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ispartof: Science vol:370 issue:6518 pages:773-773 ispartof: location:United States status: published

ispartof: CIRCULATION vol:139 issue:1 pages:137-139 ispartof: location:United States status: published

Background: A major challenge of interpreting diaphragm electromyography (EMGdi) recorded with an esophageal catheter is “cross talk” from the electrocardiogram (ECG). Time-consuming manual exclusion of ECG by selecting EMGdi signals in between QRS complexes is typically applied. We developed a customized algorithm (Labview: National Instruments, Austin, TX) to automatically deduct ECG signals during analyses. Aim: To assess agreement between manual and automated EMGdi analysis methods. Methods: EMGdi (as % of maximal EMGdi) of six patients (FEV1; 45±16%pred) was obtained using both methods during each minute of endurance cycling (80% peak work rate) before (11±4 min) and after 8 weeks of respiratory muscle training (14±8 min). Results: Time spent on manual and automated analyses was 81±21min and 29±11min, respectively (p Conclusion: Automated analyses of EMGdi required less time and highly agreed with manual analyses on a group level.

Background Biatrial, extensive, and complex ablation strategies have been published for the treatment of neurally mediated syncope, sinus node dysfunction, and functional atrioventricular block. We have developed a less extensive and more specific approach compared with previously published cardioneuroablation strategies, called cardio-neuromodulation. It is based on tailored vagolysis of the sinoatrial node through partial ablation of the anterior right-ganglionated plexus, preferentially through a right-sided approach. Methods Patients with syncope were enrolled between December 2016 and December 2017. They were assigned to group A if they had a positive head-up tilt test and to group B if they presented with a pause ≥3 seconds. The area to target during cardio-neuromodulation was designed offline on a computed tomographic scan. Slow heart rates and pauses were compared during 24-hour rhythm registration at baseline, at 1-month follow-up, and 6-month follow-up. Syncope burden was assessed before the procedure and at 3- and 6-month follow-up. Results Twenty patients underwent cardio-neuromodulation through a right-sided approach (12 in group A, 8 in group B). The first application of radiofrequency energy led to a P-P interval shortening >120 ms in all 20 patients. After a mean±SD ablation time of 7±4 minutes and mean ablated surface area of 11±6 mm 2 , the P-P interval shortened by 219±160 ms ( P P P Conclusions These data indicate that cardio-neuromodulation, through a right-sided and computed tomographic–guided procedure, is safe, fast, and highly reproducible in preventing inappropriate functional sinus bradycardia and syncope recurrence.

AIMS: Quantitative Flow Ratio (QFR) based on 3-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess the physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality 9 months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES).METHODS AND RESULTS: The current post-hoc analysis was performed in the PIONEER randomized trial (1:1 randomization to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at pre-procedural, post-procedural and 9-month angiography without pharmacologically induced hyperemia (contrast QFR). At 9 months, both the values of QFR distal to the stent (B-SES: 0.89 +/- 0.10 vs. R-ZES: 0.89 +/- 0.11, p=0.97) and the numbers of the vessels with QFR =0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% versus 3.5%, P=1.00). QFR gradient across the device (?QFR) at 9 months was also similar between both groups (B-SES: 0.03 +/- 0.04 vs. R-ZES: 0.03 +/- 0.07, p=0.95).CONCLUSIONS: Quantitative flow assessment 9 months after stenting did not differ between B-SES and R-ZES, despite of a significant difference in in-stent late lumen loss.

Item does not contain fulltext BACKGROUND: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. METHODS: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. FINDINGS: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6.1%) of 758 patients in the FIREHAWK group and in 45 (5.9%) of 764 patients in the XIENCE group (difference 0.2%, 90% CI -1.9 to 2.2, pnon-inferiority=0.004, 95% CI -2.2 to 2.6, psuperiority=0.88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0.17 mm (SD 0.48) in the FIREHAWK group and 0.11 mm (0.52) in the XIENCE group (p=0.48), with an absolute difference of 0.05 mm (95% CI -0.09 to 0.18, pnon-inferiority=0.024). INTERPRETATION: In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice. FUNDING: Shanghai Microport Medical.

OBJECTIVES: The authors sought to evaluate the accuracy of instantaneous wave-Free Ratio (iFR) pullback measurements to predict post-percutaneous coronary intervention (PCI) physiological outcomes, and to quantify how often iFR pullback alters PCI strategy in real-world clinical settings.\ud \ud BACKGROUND: In tandem and diffuse disease, offline analysis of continuous iFR pullback measurement has previously been demonstrated to accurately predict the physiological outcome of revascularization. However, the accuracy of the online analysis approach (iFR pullback) remains untested.\ud \ud METHODS: Angiographically intermediate tandem and/or diffuse lesions were entered into the international, multi-center iFR GRADIENT (Single instantaneous wave-Free Ratio Pullback Pre-Angioplasty Predicts Hemodynamic Outcome Without Wedge Pressure in Human Coronary Artery Disease) registry. Operators were asked to submit their procedural strategy after angiography alone and then after iFR-pullback measurement incorporating virtual PCI and post-PCI iFR prediction. PCI was performed according to standard clinical practice. Following PCI, repeat iFR assessment was performed and the actual versus predicted post-PCI iFR values compared.\ud \ud RESULTS: Mean age was 67+/-12 years (81% male). Paired pre-and post-PCI iFR were measured in 128 patients (134 vessels). The predicted post-PCI iFR calculated online was 0.93+/-0.05; observed actual iFR was 0.92+/-0.06. iFR pullback predicted the post-PCI iFR outcome with 1.4+/-0.5% error. In comparison to angiography-based decision making, after iFR pullback, decision making was changed in 52 (31%) of vessels; with a reduction in lesion number (-0.18+/-0.05 lesion/vessel; p = 0.0001) and length (-4.4+/-1.0 mm/vessel; p < 0.0001).\ud \ud CONCLUSIONS: In tandem and diffuse coronary disease, iFR pullback predicted the physiological outcome of PCI with a high degree of accuracy. Compared with angiography alone, availability of iFR pullback altered revascularization procedural planning in nearly one-third of patients.

Evaluation of a right ventral scapula fragment from a mature Homotherium latidens from Schoningen, Germany (337–300 ka before present - MIS 9) revealed lesions consisting of an osteophyte at the caudal border of the glenoid cavity, and a large, multilobular, cystic feature in the medio-caudal glenoid cavity. Based on the type of lesions, their localization, their severity, and exclusion of several nutritional and other etiologies such as immune mediated disease, joint infection (septic arthritis), and joint tumors, we conclude that the lesion was caused by trauma or age-related shoulder osteoarthritis (or possibly both). We cannot speculate whether the condition was symptomatic, but if it was, the animal must have functioned well enough to hunt or scavenge, since it survived a significant period of lesion development.

