Publications by authors named "Alexandra Kaider"

145 Publications

Long-term durability after surgical aortic valve replacement with the Trifecta and the Intuity valve-a comparative analysis.

Eur J Cardiothorac Surg 2021 Nov 5. Epub 2021 Nov 5.

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

Objectives: Long-term durability of surgical bio-prostheses is a key factor, especially in the era of transcatheter aortic valve replacement. We compared the incidence of structural valve deterioration (SVD) between patients undergoing surgical aortic valve replacement (SAVR) with the Trifecta (Abbott Laboratories, Abbott Park, IL, USA) or the Intuity valve (Edwards Lifesciences, Irvine, CA, USA).

Methods: Between April 2010 and May 2020, 1118 patients underwent SAVR with the Trifecta (n = 346) and the Intuity (n = 772) valve at a single centre. A total of 1070 patients (Trifecta n = 298, Intuity n = 772) were analysed after the exclusion of patients with pure regurgitation and endocarditis. Retro- and prospective echocardiographic and clinical follow-up was performed. Cox proportional hazards regression models were performed to identify prognostic factors for SVD, aortic re-interventions and mortality.

Results: With 27 cases (Trifecta n = 23, Intuity n = 4) of SVD observed, cumulative incidence of SVD was significantly higher in the Trifecta cohort (P < 0.001). Implantation of a Trifecta valve [hazard ratio (HR) 11.20; 95% confidence interval 3.79-33.09], log-transformed preoperative creatinine (HR 2.47; 1.37-4.44) and sex (male HR 0.42; 0.19-0.92) emerged as prognostic factors of SVD. A significantly higher cumulative incidence of re-interventions was observed in the Trifecta cohort (P = 0.004) and valve type was an independent time-varying risk factor (HR at 12 months 2.78; 95% confidence interval 1.42-5.45). Overall, no significant differences in all-cause mortality were observed between the groups (log-rank test: P = 0.052).

Conclusions: SVD was significantly more frequent in patients receiving a Trifecta valve and its implantation was an independent risk factor for the occurrence of SVD and aortic valve re-interventions. This comparative analysis of 2 low-gradient bioprosthesis put the long-term durability of the Trifecta valve in question and need to be taken into consideration when performing bioprosthetic SAVR.
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http://dx.doi.org/10.1093/ejcts/ezab470DOI Listing
November 2021

Evaluation of Levels of Triamcinolone Acetonide in Human Perilymph and Plasma After Intratympanic Application in Patients Receiving Cochlear Implants: A Randomized Clinical Trial.

JAMA Otolaryngol Head Neck Surg 2021 Nov;147(11):974-980

Department of Otorhinolaryngology-Head and Neck Surgery, Medical University of Vienna, Vienna, Austria.

Importance: The use of intratympanically applied steroids is of increasing interest. Consequently, research has focused on finding an ideal drug that diffuses through the round window membrane and can be retained in the perilymph.

Objective: To compare levels of triamcinolone acetonide (TAC) in perilymph and plasma after intratympanic injection.

Design, Setting, And Participants: This randomized clinical trial included 40 patients receiving cochlear implants at a single tertiary care center in Vienna, Austria. Patients were randomized to 1 of 4 treatment groups receiving 1 of 2 intratympanic doses of TAC (10 mg/mL or 40 mg/mL) at 1 of 2 approximate time points (24 hours or 1 hour) before sampling the perilymph. Inclusion was carried out between November 2017 and January 2020, and data were analyzed in December 2020.

Interventions: All patients underwent intratympanic injection of TAC. During cochlear implantation, perilymph and plasma were sampled for further analysis.

Main Outcomes And Measures: Levels of TAC measured in perilymph and plasma.

Results: Among the 37 patients (median [range] age, 57 [26-88] years; 18 [49%] men) included in the analysis, TAC was present at a median (range) level of 796.0 (46.4-7706.7) ng/mL. In the majority of patients (n = 29; 78%), no drug was detectable in the plasma after intratympanic injection. Levels above the limit of detection were less than 2.5 ng/mL. The 1-factorial analysis of variance model showed lower TAC levels in the group that received TAC, 10 mg/mL, 24 hours before surgery (median, 271 ng/mL) compared with the group that received TAC, 10 mg/mL, 1 hour before surgery (median, 2877 ng/mL), as well as in comparison with the groups receiving TAC, 40 mg/mL, 24 hours before surgery (median, 2150 ng/mL) and 1 hour before surgery (median, 939 ng/mL). The 2-factorial analysis of variance model showed lower TAC levels in the group receiving TAC, 10 mg/mL, 24 hours before surgery than the group receiving TAC, 10 mg/mL, 1 hour before surgery, and higher TAC levels in the group receiving TAC, 40 mg/mL, 24 hours before surgery compared with the group receiving TAC, 10 mg/mL, 24 hours before surgery. Patients with thickening of the middle ear had statistically significantly higher plasma levels (median, 1.4 ng/mL vs 0 ng/mL) and lower perilymph levels (median, 213.1 ng/mL vs 904 ng/mL) than individuals with unremarkable middle ear mucosa.

Conclusions And Relevance: In this randomized clinical trial, TAC was shown to be a promising drug for intratympanic therapies, with similar levels in perilymph 1 hour and 24 hours after injection (distinctly in the groups receiving the 40 mg/mL dose). There was also minimal dissemination to the plasma, especially in patients with unremarkable middle ear mucosa.

Trial Registration: ClinicalTrials.gov Identifier: NCT03248856.
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http://dx.doi.org/10.1001/jamaoto.2021.2492DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8485207PMC
November 2021

Incidence, clinical relevance and therapeutic options for outflow graft stenosis in patients with left ventricular assist devices.

Eur J Cardiothorac Surg 2021 Sep 1. Epub 2021 Sep 1.

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

Objectives: We reviewed our institutional experience with outflow graft stenosis (OGS) in 3 contemporary left ventricular assist devices (LVAD).

Methods: Data from 347 consecutive adult recipients of LVAD [Medtronic HVAD (n = 184, 53.0%), Abbott HeartMate II (n = 62, 17.9%) and Abbott HeartMate 3 (n = 101, 29.1%)] implanted between March 2006 and October 2019 were analysed retrospectively. Primary study end points were the incidence of OGS necessitating treatment and survival on LVAD support.

Results: During the study period, 17 patients (4.9%) developed OGS requiring treatment with a probability of 0.6% at 1 year, 1.9% at 2 years, 3.8% at 3 years, 4.7% at 4 years and 5.9% at 5 years of LVAD support. Notably, in 13.8% of patients, a compression-related narrowing of the outflow graft with a probability of 1.5% at 6 months, 1.8% 1 year, 6.0% at 2 years, 12.3% at 3 years, 15.4% at 4 years and 16.6% at 5 years of LVAD support with no difference between devices (P = 0.26) was observed. There was a trend towards increased risk of mortality with OGS (hazard ratio 2.21, 95% confidence interval 0.87-5.51; P = 0.09). OGS preferentially occurred in segments of the outflow graft covered by a protective coating.

