SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial

Contains fulltext : 96315.pdf (publisher's version ) (Open Access)BACKGROUND: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not. METHODS/DESIGN: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications. DISCUSSION: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications. TRIAL REGISTRATION: Clinicaltrials: NCT01220245

Current imaging modalities to visualize vulnerability within the atherosclerotic carotid plaque

BackgroundThere is increasing evidence that plaque vulnerability, rather than the degree of stenosis, is important in predicting the occurrence of subsequent cerebral ischemic events in patients with carotid artery stenosis. The many imaging modalities currently available have different properties with regard to the visualization of the extent of vulnerability in carotid plaque formation.MethodsOriginal published studies were identified using the MEDLINE database (January 1966 to March 2008). Manual cross-referencing was also performed.ResultsThere is no single imaging modality that can produce definitive information about the state of vulnerability of an atherosclerotic plaque. Each has its own specific drawbacks, which may be the use of ionizing radiation or nephrotoxic contrast agents, an invasive character, low patient tolerability, or simply the paucity of information obtained on plaque vulnerability. Functional molecular imaging techniques such as positron emission tomography (PET), single photon emission-computed tomography (SPECT) and near infra-red spectroscopy (NIRS) do seem able accurately to visualize and even quantify features of plaque vulnerability and its pathophysiologic processes. Promising new techniques like near infra-red fluorescence imaging are being developed and may be beneficial in this field.ConclusionThere is a promising role for functional molecular imaging modalities like PET, SPECT, or NIRS related to improvement of selection criteria for carotid intervention, especially when combined with CT or MRI to add further anatomical details to molecular information. Further information will be needed to define whether and where this functional molecular imaging will fit into a clinical strategy

The Influence of the Metabolic Syndrome on the Short- and Long-Term Outcome After Carotid Endarterectomy

The metabolic syndrome (MetS) is a cluster of risk factors for cardiovascular disease. The aim of this study is to determine the influence of MetS on short- and long-term outcome and survival after carotid endarterectomy (CEA). Between January 2005 and December 2014, data from all patients undergoing CEA were prospectively recorded. The metabolic syndrome was defined based on the presence of 3 of the following criteria: hypertension, high serum triglycerides, low levels of high-density lipoprotein cholesterol, high fasting serum glucose, and obesity. Primary end points were the occurrence of transient ischemic attack (TIA)/cerebrovascular accident (CVA), myocardial infarction, and mortality. A total of 564 interventions (in 525 patients) were performed, of which 244 (43.3%) were in patients who met the diagnosis of MetS. There were no differences in short- and long-term complications and overall survival between patients with and without MetS. Patients with diabetes mellitus (DM) had significantly more ipsilateral TIA/CVA after 30 days (P = .001). The presence of MetS has no negative effect on the outcome after CEA. However, patients with DM have a significantly higher risk of ipsilateral TIA/CVA

Impact of a nurse pulmonary care protocol on the incidence of ventilator associated pneumonia: A prospective study

Objective: To determine the change in incidence of ventilator-associated pneumonia (VAP) after the implementation of a package of measures in a nurse pulmonary care protocol. Design: Prospective sequential study. Setting: A 14 bed surgical ICU in a tertiary referral university hospital. Patients: Patients with a stay >3 days were eligible. Forty-six consecutive patients over a 3-month period as controls, and after a two-months instruction period, forty-six consecutive patients after the implementation of the protocol. Interventions: A package of interventions concerning nursing pulmonary care were implemented. These interventions included: (1) Discontinuing standard nebulizing therapy with acetylcysteine and salbutamol; (2) Performing bronchial suction only on indication, these indications being: sputum retention on auscultation, imminent tube obstruction, visible (and audible) sputum in the tube and before turning the patient from supine to prone position; (3) use of a closed catheter suction system in case of PEEP > 10 cm H2O; (4) use of a filter, which was replaced on a daily basis, on the bedside ambu balloon. Measurements and results: Pneumonia was diagnosed according to the CDC criteria. Mean age of all patients was 62 ± 16 and mean APACHE II score was 16.1 ± 7. The intervention and control group did not differ for age, sex and APACHE II on admission. The intervention group showed a significant reduction in pneumonia compared to the control group: 11/46 versus 21/46 (p < 0.05), with a shorter period on mechanical ventilation (95% Cl 9.4 - 16.0 versus 13.7 - 26.7 days, p < 0.05) and reduction in ICU stay (95% Cl 10.6 - 17.6 versus 14.9 - 27.8 days, p < 0.05). Conclusions: A significant reduction of the incidence of VAP can be achieved by relatively simple changes in the nurse pulmonary care protocol