OBJECTIVES The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). BACKGROUND Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. METHODS The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. RESULTS Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p amp;lt; 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). CONCLUSIONS Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year. (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. Funding Agencies|Philips; Upsala Clinical Research Centre; Volcano; Imperial College; Philips Volcano; Imperial College London; Medical Research Council

Based on our involvement in numerous consortia and projects with colleagues from low- and middle-income countries (LMICs), as well as on our extensive fieldwork experience in the global South, we have a shared concern on the actual inclusion of LMIC colleagues and institutions in coproducing highly valuable and policy-relevant science. While capacity building is stated as a major goal in various international research projects, especially when involving partners from LMICs or when focusing on research activities in these countries, we think that research from established groups and universities particularly in member countries of the Organisation for Economic Cooperation and Development (OECD), receives more interest and respect on a disproportionate basis. With the present submission, we hope to feed the debate on the academic valorization of research performed by LMICs scholars. Though difficult to measure, this merits close scrutiny.

The goal of this study was to evaluate muscle activation onset times (MAOT) of both legs during a transition task from double-leg stance (DLS) to single-leg stance (SLS) in anterior cruciate ligament injured (ACLI) (n=15) and non-injured control subjects (n=15) with eyes open and eyes closed. Significantly delayed MAOT were found in the ACLI group compared to the control group for vastus lateralis, vastus medialis obliquus, hamstrings medial, hamstrings lateral, tibialis anterior, peroneus longus and gastrocnemius in both vision conditions, for gluteus maximus and gluteus medius with eyes open and for tensor fascia latae with eyes closed. Within the ACLI group, delayed MAOT of tibialis anterior with eyes open and gastrocnemius with eyes closed were found in the injured leg compared to the non-injured leg. All other muscles were not significantly different between legs. In conclusion, the ACLI group showed delayed MAOT not only around the knee, but also at the hip and ankle muscles compared to the non-injured control group. No differences between both legs of the ACLI group were found, except for tibialis anterior and gastrocnemius. These findings indirectly support including central nervous system re-education training to target the underlying mechanisms of these altered MAOT after ACL injury.

Context Participants with chronic ankle instability (CAI) use an altered neuromuscular strategy to shift weight from double-legged to single-legged stance. Shoes and foot orthoses may influence these muscle-activation patterns. Objective To evaluate the influence of shoes and foot orthoses on onset times of lower extremity muscle activity in participants with CAI during the transition from double-legged to single-legged stance. Design Cross-sectional study. Setting Musculoskeletal laboratory. Patients or Other Participants A total of 15 people (9 men, 6 women; age = 21.8 ± 3.0 years, height = 177.7 ± 9.6 cm, mass = 72.0 ± 14.6 kg) who had CAI and wore foot orthoses were recruited. Intervention(s) A transition task from double-legged to single-legged stance was performed with eyes open and with eyes closed. Both limbs were tested in 4 experimental conditions: (1) barefoot (BF), (2) shoes only, (3) shoes with standard foot orthoses, and (4) shoes with custom foot orthoses (SCFO). Main Outcome Measure(s) The onset of activity of 9 lower extremity muscles was recorded using surface electromyography and a single force plate. Results Based on a full-factorial (condition, region, limb, vision) linear model for repeated measures, we found a condition effect (F3,91.8 = 9.39, P < .001). Differences among experimental conditions did not depend on limb or vision condition. Based on a 2-way (condition, muscle) linear model within each region (ankle, knee, hip), earlier muscle-activation onset times were observed in the SCFO than in the BF condition for the peroneus longus (P < .001), tibialis anterior (P = .003), vastus medialis obliquus (P = .04), and vastus lateralis (P = .005). Furthermore, the peroneus longus was activated earlier in the shoes-only (P = .02) and shoes-with-standard-foot-orthoses (P = .03) conditions than in the BF condition. No differences were observed for the hip muscles. Conclusions Earlier onset of muscle activity was most apparent in the SCFO condition for ankle and knee muscles but not for hip muscles during the transition from double-legged to single-legged stance. These findings might help clinicians understand how shoes and foot orthoses can influence neuromuscular control in participants with CAI.

The goal of this study was to evaluate postural stability during the transition from double-leg stance (DLS) to single-leg stance (SLS) in anterior cruciate ligament reconstructed (ACLR) (n=20) and non-injured control subjects (n=20). All ACLR subjects had fully returned to their pre-injury sport participation. Both groups were similar for age, gender, height, weight, body mass index and activity level. Spatiotemporal center of pressure outcomes of both legs of each subject were measured during the transition from DLS to SLS in eyes open and eyes closed conditions. Movement speed was standardized. The center of pressure displacement after a new stability point was reached during the SLS phase was significantly increased in the ACLR group compared to the control group in the eyes closed condition (P=.001). No significant different postural stability outcomes were found between the operated and non-operated legs. In conclusion, the ACLR group showed postural stability deficits, indicating that these persons may have a decreased ability to stabilize their body after the internal postural perturbation created by the transition from DLS to SLS. The non-operated leg may not be the best reference when evaluating postural stability of the operated leg after ACLR, as no differences were found between legs.

The MEDCOR trial is a double-blind, randomized study aiming at demonstrating the superiority of molsidomine (direct NO donor) over placebo, used as add-on treatments, on improving endothelial function (EF) after 12 months, in stable angina patients undergoing percutaneous coronary intervention.EF was assessed by peripheral vasodilator response (i.e. Endoscore) using arterial tonometry and by several biomarkers, in terms of changes versus baseline after a one-year treatment.The change in Endoscore was +75 ± 130% in placebo group and +39 ± 145% in molsidomine group (p = 0.143). There was a decrease in sICAM-1 with molsidomine (-6%) and an increase with placebo (+6%). The MPO activity/antigen ratio slightly increased with placebo (+9%) and strongly decreased with molsidomine (-42%) (p = 0.020).The MEDCOR trial was not able to demonstrate significant differences between molsidomine and placebo for all parameters, except the MPO activity/antigen ratio which significantly decreased with molsidomine (p = 0.020 versus placebo).

BACKGROUND: Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. METHODS: We randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk. RESULTS: At 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, -0.2 percentage points; 95% confidence interval [CI], -2.3 to 1.8; P

In a ranking of the gross domestic product per capita in 2015, Belgium ranked 19th in the world according to the International Monetary Fun1d and the World Bank. It has a Human Development Index of 0.890, in which it is preceded by only 20 other countries in the world. This is, at least in part, due to a well-developed social security system on which all citizens can rely. Over the last 5-10 years, however, this system has come under increasing pressure. This has resulted in insufficient, incomplete and late reimbursement of all technologies that were introduced over the last ten years in the cathlab: intracoronary imaging techniques are not reimbursed at all, and FFR only to a vastly insufficient degree. For several structural heart interventions, a system of limited and incomplete reimbursement has recently been set up, with a requirement to organise these procedures within the frames of hospital networks. Numbers of PCIs have risen by 15% over the last four years, coinciding with an increase in the number of cathlabs by 50%, aiming at better access to primary PCI for STEMI patients. This has also resulted in a decrease in the average procedure volume per centre. Two thirds of PCIs are performed via the radial access. DES penetration has increased to 74%, approaching 100% in some centres, while the uptake of BRS has been very limited so far.