Conclusions: OGS is a rare but potentially lethal complication during LVAD support. Modifications of pump design and implant techniques may be needed because OGS preferentially occurs within covered portions of the outflow graft. Systematic screening may be warranted.
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http://dx.doi.org/10.1093/ejcts/ezab382DOI Listing
September 2021

Titanium and Platinum-Fluoroplastic Stapes Prostheses Visualization on Cone Beam Computed Tomography and High-Resolution Computed Tomography.

Life (Basel) 2021 Feb 17;11(2). Epub 2021 Feb 17.

Department of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, 1090 Vienna, Austria.

The aim of this study was to evaluate whether stapes prostheses can be visualized with less metal artifacts and therefore more accurately on cone beam computed tomography in comparison to computed tomography imaging. Recent studies have shown that cone beam computed tomography has advantages when imaging metal artifacts. Patients with hearing loss or vertigo, who have undergone stapedotomy, often present a challenge for otologic surgeons. Imaging studies can deliver crucial additional information. A retrospective analysis of imaging studies and clinical data in a tertiary care center were carried out. Forty-one patients with forty-five implanted ears were evaluated in the study. All included patients had been implanted with a platinum-fluoroplastic (n = 19) or titanium (n = 26) piston and subsequently had undergone imaging months or years after surgery for various reasons. Patients underwent computed tomography or cone beam computed tomography of the temporal bone depending on availability. Piston visualization, prosthesis length, vestibular intrusion and audiologic results were compared between the groups. Piston position on imaging studies were compared to intraoperative findings. Functional length measurements of all prostheses were carried out with a mean error of -0.17 mm (±0.20). Platinum-fluoroplastic protheses were significantly underestimated in length compared to titanium prostheses. To analyze the material-dependent difference in the measurement errors of the imaging techniques the interaction was tested in an ANOVA model and showed no statistically significant result ( = 0.24). The blinded neuroradiologist viewed two implants, both platinum-fluoroplastic pistons, as located outside of the vestibule due to an underestimation of the prothesis length and the missing radiodensity of the lower end of the prosthesis. Surgeons and radiologists should be aware of the different types and radiologic features of stapes prostheses and the missing radiodensity of some protheses parts. Cone beam computed tomography is an imaging alternative with a potential advantage of reduced radiation in patients after stapes surgery suffering from vertigo or hearing loss to evaluate piston position.
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http://dx.doi.org/10.3390/life11020156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7923124PMC
February 2021

The adapted Heart Donor Score.

Transpl Int 2021 03 22;34(3):546-560. Epub 2021 Feb 22.

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

The Heart Donor Score (HDS) predicts donor organ discard for medical reasons and survival after heart transplantation (HTX) in the Eurotransplant allocation system. Our aim was to adapt the HDS for application in the United Network for Organ Sharing (UNOS) registry. To adjust for differences between the Eurotransplant and UNOS registries, the "adapted HDS" was created (aHDS) by exclusion of the covariates "valve function," "left-ventricular hypertrophy," and exclusion of "drug abuse" from the variable "compromised history." Two datasets were analyzed to evaluate associations of the aHDS with donor organ discard (n = 70 948) and survival (n = 19 279). The aHDS was significantly associated with donor organ discard [odds ratio 2.72, 95% confidence interval (CI) 2.68-2.76, P < 0.001; c-statistic: 0.937). The score performed comparably in donors <60 and ≥60 years of age. The aHDS was a significant predictor of survival as evaluated by univariate Cox proportional hazards analysis (hazard ratio 1.04, 95% CI 1.01-1.07, P = 0.023), although the association lost significance in a multivariable model. The aHDS predicts donor organ discard. Negative effects of most aHDS components on survival are likely eliminated by highly accurate donor selection processes.
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http://dx.doi.org/10.1111/tri.13822DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986732PMC
March 2021

Performance With an Adhesive Bone Conduction Device in Active Transcutaneous Bone Conduction Implant Users.

Otol Neurotol 2021 04;42(4):510-516

Department of Otorhinolaryngology, Medical University of Vienna.

Objectives: The aim of this study was to evaluate the performance and limits of an adhesive bone conduction hearing aid in patients implanted with an active transcutaneous bone conduction implant. Therefore, hearing performance and subjective benefit of patients with mixed and conductive hearing loss were assessed with both bone conduction devices.

Study Design And Patients: This cohort study was conducted at a tertiary care center. Fifteen subjects, who had been implanted with an active transcutaneous device previously, were included and used the adhesive hearing device for 3 weeks instead of the implant. Subjects underwent two sets of audiological tests as well as assessments of quality of life at the beginning and at the end of the testing period.

Results: Audiological results showed a significantly greater improvement in regards to functional hearing gain and word recognition scores with the transcutaneous bone conduction device than the nonimplantable adhesive device. Regression analysis showed a trend toward greater improvement with the transcutaneous device compared with the adhesive device in patients with an increasing bone conduction threshold. Hearing-specific and general quality-of-life questionnaires revealed no significant difference between the two devices.

Conclusion: Patients with mixed or conductive hearing loss experience hearing gain with both, the adhesive device and the active transcutaneous device. The adhesive device may be a valuable alternative to the active transcutaneous device, depending on the individual bone conduction threshold.
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http://dx.doi.org/10.1097/MAO.0000000000003045DOI Listing
April 2021

Speech Segregation in Active Middle Ear Stimulation: Masking Release With Changing Fundamental Frequency.

Ear Hear 2020 12 22;42(3):709-717. Epub 2020 Dec 22.

Department of Otorhinolaryngology, Medical University of Vienna, Vienna, Austria.

Objectives: Temporal fine structure information such as low-frequency sounds including the fundamental frequency (F0) is important to separate different talkers in noisy environments. Speech perception in noise is negatively affected by reduced temporal fine structure resolution in cochlear hearing loss. It has been shown that normal-hearing (NH) people as well as cochlear implant patients with preserved acoustic low-frequency hearing benefit from different F0 between concurrent talkers. Though patients with an active middle ear implant (AMEI) report better sound quality compared with hearing aids, they often struggle when listening in noise. The primary objective was to evaluate whether or not patients with a Vibrant Soundbridge AMEI were able to benefit from F0 differences in a concurrent talker situation and if the effect was comparable to NH individuals.

Design: A total of 13 AMEI listeners and 13 NH individuals were included. A modified variant of the Oldenburg sentence test was used to emulate a concurrent talker scenario. One sentence from the test corpus served as the masker and the remaining sentences as target speech. The F0 of the masker sentence was shifted upward by 4, 8, and 12 semitones. The target and masker sentences were presented simultaneously to the study subjects and the speech reception threshold was assessed by adaptively varying the masker level. To evaluate any impact of the occlusion effect on speech perception, AMEI listeners were tested in two configurations: with a plugged ear-canal contralateral to the implant side, indicated as AMEIcontra, or with both ears plugged, indicated as AMEIboth.

Results: In both study groups, speech perception improved when the F0 difference between target and masker increased. This was significant when the difference was at least 8 semitones; the F0-based release from masking was 3.0 dB in AMEIcontra (p = 0.009) and 2.9 dB in AMEIboth (p = 0.015), compared with 5.6 dB in NH listeners (p < 0.001). A difference of 12 semitones revealed a F0-based release from masking of 3.5 dB in the AMEIcontra (p = 0.002) and 3.4 dB in the AMEIboth (p = 0.003) condition, compared with 5.0 dB in NH individuals (p < 0.001).

