News Article | May 11, 2017
"Ik ben blij om met deze nieuwe technologie te kunnen werken en de eenvoud die het brengt bij de behandeling van aritmie," aldus Dr. Tom de Potter, MD, FEHRA, onderdirecteur, Cardiovasculair Center Cardiologie, Elektrofysiologie van het OLV Ziekenhuis in Aalst, België. "Een uniek kenmerk van het Adagio-katheter is het lange, flexibele, cirkelvormige element waardoor pulmonale aderisolatie bij de antrum mogelijk is, en het risico op schade aan de middenrifzenuw en de kans op pulmonale ader stenose verminderd wordt. Dezelfde katheter wordt geplaatst op de achterste wand om tegelijkertijd lineaire dak- en vloerlaesies te creëren voor een volledige box-isolatie." "Ik ben enthousiast over het feit dat ik betrokken ben bij dit proces," zei Lucas V.A. Boersma, MD, PhD, FESC, St. Antonius Ziekenhuis, afdeling Cardiologie, Nieuwegein, Nederland. "Behalve dat de elektrofysioloog een beter instrument krijgt om continue, lineaire laesies te creëren, kan Adagio's technologie ons ook helpen om de duur van de procedure aanzienlijk te verminderen. In de meeste gevallen kan het isoleren van de pulmonale ader gerealiseerd worden in minder dan één minuut en door middel van een enkele applicatie." Dr. James L. Cox, MD, hoogleraar chirurgie en chirurgische directeur van het Center for Heart Rhythm Disorders aan het Bluhm Cardiovascular Institute of Northwestern University in Chicago, voerde 30 jaar geleden de eerste chirurgische "Cox maze"-procedure uit in het Barnes Jewish Hospital in St. Louis. "Een van de belangrijkste redenen voor het klinische succes van de 'maze' chirurgische procedure is de mogelijkheid om continue, lineaire, transmurale ablaties uit te voeren. Ik ben verheugd over de ontwikkeling van endocardiale lineaire ablatiekatheters wat belangrijke instrumenten voor de elektrofysiologen zullen worden zodat betere resultaten geleverd kunnen worden," zei Dr. Cox. Adagio Medical, Inc. is een particulier bedrijf, gevestigd in Laguna Hills, Californië en ontwikkelt innovatieve cryo-ablatietechnologieën die continue, lineaire, transmurale laesies creëren om hartritmestoornissen te behandelen, met inbegrip van paroxysmale en persistente atriumfibrillatie, atriale flutters en ventriculaire tachycardie. Adagio Medical, Incis een portefeuillebedrijf van Fjord Ventures. Stuur voor meer informatie een e-mail naar firstname.lastname@example.org.
Brusselle G.G.,Ghent University |
VanderStichele C.,Ghent University |
Jordens P.,OLV Ziekenhuis |
Deman R.,AZ Groeninge |
And 14 more authors.
Thorax | Year: 2013
Background: Patients with severe asthma are at increased risk of exacerbations and lower respiratory tract infections (LRTI). Severe asthma is heterogeneous, encompassing eosinophilic and non-eosinophilic (mainly neutrophilic) phenotypes. Patients with neutropilic airway diseases may benefit from macrolides. Methods: We performed a randomised double-blind placebo-controlled trial in subjects with exacerbationprone severe asthma. Subjects received low-dose azithromycin (n=55) or placebo (n=54) as add-on treatment to combination therapy of inhaled corticosteroids and long-acting β2 agonists for 6 months. The primary outcome was the rate of severe exacerbations and LRTI requiring treatment with antibiotics during the 26-week treatment phase. Secondary efficacy outcomes included lung function and scores on the Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ). Results: The rate of primary endpoints (PEPs) during 6 months was not significantly different between the two treatment groups: 0.75 PEPs (95% CI 0.55 to 1.01) per subject in the azithromycin group versus 0.81 PEPs (95% CI 0.61 to 1.09) in the placebo group (p=0.682). In a predefined subgroup analysis according to the inflammatory phenotype, azithromycin was associated with a significantly lower PEP rate than placebo in subjects with noneosinophilic severe asthma (blood eosinophilia ≤200/ml): 0.44 PEPs (95% CI 0.25 to 0.78) versus 1.03 PEPs (95% CI 0.72 to 1.48) (p=0.013). Azithromycin significantly improved the AQLQ score but there were no significant between-group differences in the ACQ score or lung function. Azithromycin was well tolerated, but was associated with increased oropharyngeal carriage of macrolide-resistant streptococci. Conclusions Azithromycin did not reduce the rate of severe exacerbations and LRTI in patients with severe asthma. However, the significant reduction in the PEP rate in azithromycin-treated patients with non-eosinophilic severe asthma warrants further study. ClinicalTrials.gov number NCT00760838.
