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Vascular Surgery Clinical Trials

Homero Rivas, Ignacio Robles, Francisco Riquelme, Marcelo Vivanco, Julio Jiménez, Boris Marinkovic, Mario Uribe
OBJECTIVE: To evaluate a new magnetic surgical system during reduced-port laparoscopic cholecystectomy in a prospective, multicenter clinical trial. BACKGROUND: Laparoscopic instrumentation coupled by magnetic fields may enhance surgeon performance by allowing for shaft-less retraction and mobilization. The movements can be performed under direct visualization, generating different angles of traction and reducing the number of trocars to perform the procedure. This may reduce well-known associated complications of trocars, including incisional pain, scarring, infection, bowel, and vascular injuries, among others...
October 17, 2016: Annals of Surgery
Filippo Benedetto, Domenico Spinelli, Narayana Pipitò, Giambattista Gagliardo, Alberto Noto, Simona Villari, Antonio David, Francesco Spinelli
OBJECTIVE: The purpose of this study was to examine the outcomes of a vascular hybrid polytetrafluoroethylene (PTFE) graft, provided with a nitinol-reinforced section (NRS) on one end, in hemodialysis vascular access placement. METHODS: A retrospective study was conducted including all the consecutive patients who underwent Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) implantation for hemodialysis access placement between October 2013 and November 2015...
October 12, 2016: Journal of Vascular Surgery
Maurizio Calcagni, Simon Zimmermann, Mario F Scaglioni, Thomas Giesen, Pietro Giovanoli, Richard M Fakin
INTRODUCTION: None of the existing treatments in the management of painful end-neuromas of the superficial branch of the radial nerve (SBRN) has been proven superior due to high levels of pain relapse. Fat grafts enriched with the stromal vascular fraction (SVF) could act as a mechanic barrier with biological effects decreasing the resorption rate and boosting the graft's regenerative potential. This study describes the novel surgical treatment technique of SVF-enriched fat grafting. PATIENTS AND METHODS: In this clinical study, five consecutive patients treated for painful end-neuromas of the SBRN between 2012 and 2013 were analyzed retrospectively...
October 12, 2016: Microsurgery
Yader Sandoval, Marina Zakharova, Thomas S Rector, Emmanouil S Brilakis, Todd Drexel, Edward O McFalls, Santiago Garcia
The utility of measuring cardiac troponins (cTn) in asymptomatic patients during the perioperative period has been controversial. In the present substudy of the Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery Trial (NCT01558596), we hypothesized that surveillance of myocardial injury with cTnI in the perioperative period would lead to initiation or intensification of medical therapies for coronary artery disease. Increases in cTnI ≥0.01 μg/l in the perioperative period were considered clinically significant...
September 15, 2016: American Journal of Cardiology
Albert Busch, Elena Hartmann, Caroline Grimm, Süleyman Ergün, Ralph Kickuth, Christoph Otto, Richard Kellersmann, Udo Lorenz
OBJECTIVE: Abdominal aortic aneurysm (AAA) is a frequent, potentially life-threatening, disease that can only be treated by surgical means such as open surgery or endovascular repair. No alternative treatment is currently available, and despite expanding knowledge about the pathomechanism, clinical trials on medical aneurysm abrogation have led to inconclusive results. The heterogeneity of human AAA based on histologic examination is thereby generally neglected. In this study we aimed to further elucidate the role of these differences in aneurysm disease...
October 5, 2016: Journal of Vascular Surgery
Santiago Garcia, Thomas S Rector, Marina Zakharova, Rebekah R Herrmann, Selcuk Adabag, Stefan Bertog, Yader Sandoval, Steve Santilli, Emmanouil S Brilakis, Edward O McFalls
BACKGROUND: Remote ischemic preconditioning (RIPC) has been shown to reduce infarct size in animal models. We hypothesized that RIPC before an elective vascular operation would reduce the incidence and amount of a postoperative rise of the cardiac troponin level. METHODS AND RESULTS: Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES) was a prospective, randomized, sham-controlled phase 2 trial using RIPC before elective vascular procedures...
2016: Journal of the American Heart Association
Youn Joung Cho, Jungil Bae, Tae Kyong Kim, Deok Man Hong, Jeong-Hwa Seo, Jae-Hyon Bahk, Yunseok Jeon
General anesthesia can affect microcirculatory properties. However, differential effects on the microcirculation according to the anesthetic technique used during thoracoscopic surgery have not been well documented. We conducted a randomized clinical trial in which the effects of desflurane and propofol, both with remifentanil, on systemic arterial oxygenation during one-lung ventilation were compared in patients undergoing thoracoscopic surgery. As a subgroup analysis, we compared the effects of two commonly used anesthetic techniques, desflurane-remifentanil (n = 52) and propofol-remifentanil (n = 48), on tissue oxygen saturation using a vascular occlusion test in patients undergoing thoracoscopic surgery...
