Minimally Invasive versus Conventional Aortic Root Surgery: Results of an Intermediate-Volume Center.

BACKGROUND: We evaluate the outcome of aortic root surgery via an upper J: -shaped mini-sternotomy (MS) versus full sternotomy (FS) in an intermediate-volume center. METHODS: Between November 2011 and February 2019, 94 consecutive patients underwent aortic root surgery: 62 (66%) patients were operated via a J: -shaped MS (group A) and 32 (34%) patients via FS (group B). The primary endpoints were mortality, major adverse cardiac and cerebral events (MACCE), and reoperation in a 2-year follow-up. The secondary endpoints were perioperative complications and patient's satisfaction with the procedural results. RESULTS: Valve sparing root replacement (David procedure) was performed in 13 (21%) of the MS and 7 (22%) of the FS patients. The Bentall procedure in MS versus FS was 49 (79%) versus 25 (78%), respectively. Both groups presented similar mean operation, cardiopulmonary bypass, and cross-clamp times. Postoperative bleeding was 534 ± 300 and 755 ± 402 mL (p = 0.01) in MS and FS, respectively, erythrocyte concentrate substitution was 3 ± 3 and 5.3 ± 4.8 (p = 0.018) in MS and FS, respectively, and pneumonia rates were 0 and 9.4% (p = 0.03) in MS and FS, respectively. The 30-day mortality was 0% in both groups, whereas MACCE was 1.6 and 3% (p = 0.45) in MS and FS, respectively. After 2 years, the mortality and MACCE were 4.6 and 9.5% (p = 0.11) and 4.6 and 0% (p = 0.66) in MS and FS, respectively. The number of patients who were satisfied with the surgical cosmetic results in groups A and B was 53 (85.4%) and 26 (81%), respectively. CONCLUSION: Aortic root surgery via MS is a safe alternative to FS even in an intermediate-volume center. It offers a shorter recovery time and similar midterm results.

Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder.

PURPOSE: We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary-derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.

Outcomes in Patients with Left Bundle Branch Block after Rapid Deployment Aortic Valve Replacement.

OBJECTIVES: Increased rates of postoperative left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) frequently occur after implantation of rapid deployment valves. The impact of LBBB on follow-up outcomes remains controversial. So far, no data regarding long-term outcomes exist. AIM: The aim of this study was to analyze the impact of LBBB on postoperative outcomes after rapid deployment aortic valve replacement (RDAVR). METHODS: A total of 620 consecutive patients without preexisting LBBB or PPI who underwent rapid deployment AVR between March 2012 and September 2019 were included. New-onset LBBB was defined as any new LBBB that persisted at hospital discharge. The median follow-up time for clinical data was 1.7 years post-RDAVR. RESULTS: At discharge, new-onset LBBB was seen in 109 patients (17.5%). There were no differences between the LBBB groups and no-LBBB groups regarding baseline characteristics. At a median follow-up of 1.7 years, no difference was found between LBBB groups and no-LBBB groups concerning all-cause mortality (12.8 vs. 11.7%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.74-1.53; p = 0.54). Nevertheless, new-onset LBBB was associated with significant higher pacemaker implantation rates at follow-up (10.1 vs. 6.3%; HR: 3.58; 95% CI: 1.89-6.81 p < 0.001). CONCLUSION: After a median follow-up of 1.7 years, new-onset LBBB was not associated with increased mortality. Nevertheless, higher pacemaker implantation rates were observed in patients with new-onset LBBB after RDAVR.

Tactile misfit detection ability at the implant-abutment interface of internal connection dental implants: an in-vitro study.

