Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

PURPOSE: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. MATERIALS AND METHODS: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. RESULTS: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. CONCLUSIONS.: In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. CLINICAL IMPACT: Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. METHODS: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. RESULTS: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. CONCLUSIONS: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.

Nationwide Study to Predict Colonic Ischemia after Abdominal Aortic Aneurysm Repair in The Netherlands.

BACKGROUND: Colonic ischemia remains a severe complication after abdominal aortic aneurysm (AAA) repair and is associated with a high mortality. With open repair being one of the main risk factors of colonic ischemia, deciding between endovascular or open aneurysm repair should be based on tailor-made medicine. This study aims to identify high-risk patients of colonic ischemia, a risk that can be taken into account while deciding on AAA treatment strategy. METHODS: A nationwide population-based cohort study of 9,433 patients who underwent an AAA operation between 2014 and 2016 was conducted. Potential risk factors were determined by reviewing prior studies and univariate analysis. With logistic regression analysis, independent predictors of intestinal ischemia were established. These variables were used to form a prediction model. RESULTS: Intestinal ischemia occurred in 267 patients (2.8%). Occurrence of intestinal ischemia was seen significantly more in open repair versus endovascular aneurysm repair (7.6% vs. 0.9%; P < 0.001). This difference remained significant after stratification by urgency of the procedure, in both intact open (4.2% vs. 0.4%; P < 0.001) and ruptured open repair (15.0% vs. 6.2%); P < 0.001). Rupture of the AAA was the most important predictor of developing intestinal ischemia (odds ratio [OR], 5.9, 95% confidence interval [CI] 4.4-8.0), followed by having a suprarenal AAA (OR 3.4; CI 1.1-10.6). Associated procedural factors were open repair (OR 2.8; 95% CI 1.9-4.2), blood loss >1L (OR 3.6; 95% CI 1.7-7.5), and prolonged operating time (OR 2.0; 95% CI 1.4-2.8). Patient characteristics included having peripheral arterial disease (OR 2.4; 95% CI 1.3-4.4), female gender (OR 1.7; 95% CI 1.2-2.4), renal insufficiency (OR 1.7; 1.3-2.2), and pulmonary history (OR 1.6; 95% CI 1.2-2.2). Age <68 years proved to be a protective factor (OR 0.5; 95% CI 0.4-0.8). Associated mortality was higher in patients with intestinal ischemia versus patients without (50.6% vs. 5.1%, P < 0.001). Each predictor was given a score between 1 and 4. Patients with a score of ≥10 proved to be at high risk. A prediction model with an excellent AUC = 0.873 (95% CI 0.855-0.892) could be formed. CONCLUSIONS: One of the main risk factors is open repair. Several other risk factors can contribute to developing colonic ischemia after AAA repair. The proposed prediction model can be used to identify patients at high risk for developing colonic ischemia. With the current trend in AAA repair leaning toward open repair for better long-term results, our prediction model allows a better informed decision can be made in AAA treatment strategy.

Chimney Technique to Preserve Visceral Flow in a Coral Reef Aorta.

The coral reef aorta (CRA) is a rare phenomenon of extreme calcification in the juxtarenal and suprarenal aorta. Open revascularization has an overall in-hospital mortality rate of 13%. We present a patient with a suprarenal CRA with colon ischemia. She has an extensive past medical history of percutaneous transluminal angioplasty and stenting of the celiac trunk (CT) and superior mesenteric artery (SMA). The computed tomography angiography showed a CRA of the suprarenal aorta with occlusion of the CT stent and near occlusion of the SMA stent. Our case illustrates that the CRA in the suprarenal part of the aorta can be treated well by chimney graft procedure, although owing to lack of long-term follow-up, it might be reserved for high-risk candidates for (thoraco)abdominal aortic surgery.

Cost-Effectiveness of Drug-Eluting Stents for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: The PADI Trial.

