Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery (Jongkind V et al., J Vasc Surg 52:1376-1383,2010). Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates (Dolmatch B et al. J Vasc Interv Radiol 18:527-534,2007, Marin ML et al. J Vasc Interv Radiol 7:651-656,1996, Virmani R et al. J Vasc Interv Radiol 10:445-456,1999). However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery (Mwipatayi BP et al. J Vasc Surg 54:1561-1570,2011, Bekken JA et al. J Vasc Surg 55:1545-1546,2012). Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents.

Acute kidney injury (AKI) is a well known complication following cardiovascular procedures. The objective was to assess the incidence, risk factors, and prognostic significance of AKI after infrarenal endovascular aneurysm repair (EVAR) and complex EVAR (cEVAR; fenestrated or branched EVAR). Consecutive patients undergoing elective infrarenal EVAR or cEVAR between 2000 and 2018 in two large teaching hospitals in the Netherlands were included. AKI was determined by serum creatinine levels increasing > 1.5 times or by an absolute increase of 26.5 mmol/L from baseline value (KDIGO criteria). The primary outcome was incidence of peri-operative AKI development. Secondary outcomes included mid-term renal function (RIFLE criteria), overall survival, and risk factors for AKI development. To determine survival and risk factors for AKI, multivariable Cox regression and logistic regression analyses were performed, accounting for pre-operative renal function and other confounders. In total, 540 patients who underwent infrarenal EVAR with 147 patients who underwent cEVAR also included. The incidence of AKI was 8.7% (n = 47) in infrarenal EVAR patients and 23% (n = 34) in cEVAR patients (fenestrated EVAR 18%; branched EVAR 38%). In contrast to patients without AKI, the renal function of surviving patients with AKI remained significantly reduced at six weeks and did not return to pre-operative values following infrarenal EVAR (three year estimated glomerular filtration rate [eGFR] 59.3 ± 23.1 mL/min/1.73m²vs. pre-operative eGFR 74.0 ± 21.7 mL/min/1.73m²; p = .006) or following cEVAR (three year eGFR 52.0 ± 23.7 mL/min/1.73m²vs. pre-operative eGFR 65.4 ± 18.6 mL/min/1.73m²; p = .082). After risk adjusted analysis, compared with non-AKI, post-operative AKI development was associated with a higher three year mortality rate following both infrarenal and cEVAR (infrarenal EVAR mortality hazard ratio [HR 1.6, 95% confidence interval [CI] 1.01 - 2.7 [p = .046]; cEVAR mortality HR 2.4, 95% CI 1.1 - 5.2 [p = .033]). Following multivariable logistic regression, pre-operative chronic kidney disease (eGFR < 60 mL/min/1.73m²; odds ratio [OR] 2.2, 95% CI 1.03 - 4.8) and neck diameter (OR 1.1, 95% CI 1.01 - 1.2) were significantly associated with AKI following infrarenal EVAR, whereas for cEVAR only contrast volume (OR 1.1, 95% CI 1.0 - 1.2]) was found to be statistically significantly associated with AKI. AKI is a well described complication following infrarenal EVAR and is common after cEVAR. As AKI seems to be associated with permanent renal deterioration and lower survival, efforts to prevent AKI are essential. Future studies are required to assess what factors are associated with a higher risk of developing AKI following cEVAR.

Background: The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US) has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease) is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis. Methods/design: Sixty adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A) or US-accelerated thrombolysis (group B). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery. Discussion: The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications. Trial registration: Current Controlled Trials ISRCTN72676102

