Project description:BackgroundEndovascular 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/designTwo-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.DiscussionThe 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 registrationClinicaltrials: NCT01220245.
Project description:In this placebo-controlled randomized controlled trial, we tested whether remote ischemic preconditioning (RIPC) elicited by four 5-minute cycles of 300 mmHg of cuff inflation/deflation of the lower limb would reduce myocardial necrosis in isoflurane-anesthetized patients undergoing on-pump coronary artery bypass graft surgery. Secondary outcomes were the perioperative release of the biomarkers NTproBNP, hsCRP, S100, atrial transcriptional profiles, and short- and long-term clinical outcomes. RIPC with concomitantly applied isoflurane did not affect the release of biomarkers or clinical outcome. NTproBNP release correlated with isoflurane- but not RIPC-induced transcriptional changes. For eleven randomly selected patients from each group (RIPC/CTL=no RIPC) two atrial samples were collected, one at the time of cannulation (T1) and one fifteen min after releasing the cross clamp (T2). The samples were immediately frozen in liquid nitrogen and later used for RNA isolation and subsequent microarray hybridization. Gene-level analysis was performed. the results of exon-level analysis will be published separately (only preliminary results available so far).
Project description:In this placebo-controlled randomized controlled trial, we tested whether remote ischemic preconditioning (RIPC) elicited by four 5-minute cycles of 300 mmHg of cuff inflation/deflation of the lower limb would reduce myocardial necrosis in isoflurane-anesthetized patients undergoing on-pump coronary artery bypass graft surgery. Secondary outcomes were the perioperative release of the biomarkers NTproBNP, hsCRP, S100, atrial transcriptional profiles, and short- and long-term clinical outcomes. RIPC with concomitantly applied isoflurane did not affect the release of biomarkers or clinical outcome. NTproBNP release correlated with isoflurane- but not RIPC-induced transcriptional changes.
Project description:In four high-risk patients with chronically occluded femoro-popliteal bypass suffering from Rutherford 4-5 chronic limb threatening ischemia we performed, as an alternative for redo surgery, endovasculair relining with covered stent grafts. During follow-up (3, 8, 14 and 20 months) one patient had redo percutaneous intervention and eventually below-the-knee amputation.
Project description:Endovascular therapy in patients suffering from peripheral arterial disease shows high rates of restenosis. The poor clinical outcomes are commonly explained by the demanding mechanical environment due to leg movements, but the mechanisms responsible for restenosis remain unknown. In this study, we hypothesized that restenosis following revascularization is associated with hemodynamical markers derived from blood flow during leg flexion. Therefore, we performed personalized computational fluid dynamics (CFD) analyses of 20 patients, who underwent routine endovascular femoro-popliteal interventions. The CFD analyses were conducted using 3D models of the arterial geometry in straight and flexed positions, which were reconstructed from 2D angiographic images. Based on restenosis rates reported at 6-month follow-up, logistic regression analyses were performed to predict restenosis from hemodynamical parameters. Results showed that severe arterial deformations, such as kinking, induced by leg flexion in stented arteries led to adverse hemodynamic conditions that may trigger restenosis. A logistic regression analysis based solely on hemodynamical markers had an accuracy of 75%, which showed that flow parameters are sufficient to predict restenosis (p = 0.031). However, better predictions were achieved by adding the treatment method in the model. This suggests that a more accurate image acquisition technique is required to capture the localized modifications of blood flow following intervention, especially around the stented artery. This approach, based on the immediate postoperative configuration of the artery, has the potential to identify patients at increased risk of restenosis. Based on this information, clinicians could take preventive measures and more closely follow these patients to avoid complications.
Project description:BackgroundThe aim of the present study is to determine the incidence/progression of hiatal hernia (HH) after robotic-assisted coronary artery bypass grafting (RA-CABG) surgery.MethodsWe reviewed the pre- and post-operative computed tomography (CT) of 491 patients who underwent RA-CABG between 2000 and 2017. Post-operative CT was acquired prospectively in a research protocol. CT was reviewed to assess the presence and the size of HH.ResultsWe found 444/491 (90.4%) had pre-operative CT, while 201/491 (40.9%) had post-operative CT. In total, 155/491 (31.6%) had both pre- and long-term post-operative CT with a mean follow-up of 6.2 (±3.5) years. HH was more prevalent on post-operative CT, 64/155 (41.3%) compared to pre-operative CT, 44/155 (28.4%), P<0.0001. The diameter of pre-existing HH 2.8 (±1.8) cm was significantly greater after surgery 3.9 (±2.5) cm, P<0.0001. As well the volume of the pre-existing HH 5.8 (4.4-9.2) mL (quartile) was significantly greater after surgery 14.1 (7.2-64.9) mL, P<0.0001. 20/155 (12.9%) had a newly developed HH after RA-CABG. A binary multivariate regression including HH risk factors showed that male gender is a predictor of developing a HH after RA-CABG with Hazard Ratio of 3.038, confidence interval (1.10-8.43), P=0.033.ConclusionsRA-CABG is associated with an increased risk of developing HH and increases the size of pre-existing HH.
