Smits P.C.,Maasstad Ziekenhuis |
Hofma S.,Medisch Centrum Leeuwarden |
Togni M.,HOpital Cantonal de Fribourg |
Vazquez N.,Hospitalario Juan Canalejo |
And 10 more authors.
The Lancet | Year: 2013
Background Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer. Methods This open-label, prospective, randomised, controlled, non-inferiority trial was undertaken at 12 sites across Europe. We used limited exclusion criteria (age p>18 years, life expectancy p>5 years, reference vessel diameter 2•0-4•0 mm) to enrol patients eligible for percutaneous coronary intervention. Patients were randomly allocated (2:1) by computer-generated random numbers to receive either a biodegradable polymer biolimus-eluting stent (Nobori, Terumo, Tokyo, Japan) or a durable fluoropolymer-based everolimus-eluting stent (Xience V or Prime, Abbott Vascular, Santa Clara, CA, USA, or Promus, Boston Scientific, Natick, MA, USA). The primary endpoint was a composite of safety (cardiac death and non-fatal myocardial infarction) and efficacy (clinically indicated target vessel revascularisation) at 12 months, analysed by intention to treat. Patients received dual antiplatelet therapy for 12 months after discharge. The trial is registered with ClinicalTrials.gov, number NCT01233453. Findings From Jan 12, 2009, to Feb 7, 2011, we enrolled 2707 patients (4025 lesions), 1795 of whom were assigned to receive the biolimus-eluting stent (2638 lesions) and 912 to an everolimus-eluting stent (1387 lesions). 2688 (99•3%) patients completed 12 months' follow-up. Significantly more patients in the biolimus-eluting stent group received a non-assigned stent than did those in the everolimus-eluting stent group (105 [5•9%] vs 19 [2•1%]; p<0•0001). The primary endpoint occurred in 93 (5•2%) patients in the biolimus-eluting stent group and 44 (4•8%) patients in the everolimus-eluting stent group at 12 months (relative risk 1•07 [95% CI 0•75-1•52]; p non-inferiorityp<0•0001). Analysis per protocol did not change the outcome of this trial (pnon-inferiorityp<0•0001). Interpretation Biodegradable polymer biolimus-eluting stents are as safe and efficacious as the current standard of a thin-strut everolimus-eluting stent with a durable biocompatible polymer. We need to follow-up patients for longer to show whether the biolimus-eluting stent reduces the risk of stent thrombosis after 1 year when compared with the everolimus-eluting stent. Funding Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, Netherlands).
Kamphuisen P.W.,University of Groningen |
Brinke A.,Medisch Centrum Leeuwarden |
Rijssenbeek-Nouwens L.,Dutch Asthma Center
European Respiratory Journal | Year: 2013
Increasing evidence suggests that patients with asthma have activated coagulation within the airways. Whether this leads to an increase in venous thromboembolic events is unknown. We therefore assessed the incidence of venous thromboembolic events in patients with mild-to-moderate and severe asthma as compared with an age- and sex-matched reference population. 648 patients with asthma (283 with severe and 365 patients with mild-to-moderate asthma) visiting three Dutch outpatient asthma clinics were studied. All patients completed a questionnaire about a diagnosis of deep vein thrombosis and pulmonary embolism in the past, their risk factors, history of asthma and medication use. All venous thromboembolic events were objectively verified. In total, 35 venous thromboembolic events (16 deep vein thrombosis and 19 pulmonary embolism) occurred at a median age of 39 (range 20-63) years. The incidence of pulmonary embolism in patients with severe asthma was 0.93 (95% CI 0.42-1.44) per 1000 person-years, 0.33 (95% CI 0.07-0.60) in mild-to-moderate asthma and 0.18 (95% CI 0.03-0.33) in the general population, respectively. Severe asthma and oral corticosteroid use were independent risk factors of pulmonary embolism (hazard ratios 3.33 (1.16-9.93) and 2.82 (1.09-7.30), respectively). Asthma was not associated with deep vein thrombosis. Severe asthma greatly enhances the risk of pulmonary embolism, particularly if chronic corticosteroids are used. Copyright ©ERS 2013.
