Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study.

BACKGROUND: Over the past three decades, our understanding of sleep apnea in women has advanced, revealing disparities in pathophysiology, diagnosis, and treatment compared to men. However, no real-life study to date has explored the relationship between mask-related side effects (MRSEs) and gender in the context of long-term CPAP. METHODS: The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks, no gender specific mask series). MRSE were assessed by the patient using visual analog scales (VAS). CPAP-non-adherence was defined as a mean CPAP-usage of less than 4 h per day. The primary objective of this ancillary study was to investigate the impact of gender on the prevalence of MRSEs reported by the patient. Secondary analyses assessed the impact of MRSEs on CPAP-usage and CPAP-non-adherence depending on the gender. RESULTS: A total of 1484 patients treated for a median duration of 4.4 years (IQ25-75: 2.0-9.7) were included in the cohort, with women accounting for 27.8%. The prevalence of patient-reported mask injury, defined as a VAS score ≥ 5 (p = 0.021), was higher in women than in men (9.6% versus 5.3%). For nasal pillow masks, the median MRSE VAS score for dry mouth was higher in women (p = 0.039). For oronasal masks, the median MRSE VAS score for runny nose was higher in men (p = 0.039). Multivariable regression analyses revealed that, for both women and men, dry mouth was independently and negatively associated with CPAP-usage, and positively associated with CPAP-non-adherence. CONCLUSION: In real-life patients treated with long-term CPAP, there are gender differences in patient reported MRSEs. In the context of personalized medicine, these results suggest that the design of future masks should consider these gender differences if masks specifically for women are developed. However, only dry mouth, a side effect not related to mask design, impacts CPAP-usage and non-adherence. TRIAL REGISTRATION: INTERFACEVENT IS REGISTERED WITH CLINICALTRIALS.GOV (NCT03013283).FIRST REGISTRATION DATE IS 2016-12-23.

Ultrasound guided transcutaneous phrenic nerve stimulation in critically ill patients: a new method to evaluate diaphragmatic function.

BACKGROUND: Diaphragm dysfunction is common in intensive care unit and associated with weaning failure and mortality. Diagnosis gold standard is the transdiaphragmatic or tracheal pressure induced by magnetic phrenic nerve stimulation. However, the equipment is not commonly available and requires specific technical skills. We aimed to evaluate ultrasound guided transcutaneous phrenic nerve stimulation for daily bedside assessment of diaphragm function by targeted electrical phrenic nerve stimulation. METHODS: In this randomized cross-over study we compared a new method of ultrasound guided transcutaneous electrical phrenic nerve stimulation (SONOTEPS method) using a peripheral nerve stimulator, with the magnetic phrenic nerve stimulation. Intensive care unit adult patients under mechanical ventilation with a Richmond-Agitation-Sedation-Scale score of -4 or -5 were included. Each patient received the two methods of stimulation, in a randomized order. The primary outcome was the tracheal pressure (Ptrach) induced by stimulation. RESULTS: We analyzed 232 measures of Ptrach from 116 patients of whom 77 presented a diaphragm dysfunction (Ptrach < 11 cmH2O) and 50 a severe diaphragm dysfunction (Ptrach < 8 cmH2O). The Passing-Bablok regression showed no significant differences (intercept A of -0.03 [CI95:-0.83-0.52] and slope B of 0.98 [CI95:0.90-1.05]) between SONOTEPS method and magnetic stimulation which were positively correlated (R²=0.639). The mean bias was -1.08 (CI95 5.02, -7.18) cmH2O. The receiver operating curves showed an excellent performance for the diagnosis of diaphragm dysfunction and severe diaphragm dysfunction with respectively an area under curve of 0.90 (CI95 0.83-0.97) and 0.88 (CI95 0.82-0.95). This performance was not significantly affected by the body mass index or the presence of a neck catheter. CONCLUSIONS: The SONOTEPS method is a simple and accurate tool for bedside assessment of diaphragm function with ultrasound guided transcutaneous phrenic nerve stimulation in sedated patients with no or minimal spontaneous respiratory activity.

Artificial shrinkage before fresh blastocyst transfer and IVF outcomes: a pilot randomized controlled study.