PURPOSE: Drug-eluting stents (DES) improve clinical and morphological long-term results compared to percutaneous transluminal angioplasty (PTA) with bailout bare metal stenting (BMS) in patients with critical limb ischemia (CLI) and infrapopliteal lesions (PADI trial). We performed a cost-effectiveness analysis of DES compared to PTA ± BMS in cooperation with Dutch health insurance company VGZ, using data from the PADI trial. MATERIALS AND METHODS: In the PADI trial, adults with CLI (Rutherford category ≥ 4) and infrapopliteal lesions were randomized to receive DES with paclitaxel or PTA ± BMS. Seventy-four limbs (73 patients) were treated with DES and 66 limbs (64 patients) with PTA ± BMS. The costs were calculated by using the mean costs per stent multiplied by the mean number of stents used per patient (€750 × 1.8 for DES vs €250 × 0.3 for PTA ± BMS). These costs were compared with the costs of major amputation (€16.000) and rehabilitation (first year €15.750, second year €7.375 and third year €3.600). RESULTS: The 5-year major amputation rate was lower in the DES group (19.3% vs 34.0% for PTA ± BMS; p = 0.091). In addition, the 5-year amputation-free survival and event-free survival were significantly higher in the DES group (31.8% vs 20.4%, p=0.043; and 26.2% vs 15.3%, p=0.041, respectively). After 1 year, the cost difference per patient between DES and PTA ± BMS is €1.679 in favor of DES and €2.694 after 3 years. CONCLUSION: In our analysis, DES are cost-effective due to the higher hospital costs of amputation and rehabilitation in the PTA ± BMS group. LEVEL OF EVIDENCE: Level 1b, analysis based on clinically sensible costs and randomized controlled trial.

Validation of randomized controlled trial-derived models for the prediction of postintervention outcomes in chronic limb-threatening ischemia.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease and has a large impact on quality of life, morbidity, and mortality. Interventions are aimed at improving tissue perfusion and averting amputation and secondary cardiovascular complications with an optimal risk-benefit ratio. Several prediction models regarding postprocedural outcomes in CLTI patients have been developed on the basis of randomized controlled trials to improve clinical decision-making. We aimed to determine model performance in predicting clinical outcomes in selected CLTI cohorts. METHODS: This study validated the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL), Finland National Vascular registry (FINNVASC), and Prevention of Infrainguinal Vein Graft Failure (PREVENT III) models in data sets from a peripheral artery disease registry study (Athero-Express) and two randomized controlled trials of CLTI in The Netherlands, Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-arterial Supplementation (JUVENTAS) and Percutaneous Transluminal Angioplasty and Drug-eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI). Receiver operating characteristic (ROC) curve analysis was used to calculate their predictive capacity. The primary outcome was amputation-free survival (AFS); secondary outcomes were all-cause mortality and amputation at 12 months after intervention. RESULTS: The BASIL and PREVENT III models showed predictive values regarding postintervention mortality in the JUVENTAS cohort with an area under the ROC curve (AUC) of 81% and 70%, respectively. Prediction of AFS was poor to fair (AUC, 0.60-0.71) for all models in each population, with the highest predictive value of 71% for the BASIL model in the JUVENTAS population. The FINNVASC model showed the highest predictive value regarding amputation risk in the PADI population with AUC of 78% at 12 months. CONCLUSIONS: In general, all models performed poor to fair in predicting mortality and amputation. Because the BASIL model performed best in predicting AFS, we propose use of the BASIL model to aid in the clinical decision-making process in CLTI. However, improvements in performance have to be made for any of these models to be of real additional value in clinical practice.

Endovascular Revascularization of a Chronic Occluded Aortobifemoral Bypass.

Bilateral limb occlusion after aortobifemoral (ABF) prosthesis occurs in 1-3% patients. Multiple remedial choices are known in literature to manage a bilateral occluded ABF such as "redo" ABF bypass, axillobifemoral bypass, endovascular recanalization of the native aortoiliac system, and thrombectomy. We present a patient with an occluded ABF bypass since 2001. A new minimal invasive treatment strategy was performed by traversing the occluded limbs with aortic re-entry using stiff Terumo wires. To make way for safe passing of the stents, kissing balloon angioplasty was performed of the entire ABF bypass. Kissing Viabahn (W. L. Gore & Associates, Flagstaff, AZ) balloon-expandable stents were placed in the proximal part of the ABF bypass and extended with a Viabahn self-expandable stent (standard Viabahn). This option should be added to the known multiple remedial choices in case of bilateral limb occlusion of an ABF.

Severe Infrarenal Atheroma Load in Open Aortic Aneurysm Repair Is Not a Risk Factor for Postoperative Acute Kidney Injury.