Recent developments in wireless capture of muscle activity signals have improved the freedom of motion and the ease of use. Nevertheless, no study has examined the quality of wireless electromyographic technology during water activities. In this study the performance of a surface electromyography (SEMG) wireless system on dry land and in water was compared. Tibialis anterior muscle activity of 1 subject while contracting against a resistance of 84 Newton (N) was measured in 2 conditions: using a wireless (KINE) system with waterproof taping on the pool deck and submerged. Analysis of the raw signal showed acceptable ratios of 37 to 44 decibel (dB) between rest activity and the force activity at 84 N in both conditions. The total spectrum analysis and short term frequency analysis showed that no filtering occurred in either of the two conditions as frequencies were picked up in the entire spectrum. Spectrum analysis of rest activity or of the force buildup showed no spikes indicating any pickup of noise. The wireless system produced clean results and submersion and as a consequence recollection from the memory of the unit did not cause additional noise. Furthermore, the wireless system provided a satisfactory signal-to-rest activity ratio of approximately 40 dB and a range of 4 millivolts (mV). The KINE EMG units provided a valid means to analyze muscle activity during swimming while permitting unrestricted movement and ease of use.

Objectives To evaluate the first experience of real-time instantaneous wave–free ratio (iFR) measurement by clinicians. Background The iFR is a new vasodilator-free index of coronary stenosis severity, calculated as a trans-lesion pressure ratio during a specific period of baseline diastole, when distal resistance is lowest and stable. Because all previous studies have calculated iFR offline, the feasibility of real-time iFR measurement has never been assessed. Methods Three hundred ninety-two stenoses with angiographically intermediate stenoses were included in this multicenter international analysis. Instantaneous wave–free ratio and fractional flow reserve (FFR) were performed in real time on commercially available consoles. The classification agreement of coronary stenoses between iFR and FFR was calculated. Results Instantaneous wave–free ratio and FFR maintain a close level of diagnostic agreement when both are measured by clinicians in real time (for a clinical 0.80 FFR cutoff: area under the receiver operating characteristic curve [ROCAUC] 0.87, classification match 80%, and optimal iFR cutoff 0.90; for a ischemic 0.75 FFR cutoff: iFR ROCAUC 0.90, classification match 88%, and optimal iFR cutoff 0.85; if the FFR 0.75-0.80 gray zone is accounted for: ROCAUC 0.93, classification match 92%). When iFR and FFR are evaluated together in a hybrid decision-making strategy, 61% of the population is spared from vasodilator while maintaining a 94% overall agreement with FFR lesion classification. Conclusion When measured in real time, iFR maintains the close relationship to FFR reported in offline studies. These findings confirm the feasibility and reliability of real-time iFR calculation by clinicians., Graphical Abstract

Spontaneous coronary artery dissection is a rare cause of myocardial infarction in young, otherwise healthy people. We present a case report of a 37-year-old woman, without cardiovascular risk factors, who survived a major acute myocardial infarction due to multi-vessel spontaneous coronary artery dissection which was complicated by cardiogenic shock in the third week postpartum. She fully recovered with medical therapy in combination with angioplasty. Learning objective: Acute myocardial infarction (AMI) during pregnancy and postpartum is a rare but often catastrophic event and spontaneous coronary artery dissection is the most frequent cause of AMI in this population. Because of the high mortality rate, it is important to recognize this entity in the early stage of presentation. Coronary angiography remains the golden standard and should be performed without hesitation in unstable patients.>

Background Radiofrequency ablation (RFA) can unfavorably cause coagulum on the ablation electrode. The aim of this study was to assess this phenomenon on three different multielectrode catheters used to treat persistent atrial fibrillation with duty-cycled RFA. Methods and results Twenty-six consecutive patients have been treated with the pulmonary vein ablation catheter (PVAC) and the multiarray ablation catheter (MAAC). In 13 patients, additional ablation with the multiarray septal catheter (MASC) has been performed. The multichannel RF generator GENius™ (Medtronic Inc., Minneapolis, MN, USA) independently delivered energy in a bipolar and unipolar mode (ratio of 4/1, 2/1, or 1/1) to any of the electrodes. Versions 14.2, 14.3, and 14.4 of the generator were used. Coagulum presence was determined postablation by careful visual inspection of the catheter electrodes. No coagulum formation was visualized on the PVACs. Coagulum formation was visualized in 59% of the electrodes of the MAACs using a 2/1 mode and the 14.2 software version versus 69% using the 14.4 version and a 2/1 mode (P = 0.7) versus 14% of the electrodes applying a 1/1 ratio and the 14.4 software version (P < 0.001). Conclusions Duty-cycled RFA in 2/1 bipolar/unipolar ratio generates a substantial frequency of coagulum formation on the multielectrode catheters MAAC and MASC. The use of the 14.4 version of the software to drive the RF generator and the use of energy in the default 1/1 bipolar/unipolar ratio could significantly reduce the frequency of coagulum formation, but so far, could not completely overcome it. The PVAC did not form coagulum, regardless of generator version or energy ratio used.

Early predictability of sustained response to atypical antipsychotics in patients with schizophrenia has important implications for clinical decision making. In order to investigate whether early onset of efficacy correlates with week-6 response for the selective fast-dissociating D 2 receptor antagonist JNJ-37822681, we analysed data from a 12-week placebo- and active-controlled (olanzapine) study designed to evaluate efficacy and safety of JNJ-37822681. Factors, including baseline Positive and Negative Syndrome Scale (PANSS) total score, waist circumference, weight, body mass index group, number of previous hospitalisations, age at diagnosis, race, sex and age at study entry, and relative (%) change from baseline on day 3 (early improvement) in PANSS total score, were analysed using logistic regression models and receiver operator characteristic (ROC) curve analysis, to predict the week-6 efficacy response (≥30% improvement in PANSS total score). Results showed that week-6 response with JNJ-37822681 30 mg bid treatment could be reliably predicted by improvement in PANSS total score on day 3, the number of previous hospitalisations, and race (80% accuracy [ROC area under curve]). Early improvement (day 3) in PANSS score had the highest predictive value as a single factor across all JNJ-37822681 doses. At a specificity of 70%, sensitivity for predicting week-6 response was: 0.60, 0.64, and 0.74 in the 10-, 20-, and 30 mg bid JNJ-37822681 groups, respectively; 0.40 in olanzapine group. Early improvement in PANSS may be a simple and reliable way to predict sustained response with JNJ-37822681 in patients with acute schizophrenia.

