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PubMed | University of Würzburg, SRH Wald Klinikum Gera and University of Innsbruck
Type: Journal Article | Journal: The Laryngoscope | Year: 2016

To evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP).Feasibility, first-in-human, single-arm, open-label, prospective, multicenter study with a group sequential design and a 6-month follow-up period.Nine symptomatic BVFP subjects were implanted unilaterally with the LP System. Pre- and 6-month postimplantation evaluations consisted of the 6-Minute Walk Test (6MWT), the Peak Expiratory and Inspiratory Flow (PEF and PIF) evaluation, the PEF meter analysis, the 36-Item Short Form Health Survey (SF-36), the Glasgow Benefit Inventory (GBI), the 12-Item Voice Handicap Index (VHI-12), and the Fiberoptic Endoscopic Evaluation of Swallowing. The safety profile of the LP System was continuously monitored.The LP System implantation was achieved in 8/9 cases. Seven of the nine subjects completed the study. Absolute PEF and PIF values improved significantly 6 months postimplantation (P < .05). 6MWT results showed a non-statistically significant improvement (P = .09). The mental component of the SF-36 showed a significant improvement (P = .043), whereas the other SF-36 components, the GBI, and the VHI-12 results did not changed significantly. The LP System did not affect the voice and swallowing quality and maintained a reliable safety profile for the duration of the study.This feasibility study showed that the LP System has the potential to become an effective and safe treatment for BVFP subjects without compromising the patients voice.2b Laryngoscope, 126:1810-1816, 2016.


PubMed | SRH Wald Klinikum Gera and Jena University Hospital
Type: Journal Article | Journal: European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery | Year: 2016

Unlike laryngoscopy, laryngeal sonography is easily applicable, well tolerated by young children and less exhausting for the examiner. The aim of this study was to determine if sonography can adequately visualize the laryngeal structures and vocal fold movements of children. Synchronic video laryngoscopy and sonography of the larynx were performed in 35 children (aged 2-8 years) without a laryngeal disease. 10 investigators at differing stages of otolaryngological training were tasked with identifying vocal fold movement and specific anatomical structures after seeing (1) the sonography-only video and (2) the sonography video with a laryngoscopy video overlay. The percentage of correct identification of the structures and the vocal cord movement with and without additional video-overlay was compared. A sonographical view of the larynx could be found and the following anatomical structures were identified: subcutaneous fat tissue, left and right sternohyoid and thyrohyoid muscles, thyroid cartilage, left and right vocal folds, left and right paraglottic spaces, left and right side arytenoid cartilages, and rima glottides. Concerning the evaluation of the videos amongst the investigators: they identified >80 % of vocal fold movement and the targeted anatomical structures except the arytenoid cartilages (only up to 63 %), having the sonography only. In combination with the laryngoscopy video-overlay, investigator detection rates significantly improved (>90 % of vocal fold movement, p < 0.001; >90 % in most anatomical structures, (p < 0,001). Laryngeal sonography is a helpful diagnostic tool to identify laryngeal structures and the movement of the vocal folds in children.


Winkler M.,University of Ulm | Skopp G.,University of Heidelberg | Alt A.,University of Ulm | Miltner E.,University of Ulm | And 6 more authors.
International Journal of Legal Medicine | Year: 2013

The importance of direct and indirect alcohol markers to evaluate alcohol consumption in clinical and forensic settings is increasingly recognized. While some markers are used to prove abstinence from ethanol, other markers are suitable for detection of alcohol misuse. Phosphatidyl ethanol (PEth) is ranked among the latter. There is only little information about the correlation between PEth and other currently used markers (ethyl glucuronide, ethyl sulfate, carbohydrate deficient transferrin, gamma-glutamyl transpeptidase, and methanol) and about their decline during detoxification. To get more information, 18 alcohol-dependent patients in withdrawal therapy were monitored for these parameters in blood and urine for up to 19 days. There was no correlation between the different markers. PEth showed a rapid decrease at the beginning of the intervention, a slow decline after the first few days, and could still be detected after 19 days of abstinence from ethanol. © 2012 Springer-Verlag Berlin Heidelberg.


PubMed | Katharinenhospital Stuttgart, University of Würzburg, University of Cologne, University of Marburg and 5 more.
Type: Journal Article | Journal: The Laryngoscope | Year: 2016

Bilateral vocal fold paralysis (BVFP) is a rare but life-threatening condition mostly caused by iatrogenic damage to the peripheral recurrent laryngeal nerve. Endoscopic enlargement techniques have been the standard treatment for decades. However, prospective studies using internationally accepted phoniatric and respiratory evaluation guidelines are rare.Prospective observational multicenter study.Twelve clinical centers screened 61 patients, of whom 36 were eligible according to the study protocol. Subjects were assessed with specific phoniatric and respiratory tests preoperatively and at 1 and 6 months postoperatively.Important respiratory parameters improved significantly 6 months postoperatively (peak expiratory and expiratory flow), confirming that a glottal enlargement effectively reduced the obstruction. Objective parameters dealing with voice quality worsened significantly (maximum phonation time, voice range profile, hoarseness), whereas subjective voice assessment (VHI-12) did not change significantly.Endoscopic glottal enlargement is an effective method for relieving symptoms of dyspnea due to BVFP. Postoperatively, voice quality objectively worsened; however, this was not perceived by the patients themselves. Laryngostroboscopic findings did not correlate strongly with voice and respiratory outcomes.2b.