RESEARCH QUESTION: Does artificial shrinkage before fresh blastocyst transfer improve clinical pregnancy rates in IVF? DESIGN: In this monocentric prospective, randomized, double-blind, controlled pilot study, 150 couples undergoing fresh single-blastocyst transfer were randomized between 20 May 2018 and 22 February 2022. In the artificial shrinkage group (AS group), a single laser pulse was directed to the cellular junction of the trophectoderm on the opposite side of the inner cell mass in each blastocyst. IVF outcomes were clinical pregnancy, multiple pregnancy and live birth rates. Cell-free DNA (cfDNA) concentration was also measured by quantitative real-time PCR in the blastocyst culture medium. RESULTS: In total, 142 couples underwent fresh single-blastocyst transfer: control group, no artificial shrinkage, n = 47; and AS group, artificial shrinkage, n = 95; An intention-to-treat (ITT) analysis was employed. After a reassessment and the exclusion of patients with major protocol deviations, 139 couples underwent fresh single-blastocyst transfer under optimal conditions: control group, n = 47; and AS group, n = 92; a per-protocol analysis was used here. The clinical and laboratory characteristics were not significantly different between the groups. The clinical pregnancy rate was similar in the control and AS groups (ITT: 48.9% versus 49.5%, P = 0.97; per protocol: 48.94% versus 51.1%, P = 0.89). The multiple pregnancy rate and the live birth rate were also similar between the groups. No significant differences in gestational age, birthweight or proportion of male/female newborns were observed. The concentration of cfDNA in the blastocyst culture medium was not associated with IVF outcome. CONCLUSIONS: Large-scale randomized controlled trials are required to confirm these preliminary results.

Dermatological manifestations in Costello syndrome: A prospective multicentric study of 31 HRAS-positive variant patients.

BACKGROUND: Data on dermatological manifestations of Costello syndrome (CS) remain heterogeneous and lack in validated description. OBJECTIVES: To describe the dermatological manifestations of CS; compare them with the literature findings; assess those discriminating CS from other RASopathies, including cardiofaciocutaneous syndrome (CFCS) and the main types of Noonan syndrome (NS); and test for dermatological phenotype-genotype correlations. METHODS: We performed a 10-year, large, prospective, multicentric, collaborative dermatological and genetic study. RESULTS: Thirty-one patients were enrolled. Hair abnormalities were ubiquitous, including wavy or curly hair and excessive eyebrows, respectively in 68% and 56%. Acral excessive skin (AES), papillomas and keratotic papules (PKP), acanthosis nigricans (AN), palmoplantar hyperkeratosis (PPHK) and 'cobblestone' papillomatous papules of the upper lip (CPPUL), were noted respectively in 84%, 61%, 65%, 55% and 32%. Excessive eyebrows, PKP, AN, CCPUL and AES best differentiated CS from CFCS and NS. Multiple melanocytic naevi (>50) may constitute a new marker of attenuated CS associated with intragenic duplication in HRAS. Oral acitretin may be highly beneficial for therapeutic management of PPHK. No significant dermatological phenotype-genotype correlation was determined between patients with and without HRAS c.34G>A (p.G12S). CONCLUSIONS AND RELEVANCE: This validated phenotypic characterization of a large number of patients with CS will allow future researchers to make a positive diagnosis, and to differentiate CS from CFCS and NS.

Long-Term Outcome of Severe Metabolic Acidemia in ICU Patients, a BICAR-ICU Trial Post Hoc Analysis.

OBJECTIVES: Long-term prognosis of ICU survivors is a major issue. Severe acidemia upon ICU admission is associated with very high short-term mortality. Since the long-term prognosis of these patients is unknown, we aimed to determine the long-term health-related quality of life and survival of these patients. DESIGN: Post hoc analysis of a multicenter, randomized, controlled trial. SETTING: Twenty-six French ICUs. PATIENTS: Day 28 critically ill survivors admitted with severe acidemia and enrolled in the BICAR-ICU trial. INTERVENTION: Sodium bicarbonate versus no sodium bicarbonate infusion according to the randomization group. MEASUREMENTS AND MAIN RESULTS: The primary outcome was health-related quality of life (HRQoL) measured with the 36-item Short Form Health Survey and the EuroQol 5-D questionnaires. Secondary outcomes were mortality, end-stage renal disease treated with renal replacement therapy or renal transplantation, place of residence, professional status, and ICU readmission. HRQoL was reduced with no significant difference between the two groups. HRQoL was reduced particularly in the role-physical health domain (64/100 ± 41 in the control group and 49/100 ± 43 in the bicarbonate group, p = 0.28), but it was conserved in the emotional domains (96/100 ± 19 in the control group and 86/100 ± 34 in the bicarbonate group, p = 0.44). Forty percent of the survivors described moderate to severe problems walking, and half of the survivors described moderate to severe problems dealing with usual activities. Moderate to severe anxiety or depression symptoms were present in one third of the survivors. Compared with the French general population, HRQoL was decreased in the survivors mostly in the physical domains. The 5-year overall survival rate was 30% with no significant difference between groups. CONCLUSIONS: Long-term HRQoL was decreased in both the control and the sodium bicarbonate groups of the BICAR-ICU trial and was lower than the general population, especially in the physical domains.