In this multicenter, double-blind, placebo-controlled, randomized, four way cross-over proof-of-mechanism study, we tested the effect of the positive allosteric α7 nicotinic acetylcholine receptor (nAChR) modulator JNJ-39393406 in a key translational assay (sensory P50 gating) in 39 regularly smoking male patients with schizophrenia. All patients were clinically stable and JNJ-39393406 was administered as an adjunct treatment to antipsychotics. No indication was found that JNJ-39393406 has the potential to reverse basic deficits of information processing in schizophrenia (sensory P50 gating) or has a significant effect on other tested electrophysiological markers (MMN, P300 and quantitative resting EEG). Sensitivity analyses including severity of disease, baseline P50 gating, medication and gene variants of the CHRNA7 gene did not reveal any subgroups with consistent significant effects. It is discussed that potential positive effects in subgroups not present or not large enough in the current study or upon chronic dosing are possible, but unlikely to be developed. This article is part of a Special Issue entitled ‘Cognitive Enhancers’.

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Museum Natl Hist Nat, Paris, France Port Elizabeth Museum, Port Elizabeth, South Africa Sam Noble Museum, Norman, OK USA Harvard Univ, Museum Comparat Zool, Cambridge, MA 02138 USA North West Univ, Potchefstroom, South Africa Museu Nacl, Rio De Janeiro, Brazil Nat Hist Museum, Basel, Switzerland Senckenberg Nat Kundemuseum, Gorlitz, Germany North Carolina Museum Nat Sci, Raleigh, NC USA Univ Rennes 1, Rennes, France Univ Sao Paulo, Museu Zool, Sao Paulo, SP, Brazil Amer Museum Nat Hist, New York, NY 10024 USA Univ Huddersfield, Huddersfield, W Yorkshire, England North Dakota State Univ, Fargo, ND USA Univ Sao Paulo, Sao Paulo, SP, Brazil Fac Sci Sfax, Sfax, Tunisia DPTC PC, Manaus, Amazonas, Brazil Louisiana State Univ, Museum Nat Sci, Baton Rouge, LA 70803 USA Zool Survey India, Kolkata, India Univ Tennessee, Chattanooga, TN USA Ohio State Univ, Columbus, OH 43210 USA Univ Luterana Brasil, Museu Ciencias Nat, Canoas, Brazil Univ Firenze, Florence, Italy Univ Ovidius Constanta, Constanta, Romania Univ Mississippi, Oxford, MS USA Royal Belgian Inst Nat Sci, Brussels, Belgium Univ New Mexico, Albuquerque, NM 87131 USA Inst Nacl de Pesquisas da Amazonia, Manaus, Amazonas, Brazil Univ Stellenbosch, Matieland, South Africa Univ Fed Minas Gerais, Belo Horizonte, MG, Brazil CIBIO Ctr Invest Biodiversidade & Recursos Genet, Vairao, Portugal Museum Hist Nat, Geneva, Switzerland Univ Fed Mato Grosso, Cuiaba, Brazil Univ Austral Chile, Valdivia, Chile Univ Malaysia, Sarawak, Malaysia Indian Inst Sci, Bangalore, Karnataka, India Scottish Assoc Marine Sci, Oban, Argyll, Scotland Sam Houston State Univ, Huntsville, TX 77340 USA Museo Nacl Ciencias Nat, Madrid, Spain Sorbonne Univ, CR2P, Museum Natl Hist Nat, Paris, France Drexel Univ, Acad Nat Sci, Philadelphia, PA 19104 USA Univ Richmond, Richmond, VA 23173 USA Ctr Pesquisas Cacau, Itabuna, Brazil Univ Torino, Turin, Italy Soc Hist Nat Alcide dOrbigny, Aubiere, France Wolfden Sci Consulting, Murcia, Spain Univ Fed Rio de Janeiro, Macae, Brazil Univ Tennessee, Knoxville, TN USA Inst Humboldt, Villa De Leyva, Colombia Escuela Politec Nacl, Quito, Ecuador Calif Acad Sci, San Francisco, CA 94118 USA Museum Dept Hist Nat Var, Toulon, France Nat Environm & Wildlife Soc, Angul, India Univ Kansas, Lawrence, KS 66045 USA Kyoto Univ, Kyoto, Japan Consejo Nacl Invest Cient & Tecn, Museo Argentino Ciencias Nat Bernardino Rivadavia, Buenos Aires, DF, Argentina Univ Fed Paraiba, Joao Pessoa, Paraiba, Brazil Univ Fed Parana, Curitiba, Parana, Brazil Univ Fed Rio de Janeiro, Rio De Janeiro, Brazil Nat Hist Museum Narodini Museum, Prague, Czech Republic Nat Hist Museum Zimbabwe, Bulawayo, Zimbabwe Ateneo Manila Univ, Quezon City, Philippines Pontificia Univ Javeriana, Bogota, Colombia RACINE, St Maugan, France Univ Paris 06, Sorbonne Univ Paris, ISYEB, Paris, France Ocean Univ China, Qingdao, Peoples R China Museo Nacl Hist Nat Paraguay, San Lorenzo, Paraguay Univ Carabobo, Valencia, Venezuela Natl Ctr Biol Sci, Bengaluru, India Univ Nebraska, Lincoln, NE USA CENAK Ctr Nat Kunde, Hamburg, Germany Ohio Hist Connect, Columbus, OH USA Univ Fed Amazonas, Manaus, Amazonas, Brazil Univ Malaga, Malaga, Spain Chinese Acad Sci, Qingdao, Shandong, Peoples R China Benemerita Univ Autonoma Puebla, Puebla, Mexico Natl Polytech Inst, Ctr Res & Adv Studies, Irapuato, Mexico Field Museum Nat Hist, Chicago, IL 60605 USA Univ Texas El Paso, El Paso, TX 79968 USA Univ Fed Lavras, Lavras, Brazil Nat Hist Museum, Vienna, Austria La Sierra Univ, Riverside, CA USA Univ San Francisco Quito, Quito, Ecuador Univ Hong Kong, Hong Kong, Peoples R China CUNY, New York, NY 10021 USA CAS, Inst Vertebrate Biol, Brno, Czech Republic Sorbonne Univ, MECADEV, Museum Natl Hist Nat, Paris, France Univ Estadual Paulista, Rio Claro, Brazil Zool Staatssammlung Munchen, Munich, Germany Univ Michigan, Dearborn, MI 48128 USA Smithsonian Inst, Natl Museum Nat Hist, Washington, DC USA Helmholtz Ctr Environm Res, Leipzig, Germany Santa Rosa Jr Coll, Santa Rosa, CA USA George Washington Univ, Washington, DC 20037 USA Inst Teknol Bandung, Bandung, Indonesia Earlham Coll, Richmond, IN USA Senckenberg Forschungsinst & Nat Museum, Frankfurt, Germany Univ Estadual Londrina, Londrina, Parana, Brazil Univ Koblenz Landau, Koblenz, Germany Nat Hist Museum, London, England Ditsong Natl Museum Nat Hist, Pretoria, South Africa Bombay Nat Hist Soc, Bombay, Maharashtra, India Philipps Univ Marburg, Marburg, Germany Hess Landesmuseum, Darmstadt, Germany Smithsonian Conservat Biol Inst, Washington, DC USA Univ Pannonia, Keszthely, Hungary Staatliches Museum Nat Kunde, Stuttgart, Germany UFT, Tocantins, Portugal Museum Nat Kunde, Berlin, Germany Nat Hist Riksmuseet, Stockholm, Sweden Hikarigaoka, Munakata, Japan Inst Agr & Environm Sci, Tartu, Estonia Univ Los Andes, Merida, Venezuela Bat Jungle, Monteverde, Costa Rica Texas A&M Univ, College Stn, TX USA Yale Univ, New Haven, CT USA Univ Estadual Paulista, Sao Jose Do Rio Preto, Brazil Museo Nacl Hist Nat, Montevideo, Uruguay Consejo Nacl Invest Cient & Tecn, Fdn Miguel Lillo, San Miguel De Tucuman, Argentina Roger Tory Peterson Inst Nat Hist, Jamestown, VA USA Univ Fed Reconcavo Bahia, Cruz Das Almas, Brazil South China Normal Univ, Guangzhou 510631, Guangdong, Peoples R China Museu Ciencias Tecnol PUCRS, Porto Alegre, RS, Brazil Univ Fed Tocantins, Porto Nacl, Brazil Univ Toronto, Scarborough, ON, Canada Univ Nacl Colombia, Inst Ciencias Nat, Bogota, Colombia Natl Museum Philippines, Manila, Philippines NOVA Univ Lisbon, Caparica, Portugal Royal Saskatchewan Museum, Regina, SK, Canada Deutsch Zentrum Marine Biodiversitatsforsch, Hamburg, Germany Ctr Invest Biol Noroeste, La Paz, Mexico Naturalis Biodivers Ctr, Leiden, Netherlands Univ Douala, Douala, Cameroon Vet & Farmaceut Univ Brno, Brno, Czech Republic Univ Swaziland, Kwaluseni, Eswatini Fundacao Oswaldo Cruz, Rio De Janeiro, Brazil Univ Claude Bernard, Lyon, France Museum Vertebrate Zool, Berkeley, CA USA Smithsonian Inst, Washington, DC 20560 USA Nat Hist Museum & Inst, Chiba, Japan Senckenberg Biodiversitat & Klima Forschunsgzentr, Frankfurt, Germany Marquette Univ, Milwaukee, WI 53233 USA Univ Firenze, Museo Storia Nat, Florence, Italy Univ Fed Bahia, Salvador, BA, Brazil Fed Univ ABC, Sao Bernardo, Brazil Univ Fed Goias, Goiania, Go, Brazil Univ Alaska Museum, Fairbanks, AK USA Egerton Univ, Egerton, Kenya Museo Hist Nat, Lima, Peru IKIAM Univ Reg Amazon, Tena, Ecuador Univ Hyogo, Sanda, Japan Inst Rech Dev, Paris, France Univ Sao Paulo, Piracicaba, Brazil Niedersachs Landesbetrieb Wasserwirtschaft Kusten, Hannover, Germany Univ Complutense Madrid, Madrid, Spain Consejo Nacl Invest Cient & Tecn, Ctr Nacl Patagon, Puerto Madryn, Argentina Roosevelt Univ, Coll Profess Studies, Chicago, IL 60605 USA Western Kentucky Univ, Bowling Green, KY 42101 USA Univ Naples Federico II, Naples, Italy Univ Fed Acre, Rio Branco, Acre, Brazil Univ Fed Santa Catarina, Florianopolis, SC, Brazil Inst Bio & Geociencias Noroeste Argentino, Salta, Argentina Inst Venezolano Invest Cient, Caracas, Venezuela Umweltbundesamt, Vienna, Austria Penclen, Plumelec, France CNRS MNHN UPMC, Ctr Rech Paleobiodivers & Paleoenvironm, Paris, France Staatl Museum Nat Kunde, Stuttgart, Germany Consejo Nacl Invest Cient & Tecn, Museo Argentino Ciencias Nat Bernardino Rivada, Buenos Aires, DF, Argentina Ctr Biol Gest Populat INRA, Montferrier Sur Lez, France Loyola Univ Chicago, Chicago, IL USA Pontificia Univ Catolica Rio do Sul, Porto Alegre, RS, Brazil Durban Museum Nat Sci, Durban, South Africa Univ Estado Amazonas, Manaus, Amazonas, Brazil Brigham Young Univ, Provo, UT 84602 USA Museo Hist Nat La Salle, Caracas, Venezuela Univ Vet Med Hannover, Hannover, Germany Australian Museum, Sydney, NSW, Australia Texas Tech Univ, Lubbock, TX 79409 USA Francis Marion Univ, Florence, SC USA Univ Washington, Seattle, WA 98195 USA Univ Connecticut, Groton, CT USA Fed Univ ABC, Santo Andre, SP, Brazil Univ Fed Uberlandia, Uberlandia, MG, Brazil Fed Univ Para, Belem, Para, Brazil Yale Peabody Museum, New Haven, CT USA Univ Texas Arlington, Arlington, TX 76019 USA Senckenberg Deutsch Entomol Inst, Muncheberg, Germany CSIRO, Natl Res Collect, Canberra, ACT, Australia Univ Venda, Thohoyandou, South Africa Univ Ulsan, Ulsan, South Korea Univ Estadual Sao Paulo, Botucatu, SP, Brazil Senckenberg Forsch Inst & Nat Museum, Frankfurt, Germany Ocean Univ China, Inst Marine Biodivers & Evolut, Qingdao, Shandong, Peoples R China Univ Fed Para, Altamira, Brazil Univ Estadual Paulista, Assis, Brazil UPMC, Ctr Rech Paleobiodiversite & Paleoenvironm, CNRS, MNHN, Paris, France Tech Univ Kaiserslautern, Kaiserslautern, Germany Charles Univ Prague, Dept Zool, Prague, Czech Republic Univ Nacl Expt los Llanos Occident Ezequiel Zamor, Guanare, Venezuela Long Isl Univ, Brooklyn, NY USA Univ Ryukyus, Okinawa, Japan Pontificia Univ Catolica Ecuador, Museo Zool, Escuela Ciencias Biol, Quito, Ecuador Indiana Univ Penn, Indiana, PA USA IRD, Dakar, Senegal State Museum Nat Hist Karlsruhe, Karlsruhe, Germany Univ Toulouse III Paul Sabatier, Toulouse, France Univ Ghent, Ghent, Belgium Univ Antwerp, Antwerp, Belgium Karlsruhe Inst Technol, Karlsruhe, Germany Ctr Cellular & Mol Biol, Hyderabad, India Univ Fed ABC, Santo Andre, Brazil Yale Peabody Museum Nat Hist, New Haven, CT USA Univ Innsbruck, Mondsee, Austria Bethune Cookman Univ, Daytona Beach, FL USA Natl Museum Nat & Sci, Tokyo, Japan Zool Garten Koln, Cologne, Germany Univ Estadual Paulista, Botucatu, SP, Brazil Univ Estadual Paulista, Sao Vicente, Brazil Univ Estadual Paulista, Rio Claro, Brazil Univ Estadual Paulista, Sao Jose Do Rio Preto, Brazil Univ Estadual Paulista, Assis, Brazil