OBJECTIVE: The aim of this in-vitro study was to investigate the tactile assessment ability at the implant impression-taking stage. METHODS: Thirty clinicians (18 novices, 12 experts) were included for a tactile fit assessment by using a used/new probe (tip diameter 100 µm/20 µm). Six implant replicas and related impression copings of two internal connection implant systems were used, each with a perfect fit (0 µm) and defined vertical micro gaps of 8, 24, 55, 110 and 220 µm at the interface. Statistical analysis was performed using descriptive methods and non-parametric tests with a focus on specificity (ability to detect perfect fit), sensitivity (ability to detect misfit), and predictive values. P-values <5% were considered statistically significant. RESULTS: The tactile assessment showed a mean total sensitivity for the Straumann and Nobel Biocare systems of 83% and 80% with a used probe, and 91% and 92% with a new probe, respectively. The mean total specificities were 33% and 20% with a used probe and 17% and 3% with a new probe, respectively. No statistical significance was observed between novice and expert clinicians concerning their tactile assessment ability. CONCLUSIONS: The ability to detect a perfect fit (specificity) with a probe was very poor for both implant systems and impaired with the use of a new probe. The use of a new probe improved the gap detection ability (sensitivity) significantly at the expense of the specificity. A combination of additional chairside techniques with training and calibration could improve clinicians' ability to correctly assess the fit/misfit at the implant-abutment interface.

Use of On-Site Digital Subtraction Angiography for Left Subclavian Artery Management During Hybrid Aortic Arch Repair in DeBakey I Dissection.

PURPOSE: A hybrid aortic repair using the frozen elephant trunk (FET) technique with an open distal anastomosis in zone 2 and debranching of the left subclavian artery (LSA) has been demonstrated to be favorable and safe. Although a transposition of the LSA reduces the risk of cerebellar or medullar ischemia, this may be challenging in difficult LSA anatomies. CASE REPORT: We present the case of a 61-year old patient with DeBakey I aortic dissection, treated with FET in moderate hypothermic circulatory arrest (26°C) and selective cerebral perfusion using a Thoraflex-Hybrid (Vascutek Terumo) prosthesis anchored in zone 2, with overstenting of the LSA orifice and no additional LSA debranching. Sufficient perfusion of the LSA was proved intraoperatively using LSA backflow analysis during selective cerebral perfusion in combination with on-site digital subtraction angiography (ARTIS Pheno syngo software). No neurologic dysfunction or ischemia occurred in the postoperative course. An angiographic computed tomography revealed physiologic LSA perfusion, with subsequent thrombotic occlusion of the false lumen in the proximal descending aorta after 7 days. CONCLUSION: Using an angiography-guided management in patients with complex DeBakey I dissection and difficult anatomy may simplify a proximalization of the distal anastomosis in zone 2 for FET, even without an additional LSA debranching.

Incidence and Impact of Routine Inflammatory Parameters on Outcome after Transcatheter Aortic Valve Replacement.

BACKGROUND: Previous research reported adverse clinical outcomes in association with systemic inflammation (SI) after transcatheter aortic valve replacement (TAVR). However, data characterizing the impact of SI, as reflected by postprocedural routine inflammatory parameters (pRIP), on clinical outcome of patients undergoing TAVR are sparse. OBJECTIVES: In light of this, the present work aimed to analyze incidence and clinical significance of pRIP after transapical (TA) and transfemoral (TF)-TAVR. METHODS AND RESULTS: Data of 81 high-risk consecutive patients undergoing TAVR in our center from 2017 to 2018 were analyzed in a retrospective manner. 40 out of 81 patients (49, 4%) were treated via TF access (group A) and 41 patients via TA access (group B). Incidence, cause, and amplitude of pRIP were analyzed in relation to pre- and peri-interventional data. Assessment of outcomes was conducted according to the valve academic research consortium (VARC-2). Postprocedural C-reactive protein (pCRP) and leucocytes (pL) were significantly increased in patients undergoing TA-TAVR (group B) vs. TF-TAVR (group A; 12.1 ± 9.7 vs. 22.1 ± 7.9 mg/dl, p < 0.001 and 12.8 ± 4.0 vs. 14.2 ± 3.8/nl, p = 0.002); however, there was no significant difference regarding incidence of postprocedural fever (pF) ≥38.0°C (12.5% vs. 22%, p = 0.37). Furthermore, we observed a vast (though insignificant) trend towards a longer fever duration in group B vs. group A (9.9 ± 14.9 vs. 3.2 ± 5.9 hours, p = 0.06). Further analysis identified pCRP >30 mg/dl (hazard ratio (HR) 3.15, confidence interval (CI) 1.22-8.14, p = 0.018) and European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE I (ES)) >20% (HR 2.95, CI 1.17-7.47, p = 0.02) as predictors of mortality; in this context, we also discovered a marginally significant trend for pL > 14/nl (HR 2.44, CI 0.97-6.14, p = 0.05). Multivariate analysis by use of the fisher`s exact test revealed a significant association between pCRP >30 mg/dl and ES >20% (p < 0.001). CONCLUSION: pRIP are significantly increased in patients undergoing TA-TAVR. pCRP >30 mg/dl, ES>20%, and pL > 14/nl are hallmark of adverse prognosis and require further investigation.

