Toward Optimizing Risk Adjustment in the Dutch Surgical Aneurysm Audit.

BACKGROUND: To compare hospital outcomes of aortic aneurysm surgery, casemix correction for preoperative variables is essential. Most of these variables can be deduced from mortality risk prediction models. Our aim was to identify the optimal set of preoperative variables associated with mortality to establish a relevant and efficient casemix model. METHODS: All patients prospectively registered between 2013 and 2016 in the Dutch Surgical Aneurysm Audit (DSAA) were included for the analysis. After multiple imputation for missing variables, predictors for mortality following univariable logistic regression were analyzed in a manual backward multivariable logistic regression model and compared with three standard mortality risk prediction models: Glasgow Aneurysm Score (GAS, mainly clinical parameters), Vascular Biochemical and Haematological Outcome Model (VBHOM, mainly laboratory parameters), and Dutch Aneurysm Score (DAS, both clinical and laboratory parameters). Discrimination and calibration were tested and considered good with a C-statistic > 0.8 and Hosmer-Lemeshow (H-L) P > 0.05. RESULTS: There were 12,401 patients: 9,537 (76.9%) elective patients (EAAA), 913 (7.4%) acute symptomatic patients (SAAA), and 1,951 (15.7%) patients with acute rupture (RAAA). Overall postoperative mortality was 6.5%; 1.8% after EAAA surgery, 6.6% after SAAA, and 29.6% after RAAA surgery. The optimal set of independent variables associated with mortality was a mix of clinical and laboratory parameters: gender, age, pulmonary comorbidity, operative setting, creatinine, aneurysm size, hemoglobin, Glasgow coma scale, electrocardiography, and systolic blood pressure (C-statistic 0.871). External validation overall of VBHOM, DAS, and GAS revealed C-statistics of 0.836, 0.782, and 0.761, with an H-L of 0.028, 0.00, and 0.128, respectively. CONCLUSIONS: The optimal set of variables for casemix correction in the DSAA comprises both clinical and laboratory parameters, which can be collected easily from electronic patient files and will lead to an efficient casemix model.

A Comparative Cost-Effectiveness Analysis of Percutaneous Transluminal Angioplasty With Optional Stenting and Femoropopliteal Bypass Surgery for Medium-Length TASC II B and C Femoropopliteal Lesions.

PURPOSE: To evaluate the total midterm costs and cost-effectiveness of percutaneous transluminal angioplasty with optional stenting (PTA/S) as initial treatment compared with femoropopliteal bypass (FPB) surgery in patients with medium-length TransAtlantic Inter-Society Consensus II (TASC) B and C femoropopliteal lesions. MATERIALS AND METHODS: Over a period of 3 years, all hospital health care costs for 226 consecutive patients were calculated: 170 patients with a TASC B lesion and 56 patients with a TASC C lesion. In the 135-patient PTA/S group (mean age 69.9±10.9 years; 83 men), 108 (63.5%) patients had TASC B lesions and 27 (48.2%) patients had TASC C lesions. Ninety-one patients (mean age 68.4±10.9 years; 60 men) were treated with FPB for 62 TASC B and 29 TASC C femoropopliteal lesions. The main outcome measure was the primary patency rate at 3-year follow-up. Multiple imputation and bootstrapping techniques were used to analyze the data. The adjusted incremental cost-effectiveness ratios (ICERs) were calculated by dividing the difference in total costs by the difference in 3-year primary patency rate. Costs were expressed in euros (€), and cost differences are presented with the 95% confidence interval (CI). RESULTS: Mean total costs per patient were €29,058 in the PTA/S treatment group vs €42,437 in the FPB group (mean adjusted difference -€14,820, 95% CI -€29,044 to -€5976). Differences in 3-year primary patency between PTA/S and FPB were small and nonsignificant (68.9% and 70.3%, respectively). An ICER of 563,716 was found, indicating that FPB costs €563,716 more per one extra patient reaching 3-year primary patency in comparison with PTA/S treatment. CONCLUSION: FPB in medium-length femoropopliteal lesions involved higher total costs when evaluated over a 3-year follow-up period. An endovascular-first approach is recommended, as this will result in cost minimization for patients with medium-length femoropopliteal disease.

