European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Safety of Percutaneous Femoral Access for Endovascular Aortic Aneurysm Repair Through Previously Surgically Exposed or Repaired Femoral Arteries.

OBJECTIVE: Percutaneous femoral artery access is being increasingly used in endovascular aortic repair (EVAR). The technique can be challenging in patients with previously surgically exposed or repaired femoral arteries because of excessive scar tissue. However, a successful percutaneous approach may cause less morbidity than a "re-do" open femoral approach. The aim of this study was to assess the impact of prior open surgical femoral exposure on technical success and clinical outcomes of percutaneous approach. METHODS: This study retrospectively reviewed the clinical data of patients who underwent percutaneous EVAR between 2010 and 2020 at 2 major aortic centers. Patients were divided into 2 groups (with or without prior open surgical femoral access) for analysis of clinical outcomes. Only punctures with sheaths ≥12Fr were included for analysis. The access and (pre)closure techniques were similar in both institutions. Primary end points were intraoperative technical success, access-related revision, and access complications. A multivariate analysis was performed to identify determinants of conversion to open approach and femoral access complications in intact and re-do groins. RESULTS: A total of 632 patients underwent percutaneous (complex) EVAR: 98 had prior open surgical femoral access and 534 patients underwent de novo femoral percutaneous access. A total of 1099 femoral artery punctures were performed: 149 in re-do and 950 in intact groins. The extent of endovascular repair included 159 infrarenal, 82 thoracic, 368 fenestrated/branched, and 23 iliac branch devices. No significant differences were seen in technical success (re-do 93.3% vs intact 95.3%, p=0.311), access-related surgical revision (0.7% vs 0.6%, p=0.950), and access complications (2.7% vs 4.0%, p=0.443). For the whole group, significant predictors for access complications in multivariate analyses were main access site (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.07%-5.35%; p=0.033) and increase of the procedure time per hour (OR 1.65; 95% CI 1.34%-2.04%; p<0.001), while increase in sheath-vessel ratio had a protective effect (OR 0.33; 95% CI 0.127%-0.85%; p=0.021). Surgical conversion was predicted by main access site (OR 2.32; 95% CI 1.28%-4.19%; p=0.007) and calcification of 50% to 75% of the circumference of the access vessel (OR 3.29; 95% CI 1.38%-7.86%; p=0.005). CONCLUSION: Within our population prior open surgical femoral artery exposure or repair had no negative impact on the technical success and clinical outcomes of percutaneous (complex) endovascular aortic aneurysm repair.

Fenestrated/branched endovascular aortic repair using unilateral femoral access in patients with iliac occlusive disease.