September 26, 2016: Journal of Clinical Monitoring and Computing
Vyshak Alva Venur, José Pablo Leone
The discovery of various driver pathways and targeted small molecule agents/antibodies have revolutionized the management of metastatic breast cancer. Currently, the major targets of clinical utility in breast cancer include the human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF) receptor, mechanistic target of rapamycin (mTOR) pathway, and the cyclin-dependent kinase 4/6 (CDK-4/6) pathway. Brain metastasis, however, remains a thorn in the flesh, leading to morbidity, neuro-cognitive decline, and interruptions in the management of systemic disease...
September 13, 2016: International Journal of Molecular Sciences
Clotilde Fuentes-Orozco, Salvador González-Mercado, Joel Mario Sandoval-Sandoval, Carlos Valdespino-Mejía, Eduardo González-González, Juan Narciso Ramírez-Robles, Benjamín Gómez-Navarro, Blanca Estela Dávalos-Delgadillo, Leticia Marquez-Leaño, Anais Ramírez-Arce, Elizabeth Andalón-Dueñas, Arturo Espinosa-Partida, Michel Dassaejv Macías-Amezcua, Alejandro González-Ojeda
BACKGROUND The incidence of surgical complications after kidney transplantation ranges from 10-25%. The purpose of this study was to evaluate if the application of fibrin glue as a preventive agent reduces surgical morbidity after a living-related-donor kidney transplantation. MATERIAL AND METHODS A controlled clinical trial involving 78 recipients randomly assigned to receive fibrin glue and 79 in the control group without the application of fibrin glue. Patients were followed for six months after surgery...
September 20, 2016: Annals of Transplantation: Quarterly of the Polish Transplantation Society
Matthew Burrage, Peter Moore, Chris Cole, Stephen Cox, Wing Chi Lo, Anthony Rafter, Bruce Garlick, Paul Garrahy, Julie Mundy, Anthony Camuglia
BACKGROUND: Aortic valve replacement is indicated in patients with severe symptomatic aortic stenosis (AS). Transcatheter aortic valve replacement (TAVR) has evolved as a potential strategy in a growing proportion of patients in preference to surgical aortic valve replacement (SAVR). This meta-analysis aims to assess the differential outcomes of TAVR and SAVR in patients enrolled in published randomised controlled trials (RCTs). METHODS: A systematic literature search of Cochrane Library, EMBASE, OVID, and PubMed MEDLINE was performed...
August 29, 2016: Heart, Lung & Circulation
Neal S Kleiman, Brijeshwar J Maini, Michael J Reardon, John Conte, Stanley Katz, Vivek Rajagopal, James Kauten, Alan Hartman, Raymond McKay, Robert Hagberg, Jian Huang, Jeffrey Popma
BACKGROUND: The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. METHODS AND RESULTS: Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis...
September 2016: Circulation. Cardiovascular Interventions
Stavros K Kakkos, Joseph A Caprini, George Geroulakos, Andrew N Nicolaides, Gerard Stansby, Daniel J Reddy, Ioannis Ntouvas
BACKGROUND: It is generally assumed by practitioners and guideline authors that combined modalities (methods of treatment) are more effective than single modalities in preventing venous thromboembolism (VTE), defined as deep vein thrombosis (DVT) or pulmonary embolism (PE), or both. This is an update of the review first published in 2008. OBJECTIVES: The aim of this review was to assess the efficacy of combined intermittent pneumatic leg compression (IPC) and pharmacological prophylaxis versus single modalities in preventing venous thromboembolism...
September 7, 2016: Cochrane Database of Systematic Reviews
Antoinette de Waha, Sigrid Sandner, Moritz von Scheidt, Andreas Boening, Katharina Koch-Buettner, Dieter Hammel, Rainer Hambrecht, Bernhard C Danner, Friedrich A Schöndube, Gerold Goerlach, Theodor Fischlein, Michael Schmoeckel, Martin Oberhoffer, Rainer Schulz, Thomas Walther, Tibor Ziegelhöffer, Christoph Knosalla, Felix Schönrath, Friedhelm Beyersdorf, Matthias Siepe, Tim Attmann, Martin Misfeld, Friedrich-Wilhelm Mohr, Hans-Hinrich Sievers, Alexander Joost, Leon M Putman, Günther Laufer, Christian Hamm, Uwe Zeymer, Adnan Kastrati, Peter W Radke, Rüdiger Lange, Jochen Cremer, Heribert Schunkert
BACKGROUND: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial...
