Three new procedures for a newborn hearing screening, based on AABR and AOAE/AABR technologies

Hintergrund und Fragestellung: Hörbahn und die kortikalen Hörzentren benötigen eine frühzeitige regelmäßige akustische Stimulation für ihre Reifung. Ohne die Reizung in den ersten Lebensjahren gehen ungenutzte neuronale Vernetzungen zugrunde bzw. werden gar nicht erst entwickelt. Deshalb kommt der Einführung eines universellen Neugeborenen-Hörscreenings zur Detektion frühkindlicher Hörstörungen in den letzten Jahren eine große Bedeutung zu. Zur Sicherstellung eines effektiven Screenings muss ein optimales objektives Verfahren gewählt werden, basierend auf OAE- und ABR-Technologien, eingesetzt in Form von Mono- oder Kombinationsverfahren. Voraussetzung für den Einsatz als Screening-Gerät sind höchstmögliche Sensitivität und Spezifität, eine einfache Bedienung sowie Kostengünstigkeit. Desweiteren ist dabei jenen Verfahren der Vorrang zu geben, welche, bei immer kürzer werdenden Liegezeiten der Patientinnen und Zunahme ambulanter Geburten, mit nur einem einzigen Test eine Rate an Testauffälligen von unter 4% erreichen. Patienten und Methode: An 473 Kindern wurden in drei Geburtskliniken monaural Hörscreening-Untersuchungen durchgeführt. Zur Verfügung standen hierbei das Kombinationsgerät echo-screen TA® zur Messung von TEOAE und AABR, sowie das MB11 BERAphon® mit zwei verschiedenen Verfahren zur Messung von AABR, einerseits der Zeitgang-AABR, andererseits einer steady-state-AABR. Ergebnisse: Mit nur einer einzigen Messung erreichten alle Verfahren bis auf die Zeitgang-AABR des MB11 BERAphon® eine Testauffälligen-Rate von 5 % bzw. darunter. Zudem bietet das Kombinationsgerät echo-screen TA® die Möglichkeit, ein mittels TEOAE-Verfahren als auffällig getestetes Kind anschliessend mittels AABR-Verfahren zu überprüfen. Die mittlere Messzeit betreffend zeigte sich das TEOAE-Verfahren des echo-screen TA® erwartungsgemäß schnell. Bei den AABR-Verfahren lieferte das MB11 BERAphon® mit der steady-state-AABR vor dem echo-screen TA® und vor der Zeitgang-AABR ein Ergebnis. Im Vergleich der mittleren Untersuchungszeiten zeigte sich die längste Untersuchungszeit für die kombinierte TEOAE- und AABR-Messung des echo-screen TA®. Betrachtet man jedoch die einzelnen Verfahren untereinander, so zeigte sich auch hier der geringe Zeitaufwand des TEOAE-Verfahrens. Das AABR-Verfahren des echo-screen TA® erwies sich, aufgrund der zu klebenden Elektroden, als zeitaufwendiger als die AABR-Verfahren des MB11-BERAphon®. Die Sensitivität ergab für alle hier verwendeten Verfahren 100%. Alle Verfahren, bis auf die Zeitgang-AABR des MB11 BERAphon® zeigten sehr gute Verfahrensspezifitäten von über 96%. In der Kostenanalyse wurde deutlich, dass die alleinigen TEOAE-Messungen des echo-screen TA® günstiger als die AABR-Messungen waren. Dennoch sind auch die AABR-Verfahren des MB11 BERAphon® aufgrund des eingeschränkten Materialverbrauchs nicht mehr deutlich kostenintensiver. Schlussfolgerung: Unter Berücksichtigung aller zu erfüllenden Kriterien eines Hörscreening-Gerätes sind sowohl die steady-state-AABR das MB11 BERAphon® als auch das Kombinationsverahren des echo-screen TA® für ein universelles Hörscreening geeignet. Kosten und Zeitaufwand des echo-screen TA® sind beim Gebrauch beider Verfahren (TEOAE und AABR) im Vergleich zum Monoverfahren (steady-state-AABR des MB11 BERAphon® ) höher und bedingten in der hier vorgestellten Studie einen leichten Vorteil der steady-state-AABR bei ansonsten nahezu ausgeglichenen Ergebnissen. Die Zeitgang-AABR des MB 11 BERAphon® konnte die gültigen Qualitätskriterien zum Studienzeitpunkt nicht erfüllen, wobei anwenderbedingte Gründe weitestgehend ausgeschlossen werden können.Objective: The central acoustic channel and the cortical centres need constant stimuli for their accurate development. Without early acoustic stimulation in the very first years of living these neuronal components remain idle and eventually degenerate or even do not develop at all. Therefore, the meaning of a universal acoustic screening for newborns is of highest importance. For efficacy and safety reasons the most effective screening procedure, as OAE and ABR, has to be chosen either as a mono or combined assessment. Highest possible sensitivity, specifity as well as elementary appliance and competitive costs have to be prerequisits for this task. In relation to briefer getting hospitalisation periods and growing numbers of ambulant deliveries, these days the screening also has to be reliable with only one examination (test conspicuity under 4%). Patients and method: 473 newborns in 3 clinics have been screened with a monoaural hearing screening examination. Therefore, the echo-screen TA® (combined measurement of TEOAE and AABR) and the MB11 BERAphon® (measurement of AABR either over time or as steady-state) were utilised. Results: With one measurement the TEOAE examination (echo-screen TA®) reached 5% of conspicuous cases. For the AABR the same appliance showed only 1,3% conspicuity. Examination with the MB11 BERAphon® showed 10,6% conspicuity measuring AABR over time and 3% measuring AABR as steady-state, respectively. The mean time for the absolute measuring period with the echo-screen TA® was 21, 9 sec for TEOAE and 70, 6 sec for AABR. Thus, the mean for both measurements was 112,4 sec. With the MB11 BERAphon® the mean time was 84,2 sec for AABR over time and 43,3 sec for steady-state-AABR. The hole procedure took 272,9 sec for the TEOAE, 497,5 sec for the AABR and for both 790,6 sec examined with echo-screen TA®. AABR over time needed 333 sec and steady-state-AABR 294,5 sec for the complete MB11 BERAphon® measurement. Sensitivity for all methods was 100%. Specificity was 96,4% for the TEOAE and 99,65% for AABR with echo-screen TA®. For AABR over time specificity was 91,11% and 97,95% for steady-state-AABR with MB11 BERAphon®, respectively. The costs for TEOAE measurement were 3,26 € and for the combined measurement with AABR 7,41 €. AABR over time costs were 3,56 € and 3,35 € for steady-state-AABR with the MB11 BERAphon®. Conclusion: Concidering all requirements for a universal newborn hearing screening both, the echo-screen TA® and MB11 BERAphon® with steady-state-AABR are appropriate. The MB11 BERAphon® AABR over time wasn´t qualified for an universal hearing screening in any time of these study

