Lukaskrankenhaus GmbH

Neuß, Germany

Lukaskrankenhaus GmbH

Neuß, Germany
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Petronio A.S.,University of Pisa | Capranzano P.,University of Catania | Barbato E.,OLV Hospital | Barbato E.,University of Naples Federico II | And 4 more authors.
EuroIntervention | Year: 2017

Aims: The European Association of Percutaneous Coronary Interventions (EAPCI) assessed the current status of transcatheter valve therapy in Europe through a web-based survey. Our aim here was to report the results of that survey regarding trends in percutaneous mitral valve repair (PMVR) therapy. Methods and results: Among 301 European centres participating in the overall EAPCI survey, 246 (81.7%) responded to the PMVR section questions. A total of 176 (71.5%) have been undertaking a PMVR programme. Among responding centres (n=129), 58.1%, 15.5% and 26.4% performed ≤10, >10-40 and >40 PMVR procedures, respectively, in 2014. The majority of centres performing >40 PMVR procedures in 2014 were in Germany (82.4%). MitraClip was the most commonly performed technique (used in 91.8% of centres) followed by the valve-in-ring or valve-in-valve for failed surgical prostheses using transcatheter aortic valve devices (41.5%). Of those centres not performing PMVR (n=70), 41.4% were not considering initiating a programme, mostly for economic reasons (69.0%), or because of limited data available (20.7%) or no interest (10.3%). Conclusions: The second part of this EAPCI survey documents the limited PMVR penetration in Europe, despite an increasing interest. Possible reasons for this include economic, regulatory and logistic issues, challenging techniques, along with a lack of compelling studies and clear indications. © Europa Digital & Publishing 2017. All rights reserved.

Haude M.,Lukaskrankenhaus GmbH | Erbel R.,West German Heart Center Essen | Erne P.,Luzerner Kantonsspital | Verheye S.,ZNA Middelheim | And 8 more authors.
The Lancet | Year: 2013

Background Bioabsorbable vascular scaffolds were developed to overcome limitations of permanent bare-metal or drug-eluting coronary stents-ie, stent thrombosis (despite prolonged dual antiplatelet therapy), the life-long presence of a caged vessel segment that does not allow vasomotion or remodelling, and chronic vessel wall inflammation. We assessed the safety and performance of a new magnesium-based paclitaxel-eluting absorbable metal scaffold in symptomatic patients with de-novo coronary lesions. Methods We did a prospective, multicentre, first-in-man trial (BIOSOLVE-1) of the drug-eluting absorbable metal scaffold (DREAMS). 46 patients with 47 lesions were enrolled at five European centres. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularisation, at 6 and 12 months. Clinical follow-up was scheduled at 1, 6, 12, 24, and 36 months. Patients were consecutively assigned to angiographic and intravascular ultrasonographic follow-up at 6 months or 12 months. Optical coherence tomography was done in some patients. All patients were recommended to take dual antiplatelet therapy for at least 12 months. This trial is registered with, number NCT01168830. Findings Overall device and procedural success was 100%. Two of 46 (4%) patients had target lesion failure at 6 months (both clinically driven target lesion revascularisations), which rose to three of 43 (7%) at 12 months (one periprocedural target vessel myocardial infarction occurred during angiography at the 12 month follow-up visit). We noted no cardiac death or scaffold thrombosis. Interpretation Our results show feasibility, a good safety profile, and promising clinical and angiographic performance results up to 12 months for DREAMS. Our promising clinical results show that absorbable metal scaffolds might be an alternative to polymeric absorbable scaffolds. Funding Biotronik.

Haude M.,Lukaskrankenhaus GmbH | Ince H.,Vivantes Klinikum im Friedrichshain and Am Urban | Abizaid A.,Dante Pazzanese Institute of Cardiology | Toelg R.,Herzzentrum Segeberger Kliniken GmbH | And 11 more authors.
The Lancet | Year: 2016

Background Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. Methods We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with, number NCT01960504. Findings Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm2 [SD 1·15] post-procedure vs 6·21 mm2 [1·22] at 6 months) with a low mean neointimal area (0·08 mm2 [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. Interpretation Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. Funding Biotronik AG. © 2016 Elsevier Ltd.

Windecker S.,University of Bern | Haude M.,Lukaskrankenhaus GmbH | Neumann F.-J.,Universitats Herzzentrum Freiburg Bad Krozingen | Stangl K.,Charite Campus Mitte | And 16 more authors.
Circulation: Cardiovascular Interventions | Year: 2015

Background-Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. Methods and Results-A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm2 versus X-EES, 0.43±0.56 mm2; P=0.04). Conclusions-Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. © 2015 American Heart Association, Inc.