Impact of a nurse pulmonary care protocol on the incidence of ventilator associated pneumonia: A prospective study

Objective: To determine the change in incidence of ventilator-associated pneumonia (VAP) after the implementation of a package of measures in a nurse pulmonary care protocol. Design: Prospective sequential study. Setting: A 14 bed surgical ICU in a tertiary referral university hospital. Patients: Patients with a stay >3 days were eligible. Forty-six consecutive patients over a 3-month period as controls, and after a two-months instruction period, forty-six consecutive patients after the implementation of the protocol. Interventions: A package of interventions concerning nursing pulmonary care were implemented. These interventions included: (1) Discontinuing standard nebulizing therapy with acetylcysteine and salbutamol; (2) Performing bronchial suction only on indication, these indications being: sputum retention on auscultation, imminent tube obstruction, visible (and audible) sputum in the tube and before turning the patient from supine to prone position; (3) use of a closed catheter suction system in case of PEEP > 10 cm H2O; (4) use of a filter, which was replaced on a daily basis, on the bedside ambu balloon. Measurements and results: Pneumonia was diagnosed according to the CDC criteria. Mean age of all patients was 62 ± 16 and mean APACHE II score was 16.1 ± 7. The intervention and control group did not differ for age, sex and APACHE II on admission. The intervention group showed a significant reduction in pneumonia compared to the control group: 11/46 versus 21/46 (p < 0.05), with a shorter period on mechanical ventilation (95% Cl 9.4 - 16.0 versus 13.7 - 26.7 days, p < 0.05) and reduction in ICU stay (95% Cl 10.6 - 17.6 versus 14.9 - 27.8 days, p < 0.05). Conclusions: A significant reduction of the incidence of VAP can be achieved by relatively simple changes in the nurse pulmonary care protocol

Circumference as an alternative for diameter measurement in endovascular aneurysm repair

Appropriate sizing of endografts for endovascular aneurysm repair has traditionally been performed by one standardized method. By measuring the average of the minor and major axes in the sealing zone, the endograft size is traditionally calculated. However, no adequate scientific evaluation has been performed to validate this method. The guidelines that were published are based on theories and experience, more than scientific evidence. In case the central lumen line artery cross-section is a circular disk, the vessel diameter is a reliable estimation. Yet the aortic neck cross-section may not always be geometrically a perfect circular disk. Application of the standardized method might therefore lead to inaccurate endograft sizing, potentially leading to endoleaks. We hypothesize that in these cases the circumference of the vessel is a mathematically correct reference to deduct the appropriate endograft diameter. The following formula was applied in this study: diameter of the corresponding circle (d) equals circumference (C) divided by (d=c/pi). This study provides a theoretical analysis of the mathematical implications of this method. Only in pi case of highly irregularly shaped cylinders, the circumference-based method was more accurate than the standardized method. Nonetheless, the circumferential method was a practical reference in case the aortic neck was irregularly shaped. Also, the circumference method was accurate in all cases in deducting the diameter of a matching circle. Therefore, the hypothesis that was raised in this study has a strong theoretical base. We predict that in case this hypothesis holds true in the clinical practice, application of the circumference method might lead to less endoleaks than the standardized method. (C) 2015 Elsevier Ltd. All rights reserved