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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Undersizing but overfilling eliminates the gray zones of sizing for transcatheter aortic valve replacement with the balloon-expandable bioprosthesis.

BACKGROUND: Current recommendations for valve size selection are based on multidimensional annular measurements, yet the overlap between two different transcatheter heart valve (THV) sizes remains. We sought to evaluate whether undersizing but overfilling eliminates the gray zones of valve sizing. METHODS: Data of 246 consecutive patients undergoing transcatheter aortic valve replacement (TAVR) with the balloon-expandable bioprosthesis with either conventional sizing and nominal filling (group 1 (NF-TAVR), n = 154) or undersizing but overfilling under a Less Is More (LIM)-Principle (group 2 (LIM-TAVR), n = 92) were compared. Paravalvular leakage (PVL) was graded angiographically and quantitatively using invasive hemodynamics. RESULTS: Annulus rupture (AR) occurred only in group 1 (n = 3). Due to AR adequate evaluation of PVL was possible in 152 patients of group 1. More than mild PVL was found in 13 (8.6%) patients of group 1 and 1 (1.1%) patient of group 2 (p = 0.019). Postdilatation was performed in 31 (20.1%) patients of group 1 and 6 patients (6.5%) of group 2 (p = 0.003). For patients with borderline annulus size in group 1 (n = 35, 22.7%) valve size selection was left to the physicians choice resulting in selection of the larger prosthesis in 10 (28.6%). In group 2 all patients with borderline annulus (n = 36, 39.1%) received the smaller prosthesis (LIM-TAVR). The postprocedural mean transvalvular pressure gradient was significantly higher in the NF-TAVR-group (11.7 ± 4 vs. 10.1 ± 3.6 mmHg, p = 0.005). CONCLUSION: LIM-TAVR eliminates the gray zones of sizing and associated PVL, can improve THV-performance, reduce incidence of annular rupture and simplify the procedure especially in borderline cases.

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.

Sleep disorders in migrants and refugees: a systematic review with implications for personalized medical approach.

BACKGROUND: Sleep disorders are very common in migrants and refugees, often as a comorbid disorder to different somatic or psychiatric diagnoses and psychological disturbances such as metabolic syndrome, post-traumatic stress disorder, depression, and anxiety disorders. OBJECTIVES: To review published prevalence rates as well as possible predictors for sleep disturbances in these vulnerable groups, including pre-migration stress, acculturation, and trauma before, during, and after migration, integration, and lifestyle in the host country with implications for predictive, preventive, and personalized medical approach (3PM). DATA SOURCES: Electronic databases PubMed, PsycInfo, and Web of Knowledge were searched using (combined) search terms "migrant," "asylum seeker," "refugee," "sleep disturbances," "sleep disorder," "insomnia," and "sleep wake disorder." STUDY ELIGIBILITY CRITERIA: Peer-reviewed studies from 2000 to 2018 reporting data on prevalence and/or predictors of any measure of sleep disturbance were included. PARTICIPANTS: Studies on international migrants and refugees, as well as internally displaced populations, were included. METHODS: We conducted a systematic review on the topic of sleep disorders in migrant and refugee populations. Only published articles and reviews in peer-reviewed journals were included. RESULTS: We analyzed five studies on sleep disorders in migrants, five studies on adult refugees, and three on refugee children and adolescents. Prevalence of sleep disorders in migrants and refugees ranges between 39 and 99%. In migrant workers, stress related to integration and adaptation to the host society is connected to higher risks of snoring, metabolic diseases, and insomnia. Sleep disturbances in refugees are predicted by past war experience. Sleep difficulties in adult and child refugees are strongly correlated to trauma. Torture of parents and grandparents can predict sleep disorders in refugee children, while being accompanied by parents to the host country has a protective effect on children's sleep. CONCLUSIONS AND IMPLICATIONS: Considering the differences in risk factors, vulnerability, and traumatic life events for different migrant populations, origins of sleep difficulties vary, depending on the migrant populations. Effects on sleep disturbances and sleep quality may be a result of integration in the host country, including changes of lifestyle, such as diet and working hours with implication for OSAS (obstructive sleep apnea) and insomnia. Compared with migrant populations, sleep disturbances in refugee populations are more correlated with mental health symptoms and disorders, especially PTSD (post-traumatic stress disorder), than with psychosocial problems. In juvenile refugee populations, psychological problems and disturbed sleep are associated with traumatic experiences during their journey to the host country. Findings highlight the need for expert recommendations for development of 3P approach stratified in the following: (1) prediction, including structured exploration of predisposing and precipitating factors that may trigger acute insomnia, screening of the according sleep disorders by validated translated questionnaires and sleep diaries, and a face-to-face or virtual setting and screening of OSAS; (2) target prevention by sleep health education for female and male refugees and migrant workers, including shift workers; and (3) personalized medical approach, including translated cognitive behavioral treatment for insomnia (CBT-I) and imagery rehearsal therapy for refugees and telehealth programs for improved CPAP adherence in migrants, with the goal to enable better sleep health quality and improved health economy.

