The Ratio Between the Infrarenal and Suprarenal Aortic Diameter Is a Predictor of Durable Proximal Seal After Endovascular Aneurysm Repair.

OBJECTIVES: The aim of this study was to assess whether the ratio of the mean infrarenal neck diameter to the suprarenal aortic diameter is a predictor for a durable proximal seal after endovascular aneurysm repair (EVAR). METHODS: A total of 439 patients who underwent elective EVAR between 2004 and 2018 in a single vascular referral center met our inclusion criteria. Ratios were calculated by dividing the mean infrarenal neck diameter by 4 different suprarenal aortic diameters. Patients who developed a late type 1A endoleak (n=20) or proximal neck dilatation mandating revision (n=8) were compared with the 411 patients without long-term proximal seal complications. RESULTS: Patients who developed a late type 1A endoleak had more frequently hypertension, a shorter infrarenal neck length, and a larger mean infrarenal neck diameter. The ratio of the mean infrarenal neck diameter to all 4 suprarenal aortic diameters was higher in the late type 1A endoleak group compared with the group without a late type 1A endoleak. Least absolute shrinkage and selection operator (LASSO) logistic regression identified a combination of 6 variables as the best combination to predict a late type 1A endoleak: presence of hypertension, increased mean infrarenal neck diameter, decreased aneurysm neck length, larger ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the superior mesenteric artery (SMA), larger ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the upper renal artery, and increased ß-angle. Of these, based on both the univariate area under the curve (AUC) and optimal LASSO model restricted to a single predictor, the ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the SMA (AUC, 0.770; cutoff value, 0.997) was considered the best prognostic variable. CONCLUSION: The ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the SMA is a good predictor for a late type 1A endoleak. Patients with mean infrarenal neck diameter larger than the diameter proximal to the SMA (ratio >1) are at risk for a late type 1A endoleak. CLINICAL IMPACT: In this single-center, retrospective cohort study, we found that the ratio of the mean infrarenal neck diameter to the aortic diameter proximal to the SMA is a good predictor for a late type 1A endoleak. We conclude that the suprarenal diameter must be taken into account before assessing endovascular aortic aneurysm repair eligibility. Patients with a ratio >1 may not be the best candidates for a durable result after EVAR and may be better off with fenestrated EVAR or open repair.

A Ratio Between Infrarenal and Suprarenal Aortic Diameters Corrects for Absolute Aortic Diameter Variations due to Patients' Sex and Body Size.

OBJECTIVES: Aortic diameters may differ significantly between patients with different gender and body size. The aim of this study was to relate absolute aortic diameters to age, sex, height, and weight of the patients and to correct for these factors by calculating the ratio between the infrarenal and the suprarenal aortic diameters. METHODS: A total of 458 patients who underwent elective endovascular aneurysm repair (EVAR) between 2004 and 2018 were included. The aortic anatomy in this group of elective EVAR patients was compared with a control group of 75 patients without an abdominal aortic aneurysm (AAA). The aortic diameter was measured at 4 suprarenal points and 4 infrarenal points. Ratios were calculated by dividing the mean infrarenal neck diameter by 4 suprarenal measurements. RESULTS: Patients in the aneurysm group had significantly larger suprarenal and infrarenal aortic diameters. The ratios between the mean infrarenal neck diameter and all 4 suprarenal measurements were larger in the AAA group than in the control group. In both groups, there was a significant correlation between the mean infrarenal neck diameter and sex, height, weight, and body surface area (BSA). However, in both groups, all 4 ratios between the mean infrarenal neck diameter and suprarenal aortic diameters were not correlated with age, sex, height, weight, or BSA, except for the ratio between the mean infrarenal neck diameter and the aortic diameter measurement proximal to the upper renal artery, which was correlated to weight and BSA in the control group. CONCLUSION: The mean infrarenal neck diameter is correlated with sex, height, weight, and BSA. However, when the suprarenal aortic diameter was used as an internal control for the mean infrarenal neck diameter, we were able to correct for these variations in aortic diameters due to sex and body size. The clinical relevance of this ratio in patients treated by EVAR has yet to be assessed in future research. CLINICAL IMPACT: In the assessment for EVAR suitability the absolute diameter of the aneurysm neck is taken into account. We believe that using absolute diameters is not the appropriate way to assess this suitability, but that patient characteristics such as age, gender and body size, should be factored into this assessment. In this paper, we show that suprarenal and infrarenal aortic diameters are both significantly increased in patients with an aneurysm compared with patients without an aneurysm. Besides, we found that mean infrarenal aortic diameter is correlated with sex, height, weight, and body surface area. Finally, we propose a new ratio system, using suprarenal diameters as an internal control, to correct for aortic diameter variations due to sex and body size.