Long-Term Clinical Outcomes of Percutaneous Transluminal Angioplasty with Optional Stenting in Patients with Superficial Femoral Artery Disease: A Retrospective, Observational Analysis.

BACKGROUND AND OBJECTIVE: The recent ESC guideline advises primary stent placement in superficial femoral arterial disease (SFAD). The aim of this study was to compare clinical outcomes of SFAD patients selected for stent placement with plain percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: A single centre retrospective, observational analysis was performed of all consecutive patients undergoing endovascular treatment for SFAD from 2004 to 2015. Primary endpoints were primary and secondary clinical patency rates in patients with or without stent placement. Secondary endpoints were recurrence rates and number of amputations. Kaplan-Meier curves were used to compare patency rates. Multivariable Cox regression analysis was performed to adjust for confounding variables and to identify variables associated with loss of patency. RESULTS: A total of 389 patients were analysed with a median follow up of 42 months. Two hundred and fifty one patients (64.5%) were stented. Primary clinical patency rates at 1, 3, and 5 years were 82.8%, 71.0%, and 65.6% after PTA and 76.3%, 65.7%, and 58.1% after stent placement (PTA-S), respectively (p = .30). Secondary patency rates were also comparable for the PTA and PTA-S group resulting in 1, 3 and 5 year clinical secondary patency of 89.1%, 81.0%, and 76.3% in the PTA group versus 87.8%, 78.5%, and 71.9% in the PTA-S group (p = .58). Multivariable analysis revealed equal primary and secondary clinical patency between the treatment groups. The absolute re-intervention rate was 29.3%. The number of re-interventions and amputation rate did not significantly differ between the two groups (p = .41 and p = .75). CONCLUSIONS: Selective stenting in patients with SFAD shows comparable results in long-term clinical outcomes in patients who were treated with plain PTA as well as patients who are selected for stent placement. An approach of selective stenting is justified.

Cost-Effectiveness of Two Decision Strategies for Shunt Use During Carotid Endarterectomy.

BACKGROUND: Arterial shunting during carotid endarterectomy (CEA) is essential in some patients because of insufficient cerebral perfusion during cross-clamping. However, the optimal diagnostic modality identifying these patients is still debated. None of the currently used modalities has been proved superior to another. The aim of this study was to assess the cost-effectiveness of two modalities, stump pressure measurement (SPM) versus electroencephalography (EEG) combined with transcranial Doppler (TCD) during CEA. METHODS: Two retrospective cohorts of consecutive patients undergoing CEA with different intraoperative neuromonitoring strategies (SPM vs. EEG/TCD) were analyzed. Clinical data were collected from patient hospital records. Primary clinical outcome was in-hospital stroke or death. Total admission costs were calculated based on volumes of healthcare resources. Analyses of effects and costs were adjusted for clinical differences between patients by means of a propensity score, and cost-effectiveness was estimated. RESULTS: A total of 503 (239 SPM; 264 EEG/TCD) patients were included, of whom 19 sustained a stroke or died during admission (3.3 vs. 4.2%, respectively, adjusted risk difference 1.3% (95% CI -2.3-4.8%)). Median total costs were €4946 (IQR 4424-6173) in the SPM group versus €7447 (IQR 6890-8675) in the EEG/TCD group. Costs for neurophysiologic assessments were the main determinant for the difference. CONCLUSIONS: Given the evidence provided by this small retrospective study, SPM would be the favored strategy for intraoperative neuromonitoring if cost-effectiveness was taken into account when deciding which strategy to adopt.

Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease.