Schiffl H.,Ludwig Maximilians University of Munich | Lang S.M.,SRH Wald Klinikum Gera
Molecular Diagnosis and Therapy | Year: 2012

Acute kidney injury (AKI) represents a common disorder in hospitalized patients, and its incidence is rising at an alarming rate. Despite significant improvements in critical care and renal replacement therapies (RRT), the outcome of critically ill patients with AKI necessitating RRT remains unacceptably dismal. In current clinical practice, the diagnosis and severity classification of AKI is based on a rise in serum creatinine levels, which may occur 2-3 days after the initiating renal insult and delay potentially effective therapies that are limited to the early stage.The emergence of numerous renal tubular damage-specific biomarkers offers an opportunity to diagnose AKI at an early timepoint, to facilitate differential diagnosis of structural and functional AKI, and to predict the outcome of established AKI. The purposes of this review are to summarize and to discuss the performance of these novel AKI biomarkers in various clinical settings.The most promising AKI biomarkers include plasma and urinary neutrophil gelatinase-associated lipocalin (NGAL), urinary interleukin (IL)-18, urinary liver-type fatty acid binding protein (L-FABP), urinary cystatin C, and urinary kidney injury molecule (KIM)-1. However, enthusiasm about their usefulness in the emergency department seems unwarranted at present. There is little doubt that urinary biomarkers of nephron damage may enable prospective diagnostic and prognostic stratification in the emergency department. However, comparison of the areas under the receiver-operating characteristic curves of these biomarkers with clinical andor routine biochemical outcome parameters reveals that none of these biomarkers has a clear advantage beyond the traditional approach in clinical decision making in patients with AKI. The performance of various biomarkers for predicting AKI in patients with sepsis or with acute-on-chronic kidney disease is poor. The inability of biomarkers to improve classification of 'unclassifiable' (structural or functional) AKI, in which accurate differential diagnosis of pre-renal versus intrinsic renal AKI has the most value, illustrates another problem. Future research is necessary to clarify whether serial measurements of a specific biomarker or the use of a panel of biomarkers may be more useful in critically ill patients at risk of AKI.Whether or not the use of AKI biomarkers revolutionizes critical care medicine by early diagnosis of severe AKI and individualizes the management of AKI patients remains to be shown. Currently, the place of biomarkers in this decision-making process is still uncertain. Indiscriminate use of various biomarkers may distract clinicians from adequate clinical evaluation, may result in worse instead of better patient outcomes, and may waste money. Future large randomized studies are necessary to demonstrate the association between biomarker levels and clinical outcomes, such as dialysis, clinical events, or death. It needs to be shown whether assignment to earlier treatment for AKI on the basis of generally accepted biomarker cut-off levels results in a reduction in mortality and an improvement in recovery of renal function. © 2012 Springer International Publishing AG. All rights reserved.


Schiffl H.,Ludwig Maximilians University of Munich | Lang S.M.,SRH Wald Klinikum Gera
Pediatric Nephrology | Year: 2013

Pediatric acute kidney injury is rising with the advances in technology available for children with chronic conditions or those who are critically ill. Serum creatinine and urine output, traditional markers of renal function, often allow only delayed and unreliable diagnosis of acute kidney injury. Biomarker development in pediatric patients with low disease prevalence is challenging (small cohorts, few analyzable events). In this issue of Pediatric Nephrology, Ivanisevic and colleagues report that urinary liver-type fatty-acid-binding protein (L-FABP) can be used for early identification of pediatric acute kidney injury in a small cohort undergoing cardiac surgery. Addition of the biomarker resulted in an improvement in early diagnosis compared with a clinical model (age, gender, body weight, cardiopulmonary bypass duration, and aortic clamp time). It is noteworthy that the preoperative clinical model performed excellently in predicting postsurgery pediatric acute kidney injury. Further work is needed before this or other novel biomarkers (alone or in combination) can be implemented in clinical practice. Large-scale observational studies are needed to test these biomarkers against hard clinical endpoints, independent of serial measurements of serum creatinine concentrations. Prospective randomized interventional trials using exclusively high biomarker levels to define acute kidney injury should demonstrate improved clinical outcomes. © 2013 IPNA.