OBJECTIVE: Fenestrated/branched endovascular aortic repair (F/BEVAR) in patients with occluded iliac arteries is challenging owing to limited access for branch vessel catheterization and increased risk for leg and spinal ischemic complications. The aim of this study was to analyze technical strategies and outcomes of F/BEVAR in patients with unilateral iliofemoral occlusive disease. METHODS: We performed a retrospective review of all consecutive patients treated by F/BEVAR in two institutions (2003-2021). Patients with unilateral iliofemoral occlusive disease were included in the analysis. All patients had one patent iliac artery that was used for advancement of the fenestrated-branch component. Preloaded catheter/guidewire systems or steerable sheaths were used as adjuncts to facilitate catheterization. Primary endpoints were technical success, mortality, major adverse events (stroke, spinal cord injury, dialysis or decrease in the glomerular filtration rate of more than 50%, bowel ischemia, myocardial infarction, or respiratory failure), primary iliac patency, and freedom from reinterventions. RESULTS: There were 959 patients treated with F/BEVAR. Of these, 15 patients (1.56%; mean age, 74 years; 80% male) had occluded iliac arteries and 1 patent iliofemoral access and were treated for a thoracoabdominal aortic aneurysm (n = 8) or juxtarenal abdominal aortic aneurysm (n = 7). Brachial access was used in 14 of the 15 patients and preloaded systems in 7 of the 15 patients (47%). The remaining 53% had staggered deployment of stent grafts. There were seven physician-modified endovascular grafts, seven custom-made devices, and one off-the-shelf device used. Thirteen patients (87%) had distal seal using aortouni-iliac stent grafts and two (13%) had distal seal in the infrarenal aorta. Concomitant femoral crossover bypass (FCB) was performed in two patients and six patients had a prior FCB. Technical success was 100%. There were no intraoperative complications or early lower extremity ischemic complications, and all FCB were preserved. There was one mortality (7%) within 30 days owing to retrograde type A dissection. Major adverse events occurred in 20% of patients. The median follow-up was 12 months (range, 0-85 months). Two patients (13%) required three reinterventions. One patient required proximal stent graft extension for an acute type B dissection (3 months) and another required iliac extension for type Ib endoleak of an aortouni-iliac graft (21 months) and thrombolysis of that extension (50 months). At last follow-up, all patients had primary graft patency except one with secondary graft patency without new claudication. One patient had a single renal artery stent occlusion at follow-up with no r-intervention. The overall survival rate was 60%, without aortic-related deaths. CONCLUSIONS: Although challenging, F/BEVAR with unilateral femoral/brachial approach is feasible in patients with occluded iliac limbs, with an important rate of ischemic complications, but satisfactory outcomes.

Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised controlled trial.

INTRODUCTION: Current evidence on vascular access strategies for haemodialysis patients is based on observational studies that are at high risk of selection bias. For elderly patients, autologous arteriovenous fistulas that are typically created in usual care may not be the best option because a significant proportion of fistulas either fail to mature or remain unused. In addition, long-term complications associated with arteriovenous grafts and central venous catheters may be less relevant when considering the limited life expectancy of these patients. Therefore, we designed the Optimising Access Surgery in Senior Haemodialysis Patients (OASIS) trial to determine the best strategy for vascular access creation in elderly haemodialysis patients. METHODS AND ANALYSIS: OASIS is a multicentre randomised controlled trial with an equal participant allocation in three treatment arms. Patients aged 70 years or older who are expected to initiate haemodialysis treatment in the next 6 months or who have started haemodialysis urgently with a catheter will be enrolled. To detect and exclude patients with an unusually long life expectancy, we will use a previously published mortality prediction model after external validation. Participants allocated to the usual care arm will be treated according to current guidelines on vascular access creation and will undergo fistula creation. Participants allocated to one of the two intervention arms will undergo graft placement or catheter insertion. The primary outcome is the number of access-related interventions required for each patient-year of haemodialysis treatment. We will enrol 195 patients to have sufficient statistical power to detect an absolute decrease of 0.80 interventions per year. ETHICS AND DISSEMINATION: Because of clinical equipoise, we believe it is justified to randomly allocate elderly patients to the different vascular access strategies. The study was approved by an accredited medical ethics review committee. The results will be disseminated through peer-reviewed publications and will be implemented in clinical practice guidelines. TRIAL REGISTRATION NUMBER: NL7933. PROTOCOL VERSION AND DATE: V.5, 25 February 2021.

Fiber Optic RealShape technology in endovascular surgery.

Fiber Optic RealShape technology is a new endovascular guidance system that aims to simplify endovascular procedures by improving wire, catheter, and device visualization, while reducing reliance on ionizing radiation. Developed by Philips, the system uses light refracted through optical fibers to generate real-time renderings of wires and catheters in three-dimensional space. Currently, devices with embedded Fiber Optic RealShape technology are being studied in human patients undergoing endovascular procedures. Early findings demonstrate the technology to be safe and effective in offsetting procedural complexity. Research and development to improve rendering accuracy and expand the selection of available Fiber Optic RealShape-enabled endovascular devices continues.

Use of covered stent grafts as treatment of traumatic venous injury to the inferior vena cava and iliac veins: A systematic review.