Editor's Choice - Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery.

OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. CONCLUSION: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

Covered Stents vs. Angioplasty for Common Iliac Artery In Stent Restenosis: A Retrospective Comparison.

OBJECTIVE: The optimal endovascular treatment for common iliac artery in stent re-stenosis has yet to be assessed. Treatment options include, among others, angioplasty alone and repeated stenting with covered stents. METHODS: This study retrospectively compared patency and target lesion revascularisation of these treatments. All patients who underwent endovascular treatment of common iliac artery in stent re-stenosis between 2007 and 2017 were included retrospectively. The primary end point was freedom from re-stenosis. Secondary endpoints were target lesion revascularisation rate (TLR) and freedom from occlusion during follow up. RESULTS: Seventy-four interventions were included, consisting of 37 angioplasties and 37 covered stent placements in 57 patients. Freedom from re-stenosis at four years was 72.6% (95% confidence interval [CI] 51.8% - 88.7%) in the covered stent group vs. 43.5% (95% CI 25.9% - 59.8%) in the percutaneous transluminal angioplasty (PTA) group (p = .003). The target lesion revascularisation (TLR) rate was 16.4% (95% CI 7.1% - 35.6%) and 43.6% (95% CI 28.0% - 63.2%) respectively (p = .020). There was no difference in freedom from occlusion; this was 90.8% (95% CI 73.9% - 97.0%) in the covered stent group and 79.1% (95% CI 58.4% - 90.3%) in the PTA group (p = .49). The difference in freedom from re-stenosis and TLR remained significant after sensitivity and multivariable analyses. CONCLUSION: Covered stents offer better outcomes for common iliac artery in stent re-stenosis than angioplasty alone.

Radiation exposure during direct versus indirect image acquisition during fluoroscopy-controlled internal fixation of a hip fracture: Results of a randomized controlled trial.

BACKGROUND: Intra-operative image acquisition can be obtained indirectly (via verbal request to a technician) or directly (executed at the tableside, by a surgeon stepping on a foot pedal). Direct image acquisition could reduce the exposure time and thus the risk of radiation damage. The aim of this randomized controlled trial was to compare direct surgeon-controlled fluoroscopy with indirect technician-operated fluoroscopy during internal fixation of a hip fracture. METHODS: From March 5, 2014 to August 19, 2015, 100 patients who had sustained a hip fracture that required internal fixation were enrolled. Patients were randomized between direct surgeon-controlled image acquisition using a foot pedal (n = 52) and indirect image acquisition by a radiology technician (n = 48). The primary outcome measure was the radiation exposure time; secondary outcome measures were the associated effective radiation dose and the dose area product. (DAP) RESULTS: A total of 96 patients (with a median age of 84 years) were enrolled in this study. Eighty-nine (93%) patients had a pertrochanteric fracture. No statistically significant differences between direct image acquisition and indirect image acquisition were found for overall radiation time, total radiation dose or DAP for the total population. When adjusted for potential confounders, a difference in overall radiation time of 18.50 s (95% CI 2.19; 34.81, p = 0.027) was found in favour of indirect image acquisition. CONCLUSION: This study showed statistically significantly lower radiation duration using indirect fluoroscopy for the total population and the pertrochanteric fracture subgroup when adjusted for several confounders. No significant effect on radiation dose and DAP was found.

