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Stone G.W.,Columbia University | Stone G.W.,Cardiovascular Research Foundation | Ellis S.G.,Cleveland Clinic | Colombo A.,San Raffaele Scientific Institute | And 6 more authors.
JACC: Cardiovascular Interventions | Year: 2011

Objectives: These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS). Background: Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES. Methods: The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis. Results: The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p < 0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18). Conclusions: In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES. © 2011 American College of Cardiology Foundation.


Andreone P.,University of Bologna | Colombo M.G.,University of Milan | Enejosa J.V.,Abbvie Inc. | Koksal I.,Karadeniz Technical University | And 9 more authors.
Gastroenterology | Year: 2014

Background & Aims The interferon-free regimen of ABT-450 (a protease inhibitor), ritonavir, ombitasvir (an NS5A inhibitor), dasabuvir (a non-nucleoside polymerase inhibitor), and ribavirin has shown efficacy in patients with hepatitis C virus (HCV) genotype 1b infection - the most prevalent subgenotype worldwide. We evaluated whether ribavirin is necessary for ABT-450, ritonavir, ombitasvir, and dasabuvir to produce high rates of sustained virologic response (SVR) in these patients. Methods We performed a multicenter, open-label, phase 3 trial of 179 patients with HCV genotype 1b infection, without cirrhosis, previously treated with peginterferon and ribavirin. Patients were assigned randomly (1:1) to groups given ABT-450, ritonavir, ombitasvir, and dasabuvir, with ribavirin (group 1) or without (group 2) for 12 weeks. The primary end point was SVR 12 weeks after treatment (SVR12). We assessed the noninferiority of this regimen to the rate of response reported (64%) for a similar population treated with telaprevir, peginterferon, and ribavirin. Results Groups 1 and 2 each had high rates of SVR12, which were noninferior to the reported rate of response to the combination of telaprevir, peginterferon, and ribavirin (group 1: 96.6%; 95% confidence interval, 92.8%-100%; and group 2: 100%; 95% confidence interval, 95.9%-100%). The rate of response in group 2 was noninferior to that of group 1. No virologic failure occurred during the study. Two patients (1.1%) discontinued the study owing to adverse events, both in group 1. The most common adverse events in groups 1 and 2 were fatigue (31.9% vs 15.8%) and headache (24.2% vs 23.2%), respectively. Decreases in hemoglobin level to less than the lower limit of normal were more frequent in group 1 (42.0% vs 5.5% in group 2; P <.001), although only 2 patients had hemoglobin levels less than 10 g/dL. Conclusions The interferon-free regimen of ABT-450, ritonavir, ombitasvir, and dasabuvir, with or without ribavirin, produces a high rate of SVR12 in treatment-experienced patients with HCV genotype 1b infection. Both regimens are well tolerated, as shown by the low rate of discontinuations and generally mild adverse events. ClinicalTrials.gov number: NCT01674725. © 2014 by the AGA Institute.


Bruder O.,Elisabeth Hospital | Wagner A.,Hahnemann University | Jensen C.J.,Elisabeth Hospital | Schneider S.,Institute Fr Herzinfarktforschung | And 7 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: We sought to establish the prognostic value of a comprehensive cardiovascular magnetic resonance (CMR) examination in risk stratification of hypertrophic cardiomyopathy (HCM) patients. Background: With annual mortality rates ranging between 1% and 5%, depending on patient selection, a small but significant number of HCM patients are at risk for an adverse event. Therefore, the identification of and prophylactic therapy (i.e., defibrillator placement) in patients with HCM who are at risk of dying are imperative. Methods: Two-hundred forty-three consecutive patients with HCM were prospectively enrolled. All patients underwent initial CMR, and 220 were available for clinical follow-up. The mean follow-up time was 1,090 days after CMR. End points were all-cause and cardiac mortality. Results: During follow-up 20 of the 220 patients died, and 2 patients survived sudden cardiac death due to adequate implantable cardioverter-defibrillator discharge. Most events (n = 16) occurred for cardiac reasons; the remaining 6 events were related to cancer and accidents. Our data indicate that the presence of scar visualized by CMR yields an odds ratio of 5.47 for all-cause mortality and of 8.01 for cardiac mortality. This might be superior to classic clinical risk factors, because in our dataset the presence of 2 risk factors yields an odds ratio of 3.86 for all-cause and of 2.20 for cardiac mortality, respectively. Multivariable analysis also revealed the presence of late gadolinium enhancement as a good independent predictor of death in HCM patients. Conclusions: Among our population of largely low or asymptomatic HCM patients, the presence of scar indicated by CMR is a good independent predictor of all-cause and cardiac mortality. © 2010 American College of Cardiology Foundation.


