Imelda Hospital

Bonheiden, Belgium

Imelda Hospital

Bonheiden, Belgium
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Zeller T.,Universitats Herzzentrum Freiburg Bad Krozingen | Beschorner U.,coreLab Bad Krozingen GmbH | Pilger E.,Medical University of Graz | Bosiers M.,A.Z. Sint Blasius | And 6 more authors.
JACC: Cardiovascular Interventions | Year: 2015

Objectives The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia. Background DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce. Methods In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory. Results The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively. Conclusions The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA. © 2015 American College of Cardiology Foundation.

Zeller T.,Universitats Herzzentrum Freiburg Bad Krozingen | Baumgartner I.,University of Bern | Scheinert D.,Park Hospital Leipzig | Brodmann M.,Medical University of Graz | And 8 more authors.
Journal of the American College of Cardiology | Year: 2014

Background Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.Objectives The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI).Methods Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR.Results Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080).Conclusions In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733). © 2014 by the American College of Cardiology Foundation.

Bergs J.,Hasselt University | Hellings J.,Hasselt University | Cleemput I.,Hasselt University | Zurel O.,Hasselt University | And 6 more authors.
British Journal of Surgery | Year: 2014

Background: The World Health Organization (WHO) surgical safety checklist (SSC) was introduced to improve the safety of surgical procedures. This systematic review evaluated current evidence regarding the effectiveness of this checklist in reducing postoperative complications. Methods: The Cochrane Library, MEDLINE, Embase and CINAHL were searched using predefined inclusion criteria. The systematic review included all original articles reporting a quantitative measure of the effect of the WHO SSC on postoperative complications. Data were extracted for postoperative complications reported in at least two studies. A meta-analysis was conducted to quantify the effect of the WHO SSC on any complication, surgical-site infection (SSI) and mortality. Yule's Q contingency coefficient was used as a measure of the association between effectiveness and adherence with the checklist. Results: Seven of 723 studies identified met the inclusion criteria. There was marked methodological heterogeneity among studies. The impact on six clinical outcomes was reported in at least two studies. A meta-analysis was performed for three main outcomes (any complication, mortality and SSI). Risk ratios for any complication, mortality and SSI were 0·59 (95 per cent confidence interval 0·47 to 0·74), 0·77 (0·60 to 0·98) and 0·57 (0·41 to 0·79) respectively. There was a strong correlation between a significant decrease in postoperative complications and adherence to aspects of care embedded in the checklist (Q = 0·82; P = 0·042). Conclusion: The evidence is highly suggestive of a reduction in postoperative complications and mortality following implementation of the WHO SSC, but cannot be regarded as definitive in the absence of higher-quality studies. Saves lives © 2014 BJS Society Ltd.

Bosiers M.,AZ Saint Blasius | Diaz-Cartelle J.,Boston Scientific Corporation | Scheinert D.,Park Hospital | Peeters P.,Imelda Hospital | Dawkins K.D.,Boston Scientific Corporation
Journal of Endovascular Therapy | Year: 2014

Purpose: To report outcomes of a multicenter, nonrandomized study evaluating the safety and effectiveness of a guidewire-mounted mechanical recanalization device with a rotating distal tip (TruePath) in facilitating the crossing of infrainguinal chronic total occlusions (CTOs). Methods: Eligible patients had lower extremity ischemia and an angiographically confirmed occlusion, with no antegrade flow for at least 30 days, in an infrainguinal artery. Enrollment occurred when a previous or concurrent attempt to cross the CTO with a conventional guidewire had failed. A total of 85 patients with 85 lesions were enrolled; 61 (71.8%) target lesions were in the superficial femoral artery and 68 (80%) were considered moderately or heavily calcified. Clinical evaluations were assessed immediately post procedure and at 30- day follow-up. Results: Freedom from clinical perforation at the time of the procedure was achieved in 98.8% of patients. The device facilitated CTO crossing into the distal true lumen (technical success) in 68 (80.0% ) patients, with subsequent distal guidewire positioning in 65 (76.5%). The average ABI (n=58) improved from 0.65 (range 0.35-1.20) at baseline to 1.00 (range 0.50-2.00) through 30-day follow-up. Symptoms improved in 70 (82.4%) patients upon treatment, and improvement was maintained in 57/70 (81.4%) through 30 days. Conclusion: The ReOpen Study demonstrated that the TruePath device is safe and effective for facilitating crossing of CTOs resistant to conventional guidewire maneuvers. © 2014 by the International Society of Endovascular Specialists.

Bosiers M.,AZ St Blasius | Peeters P.,Imelda Hospital | Tessarek J.,St Bonifatius Hospital | Deloose K.,AZ St Blasius | Strickler S.,MED Institute Inc.
Journal of Cardiovascular Surgery | Year: 2013

Aim. The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup. Methods. The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymerfree paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D. Results. The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%. Conclusion. The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.