Obesity in women with asthma: Baseline disadvantage plus greater small-airway responsiveness.

BACKGROUND: Obesity is known to diminish lung volumes and worsen asthma. However, mechanistic understanding is lacking, especially as concerns small-airway responsiveness. The objective of this study was therefore to compare small-airway responsiveness, as represented by the change in expiratory:inspiratory mean lung density ratios (MLDe/i , as determined by computed tomography [CT]) throughout methacholine testing in obese versus non-obese women with asthma. METHODS: Thoracic CT was performed during methacholine bronchoconstriction challenges to produce standardized response curves (SRC: response parameter versus ln[1 + % PD20], where PD20 is the cumulative methacholine dose) for 31 asthma patients (n = 18 non-obese and n = 13 obese patients). Mixed models evaluated obesity effects and interactions on SRCs while adjusting for age and bronchial morphology. Small airway responsiveness as represented by SRC slope was calculated for each third of the MLDe/i response and compared between groups. RESULTS: Obesity-associated effects observed during experimental bronchoconstriction included: (i) a significant baseline effect for forced expiratory volume in 1 second with lower values for the obese (73.11 ± 13.44) versus non-obese (82.19 ± 8.78; p = 0.002) groups prior to methacholine testing and (ii) significantly higher responsiveness in small airways as estimated via differences in MLDe/i slopes (group×ln(1 + % PD20 interaction; p = 0.023). The latter were pinpointed to higher slopes in the obese group at the beginning 2/3 of SRCs (p = 0.004 and p = 0.021). Significant obesity effects (p = 0.035 and p = 0.008) indicating lower forced vital capacity and greater % change in MLDe/I (respectively) throughout methacholine testing, were also observed. CONCLUSION: In addition to baseline differences, small-airway responsiveness (as represented by the change in MLDe/i ) during methacholine challenge is greater in obese women with asthma as compared to the non-obese.

Rheology predicts sputum eosinophilia in patients with muco-obstructive lung diseases.

BACKGROUND: Mucus is known to play a pathogenic role in muco-obstructive lung diseases, but little is known about the determinants of mucus rheology. The purpose of this study is to determine which sputum components influence sputum rheology in patients with muco-obstructive lung diseases. METHODS: We performed a cross sectional prospective cohort study. Spontaneous sputum was collected from consecutive patients with muco-obstructive lung diseases. Sputum rheology was assessed using the Rheomuco® rheometer (Rheonova, Grenoble); the elastic modulus G', viscous modulus G″, and the critical stress threshold σc were recorded. Key quantitative and qualitative biological sputum components were determined by cytology, nucleic acid amplification tests and mass spectrometry. RESULTS: 48 patients were included from January to August 2019. Among them, 10 had asthma, 14 COPD and 24 non-CF bronchiectasis (NCFB). The critical stress threshold σc predicted a sputum eosinophilia superior to 1.25% with 89.19% accuracy (AUC = 0.8762). G' and G″ are positively correlated with MUC5AC protein concentration ((rho = 0.361; P = .013) and (rho = 0.335; P = .021), respectively). σc was positively correlated with sputum eosinophilia (rho = 0.394; P = .012), MUC5B (rho = 0.552; P < .001) and total protein (rho = 0.490; P < .001) concentrations. G' and G″ were significantly higher in asthma patients (G' = 14.49[7.18-25.26]Pa, G'' = 3.0[2.16-5.38]Pa) compared to COPD (G' = 5.01[2.94-6.48]Pa, P = .010; G'' = 1.45[1.16-1.94]Pa, P = .006) and to NCFB (G' = 4.99[1.49-10.49]Pa, P = .003; G'' = 1.46[0.71-2.47]Pa, P = .002). CONCLUSION: In muco-obstructive lung diseases, rheology predicts sputum eosinophilia and is correlated with mucin concentrations, regardless of the underlying disease. CLINICAL TRIAL REGISTRATION: (registrar, website, and registration number), where applicable NCT04081740.