Schildmann J.,Ruhr University Bochum | Ritter P.,Elisabeth Hospital | Salloch S.,Ruhr University Bochum | Uhl W.,Ruhr University Bochum | Vollmann J.,Ruhr University Bochum
Annals of Oncology | Year: 2013

Background: Information about diagnosis, treatment options and prognosis has been emphasized as a key to empower cancer patients to make treatment decisions reflecting their values. However, surveys indicate that patients' preferences regarding information and treatment decision-making differ. In this qualitative interview study, we explored pancreatic cancer patients' perceptions and preferences on information and treatment decision-making. Patients and methods: Qualitative in-depth interviews with patients with pancreatic cancer. Purposive sampling and qualitative analysis were carried out. Results: We identified two stages of information and treatment decision-making. Patients initially emphasize trust in their physician and indicate rather limited interest in details about surgical and medical treatment. In the latter stage of disease, patients perceive themselves more active regarding information seeking and treatment decision-making. All patients discuss their poor prognosis. Reflecting on their own situation, all patients interviewed pointed out that hope was an important driver to undergo further treatment also in advanced stages of the disease. Interviewees unanimously emphasized the difficulty of anticipating the time at which stopping cancer treatment would be the right decision. Conclusions: The findings can serve as starting point for reflection on professional decision-making in pancreatic cancer and larger representative surveys on ethical issues in treatment decision-making in pancreatic cancer. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Dubbelman Y.,Elisabeth Hospital | Groen J.,Erasmus University Rotterdam | Wildhagen M.,Erasmus University Rotterdam | Rikken B.,IJsselland Hospital | Bosch R.,University Utrecht
Neurourology and Urodynamics | Year: 2012

Objectives: We aim to quantify changes in detrusor function and pressure-flow parameters after radical retropubic prostatectomy (RRP) and to determine the impact of the level of intensity of pelvic floor muscle exercises (PFME) on these changes. We also tried to identify preoperative urodynamic factors, predictive of postoperative continence status. Methods: Sixty-six patients were included in the study. An urodynamic examination was performed before surgery and 26 weeks after catheter removal. All patients were instructed in PFME. However the intensity of PFME varied between instructions based on an information folder only (F-PFME) and intensive guidance by a physiotherapist, in addition to the folder (PG-PFME). Results: In 66 men pre- as well as postoperative urodynamic studies were available for analysis. Overall, Q max increased, p det.Qmax and the urethral resistance factor URA decreased significantly after surgery. At baseline, detrusor overactivity (DOA) was found in 34% and 5.3% of the men who were still incontinent 6 months postoperatively and those who regained continence, respectively (P = 0.015). Postoperatively, Q max was significantly higher (P = 0.04) and URA significantly lower (P = 0.047) in the physiotherapist-guided group. No prognostic standard urodynamic factors for post-RP incontinence (PRPI) were identified. Conclusion: In univariate analysis, preoperative DOA is associated with a higher risk of remaining incontinent after surgery. However, in multivariate analysis, urodynamic parameters predictive of PRPI could not be identified. Therefore, standard preoperative filling cystometry and pressure-flow studies seem to have no role as preoperative predictors of PRPI in patients with localized prostate cancer. More intensive PFME might have a lowering effect on bladder outflow resistance after RRP. © 2012 Wiley Periodicals, Inc.


Van't Sant H.P.,Ikazia Hospital | Weidema W.F.,Ikazia Hospital | Hop W.C.J.,Erasmus Medical Center | Oostvogel H.J.M.,Elisabeth Hospital | Contant C.M.E.,Maasstad Hospital
Annals of Surgery | Year: 2010