BACKGROUND: Acute kidney injury (AKI) after open aortic repair is subject to multiple patient- and operation-related variables. Hostile neck morphology in open aneurysm repair is thought to contribute to this AKI risk postoperatively. The aim of this study was to evaluate if large neck atheroma is a possible risk factor in the postoperative development of AKI. METHODS: Retrospectively 137 patients were evaluated for neck atheroma and AKI incidence. Atheroma load measurements were performed by 2 different techniques. Results were compared, and secondly a univariate analysis was performed for multiple additional risk factors regarding AKI occurrence. RESULTS: Significant (>30%) neck atheroma was not associated with a higher risk for developing AKI (odds ratio [OR]: 1.81; 95% confidence intervals: 0.74-4.44). Overall incidence of AKI based upon Acute Kidney Injury Network criteria was 19.7%. In univariate analysis coronary artery disease and the presence of a renal artery stenosis were both significantly associated with AKI (OR: 2.38, 3.31, respectively) as well as the use of B-blockers and angiotensin converting enzyme inhibitors (OR 3.05, 2.48, respectively). CONCLUSIONS: Cross-clamping in case of significant neck atheroma during open aortic aneurysm repair is not associated with increased risk of AKI. Defining high-risk patients based on additional risk factors must be a part of preoperative patient selection.

Randomized trial of one-hour sodium bicarbonate vs standard periprocedural saline hydration in chronic kidney disease patients undergoing cardiovascular contrast procedures.

BACKGROUND: Guidelines advise periprocedural saline hydration for prevention of contrast induced-acute kidney injury (CI-AKI). We analysed whether 1-hour sodium bicarbonate hydration administered solely prior to intra-arterial contrast exposure is non-inferior to standard periprocedural saline hydration in chronic kidney disease (CKD) patients undergoing elective cardiovascular diagnostic or interventional contrast procedures. METHODS: We performed an open-label multicentre non-inferiority trial between 2011-2014. Patients were randomized to 1 hour pre-procedure sodium bicarbonate hydration (250 ml 1.4%, N = 168) or 4-12 hours saline hydration (1000 ml 0.9%, N = 165) prior to and following contrast administration (2000 ml of saline total). Primary outcome was the relative serum creatinine increase (%) 48-96 hours post contrast exposure. Secondary outcomes were: incidence of CI-AKI (serum creatinine increase>25% or >44µmol/L), recovery of renal function, the need for dialysis, and hospital costs within two months follow-up. RESULTS: Mean relative creatinine increase was 3.1% (95%CI 0.9 to 5.2%) in the bicarbonate and 1.1% (95%CI -1.2 to 3.5%) in the saline arm, mean difference 1.9% (95%CI -1.2 to 5.1%, p-non-inferiority <0.001). CI-AKI occurred in 11 (6.7%) patients randomized to sodium bicarbonate and 12 (7.5%) to saline (p = 0.79). Renal function did not fully recover in 40.0% and 44.4% of CI-AKI patients, respectively (p = 0.84). No patient required dialysis. Mean costs for preventive hydration and clinical preparation for the contrast procedure were $1158 for sodium bicarbonate vs. $1561 for saline (p < 0.001). CONCLUSION: Short hydration with sodium bicarbonate prior to elective cardiovascular diagnostic or therapeutic contrast procedures is non-inferior to standard periprocedural saline hydration in CKD patients with respect to renal safety and results in considerable healthcare savings. TRIAL REGISTRATION: Netherlands Trial Register (http://www.trialregister.nl/trialreg/index.asp), Nr NTR2699.

Safety and effectiveness of selective carotid angioplasty prior to cardiac surgery: a single-centre matched case-control study.

OBJECTIVES: Reducing the rate of postoperative stroke after cardiac surgery remains challenging, especially in patients with occlusive cerebrovascular disease. Angioplasty in all patients with high-grade carotid artery stenosis has not been shown to be effective in reducing the post-surgical stroke rate. In this study, we present the initial results of a different approach using selective carotid angioplasty only in patients with poor intracranial collaterals. METHODS: We conducted a single-centre study to assess the safety of this procedure. The postangioplasty complication rate of the study group was compared to that of patients who were scheduled for symptomatic carotid artery angioplasty. To determine the effectiveness of this procedure, the post-cardiac surgery complication rate of the study group was compared with that of the matched case controls. RESULTS: Twenty-two patients were treated with selective carotid angioplasty without developing persistent major neurological complications. All patients except 1 patient subsequently underwent surgery without developing persistent major neurological disabilities. Two patients died of cardiogenic shock within 30 days. CONCLUSIONS: Selective carotid angioplasty prior to cardiac surgery in patients with a presumed high risk of stroke was relatively safe and effective in this study group. Although this strategy does not prevent stroke in these high-risk patients, data suggest that this approach shifts the postoperative type of stroke from a severe haemodynamic stroke towards a minor embolic stroke with favourable neurological outcomes. Larger studies are needed to determine whether this strategy can effectively eliminate the occurrence of haemodynamic stroke after cardiac surgery.