Single-Center Outcomes with Rapid Deployment Aortic Valve Replacement.

OBJECTIVES: Rapid-deployment valves can reduce procedural times and may facilitate minimally invasive surgery. In our institution, more than 500 patients underwent rapid deployment aortic valve replacement (AVR). METHODS: A total of 510 patients underwent rapid deployment AVR between March 2012 and September 2017, of whom 270 patients underwent isolated AVR and 240 underwent AVR with concomitant procedures. The cumulative follow-up time was 1,444 patient-years, the median follow-up time 2.8 years, respectively RESULTS: An early all-cause mortality of 3.5% (n = 18) was seen with a cumulative survival of 91.9 ± 2.2% after 12 months. Mean cross-clamp times were 37 ± 19 minutes for isolated AVR and 93 ± 29 minutes for AVR with concomitant procedures. The rate of new pacemaker implantation was 7.8% (n = 40). No case of structural degeneration occurred in the follow-up. Three (0.6%) cases of endocarditis were registered. CONCLUSIONS: Rapid deployment AVR can be performed safely with low complication rates and good hemodynamic results. Therefore, the relevance in aortic valve surgery can be stressed.

Shiftwork and Alcohol Consumption: A Systematic Review of the Literature.

INTRODUCTION: Shiftwork can be a risk factor for a number of different somatic and psychological health conditions, especially sleep disorders. Shiftworkers sleep less than dayworkers, and 20-40% of them suffer from difficulties initiating and maintaining sleep, which result in reduced capacity for work and social life. A common coping strategy might be the use of alcohol, which presents a health and safety hazard as it further impairs sleep quality and exacerbates sleepiness in the workplace. This review aimed to assess the extent of such possible connections. METHODS: We performed a systematic search of the scientific literature on shiftwork and alcohol consumption in PubMed, PsycInfo, and Cochrane Library. Only original studies comparing shiftworkers with non-shiftworkers were included. The recommendations of the Preferred Reporting Items of Systematic Reviews and Meta-Analyses were followed. RESULTS: Fourteen articles are included in this review. Six studies report some kind of connection between shift- or nightwork and alcohol consumption, especially as a sleep aid. Conflicting or negative results are reported by 3 studies. DISCUSSION: Shiftwork, especially working at night and in rotation shifts, is associated with binge drinking disorder in different professions. The reasons for pathological consumption of alcohol can be self-medication of sleep problems or coping with stress and psychosocial problems typical for shiftwork. Nurses aged over 50 years represent one important risk group. These results can be important for preventive programs against sleep disorders, including measures other than drinking alcohol as a sleep aid in the workplace of shiftworkers.

Outcomes after transcatheter aortic valve replacement in older patients.

