patients undergoing carotid endarterectomy. Therefore, 50 patients undergoing carotid endarterectomy were enrolled. A bolus of 3000 IU unfractionated heparin was administered 2 min before carotid cross-clamping additionally to standard antiaggregatory therapy. Haemostaseological point of care testing was performed twice, prior to surgery and 10 min after unfractionated heparin administration by the use of aggregometric and viscoelastic point of care testing. Following unfractionated heparin administration, the activated partial thromboplastin time increased significantly and clotting time in viscoelastic INTEM test was shown to be significantly prolonged. In contrast, the antiaggregatory effect of aspirin was not diminished in aggregometric ASPI test. A low-dose unfractionated heparin regime during carotid endarterectomy was therefore considered to be safe, without diminishing the antiplatelet effect of aspirin. Moreover, aggregometric point of care testing was identified to be a suitable tool for the identification of patients with primary aspirin resistance ( n = 3).

Purpose: To compare the radiation exposure associated with intraoperative contrast-enhanced cone-beam computed tomography (ceCBCT) acquisitions to standard 3-phase multidetector computed tomography (MDCT) angiography used for assessing technical success after endovascular aortic repair (EVAR). Methods: Effective doses (EDs) were calculated for 66 EVAR patients (mean age 71 years; 61 men) with a mean 27.7-kg/m2 body mass index (range 17–49) who had both intraoperative ceCBCT and postoperative 3-phase MDCT angiography between November 2012 and April 2015. In addition, EDs were directly determined using thermoluminescent dosimeters (TLDs) embedded in anthropomorphic phantoms with body mass indexes of 22 and 30 kg/m2. Effective doses were calculated by summing doses recorded by all TLDs corresponding to a specific tissue type before applying the International Commission on Radiological Protection (ICRP) 60 and 103 weighting factors. EDs were compared with each other for both imaging modalities as well as to TLD measurements. Results: Average EDs of the patient collective were 4.9±1.1 mSv for ceCBCT, 2.6±1.2 mSv for single-phase MDCT (46% decrease, covering solely the area of the implanted endograft), and 13.6±5.5 mSv for comprehensive 3-phase MDCT examinations (178% increase, anatomical coverage from the aortic arch to femoral artery bifurcation). EDs determined in phantom measurements ranged from 3.1 to 4.5 mSv for ceCBCT, amounting to 2.6 mSv for a single MDCT phase (15% to 40% decrease) using ICRP 60 conversion factors. Applying ICRP 103 factors resulted in higher values for ceCBCT and slightly lower ones for MDCT. Conclusion: ceCBCT offers the chance for immediate intraoperative revisions of endograft-related problems. Requiring only a single-phase acquisition, ceCBCT is associated with a considerable reduction in ED (50%–75%) compared to standard 3-phase MDCT angiography after EVAR. On the other hand, MDCT has a larger field of view and is associated with less radiation exposure for a single phase (reduction of 20%–60%) if only the stented region is covered; however, MDCT angiography also uses larger amounts of contrast.

Objectives: The aim of this study was to evaluate short- and midterm outcomes of endovascular aneurysm repair in patients with inflammatory abdominal aortic aneurysm (IAAA) focusing on changes in perianeurysmal inflammation and hydronephrosis. Methods: A retrospective study was performed considering data prospectively gathered from 1998 to 2013 in 3 centers. Patient demographics, preoperative clinical characteristics, clinical presentation, preoperative imaging measurements, procedural, and postoperative data were collected. Main outcome was to define evolution of periaortic fibrosis and hydronephrosis at computed tomography angiography (CTA) during follow-up. Results: A total of 22 patients (male n = 20; mean age 70.9 years ± 9.3) were included (mean AAA diameter: 58 mm ± 11, symptomatic: 50%, ruptured: 9.1%). Hydroureteronephrosis was preoperatively diagnosed by CTA in 6 (27.3%) cases. Median clinical follow-up was 2.2 years (range 0.1-14.5). Nine patients died during follow-up. At 1, 2, 4, and 6 years, overall survival was 85.4%, 74.3%, 56.6%, and 49.5%, respectively. Among these 13 patients with CTA follow-up, the mean AAA diameter was 56.2 mm ± 15.5, and progression of sac diameter was detected in 1 (7.7%) patient. Median maximum thickness of perianeurysmal inflammation was 5 mm (range 2-11) and decreased/remained unchanged in 92.3% of patients. Regression of hydroureteronephrosis occurred in 3 of 5 patients available for follow-up. There were no cases of de novo hydroureteronephrosis. Conclusion: Endovascular treatment of IAAA has comparable short-term outcomes with non-IAAA. During midterm follow-up, aneurysm sac progression is rare, and perianeurysmal fibrosis decreases or remains unchanged in most cases. Hydronephrosis regression can occur in some but not all instances and thus warrants close surveillance.