Hermans M.P.,Cliniques Universitaires St Luc |
Brotons C.,EAP Sardenya Biomedical Research Institute |
Elisaf M.,University of Ioannina |
Michel G.,Center Hospitalier Of Luxembourg |
And 2 more authors.
European Journal of Preventive Cardiology | Year: 2013
Background: Micro- and macrovascular complications of type 2 diabetes have an adverse impact on survival, quality of life and healthcare costs. The OPTIMISE (OPtimal Type 2 dIabetes Management Including benchmarking and Standard trEatment) trial comparing physicians' individual performances with a peer group evaluates the hypothesis that benchmarking, using assessments of change in three critical quality indicators of vascular risk: glycated haemoglobin (HbA1c), low-density lipoprotein-cholesterol (LDL-C) and systolic blood pressure (SBP), may improve quality of care in type 2 diabetes in the primary care setting. Design: This was a randomised, controlled study of 3980 patients with type 2 diabetes. Methods: Six European countries participated in the OPTIMISE study (NCT00681850). Quality of care was assessed by the percentage of patients achieving pre-set targets for the three critical quality indicators over 12 months. Physicians were randomly assigned to receive either benchmarked or non-benchmarked feedback. All physicians received feedback on six of their patients' modifiable outcome indicators (HbA1c, fasting glycaemia, total cholesterol, high-density lipoprotein-cholesterol (HDL-C), LDL-C and triglycerides). Physicians in the benchmarking group additionally received information on levels of control achieved for the three critical quality indicators compared with colleagues. Results: At baseline, the percentage of evaluable patients (N=3980) achieving pre-set targets was 51.2% (HbA1c; n=2028/3964); 34.9% (LDL-C; n=1350/3865); 27.3% (systolic blood pressure; n=911/3337). Conclusions: OPTIMISE confirms that target achievement in the primary care setting is suboptimal for all three critical quality indicators. This represents an unmet but modifiable need to revisit the mechanisms and management of improving care in type 2 diabetes. OPTIMISE will help to assess whether benchmarking is a useful clinical tool for improving outcomes in type 2 diabetes. © 2012 The European Society of Cardiology.
PubMed | Grand Hopital de Charleroi, Ghent University, Jules Bordet Institute, University Hospitals Leuven euven and 5 more.
Type: Journal Article | Journal: Critical reviews in oncology/hematology | Year: 2015
Liver metastases in colorectal cancer patients decreases the expected 5 year survival rates by a factor close to nine. It is generally accepted that resection of liver metastases should be attempted whenever feasible. This manuscript addresses the optimal therapeutic plan regarding timing of resection of synchronous liver metastases and the use of chemotherapy in combination with resection of synchronous metachronous liver metastases. The aim is to pool all published results in order to attribute a level of evidence to outcomes and identify lacking evidence areas. A systematic search of guidelines, reviews, randomised controlled, observational studies and updating a meta-analysis was performed. Data were extracted and analysed. Data failed to demonstrate an effect of timing of surgery or use of chemotherapy on overall survival. Concomitant resection of liver metastases and the primary tumour may result in lower postoperative morbidity. Systemic peri-operative chemotherapy may improve progression free survival compared to surgery alone.
Nickenig G.,University of Bonn |
Estevez-Loureiro R.,Royal Brompton Hospital |
Franzen O.,Rigshospitalet |
Tamburino C.,Ferrarotto Hospital |
And 34 more authors.