OBJECTIVE: Venous injury to the inferior vena cava or iliac veins is rare but can result in high mortality rates. Traditional treatment by repair or ligation can be technically demanding. A relatively new treatment modality is the use of a covered stent to cover the venous defect. The aim of the present systematic review was to assess the techniques, results, and challenges of covered stent graft repair of traumatic injury to the inferior vena cava and iliac veins. METHODS: The PubMed (Medline) and Embase databases were systematically searched up to September 2020 by two of us (R.R.S. and D.D.) independently for studies reporting on covered stenting of the inferior vena cava or iliac veins after traumatic or iatrogenic injury. A methodologic quality assessment was performed using the modified Newcastle-Ottawa scale. Data were extracted for the following parameters: first author, year of publication, study design, number of patients, type and diameter of the stent graft, hemostatic success, complications, mortality, postoperative medication, follow-up type and duration, and venous segment patency. The main outcome was clinical success of the intervention, defined as direct hemostasis, with control of hemorrhage, hemodynamic recovery, and absence of contrast extravasation. RESULTS: From the initial search, which yielded 1884 records, a total of 28 studies were identified for analysis. All reports consisted of case reports, except for one retrospective cohort study and one case series. A total of 35 patients had been treated with various covered stent grafts, predominantly thoracic or abdominal aortic endografts. In all patients, the treatment was technically successful. The 30-day mortality rate for the entire series was 2.9%. Three perioperative complications were described: one immediate stent occlusion, one partial thrombosis, and one pulmonary embolism. Additional in-stent thrombus formation was seen during follow-up in three patients, leading to one stent graft occlusion (asymptomatic). The postoperative anticoagulation strategy was highly heterogeneous. The median follow-up was 3 months (range, 0.1-84 months). However, follow-up with imaging studies was not performed in all cases. CONCLUSIONS: In selected cases of injury to the inferior vena cava and iliac veins, covered stent grafts can be successful for urgent hemostasis with good short-term results. Data on long-term follow-up are very limited.

Stabilization of a steerable sheath during retrograde access to antegrade-oriented branches in complex endovascular aortic aneurysm repair.

During branched endovascular aneurysm repair, cannulation of the visceral target vessels through antegrade branches and insertion of bridging stents are frequently done from an upper extremity access. A retrograde femoral approach is a challenging alternative when an antegrade approach is not preferred. Herein, we describe a technique to increase stability of a steerable sheath, using a single suture, for bridging antegrade-facing branches from a retrograde access. This technique secures the sheath's deflected tip and provides more pushability to the steerable sheath.

Can Electric Nose Breath Analysis Identify Abdominal Wall Hernia Recurrence and Aortic Aneurysms? A Proof-of-Concept Study.

Introduction. This pilot study evaluates if an electronic nose (eNose) can distinguish patients at risk for recurrent hernia formation and aortic aneurysm patients from healthy controls based on volatile organic compound analysis in exhaled air. Both hernia recurrence and aortic aneurysm are linked to impaired collagen metabolism. If patients at risk for hernia recurrence and aortic aneurysms can be identified in a reliable, low-cost, noninvasive manner, it would greatly enhance preventive options such as prophylactic mesh placement after abdominal surgery. Methods. From February to July 2017, a 3-armed proof-of-concept study was conducted at 3 hospitals including 3 groups of patients (recurrent ventral hernia, aortic aneurysm, and healthy controls). Patients were measured once at the outpatient clinic using an eNose with 3 metal-oxide sensors. A total of 64 patients (hernia, n = 29; aneurysm, n = 35) and 37 controls were included. Data were analyzed by an automated neural network, a type of self-learning software to distinguish patients from controls. Results. Receiver operating curves showed that the automated neural network was able to differentiate between recurrent hernia patients and controls (area under the curve 0.74, sensitivity 0.79, and specificity 0.65) as well as between aortic aneurysm patients and healthy controls (area under the curve 0.84, sensitivity 0.83, and specificity of 0.81). Conclusion. This pilot study shows that the eNose can distinguish patients at risk for recurrent hernia and aortic aneurysm formation from healthy controls.