Remote Iliac Artery Endarterectomy: A Case Series and Systematic Review.

PURPOSE: To evaluate the long-term results of remote iliac artery endarterectomy (RIAE) in 2 vascular referral centers and review existing literature. METHODS: A retrospective analysis was conducted of 109 consecutive patients (mean age 64.2±10.7 years; 72 men) who underwent 113 RIAE procedures for lower limb ischemia from January 2004 to August 2015 at 2 vascular centers. The majority of limbs (82, 72.6%) had TASC II D lesions (31 TASC II C). Primary outcome measures were primary, assisted primary, and secondary patency. A comprehensive literature search was performed in the PubMed and EMBASE databases to identify all English-language studies published after 1990 reporting the results of RIAE. RESULTS: Technical success was achieved in 95 (84.1%) of the 113 procedures. The complication rate was 13.7%, and 30-day mortality was 0%. At 5 years, primary patency was 78.2%, assisted primary patency was 83.4%, and secondary patency was 86.7%. Hemodynamic success was obtained in 91.7% of patients, and clinical improvement was observed in 95.2%. Freedom from major amputation was 94.7% at 5 years. The systematic review comprised 6 studies including 419 RIAEs, and pooled data showed results similar to the current study. CONCLUSION: For external iliac artery occlusions extending into the common femoral artery, RIAE appears to be a valuable hybrid treatment option. It combines acceptable morbidity and low mortality with good long-term patency. It has some advantages over an open surgical iliofemoral bypass or complete endovascular revascularization and could be the best treatment option in selected cases.

The use of covered stents in aortoiliac obstructions: a systematic review and meta-analysis.

INTRODUCTION: During the past decade, endovascular treatment has become the treatment of choice for all types of aortoiliac occlusive disease, including TASC C and D lesions. Patency rates, however, are still below those of open surgical techniques. One propagated technique to improve patency rates is the use of covered stents. This review assessed the available literature on covered stents for aortoiliac occlusive disease. EVIDENCE ACQUISITION: An extensive search was performed of the MEDLINE, Embase, and Cochrane databases. All studies reporting on covered stents, including stent grafts for endovascular aneurysm repair, were included. A systematic review and meta-analysis was performed. EVIDENCE SYNTHESIS: We identified 19 studies comprising 12 single-arm series, 6 retrospective series, and 1 randomized controlled trial. The meta-analysis did not show a significant difference in primary patency at 1, 2, and 3 to 5 years for covered stents compared with bare-metal stents (91.7% vs. 88.5%, 85.4% vs. 80.9%, and 80.7% vs. 72.0%, respectively). Several studies found a significant difference in TASC C and D lesions in favor of covered stents. CONCLUSIONS: High-quality evidence supporting the use of covered stents for aortoiliac occlusive arterial disease is limited. The use of covered stents in TASC C and D lesions may improve patency rates. However, because the TASC classification is very heterogeneous, more research is needed to identify specifically which lesion characteristics might benefit most from covered stent placement.

Angiosome-directed revascularization in patients with critical limb ischemia.