OBJECTIVE: This study evaluates the effects of mechanical bowel preparation (MBP) on anastomosis below the peritoneal verge and questions the influence of MBP on anastomotic leakage in combination with a diverting ileostomy in lower colorectal surgery. SUMMARY BACKGROUND DATA: In a previous large multicenter randomized controlled trial MBP has shown to have no influence on the incidence of anastomotic leakage in overall colorectal surgery. The role of MBP in lower colorectal surgery with or without a diverting ileostomy remains unclear. METHODS: This study is a subgroup analysis of a prior multicenter (13 hospitals) randomized trial comparing clinical outcome of MBP versus no MBP. Primary end point was the occurrence of anastomotic leakage and secondary endpoints were septic complications and mortality. RESULTS: Total of 449 Patients underwent a low anterior resection with a primary anastomosis below the peritoneal verge. The incidence of anastomotic leakage was 7.6% for patients who received MBP and 6.6% for patients who did not. Significant risk factors for anastomotic leakage were the American Society of Anesthesiologists-classification (P = 0.005) and male gender (P = 0.007). Of total, 48 patients received a diverting ileostomy during initial surgery; 27 patients received MBP and 21 patients did not. There were no significant differences regarding septic complications and mortality between both groups. CONCLUSION: MBP has no influence on the incidence of anastomotic leakage in low colorectal surgery. Furthermore, omitting MBP in combination with a diverting ileostomy has no influence on the incidence of anastomotic leakage, septic complications, and mortality rate. Copyright © 2009 by Lippincott Williams & Wilkins.


Hovelius L.,Umeå University | Hovelius L.,Gavle Hospital | Vikerfors O.,Vasteras Hospital | Olofsson A.,Gavle Hospital | And 2 more authors.
Journal of Shoulder and Elbow Surgery | Year: 2011

Background: In 2 Swedish hospitals, 88 consecutive shoulders underwent Bankart repair (B), and 97 consecutive shoulders underwent Bristow-Latarjet repair (B-L) for traumatic anterior recurrent instability. Materials and methods: Mean age at surgery was 28 years (B-L group) and 27 years (B group). All shoulders had a follow-up by letter or telephone after a mean of 17 years (range, 13-22 years). The patients answered a questionnaire and completed the Western Ontario Shoulder Index (WOSI), Disability of Arm Shoulder and Hand (DASH), and SSV (Simple Shoulder Value) assessments. Results: Recurrance resulted revision surgery in 1 shoulder in the B-L group and in 5 shoulders in the B group (P = .08). Redislocation or subluxation after the index operation occurred in 13 of 97 B-L shoulders and in 25 of 87 of B shoulders (after excluding 1 patient with arthroplasty because of arthropathy, P = .017) Of the 96 Bristow shoulders, 94 patients were very satisfied/satisfied compared with 71 of 80 in the B series (P = .01). Mean WOSI score was 88 for B-L shoulders and 79 for B shoulders (P = .002) B-L shoulders also scored better on the DASH (P = .002) and SSV (P = .007). Patients had 11° loss of subjectively measured outward rotation with the arm at the side after B-L repair compared with 19° after Bankart (P = .012). The original Bankart, with tunnels through the glenoid rim, had less redislocation(s) or subluxation(s) than shoulders done with anchors (P = .048). Conclusions: Results were better after the Bristow-Latarjet repair than after Bankart repairs done with anchors with respect to postoperative stability and subjective evaluation. Shoulders with original Bankart repair also seemed to be more stable than shoulders repaired with anchors. © 2011 Journal of Shoulder and Elbow Surgery Board of Trustees.


Gordins V.,Frolunda Specialist Hospital | Hovelius L.,Gavle Hospital | Sandstrom B.,Gavle Hospital | Rahme H.,Elisabeth Hospital | Bergstrom U.,Umeå University
Journal of Shoulder and Elbow Surgery | Year: 2015

Background: Transfer of the coracoid (Bristow-Latarjet [B-L]) is used to stabilize anterior shoulder instability. We report the long-term results of our first 31 operations with this method. Materials and methods: Thirty-six patients (mean age, 26.7years) had a B-L repair from 1977 to 1979. Five patients died, and during 2012 to 2013, the remaining 31 shoulders had a follow-up with questionnaire, physical examination, Western Ontario Shoulder Instability Index, Subjective Shoulder Value, Subjective Assessment of Shoulder Function, subjective assessment of loss of motion, and radiologic imaging. Results: One patient required revision surgery because of recurrence and another because of repeat dislocation. Six patients reported subluxations. Eighteen patients (58%) were very satisfied, and 13 (42%) were satisfied. The mean Western Ontario Shoulder Instability Index score (100 possible) was 85, and the median score was 93. According to Samilson-Prieto classification of arthropathy of the shoulder, 39% were classified as normal, 27% as mild, 23% as moderate, and 11% as severe. The classification of arthropathy varied with observers and radiologic views. Age younger than 22years at the primary dislocation meant less arthropathy at follow-up (. P=.045). Conclusion: The degree of arthropathy 33 to 35years after the B-L repair seems to follow the natural history of shoulder dislocation with respect to arthropathic joint degeneration. Postoperative restriction of external rotation does not increase later arthropathy. © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees.