Comparing Mobile C-Arm with a Hybrid Operating Room for Imaging in Fenestrated Stent-Graft Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: To evaluate the advantages of a hybrid operating room (OR) (group 2) compared with a fluoroscopic mobile C-arm (group 1) during fenestrated stent-graft endovascular aneurysm repair (f-EVAR). METHODS: This single-center study retrospectively analyzed prospectively collected data of consecutive patients treated with f-EVAR for short-necked, juxtarenal, and suprarenal aortic aneurysms between January 2006 and July 2016. Primary end points were technical success and perioperative complications. Secondary end points included 30-day and 1-year mortality as well as target vessel patency. RESULTS: About 96 patients were treated (85 men; 74.1 ± 6.3 years); 46 patients (48%) belonging to group 1 and 50 (52%) patients belonging to group 2. Technical success was achieved in 92.7% of the procedures (group 1 91.3% vs. group 2 94%, P = 0.72). Significantly more complex interventions were performed in group 2 (n = 38 of 50) compared with group 1 (n = 14 of 46; P < 0.001), in which primarily renal f-EVAR interventions were performed. In group 2, significantly less contrast was used (median 150 mL vs. 100 mL; P < 0.001). The 30-day mortality in group 1 was 9% and 2% in group 2 (P = 0.14), and 1-year survival was also not significantly different between both groups. Target visceral vessel primary patency was significantly higher in group 1 (87.6% vs. 85.5% [P = 0.006] and 83.8% vs. 78.3% [P = 0.03]) at 6 and 12 months, respectively). There was no significant difference in renal artery primary patency at 6 and 12 months. CONCLUSIONS: Immediate and 1-year outcomes after f-EVAR for abdominal aortic aneurysm were comparable using a hybrid OR compared with a mobile C-arm, despite the use of significantly more complex stent grafts in the patients treated in the hybrid OR. The use of a hybrid OR may assist in achieving satisfying results in complex f-EVAR.

Neurophysiological and paraspinal oximetry monitoring to detect spinal cord ischemia in patients during and after descending aortic repair: An international multicenter explorative study.

BACKGROUND: During descending aortic repair, critically decreased blood flow to the myelum can result in ischemic spinal cord injury and transient or permanent paraplegia. Assessment of motor evoked potentials (MEPs) has been shown to be a valuable tool which allows to detect spinal cord ischemia (SCI) intraoperatively within a therapeutic window suitable to prevent progression to paraparesis or paraplegia. MEP monitoring is not feasible during postoperative care in the awakening patient. Therefore, ancillary techniques to monitor integrity of spinal cord function are needed to detect delayed spinal cord ischemia. OBJECTIVE: The purpose of this study is to evaluate whether assessment of long loop reflexes (LLR; F-waves) and paraspinal muscle oximetry using Near-Infrared Spectroscopy (NIRS) are feasible and valid in detecting delayed SCI. METHODS: We aim to include patients from three tertiary referral centers undergoing aortic repair with MEP monitoring in this study.F-wave measurements and paraspinal NIRS oximetry will be operated intra- and postoperatively. Measurement characteristics and feasibility will be assessed in the first 25 patients. Subsequently, a second cohort of 75 patients will be investigated to determine the sensitivity and specificity of F-waves and NIRS in detecting perioperative SCI. In this context for the MEP group SCI is defined intraoperatively as significant MEP changes and postoperatively as newly developed paraplegia. CONCLUSIONS: A clinical study design and protocol is proposed to assess if F-waves and/or NIRS-based paraspinal oximetry are feasible and valid in detecting and monitoring for occurrences of delayed SCI.

Duplex-guided versus Conventional Percutaneous Transluminal Angioplasty of Iliac TASC II A and B Lesion: A Randomized Controlled Trial.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. METHODS: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle-brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. RESULTS: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. CONCLUSIONS: DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil.

Prevention of postcontrast acute kidney injury after percutaneous transluminal angioplasty by inducing RenalGuard controlled furosemide forced diuresis with matched hydration: study protocol for a randomised controlled trial.

INTRODUCTION: Percutaneous transluminal angioplasty (PTA) is often complicated due to postcontrast acute kidney injury (PC-AKI) in patients diagnosed with chronic kidney disease (CKD). Hydration therapy is the cornerstone in the prevention of PC-AKI. Furosemide forced diuresis with matched hydration using the RenalGuard system enables a steady balance between diuresis and hydration. A randomised controlled trial will be performed in order to investigate whether furosemide forced diuresis with matched hydration in combination with the RenalGuard system decreases incidence of PC-AKI in patients with CKD receiving a PTA of the lower extremities. Furthermore, we will investigate whether sampling of urine biomarkers 4 hours after intervention can detect PC-AKI in an earlier stage compared with the golden standard, serum creatinine 48-72 hours postintervention. METHODS AND ANALYSIS: A single-centre randomised controlled trial will be conducted. Patients >18 years in need of a PTA of the lower extremities and diagnosed with CKD will be randomly assigned to receive either standard of care prehydration and posthydration or furosemide forced diuresis with matched hydration periprocedural using the RenalGuard system. Four hours postintervention, a urine sample will be collected of all participating patients. Serum creatinine will be sampled within 10 days prior to intervention as well as 1, 3 and 30 days postintervention. The primary endpoint is incidence of PC-AKI post-PTA. Secondary endpoint is the rise of urine biomarkers 4 hours postintervention. ETHICS AND DISSEMINATION: Study protocol is approved by the research ethics committee and institutional review board (reference number 16 T-201 and NL59809.096.16). Study results will be disseminated by oral presentation at conferences and will be submitted to a peer-reviewed journal. It is anticipated that study results will offer a solution to contrast-induced nephropathy in patients with CKD receiving a PTA of the lower extremities. TRIAL REGISTRATION NUMBER: NTR6236; Pre-results. EUDRACT NUMBER: 2016-005072-10.

Editor's Choice - Open Thoracic and Thoraco-abdominal Aortic Repair After Prior Endovascular Therapy.

OBJECTIVE: The aim was to present current results of open thoracic and thoraco-abdominal aortic repair as secondary procedure after prior endovascular therapy. METHODS: This was a retrospective cross border single centre study. From 2006 to July 2017 45 open thoracic aortic (TAA) or thoraco-abdominal aortic aneurysm (TAAA) operations were performed on 44 patients (median age 58 [15-80] years) as secondary surgery after previous endovascular therapy comprising TEVAR (n = 38; 86%), EVAR (n = 3; 7%), fenestrated EVAR (n = 1; 2%) and TEVAR plus EVAR (n = 1; 2%). Eleven patients (25%) had had previous open aortic surgery at the secondary surgery site. Indications for TAA(A) repair were Type I endoleak (n = 10; 23%), post-dissection aneurysm progression due to persisting false lumen perfusion (n = 8; 18%), proximal/distal disease progression (n = 16; 36%), device fracture/dislocation (n = 4; 9%), infection (n = 5; 11%), and initial endograft misplacement (n = 1; 2%). The operations included descending thoracic aortic repair (n = 13, 29%), TAAA Type I (n = 4; 9%), Type II (n = 5; 11%), Type III (n = 13; 29%), Type IV (n = 7; 16%), and Type V repair (n = 3; 7%) with simultaneous arch repair in 18% (n = 8). The median time to secondary surgery was 36 (2-168) months. The median follow up was 39 (3-118) months. RESULTS: In hospital mortality was 20% (n = 9) due to intra-operative aneurysm rupture, pneumonia induced sepsis, hemorrhagic cerebellar infarction, mesenteric ischaemia, broncho-esophageal fistula, and multiorgan failure (1/9) as well as haemorrhage (3/9). Estimated survival was 73% at 1 year and 71% overall. The most frequent complications were pneumonia (n = 19; 43%), bleeding requiring revision (n = 11; 25%) and sepsis (n = 14; 32%). Transient dialysis was required in 32% (n = 14), permanent dialysis in 6% (n = 2). Permanent spinal cord deficit (paraparesis) occurred in 6% (n = 2). Estimated freedom from aortic re-intervention was 86%. CONCLUSION: Open TAA(A) repair as a secondary procedure after previous endovascular aortic therapy is an important treatment option even in the endovascular era. It represents a durable treatment that can produce respectable outcomes. Yet the peri-operative morbidity and mortality are relevant and a specialised team and infrastructure are mandatory for these complex procedures. Therefore, centralisation is required.