High and immeasurable ankle-brachial index as predictor of poor amputation-free survival in critical limb ischemia.

OBJECTIVE: The objective of this study was to assess the prognostic value of a high or immeasurable ankle-brachial index (ABI) at baseline for major amputation and amputation-free survival (AFS) in patients with critical limb ischemia (CLI). METHODS: Data from two recent trials in patients with CLI and proven infrapopliteal arterial obstructive disease were pooled. Patients were allocated to the low (<0.7), intermediate (0.7-1.4), or high (>1.4)/immeasurable ABI subgroup. Major amputation and AFS rates were compared. Hazard ratios for major amputation and death were calculated. The net reclassification improvement of incorporating high/immeasurable ABI in the Project of Ex-Vivo vein graft Engineering via Transfection III (PREVENT III) prediction model was derived. RESULTS: There were 146 patients (56.2%) who had a low ABI, 81 patients (31.2%) who had an intermediate ABI, and 33 patients (12.7%) who had a high/immeasurable ABI at baseline. Patients with high/immeasurable ABI showed higher 5-year major amputation (52.1%) and lower 5-year AFS (5.0%) rates than the intermediate (25.5% and 41.6%, respectively) and low ABI patients (23.5% and 46.9%, respectively; both P < .001). This same trend was observed in subgroup analysis of diabetics and nondiabetics. Adjusted hazard ratio of high/immeasurable ABI for major amputation/death risk was 2.93 (P < .001). Adding a high/immeasurable ABI as model factor to the PREVENT III model yielded a net reclassification index of 0.38 (P < .0001). CONCLUSIONS: A high/immeasurable ABI in patients with CLI and infrapopliteal arterial obstructive disease is an independent risk factor of major amputation and of poor AFS, in both diabetics and nondiabetics. Incorporating high/immeasurable ABI in the PREVENT III prediction model improves its performance.

Determinants of Acute Kidney Injury and Renal Function Decline After Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE/BACKGROUND: Endovascular aneurysm repair (EVAR) may be associated with renal injury and more insight is needed into potential risk factors. The aim was to identify clinical, anatomical, and peri-procedural parameters as potential risk factors for the occurrence of acute kidney injury (AKI) and to evaluate chronic kidney disease (CKD) after EVAR. METHODS: A cohort of 212 consecutive patients who underwent elective EVAR for abdominal aortic aneurysm from January 2009 to October 2016 was included. A subgroup of 149 patients with 2 years follow-up was compared with a set of 135 non-operated aneurysm patients with smaller aneurysms (similar cardiovascular risk profile) to assess CKD. Primary outcomes were AKI (Acute Kidney Injury Network criteria) and CKD measured by estimated glomerular filtration rate (Kidney Disease Improving Global Outcomes guidelines). For AKI, candidate risk factors were identified by univariate and multivariate logistic regression analysis; for chronic renal function decline, risk factors were identified using Cox regression analysis. RESULTS: AKI occurred in 30 patients (15%). On multivariate analysis, the use of angiotensin II blocker (odds ratio [OR] 4.08, 95% confidence interval [CI] 1.38-12.07) and peri-operative complications (OR 3.12, 95% CI 1.20-8.10) were independent risk factors for AKI, whereas statin use was a protective factor (OR 0.19, 95% CI 0.07-0.52). EVAR resulted in a significant increase (23.5%) in the occurrence of CKD compared with the control group (6.7%; p <.001). On univariate and multivariate Cox regression the risk factors: aortic neck diameter (per mm increase) (hazard ratio [HR] 1.13, 95% CI 1.02-1.25), renal artery stenosis >50% (HR 2.24, 95% CI 1.05-4.79), and the occurrence of AKI (HR 2.19, 95% CI 0.99-4.85) were significant predictors of CKD. CONCLUSION: This study identified use of angiotensin II blockers and peri-operative complications as risk factors for AKI. In addition, the problem of renal function decline after EVAR is highlighted, which indicates that prolonged protective measures (e.g., in those patients at high risk) over time are needed to improve patient outcomes.

Impact of the Haga Braincare Strategy on the burden of haemodynamic and embolic strokes related to cardiac surgery.