Guntinas-Lichius O.,Friedrich - Schiller University of Jena | Wendt T.,Friedrich - Schiller University of Jena | Buentzel J.,Suedharzkrankenhaus Nordhausen | Esser D.,Helios Klinikum Erfurt | And 4 more authors.
Journal of Cancer Research and Clinical Oncology | Year: 2010

Objective: To describe epidemiology and prognosis of head and neck cancer in Germany. Methods: We analyzed the Thuringian cancer registry database from 1996 to 2005. 3,821 cases with primary head and neck cancer were evaluated for patient's characteristics, tumor stage, incidence, treatment, and trends in overall survival. Results: During the period 1996-2005, the incidence of oropharynx, hypopharynx, larynx, and salivary gland cancer increased significantly for males, and of oral cavity and hypopharynx cancer for females. There was a significant trend using more multimodal therapy combining surgery, radiotherapy, and chemotherapy, and to use less radiotherapy as a single modality. The median follow-up time of patients alive was 42 months. The 5-year overall survival rate (OS) for all patients was 47.8%. The site-specific 5-year OS for lip, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, salivary gland, and nose/paranasal sinus cancer was 75.7, 42.6, 43.5, 45.9, 27.2, 57.3, 61.0, and 34.9%, respectively. The multivariate analysis showed that male gender, age ≥60 years, therapy without surgery, higher T classification, N classification, and M classification were independent significant negative risk factors for OS (p < 0.0001). Cancer of the oral cavity and of the hypopharynx had a significant lower OS than lip cancer (p = 0.012 and p = 0.044, respectively). Comparing the periods 1996-2000 with the period 2001-2005, there was no significant improvement of OS for any subsite. Conclusions: Many subsites of head and neck cancer have changing incidence. Although treatment strategies have changed, outcome has not improved significantly from 1995 to 2006. © 2009 Springer-Verlag.


Schiffl H.,Ludwig Maximilians University of Munich | Lang S.,SRH Wald Klinikum Gera
Indian Journal of Nephrology | Year: 2013

The use of conventional intermittent hemodialysis (IHD) represents a mainstay of supportive care of patients with acute kidney injury (AKI). However, a number of fundamental questions regarding the optimal management of IHD remain unanswered after more than six decades of renal replacement therapy (RRT). This review summarizes current evidence regarding the timing of initiation of intermittent hemodialysis, the comparative outcomes (mortality and recovery of renal function), the prescription of the intensity of this therapy and discontinuation of dialysis. The way conventional IHD is performed has an impact on the outcome of sick patients with AKI. The value of regular education and training of those who provide IHD cannot be emphasized enough. However, we must be realistic in our expectations that no mode of RRT per se will substantially alter the excessive mortality of critically ill-patients with AKI.


Mueller A.H.,SRH Wald Klinikum Gera
Current Opinion in Otolaryngology and Head and Neck Surgery | Year: 2011

Purpose of Review: This article reviews literature on the scientific background of functional electric stimulation of the immobile larynx, the status of animal pacing trials, and first clinical attempts to establish laryngeal pacing. Recent Findings: Impaired vocal fold motion is seen following recurrent laryngeal nerve paralysis and is a result of inadequate or synkinetic reinnervation. The term vocal fold paralysis should only be used after verification using laryngeal electromyography. A variety of animal trials give clear evidence supporting the feasibility of laryngeal pacing as a new dynamic approach for the rehabilitation of patients with bilateral vocal fold motion impairment. Laryngeal pacing has become clinically applicable with minimal invasive electrode insertion and newly designed stimulation circuits. Summary: Laryngeal pacing seems to be on the right path to open up a dynamic rehabilitation of the bilaterally motion-impaired larynx. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Forster G.,SRH Wald Klinikum Gera | Arnold D.,Friedrich - Schiller University of Jena | Bischoff S.J.,Friedrich - Schiller University of Jena | Schubert H.,Friedrich - Schiller University of Jena | And 2 more authors.
European Archives of Oto-Rhino-Laryngology | Year: 2013

Functional electrical stimulation (FES) of the posterior cricoarytenoid muscle (PCA) to restore respiratory function of the larynx may become an option for the treatment of bilateral recurrent laryngeal nerve paralysis (RLNP) in the near future. The feasibility of this has been shown in several animal trials and in a human pilot study. The common open surgical inferolateral approach for electrode insertion into the PCA for FES has a risk of damaging the recurrent laryngeal nerve (RLN) and may result in postoperative swelling and scaring of the larynx. Therefore, a minimal invasive electrode insertion technique is needed. A new miniaturized bipolar spiral tip electrode and a new electrical stimulatable insertion needle were tested in a short-term trial for an endoscopically guided and functionally controlled transcricoidal electrode insertion in eight Göttingen minipigs with bilateral normal RLN function. The feasibility of this technique was evaluated and the achieved positions of the electrodes in the PCA were analyzed using intraoperative stimulation threshold data and 3D-CT reconstructions. In seven cases it was possible to place two well-performing electrodes into the PCA. They were positioned one on either side. In one animal no functioning electrode position could be achieved because the PCA was missed. Thresholds of the electrode tips varied between 0.2 and 2.5 mA (mean 0.71 mA). In any case maximal glottal opening could be reached before adductors were co-activated. The majority of electrodes were placed into the central lower part of the PCA with no apparent correlation between threshold and electrode position. Surgical trauma might be further reduced by using endoscopy via a laryngeal mask avoiding the temporary tracheostomy used in this trial. If the implanted electrodes remain stable in long-term tests, we suggest that this method could soon be transferred into human application. © 2012 Springer-Verlag.

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