This study aimed to assess aneurysm sac dynamics and its prognostic significance following fenestrated and branched endovascular aneurysm repair (F/BEVAR). Patients undergoing F/BEVAR for degenerative complex aortic aneurysm from 2008 to 2020 at two large vascular centres with two imaging examinations (30 day and 1 year) were included. Patients were categorised as regression and non-regression, determined by the proportional volume change (> 5%) at 1 year compared with 30 days. All cause mortality and freedom from graft related events were assessed using Kaplan-Meier methods. Factors associated with non-regression at 1 year and aneurysm sac volume over time were examined for FEVAR and BEVAR independently utilising multivariable logistic regression and linear mixed effects modelling. A total of 165 patients were included: 122 FEVAR, of whom 34% did not regress at 1 year imaging (20% stable, 14% expansion); and 43 BEVAR, of whom 53% failed to regress (26% stable, 28% expansion). Following F/BEVAR, after risk adjusted analysis, non-regression was associated with higher risk of all cause mortality within 5 years (hazard ratio [HR] 2.56, 95% confidence interval [CI] 1.09 - 5.37; p = .032) and higher risk of graft related events within 5 years (HR 2.44, 95% CI 1.10 - 5.26; p = .029). Following multivariable logistic regression, previous aortic repair (odds ratio [OR] 2.56, 95% CI 1.11 - 5.96; p = .029) and larger baseline aneurysm diameter (OR/mm 1.04, 95% CI 1.00 - 1.09; p = .037) were associated with non-regression at 1 year, whereas smoking history was inversely associated with non-regression (OR 0.21, 95% CI 0.04 - 0.96; p = .045). Overall following FEVAR, aneurysm sac volume decreased significantly up to 2 years (baseline vs. 2 year, 267 [95% CI 250 - 285] cm³vs. 223 [95% CI 197 - 248] cm³), remaining unchanged thereafter. Overall following BEVAR, aneurysm sac volume remained stable over time. Similar to infrarenal EVAR, non-regression at 1 year imaging is associated with higher risk of 5 year all cause mortality and graft related events after F/BEVAR. Following FEVAR for juxtarenal aortic aneurysm, aneurysm sacs generally displayed regression (66% at 1 year), whereas after BEVAR for thoraco-abdominal aortic aneurysm, aneurysm sacs displayed a concerning proportion of growth at 1 year (28%), potentially suggesting a persistent risk of rupture and consequently requiring intensified surveillance following BEVAR. Future studies will have to elucidate how to improve sac regression following complex EVAR, and whether the high expansion risk after BEVAR is due to advanced disease extent.

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.

Purpose: Endovascular revascularization is the preferred treatment to improve perfusion of the lower extremity in patients with chronic limb-threatening ischemia (CLTI). Patients with CLTI often present with stenotic-occlusive lesions involving the infrapopliteal arteries. Although the frequency of treating infrapopliteal lesions is increasing, the reintervention rates remain high. This study aimed to determine the outcomes and patency of infrapopliteal endovascular reinterventions. Methods: This retrospective, multicenter cohort study of 3 Dutch hospitals included patients who underwent an endovascular infrapopliteal reintervention in 2015 up to 2021 after a primary infrapopliteal intervention for CLTI. The outcome measures after the reintervention procedures included technical success rate, the mortality rate and complication rate (any deviation from the normal postinterventional course) at 30 days, overall survival, amputation-free survival (AFS), freedom from major amputation, major adverse limb event (MALE), and recurrent reinterventions (a reintervention following the infrapopliteal reintervention). Cox proportional hazard models were used to determine risk factors for AFS and freedom from major amputation or recurrent reintervention. Results: Eighty-one patients with CLTI were included. A total of 87 limbs underwent an infrapopliteal reintervention in which 122 lesions were treated. Technical success was achieved in 99 lesions (81%). The 30-day mortality rate was 1%, and the complication rate was 13%. Overall survival and AFS at 1 year were 69% (95% confidence interval [CI], 55%–79%) and 54% (95% CI, 37%–67%), respectively, and those at 2.5 years were 45% (95% CI, 33%–56%) and 21% (95% CI, 11%–33%), respectively. Freedom from major amputation, MALE, and recurrent reinterventions at 1 year and 2.5 years were 59% (95% CI, 46%–70%) and 41% (95% CI, 25%–56%); 54% (95% CI, 41%–65%) and 36% (95% CI, 21%–51%); and 68% (95% CI, 55%–78%) and 51% (95% CI, 33%–66%), respectively. A Global Limb Anatomic Staging System score of III showed an increased hazard ratio of 2.559 (95% CI, 1.078–6.072; p=0.033) for freedom of major amputation or recurrent reintervention. Conclusions: The results of this study indicate that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, outcomes and patency were moderate to poor, with low AFS, high rates of major amputations, and recurrent reinterventions. Clinical Impact: This multicenter retrospective study evaluating outcome and patency of endovascular infrapopliteal reinterventions for CLTI, shows that endovascular infrapopliteal reinterventions can be performed with acceptable 30-day mortality and complication rates. However, the short- and mid-term outcomes of the infrapopliteal reinterventions were moderate to poor, with low rates of AFS and a high need for recurrent reinterventions. While the frequency of performing infrapopliteal reinterventions is increasing with additional growing complexity of the disease, alternative treatment options such as venous bypass grafting or deep venous arterialization may be considered and should be studied in randomized controlled trials.