OBJECTIVES: This study prospectively evaluates the impact of the Haga Braincare Strategy (HBS) on the occurrence of haemodynamic and embolic stroke in a cohort of patients who underwent coronay artery bypass grafting (CABG), valve replacement of a combination of both types of surgery between 2012 and 2015 at the Haga Teaching Hospitals. METHODS: The HBS is a dual strategy based on a preoperative vascular work-up of the cerebral circulation by transcranial Doppler and a perioperative monitoring of the cerebral circulation by cerebral oximetry. Duplex of the carotid arteries and/or computed tomography angiography prior to surgery was performed in high-risk patients. Patients with severe carotid artery stenosis were scheduled for carotid angioplasty prior to surgery or waived from surgery. RESULTS: A total of 1065 patients were included. Poor cerebral haemodynamics were identified by transcranial Doppler in 2.1% of patients (n = 22). Based on the HBS, 3 patients were waived from surgery, 4 received preoperative carotid angioplasty followed by cardiac surgery and the remaining patients were operated while being monitored with bilateral cerebral oximetry sensors. In all, 2.2% of the study group experienced a stroke (n = 23), of which none were classified as haemodynamic. Most of the remaining presumed embolic strokes showed a minor to moderate stroke severity. CONCLUSIONS: In this single-centre prospective follow-up study, surveillance of cerebral perfusion by the HBS eliminated the occurrence of haemodynamic stroke while most of the residual strokes had a good to favourable prognosis.

Antegrade Ureteral Stenting is a Good Alternative for the Retrograde Approach.

BACKGROUND/AIMS: Double J (JJ) stents for treating obstructive ureteral pathology are generally inserted through a retrograde route with cystoscopic guidance. Antegrade percutaneous insertion using fluoroscopy can be performed alternatively but is less known. Indications, success rate and complications of antegrade ureteral stenting were evaluated. METHODS: Data of consecutive patients in which antegrade ureteral stenting was performed were retrospectively analysed using the radiology information system and patient records. Patient characteristics, details of the antegrade JJ stent insertion procedure and registered complications were collected. Furthermore, it was investigated if prior to the antegrade procedure a retrograde attempt for JJ stent insertion was performed. RESULTS: Total 130 attempts for antegrade JJ stent insertion were performed in 100 patients. A percutaneous nephrostomy catheter had already been placed in the majority of kidneys (n = 109) for initial treatment of hydronephrosis. Most prevelant indication for a JJ stent was obstructive ureteral pathology due to malignancy (n = 63). A JJ stent was successfully inserted in 125 of 130 procedures. In 21 cases, previous retrograde ureteral stenting had failed but, subsequent antegrade ureteral stenting was successful. There were 8 procedure related complications; 6 infections, 1 false tract and 1 malposition. CONCLUSION: Antegrade percutaneous insertion of a JJ stent is a good alternative for retrograde insertion.

Diabetes Is Associated With Decreased Limb Survival in Patients With Critical Limb Ischemia: Pooled Data From Two Randomized Controlled Trials.

OBJECTIVE: Although never assessed prospectively, diabetes mellitus (DM) is assumed to negatively affect the outcomes of critical limb ischemia (CLI). DM was highly prevalent in two recently conducted randomized controlled trials in CLI patients, the PADI (Percutaneous Transluminal Balloon Angioplasty [PTA] and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia) and JUVENTAS (Rejuvenating Endothelial Progenitor Cells via Transcutaneous Intra-Arterial Supplementation) trials. To determine the implications of DM in a population of patients with infrapopliteal CLI, clinical outcomes were compared in patients with and without DM. RESEARCH DESIGN AND METHODS: Individual data from patients with CLI (Rutherford category ≥4) were pooled. Patients were considered to have DM when this diagnosis was reported in the hospital electronic medical records. Rates of major amputation (above ankle level) and major events (major amputation or death) were compared between CLI patients with and without DM. Hazard ratios (HRs) were calculated. RESULTS: Of a total of 281 patients, DM was present in 49.1%. The major amputation rate at 5 years of follow-up was higher in patients with DM than in patients without DM (34.1% vs. 20.4%, P = 0.015). The major event and death rate did not differ. The unadjusted HR of DM for the major amputation risk was 1.87 (95% CI 1.12-3.12). Model factors with significant HRs in the multivariate analysis were baseline Rutherford category (HR 1.95; 95% CI 1.24-3.06) and ankle-brachial index (ABI) >1.4 (HR 2.78; 95% CI 1.37-5.64). CONCLUSIONS: CLI patients with DM are at a significantly higher risk of major amputation than CLI patients without DM. This increased risk is associated with a higher prevalence of baseline ABI >1.4 and more severe ischemia at initial presentation in patients with DM.