OBJECTIVE: Arterial closure devices (ACDs) seem to be safe and effective to obtain hemostasis for cardiac interventions and diagnostic vascular procedures. However, only limited evidence is presented on therapeutic interventions in patients with peripheral atherosclerotic disease. We compared ischemic and hemorrhagic complications of an ACD vs manual compression (MC) after puncture of the femoral artery for endovascular lower extremity procedures. METHODS: The records of all subsequent endovascular interventions for peripheral artery disease performed in a large teaching hospital, from January 2012 to April 2014, were retrospectively reviewed. The primary outcome was an ischemic complication requiring reintervention. Secondary outcomes were hematoma (needing conservative or invasive intervention) and infection (needing intervention or antibiotics). Multivariate analysis was performed to identify predictors for any complication. RESULTS: The Angio-Seal (St. Jude Medical, Minnetonka, Minn) closure device was used in 244 of 463 endovascular interventions (54%). Five patients (2%) who received an ACD needed emergency surgery for ischemic complications vs none in the MC group (P = .06). Hematomas occurred in 22 patients (9%) after ACD vs in six (3%) after MC (adjusted odds ratio [OR], 3.4; 95% confidence interval [CI], 1.4-8.9; P = .015). There were no infections in either group. ACD (OR, 3.8; 95% CI, 1.5-9.7) and current smoking (OR, 2.6; 95% CI, 1.01-6.7) were independent predictors for any complication. CONCLUSIONS: This study demonstrates that ACD use in patients with peripheral artery disease can lead to serious adverse events resulting in increased morbidity. Therefore, the potential benefits of an ACD over MC should be carefully weighed.

Clarivein mechanochemical ablation of the great and small saphenous vein: Early treatment outcomes of two hospitals.

OBJECTIVES: Mechanochemical endovenous ablation is a novel technique for the treatment of great saphenous vein and small saphenous vein incompetence which combines mechanical injury of the endothelium with simultaneous infusion of liquid sclerosant. The main objective of this study was to evaluate early occlusion. METHODS: All consecutive patients who were eligible for the treatment with mechanochemical endovenous ablation were included. Inclusion period was from the introduction of the device in the hospitals (September 2011 and December 2011) until December 2012. RESULTS: A total of 449 patients were included representing 570 incompetent veins. In 506 treated veins, duplex ultrasonography was performed at follow-up: 457 veins (90%) were occluded at a follow-up of 6 to 12 weeks. In univariate and multivariate analysis, failure of treated great saphenous vein was associated with saphenofemoral junction incompetence (OR 4; 95% CI 1.0-17.1, P = 0.049). CONCLUSIONS: The Clarivein device proves to be safe and had a high short-term technical effectiveness.

Comparative study of venous arterialization and pedal bypass in a patient cohort with critical limb ischemia.

OBJECTIVES: Patients with critical limb ischemia (CLI) have a poor life expectancy, and aggressive revascularization is accepted as a means to maintain their independence in the end stage of life. The goal of this case-control study was to evaluate the clinical outcome of distal venous arterialization and compare this with pedal bypass surgery in patients with CLI, and to identify potential risk factors that could be used to effectively identify patients at high risk of graft occlusion and amputation. METHODS: A retrospective cohort of patients was treated for CLI using venous arterialization or pedal bypass between 2007 and 2012. Kaplan-Meier and Cox regression analyses were used to evaluate predictors for limb salvage and patency. RESULTS: In 40 patients with CLI, 21 venous arterializations and 19 pedal bypasses were performed. In the venous arterialization group, early occlusion was 15%, 1-year patency was 71%, and limb salvage was 53%. In the PB group, early occlusion was 23%, one-year patency was 75% and limb salvage was 47%. The only independent risk factor for limb salvage in multivariate analysis was bypass occlusion (P<0.001). CONCLUSIONS: Limb salvage after venous arterialization was equal to limb salvage after pedal bypass surgery in this clinical comparative study.

A ruptured aneurysm after stent graft puncture during computed tomography-guided thrombin injection.

Type II endoleaks occur in 5% to 10% of patients who are treated by endovascular aneurysm repair. A persistent type II endoleak combined with documented aneurysm expansion is generally considered an indication for intervention. Thrombin injection directly into the aneurysm sac is described as a safe and efficient treatment option. We present a patient with a ruptured aneurysm caused by a puncture of the stent graft during computed tomography-guided thrombin injection. This case highlights a possible harmful complication of thrombin injection and emphasizes the need for caution while performing such a procedure.

Abdominal aortic embolization of a Figulla atrial septum occluder device, at the level of the celiac axis, after an atrial septal defect closure: hybrid attempt.

A 41-year-old woman was treated with a Figulla (Occlutec, Helsingborg, Sweden) atrial septum occluder device with no intraprocedural complications. Five months later, dislocation of the device in the abdominal aorta was detected. The occluder device was located at the level of the celiac axis, nearly obstructing the entire aorta. Owing to total incorporation of the device, endoluminal retrieval was not possible. Through a medial rotation approach, the device was safely removed. This is a rare complication after endoluminal closure of an atrial septum defect. The retrieval possibilities are discussed.