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.

Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data.

In western societies, about one in six employees works in shifts. Shiftwork is associated with a number of poor somatic and psychological health outcomes, especially sleep issues. Higher rates of absenteeism and accidents in the workplace are possible consequences. Still, prevention programs and treatment options that are specifically tailored to shift-workers' needs are rare. We devised a 4-week online cognitive behavioral therapy for insomnia (CBT-I) intervention (n = 21) and compared sleep outcomes to a face-to-face outpatient treatment for shift-workers (n = 12) using a sleep diary and the Epworth Sleepiness Scale (ESS). In the online sample, measures also included the World Health Organization wellbeing questionnaire (WHO-5) and the Insomnia Severity Index (ISI). In the outpatient sample, the Beck Depression Inventory (BDI-II), the Montgomery-Åsberg Depression Rating Scale (MADRS), and the Pittsburgh Sleep Quality Index (PSQI) were administered. Results showed significant improvements in sleep efficiency by 7.2% in the online sample and 7.7% in the outpatient sample. However, no significant difference was found in the rate of improvement in sleep efficiency across four weeks of treatment between the samples. In the online sample, the wellbeing (WHO-5) and insomnia symptoms (ISI) scores were significantly improved following the CBT-I intervention (p < 0.004 and p < 0.002 respectively). In the outpatient sample, symptoms of depression (BDI-II and MADRS scores) and insomnia symptoms (PSQI scores) improved significantly following the CBT-I intervention. In summary, CBT-I significantly improved sleep efficiency in both the online and outpatient samples, in addition to wellbeing, symptoms of insomnia, and depression. The findings of this study demonstrate online CBT-I as a feasible approach for treating insomnia in shift-workers. Future randomized controlled trials are needed.

Feasibility of Transfemoral Aortic Valve Implantation in Patients With Aortic Disease and Simultaneous or Sequential Endovascular Aortic Repair.

OBJECTIVES: The transfemoral approach for transcatheter aortic valve implantation (TF-TAVI) is associated with a significant survival benefit for intermediate and high-risk patients. Due to the increased procedural risk, many operators avoid TF-TAVI in patients with aortic disease. Moreover, significant peri-interventional device interaction may occur in patients with previous endovascular aortic repair (EVAR). We evaluated the feasibility of TF-TAVI in patients with aortic disease in combination with simultaneous or sequential EVAR. METHODS: Data from 15 TF-TAVI patients with concomitant aortic disease treated between 2009 and 2019 in three German heart centers representing 4410 TAVI procedures were analyzed. RESULTS: Two patients with progressive penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta underwent sequential and simultaneous thoracic EVAR (TEVAR), respectively. One patient with stable PAU and 4 patients with not yet relevant abdominal aortic aneurysm (AAA) underwent isolated TF-TAVI. One patient with relevant AAA underwent TF-TAVI and sequential EVAR. Seven patients with previous EVAR due to an AAA underwent TF-TAVI (5 with a bifurcated graft and 2 with a straight graft). TF-TAVI and sequential or simultaneous TEVAR were technically successful in all patients. Vascular complications occurred in 1 patient. One patient died within 30 days and 2 patients died within 12 months. CONCLUSION: TF-TAVI can be performed successfully in patients with aortic disease or previous endovascular aortoiliac intervention. Simultaneous and sequential (T)EVAR is feasible.