BACKGROUND: Previous studies mainly focused on muscles at the operated knee after anterior cruciate ligament reconstruction, less on muscles around other joints of the operated and non-operated leg. The aim of this study was to investigate muscle activation onset times during the transition from double-leg stance to single-leg stance in anterior cruciate ligament reconstructed subjects. METHODS: Lower extremity muscle activation onset times of both legs of 20 fully returned to sport anterior cruciate ligament reconstructed subjects and 20 non-injured control subjects were measured during the transition from double-leg stance to single-leg stance in eyes open and eyes closed conditions. Analysis of covariance (ANCOVA) was used to evaluate differences between groups and differences between legs within both groups, while controlling for peak center of pressure velocity. FINDINGS: Significantly delayed muscle activation onset times were found in the anterior cruciate ligament reconstructed group compared to the control group for gluteus maximus, gluteus medius, vastus medialis obliquus, medial hamstrings, lateral hamstrings and gastrocnemius in both eyes open and eyes closed conditions (P.05). INTERPRETATION: Despite completion of rehabilitation and full return to sport, the anterior cruciate ligament reconstructed group showed neuromuscular control deficits that were not limited to the operated knee joint. Clinicians should focus on relearning multi-segmental anticipatory neuromuscular control strategies after anterior cruciate ligament reconstruction. publisher: Elsevier articletitle: Lower extremity muscle activation onset times during the transition from double-leg stance to single-leg stance in anterior cruciate ligament reconstructed subjects journaltitle: Clinical Biomechanics articlelink: http://dx.doi.org/10.1016/j.clinbiomech.2016.04.014 content_type: article copyright: © 2016 Elsevier Ltd. All rights reserved. ispartof: Clinical Biomechanics vol:35 pages:116-123 ispartof: location:England status: published

Although there still is conflicting evidence whether schizophrenia is a neurodegenerative disease, cognitive changes in schizophrenia resemble those observed during normal aging. In contrast to extensively demonstrated deficits in explicit learning, it remains unclear whether implicit sequence learning is impaired in schizophrenia and normal aging. Implicit sequence learning was investigated using a computerized drawing task, the implicit pattern learning task (IPLT) in 30 stable patients with schizophrenia, 30 age-matched controls and 30 elderly subjects on two consecutive days and after 1 week (sessions 1, 2 and 3). Fixed sequence trials were intermixed with random trials, and sequence learning was assessed by subtraction of the response time in fixed sequence trials from random trials. Separate analyses of response times and movement accuracy (i.e., directional errors) were performed. Explicit sequence knowledge was assessed using three different awareness tasks. All groups learned equally during sessions 1 and 2. In session 3, control subjects showed significantly larger learning scores than patients with schizophrenia (p = .012) and elderly subjects (p = .021). This group difference is mainly expressed in movement time and directional errors. Patients with schizophrenia demonstrated less subjective sequence awareness, and both patients with schizophrenia and elderly subjects had less explicit sequence recall. Explicit recall was positively correlated with task performance in all groups. After a short 24 h interval, all subjects showed similar improvements in implicit sequence learning. However, no benefit of prior task exposure 1 week later was observed in patients with schizophrenia and elderly subjects compared to controls. As patients with schizophrenia and elderly both display less explicit sequence recall, the control group superiority after 1 week could be explained by an explicit learning component. The few patients with schizophrenia and elderly subjects who had some sequence recall could possibly utilize this explicit knowledge to improve their task performance but did this by distinct mechanisms.

Background The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions. Methods and Materials This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n = 72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR). Results At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66 ± 0.61 mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup. Conclusion Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective.

JNJ-37822681 is a novel, highly selective dopamine D 2 receptor antagonist characterized by a rapid dissociation rate from the dopamine D 2 receptor. This profile was hypothesized to confer antipsychotic efficacy and improved tolerability. In this 12-week study, the efficacy and safety of JNJ-37822681 were evaluated in patients with an acute exacerbation of schizophrenia, randomly assigned (1:1:1:1:1) to JNJ-37822681 (10-, 20- or 30-mg bid), olanzapine (15 mg once-daily), or placebo (for 6 weeks followed by olanzapine for 6 weeks). Of 498 randomized patients, 298 (60%) completed the study. All JNJ-37822681 dose groups and the olanzapine group showed significantly greater reduction in PANSS total score from baseline to week 6 versus placebo (all p-values

The majority of investigations in hand cycling thus far were carried out in little realistic conditions, particularly with regard to ergonomics and mechanical characteristics such as steering and stabilization mechanisms. In addition, integrated investigations studying both the physiological and biomechanical responses during realistic maximal and submaximal hand cycling have not yet been conducted. This paper illustrates the design, the working, and the possibilities of a newly developed handbike ergometer that simulates hand cycling in realistic ergonomic and mechanical conditions with a continuous control of the workload. Built-in force transducers in both crank handles allow the registration of the orthogonal force components in three dimensions along a pre-defined X, Y, and Z-axes in function of time and/or position. Consequently, the resultant force and the forces exerted in each plane of the test person can be calculated to evaluate the forward, upward, and sideward force generation during hand cyc...