News Article | October 31, 2016
NEW YORK, NY (Oct. 31) -- A major international study has found that drug-eluting stents, a less-invasive alternative to bypass surgery, are as effective as surgery for many patients with a blockage in the left main coronary artery. Findings from the EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial were published this morning online in the New England Journal of Medicine and presented at the annual Transcatheter Cardiovascular Therapeutics conference in Washington, DC. The trial research team included interventional cardiologists and cardiac surgeons from 126 centers in 17 countries. Coronary artery bypass graft (CABG) surgery has long been considered the definitive treatment for patients with left main coronary artery disease (LMCAD), in which the artery that supplies oxygen-rich blood to most of the heart muscle is clogged with atherosclerotic plaque. About two-thirds of all LMCAD patients have mild to moderate disease in the remainder of the coronary arteries. "Our study has shown that many patients with left main coronary artery disease who prefer a minimally invasive approach can now rest assured that a stent is as effective as bypass surgery for at least 3 years, and is initially safer, with fewer complications from the procedure," said first author Gregg W. Stone, MD, professor of medicine at Columbia University Medical Center and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia. Stents, which are placed into the diseased artery via a catheter that is inserted through a small opening in a blood vessel in the groin, arm, or neck, are a less-invasive treatment option for many people with coronary artery disease. However, coronary artery bypass surgery (CABG) has long been considered the definitive treatment for patients with LMCAD, which affects a large portion of the heart muscle. Previously, randomized clinical trials suggested that first-generation drug-eluting stents, which release antiproliferative medications to prevent the artery from becoming re-occluded after stent placement, might be appropriate for patients with LMCAD without extensive blockages in the remainder of the heart arteries. The trial results, however, were inconclusive. "Since that time, stents have gotten better, and so has cardiac bypass surgery," said Dr. Stone. "That required us to take a fresh look at the relative safety and effectiveness of the two approaches." In the current study, 1,905 patients with LMCAD and low or intermediate coronary artery disease complexity (as determined by the SYNTAX score, an angiographic tool for measuring disease severity) were randomized to receive a drug-eluting stent that releases the antiproliferative agent everolimus (XIENCE, made by Abbott Vascular of Santa Clara, CA) or bypass surgery. The patients were followed for at least two years, with a median follow-up of three years. "We found that approximately 15 percent of patients in both groups had a heart attack, stroke, or died within three years," said Dr. Stone, lead author of the paper. "In other words, stents were equally effective as bypass surgery." The researchers also analyzed what happened to the patients in the first 30 days after treatment, when serious complications are most likely to occur. Within that period, stent patients had a significantly lower incidence (4.9 percent) of death, stroke, heart attack, or revascularization than those who had bypass surgery (7.9 percent). In addition, fewer stent patients had major bleeding, infections, kidney failure, or severe abnormal heart rhythms compared to those treated with surgery. The researchers reported that bypass surgery should still be considered standard therapy for those with LMCAD and extensive blockages in the remainder of the heart arteries, although the study did not include patients with severe disease. "Our study establishes stents as an acceptable or preferred alternative for patients with LMCAD and low or moderate disease complexity in the other 3 coronary arteries--about two-thirds of all LMCAD patients," said Dr. Stone. "While bypass is still considered a more durable repair, patients and doctors may prefer a percutaneous treatment approach, which is associated with better upfront results, fewer complications, and quicker recovery." Coronary artery disease (CAD), the most common form of heart disease in the US, results from the buildup of atherosclerotic plaques in the arteries that supply oxygenated blood to the heart. CAD frequently leads to strokes or heart attacks, killing more than 370,000 people annually, according to the Centers for Disease Control and Prevention. The left main artery, the primary supply of blood to the heart, is affected in about 10 percent of people with CAD. The study is titled, "Comparison of Everolimus-Eluting Stents and Bypass Graft Surgery in Selected Patients with Left Main Coronary Artery Disease." The other contributors are: Joseph F. Sabik (Cleveland Clinic Foundation, Cleveland, OH); Patrick W. Serruys (International Centre for Circulatory Health, NHLI, Imperial College London, London, UK); Charles A. Simonton (Abbott Vascular, Santa Clara, CA); Philippe Généreux, Erick Schampaert, and Pierre Pagé (Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada); John Puskas and Roxana Mehran (Mount Sinai Hospital, New York, NY); Nicholas Lembo, David E. Kandzari, and W. Morris Brown, III (Piedmont Hospital, Atlanta, GA); Marie-Claude Morice (Générale de Santé, Hopital Privé Jacques Cartier, Massy, France); David Taggart and Adrian Banning (John Radcliffe Hospital, Oxford, UK); Béla Merkely and Ferenc Horkay (Semmelweis University, Budapest, Hungary); Piet W. Boonstra and Ad Johannes van Boven (Medisch Centrum Leeuwarden, Leeuwarden, The Netherlands); Imre Ungi and Gabor Bogáts (University of Szeged, Szeged, Hungary); Samer Mansour and Nicolas Noiseux (Hôpital Hôtel-Dieu de Montréal, Montréal, Québec, Canada); Manel Sabaté and Jose Pomar (Hospital Clinic, Barcelona, Spain); Mark Hickey and Anthony Gershlick (University Hospitals of Leicester NHS Trust, Leicester, UK); Pawel Buszman and Andrzej Bochenek (Medical University of Silesia, Katowice, Poland and American Heart of Poland, Ustron, Poland); Ovidiu Dressler (Cardiovascular Research Center, New York, NY); Ioanna Kosmidou (NewYork-Presbyterian, New York, NY); Stuart J. Pocock (London School of Hygiene and Tropical Medicine, London, UK); and Arie Pieter Kappetein (Erasmus Medical Center, Rotterdam, The Netherlands). The study was sponsored and funded by Abbott Vascular, Santa Clara, CA. Additional authors' disclosures are included in the article. Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org. NewYork-Presbyterian is one of the nation's most comprehensive healthcare delivery networks, focused on providing innovative and compassionate care to patients in the New York metropolitan area and throughout the globe. In collaboration with two renowned medical school partners, Weill Cornell Medicine and Columbia University College of Physicians & Surgeons, NewYork-Presbyterian is consistently recognized as a leader in medical education, groundbreaking research and clinical innovation. 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van Wingerden J.J.,Medisch Centrum Leeuwarden |
Coret M.E.H.,Medisch Centrum Leeuwarden |
van Nieuwenhoven C.A.,Medisch Centrum Leeuwarden |
Totte E.R.,Leeuwarden Institute for Minimal Invasive Surgery
European Journal of Cardio-thoracic Surgery | Year: 2010
Objective: To report our experience with the laparoscopically harvested omental flap in the treatment of deep sternal wound infection, and to present a modification and introduce two supportive techniques in the perioperative management. Methods: Between June 2005 and September 2007, six patients with grade IV (El Oakley-Wright classification) deep sternal wound infection following a median sternotomy for coronary artery bypass grafting underwent a reconstruction with a laparoscopically harvested omental flap. The median age of the cohort of six, consisting of one female and five males, was 67 years (range: 61-77 years). In five patients, an unilateral internal thoracic artery had been used. Considerable preoperative risk factors were present: one patient suffered from severe chronic obstructive pulmonary disease (COPD) Forced expiratory volume in 1 s (FEV1)1L; two from moderate chronic obstructive airway disease, three from insulin-dependent diabetes mellitus and three were on glucocorticoid steroid therapy preoperatively. Abdominal surgery had previously been performed in four patients. In all cases, the mediastinal wound was prepared with vacuum-assisted (≤125 mmHg) therapy following debridement and pulsed irrigation. White, small-pore foam was placed over the right ventricle when the risk of adhesion to the sternal remnants or secondary haemorrhage was a concern. In all cases, the position of the spread-out omental flap was maintained intrathoracically with autologous fibrin glue and in one case the split-skin graft covering the flap was also dealt with in this way. In the five other cases, the omental flap was covered by mobilising and advancing the local soft tissue and skin towards the midline. Portable sonography proved useful in monitoring the doubtful intrathoracic flap. Results: The 30-day perioperative mortality rate was zero, with a 2-year overall survival of 100%. One patient received a temporary colostomy due to a partial transverse colon necrosis. Follow-up ranged from 20 to 53 months (median: 39 months) for the group as a whole. Death occurred in one case 2.8 years after reconstruction due to reasons other than cardiac or mediastinal conditions. Conclusion: The laparoscopically harvested omental flap can contribute to a successful outcome following deep sternal wound infection and deserves serious consideration in type IV mediastinitis in particular, regardless of the co-morbidity or previous abdominal surgery. © 2009 European Association for Cardio-Thoracic Surgery.