Editor's Choice - Open Thoracic and Thoraco-abdominal Aortic Repair in Patients with Connective Tissue Disease.

OBJECTIVE/BACKGROUND: The aim is to present current results of open complex aortic repair in patients with connective tissue disease (CTD). METHODS: This was a retrospective cross-border, single centre study. From February 2000 to April 2016 72 aortic operations were performed on 65 patients with CTD (41 male, median age 41 years [range 19-70 years]). Fifty-six patients (86%) underwent at least one previous aortic repair (71 open, four endovascular), including 33 patients (51%) operated before at the site of the procedure reported here. The open procedures, counting eight emergency operations (11%), included aortic arch revision (n = 1; 1%), descending thoracic aortic repair (n = 11; 15%), TAAA type I repair (n = 12; 17%), type II repair (n = 29; 40%), type III repair (n = 12; 17%), and type IV repair (n = 5; 7%). Simultaneous repair of the ascending aorta and/or the aortic arch was performed in two (3%) and eight cases (11%), respectively. Seven patients (10%) underwent staged procedures. Median follow-up was 42 months (0.5-180 months). RESULTS: The in hospital mortality was 14% (n = 9) as a result of haemorrhage (n = 3/9), neurological (n = 3/9), cardiac (n = 2/9), and pulmonary (n = 1/9) complications. Paraplegia and paraparesis occurred in one (2%) and three patients (5%), respectively. Seven patients (11%) required temporary dialysis; none needed permanent dialysis. Major complications were revision surgery for bleeding or haematoma (n = 20/65), sepsis (n = 10/65), myocardial infarction/severe cardiac arrhythmia (n = 2/65), stroke (n = 2/65), as well as multiorgan failure, abdominal compartment syndrome, mesenteric and peripheral ischaemia (all n = 1/65). Multivariate analysis identified an operating time > 7 hours (p = .006) as an independent predictor of increased mortality. Freedom from re-intervention was 85%, 1 year survival was 80%, and overall survival was 75%. CONCLUSION: Open TAA(A) repair is a durable therapy for patients with CTD. Often being performed as revision surgery, it can be associated with relevant risks and should therefore be reserved for specialised centres. Staged procedures and thus reducing operating time, if applicable, should be preferred.

Computed Tomography Imaging Features in Acute Uncomplicated Stanford Type-B Aortic Dissection Predict Late Adverse Events.