Waksman R.,MedStar Washington Hospital Center | Prati F.,CLI Foundation | Bruining N.,Erasmus University Rotterdam | Haude M.,Lukaskrankenhaus GmbH | And 9 more authors.
Circulation: Cardiovascular Interventions | Year: 2013

Background-The drug-eluting absorbable metal scaffold has demonstrated feasibility, safety, and promising clinical and angiographic outcomes at 12 months in human coronary arteries. This study aimed to evaluate the degradation rate and long-term vascular responses to drug-eluting absorbable metal scaffold. Methods and Results-BIOSOLVE-I was a multicenter, single-arm, first-in-man trial assessing the safety and performance of drug-eluting absorbable metal scaffold in 46 patients with coronary artery disease. Patients who underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography, at 6 and 12 months were included in this study. From postimplantation to follow-up, arterial curvature and angulation were significantly increased by the degradation process. The greatest increase was seen from postimplantation to 6 months. The systolic-diastolic changes of the curvature and angulation gradually improved throughout the follow-up period. At the site of implantation, vasoconstriction (-10% mean reduction) was observed during the acetylcholine test at 6 months. The average percent hyperechogenicity of the scaffolded segments showed a continuous decrease over time, with the most pronounced changes within the first 6 months (from 22.1±7.0% to 15.8±3.7%; P<0.001). Struts discernible on optical coherence tomography at 6 and 12 months showed full neointimal coverage, with stabilization of the mean scaffold area from 6 to 12 months. Furthermore, the mean neointimal area (1.55±0.51 versus 1.58±0.34 mm2; P=0.794) remained unchanged from 6 to 12 months. Conclusions-This serial analysis of drug-eluting absorbable metal scaffold confirmed the safety and efficacy of this new device, with vasomotion restoration and continued degradation over time demonstrated by multi-invasive imaging modalities. © 2013 American Heart Association, Inc.

Kleinbongard P.,University of Duisburg - Essen | Bose D.,Universitatsklinikum | Baars T.,Universitatsklinikum | Mohlenkamp S.,Universitatsklinikum | And 10 more authors.
Circulation Research | Year: 2011

Rationale: Stent implantation into atherosclerotic plaques releases, apart from particulate debris, soluble substances that contribute to impaired microvascular perfusion. Objective: To quantify the release of vasoconstrictors and to determine the efficacy of coronary dilators to attenuate their action. Methods and Results: Using a distal protection/aspiration device, coronary arterial blood was retrieved before and during stenting in 22 patients with severe saphenous vein aorto-coronary bypass stenoses. The release of catecholamines, endothelin, serotonin, thromboxane B2, and tumor necrosis factor (TNF)α was measured. The response of rat mesenteric arteries with intact (+E) and denuded (-E) endothelium to aspirate plasma was normalized to that by KCl. Responses to selective receptor blockade, adenosine, nitroprusside, and verapamil against the aspirate-induced constriction were determined. The coronary arterial plasma withdrawn before stenting induced 21±5% and the aspirate plasma after stenting induced 95±8% of maximum KCl-induced vasoconstriction. Serotonin, thromboxane B2, and TNFα release into aspirate plasma increased by 1.9±0.2 μmol/L, 25.6±3.1 pg/mL, and 19.7±6.1 pg/mL, respectively, during stenting. The aspirate-induced vasoconstriction was largely antagonized by selective serotonin receptor blockade, with little further antagonism by additional thromboxane receptor blockade. TNFα did not induce constriction per se but potentiated the constriction with serotonin and the thromboxane-analog U-46619 in arteries +E. The concentrations to induce half-maximal vasodilation were comparable for nitroprusside (+E, 3.3×10-8; -E, 1.9×10-8 mol/L) and verapamil (+E, 8.3×10-8; -E, 7.8×10 -8 mol/L), and the vasoconstriction was eventually eliminated. The vasodilator response to adenosine was dependent on functional endothelium and weaker. Conclusion: Serotonin is the main coronary vasoconstrictor after stenting, and thromboxane and TNFα somewhat potentiate the serotonin response. Nitroprusside and verapamil are more potent than adenosine to attenuate the aspirate plasma-induced vasoconstriction, and they are not dependent on functional endothelium. Copyright © 2011 American Heart Association. All rights reserved.

Petronio A.S.,University of Pisa | Capranzano P.,University of Catania | Barbato E.,OLV Hospital | Barbato E.,University of Naples Federico II | And 4 more authors.
EuroIntervention | Year: 2016