Snijders C.,Medisch Centrum Leeuwarden
Tijdschrift voor Kindergeneeskunde | Year: 2014
This manuscript looks back on the NEOSAFE study, a prospective multicenter survey, which analysed a number of aspects of safety culture, incident reporting and incident analysis. A voluntary, non-punitive incident reporting system (NEOSAFE) was introduced in eight level III Neonatal Intensive Care Units (NICUs) in The Netherlands. An incident was defined as any unintended event which (could have) reduced the safety margin for the patient. After introduction of the voluntary, non-punitive reporting system, the impact of process deviations in the NICU became more visible through the great number of incident reports and subsequent analysis. Future studies should focus on the development of powerful interventions to prevent adverse events in the NICU. © 2014, Bohn, Stafleu van Loghum.
[Prevalence of gestational diabetes in high-risk pregnancies: screened using an oral glucose tolerance test]. [Prevalentie van diabetes gravidarum bij risicozwangeren: screening met behulp van orale glucosetolerantietest.]
Arendz I.J.,Medisch Centrum Leeuwarden
Nederlands tijdschrift voor geneeskunde | Year: 2013
To determine the prevalence of gestational diabetes mellitus in high-risk pregnancies during the second or third trimester diagnosed by screening with the 75-gram oral glucose tolerance test (75 g-OGTT) and, to determine the prevalence of the need for insulin therapy after an initial dietary intervention. Prospective cohort study. Pregnant women at high-risk for gestational diabetes mellitus were challenged with the 75 g-OGTT in the second or third trimester, ideally between the 24th and the 28th week of pregnancy. The diagnosis of gestational diabetes mellitus was established when the fasting plasma glucose was ≥ 7.0 mmol/l or when the plasma glucose was ≥ 7.8 mmol/l two hours after the oral ingestion of 75 g glucose. The women with gestational diabetes were initially treated with a dietary regime. Insulin treatment was added if the hyperglycaemia persisted. A total of 471 pregnant women were included. Of these women, 75.8% underwent the 75 g-OGTT between the 24th and 28th week of pregnancy; 24.2% underwent the test between the 28th and 35th week. The diagnosis of gestational diabetes mellitus was established in 24.2% of the pregnant women. Dietary intervention was successful in normalising the blood glucose levels in 77.2% of the cases. The remaining 22.8% needed the additional insulin treatment. We ascertained that the prevalence of gestational diabetes mellitus in high-risk pregnancies was high. In most cases, the gestational diabetes mellitus could be managed by diet. A multidisciplinary approach involving obstetricians, gynaecologists, dieticians and internists is needed to ensure a timely diagnosis and adequate treatment during pregnancy.
Robinson A.P.,Medisch Centrum Leeuwarden
American journal of orthopedics (Belle Mead, N.J.) | Year: 2014
Pseudoaneurysms of the brachial artery are rare and most often occur after a penetrating injury. The incidence of periprosthetic humerus fractures is low, and surgical treatment can be demanding. The treatment of choice for an occluded pseudoaneurysm of the brachial artery is saphenous vein bypass. In this article, we report the case of a 73-year-old woman who presented with an occluded pseudoaneurysm of the brachial artery sustained after a neglected periprosthetic humerus fracture. A saphenous vein bypass was performed after removal of the distal tip of the prosthesis. Patency was observed 3 months after surgery. This case shows malunion of a neglected periprosthetic humerus fracture and a good result after saphenous vein bypass.