Conclusions: Though AMEI users deal with problems resulting from cochlear damage, hearing amplification with the implant enables a masking release based on F0 differences when F0 between a target and masker sentence was at least 8 semitones. Additional occlusion of the ear canal on the implant side did not affect speech performance. The current results complement the knowledge about the benefit of F0 within the acoustic low-frequency hearing.
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http://dx.doi.org/10.1097/AUD.0000000000000973DOI Listing
December 2020

Differential Effects of Clopidogrel With or Without Aspirin on Platelet Reactivity and Coagulation Activation: A Randomized Trial in Healthy Volunteers.

Clin Pharmacol Ther 2021 06 30;109(6):1546-1554. Epub 2020 Nov 30.

Department of Medicine I, Medical University of Vienna, Vienna, Austria.

Dual antiplatelet therapy (DAPT) is standard in acute coronary syndrome but confers a bleeding risk. To compare effects of clopidogrel single antiplatelet therapy (SAPT) with clopidogrel-based DAPT on hemostatic system activation we conducted a randomized clinical trial in 44 volunteers (clopidogrel (d1: 600 mg, d2-6: 150 mg) ± aspirin (100 mg)). Multiple electrode aggregometry-adenosine diphosphate (MEA-ADP) and MEA-arachidonic acid (MEA-AA) triggered aggregometry, vasodilator-stimulated phosphoprotein (VASP), beta thromboglobulin, p-selectin, thromboxane B , d-Dimer, prothrombin fragment 1.2 (f1.2), and a phospholipid-dependent clotting time were measured in venous blood. Changes are described by mean differences (Δmean (95% confidence interval (CI)) or geometric mean ratios (95% CI)). DAPT and SAPT comparably and significantly decreased MEA-ADP at 2 hours (-60% vs. -63%; P = 0.35, Δmean -4.9, 95% CI -15.4 to 5.5). At 24 hours (-59% vs. -47%, P = 0.04, Δmean -11.1, 95% CI -21.7 to -0.4]) and 8 days (-61% vs. -53%, P = 0.04, Δmean -11.3, 95% CI -22.0 to -0.6). Both treatments significantly reduced VASP and MEA-AA after 2 hours and 8 days. DAPT inhibited MEA-AA significantly stronger at 2 hours (-77% vs. -30%; P < 0.0001, Δmean -39.6, 95% CI -54.2 to -25.0), at 24 hours (-80% vs. -27%, P < 0.0001, Δmean -47.8, 95% CI -62.3 to -33.3), and 8 days (-79% vs. -27%, P < 0.0001, Δmean -48.9, 95% CI -62.5 to -35.4). Neither treatment significantly influenced beta thromboglobulin or p-selectin. DAPT abolished and SAPT reduced thromboxane B after 24 hours and 8 days. The d-Dimer was reduced by DAPT (0.94, 95% CI 0.89-1.00, P = 0.04) at 2 hours but not after 24 hours and 8 days. SAPT did not decrease d-Dimer. Neither treatment affected f1.2. DAPT and SAPT comparably affect platelet and coagulation activation in venous blood.
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http://dx.doi.org/10.1002/cpt.2106DOI Listing
June 2021

Association of ABO blood group with bleeding severity in patients with bleeding of unknown cause.

Blood Adv 2020 10;4(20):5157-5164

Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.

Blood group O has been associated with an increased bleeding tendency due to lower von Willebrand factor (VWF) and factor VIII (FVIII) levels. We explored whether blood group O is independently associated with bleeding severity in patients with mild-to-moderate bleeding of unknown cause (BUC) in the Vienna Bleeding Biobank cohort. Bleeding severity was recorded with the Vicenza bleeding score (BS). Blood group O was overrepresented in 422 patients with BUC compared with its presence in 23 145 healthy blood donors (47.2% vs 37.6%; odds ratio, 1.48; 95% confidence interval [CI], 1.22-1.79). The BS and the number of bleeding symptoms were significantly higher in patients with blood group O than in patients with non-O after adjustment for VWF and FVIII levels and sex (least-square [LS] means of BSs: 6.2; 95% CI, 5.8-6.6 vs 5.3; 4.9-5.7; and of number of symptoms: LS, 3.5; 95% CI, 3.2-3.7 vs 3.0; 2.8-3.2, respectively). Oral mucosal bleeding was more frequent in those with blood group O than in those with other blood types (group non-O; 26.1% vs 14.3%), independent of sex and VWF and FVIII levels, whereas other bleeding symptoms did not differ. Patients with blood group O had increased clot density in comparison with those with blood group non-O, as determined by rotational thromboelastometry and turbidimetric measurement of plasma clot formation. There were no differences in thrombin generation, clot lysis, or platelet function. Our data indicate that blood group O is a risk factor for increased bleeding and bleeding severity in patients with BUC, independent of VWF and FVIII levels.
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http://dx.doi.org/10.1182/bloodadvances.2020002452DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594405PMC
October 2020

The impact of structural optical coherence tomography changes on visual function in retinal vein occlusion.

Acta Ophthalmol 2021 Jun 30;99(4):418-426. Epub 2020 Sep 30.

Department of Ophthalmology, Vienna Reading Center and OPTIMA Study Group, Medical University of Vienna, Vienna, Austria.

Purpose: We aimed to determine the correlation between optical coherence tomography (OCT)- and demographic features and baseline best corrected visual acuity (BCVA) in treatment-naïve patients with retinal vein occlusion (RVO).

Methods: This was a cross-sectional posthoc analysis of OCT images that included RVO patients from two prospective, open-label, multicentre studies. The morphological grading was done manually, in the standardized setting of a reading centre. Main outcome measure was the estimated difference in Early Treatment Diabetic Retinopathy Study letters associated with each individual biomarker.

Results: Included were 381/301 treatment-naïve patients with BRVO/CRVO. For BRVO, statistically significant correlations with BCVA were seen for a 100 µm increase in central subfield thickness (CST; -3.1 letters), intraretinal cysts at centre point (CP; +4.1), subretinal fluid (SRF) at CP (+3.0) and hyperreflective foci (HRF) at the central B-scan (-2.2). In CRVO, a 100 µm increase in CST was associated with a loss of -3.4 letters. In the total cohort, 100 µm increase in CST, SRF at CP and HRF at the central B-scan correlated with a difference of -3.2,+3.2 and -2.0 letters. A 10-year increase in age and female gender yielded a -2.0 and -2.5 letter decrease in the total cohort. Adjusted multiple R for the respective group was 18.3%/26.3%/23.5%.

Conclusions: Of all parameters studied, only CST and age were consistently associated with worse BCVA in treatment-naïve RVO patients. Morphology on OCT explained only a modest part of functional loss in this patient cohort.
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http://dx.doi.org/10.1111/aos.14621DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8359321PMC
June 2021

Biological properties of bone marrow plasma cells influence their recovery in aspirate specimens: impact on classification of plasma cell disorders and potential bias to evaluation of treatment response.

Ann Hematol 2020 Nov 15;99(11):2599-2609. Epub 2020 Sep 15.

Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.

