Is The Late Neandertal Mandibular Sample from Vindija Cave (Croatia) Biased?

The late Neandertal sample from Vindija (Croatia) has been described as transitional between the earlier Central European Neandertals from Krapina (Croatia) and modern humans. However, the morphological differences indicating this transition may rather be the result of different sex and/or age compositions between the samples. This study tests the hypothesis that the metric differences between the Krapina and Vindija mandibular samples are due to sample bias. Mandibles are the focus of this paper because past studies have posited this region as particularly indicative of the Vindija sample’s transitional nature. The results indicate that the metric differences between the Krapina and Vindija mandibular samples are not due to sample bias. This conclusion is consistent with an earlier analysis of sample bias for the Vindija supraorbital sample

Development of an item list to assess the forgotten joint concept in shoulder patients

BackgroundTo generate an item list for the assessment of joint awareness in shoulder patients and to collect patient feedback on the comprehensibility of the items and the forgotten joint concept.MethodsItem content was generated on the basis of literature search and expert ratings following a stepwise refinement procedure, including final evaluation by an international expert board (n?=?12) including members with various professional backgrounds. Items were translated from English to German and evaluated in 30 German-speaking shoulder patients in Switzerland and 30 shoulder patients in the UK.ResultsLiterature search identified 45 questionnaires covering 805 issues potentially relevant for the assessment of joint awareness. Stepwise item selection resulted in 97 items to be evaluated by the international expert board leaving 70 items for collecting patient feedback. The majority of patients indicated that the introductory text explaining the forgotten joint concept was easy or very easy to understand (79.3%) and that the items were clear (91.4%).ConclusionWe developed a list of 70 questions for the assessment of joint awareness in shoulder patients and obtained positive patient feedback for these. In a next step, we will administer the items to a large international patient sample to obtain data for psychometric analysis and development of a measurement model, which is the basis for creation of computer-adaptive assessments or static short-forms

A MEMS Condenser Microphone-Based Intracochlear Acoustic Receiver.

GOAL Intracochlear sound pressure (ICSP) measurements are limited by the small dimensions of the human inner ear and the requirements imposed by the liquid medium. A robust intracochlear acoustic receiver (ICAR) for repeated use with a simple data acquisition system that provides the required high sensitivity and small dimensions does not yet exist. The work described in this report aims to fill this gap and presents a new MEMS condenser microphone (CMIC) based ICAR concept suitable for ICSP measurements in human temporal bones. METHODS The ICAR head consisted of a passive protective diaphragm (PD) sealing the MEMS CMIC against the liquid medium, enabling insertion into the inner ear. The components of the MEMS CMIC-based ICAR were expressed by a lumped element model (LEM) and compared to the performance of successfully fabricated ICARs. RESULTS Good agreement was achieved between the LEM and the measurements with different sizes of the PD. The ICSP measurements in a human cadaver temporal bone yielded data in agreement with the literature. CONCLUSION Our results confirm that the presented MEMS CMIC-based ICAR is a promising technology for measuring ICSP in human temporal bones in the audible frequency range. SIGNIFICANCE A sensor for evaluation of the biomechanical hearing process by quantification of ICSP is presented. The concept has potential as an acoustic receiver in totally implantable cochlear implants

A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation:Rationale and design of the TAVI PCI trial

Background: About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown. Study design: The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy “angiography-guided complete revascularization after (within 1-45 days) TAVI” is noninferior to the strategy “angiography-guided complete revascularization before (within 1-45 days) TAVI” using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year. Conclusions: The TAVI PCI trial tests the hypothesis that the strategy “PCI after TAVI” is noninferior to the strategy “PCI before TAVI” in patients with severe aortic stenosis and concomitant coronary artery disease.</p

Randomized Trial of Early mTOR Inhibition in Patients with Acute ST-Segment Elevation Myocardial Infarction.

BACKGROUND Early inflammation following acute ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) affects myocardial infarct (MI) size and left ventricular remodeling. The mammalian target of rapamycin (mTOR) is involved in the enhanced inflammatory response and its inhibition has exerted beneficial effects on MI size in preclinical models of acute MI. OBJECTIVES The Controlled Level EVERolimus in Acute Coronary Syndromes trial (CLEVER-ACS) evaluated the effects of targeting inflammation by mTOR inhibition in patients with STEMI undergoing PCI. METHODS CLEVER-ACS was a randomized, multicenter, international, double-blind, placebo-controlled trial. A total of 150 patients with STEMI undergoing PCI were randomly assigned to oral everolimus (days 1-3: 7.5 mg qd, days 4-5: 5.0 mg qd) or placebo for 5 days. The primary endpoint was the change in myocardial infarct size, the secondary endpoint the change in microvascular obstruction (MVO) from baseline (12 hours - 5 days after PCI) to 30 days as assessed by cardiac magnetic resonance imaging (CMR). RESULTS The changes in MI size from baseline to 30 days, the primary endpoint, were -14.2 (95% CI -17.4 to -11.1) g and -12.3 (95% CI -16.0 to -8.7) g in the everolimus and placebo groups (p=0.99). Corresponding changes in MVO were -4.8 (-6.7 to -2.9) g and -6.3 (-8.7 to -4.0) g in the everolimus and placebo groups (p=0.14). Adverse events did not differ between the study groups. CONCLUSIONS Among STEMI patients undergoing PCI, early mTOR inhibition with everolimus did not reduce MI size or MVO at 30 days

Timing of Complete Revascularization with Multivessel PCI for Myocardial Infarction

BACKGROUND In patients with ST-segment elevation myocardial infarction (STEMI) with multivessel coronary artery disease, the time at which complete revascularization of nonculprit lesions should be performed remains unknown. METHODS We performed an international, open-label, randomized, noninferiority trial at 37 sites in Europe. Patients in a hemodynamically stable condition who had STEMI and multivessel coronary artery disease were randomly assigned to undergo immediate multivessel percutaneous coronary intervention (PCI; immediate group) or PCI of the culprit lesion followed by staged multivessel PCI of nonculprit lesions within 19 to 45 days after the index procedure (staged group). The primary end point was a composite of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year after randomization. The percentages of patients with a primary or secondary end-point event are provided as Kaplan-Meier estimates at 6 months and at 1 year. RESULTS We assigned 418 patients to undergo immediate multivessel PCI and 422 to undergo staged multivessel PCI. A primary end-point event occurred in 35 patients (8.5%) in the immediate group as compared with 68 patients (16.3%) in the staged group (risk ratio, 0.52; 95% confidence interval, 0.38 to 0.72; P<0.001 for noninferiority and P<0.001 for superiority). Nonfatal myocardial infarction and unplanned ischemia-driven revascularization occurred in 8 patients (2.0%) and 17 patients (4.1%), respectively, in the immediate group and in 22 patients (5.3%) and 39 patients (9.3%), respectively, in the staged group. The risk of death from any cause, the risk of stroke, and the risk of hospitalization for heart failure appeared to be similar in the two groups. A total of 104 patients in the immediate group and 145 patients in the staged group had a serious adverse event. CONCLUSIONS Among patients in hemodynamically stable condition with STEMI and multivessel coronary artery disease, immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1 year. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.)