Coronary 64-slice CT angiography predicts outcome in patients with known or suspected coronary artery disease

The aim of this study was to assess the prognostic value of 64-slice CT angiography (CTA) in patients with known or suspected coronary artery disease (CAD). Sixty-four-slice coronary CTA was performed in 220 patients [mean age 63 ± 11years, 77 (35%) female] with known or suspected CAD. CTA images were analyzed with regard to the presence and number of coronary lesions. Patients were followed-up for the occurrence of the following clinical endpoints: death, nonfatal myocardial infarction, unstable angina, and coronary revascularization. During a mean follow-up of 14 ± 4months, 59 patients (27%) reached at least one of the predefined clinical endpoints. Patients with abnormal coronary arteries on CTA (i.e., presence of coronary plaques) had a 1st-year event rate of 34%, whereas in patients with normal coronary arteries no events occurred (event rate, 0%, p < 0.001). Similarly, obstructive lesions (≥50% luminal narrowing) on CTA were associated with a high first-year event rate (59%) compared to patients without stenoses (3%, p < 0.001). The presence of obstructive lesions was a significant independent predictor of an adverse cardiac outcome. Sixty-four-slice CTA predicts cardiac events in patients with known or suspected CAD. Conversely, patients with normal coronary arteries on CTA have an excellent mid-term prognosi

Evaluation of temporal windows for coronary artery bypass graft imaging with 64-slice CT