Methods to estimate bone marrow plasma cells (BMPC) basically include histopathology, cytomorphology, and flow cytometry. The present study compares the outcomes of these methods with special focus on the impact of BMPC-specific characteristics on their recovery by either method. Laboratory reports of diagnostic samples from 238 consecutive patients with suspected or known plasma cell disease were retrospectively analyzed. The median (IQR) proportion of BMPC was 30.0% (15.0-70.0%) by histological review (hBMPC), 7.0% (2.0-16.0%) by smear review (sBMPC), and 3.0% (0.8-10.0%) by flow cytometry (fBMPC). The disparity of results between core biopsy and aspirate smear was enhanced in case of poor quality of the smear, increased BM fiber content, higher grade cell atypia, expression of CD56 (all P < 0.0001), the number of cytogenetic aberrations (P = 0.0002), and abnormalities of the MYC gene (P = 0.0002). Conversely, expression of CD19 and a non-clonal plasma cell phenotype were associated with a lower difference between hBMPC and sBMPC (both P < 0.0001). The disparity between the percentages of sBMPC and fBMPC was associated with the quality of the smear (P = 0.0007) and expression of CD56 (P < 0.0001). Our results suggest that the recovery of BMPC in aspirate specimens not only is a matter of sampling quality but also depends on biological cell properties. Aspiration failure due to malignant type features of BMPC may lead to misclassification of plasma cell disorders and represent a bias for the detection of minimal residual disease after therapy.
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http://dx.doi.org/10.1007/s00277-020-04249-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7536141PMC
November 2020

Treatment patterns and bleeding outcomes in persons with severe hemophilia A and B in a real-world setting.

Ann Hematol 2020 Dec 11;99(12):2763-2771. Epub 2020 Sep 11.

Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.

The current standard of care treatment for severe hemophilia A and B (SHA and SHB) is the prophylactic intravenous replacement of coagulation factor VIII or IX (FVIII/FIX) to prevent spontaneous bleeding. Persons with hemophilia without prophylactic treatment receive therapy in case of bleeding, i.e., on demand. To assess treatment patterns, utilization of products, and bleeding outcomes in a real-world cohort of persons with SHA and SHB, defined as FVIII or FIX activity < 1%, data was retrospectively collected from hemophilia-specific patient diaries used for home treatment, medical records, and entries into the Austrian Hemophilia Registry from the year 2012 to 2017. Fifty-three male persons with SHA (n = 47) and SHB (n = 6) were included; 26 with SHA and 5 with SHB were on prophylaxis, 8 and 1 switched therapy regimen, and 13 and 0 received on-demand therapy. Persons on prophylaxis used a mean factor FVIII or FIX dose of 71.7 and 40.1 IU/kg/week. Median (IQR) annualized bleeding rates (ABR) in SHA were 28.0 (23.4-31.3) in the on-demand, 4.9 (1.6-13.5) in the prophylaxis group, and 3.0 (2.0-6.8) in the prophylactic group of SHB. Three persons with SHA had zero bleeds during the observation period. On-demand therapy and hepatitis B and C were associated with higher ABR but not age, weight, and HIV positivity. Bleeding rates and the proportion of on-demand therapy in persons with hemophilia were high in our real-world cohort. Further improvement is needed, which might be facilitated with the advent of factor products with extended half-life or non-factor therapies.
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http://dx.doi.org/10.1007/s00277-020-04250-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7683481PMC
December 2020

Longitudinal analysis of extracellular vesicle-associated tissue factor activity in cancer patients.

Thromb Res 2020 11 24;195:215-218. Epub 2020 Jul 24.

Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Comprehensive Cancer Center, Medical University Vienna, Austria. Electronic address:

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http://dx.doi.org/10.1016/j.thromres.2020.07.041DOI Listing
November 2020

Correction to: The Prognostic Index Independently Predicts Survival in Patients with Pancreatic Ductal Adenocarcinoma Undergoing Resection.

Ann Surg Oncol 2020 Dec;27(Suppl 3):985

Division of General Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.

In the original article there are errors in the authors' affiliations.
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http://dx.doi.org/10.1245/s10434-020-09010-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7852886PMC
December 2020

Changes in Acoustic Aspects of Vocal Function in Children After Adenotonsillectomy.

J Voice 2020 Jul 20. Epub 2020 Jul 20.

Department of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna, Vienna, Austria. Electronic address:

Background: Adenotonsillectomy is one of the most common pediatric surgical procedures. Postoperative voice changes are a very common concern among patient's parents. Therefore, the aim of this study is to analyze acoustic voice parameters after adenotonsillectomy, tonsillectomy, and adenoidectomy in pediatric patients in a tertiary referral academic center.

Patients And Methods: All pediatric patients undergoing an adenotonsillectomy, tonsillectomy or adenoidectomy in a single center from 2002 to 2018 were included in the study. Change of fundamental frequency, jitter, shimmer, and harmonic-noise ratio at first, seventh and 30th postoperative day compared to preoperative values were the primary outcome parameters. Statistical analysis was performed using repeated measures analysis of variance model.

Results: A total of 1258 patients were included in the study. The mean age of patients at the time of surgery was 8.3 years (range 3.0-18.0 years). Around 698 were male (55.5%) and 560 female (44.5%). The values of fundamental frequency increased significantly after the first and seventh postoperative day (P = 0.001 both) but normalized 1 month after surgery (P = 0.962). At the first postoperative month, values of jitter and shimmer decreased significantly (P = 0.005 and P = 0.002, respectively). Measurements of harmonic-noise ratio revealed a significant increase 30 days after surgery (P = 0.004).

Conclusion: Statistically significant differences in objective voice parameters within the first postoperative month after tonsillectomy, adenoidectomy, and adenotonsillectomy were observed. The fundamental frequency returned to normal 1 month after surgery. These findings can contribute in soothing the concerns of parents regarding postoperative voice changes.
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http://dx.doi.org/10.1016/j.jvoice.2020.06.022DOI Listing
July 2020

Blood stream infection and outcomes in recipients of a left ventricular assist device.

Eur J Cardiothorac Surg 2020 11;58(5):907-914

Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.

Objectives: Our aim was to investigate associations between blood stream infection [≥1 positive blood culture (BC)] and outcomes in recipients of a left ventricular assist device (LVAD).

Methods: We retrospectively analysed all adult recipients of a continuous-flow LVAD between 2006 and 2016 at the Division of Cardiac Surgery, Medical University of Vienna (n = 257; devices: Medtronic HeartWare® HVAD®, Abbott HeartMate II®, Abbott HeartMate 3™). The primary outcome was all-cause mortality during follow-up. Secondary outcomes included the risk of stroke and pump thrombus during follow-up as well as the probability of heart transplantation (HTx). Risk factors for the development of ≥1 positive BC were evaluated additionally.

Results: The incidence of ≥1 positive BC during the first year of LVAD support was 32.1% [95% confidence interval (CI) 26.4-37.9]. Multivariable Cox proportional cause-specific hazards regression analysis showed that a positive BC was associated with significantly increased all-cause mortality [hazard ratio (HR) 5.51, 95% CI 3.57-8.51; P < 0.001]. Moreover, a positive BC was associated with a significantly increased risk of stroke (HR 2.41, 95% CI 1.24-4.68; P = 0.010). There was no association with the risk of pump thrombus or the probability of HTx. Independent risk factors for a positive BC included preoperative albumin and extracorporeal membrane oxygenation/intra-aortic balloon pump support.