OBJECTIVE: Direct revascularization (DR), according to the angiosome concept, provides direct blood flow to the site of tissue loss in patients with critical limb ischemia (CLI). DR may lead to improved outcomes; however, evidence for this is controversial. This systematic review and meta-analysis investigated the outcomes of surgical and endovascular DR compared with indirect revascularization (IR) in patients with CLI. METHODS: A systematic review was undertaken using the Cochrane Collaboration specified tool, and a meta-analysis was done according to the MOOSE (Meta-analysis of Observational Studies in Epidemiology) criteria. The electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched for studies of DR compared with IR in patients with CLI with tissue loss. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. When possible, data were systematically pooled, and a meta-analysis was performed for wound healing, major amputation, amputation-free survival, and overall survival. RESULTS: Of 306 screened abstracts, 19 cohort studies with 3932 patients were included. Nine scored 7 or higher on the Newcastle-Ottawa score. DR significantly improved wound healing (risk ratio [RR], 0.60; 95% confidence interval [CI], 0.51-0.71), major amputation (RR, 0.56; 95% CI, 0.47-0.67), and amputation-free survival rates (RR, 0.83; 95% CI, 0.69-1.00) compared with IR. This significance was lost in major amputation on sensitivity analysis for bypass studies. No significant difference was found in overall survival. In studies stratifying for collaterals, no differences between DR and IR were found in wound healing or major amputations in the presence of collaterals. CONCLUSIONS: DR significantly improves wound healing and major amputation rates after endovascular treatment in patients with CLI, supporting the angiosome theory. In the presence of collaterals, outcomes after IR are similar to outcomes after DR. Alternatively, patients without collaterals may benefit even more from DR as a primary treatment strategy. The angiosome theory is less applicable in bypass surgery, because bypasses are generally anastomosed to the least affected artery, with runoff passing the ankle to maintain bypass patency.

Endovascular Treatment of Common Iliac Artery Aneurysms With an Iliac Branch Device: Multicenter Experience of 140 Patients.

PURPOSE: To evaluate the efficacy, feasibility, and long-term outcomes of the Zenith ZBIS iliac branch device (IBD) to preserve internal iliac artery (IIA) perfusion in a large Dutch multicenter cohort. METHODS: Between September 2004 and August 2015, 140 patients (mean age 70.9±7.4 years; 130 men) with 162 IBD implantations were identified in 7 vascular centers. The indication for IBD implantation was an abdominal aortic aneurysm >55 mm with a concomitant common iliac artery (CIA) aneurysm >20 mm (n=40), a CIA aneurysm with a diameter >30 mm (n=89), or revision of a type Ib endoleak after endovascular aneurysm repair (n=11). RESULTS: Technical success (aneurysm exclusion, no type I or III endoleak, and a patent IIA) was obtained in 157 (96.9%) of 162 IBD implantations. Six (4.3%) patients developed major complications; 2 (1.4%) died. Mean follow-up was 26.6±24.1 months, during which 17 (12.1%) IBD-associated secondary interventions were performed. Including technical failures and intentional IIA embolizations, 15 (9.3%) IIA branch occlusions were identified; buttock claudication developed in 6 of these patients. The freedom from secondary intervention estimate was 75.9% (95% confidence interval 59.7 to 86.3) at 5 years. CONCLUSION: CIA aneurysms can be treated safely and effectively by IBDs with preservation of antegrade flow to the IIA. Secondary interventions are indicated in >10% of patients during follow-up but can be performed endovascularly in most.

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty in patients with femoropopliteal arterial occlusive disease.

OBJECTIVE: The optimal percutaneous treatment for femoropopliteal arterial occlusive disease has yet to be assessed. This systematic review and meta-analysis assessed the efficacy of drug-eluting balloons (DEBs) compared with uncoated balloons (UCBs) for the treatment of femoropopliteal arterial occlusive disease. METHODS: We used Preferred Reporting Items for Systematic Reviews and Meta-Analysis Statement (PRISMA) standards to systematically search the electronic databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for trials comparing DEBs vs UCBs in the femoropopliteal arteries. All articles were critically assessed for relevance, validity, and availability of data regarding patient and lesion characteristics and outcomes. All data were systematically pooled, and meta-analysis was performed on binary restenosis, late lumen loss (LLL), target lesion revascularization (TLR), major amputation, mortality, and changes in the ankle-brachial index and the Rutherford-Baker classification. RESULTS: From 364 screened articles, we included nine trials, all of which had a low risk of bias. We found a significant reduction of binary restenosis at 6 months (14.3% vs 40.1%; P < .0001), binary restenosis at 1 year (26.6% vs 47.4%; P = .008), LLL at 6 months (-0.80 mm; P < .00001), TLR at 1 year (10.4% vs 26.9; P = .0008), and TLR at 2 years (13.8% vs 40.7%; P = .0003) after DEB angioplasty compared with UCB angioplasty. The difference in amputation rate and mortality was not significant. Definitions on changes in ankle-brachial index and Rutherford classifications were heterogeneous and, therefore, could not be pooled in sufficient numbers. CONCLUSIONS: Compared with UCB angioplasty, the use of DEBs increases the durability of the treatment effect in femoropopliteal arterial disease, expressed by a significant decrease of binary restenosis, LLL, and TLR at short-term and midterm follow-up.