Endovascular aneurysm sealing (EVAS) using the Nellix system is a new and different method of abdominal aortic aneurysm repair. Normal postoperative imaging has unique appearances that change with time; complications also have different and specific appearances. This consensus document on the imaging findings after Nellix EVAS is based on the collective experience of the sites involved in the Nellix EVAS Global Forward Registry and the US Investigational Device Exemption Trial. The normal findings on computed tomography (CT), duplex ultrasound, magnetic resonance imaging, and plain radiography are described. With time, endobag appearances change on CT due to contrast migration to the margins of the hydrogel polymer within the endobag. Air within the endobag also has unique appearances that change over time. Among the complications after Nellix EVAS, type I endoleak usually presents as a curvilinear area of flow between the endobag and aortic wall, while type II endoleak is typically small and usually occurs where an aortic branch artery lies adjacent to an irregular aortic blood lumen that is not completely filled by the endobag. Procedural aortic injury is an uncommon but important complication that occurs as a result of overfilling of the endobags during Nellix EVAS. The optimum imaging surveillance algorithm after Nellix EVAS has yet to be defined but is largely CT-based, especially in the first year postprocedure. However, duplex ultrasound also appears to be a sensitive modality in identifying normal appearances and complications.

Purpose: To associate regions of highest local rupture risk from finite element analysis (FEA) to subsequent rupture sites in abdominal aortic aneurysms (AAA). Methods: This retrospective multicenter study analyzed computed tomography angiography (CTA) data from 13 asymptomatic AAA patients (mean age 76 years; 8 men) experiencing rupture at a later point in time between 2005 and 2011. All patients had CTA scans before and during the rupture event. FEA was performed to calculate peak wall stress (PWS), peak wall rupture risk (PWRR), rupture risk equivalent diameters (RRED), and the intraluminal thrombus volume (ILTV). PWS and PWRR locations in the prerupture state were compared with subsequent CTA rupture findings. Visible contrast extravasation was considered a definite (n=5) rupture sign, while a periaortic hematoma was an indefinite (n=8) sign. A statistical comparison was performed between the 13-patient asymptomatic AAA group before and during rupture and a 23-patient diameter-matched asymptomatic AAA control group that underwent elective surgery. Results: The asymptomatic AAAs before rupture showed significantly higher PWRR and RRED values compared to the matched asymptomatic AAA control group (median values 0.74 vs 0.52 and 77 vs 59 mm, respectively; p

Purpose: To report initial experience with automatic pressure-controlled cerebrospinal fluid drainage (CSFD) during thoracic endovascular aortic repair (TEVAR). Methods: A prospective nonrandomized study enrolled 30 consecutive patients (median age 68 years, range 42–89; 18 men) who underwent TEVAR between March 2012 and July 2013 and were considered to be at high risk for postoperative spinal cord ischemia (SCI), fulfilling 2 of the following criteria: stent-graft length >20 cm, left subclavian artery coverage, and previous infrarenal aortic repair. All patients received perioperative CSFD via the LiquoGuard system. The protocol aimed for a CSF pressure of 10 mm Hg and duration of CSFD of 3 or 7 days in asymptomatic or symptomatic patients, respectively. Muscle strength of the lower extremities was assessed with the Oxford muscle strength grading scale. Results: Completion of the CSFD protocol was achieved in 26 (87%) of 30 patients. CSFD was prematurely stopped due to catheter dislocation in 1 patient and bloody spinal fluid in 3 patients. CSFD was performed for a median of 3 days (range 1–7). Median total CSFD volume was 714 mL (range 13–2369), with a median 192 mL drained per 24 hours. The SCI rate was 3% (1/30). CSFD-related complications were observed in 33% of the patients: 1 fatal intracranial hemorrhage, 3 bloody spinal fluid episodes, 3 persistent CSF leaks requiring epidural blood patch, and 3 post lumbar puncture headaches. Mortality during a median follow-up of 16 months (range 10–25) was 3% (1/30). Conclusion: Prophylactic CSFD was associated with a low SCI rate in a high-risk patient collective undergoing TEVAR. Monitoring and drainage by an automatic modus was feasible, reproducible, and reliable but associated with relevant drainage-associated complications.