Dendale P.,Hasselt University | Dendale P.,Jessa Hospital | De Keulenaer G.,Middelheim Hospital | Troisfontaines P.,CHU Citadelle | And 8 more authors.
European Journal of Heart Failure | Year: 2012

Aims: Chronic heart failure (CHF) patients are frequently rehospitalized within 6 months after an episode of fluid retention. Rehospitalizations are preventable, but this requires an extensive organization of the healthcare system. In this study, we tested whether intensive follow-up of patients through a telemonitoring-facilitated collaboration between general practitioners (GPs) and a heart failure clinic could reduce mortality and rehospitalization rate. Methods and results: One hunderd and sixty CHF patients [mean age 76 ± 10 years, 104 males, mean left ventricular ejection fraction (LVEF) 35 ± 15%] were block randomized by sealed envelopes and assigned to 6 months of intense follow-up facilitated by telemonitoring (TM) or usual care (UC). The TM group measured body weight, blood pressure, and heart rate on a daily basis with electronic devices that transferred the data automatically to an online database. Email alerts were sent to the GP and heart failure clinic to intervene when pre-defined limits were exceeded. All-cause mortality was significantly lower in the TM group as compared with the UC group (5% vs. 17.5%, P = 0.01). The total number of follow-up days lost to hospitalization, dialysis, or death was significantly lower in the TM group as compared with the UC group (13 vs. 30 days, P = 0.02). The number of hospitalizations for heart failure per patient showed a trend (0.24 vs. 0.42 hospitalizations/patient, P = 0.06) in favour of TM. Conclusion: Telemonitoring-facilitated collaboration between GPs and a heart failure clinic reduces mortality and number of days lost to hospitalization, death, or dialysis in CHF patients. © The Author 2012.

Bosiers M.,AZ Sint Blasius | Scheinert D.,Park Hospital | Peeters P.,Imelda Hospital | Torsello G.,St Franziskus Hospital | And 6 more authors.
Journal of Vascular Surgery | Year: 2012

Objective: Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision). Methods: A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of <50% restenosis based on quantitative analysis of contrast angiography. Results: Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P =.0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P <.0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P =.001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P =.68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P =.001). Conclusions: Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents. © 2012 Society for Vascular Surgery.

Bosiers M.,Algemeen Ziekenhuis Sint Blasius | Deloose K.,Algemeen Ziekenhuis Sint Blasius | Callaert J.,Algemeen Ziekenhuis Sint Blasius | Moreels N.,Algemeen Ziekenhuis Sint Blasius | And 3 more authors.
Journal of Vascular Surgery | Year: 2011

Objectives: This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length. Methods: Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging. Results: Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year. Conclusions: The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions. © 2011 Society for Vascular Surgery.

Baekelandt J.,Imelda Hospital
Journal of Minimally Invasive Gynecology | Year: 2015

The aim of this study was to demonstrate the feasibility of a total hysterectomy performed entirely by transvaginal natural orifice transluminal endoscopic surgery (vNOTES). Conventional, reusable laparoscopic instruments were used, inserted through an inexpensive, self-constructed single-port device. Ten total vaginal NOTES hysterectomies (TVNHs) were performed by a single surgeon. The self-constructed single-port device was made by assembling a surgical glove, a wound protector or modified laryngeal mask airway, 1 reusable 10-mm trocar, and 4 reusable 5-mm trocars. This gloveport was inserted into the vagina to create a pneumovagina. The conventional steps of a vaginal hysterectomy were followed, but performed endoscopically with standard reusable endoscopic instruments. The patient and perioperative data were analyzed. No conversion to standard laparoscopy or laparotomy was necessary in any of the 10 patients who underwent a TVNH. Mean operation time was 97 min (range: 60-120); mean drop in hemoglobin level was 1.5 g/dL (range: 0.5-2.4). There were no operative complications, and postoperative pain scores were very low. This first report on a small number of patients demonstrates that TVNH is possible. By incorporating the advantages of endoscopic surgery, TVNH broadens the indications for vaginal hysterectomy and helps overcome its limitations. At the same time, the NOTES approach avoids abdominal wall wounds and trocar-related complications. TVNH is feasible, even when performed with reusable, conventional laparoscopic instruments. This frugally innovative technique also enables surgeons to perform hysterectomies by vNOTES in low resource settings. © 2015 AAGL.

Tollens T.,Imelda Hospital
Surgical technology international | Year: 2012

The ideal mesh suited for intraperitoneal placement should address both requirements of tissue separation on the visceral surface and tissue integration on the parietal surface. Meshes with bioresorbable coatings have recently been demonstrated to be successful. In this article, the results are shown of a study with a new type of tissue-separating lightweight mesh with a bioresorbable coating (Physiomesh; Ethicon, Somerville, NJ) in laparoscopic ventral hernia repair. In this single-center retrospective analysis, 88 patients (50 men, 38 women) undergoing hernia surgery between November 16, 2010 and August 10, 2012 at the Imelda Hospital Bonheiden were included. Patients were asked to score their pre- and postoperative pain (1 month after surgery) on a visual analogue scale (VAS), as well as the chronic postoperative pain (pain at more than 6 months after surgery). The time period after which patients were pain free and after which they could return to work was also noted. Our results demonstrate that Physiomesh is a good alternative to the existing meshes leading to significant pain reduction, early return to work, acceptable complications, and low recurrence and reintervention rates.

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