Journal of the American College of Cardiology | Year: 2014
Background The use of transcatheter mitral valve repair (TMVR) has gained widespread acceptance in Europe, but data on immediate success, safety, and long-term echocardiographic follow-up in real-world patients are still limited. Objectives The aim of this multinational registry is to present a real-world overview of TMVR use in Europe. Methods The Transcatheter Valve Treatment Sentinel Pilot Registry is a prospective, independent, consecutive collection of individual patient data. Results A total of 628 patients (mean age 74.2 ± 9.7 years, 63.1% men) underwent TMVR between January 2011 and December 2012 in 25 centers in 8 European countries. The prevalent pathogenesis was functional mitral regurgitation (FMR) (n = 452 [72.0%]). The majority of patients (85.5%) were highly symptomatic (New York Heart Association functional class III or higher), with a high logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (20.4 ± 16.7%). Acute procedural success was high (95.4%) and similar in FMR and degenerative mitral regurgitation (p = 0.662). One clip was implanted in 61.4% of patients. In-hospital mortality was low (2.9%), without significant differences between groups. The estimated 1-year mortality was 15.3%, which was similar for FMR and degenerative mitral regurgitation. The estimated 1-year rate of rehospitalization because of heart failure was 22.8%, significantly higher in the FMR group (25.8% vs. 12.0%, p[log-rank] = 0.009). Paired echocardiographic data from the 1-year follow-up, available for 368 consecutive patients in 15 centers, showed a persistent reduction in the degree of mitral regurgitation at 1 year (6.0% of patients with severe mitral regurgitation). Conclusions This independent, contemporary registry shows that TMVR is associated with high immediate success, low complication rates, and sustained 1-year reduction of the severity of mitral regurgitation and improvement of clinical symptoms. © 2014 by the American College of Cardiology Foundation.
Final results of a phase IIa, randomised, open-label trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: The SEISMIC trial
Duckers H.J.,Erasmus Medical Center |
Houtgraaf J.,Erasmus Medical Center |
Hehrlein C.,Albert Ludwigs University of Freiburg |
Schofer J.,Universitares Herzzentrum Hamburg |
And 11 more authors.
EuroIntervention | Year: 2011
Aims: The SEISMIC study was an open-label, prospective, randomised study to assess the safety and feasibility of percutaneous myoblast implantation in heart failure patients with implanted cardioverter-defibrillators (ICD). Methods and results: Patients were randomised 2:1 to autologous skeletal myoblast therapy vs. optimal medical treatment. The primary safety end-point was defined as the incidence of procedural and device related serious adverse events, whereas the efficacy endpoints were defined as the change in global LVEF by MUGA scan, change in NYHA classification of heart failure and in the distance achieved during a six-minute walk test (6MW) at 6-month follow-up. Forty subjects were randomised to the treatment arm (n=26), or to the control arm (n=14). There were 12 sustained arrhythmic events and one death after episodes of ventricular tachycardia (VT) in the treatment group and 14 events in the control group (P=ns). At 6-month follow-up, 6MW distance improved by 60.3±54.1 meters in the treated group as compared to no improvement in the control group (0.4±185.7 meters; P=ns). In the control group, 28.6% experienced worsening of heart failure status (4/14), while 14.3% experienced an improvement in NYHA classification (2/14). In the myoblast-treatment arm, one patient experienced a deterioration in NYHA classification (8.0%), whereas five patients improved one or two classes (20.0%; P=0.06). However, therapy did not improve global LVEF measured by MUGA at 6-month follow-up. Conclusions: These data indicate that implantation of myoblasts in patients with HF is feasible, appears to be safe and may provide symptomatic relief, though no significant effect was detected on global LVEF. © Europa Edition 2011. All rights reserved.
Bosmans J.M.,University of Antwerp |
Kefer J.,UCLouvain |
De Bruyne B.,OLV Ziekenhuis |
Herijgers P.,University Hospital Leuven |
And 4 more authors.
Interactive Cardiovascular and Thoracic Surgery | Year: 2011
We report clinical outcomes following transcatheter aortic valve implantation (TAVI), using the CoreValve revalving system (18 Fr transfemoral or subclavian) or the Edwards Sapien valve (22 Fr transfemoral or 24 Fr transapical) as part of a Belgian prospective nonrandomized multicentre registry. All 15 Belgian centres performing TAVI participated to this registry (seven exclusively Edwards Sapien, eight exclusively CoreValve). All consecutive high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVI. Three hundred and twenty-eight patients underwent TAVI with CoreValve (n=141; eight subclavian and 133 transfemoral) or Edwards Sapien (n=187; 99 transfemoral and 88 transapical) up to April 2010. Procedural success was 97%. Onemonth survival was 88% for the Edwards and 89% for the CoreValve treated patients. One-month mortality was both related to cardiac and non-cardiac reasons. Overall one-year survival was 78% in the CoreValve transfemoral treated patients, 100% in the CoreValve subclavian treated patients, 82% in the Edwards transfemoral treated patients and 63% in the Edwards transapical treated patients. This mid-term mortality was mainly related to age-related, non-cardiac complications. © 2011 Published by European Association for Cardio-Thoracic Surgery. All rights reserved.