Objectives: To evaluate hemodynamic changes during aneurysmal dilatation in chronic type B aortic dissections compared to hemodynamic parameters in the healthy aorta with the use of computational fluid dynamics (CFD). Methods: True lumen (TL)/false lumen (FL) dimensional changes, changes in total pressure (TP), and wall shear stress (WSS) were evaluated at follow-up (FU) compared to initial examination (IE) with transient CFD simulation with geometries derived from clinical image data and inflow boundary conditions from magnetic resonance images. The TL/FL pressure gradient between ascending and descending aorta (DAo) and maximum WSS at the site of largest dilatation was compared to values for the healthy aorta. Results: Hemodynamic changes at site of largest FL dilatation included 77% WSS reduction and 69% TP reduction. Compared to the healthy aorta, pressure gradient between ascending and DAo was a factor of 1.4 higher in the TL and a factor of 1.5 in the FL and increased at FU (1.6 and 1.7, respectively). Maximum WSS at the site of largest dilatation was a factor of 3 lower than that for the healthy aorta at IE and decreased by more than a factor of 2 at FU. Conclusions: The FL dilatation at FU favorably reduced TP. In contrast, unfavorable increase in pressure gradient between ascending and DAo was observed with higher values than in the healthy aorta. Maximum WSS was reduced at the site of largest dilation compared to healthy aorta.

Purpose: To report our initial experience with total and subtotal endovascular aortic arch reconstruction combined with supra-aortic vessel transposition in high-risk patients and to present a new morphological classification of thoracic aortic lesions for patient and procedure selection. Methods: Among 80 patients treated with thoracic stent-grafts at our department between 1997 and 2003, 8 patients (6 men; mean age 71 years, range 45–81) unfit for open repair were not candidates for standard endovascular repair due to inadequate proximal landing zones on the aortic arch. Commercially available endografts (Excluder, Zenith, Endofit, Talent) were used to repair the arch after supra-aortic vessel transposition was performed. The endograft was implanted transfemorally or via an iliac Dacron conduit graft with standardized endovascular techniques and deployed during intravenous adenosine-induced asystole. The imaging data from all thoracic endograft patients was analyzed to classify thoracic and thoracoabdominal lesions according to a 4-level anatomical system. Results: Deployment success was 100% after staged supra-aortic vessel transposition, but 1 patient died of endograft-related rupture of the proximal aortic arch. There was no neurological complication. Mean follow-up was 16 months (range 1–36). Patency of all endografts and conventional bypasses was 100%, and no migration was observed. One minor type II endoleak was demonstrated. Conclusions: Initial results are encouraging for endovascular aortic arch repair in combination with supra-aortic transposition in selected high-risk patients with complex aortic pathologies.

Purpose: To analyze the incidence and etiology of renal infarctions following endovascular abdominal aortic aneurysm (AAA) repair detected on computed tomography (CT) and determine any association with infrarenal versus suprarenal fixation. Methods: Between August 1994 and October 2001, 663 patients (604 men; mean age 68.5 years, range 40–98) underwent endovascular AAA repair with predominately bifurcated (505, 77%) stent-grafts. About a third (202, 30%) of the devices were deployed in a suprarenal position. Contrast-enhanced CT scans were performed on days 10, 90, and 365 after operation and then annually. Two radiologists blinded to procedural details compared the preoperative and postoperative scans to identify renal infarctions from inadvertent renal artery occlusion by the endograft. Only patients with inadvertent infarctions were analyzed relative to endograft fixation position and stent-graft type. Results: Mean follow-up was 37 months (range 0.1–75). Overall renal infarction rate was 11.9% (n=79); 23 (3.4%) patients suffered from limited, segmental infarction due to intentional covering of preoperatively diagnosed accessory renal arteries. Unintentional renal ischemia was identified in 56 (8.5%) patients. In this subgroup, 39 (19%) were observed in the 202 patients with suprarenal fixation versus 17 (3.7%) in the 461 stent-grafts positioned infrarenally (RR 3.35, 95% CI 2.20 to 5.04, p < 0.00001). There was a significant correlation between the incidence of infarction and the device type (14.3% for modular grafts versus 5.6% for unibody designs, p = 0.0002). Seventeen (2.6%) patients suffered from unilateral kidney loss, with dialysis required in 2 cases. Creatinine and urea showed no significant postoperative elevation in the overall patient population, but both levels were significantly (p < 0.02) elevated in patients with complete unilateral renal infarcts. Conclusions: Transrenal fixation of aortic endografts had a 3-fold higher risk for renal infarction in this large patient population. There is no significant difference for specific endografts, but modular designs were associated with a higher rate of renal infarction. The need to occlude preoperatively diagnosed accessory renal arteries with an endograft should be considered a contraindication for current available devices.

Department of Vascular and Endovascular Surgery, University of Heidelberg - Heidelberg--> - GERMANY (Kotelis, Drosos)

Address for correspondence: Dittmar Bockler, Department of Vascular and Endovascular Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Tel: 49 6221 566249; Fax: 49 6221 566423; E-mail: dittmar_boeckler@med.uni-heidelberg.de Figure 1A The arrow indicates dissection of the left renal artery. Note minor contrast enhancement of the left kidney. Computed tomographic angiography: axial view.