September 2016: American Heart Journal
Kamel Mohammedi, Mark Woodward, Yoichiro Hirakawa, Sophia Zoungas, Stephen Colagiuri, Pavel Hamet, Stephen Harrap, Neil Poulter, David R Matthews, Michel Marre, John Chalmers
BACKGROUND: Peripheral arterial disease (PAD) is known to be associated with high cardiovascular risk, but the individual impact of PAD presentations on risk of macrovascular and microvascular events has not been reliably compared in patients with type 2 diabetes. We aimed to evaluate the impact of major PAD, and its different presentations, on the 10-year risk of death, major macrovascular events, and major clinical microvascular events in these patients. METHODS: Participants in the action in diabetes and vascular disease: PreterAx and DiamicroN modified-release controlled evaluation (ADVANCE) trial and the ADVANCE-ON post-trial study were followed for a median of 5...
2016: Cardiovascular Diabetology
Y E Chee, S E Liu, M G Irwin
Management of acute coagulopathy and blood loss during major vascular procedures poses a significant haemostatic challenge to anaesthetists. The acute coagulopathy is multifactorial in origin with tissue injury and hypotension as the precipitating factors, followed by dilution, hypothermia, acidemia, hyperfibrinolysis and systemic inflammatory response, all acting as a self-perpetuating spiral of events. The problem is confounded by the high prevalence of antithrombotic agent use in these patients and intraoperative heparin administration...
September 2016: British Journal of Anaesthesia
Nikolaos Patelis, George N Kouvelos, Andreas Koutsoumpelis, Demetrios Moris, Miltiadis I Matsagkas, Eleni Arnaoutoglou
Cardiovascular complications signify a major cause of morbidity and mortality in patients undergoing vascular surgery adversely affecting both short- and long-term prognosis. During the last decade, unmet needs for a distinct cardiovascular risk assessment have led to an intensive research for establishment of biomarkers with sufficient predictive value. This literature review aims in examining the value of several biomarkers in predicting the incidence of major adverse cardiac events in vascular surgery patients...
September 2016: Journal of Clinical Anesthesia
Alik Farber, Robert T Eberhardt
Importance: Chronic critical limb ischemia, marked by intractable lower extremity ischemic rest pain and tissue loss, is a highly morbid condition that leads to the loss of ambulation and decreased quality of life. It is associated with a high risk of limb loss and mortality and presents a significant economic burden to society. Objective: To review the current state of epidemiology, pathophysiology, diagnosis, and treatment of critical limb ischemia. Evidence Review: An extensive literature search of the subject matter was conducted on material published in English between 1980 and 2016; both landmark and recently published articles were evaluated...
August 17, 2016: JAMA Surgery
Carlo Tremolada, Valeria Colombo, Carlo Ventura
In the past few years, interest in adipose tissue as an ideal source of mesenchymal stem cells (MSCs) has increased. These cells are multipotent and may differentiate in vitro into several cellular lineages, such as adipocytes, chondrocytes, osteoblasts, and myoblasts. In addition, they secrete many bioactive molecules and thus are considered "mini-drugstores." MSCs are being used increasingly for many clinical applications, such as orthopedic, plastic, and reconstructive surgery. Adipose-derived MSCs are routinely obtained enzymatically from fat lipoaspirate as SVF and/or may undergo prolonged ex vivo expansion, with significant senescence and a decrease in multipotency, leading to unsatisfactory clinical results...
2016: Current Stem Cell Reports
Karina Newhall, Bjoern Suckow, Emily Spangler, Benjamin S Brooke, Andres Schanzer, TzeWoei Tan, Mary Burnette, Maria Orlando Edelen, Alik Farber, Philip Goodney
BACKGROUND: Despite the recognized benefits of smoking cessation, many clinicians question if a brief smoking cessation intervention can help dedicated smokers with peripheral arterial disease understand nicotine dependence and harms related to smoking. We investigated the impact and durability of a multi-modal smoking cessation intervention on patient attitudes regarding nicotine dependence and the health effects of smoking. METHODS: We conducted a pilot cluster randomized trial of a brief smoking cessation intervention at eight vascular surgery practices between September 1, 2014 and August 31, 2015...
August 10, 2016: Annals of Vascular Surgery
Renato Riera Toledo, Maria Elisabeth Rennó de Castro Santos, Taylor Brandão Schnaider
BACKGROUND: Venous ulcers are common complications of chronic venous insufficiency that result in severe physical and mental suffering to patients. The oral administration of diosmin/hesperidin has been used as adjuvant therapy in the treatment of chronic venous insufficiency. The purpose of this study was to evaluate and compare the effect of pycnogenol and diosmin/hesperidin on the healing of venous ulcers. METHODS: This longitudinal, prospective, randomized clinical trial was conducted with 30 adult patients with venous ulcers from a vascular surgery outpatient clinic of a university hospital...
August 10, 2016: Annals of Vascular Surgery
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