BACKGROUND: Medical treatment of initially uncomplicated acute Stanford type-B aortic dissection is associated with a high rate of late adverse events. Identification of individuals who potentially benefit from preventive endografting is highly desirable. METHODS AND RESULTS: The association of computed tomography imaging features with late adverse events was retrospectively assessed in 83 patients with acute uncomplicated Stanford type-B aortic dissection, followed over a median of 850 (interquartile range 247-1824) days. Adverse events were defined as fatal or nonfatal aortic rupture, rapid aortic growth (>10 mm/y), aneurysm formation (≥6 cm), organ or limb ischemia, or new uncontrollable hypertension or pain. Five significant predictors were identified using multivariable Cox regression analysis: connective tissue disease (hazard ratio [HR] 2.94, 95% confidence interval [CI]: 1.29-6.72; P=0.01), circumferential extent of false lumen in angular degrees (HR 1.03 per degree, 95% CI: 1.01-1.04, P=0.003), maximum aortic diameter (HR 1.10 per mm, 95% CI: 1.02-1.18, P=0.015), false lumen outflow (HR 0.999 per mL/min, 95% CI: 0.998-1.000; P=0.055), and number of intercostal arteries (HR 0.89 per n, 95% CI: 0.80-0.98; P=0.024). A prediction model was constructed to calculate patient specific risk at 1, 2, and 5 years and to stratify patients into high-, intermediate-, and low-risk groups. The model was internally validated by bootstrapping and showed good discriminatory ability with an optimism-corrected C statistic of 70.1%. CONCLUSIONS: Computed tomography imaging-based morphological features combined into a prediction model may be able to identify patients at high risk for late adverse events after an initially uncomplicated type-B aortic dissection.

Real-Time Patient and Staff Radiation Dose Monitoring in IR Practice.

PURPOSE: Knowledge of medical radiation exposure permits application of radiation protection principles. In our center, the first dedicated real-time, automated patient and staff dose monitoring system (DoseWise Portal, Philips Healthcare) was installed. Aim of this study was to obtain insight in the procedural and occupational doses. MATERIALS AND METHODS: All interventional radiologists, vascular surgeons, and technicians wore personal dose meters (PDMs, DoseAware, Philips Healthcare). The dose monitoring system simultaneously registered for each procedure dose-related data as the dose area product (DAP) and effective staff dose (E) from PDMs. Use and type of shielding were recorded separately. All procedures were analyzed according to procedure type; these included among others cerebral interventions (n = 112), iliac and/or caval venous recanalization procedures (n = 68), endovascular aortic repair procedures (n = 63), biliary duct interventions (n = 58), and percutaneous gastrostomy procedure (n = 28). RESULTS: Median (±IQR) DAP doses ranged from 2.0 (0.8-3.1) (percutaneous gastrostomy) to 84 (53-147) Gy cm2 (aortic repair procedures). Median (±IQR) first operator doses ranged from 1.6 (1.1-5.0) µSv to 33.4 (12.1-125.0) for these procedures, respectively. The relative exposure, determined as first operator dose normalized to procedural DAP, ranged from 1.9 in biliary interventions to 0.1 µSv/Gy cm2 in cerebral interventions, indicating large variation in staff dose per unit DAP among the procedure types. CONCLUSION: Real-time dose monitoring was able to identify the types of interventions with either an absolute or relatively high staff dose, and may allow for specific optimization of radiation protection.

Loss of Kidney Function after Endovascular Treatment of Peripheral Arterial Disease.

BACKGROUND: Administration of radiocontrast during endovascular procedures for peripheral arterial disease (PAD) may cause acute kidney injury, which generally recovers with supportive treatment. Long-term effects of endovascular procedures on renal function remain to be investigated. METHOD: This retrospective observational cohort study includes all patients who newly presented to the vascular surgery outpatient clinic with Rutherford class II or III PAD and who were treated with either supervised exercise therapy or endovascular interventions. Changes in estimated glomerular filtration rates (eGFR) after 1 year were compared between the 2 treatment groups. Multivariate regression analysis and propensity score-matched paired analysis were done to correct for potential confounders. RESULTS: One year after treatment, eGFR was reduced by 8.6 mL/min (95% confidence interval [CI], 7.3-9.9, P < 0.001) after endovascular intervention (n = 284) and by 1.7 mL/min (95% CI, 0.9-25, P < 0.001) after supervised exercise therapy (n = 299). After correction for potential confounders, endovascular interventions were associated with 9.2 mL/min (95% CI, 5.9-12.4, P < 0.001) more renal decline compared to exercise therapy. Similar results were found in the propensity score-matched paired analysis. CONCLUSIONS: Endovascular procedures for PAD are associated with clinically relevant and long-term loss of kidney function.