Freezing of gait (FOG) is an incapacitating problem in Parkinson's disease that is difficult to manage therapeutically. We tested the hypothesis that impaired rhythm and amplitude control is a common mechanism of freezing which is also present during other rhythmic tasks. Therefore, we compared the occurrence and spatiotemporal profiles of freezing episodes during upper limb motion, lower limb motion, and FOG. Eleven freezers, 12 non-freezers, and 11 controls performed a rhythmic bilateral finger movement task. The triggering effect of movement speed, amplitude, and coordination pattern was evaluated. Regression slopes and spectral analysis addressed the spatial and temporal kinematic changes inherent to freezing episodes. The FOG Questionnaire score significantly predicted severity of upper limb freezing, present in 9 freezers, and of foot freezing, present in 8 freezers. Similar to gait, small-amplitude movements tended to trigger upper limb freezing, which was preceded by hastened movement and a strong amplitude breakdown. Upper limb freezing power spectra were broadband, including increased energy in the "freeze band" (3-8 Hz). Contrary to FOG, unilateral upper limb freezing was common and occurred mainly on the disease-dominant side. The findings emphasize that a core motor problem underlies freezing which can affect various movement effectors. This deficit may originate on the disease-dominant body side and interfere with amplitude and timing regulation during repetitive limb movements. These results may shift current thinking on the origins of freezing as being not exclusively a gait failure. © 2011 Movement Disorder Society. ispartof: Movement Disorders vol:27 issue:2 pages:254-263 ispartof: location:United States status: published

Context: Acceptable measurement stability during data collection is critically important to research. To interpret differences in measurement outcomes among participants or changes within participants after an intervention program, we need to know whether the measurement is stable and consistent. Objective: To determine the within-session stability of muscle activation patterns for a voluntary postural-control task in a group of noninjured participants and a group of participants with chronic ankle instability (CAI). Design: Descriptive laboratory study. Setting: Musculoskeletal laboratory. Patients or Other Participants: Twenty control participants (8 men, 12 women; age = 21.8 ± 2.4 years, height = 164.3 ± 13.4 cm, mass = 68.4 ± 17.9 kg) and 20 participants with CAI (12 men, 8 women; age = 21.2 ± 2.1 years, height = 176 ± 10.2 cm, mass = 71.7 ± 11.3 kg). Intervention(s): Participants performed 4 barefoot standing trials, each of which included a 30-second double-legged stance followed by a 30-second single-legged stance in 3 conditions: with vision, without vision, and with vision on a balance pad. Main Outcome Measure(s): The activity of 7 muscles of the lower limb was measured for the stance task in the 3 different conditions for each trial. The onset of muscle activity and muscle recruitment order were determined and compared between the first and the fourth trials for both groups and for each condition. Results: We found no differences in the onset of muscle activity among trials for both groups or for each condition. The measurement error was 0.9 seconds at maximum for the control group and 0.12 seconds for the CAI group. In the control group, 70% to 80% of the participants used the same muscle recruitment order in both trials. In the CAI group, 75% to 90% used the same recruitment order. Conclusions: Within 1 session, measurement stability for this task was acceptable for use in further research. Furthermore, no differences were found in measurement stability across conditions in the control or CAI groups.

The purpose of this study was to compare the peak and submaximal metabolic and cardiorespiratory responses during steady-state arm-powered (AP) and arm-trunk-powered (ATP) handbike ergometry. Twelve male able-bodied participants with no prior experience in handcycling completed a maximal progressive incremental test and a series of 6-minute submaximal tests at 130 W with various cadences in a custom-designed handbike ergometer that allowed a realistic simulation of AP and ATP handcycling. Peak power output, peak oxygen uptake, and peak ventilation were significantly lower, whereas peak blood lactate concentration was significantly higher during AP handcycling. Mean gross mechanical efficiency was significantly higher during AP handcycling (range 16.7 to 20.5%) compared with ATP handcycling (range 15.8 to 17.6%). These results suggest that AP handcycling is advantageous during submaximal steady-state handcycling, whereas ATP handcycling allows for a higher peak power output generation. However, it remains unclear which handbike configuration would be favorable during competition.

Dissection of the ascending aorta is a very rare but life-threatening complication during diagnostic angiography. We present a case of an elderly woman who underwent an elective diagnostic coronary angiography, complicated with an iatrogenic ascending aorta dissection that did not involve the coronary arteries but originated 4 cm distal of the aortic valve. The patient developed cardiogenic shock due to acute pericardial tamponade and so immediate, life-saving cardiac surgery with implantation of a supracoronary graft was successfully performed. A biopsy from the excised aorta showed loss of smooth muscle cells and accumulation of basophilic ground substance, clear features of cystic media necrosis. This is believed to be the underlying cause of the dissection besides a nonselective injection of the right coronary artery.

[Kogame, Norihiro; Asano, Taku; Chichareon, Ply; Modolo, Rodrigo; Takahashi, Kuniaki] Acad Med Ctr, Amsterdam, Netherlands. [Chang, Chun-Chin] Taipei Vet Gen Hosp, Taipei, Taiwan. [Katagiri, Yuki] Univ Amsterdam, Acad Med Ctr, Amsterdam, Netherlands. [Janssens, Luc] Imlealdaziekenhuis, Bonheiden, Belgium. [Lemos, Pedro A.] Univ Sao Paulo, Fac Med, Inst Coracao InCor, Sao Paulo, SP, Brazil. [Macaya, Carlos] Hosp Clin San Carlos, IdISSC, Madrid, Spain. [Jasionowicz, Pawel] Nyskie Ctr Kardiol, Sklodowskiej Curie, Nysa, Poland. [Kukreja, Neville] Hertfordshire Cardiac Ctr, Stevenage, Herts, England. [Abdellaoui, Mohamed] CH Grp Hosp Mutualiste, Grenoble, France. [Onuma, Yoshinobu] Erasmus MC, Thoraxctr, Rotterdam, Netherlands. [Vranckx, Pascal] Hartctr Hasselt, Hasselt, Belgium. [Valgimigli, Marco] Inselpsital, Swiss Cardiovasc Ctr, Bern, Switzerland. [Windecker, Stephan] Univ Hosp Bern, Bern, Switzerland. [Serruys, Patrick] Imperial Coll, London, England.

The aim of this study is to compare the safety and efficacy of the biodegradable polymer coated sirolimus-eluting coronary stent (SES, BioMime™, Meril Life Sciences, India) with durable polymer coated everolimus-eluting coronary stent (EES, XIENCE family, Abbott Vascular, California, USA) in de