Conclusions: Blood stream infection is common and associated with a significantly increased risk of all-cause mortality and stroke at any given time during LVAD support. Effective strategies of prevention and treatment are necessary.
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http://dx.doi.org/10.1093/ejcts/ezaa153DOI Listing
November 2020

Molecular-level HLA mismatch is associated with rejection and worsened graft survival in heart transplant recipients - a retrospective study.

Transpl Int 2020 09 23;33(9):1078-1088. Epub 2020 Jun 23.

Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

The aim was to evaluate the association of molecular-level human leukocyte antigen (HLA) mismatching with post-transplant graft survival, rejection, and cardiac allograft vasculopathy (CAV). We retrospectively analyzed all primary cardiac transplant recipients between 01/1984-06/2016. 1167 patients fulfilled inclusion criteria and had HLA typing information available. In 312 donor-recipient pairs, typing at serological split antigen level was available. We used the Epitope MisMatch Algorithm to calculate the number of amino acid differences in antibody-verified HLA eplets (amino acid mismatch load (AAMM)) between donor and recipient. Patients with a higher HLA-DR AAMM load had inferior 1-year graft survival (hazard ratio [HR], 1.14; 95% confidence interval [CI], 1.01-1.28). The HLA-AB AAMM load showed no impact on graft survival. In the subgroup with available split-level information, we observed an inferior graft survival for a higher HLA-DR AAMM load 3 months after transplantation (HR, 1.22; 95% CI, 1.04-1.44) and a higher risk for rejection for an increasing HLA-AB (HR, 1.70; 95% CI, 1.29-2.24) and HLA-DR (HR, 1.32; 95% CI, 1.09-1.61) AAMM load. No impact on the development of CAV was found. Molecular-level HLA mismatch analysis could serve as a tool for risk stratification after heart transplantation and might take us one step further into precision medicine.
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http://dx.doi.org/10.1111/tri.13657DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7540475PMC
September 2020

The discriminatory power of bleeding assessment tools in adult patients with a mild to moderate bleeding tendency.

Eur J Intern Med 2020 08 18;78:34-40. Epub 2020 Apr 18.

Clinical Division of Hematology and Hemostaseology, Department of Medicine I, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria.

Background: Bleeding assessment tools (BATs) have been developed to quantify bleeding severity. Their ability to predict for the diagnosis of a bleeding disorder has not been thoroughly investigated.

Objectives: To evaluate the ability of the Vicenza BAT and the ISTH BAT to distinguish patients with an established bleeding disorder from those with bleeding of unknown cause (BUC).

Patients/methods: Three-hundred fifty-nine patients (228 with BUC, 64%) from the Vienna Bleeding Biobank were assessed in this study.

Results: The bleeding scores were similar in patients with an established diagnosis of a bleeding disorder compared to patients with BUC. Both BATs had a low sensitivity and specificity for the diagnosis of a bleeding disorder with areas under the receiver operating characteristic (ROC) curves of 0.53 (95% confidence interval 0.47-0.60) for the Vicenza BAT and 0.52 (0.46-0.59) for the ISTH BAT. In terms of specific diagnoses, both scores were most accurate in diagnosing von Willebrand disease (VWD, areas under the ROC curve; Vicenza BAT 0.67 (0.45-0.90); ISTH BAT 0.70 (0.50-0.90)). A separate evaluation of different bleeding symptoms in patients who had undergone surgery and tooth extraction revealed that postpartum bleeding and bleeding from small wounds was predictive for diagnosing a MBD in multivariable analysis.

Conclusions: The Vicenza- and the ISTH BAT have a low ability to distinguish patients with an established bleeding disorder from those with BUC.
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http://dx.doi.org/10.1016/j.ejim.2020.04.023DOI Listing
August 2020

Conduction disturbances following surgical aortic valve replacement with a rapid-deployment bioprosthesis.

J Thorac Cardiovasc Surg 2021 Sep 19;162(3):803-811. Epub 2020 Feb 19.

Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria. Electronic address:

Background: The implantation of rapid-deployment aortic valves may interfere with the conduction system of the heart. This study evaluates the occurrence and predictive factors of conduction anomalies in patients undergoing surgical aortic valve replacement (SAVR) with a rapid-deployment balloon-expandable bioprosthesis in a single-center, real-world experience.

Methods: Between May 2010 and April 2019, 700 consecutive patients were included in a prospective, ongoing database with a longitudinal follow-up preoperatively, at discharge, and at 3 months, 1 year, 3 years, and 5 years postoperatively. Thirty-seven patients (5.3%) had a permanent pacemaker at baseline and were excluded from further analysis, leaving 663 patients for analysis. Assessment of conduction anomalies was performed by electrocardiography (ECG) monitoring and repeated 12-lead ECG during the hospital stay and at postoperative follow-ups.

Results: Preoperatively, 126 patients (19.0%) presented with different conduction disturbances. New permanent pacemaker implantation (PPI) occurred in 61 patients during the first 14 days (cumulative incidence, 9.4%). The indication for PPI was complete atrioventricular block in 47 cases (77%). Preoperative conduction anomalies, such as right bundle branch block, as well as operative characteristics (concomitant procedures) were found to be independent predictors for new PPI. One-year survival was 98% in patients with new early PPI and 96% in those without new early PPI (P = .60).

Conclusions: The PPI rate was in the range of previous reports for rapid-deployment prostheses. PPI did not have a significant influence on short- to intermediate-term survival. Case selection with exclusion of patients presenting with baseline conduction disturbances may decrease the rate of new PPIs after SAVR with rapid-deployment balloon-expandable bioprostheses.
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http://dx.doi.org/10.1016/j.jtcvs.2020.01.083DOI Listing
September 2021

Reply to Comments by Sun et al. on "The Prognostic Index Independently Predicts Survival in Patients with Pancreatic Ductal Adenocarcinoma Undergoing Resection".

Ann Surg Oncol 2020 12 19;27(Suppl 3):946-947. Epub 2020 Mar 19.

Pancreatic Cancer Unit, Division of General Surgery, Department of Surgery, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.

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http://dx.doi.org/10.1245/s10434-020-08373-1DOI Listing
December 2020

Increased serum neurofilament light chain concentration indicates poor outcome in Guillain-Barré syndrome.

J Neuroinflammation 2020 Mar 17;17(1):86. Epub 2020 Mar 17.

Department of Neurology, Medical University of Vienna, Vienna, Austria.

Background: Guillain-Barré syndrome (GBS) is an autoimmune disease that results in demyelination and axonal damage. Five percent of patients die and 20% remain significantly disabled on recovery. Recovery is slow in most cases and eventual disability is difficult to predict, especially early in the disease. Blood or cerebrospinal fluid (CSF) biomarkers that could help identify patients at risk of poor outcome are required. We measured serum neurofilament light chain (sNfL) concentrations from blood taken upon admission and investigated a correlation between sNfL and clinical outcome.

Methods: Baseline sNfL levels in 27 GBS patients were compared with a control group of 22 patients with diagnoses not suggestive of any axonal damage. Clinical outcome parameters for GBS patients included (i) the Hughes Functional Score (HFS) at admission, nadir, and discharge; (ii) the number of days hospitalised; and (iii) whether intensive care was necessary.

