Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.

The objective and scope of this Limited Output Transcranial Electrical Stimulation 2023 (LOTES-2023) guidance is to update the previous LOTES-2017 guidance. These documents should therefore be considered together. The LOTES provides a clearly articulated and transparent framework for the design of devices providing limited output (specified low-intensity range) transcranial electrical stimulation for a variety of intended uses. These guidelines can inform trial design and regulatory decisions, but most directly inform manufacturer activities - and hence were presented in LOTES-2017 as "Voluntary industry standard for compliance controlled limited output tES devices". In LOTES-2023 we emphasize that these standards are largely aligned across international standards and national regulations (including those in USA, EU, and South Korea), and so might be better understood as "Industry standards for compliance controlled limited output tES devices". LOTES-2023 is therefore updated to reflect a consensus among emerging international standards, as well as best available scientific evidence. "Warnings" and "Precautions" are updated to align with current biomedical evidence and applications. LOTES standards applied to a constrained device dose range, but within this dose range and for different use-cases, manufacturers are responsible to conduct device-specific risk management.

Sexual activity in patients with left ventricular assist devices and their partners: impact of the device on quality of life, anxiety and depression.

OBJECTIVES: Prolonged support with a left ventricular assist device (LVAD) has evolved as an alternative treatment strategy for patients with end-stage heart disease. This requires a shift in focus on sexual activity and psychosocial outcomes in patients with an LVAD and their partners. METHODS: This cross-sectional study was designed to capture Sexual Activities in Left Ventricular Assist Device Patients Or PaRtners (SALVADOR) perceptions on illness-related changes in the quality of sexual activity and its impact on quality of life, anxiety and depression using standardized patient-reported outcome scales (Sexual Adjustment Scale, 36-Item Short Form Health Survey, Hospital Anxiety and Depression Scale). A total of 72 patients with LVADs (50% response rate) along with 48 partners participated. RESULTS: For patients with an LVAD (median age 60 years; 84.7% male), median time on the device was 650 days; 69.5% stayed in long-term partnerships (median 23 years). Prevalence rates for illness-related changes in the quality of sexual activity were 58.3% for patients and 52.1% for partners. Device-related disturbances in sexual activities occurred due to battery pockets (patients/partners: 59.2%/37.6%; P = 0.006) and the driveline (46.3%/37.5%; P = 0.033) and led to significantly increased distress in patients/partners (battery pockets: 53.5%/41.3%; P = 0.006; driveline 54.9%/37.5%; P = 0.004). Disturbances in sexual activity were independently associated with higher rates of depression (odds ratio 1.33, 95% confidence interval 1.14-1.55; P = 0.001) in patients and lower mental quality of life (odds ratio 6.18, 95% confidence interval 1.13-33.98; P = 0.036) in partners. CONCLUSIONS: Disturbances in sexual activity are common in patients with an LVAD and their partners while the patients are on durable long-term support. Counselling on long-term adjustment should provide a platform for information seeking on illness-related changes in the quality of sexual activity.

Making eye contact without awareness.

Direct gaze is a potent non-verbal signal that establishes a communicative connection between two individuals, setting the course for further interactions. Although consciously perceived faces with direct gaze have been shown to capture attention, it is unknown whether an attentional preference for these socially meaningful stimuli exists even in the absence of awareness. In two experiments, we recorded participants' eye movements while they were exposed to faces with direct and averted gaze rendered invisible by interocular suppression. Participants' inability to correctly guess the occurrence of the faces in a manual forced-choice task demonstrated complete unawareness of the faces. However, eye movements were preferentially directed towards faces with direct compared to averted gaze, indicating a specific sensitivity to others' gaze directions even without awareness. This oculomotor preference suggests that a rapid and automatic establishment of mutual eye contact constitutes a biological advantage, which could be mediated by fast subcortical pathways in the human brain.

Mechanical circulatory support devices as destination therapy-current evidence.