Temporal windows providing the best image quality of different segments and types of coronary artery bypass grafts (CABGs) with 64-slice computed tomography (CT) were evaluated in an experimental set-up. Sixty-four-slice CT with a rotation time of 330ms was performed in 25 patients (four female; mean age 59.9years). A total of 84 CABGs (62 individual and 22 sequential grafts) were evaluated, including 28 internal mammary artery (33.3%), one radial artery with sequential grafting (2.4%), and 54 saphenous vein grafts (64.3%). Ten data sets were reconstructed in 10% increments of the RR-interval. Each graft was separated into segments (proximal and distal anastomosis, and body), and CABG types were grouped according to target arteries. Two readers independently assessed image quality of each CABG segment in each temporal window. Diagnostic image quality was found with good inter-observer agreement (kappa=0.62) in 98.5% (202/205) of all graft segments. Image quality was significantly better for saphenous vein grafts versus arterial grafts (P<0.001) and for distal anastomosis to the right coronary compared with other target coronary arteries (P<0.05). Overall, best image quality was found at 60%. Image quality of proximal segments did not significantly vary with the temporal window, whereas for all other segments image quality was significantly better at 60% compared with other temporal windows (P<0.05). Sixty-four-slice CT provides best image quality of various segments and types of CABG at 60% of the RR-interva

13N-ammonia myocardial perfusion imaging with a PET/CT scanner: impact on clinical decision making and cost-effectiveness

Purpose: The purpose of the study is to determine the impact of 13N-ammonia positron emission tomography (PET) myocardial perfusion imaging (MPI) on clinical decision making and its cost-effectiveness. Materials and methods: One hundred consecutive patients (28 women, 72 men; mean age 60.9 ± 12.0years; range 24-85years) underwent 13N-ammonia PET scanning (and computed tomography, used only for attenuation correction) to assess myocardial perfusion in patients with known (n = 79) or suspected (n = 8) coronary artery disease (CAD), or for suspected small-vessel disease (SVD; n = 13). Before PET, the referring physician was asked to determine patient treatment if PET would not be available. Four weeks later, PET patient management was reassessed for each patient individually. Results: Before PET management strategies would have been: diagnostic angiography (62 of 100 patients), diagnostic angiography and percutaneous coronary intervention (PCI; 6 of 100), coronary artery bypass grafting (CABG; 3 of 100), transplantation (1 of 100), or conservative medical treatment (28 of 100). After PET scanning, treatment strategies were altered in 78 patients leading to: diagnostic angiography (0 of 100), PCI (20 of 100), CABG (3 of 100), transplantation (1 of 100), or conservative medical treatment (76 of 100). Patient management followed the recommendations of PET findings in 97% of the cases. Cost-effectiveness analysis revealed lower costs of €206/patient as a result of PET scanning. Conclusion: In a population with a high prevalence of known CAD, PET is cost-effective and has an important impact on patient managemen

Impact of hypertension on the diagnostic accuracy of coronary angiography with computed tomography

Objective Hypertension induces coronary artery disease (CAD) and progression of arterial wall calcification. As coronary calcifications may cause artefacts in 64-slice computed tomography coronary angiography (CTCA), we sought to determine the diagnostic accuracy of CTCA in patients with and without arterial hypertension. Methods Eighty-five consecutive patients with suspected CAD underwent CTCA, calcium-scoring and conventional coronary angiography, and were grouped as hypertensive (28 women, 31 men, mean age 65±9years, age range 49-82years) or normotensive patients (10 women, 16 men, mean age 62±11years, age range 39-77years). On an intention-to-diagnose-basis, no coronary segment was excluded and non-evaluative segments were rated as false positive. Results Per-patient sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in the hypertensive group were 91.4, 83.3, 88.9, and 86.9%, while the respective values in the normotensive group were 100, 78.9, 63.6, and 100% (P=0.42, 0.71, 0.05, and 0.15). In the hypertensive group the prevalence of CAD was 59% and the mean calcium-score was 256; respective values in the normotensive group were 27% and 69, (P<0.01, and<0.05 vs. hypertensives). Conclusions Although hypertensives have significantly higher coronary calcifications, sensitivity and specificity are comparably high as in normotensives. The prevalence of CAD is higher in hypertensives and brings about a trend towards a lower NPV and a higher PP

Dual-source computed tomography coronary angiography: influence of obesity, calcium load, and heart rate on diagnostic accuracy