BACKGROUND: The prevalence of aortic valve stenosis is increasing due to the continuously growing geriatric population. Data on procedural success and mortality of very old patients are sparse, raising the question of when this population may be deemed as "too old even for transcatheter aortic valve replacement (TAVR)." We, therefore, sought to evaluate the influence of age on outcome after TAVR and the impact of direct implantation. METHODS: The data of 394 consecutive patients undergoing TF-TAVR were analyzed. Patients were divided into four age groups: ≤75 (group 1, n = 28), 76-80 (group 2, n = 107), 81-85 (group 3, n = 148), and >85 (group 4, n = 111) years. Direct implantation was performed when possible according to current recommendations. Survival was evaluated by Kaplan-Meier analysis. RESULTS: Mortality at 30 days and 1 year was not significantly different between the four age groups (3.6 vs. 6.7 vs. 5.4 vs. 2.7% and 7.6 vs. 17 vs. 14.5 vs. 13%m respectively, log-rank p = 0.59). Direct implantation without balloon aortic valvuloplasty was more frequently performed on patients aged >85 vs. ≤85 years (33.3 vs. 14.1%, p < 0.001). the incidence of procedural complications frequently associated with advanced age (stroke, vascular complications) was not significantly increased in group 4. CONCLUSION: Outcome after TF-TAVR is comparable among different age cohorts, even in very old patients. Direct implantation simplifies the procedure and could therefore play a role in reducing the incidence of peri-interventional complications in patients of advanced age.

Effect of Tenebrio molitor larvae meal on the antioxidant status and stress response pathways in tissues of growing pigs.

Insect meal (IM) produced from edible insects, such as Tenebrio molitor, has been recognised as a potentially suitable protein component in feeding rations for monogastric livestock. While several studies with broilers have shown that animal´s health is not negatively affected by IM, less is known with regard to the influence of IM on metabolism of pigs. The present study investigates whether IM from Tenebrio molitor larvae causes oxidative stress and activates oxidative stress-sensitive signalling pathways in key metabolic tissues of pigs. To address this question, male 5-week-old crossbred pigs were randomly assigned to three groups of 10 pigs each and fed nutrient-adequate, isonitrogenous diets either without (CON) or with 5% IM or 10% IM from Tenebrio molitor larvae for 4 weeks. Concentrations of thiobarbituric acid reactive substances, tocopherols and glutathione in liver, gastrocnemius muscle and/or plasma did not differ between groups. Activities of the antioxidant enzymes catalase (CAT), glutathione peroxidase (GPX) and superoxide dismutase (SOD) in the liver and of GPX and SOD in gastrocnemius muscle were not different between groups, whereas the activity of CAT in skeletal muscle was increased in the two IM-fed groups compared to group CON (p < 0.05). The mRNA levels of most of the target genes of oxidative stress-sensitive signalling pathways, such as nuclear factor-κB, nuclear factor erythroid 2-related factor 2 and endoplasmic reticulum stress-induced unfolded protein response, in liver and gastrocnemius muscle did not differ between the three groups. The present study shows that feeding a diet containing adequate levels of antioxidants, such as vitamin E and selenium, and Tenebrio molitor larvae meal as a protein component neither causes oxidative stress nor activates oxidative stress-sensitive signalling pathways in key metabolic tissues of growing pigs. Based on these observations, IM from Tenebrio molitor larvae can be regarded as a safe source of protein in growing pigs.

Intermediate Outcomes after Rapid Deployment Aortic Valve Replacement in Multiple Valve Surgery.

BACKGROUND: Multiple valve surgery is associated with significant higher operative risks. Reduced cross-clamp and cardiopulmonary bypass times in multiple valve surgery may potentially be beneficial as they can be considered independent risk factors for increased morbidity and mortality following cardiac surgery. We report first intermediate outcomes of the Edwards Intuity valve system (Edwards Lifesciences, Irvine, California, United States) in combined procedures METHODS: Fifty-eight patients underwent rapid deployment aortic valve replacement with concomitant mitral valve surgery between January 2014 and November 2017 in our institution. The valve was assessed echocardiographically after 12 months. The median follow-up was 1.7 years with a cumulative follow-up time of 115.3 patient years. RESULTS: The mean age was 73.5 ± 6.2 years and the mean logistic Euroscore was 11.6 ± 3.1%. Concomitant mitral valve repair was performed in 43 cases (74.1%), and mitral valve replacement in 15 cases (19.0%). The mean cross-clamp time was 93 ± 21 minutes along with a mean bypass time of 118 ± 24 minutes. All-cause mortality after 30 days was 8.6%. Overall actuarial survival at 1 year was 87.2 ± 4.5% and after 2 years 82.8 ± 5.3%, respectively. CONCLUSIONS: Rapid deployment aortic valve replacement in multiple valve surgery can be performed safely with good intermediate outcomes in elderly, high-risk patients.