Secondary interventions in patients with autologous infrainguinal bypass grafts strongly improve patency rates.

OBJECTIVE: To describe the patency of percutaneous transluminal angioplasty (PTA) of autologous infrainguinal bypasses at risk. METHODS: This was a retrospective single-center cohort study of consecutive patients who underwent primary PTA of an infrainguinal autologous bypass at risk from January 2009 to December 2013. Duplex ultrasound surveillance was performed for at least 1 year after PTA. The primary study end point was the number of secondary interventions. Secondary end points were freedom from recurrent stenosis or bypass occlusion and the patency of the infrainguinal autologous bypass at 1 year after primary PTA. RESULTS: A total of 69 infrainguinal bypasses at risk in 69 patients were identified and treated with PTA. Technical success was achieved in 91%. The median follow-up was 17 months (range, 1-58 months). During follow-up, 30 bypasses (43%) remained free of significant stenosis or bypass occlusion, 29 bypasses (42%) developed recurrent stenosis, and 10 bypasses (14%) occluded. Rates of primary assisted, and secondary patency at 1 year were 84%, and 86%. Five (7%) major amputations were performed, all after bypass occlusion. CONCLUSIONS: Secondary interventions after PTA of a bypass at risk are common. However, repeated secondary interventions of autologous infrainguinal bypasses at risk result in patency rates of more than 80% at 1 year.

Self-expanding stents and aortoiliac occlusive disease: a review of the literature.

The treatment of symptomatic aortoiliac occlusive disease has shifted from open to endovascular repair. Both short- and long-term outcomes after percutaneous angioplasty and stenting rival those after open repair and justify an endovascular-first approach. In this article, we review the current endovascular treatment strategies in patients with aortoiliac occlusive disease, indications for primary and selective stenting in the iliac artery, and physical properties and future perspectives of self-expanding stents.

DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents in the common iliac artery: study protocol for a randomized controlled trial.

BACKGROUND: 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. METHODS/DESIGN: This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included. The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment. The primary endpoint is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure-related parameters. TRIAL REGISTRATION: Dutch Trial Register, NTR3381.

[Breast cancer in an accessory breast]. / Mammacarcinoom in een accessoire borst.

BACKGROUND: There are two types of ectopic breast tissue: accessory breast (polymastia) and aberrant breast tissue. Breast cancer may arise in any type of ectopic breast tissue, although rarely. CASE DESCRIPTION: A 50-year old woman had a palpable mass near an accessory nipple. Physical and X-ray examination suggested a benign tumour, but after excision and pathological examination it turned out to be breast cancer. After follow-up examination a re-excision with a sentinel node procedure was performed. There was no indication for adjuvant therapy. CONCLUSION: Due to the atypical location, the diagnosis 'breast cancer in an accessory breast' is usually made in a late stage. Due to the small amount of breast tissue, invasion of skin or underlying tissue is more common. Drainage of lymph fluids may be different as well, which has to be taken into account when performing a sentinel node procedure. Also, lymph node metastases may present in the ipsilateral mamma. These particulars should be taken into account in the treatment of cancer in ectopic breast tissue.