Aims To prospectively investigate the diagnostic accuracy of dual-source computed tomography coronary angiography (CTCA) to diagnose coronary stenoses in relation to body mass index (BMI), Agatston score (AS), and heart rate (HR) as compared with catheter coronary angiography (CCA). Methods and results Hundred and fifty consecutive patients (47 female, mean age 62.9 ± 12.1 years) underwent dual-source CTCA without HR control. Patients were divided into subgroups depending on the median of their BMI (26.0 kg/m2), AS (194), and HR (66 b.p.m.). CCA was considered the standard of reference. Mean BMI was 26.5 ± 4.2 kg/m2 (range 18.3-39.1 kg/m2), mean AS was 309 ± 408 (range 0-4387), and HR was 68.5 ± 12.6 b.p.m. (range 35-102 b.p.m.). Diagnostic image quality was found in 98.1% of all segments (2020/2059). Considering not-evaluative segments at CTCA as false-positive, overall per-patient sensitivity, specificity, positive, and negative predictive value were 96.6%, 86.8%, 82.6%, and 97.5%, respectively. High HR did not deteriorate diagnostic accuracy of CTCA. High BMI and AS were associated with a decrease in per-patient specificity to 84.1% and 77.8%, respectively, while sensitivity and negative predictive value remained high. Conclusion Dual-source CTCA provides high diagnostic accuracy irrespective of the HR and serves as a modality to rule-out coronary artery stenoses even in patients with high BMI and A

Accuracy of quantitative coronary angiography with computed tomography and its dependency on plaque composition: Plaque composition and accuracy of cardiac CT

Objective: To determine the impact of plaque composition on accuracy of quantitative 64-slice computed tomography coronary angiography (CTCA). Methods: The institutional review board approved this study; written informed consent was obtained from all patients. One hundred consecutive patients (42 women, mean age 64.6±9.4years, age range 39-87years) underwent CTCA and invasive quantitative coronary angiography (QCA) to determine (a) the diagnostic accuracy of CTCA for the detection of significant stenosis (diameter reduction of≥50%), and (b) the accuracy of stenosis grading. In CTCA stenosis severity was graded in 10% steps and evaluated separately for calcified and non-calcified coronary lesions using Pearson-linear-regression analysis, Bland/Altman-analysis (BA), and Mann-Whitney-U-test. Results: In 60/100 patients 139 significant coronary artery stenoses were identified with QCA. On a per-segment analysis, sensitivity of CTCA was 75.5%, and specificity was 96.6% (positive predictive value: 72.9%, negative predictive value: 97.0%). Quantification of stenosis grading correlated moderately between methods (r=0.60; P<0.001), with an overestimation by CTCA of 5.5% (BA limits-of-agreement −29 to 39%). BA limits-of-agreement were greater in calcified lesions (−29.2 to 45.6%; mean error 8.2%) than in non-calcified lesions (−25.9 to 30.2%; mean error 2.2%) and differed significantly (P<0.05). Conclusions: Diagnostic accuracy of CTCA is high, however agreement for quantitative lesion severity assessment between CTCA and QCA is moderate for calcified but superior for non-calcified lesion

Accuracy of dual-source CT coronary angiography: first experience in a high pre-test probability population without heart rate control

The aim of this study was to assess the diagnostic accuracy of dual-source computed tomography (DSCT) for evaluation of coronary artery disease (CAD) in a population with extensive coronary calcifications without heart rate control. Thirty patients (24 male, 6 female, mean age 63.1±11.3years) with a high pre-test probability of CAD underwent DSCT coronary angiography and invasive coronary angiography (ICA) within 14±9days. No beta-blockers were administered prior to the scan. Two readers independently assessed image quality of all coronary segments with a diameter ≥1.5mm using a four-point score (1: excellent to 4: not assessable) and qualitatively assessed significant stenoses as narrowing of the luminal diameter >50%. Causes of false-positive (FP) and false-negative (FN) ratings were assigned to calcifications or motion artifacts. ICA was considered the standard of reference. Mean body mass index was 28.3±3.9kg/m2 (range 22.4-36.3kg/m2), mean heart rate during CT was 70.3±14.2bpm (range 47-102bpm), and mean Agatston score was 821±904 (range 0-3,110). Image quality was diagnostic (scores 1-3) in 98.6% (414/420) of segments (mean image quality score 1.68±0.75); six segments in three patients were considered not assessable (1.4%). DSCT correctly identified 54 of 56 significant coronary stenoses. Severe calcifications accounted for false ratings in nine segments (eight FP/one FN) and motion artifacts in two segments (one FP/one FN). Overall sensitivity, specificity, positive and negative predictive value for evaluating CAD were 96.4, 97.5, 85.7, and 99.4%, respectively. First experience indicates that DSCT coronary angiography provides high diagnostic accuracy for assessment of CAD in a high pre-test probability population with extensive coronary calcifications and without heart rate contro