Objectives The aim of this study was to assess the risk-benefit of enoxaparin (Sanofi-Aventis, Paris, France) in primary percutaneous coronary intervention (PCI). Background Randomized studies have demonstrated the superiority of enoxaparin over unfractionated heparin (UFH) in acute ST-segment elevation myocardial infarction (STEMI) treated with fibrinolytics. Methods In the FINESSE (Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events) trial—a double-blind, placebo-controlled study—2,452 patients with STEMI were randomized to primary PCI or facilitated PCI with abciximab alone or with half-dose reteplase. In this prospective FINESSE substudy, centers pre-specified use of either enoxaparin (0.5 mg/kg intravenous [IV], 0.3 mg/kg subcutaneous [SC]) or UFH (40 U/kg IV, 3,000 U maximum) with PCI. A logistic-regression model and a propensity multivariate model, both adjusted for baseline variables, were used to evaluate primary safety and secondary efficacy end points for enoxaparin versus UFH. Results Enoxaparin was administered to 759 patients and UFH to 1,693 patients. Nonintracranial Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding was not significantly different, but lower nonintracranial TIMI major bleeding was found with enoxaparin (2.6% vs. UFH 4.4%, logistic-regression adjusted odds ratio [OR]: 0.55; 95% confidence interval [CI]: 0.31 to 0.99, p = 0.045), whereas intracranial hemorrhage was similar (0.27% vs. 0.24%, adjusted OR: 1.03; 95% CI: 0.11 to 9.68, p = 0.980). Lower death, myocardial infarction, urgent revascularization, or refractory ischemia through 30 days was also associated with enoxaparin (5.3%) versus UFH (8.0%, adjusted OR: 0.47, 95% CI: 0.31 to 0.72, p = 0.0005) as was all-cause mortality through 90 days (3.8% vs. 5.6%, respectively, adjusted OR: 0.59, 95% CI: 0.35 to 0.99, p = 0.046). End points evaluating the net clinical benefit also significantly favored enoxaparin over UFH. Conclusions Enoxaparin seems to be associated with a lower risk of cardiovascular outcomes compared with UFH in patients with STEMI undergoing primary PCI. Confirmation of these findings in a randomized study is warranted. (A Study of Abciximab and Reteplase When Administered Prior to Catheterization After a Myocardial Infarction [Finesse]; NCT00046228)

Paliperidone extended-release tablet (paliperidone ER) is a centrally active dopamine D(2)- and serotonergic 5-HT(2A)-receptor antagonist that is registered for the treatment of schizophrenia. The controlled rate of release of paliperidone from the ER formulation is designed to have a slower absorption rate, which results in gradual ascending plasma concentrations with observed maximum plasma concentrations occurring at 24 hours after dosing on the first dosing day. On subsequent treatment days, the ER formulation provides minimal fluctuations in plasma concentrations. Paliperidone is eliminated with a terminal half-life of approximately 24 hours. Steady state is achieved after 4 daily doses. Paliperidone ER exhibits time-invariant pharmacokinetics. It shows a 3.5-fold accumulation upon steady state, mainly caused by the controlled release characteristics of the formulation. Paliperidone ER displays dose proportionality over the dose range of 3 to 15 mg; the 90% confidence intervals of the pairwise dose comparisons are all included in the 80% to 125% bioequivalence limits.

Objectives This study assessed the impact of hepatic impairment on the pharmacokinetics (PK) of paliperidone and its enantiomers. Methods A single 1 mg dose of paliperidone immediate-release (IR) was administered to subjects with moderate hepatic impairment (n = 10) and demographically matched individuals with normal hepatic function (n = 10). Results Plasma protein binding was lower in hepatically impaired subjects resulting in a 27% higher unbound fraction of paliperidone compared with healthy individuals. After correcting for the difference in plasma protein binding, unbound exposures were comparable between groups. All other PK parameters were similar between the two groups. Paliperidone IR was equally well tolerated in both groups. Conclusions The impact of moderate hepatic impairment on paliperidone PK is not considered clinically relevant as the PK profile of unbound paliperidone is similar for subjects with moderate hepatic impairment and those with normal hepatic function. Dosage adjustments of paliperidone are not required in subjects with mild or moderate hepatic impairment.

Objective The effect of trimethoprim, a potent organic cation transport inhibitor, on the pharmacokinetics (PK) of paliperidone extended-release tablets (paliperidone ER), an organic cation mainly eliminated via renal excretion, was assessed. Methods Open-label, two-period, randomized, crossover study in 30 healthy males. Single dose of paliperidone ER 6 mg was administered either alone on day 1 or day 5 during an 8-day treatment period of trimethoprim 200 mg twice daily. Serial blood and urine samples were collected for PK and plasma protein binding of paliperidone and its enantiomers. The 90% confidence interval (CI) of ratios with/without trimethoprim for PK parameters of paliperidone and its enantiomers calculated. Results Creatinine clearance decreased from 119 to 102 mL min−1 with trimethoprim. Addition of trimethoprim increased unbound fraction of paliperidone by 16%, renal clearance by 13%, AUC∞ by 9%, and t½ by 19%. The 90% CIs for ratios with/without trimethoprim were within the 80–125% range for Cmax, AUClast, and renal clearance. For AUC∞, 90% CI was 79.37–101.51, marginally below the lower bound of the acceptance range. Paliperidone did not affect steady-state plasma concentrations of trimethoprim. Conclusions No clinically important drug interactions are expected when paliperidone ER is administered with organic cation transport inhibitors. Copyright © 2009 John Wiley & Sons, Ltd.

Objectives The aim of this report was to evaluate 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. Background Treatment delays remain common for patients with primary PCI leading to studies evaluating possible benefit of “facilitated” PCI. In the FINESSE trial, no reduction in the 90-day primary ischemic end point and an increase in bleeding were observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups. Methods A total of 2,452 patients with ST-segment elevation myocardial infarction (MI) and anticipated 1 to 4 h delay until catheterization were randomized to reduced-dose reteplase + abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the cath lab. One-year mortality was a pre-specified secondary end point. Results One-year mortalities in the 3 groups noted in the preceding text were 6.3%, 7.4%, and 7.0%, respectively (p = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (p = 0.053 for combination treatment vs. primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (p = 0.09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure 1, anterior MI, body mass index ≤25 kg/m2, heart rate >100 beats/min, and no statin use. Conclusions These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups such as patients with anterior MI may deserve further study. (The FINESSE trial; NCT00046228 )

Udgivelsesdato: 2008-May-22 BACKGROUND: We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI). METHODS: In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization. RESULTS: A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49). CONCLUSIONS: Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)

This open-label, randomized, 2-way crossover study characterized the pharmacokinetics and pharmacodynamics of a transdermal contraceptive patch and a norgestimate-containing oral contraceptive. Healthy women (n = 34) applied a patch once weekly for 3 consecutive weeks during each of 2 cycles and received an oral contraceptive for 21 consecutive days during each of 2 cycles. Plasma concentrations of norelgestromin and ethinyl estradiol peaked and waned after daily oral contraceptive administration, whereas they rose and reached steady-state levels after first patch application. Norelgestromin exposure was similar; ethinyl estradiol exposure was higher for the patch than oral contraceptive. Hepatic estrogenic activity, assessed by hepatic globulin synthesis, was similar for corticosteroid-binding globulin and corticosteroid-binding globulin-binding capacity and higher for sex hormone-binding globulin for the patch versus oral contraceptive. The clinical significance of the differences in pharmacokinetic and pharmacodynamic profiles between the patch and oral contraceptive is not fully known. No serious adverse events or discontinuations due to adverse events were recorded.