Loss of kidney function in patients with critical limb ischemia treated endovascularly or surgically.

BACKGROUND: Acute kidney injury after the administration of contrast material during endovascular procedures for peripheral arterial disease generally recovers with supportive treatment. However, long-term effects of endovascular procedures for critical limb ischemia on renal function remain to be investigated. METHODS: This retrospective observational cohort study included all patients who newly presented to the vascular surgery outpatient clinic with Rutherford class 4 to class 6 peripheral arterial disease and who were treated with either endovascular or surgical interventions. Changes in estimated glomerular filtration rate (eGFR) after 1 year were compared between the two types of intervention. Multivariate linear regression analysis was done to correct for potential confounders. RESULTS: One year after treatment, eGFR was reduced by 15.0 mL/min (95% confidence interval [CI], 13.1-17.0; P < .001) after endovascular interventions (n = 209) and by 7.6 mL/min (95% CI, 5.1-10.0; P < .001) after surgical therapy (n = 81). Although eGFR rates decreased in both groups, loss of renal function was significantly greater in patients after endovascular interventions (P < .001). Furthermore, 77% of patients receiving endovascular interventions experienced fast renal decline (defined as >4 mL/min loss of eGFR within 1 year) compared with 54% of patients treated surgically (P < .001). After correction for potential confounders, endovascular intervention was associated with 7.4 mL/min (95% CI, 5.4-9.3; P < .001) greater loss of renal function compared with patients treated surgically. CONCLUSIONS: Endovascular procedures for critical limb ischemia are associated with clinically relevant permanent long-term loss of kidney function. This loss of renal function is greater than in comparable patients who were treated with open surgery.

Individualized CT Angiography Protocols for the Evaluation of the Aorta: A Feasibility Study.

PURPOSE: Ionizing radiation and iodinated contrast media are potential drawbacks to repetitive follow-up CT angiography in current practice. The aim of the present study was to optimize radiation dose and contrast agent volume by using individualized CT angiography protocols. MATERIALS AND METHODS: Eighty consecutive patients referred for CT angiography of the whole aorta were prospectively evaluated. Patients were divided into groups of patients with a body mass index (BMI) < 28 kg/m(2) (group 1; n = 50) and those with a BMI ≥ 28 kg/m(2) (group 2; n = 30). A control group consisted of 50 consecutive patients who were retrospectively evaluated. CT angiography parameters on a second-generation dual-source scanner were 128 × 0.6-mm collimation, pitch of 0.9, rotation time of 0.33 seconds, tube voltages of 80/100/120 kVp (group 1/group 2/control), reference tube current of 400 mA, and image reconstruction at 1-mm/0.8-mm slice thickness (kernels, B30f [control] and I30f/strength 3 [groups 1/2]). The control group received 120 mL of contrast agent (300 mgI/mL) at 4.8 mL/s; groups 1 and 2 received 44 mL and 53 mL at 3.3 mL/s and 4 mL/s, respectively. Effective dose was evaluated for each patient. Image quality was determined by qualitative image analysis at the levels of the thoracic, abdominal, and pelvic aorta as nondiagnostic, diagnostic, good, or excellent, and quantitative image analysis was performed, including attenuation values and contrast-to-noise ratio (CNR). RESULTS: Mean effective radiation dose values for CT angiography of the aorta were 3.7 mSv ± 0.7 in group 1, 6.7 mSv ± 1.4 in group 2, and 8.7 mSv ± 1.9 in the control group (P < .001). Mean attenuation values and CNR levels were 334 HU ± 66 and 16 ± 8, respectively, in group 1, 277 HU ± 56 and 14 ± 5 in group 2, and 305 HU ± 77 and 11 ± 4 in the control group. CONCLUSIONS: Iterative reconstruction algorithms resulted in 23%-57% less radiation in combination with 55%-63% less contrast agent volume compared with standard CT protocols.