A New Approach for Testing Fetal Heart Rate Monitors.

In this paper, a new approach for the periodical testing and the functionality evaluation of a fetal heart rate monitor device based on ultrasound principle is proposed. The design and realization of the device are presented, together with the description of its features and functioning tests. In the designed device, a relay element, driven by an electric signal that allows switching at two specific frequencies, is used to simulate the fetus and the mother's heartbeat. The simulator was designed to be compliant with the standard requirements for accurate assessment and measurement of medical devices. The accuracy of the simulated signals was evaluated, and it resulted to be stable and reliable. The generated frequencies show an error of about 0.5% with respect to the nominal one while the accuracy of the test equipment was within ±3% of the test signal set frequency. This value complies with the technical standard for the accuracy of fetal heart rate monitor devices. Moreover, the performed tests and measurements show the correct functionality of the developed simulator. The proposed equipment and testing respect the technical requirements for medical devices. The features of the proposed device make it simple and quick in testing a fetal heart rate monitor, thus providing an efficient way to evaluate and test the correlation capabilities of commercial apparatuses.

Two-stage weaning strategy using veno-veno-arterial perfusion for patients on extracorporeal membrane oxygenation following cardiogenic shock.

OBJECTIVES: Veno-arterial extracorporeal membrane oxygenation represents the last therapy option in refractory cardiogenic shock. Successful weaning becomes difficult if the myocardial function recovers but pulmonary impairment persists. We present our experience with a new weaning strategy, using a stepwise mode-switch from veno-arterial to veno-veno-arterial and veno-venous extracorporeal membrane oxygenation setting for patients with primary cardiogenic shock and subsequent respiratory failure. METHODS: From 81 patients treated with veno-arterial extracorporeal membrane oxygenation following acute cardiogenic shock between January 2014 and April 2018, eight patients with cardiac and pulmonary failure were identified to be treated using the following protocol: patients were put on veno-arterial extracorporeal membrane oxygenation, a second inflow cannula was inserted via the right jugular vein and cardiac weaning was performed via veno-veno-arterial support. Finally, patients were pulmonary weaned via veno-venous extracorporeal membrane oxygenation mode. RESULTS: In the mode-switch group, etiologies of cardiogenic shock were cardiac arrest (12.5%), myocardial infarction (12.5%) and post-cardiotomic heart failure (75%). Mean time between onset of cardiogenic shock and start of veno-arterial extracorporeal membrane oxygenation was 76 ± 117 min. At implantation, lactate and pH values were 9.5 ± 5.0 mmol/L and 7.2 ± 0.2. Total extracorporeal membrane oxygenation-time was 9.3 ± 4.7 days, with a mode-switch from veno-arterial to veno-veno-arterial after 3.9 ± 2.7 days. The weaning rate in the mode-switch group was 75% (vs. 41% in the entire cohort) and the 30-day survival was 50% (vs 32% in the cohort). 38% of the patients presented a favorable neurological outcome. CONCLUSION: Mode-switch from veno-arterial to veno-veno-arterial and weaning via veno-venous extracorporeal membrane oxygenation mode is feasible for combined cardiac and pulmonary failure, with promising results due to an optimized pre-pulmonary oxygenation.

Development of autoimmune pancreatitis is independent of CDKN1A/p21-mediated pancreatic inflammation.