Hovelius L.,Umeå University | Hovelius L.,Gavle Hospital | Sandstrom B.,Gavle Hospital | Olofsson A.,Gavle Hospital | And 2 more authors.
Journal of Shoulder and Elbow Surgery | Year: 2012

Background: We evaluated the results of the May modification of the Bristow-Latarjet procedure (" coracoid in standing position" ) in 319 shoulders with respect to (1) coracoid healing and position and (2) surgical treatment of the joint capsule. Methods: From 1980 until 2004, all shoulders with a Bristow-Latarjet repair were registered at our hospital. This study consists of 3 different cohorts with respect to follow-up. Series 1, 118 shoulders operated on during 1980 through 1985, had 15 years' radiographic and clinical follow-up. Series 2, 167 shoulders that had surgery during 1986 through 1999, underwent retrospective follow-up by a questionnaire and scores-Western Ontario Shoulder Instability Index; Disabilities of the Arm, Shoulder and Hand; and Subjective Shoulder Value-after 10 to 23 years. Series 3, 34 shoulders treated during 2000 through 2004, with an added modified Bankart repair (" capsulopexy" ) in 33 shoulders, were prospectively followed up for 5 to 8 years with the same questionnaire and scores as series 2. Results: Of 319 shoulders, 16 (5%) had 1 or more redislocations and 3 of these (1%) had revision surgery because of remaining instability. One or more subluxations were reported in 41 shoulders (13%). The worst scores were found in 16 shoulders with 2 or more subluxations (P < .001). Radiographs showed bony healing in 246 of 297 shoulders (83%), fibrous union in 34 (13%), migration by 0.5 cm or more in 14 (5%), and no visualization in 3 (1%). Five of six shoulders that had the transplant positioned 1 cm or more medial to the glenoid rim had redislocations (83%, P = .001). Shoulders with migrated transplants did not differ from those with bony or fibrous healing with respect to redislocations and subluxations. When just a horizontal capsular shift was added to the transfer, the recurrence rate (redislocations or subluxations) decreased, with 2 of 53 (4%)compared with 37 of 208 (18%) with just anatomic closure of the capsule (P = .005), and the Western Ontario Shoulder Instability Index score improved (92 vs 85.6, P = .048). In total, for 307 of 319 shoulders (96%), patients were satisfied or very satisfied at final follow-up. Conclusion: The open Bristow-Latarjet procedure yields good and consistent results, with bony fusion of the coracoid in 83%. A position of the coracoid 1 cm or more medial to the rim meant significantly more recurrences. The rate of recurrences decreased and subjective results improved when a horizontal capsular shift was added to the coracoid transfer. © 2012 Journal of Shoulder and Elbow Surgery Board of Trustees.


van Rijn J.,Elisabeth Hospital | Gosens T.,Elisabeth Hospital
Journal of Hand Surgery | Year: 2010

Purpose: The purpose of this study was to evaluate a cemented prosthesis (Avanta SR TMC prosthesis; Avanta Orthopaedics, San Diego, CA) of the basal thumb joint on the outcomes of range of motion, strength, pain, function, and loosening. Methods: Between July 2004 and December 2007, a total of 15 prostheses in 13 patients were implanted, with an average follow-up period of 36 months (range, 21-63 mo). Before and during the follow-up, the following scores were recorded: Kapandji-score (range of opposition), strength (hand dynamometer and pinch meter), pain (sequential occupational dexterity assessment [SODA], and Michigan Hand Outcomes Questionnaire [MHQ]) and function (9-hole peg test, SODA and MHQ). Radiographs taken before and after surgery were reviewed. Results: The measurements of range of opposition and strength did not show any significant postoperative improvement. Pain during activities (SODA) decreased significantly, and the function with both hands (SODA and MHQ) improved significantly after surgery. The review of pre- and postoperative radiographs did not show any signs of implant loosening after surgery. One failure and one nerve injury occurred. Conclusions: In this group of patients, the Avanta SR TMC prosthesis provided statistically significant improvements in function with both hands and in pain during activity, but no significant change in range of motion, strength, or in function of the operated hand used alone. Prosthesis loosening was not detected. Type of study/level of evidence: Therapeutic IV. © 2010 American Society for Surgery of the Hand.

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