Results: The median sNfL concentration in our GBS sample on admission was 85.5 pg/ml versus 9.1 pg/ml in controls. A twofold increase in sNfL concentration at baseline was associated with an HFS increase of 0.6 at nadir and reduced the likelihood of discharge with favourable outcome by a factor of almost three. Higher sNfL levels upon admission correlated well with hospitalisation time (r = 0.69, p < 0.0001), during which transfer to intensive care occurred more frequently at an odds ratio of 2.4. Patients with baseline sNfL levels below 85.5 pg/ml had a 93% chance of being discharged with an unimpaired walking ability.

Conclusions: sNfL levels measured at hospital admission correlated with clinical outcome in GBS patients. These results represent amounts of acute axonal damage and reflect mechanisms resulting in disability in GBS. Thus, sNfL may serve as a convenient blood-borne biomarker to personalise patient care by identifying those at higher risk of poor outcome.
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http://dx.doi.org/10.1186/s12974-020-01737-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7079539PMC
March 2020

The pro-inflammatory marker soluble suppression of tumorigenicity-2 (ST2) is reduced especially in diabetic morbidly obese patients undergoing bariatric surgery.

Cardiovasc Diabetol 2020 02 26;19(1):26. Epub 2020 Feb 26.

Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.

Background: High soluble suppression of tumorigenicity-2 (sST2) is a marker of poor prognosis in chronic inflammatory conditions. ST2 and its ligand interleukin (IL)-33 are elevated in adipose tissue of obese individuals. We aimed to evaluate circulating sST2 and IL-33 as possible markers of metabolic benefit in morbidly overweight patients after Roux-en-Y gastric bypass (RYGB) bariatric surgery.

Methods: sST2, IL-33, high sensitive IL-6, high sensitive C-reactive protein (hsCRP), leptin, cholesterol metabolism and liver parameters were measured in 80 morbidly obese individuals before and 1 year after bariatric surgery.

Results: sST2 was higher (P = 0.03) in diabetics as compared to individuals without diabetes. Baseline sST2 was also higher in males than in females (P= 0.0002). One year after bariatric surgery, sST2 levels were decreased (median 120, IQR 59-176 pg/mL) as compared to sST2 before surgery (median 141, IQR 111-181, P = 0.0024), and the diabetic group showed most pronounced reduction in sST2 (P = 0.0016). An association was found between sST2 and liver function parameters before and after bariatric surgery, and between baseline sST2 and total cholesterol, triglyceride, total low density lipoprotein (LDL), small dense LDL, Apolipoprotein B as well as with small dense high density lipoproteins (HDL). In the subgroup of diabetic patients positive correlation between IL-33 and sST2 (r = 0.44, P = 0.05) was noticed.

Conclusions: Circulating sST2 is associated with markers of liver functions and lipid metabolism in severely obese patients and a reduction of sST2 was shown after successful bariatric surgery, most prominently in diabetic patients.
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http://dx.doi.org/10.1186/s12933-020-01001-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045735PMC
February 2020

The Prognostic Index Independently Predicts Survival in Patients with Pancreatic Ductal Adenocarcinoma Undergoing Resection.

Ann Surg Oncol 2020 Jun 3;27(6):2017-2024. Epub 2020 Jan 3.

Pancreatic Cancer Unit, Division of General Surgery, Department of Surgery, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.

Background: Cancer-related inflammation is associated with tumour proliferation, maintenance and dissemination. It therefore impacts pancreatic cancer survival. The goal of this study was to examine the Prognostic Index (PI) as a prognostic biomarker for survival in patients with pancreatic ductal adenocarcinoma (PDAC). In addition, we explored factors known to interact with the immune and inflammation cascade that might interfere with the PI's strength for prognostication.

Methods: Patients with PDAC undergoing resection were analysed retrospectively. The PI was calculated from preoperatively derived C-reactive protein levels and white blood count. Data were subject to correlation and survival analysis.

Results: Of 357 patients, 235 (65.8%) patients had a PI 0, 108 (30.3%) PI 1, and 14 (3.9%) PI 2. Median (quartiles) survival with a high PI (group 1 + 2) was 13.2 months (7.7-27.0), compared with 18.7 months (10.2-35.4) with a low PI (group 0; p = 0.012). The PI proved to be an independent prognostic factor for cancer-specific survival (p = 0.003) adjusted for conventional prognostic factors. Prognostic strength was influenced by the presence of a bile stent (p = 0.032).

Conclusions: The PI is a strong and solid independent prognostic tool for survival in patients with PDAC undergoing resection. Preoperative survey of inflammatory activity as provided by the use of a biomarker like the PI may help to identify those patients at risk of a poor prognosis.
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http://dx.doi.org/10.1245/s10434-019-08161-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7210221PMC
June 2020

Does a Competing Risk Analysis Show Differences in the Cumulative Incidence of Revision Surgery Between Patients with Oncologic and Non-oncologic Conditions After Distal Femur Replacement?

Clin Orthop Relat Res 2020 05;478(5):1062-1073

K. Staats, K. Vertesich, I. K. Sigmund, P. T. Funovics, R. Windhager, Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.

Background: Distal femur replacement is frequently used for limb salvage after bone tumor resections. It is also used in patients with severe bone loss because of traumatic conditions or revision TKA. Some studies on distal femur replacement reported on revision-free survival without distinguishing between patients with oncologic diagnoses and those without, although these patients might be incomparable because of their differences in important patient- and disease-specific characteristics. This may lead to an inaccurate and undifferentiated interpretation of the results of survival analyses.

Questions/purposes: (1) What is the overall cumulative incidence of revision surgery after cemented and cementless distal femoral replacement, as determined with a competing risk analysis? (2) Does the cumulative incidence of revision surgery change over time? (3) Are there differences in the cumulative incidence of revision surgery between patients with oncologic conditions and those without who are treated with cemented or cementless distal femoral replacement?

Methods: A total of 403 patients were possible candidates for distal femoral replacement. Of these, 56 patients elected to undergo different procedures, 83 were excluded because an expendable growing prosthesis was implanted, and 28 were lost to follow-up. Therefore, 229 patients who underwent distal femoral replacement for oncologic or non-oncologic reasons between 1983 and 2016 were retrospectively included in this study. The type of fixation method (cemented or cementless) was obtained from the patients' medical records, operation reports, and radiographic analyses from plain radiographs. All radiographs were standardized and obtained at standard time intervals in our institution. No algorithm regarding the fixation approach was followed. According to our data, patients receiving cementless fixation were younger and therefore likely to be more active than those receiving cemented fixation. The median follow-up duration of the overall cohort was 85 months (range 0.1-391 months). Patients who died or had revision surgery before the 2-year minimum follow-up interval were adequately considered using competing risk calculation. The reasons for revision surgery were classified using the classification system proposed by the International Society for Limb Salvage. A competing risk analysis was performed to estimate the cumulative incidence function of revision, accounting for death as a competing event. To evaluate the influence of potential prognostic factors, including diagnosis (oncologic versus non-oncologic), fixation (cemented versus cementless), year of distal femoral replacement, age, and sex on the occurrence of revision surgery, univariate and multivariable Fine and Gray models were applied.