OBJECTIVE: Chronic pancreatitis (CP) and autoimmune pancreatitis (AIP) are characterised by different inflammatory processes. If pancreatic inflammation is a prerequisite for autoimmunity is still unclear. AIP is considered mostly a T cell-mediated disease; however, in induction of CP, macrophages play a pivotal role. p21-a member of cyclin-dependent kinase inhibitors-can influence inflammatory processes, in particular can regulate T cell activation and promote macrophage development. We therefore examined the role of p21-mediated inflammation in AIP. DESIGN: We intercrossed lymphotoxin (LT) overexpressing mice (Tg(Ela1-LTa,b))-a model to study AIP development-with p21-deficient mice. Furthermore, we characterised p21 expression in human AIP and non-AIP specimens. RESULTS: p21 deficiency in LT mice (LTp21-/-) prevented early pancreatic injury and reduced inflammation. In acinar cells, diminished proliferation and abrogated activation of non-canonical nuclear factor kappa-light-chain-enhancer of activated B cell (NF-κB) pathway was observed. In contrast, 12-month-old LT mice with and without p21 had similar inflammatory signatures and T-B cell infiltration. Interestingly, LT and LTp21-/- mice had comparable tertiary lymphoid organs (TLOs), autoantibodies and elevated IgG levels. However, acinar cell proliferation, acinar-to-ductal metaplasia and acinar non-canonical NF-κB pathway activation remained impaired in LTp21-/- pancreata. CONCLUSIONS: Our findings indicate that p21 is crucial for pancreatic inflammation in LT-driven pancreatic injury. p21 is involved in early acinar secretion of inflammatory mediators that attract innate immune cells. However, p21 is not essential for humoral immune response, accountable for autoimmunity. Remarkably, p21 renders acinar cells less susceptible to proliferation and transdifferentiation. We therefore suggest that AIP can also develop independent of chronic inflammatory processes.

Prevalence of psychiatric diagnoses in asylum seekers with follow-up.

BACKGROUND: In the study, the frequency and nature of asylum seekers' psychiatric diagnoses in a German admission center were examined. Additional aims were to identify changes in those diagnoses over time and to investigate health care utilization of mentally ill asylum seekers in the community. METHODS: The sample for the study "Psychiatric Examination of Asylum Seekers" in Bavaria consisted of a total of 283 asylum seekers and included 2 subsamples: help-seeking individuals and a randomly selected group. 34 of all asylum seekers were part of an extensive psychiatric follow-up examination (t2) about six months after the first examination (t1). Here, we used psychometric tools and a psychiatric interview by a medical doctor and a psychologist with the help of translators. RESULTS: 79% of help-seekers and 45% of the random group received at least one psychiatric diagnosis at t1. The most frequent diagnoses were trauma- and stress-related disorders, affective disorders, and insomnia. Men and Muslims were underrepresented in the help-seeking group. In the follow-up subsample, the rate of psychiatric diagnoses went down from 74% at t1 to 38% at t2. In contrast, the number of PTSD cases increased from 4 at t1 to 7 at t2. The severity of PTSD symptoms such as hyperarousal and avoidance also increased. Of the 13 persons in the follow-up-sample diagnosed with depression at t1, only 2 still fit the criteria of the disease at t2. Only 5 subjects had received some sort of psychotherapy or counseling. CONCLUSION: The prevalence of mental illness in asylum seekers reported here corresponds to the usual range in the literature. It is significantly higher than in European civil society, especially regarding PTSD. At t2, the diagnoses of PTDS had increased within several months without evident additional traumatic events. Asylum seekers' psychiatric diagnoses soon after arrival should be recorded carefully and examination should be repeated after six months. The psychiatric and psychotherapeutic treatment of asylum seekers is still insufficient. Psychoeducative steps should be taken to relieve the stigma on mental illness, especially among males and Muslims.

Thermal Energy Harvesting on the Bodily Surfaces of Arms and Legs through a Wearable Thermo-Electric Generator.