Frequency and consequences of early in-stent lesions after carotid artery stent placement.

PURPOSE: To examine the prevalence of in-stent lesions 1 month after carotid artery stent placement with multidetector computed tomography (CT) angiography and to evaluate their possible causes and their consequences during 1-year follow-up. MATERIALS AND METHODS: Sixty-nine patients with symptomatic carotid artery stenosis underwent multidetector CT angiography of the carotid arteries 1 month after carotid artery stent placement. Patients were followed-up until 1 year after stent placement, when duplex ultrasonography (US) was performed. In-stent lesions were defined as hypo- or hyperattenuating lesions at the stent wall found with multidetector CT. Significant restenosis (70%) at 1 year was defined as a peak systolic velocity of more than 300 cm/sec at duplex US. The Fisher exact test was used to assess the relationship between early in-stent lesions and ischemic events and restenosis. RESULTS: At 1 month, 14 of the 69 patients (20%) were found to have in-stent lesions. In one patient, the stent was occluded. The other 13 in-stent lesions did not result in significant lumen reduction. In the year following stent placement, no difference in ischemic events was found between patients with (14%) and those without (13%) early in-stent lesions (P = .99). There was no difference in the occurrence of restenosis at 1 year (7% vs 4%, P = .59). CONCLUSIONS: At 1 month after carotid artery stent placement, in-stent lesions are found in about one-fifth of patients. These lesions do not appear to be related to recurrent ischemic events or to restenosis at 1 year.

Aprotinin does not diminish blood loss in elective operations for infrarenal abdominal aneurysms: a randomized double-blind controlled trial.

Surgery for abdominal aneurysm is associated with substantial blood loss. In cardiac surgery, aprotinin, a fibrinolysis inhibitor, has shown to reduce blood loss significantly. Our aim was to assess the effect of aprotinin, when administered during elective surgery of infrarenal abdominal aneurysm, on coagulation, blood loss, and morbidity. A double-blind randomized trial was performed on 35 consecutive patients. They were randomized to either an aprotinin or a placebo group. The aprotinin group received 2,000,000 kallikrein inhibiting units (KIU) of aprotinin (500,000 KIU in 50 mL NaCl 0.9%) as a starting dose, followed by 500,000 KIU per hour during the operation. The placebo group received equal amounts of only NaCl 0.9%. During the operation and 24 hr thereafter, blood samples were taken to assess coagulation factors. Blood loss was measured in suction devices and swabs. All patients were followed until their discharge from the hospital. Statistical analysis was performed by independent t-test or Mann-Whitney U-test and chi-squared test. There was no significant difference in the amount of blood loss or the amount of blood products administered between the two groups. Morbidity and mortality were also comparable. In both groups, consumption of clotting factors could be detected, indicating activation of the coagulation cascade. However, in the aprotinin group, the alpha2-antiplasmin level was raised during surgery, indicating inhibition of fibrinolysis. Administration of aprotinin during elective operations for infrarenal aortic aneurysm induces inhibition of fibrinolysis. However, it does not significantly reduce blood loss or the need for blood products.

Aortic stent-graft infection following septic complications of a kidney stone.

A 73-year-old man was treated because of a renal pelvis blowout of the left kidney for which he received a nephrostomy catheter without antibiotic prophylaxis. Almost a year previously this patient had undergone endovascular repair of a symptomatic infrarenal abdominal aorta aneurysm. Four weeks after the diagnosis and treatment of the ruptured renal pelvis, a new computed tomography scan and ultrasound-guided fine needle aspiration confirmed the diagnosis of infected aortic stent-graft. An extra-anatomic axillo-uniiliac bypass and graft excision was performed. Two weeks after discharge the patient returned to the hospital with an occlusion of his left renal artery and died of renal failure. This is the first time an infected aortic stent-graft after a renal pelvis blowout has been reported. Although infections of aortic stent-grafts occur rarely, one should be aware of the possibility in aortic stent-graft patients undergoing abdominal procedures without antibiotic prophylaxis.