Results: The competing risks analysis revealed cumulative incidences of revision surgery for any cause (Types 1 to 5) of 26% (95% CI, 20.3%-31.9%) at 12 months, 37.9% (95% CI, 31.3%-44.4%) at 24 months, 52.6% (95% CI, 45.1%-59.5%) at 5 years, and 58.2% (95% CI, 50.1%-65.4%) at 10 years for all patients. Rotating hinge-type prostheses showed a lower cumulative incidence of revision surgery (41.6%; 95% CI, 31.8%-51%) than fixed-hinge prostheses did (64%; 95% CI, 50.5%-74.5% ) at 5 years (Gray's test: p = 0.01). According to the multivariate Fine and Gray model, the year of surgery did not have any effect on the risk of revision surgery (1994 to 2003: hazard ratio 0.70; 95% CI, 0.46-1.07); 2004 to 2016: HR 0.83; 95% CI, 0.52-1.34; p = 0.26). The multivariate analysis, adjusted for disease, sex, age, cementation, and year of surgery, revealed a difference in the risk of revision surgery between patients with oncologic disease and those with non-oncologic disease (HR 0.44 for oncologic versus non-oncologic; 95% CI, 0.22-0.87; p = 0.02) and a reduction in the risk of overall revision with cemented fixation in patients with oncologic disease (HR 0.53; 95% CI, 0.29-0.98; p = 0.03).

Conclusion: This study indicates that even with newer implants, there was a high incidence of revision surgery after distal femoral replacement. According to our analysis, patients with oncologic diagnoses have a lower likelihood of revision when the stem is cemented whereas the type of fixation did not impact patients with non-oncologic diagnoses. Because of differences in patient demographics (age, etiology of disease, and use of chemotherapy) and outcomes of fixation, oncologic and non-oncologic patients should be analyzed separately in survival studies about distal femoral replacement.

Level Of Evidence: Level III, therapeutic study.
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http://dx.doi.org/10.1097/CORR.0000000000001106DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7170673PMC
May 2020

Ganglion cell layer thickening in well-controlled patients with type 1 diabetes: an early sign for diabetic retinopathy?

Acta Ophthalmol 2020 May 25;98(3):e292-e300. Epub 2019 Oct 25.

Department of Ophthalmology, University of Basel, Basel, Switzerland.

Purpose: To evaluate early changes in retinal layers using optical coherence tomography (OCT) in patients with long-standing type 1 diabetes (DM1) receiving intensified insulin therapy.

Methods: In a cross-sectional case-control study 150 patients with DM1 and 150 age- and sex-matched healthy control participants underwent OCT imaging. Scans of both eyes were analysed for different layers (NFL, GCL (+IPL), INL, outer layer complex (OLC, including OPL, ONL and ELM) and photoreceptors (PR)) in all subfields of an ETDRS grid. All analyses were performed semi-automatically using custom software by certified graders of the Vienna Reading Center. ANOVA models were used to compare the mean thickness of the layers between patients and controls.

Results: Six hundred eyes with 512 datapoints in 49 b-scans in each OCT were analysed. Mean thickness in patients/controls was 31.35 μm/30.65 μm (NFL, p = 0.0347), 76.7 μm/73.15 μm (GCL, p ≤ 0.0001), 36.29 μm/37.13 μm (INL, p = 0.0116), 114.34 μm/112.02 μm (OLC, p < 0.0001) and 44.71 μm/44.69 μm (PR, p = 0.9401). When evaluating the ETDRS subfields separately for clinically meaningful hypotheses, a significant swelling of the GCL in patients could be found uniformly and a central swelling for the OLC, whereas the distribution of NFL and INL thickening suggests that their statistical significance was not clinically relevant.

Conclusion: These preliminary results demonstrate that preclinical retinal changes in patients with long-standing DM1 can be found by retinal layer evaluation. However, the changes are layer-specific, with significant thickening of the GCL and less so of the OLC suggesting a role as an early sign for diffuse swelling and the evolution of DME even in well-controlled diabetes.
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http://dx.doi.org/10.1111/aos.14273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7216836PMC
May 2020

Implementation of Electrical Auricular Acupuncture and Low Frequency Modulated Electric Current Therapy in Pain Management of Patients with Knee Osteoarthritis: A Randomized Pilot Trial.

J Clin Med 2019 Aug 15;8(8). Epub 2019 Aug 15.

Department of Special Anaesthesia and Pain Therapy, Outpatient Pain Center, Vienna General Hospital, Medical University of Vienna, 1090 Vienna, Austria.

Background: Knee osteoarthritis is a major cause of knee pain. Conservative therapy resources are limited due to adverse effects. Therefore, alternative non-invasive therapy approaches to reduce pain medications are gaining importance. The current study analyses if electrical auricular acupuncture (EAA) or low frequency modulated electric current therapy (LFMECT) could support analgesic treatment.

Methods: In a randomized pilot trial patients with painful knee OA were treated with EAA (group 1) or LFMECT (group 2) additional to standard pharmacological analgesic treatment. In total 19 female and 10 male patients with a mean age of 59.1 years (standard deviation ± 13.6) and a mean BMI of 28.9 kg/m (± 5.2) were included. Patients were randomly assigned to one of the groups stratified for age, gender and BMI. Before starting of the active study period and collecting of the initial data on day 1, all patients received a pharmacological analgesic baseline therapy for one week. At the next study stage patients started their randomly assigned treatment protocol for 42 days and final follow-up was set on day 70. Patients recorded their pain intensity (numerical rating scale; NRS) using a standardized patient diary. The pain free walking time in min was recorded and range of motion was assessed.

Results: Rescue medication intake was comparable between both groups on day 42 ( = 0.55) and day 70 ( = 0.35). After the active study period (day 42) pain scores decreased significantly in both groups (group 1 = 0.02; group 2 = 0.0006). At follow up median pain scores further decreased in group 1 ( = 0.0002) and remained at a low level in group 2 ( = 0.001). Level of pain decreased in about 50% in both groups and was comparable during the study period. Total mean range of motion (ROM) increased in both groups (group 1 = 0.0003; group 2 = 0.02). Group 1 had more improvement of mean total ROM compared to group 2 ( = 0.034). Pain-free walking time increased in both groups and was comparable between both groups ( = 0.31). Any adverse effects due to EAA or LFMECT were not observed.

Conclusions: Data of the current study indicates that implementation of EAA or LFMECT seems to be beneficial to reduce knee pain and improve knee function in patients with knee osteoarthritis.
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http://dx.doi.org/10.3390/jcm8081229DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6723024PMC
August 2019

Differential Effects of Ticagrelor With or Without Aspirin on Platelet Reactivity and Coagulation Activation: A Randomized Trial in Healthy Volunteers.

Clin Pharmacol Ther 2020 02 28;107(2):415-422. Epub 2019 Sep 28.

Department of Medicine I, Medical University of Vienna, Vienna, Austria.