This work analyzes the results of measurements on thermal energy harvesting through a wearable Thermo-electric Generator (TEG) placed on the arms and legs. Four large skin areas were chosen as locations for the placement of the TEGs. In order to place the generator on the body, a special manufactured band guaranteed the proper contact between the skin and TEG. Preliminary measurements were performed to find out the value of the resistor load which maximizes the power output. Then, an experimental investigation was conducted for the measurement of harvested energy while users were performing daily activities, such as sitting, walking, jogging, and riding a bike. The generated power values were in the range from 5 to 50 μW. Moreover, a preliminary hypothesis based on the obtained results indicates the possibility to use TEGs on leg for the recognition of locomotion activities. It is due to the rather high and different biomechanical work, produced by the gastrocnemius muscle, while the user is walking rather than jogging or riding a bike. This result reflects a difference between temperatures associated with the performance of different activities.

Trends in the Treatment of Chronic Wounds.

Chronic wounds remain one of the significant burdens to health across the world, mainly in view of diabetes and its natural consequences. This category of lesions includes pressure ulcers, vascular diseases, and surgery-related wounds, which affect millions and pose a major challenge to the healthcare industry. The paper reviews the various physiological mechanisms of wound healing, factors that impede it, and some new treatments emerging at this moment. In contrast, current developments include surgical and non-surgical alternatives like topical dressings, medicated formulations, and skin substitutes. Advanced wound care today covers tissue-engineered skin substitutes, 3D-printed wound dressings, topical medicated formulations, and growth factor-based therapies. These are non-invasive, biocompatible methods that are cost-effective, userfriendly, and more conducive to natural healing than traditional therapies. Hydrogel dressings have high water content to create a moist environment that encourages healing. They also reflect excellent physicochemical and biological properties, which enhance autolytic debridement and reduction of pain due to the moisture retention, biocompatibility, and non-toxicity conferred. Tissue-engineered skin substitutes, comprising allogeneic or autologous cells, wound-healing enhancement bioengineered allogeneic cellular therapies are like the natural skin and encourage regeneration. 3D printing allows the production of customized dressings to aid in better treatment. Newer therapies, including bioengineered allogeneic cellular therapies and fish skin grafting, require more clinical trials to confirm safety and efficacy. With such innovations in wound healing technologies and therapies, the future looks quite promising in managing chronic wounds, enhancing healing, reducing healthcare expenditure, and promoting a better quality of life for patients.

Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic.

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to "non-medical" products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.

Peroneal Electric Transcutaneous NeuroModulation (eTNM®): A Novel Method for the Treatment of the Overactive Bladder.

Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.

Impact of the coronavirus disease 2019 (COVID-19) pandemic on the care of patients with acute and chronic aortic conditions.

OBJECTIVES: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on acute and elective thoracic and abdominal aortic procedures. METHODS: Forty departments shared their data on acute and elective thoracic and abdominal aortic procedures between January and May 2020 and January and May 2019 in Europe, Asia and the USA. Admission rates as well as delay from onset of symptoms to referral were compared. RESULTS: No differences in the number of acute thoracic and abdominal aortic procedures were observed between 2020 and the reference period in 2019 [incidence rates ratio (IRR): 0.96, confidence interval (CI) 0.89-1.04; P = 0.39]. Also, no difference in the time interval from acute onset of symptoms to referral was recorded (<12 h 32% vs > 12 h 68% in 2020, < 12 h 34% vs > 12 h 66% in 2019 P = 0.29). Conversely, a decline of 35% in elective procedures was seen (IRR: 0.81, CI 0.76-0.87; P < 0.001) with substantial differences between countries and the most pronounced decline in Italy (-40%, P < 0.001). Interestingly, in Switzerland, an increase in the number of elective cases was observed (+35%, P = 0.02). CONCLUSIONS: There was no change in the number of acute thoracic and abdominal aortic cases and procedures during the initial wave of the COVID-19 pandemic, whereas the case load of elective operations and procedures decreased significantly. Patients with acute aortic syndromes presented despite COVID-19 and were managed according to current guidelines. Further analysis is required to prove that deferral of elective cases had no impact on premature mortality.