Aims: Our aim was to identify current discrepancies among European countries, and provide a basis for a general agreement on decision making specifically related to TAVI procedures. The European Association of Percutaneous Coronary Interventions (EAPCI) therefore assessed the current status of transcatheter valve therapy (TAVI) in Europe through a web-based survey. Methods and results: Three hundred and one European centres responded to the survey (61.4% of the invited centres). Fewer than 200 TAVI procedures per site had been performed up to the date of response in 47% of centres, while over 500 procedures had been performed in 21% of centres. The Heart Team consisted mostly of interventional cardiologists and cardiac surgeons. In 79% of the centres, specific TAVI protocols are in place. Of note, 45% of centres perform TAVI in intermediate-risk patients, while only 10% do so in low-risk patients. Valve selection was based principally on patient-specific variables (74%), followed by operators' skills (55%), rates of valve-related complications (31%), and device cost (30%). Multislice computed tomography is the imaging modality most frequently performed prior to TAVI. Coronary revascularisation is usually performed before TAVI (86%), while no uniformity was observed in terms of antithrombotic therapy. Conclusions: The EAPCI survey documents the current TAVI practice and penetration in Europe. Despite economic and regulatory difficulties, the procedure is increasingly performed and mostly according to specific protocols. The heterogeneity of the approach apparent in the survey suggests a call for an update in practice recommendations. © 2016 Europa Digital & Publishing. All rights reserved.

Valgimigli M.,Erasmus Medical Center | Costa F.,Erasmus Medical Center | Byrne R.,TU Munich | Haude M.,Lukaskrankenhaus GmbH | And 2 more authors.
EuroIntervention | Year: 2015

Aims: Our aim was to report on a survey initiated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) concerning opinion on the evidence relating to dual antiplatelet therapy (DAPT) duration after coronary stenting. Methods and results: Results from three randomised clinical trials were scheduled to be presented at the American Heart Association Scientific Sessions 2014 (AHA 2014). A web-based survey was distributed to all individuals registered in the EuroIntervention mailing list (n=15,200) both before and after AHA 2014. A total of 1,134 physicians responded to the first (i.e., before AHA 2014) and 542 to the second (i.e., after AHA 2014) survey. The majority of respondents interpreted trial results consistent with a substantial equipoise regarding the benefits and risks of an extended versus a standard DAPT strategy. Two respondents out of ten believed extended DAPT should be implemented in selected patients. After AHA 2014, 46.1% of participants expressed uncertainty about the available evidence on DAPT duration, and 40.0% the need for clinical guidance. Conclusions: This EAPCI survey highlights considerable uncertainty within the medical community with regard to the optimal duration of DAPT after coronary stenting in the light of recent reported trial results. Updated recommendations for practising physicians to guide treatment decisions in routine clinical practice should be provided by international societies. © Europa Digital & Publishing 2015. All rights reserved.

Laufenberg M.,Ev. Krankenhaus Bethesda | Schneider T.,Lukaskrankenhaus GmbH
Medizinische Klinik - Intensivmedizin und Notfallmedizin | Year: 2016

A 58-year male patient was admitted to the intensive care unit of our hospital due to an exacerbated COPD (GOLD IV) complicated by a pneumonia. The clinical course deteriorated despite of evidence based intensive care treatment and lungprotective ventilation, a vv-ECMO and a volatile sedation were established. After a few days vv-ECMO could be discontinued and the patient was discharged from hospital after 20 days. Our case report suggests that early support with vv-ECMO could reduce the cumulative duration of invasive ventilation in case of severe COPD exacerbation. The combination with volatile sedatives make it possible to guide the patient to spontaneous breathing with only a short weaning periode. © 2016 Springer-Verlag Berlin Heidelberg

Melin M.,Lukaskrankenhaus GmbH | Schwarz K.,Lukaskrankenhaus GmbH | Lammers B.J.,Lukaskrankenhaus GmbH | Goretzki P.E.,Lukaskrankenhaus GmbH
Langenbeck's Archives of Surgery | Year: 2013

Purpose: Intraoperative neuromonitoring (IONM) in thyroid surgery allows for changing the operative strategy during bilateral procedures to avoid bilateral recurrent laryngeal nerve palsy (RLNP). While this strategy is comprehendible for the surgeon, the question remains, whether it is always necessary. Methods: Two thousand five hundred forty-six patients underwent surgery with IONM between January 2008 and October 2010 (4,012 nerves at risk). We performed a retrospective review of all patients after thyroid surgery. In 98 cases, signal loss occurred on the primary side. Of these patients, 64 required bilateral surgery. We proceeded with the contralateral surgery in 24 cases. Forty operations were ended unilaterally. The second operation was performed on 18 patients in total, 16 after confirmation of primarily intact (n = 8) or recovered vocal cord function (n = 8) and twice under persisting dysfunction. Patient satisfaction was evaluated using a five-point scale. Results: We have shown a significant difference (p = 0.017) in the rate of bilateral RLNP when signal loss on the primary side resulted in termination of the procedure compared to continuation. Our evaluation of patient satisfaction did not show a significant difference when comparing the two-stage operation to other procedures. Conclusions: We have shown a significant difference in the rate of bilateral RLNP when comparing termination and continuation of a bilateral procedure after primary IONM signal loss. We strongly recommend a two-stage thyroidectomy after signal loss on the primary side of resection in benign bilateral goiter surgery. © 2012 Springer-Verlag Berlin Heidelberg.

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