Hermans M.P.,Cliniques Universitaires St Luc |
Elisaf M.,University of Ioannina |
Michel G.,Center Hospitalier Of Luxembourg |
Muls E.,UZ Gasthuisberg |
And 3 more authors.
Diabetes Care | Year: 2013
OBJECTIVE-To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. RESEARCH DESIGN ANDMETHODSdPrimary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. RESULTS-Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). CONCLUSIONS-In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile. © 2013 by the American Diabetes Association.
PubMed | University of Coimbra, Heart Hospital, University of Zürich, AZ Delta Roeselare and 18 more.
Type: | Journal: International journal of cardiology | Year: 2016
Left atrial appendage occlusion (LAAO) using the Amplatzer cardiac plug (ACP) is a preventive treatment of atrial fibrillation related thromboembolism.To assess the safety and efficacy of LAAO in patients with chronic kidney disease (CKD).Among the ACP multicentre registry, 1014 patients (758yrs) with available renal function were included.Patients with CKD (N=375, CHA2DS2-VASc: 4.91.5, HASBLED: 3.41.3) were at higher risk than patients without CKD (N=639, CHA2DS2-VASc: 4.21.6, HASBLED: 2.91.2; p<0.001 for both). Procedural (97%) and occlusion (99%) success were similarly high in all stages of CKD. Peri-procedural major adverse events (MAE) were observed in 5.1% of patients, 0.8% of death, with no difference between patients with and those without CKD (6.1 vs 4.5%, p=0.47). In patients with complete follow-up (1319 patients years), the annual stroke+transient ischaemic attack (TIA) rate was 2.3% and the observed bleeding rate was 2.1% (62 and 60% less than expected, similarly among patients with and those without CKD). Kaplan-Meier analysis showed a lower overall survival (84 vs 96% and 84 vs 93% at 1 and 2yrs. respectively; p<0.001) among patients with an eGFR <30ml/min/1.73m(2).LAAO using the ACP has a similar procedural safety among CKD patients compared to patients with normal renal function. LAAO with ACP offers a dramatic reduction of stroke+TIA rate and of bleeding rate persistent in all stages of CKD, as compared to the expected annual risk.
PubMed | Unit of Urology, OLV Ziekenhuis, University of Bologna and URI Integrated Regional University Brazil
Type: | Journal: Urologic oncology | Year: 2016
To test the prognostic role of treatment delay in patients affected by prostate cancer (PCa).The study included 2,653 patients treated with radical prostatectomy (RP) at a single institution between 2006 and 2011. The evaluated outcomes were biochemical recurrence (BCR) and clinical recurrence (CR). Multivariable Cox regression analysis was used to test the association between time from diagnosis to RP and oncological outcomes. Nonparametric curve fitting methods were used to graphically explore the relationship between time from diagnosis to RP and oncological outcomes. Sensitivity analyses were repeated in the subgroups of low-, intermediate-, and high-risk patients.At median follow-up of 56 months (interquartile range: 26, 92), 283 patients experienced BCR, and 84 patients developed CR. Median time from PCa diagnosis to surgery was 2.8 months (interquartile range: 1.6, 4.7). At multivariable Cox regression analysis, time from biopsy to RP was significantly associated with an increased risk of BCR (hazard ratio = 1.02, P = 0.0005) and CR (hazard ratio = 1.03, P = 0.0002). Using Nonparametric curve fitting methods, a significant increased risk of BCR and CR after approximately 18 months was observed. However, when sensitivity analyses were repeated according to risk groups, this effect was maintained in high-risk patients only, and such time interval was reduced to 12 months.Despite the overall trend on higher rate of cancer relapse after RP, the effect of treatment delay from biopsy to RP was significantly evident in high-risk patients only. Even in high-risk patients surgical treatment can be postponed safely, but not beyond the 12-month landmark.