Project description:BackgroundThe impact of utilization of intraoperative transesophageal echocardiography (TEE) at the time of isolated coronary artery bypass grafting (CABG) on clinical decision making and associated outcomes is not well understood.ObjectivesThe purpose of this study was to determine the association of TEE with post-CABG mortality and changes to the operative plan.MethodsA retrospective cohort study of planned isolated CABG patients from the Society of Thoracic Surgeons Adult Cardiac Surgery Database between January 1, 2011, and June 30, 2019, was performed. The exposure variable of interest was use of intraoperative TEE during CABG compared with no TEE. The primary outcome was operative mortality. The association of TEE with unplanned valve surgery was also assessed.ResultsOf 1,255,860 planned isolated CABG procedures across 1218 centers, 676,803 (53.9%) had intraoperative TEE. The percentage of patients receiving intraoperative TEE increased over time from 39.9% in 2011 to 62.1% in 2019 (p trend <0.0001). CABG patients undergoing intraoperative TEE had lower odds of mortality (adjusted odds ratio: 0.95; 95% confidence interval: 0.91 to 0.99; p = 0.025), with heterogeneity across STS risk groups (p interaction = 0.015). TEE was associated with increased odds of unplanned valve procedure in lieu of planned isolated CABG (adjusted odds ratio: 4.98; 95% confidence interval: 3.98 to 6.22; p < 0.0001).ConclusionsIntraoperative TEE usage during planned isolated CABG is associated with lower operative mortality, particularly in higher-risk patients, as well as greater odds of unplanned valve procedure. These findings support usage of TEE to improve outcomes for isolated CABG for high-risk patients.
Project description:BackgroundCoronary artery bypass graft (CABG) surgery is performed because of anticipated survival benefit, improvement in quality of life, or both. We performed this study to explore variations in clinical indications for CABG surgery among California hospitals and surgeons.MethodsUsing California CABG Outcomes Reporting Program data, we classified all isolated CABG cases in 2003-2004 as having "probable survival enhancing indications (SEIs)", "possible SEIs" or "non-SEIs." Patient and hospital characteristics associated with SEIs were examined.ResultsWhile 82.9% of CABG were performed for probable SEIs, the range extended from 68% to 96% among hospitals and 51% to 100% among surgeons. SEI rates were higher among patients aged >or= 65 compared with those aged 18-64 (Adjusted Odds Ratio [AOR] > 1.29 for age groups 65-69, 70-74 and >or= 75; all p < 0.001), among Asians and Native Americans compared with Caucasians (AOR 1.22 and 1.15, p < 0.001); and among patients with hypertension, peripheral vascular disease, diabetes, cerebrovascular disease and congestive heart failure compared to patients without these conditions (AOR > 1.09, all p < 0.001). Variations in indications for surgery were more strongly related to patient mix than to surgeon or hospital effects (intraclass correlation [ICC] = 0.04 for hospital; ICC = 0.01 for surgeon).ConclusionCalifornia hospitals and surgeons vary in their distribution of indications for CABG surgery. Further research is required to identify the roles of market factors, referral patterns, patient preferences, and local clinical culture in producing the observed variations.
Project description:ObjectivesCoronary artery bypass grafting for advanced coronary artery disease is a well-established procedure with excellent long-term results. The issue of saphenous vein graft (SVG) performance and its relation to clinical symptoms and thereby the potential for improvement by using superior grafts are still not fully understood. We aim to estimate the contribution of late SVG failure to the long-term outcome.MethodsA study population operated between 1997 and 2020, with an internal thoracic artery with a single distal anastomosis and 1, 2 or 3 distal SVG anastomoses, was isolated from the Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies registry. Data regarding postoperative clinically driven coronary angiography and status of bypass grafts were collected.ResultsThe study population consisted of 44 951 patients. Clinically driven angiography occurred in 10.1% (9.5-10.8), 7.9% (7.6-8.3) and 7.1% (6.7-7.5), respectively, of patients within 3 years and 23.6% (22.6-24.5), 20.0% (19.5-20.6) and 17.5% (16.9-18.2), respectively, of patients within 10 years after surgery. Excluding the first 3 postoperative years, no failed SVGs were found in >75%, 60% and 45%, respectively, of cases when an angiography was performed in the first 10 years after surgery.ConclusionsThe results suggest that the risk of symptomatic graft failure due to vein graft disease during the first 10 years after surgery is in the range of 1-2% for every grafted coronary vessel and provide an estimate for the upper limit of the improvements in results that could be achieved by replacing SVGs with superior grafts.