Global benchmarks in primary robotic bariatric surgery redefine quality standards for Roux-en-Y gastric bypass and sleeve gastrectomy

BACKGROUND Whether the benefits of the robotic platform in bariatric surgery translate into superior surgical outcomes remains unclear. The aim of this retrospective study was to establish the 'best possible' outcomes for robotic bariatric surgery and compare them with the established laparoscopic benchmarks. METHODS Benchmark cut-offs were established for consecutive primary robotic bariatric surgery patients of 17 centres across four continents (13 expert centres and 4 learning phase centres) using the 75th percentile of the median outcome values until 90 days after surgery. The benchmark patients had no previous laparotomy, diabetes, sleep apnoea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, history of thromboembolic events, BMI greater than 50 kg/m2, or age greater than 65 years. RESULTS A total of 9097 patients were included, who were mainly female (75.5%) and who had a mean(s.d.) age of 44.7(11.5) years and a mean(s.d.) baseline BMI of 44.6(7.7) kg/m2. In expert centres, 13.74% of the 3020 patients who underwent primary robotic Roux-en-Y gastric bypass and 5.9% of the 4078 patients who underwent primary robotic sleeve gastrectomy presented with greater than or equal to one complication within 90 postoperative days. No patient died and 1.1% of patients had adverse events related to the robotic platform. When compared with laparoscopic benchmarks, robotic Roux-en-Y gastric bypass had lower benchmark cut-offs for hospital stay, postoperative bleeding, and marginal ulceration, but the duration of the operation was 42 min longer. For most surgical outcomes, robotic sleeve gastrectomy outperformed laparoscopic sleeve gastrectomy with a comparable duration of the operation. In robotic learning phase centres, outcomes were within the established benchmarks only for low-risk robotic Roux-en-Y gastric bypass. CONCLUSION The newly established benchmarks suggest that robotic bariatric surgery may enhance surgical safety compared with laparoscopic bariatric surgery; however, the duration of the operation for robotic Roux-en-Y gastric bypass is longer

Accuracy of dual-source CT coronary angiography: first experience in a high pre-test probability population without heart rate control

The aim of this study was to assess the diagnostic accuracy of dual-source computed tomography (DSCT) for evaluation of coronary artery disease (CAD) in a population with extensive coronary calcifications without heart rate control. Thirty patients (24 male, 6 female, mean age 63.1±11.3 years) with a high pre-test probability of CAD underwent DSCT coronary angiography and invasive coronary angiography (ICA) within 14±9 days. No beta-blockers were administered prior to the scan. Two readers independently assessed image quality of all coronary segments with a diameter ≥1.5 mm using a four-point score (1: excellent to 4: not assessable) and qualitatively assessed significant stenoses as narrowing of the luminal diameter >50%. Causes of false-positive (FP) and false-negative (FN) ratings were assigned to calcifications or motion artifacts. ICA was considered the standard of reference. Mean body mass index was 28.3±3.9 kg/m(2) (range 22.4–36.3 kg/m(2)), mean heart rate during CT was 70.3±14.2 bpm (range 47–102 bpm), and mean Agatston score was 821±904 (range 0–3,110). Image quality was diagnostic (scores 1–3) in 98.6% (414/420) of segments (mean image quality score 1.68±0.75); six segments in three patients were considered not assessable (1.4%). DSCT correctly identified 54 of 56 significant coronary stenoses. Severe calcifications accounted for false ratings in nine segments (eight FP/one FN) and motion artifacts in two segments (one FP/one FN). Overall sensitivity, specificity, positive and negative predictive value for evaluating CAD were 96.4, 97.5, 85.7, and 99.4%, respectively. First experience indicates that DSCT coronary angiography provides high diagnostic accuracy for assessment of CAD in a high pre-test probability population with extensive coronary calcifications and without heart rate control