Dual antiplatelet therapy (DAPT) is standard in acute coronary heart disease but confers a bleeding risk. To compare the effects of ticagrelor-monotherapy with ticagrelor-based DAPT on hemostatic system activation, we conducted a randomized controlled trial in 44 volunteers using a loading-dose regimen and measured platelet-aggregometry triggered by adenosine diphosphate (multiple electrode aggregometry (MEA)-ADP) and arachidonic acid (MEA-AA), the vasodilator-stimulated phosphoprotein (VASP), prothrombin fragment 1.2 (f1.2), and d-Dimer. Ticagrelor-based DAPT and ticagrelor-monotherapy significantly decreased MEA-ADP (Δmean: -51.4 (-56.9; -45.8) and -46.2 (-51.7; -40.7)) and VASP (Δmean: -70.3 (-76.2; -64.4) and -69.6 (-75.5; -63.7)) at 2 hours and over 24 hours. MEA-AA was reduced significantly by both treatments (Δmean: -72.9 (-80.6; -65.3) and -25.7 (-33.3; -18.0)) at 2 hours, and stronger by ticagrelor-based DAPT over 24 hours. Both treatments decreased f1.2 (geometric mean ratio (GMR): 0.92 (0.84; 1.01) and 0.88 (0.80; 0.96)) and d-Dimer (GMR: 0.89 (0.86; 0.92) and 0.91 (0.88; 0.94)) at 2 hours and d-Dimer over 24 hours. Ticagrelor-monotherapy and ticagrelor-based DAPT comparably affect hemostatic system activation.
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http://dx.doi.org/10.1002/cpt.1616DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006887PMC
February 2020

Bilateral or unilateral antegrade cerebral perfusion during surgery for acute type A dissection.

J Thorac Cardiovasc Surg 2020 Jun 8;159(6):2159-2167.e2. Epub 2019 Jul 8.

Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria.

Objective: The study objective was to investigate outcomes associated with the application of bilateral or unilateral antegrade cerebral perfusion during surgery for acute type A dissection.

Methods: Patients who underwent surgery for type A dissection with the application of antegrade cerebral perfusion between 2009 and 2017 at the Division of Cardiac Surgery, Medical University of Vienna were analyzed retrospectively (bilateral antegrade cerebral perfusion: n = 91, 49.5%; unilateral antegrade cerebral perfusion: n = 93, 50.5%). The primary outcome variable was overall survival. Subgroup analyses were performed in patients requiring antegrade cerebral perfusion durations of 50 minutes or more and less than 50 minutes. Secondary outcome variables were 30-day mortality, adverse outcome, permanent and temporary neurologic deficits, renal replacement therapy, prolonged ventilation, intensive care unit stay, and hospital stay.

Results: Multivariable Cox proportional hazards analysis demonstrated no significant association of bilateral antegrade cerebral perfusion with overall survival (hazard ratio, 0.63; 95% confidence interval, 0.34-1.14, P = .126). Propensity score modeling using the method of inverse probability of treatment weighting confirmed this result (hazard ratio, 0.73; 95% confidence interval, 0.33-1.60, P = .428). Bilateral antegrade cerebral perfusion was associated with significantly improved overall survival in patients requiring antegrade cerebral perfusion durations of 50 minutes or more (P = .017). The bilateral antegrade cerebral perfusion and unilateral antegrade cerebral perfusion groups showed comparable rates of secondary outcome variables.

Conclusions: In the present study, bilateral antegrade cerebral perfusion and unilateral antegrade cerebral perfusion are associated with comparable outcomes after surgery for type A dissection. Subgroup analyses suggest that bilateral antegrade cerebral perfusion is associated with superior overall survival in patients requiring antegrade cerebral perfusion durations of 50 minutes or more. An adequately powered prospective randomized controlled trial is required to validate these results.
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http://dx.doi.org/10.1016/j.jtcvs.2019.06.057DOI Listing
June 2020

The role of ADAMTS-13 and von Willebrand factor in cancer patients: Results from the Vienna Cancer and Thrombosis Study.

Res Pract Thromb Haemost 2019 Jul 6;3(3):503-514. Epub 2019 May 6.

Clinical Division of Hematology and Hemostaseology Department of Medicine I Medical University of Vienna Vienna Austria.

Background: Cancer-associated venous thromboembolism (VTE) is an important complication in the course of a malignant disease. Low ADAMTS-13 (a disintegrin-like and metalloproteinase with thrombospondin type 1 motif 13) and increased von Willebrand Factor (VWF) levels in cancer patients have been described numerously.

Objectives: Investigation of the influence of ADAMTS-13 and VWF on the probability of VTE and survival in malignancy.

Patients/methods: In the framework of the ongoing prospective Cancer and Thrombosis Study (CATS) ADAMTS-13 activity and VWF antigen levels were investigated in cancer patients.

Results: In total, 795 patients with various tumor types (364 female/431 male, median age 62 years) were included; of those, 56 developed VTE and 359 patients died during a median follow-up time of 730 days. The hazard ratio (HR) of VTE per doubling of VWF level was 1.56 (95% confidence interval [CI] 1.13-2.16) in multivariable competing risk analysis. ADAMTS-13 levels showed no correlation with the incidence of VTE in univariate competing risk analysis. The HR of mortality per doubling of VWF level was 1.46 (95% CI 1.28-1.66) and per SD increment of ADAMTS-13was 0.90 (95% CI 0.81-1.00) in multivariable Cox regression analysis. Patients with VWF >75th percentile and concomitant low (<25th percentile) or medium (25-75th percentile) ADAMTS-13 values had the highest probability of mortality (HR 4.31 and 4.75, respectively).

Conclusions: High VWF levels were significantly associated with the risk of developing VTE in cancer patients, whereas ADAMTS-13 was not. Low ADAMTS-13 and increased VWF levels were independently associated with worse overall survival.
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http://dx.doi.org/10.1002/rth2.12197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611368PMC
July 2019

Intratympanic Triamcinolone Acetonide as Treatment Option for Idiopathic Sudden Sensorineural Hearing Loss.

Otol Neurotol 2019 07;40(6):720-727

Department of Otorhinolaryngology, Head and Neck Surgery, Medical University of Vienna.

Introduction: Corticosteroids represent the most commonly used treatment option for patients with idiopathic sudden sensorineural hearing loss. In the past, these compounds were mainly formulated and tested for intravenous or oral administration. Intratympanic application is increasingly being used, often as salvage treatment. The most suitable corticosteroid for local application has yet to be identified. Trials have suggested that triamcinolone acetonide has superior molecular properties for this treatment modality.

Methods: The main aim of this study was to retrospectively assess the first audiometric results of patients diagnosed with idiopathic sudden sensorineural hearing loss and treated simultaneously with systemic prednisolone and intratympanic triamcinolone acetonide. This data was then compared to systemic treatment only, as well as to historic cohorts treated intratympanically with widely used corticosteroids, namely dexamethasone or methylprednisolone.

Results: 90 patients received intravenous prednisolone only, and 89 individuals underwent intravenous treatment combined with three to four simultaneous intratympanic applications of triamcinolone. Eight patients received intratympanic triamcinolone as first-line treatment. After adjusting data for sex, time since onset, age, and severity of hearing loss, no statistically significant difference between the two main treatment groups could be identified. No major adverse events were observed, specifically no otitis media or persistent vertigo. Two perforated tympanic membranes healed spontaneously within several days.

Conclusion: While the exact role of intratympanic injections requires additional trials, triamcinolone resulted in similar outcomes compared to studies using dexamethasone or methylprednisolone. Due to favorable pharmacological properties, triamcinolone represents a safe and efficacious alternative for intratympanic treatment in idiopathic sensorineural hearing loss.
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http://dx.doi.org/10.1097/MAO.0000000000002283DOI Listing
July 2019
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