Wieldraaijer F.,Medisch Centrum Leeuwarden
Nederlands tijdschrift voor geneeskunde | Year: 2011
To determine whether there are any differences between children known to be maltreated and a control group, the goal being an earlier detection of maltreated children in the emergency department (ED). Retrospective case control study. Children in whom child abuse had been ascertained by the Dutch child protection services (Advies- en Meldpunt Kindermishandeling, AMK) in Friesland in 2008, were compared with matched control children from Leeuwarden Medical Centre. For each child we established the total number of ED visits and the number of hospitals visited in Friesland in the 3 years prior to registration at the AMK. For each ED visit we recorded the reason for the visit, type of injury, if applicable, length of delay before seeking medical attention, diagnosis, reason for admission, completeness of the screening questionnaire and registration, if applicable, at the AMK. For each ED visit we assessed in retrospect whether there was a possibility of child abuse, whereby assessors were not aware of the group each child was in. In the group of maltreated children, 93 of the 676 children collectively visited the ED 129 times, compared with 61 of 676 children in the control group who visited 69 times (odds ratio (OR):1.61; 95% CI: 1.14-2.27). 24 (26%) of the maltreated children who visited the ED went more than once; in the control group 6 children visited the ED more than once (9.8%) (OR: 3.19; 95% CI: 1.22-8.35). In retrospect the researchers suspected 11 cases of child abuse in the group of maltreated children but not one in the control group. These results were all significantly different between both groups, the other variables showed no significant difference. For 3 of the 93 maltreated children (3%) contact had been made with the AMK at the time of the most recent ED visit. Children who were maltreated visited the ED more frequently and were more likely to visit the ED several times over a period of 3 years. Child abuse was not sufficiently detected in the ED.
de Visscher J.G.,Medisch Centrum Leeuwarden.
Nederlands tijdschrift voor tandheelkunde | Year: 2013
A 47-year-old man was referred to an oral and maxillofacial surgeon by his dentist because ofa painful ulcer with exposed bone at the lingual side of teeth 47 and 48. The lesion was diagnosed as lingual mandibular osteonecrosis. Characteristics of lingual mandibular osteonecrosis are exposed bone in the molar area and sequestration. The disorder can appear spontaneously or following damage to the mucous membrane. Treatment options are surgical smoothening of exposed bone, surgical removal of necrotic bone and awaiting spontaneous sequestration.
van Wingerden J.J.,University of Amsterdam |
Lapid O.,University of Amsterdam |
Boonstra P.W.,Medisch Centrum Leeuwarden |
de Mol B.A.J.M.,University of Amsterdam
Interactive Cardiovascular and Thoracic Surgery | Year: 2011
The primary question addressed was whether muscle flaps (MFs) offer a significant advantage over an omental flap (OF) in the management of deep sternal wound infection (DSWI) following cardiovascular surgery in terms of outcome (morbidity and mortality). Altogether, 333 citations (from PubMed and EMBASE and using a manual search, without language restriction) were identified using the reported strategy. Focusing on publications from single institutions with experience with both types of flap in the treatment of DSWI, 16 studies represented the best evidence on the topic. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. These 16 observational studies covered 1046 patients, and all reported mortality rates. Unadjusted data from five of six studies investigating a possible association between mortality and flap type suggested a higher mortality rate following reconstruction with MFs. A meta-analysis of all six studies indicates a slight, but not significant, survival advantage for reconstruction with an OF [overall relative risk 1.29 (95% confidence interval 0.58-2.88)]. Thirteen studies reported on the number of individual postoperative complications for a total of 964 patients. Data, unadjusted for potentially confounding surgical factors, on complications following flap closure, such as complete or partial flap loss, haematoma, arm or shoulder weakness and chronic chest wall pain, suggested that these complications were more common following MF reconstruction. Four studies evaluated patients with recurrent sternal wound infection (n = 521). Two of these were associated with a high incidence (> 17.5%) of re-exploration for recurrent sternal infection following MF reconstruction. The most commonly reported complications following an OF were abdominal or diaphragmatic hernias, with an incidence of < 5%. We conclude that the weight of current evidence is insufficient to prove the superiority of reconstruction with MFs to a laparotomy-harvested, OF in the treatment of DSWI. The results suggest that use of the omentum may be associated with lower mortality and fewer complications. © 2011 Published by European Association for Cardio-Thoracic Surgery. All rights reserved.