Advanced heart failure is an increasing problem worldwide. Nowadays, mechanical circulatory support devices (MSCD) are an established therapeutic option for terminal heart failure after exhaustion of medical and conventional surgical treatment, and are becoming a realistic alternative to heart transplantation (HTX). There are a number of different treatment options for these patients, such as bridge to transplantation (BTT), bridge to candidacy (BTC), bridge to recovery (BTR) and the destination therapy (DT) option. The latter option has become more frequent throughout the last years, due to a donor organ shortage and an increasing number of older patients with terminal heart failure who are not eligible for HTX. These factors have led to a rapidly increasing number of LVAD implantations as well as centers which perform these procedures. This has also been due to improved LVAD survival rates and quality of life following the introduction of smaller, intrapericardial and more durable continuous flow left ventricular devices. The most common complications for these patients are device-related problems, such as coagulation disorders, gastrointestinal bleeding, device related infection, pump thrombosis or cerebrovascular accidents. However, some questions still remain unanswered or under debate, such as the exact time-point for LVAD implantation. In addition, aspects such as better biocompatibility for LVADs remain a major challenge. This review will concentrate on DT for terminal heart failure and provide an overview of the current evidence for LVAD implantation in this patient group, with particular emphasis on indication and time-point of implantation, choice of LVADs, and long term outcomes and quality of life.

Incremental learning by message passing in hierarchical temporal memory.

Hierarchical temporal memory (HTM) is a biologically inspired framework that can be used to learn invariant representations of patterns in a wide range of applications. Classical HTM learning is mainly unsupervised, and once training is completed, the network structure is frozen, thus making further training (i.e., incremental learning) quite critical. In this letter, we develop a novel technique for HTM (incremental) supervised learning based on gradient descent error minimization. We prove that error backpropagation can be naturally and elegantly implemented through native HTM message passing based on belief propagation. Our experimental results demonstrate that a two-stage training approach composed of unsupervised pretraining and supervised refinement is very effective (both accurate and efficient). This is in line with recent findings on other deep architectures.

Intracardiac left ventricular support in beating heart, multi-vessel revascularization.

BACKGROUND: Less invasive operation procedures without support of extracorporeal circulation are becoming increasingly important. A basic requirement for good long-term results in such cases is, however, the complete revascularization of the affected coronary vessels. The unsatisfactorily high conversion rate from bypass operations originally planned as off-pump to conventional operations with heart-lung machines, because of the failure to reach the target vessels on the rear wall of the heart through hemodynamic instability led to investigation of the efficiency of a microaxial pump (Impella elect) placed in the left ventricle. METHODS: In a prospective project 15 of 38 consecutive patients selected for coronary revascularization with beating heart had a micro pump transaortically implanted in the left ventricle to support the heart during the operation with a flow rate of 2.5 to 3.9 l/min. RESULTS: With 8 of 23 patients operated on without pump support, the operation had to be converted to conventional methods with a heart-lung machine. Only one patient out of the left-ventricle-supported group had to be further operated on conventionally because of a deep intramyocardial positioned left anterior descending coronary artery (LAD) (p < 0.05). The investigated laboratory parameters, especially creatine kinase (CK), CK-MB isoenzyme, and clotting showed no significant difference. There tended to be a higher blood loss recorded with the pump-supported patients. CONCLUSION: In summary, it appeared that the application of a left ventricular coaxial pump with comparable results seemed to make possible complete revascularization in nearly all patients.

Platelet function test HemoSTATUS 2: tool or toy for an optimized management of hemostasis?

BACKGROUND: Bleeding after open heart surgery is a common but unintended problem, which is unequivocally related to platelet function. The target of our study was to correlate platelet activation levels and postoperative blood loss as well as the predictive power of measurements focusing on postoperative hemostasis. MATERIALS AND METHODS: The prospective trial comprised 100 patients (mean age: 64.3 years, 68% male) undergoing cardiac surgery. Platelet activation was measured by the new and modified HemoSTATUS test. Blood samples were drawn pre-, intra- and postoperatively. Standard hemostasis tests, including activated clotting time (ACT), partial thromboplastin time (PTT), hemoglobin, platelet count, antithrombin III (AT III) and fibrinogen, were measured according to the clinical routine. Blood loss and consumed blood products were documented up to the 24th hour after the operation. RESULTS: Platelet activation showed a typical change, with lowest levels after the end of extracorporeal circulation and a restitution to preoperative levels after 24 h. Mean blood loss was 461 ml. Statistical analysis showed neither a correlation to the platelet activation measurements nor to low pre-, intra- or postoperative levels. CONCLUSION: The HemoSTATUS platelet function test is not suitable for a reliable monitoring of platelet pathophysiology and patient outcome after extracorporeal circulation. Furthermore, no correlation of preoperative platelet activation and blood loss could be shown.