Anaphylaxis in Brazil between 2011 and 2019.

BACKGROUND: There is a lack of population-based studies of anaphylaxis from low- and middle-income countries. This hampers public health planning and investments and may influence availability of adrenaline auto-injectors. OBJECTIVE: We conducted the first national population-based study of anaphylaxis hospitalization in Brazil. METHODS: Descriptive study using routinely reported data to the Brazilian Hospital Information System for the years 2011-2019. Information available is coded based on the International Classification of Diseases (ICD)-10 and covers main cause of hospitalization (primary cause) and any conditions contributing to it (secondary cause). RESULTS: Over 9 years, we identified 5716 admissions due to anaphylaxis for all causes. The average hospitalization rate related to anaphylaxis was 0.71/100,000 population per year, with a 2.4% (95% CI 1.9%, 2.9%) increase per annum over the study period. Admissions were more frequent among females (52.8%), except for cases due to insect sting. Most admissions occurred in adulthood, from 30 to 59 years (36.3%) but 13.8% in preschool children (0-4 years). There were more young children admitted for food-related anaphylaxis, and more adults admitted for drug/iatrogenic-related anaphylaxis. There were 334 cases (5.8% of admissions) of fatal anaphylaxis over the study period, with increased case fatality rate over time. CONCLUSIONS AND CLINICAL RELEVANCE: This is the first study of anaphylaxis hospital admissions using nation-wide data from a low- or middle-income country. Hospital admissions and fatalities from anaphylaxis in Brazil appear to be increasing.

Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea.

BACKGROUND: Whether the COVID-19 pandemic impacts Positive Airway Pressure (PAP) adherence over the long-term is unknown and only preliminary short-term data have been reported. METHODS: With the aim of describing the impact of the first and second waves of COVID-19 on PAP adherence during 2020 in France, we designed a cross-sectional study of Sleep-Apnea (SA)-patients under PAP telemonitoring. To examine PAP adherence in adult SA patients, we assessed de-identified data from a non-profit healthcare provider database during the period January 1, 2019 to December 31, 2020. Included patients met the following criteria: (i) PAP-treated for at least 4 months before January 1, 2019 and with continuous PAP during both 2019 and 2020; (ii) ≥ 360 daily PAP telemonitored data per year. For PAP adherence, data were collected using the PAP-software. RESULTS: 8477/10482 patients were finally included in the analysis [72.4% male, median age 70 years (IQ25-75: 61-77], 25.6% < 62 years old, initial Apnea-Hypopnea Index (AHI) of 41 (31-59)/h. Median PAP adherence was 7.21 (6.12-8.10) h/day in 2020 versus 7.12 (6.05-8.02) h/day in 2019, p < 0.001. The median difference in PAP adherence between the first 2020 lockdown and the corresponding 2019 weeks was 9.75 (CI95% 8.75-10.75) min/day, p < 0.001. The median difference in PAP adherence between the second 2020 lockdown and the corresponding 2019 weeks was 5.00 (CI95% 4.00-6.00) min/day, p < 0.001. If we consider the minimal clinically important difference of 30 min for PAP adherence, 30.4% and 26% of the patients increased their PAP adherence by at least 30 min during the first and second lockdowns respectively; 17.6% and 19.3% of the patients lowered their PAP adherence by at least 30 min in the first and second lockdowns, respectively. CONCLUSION: During the first and second lockdowns, the COVID-19 pandemic had a clinically irrelevant effect on PAP adherence for the study population. Future studies are needed to describe COVID-19 pandemic impact on PAP adherence not only for long-term PAP-treated SA patients but also for incident cases. Trial registration The COVADENE study was registered on March 1st, 2021 on ClinicalTrials.gov (Identifier: NCT04775966).

Development and validation of a composite score to predict severe forms of ischemic colitis.

OBJECTIVE: To develop a simple scoring system in order to predict the risk of severe (death and/or surgery) ischemic colitis METHODS: In this retrospective study, 205 patients diagnosed with ischemic colitis in a tertiary hospital were consecutively included over a 6-year period. The study sample was sequentially divided into a training cohort (n = 103) and a validation cohort (n = 102). In the training cohort, multivariable analysis was used to identify clinical, biological, and CT variables associated with poor outcome and to build a risk scoring system. The discriminative ability of the score (sensitivity, specificity, positive predictive value, negative predictive value) was estimated in the two cohorts to externally validate the score, and a receiver operating characteristic curve was established to estimate the area under the curve of the score. Bootstrapping was used to validate the score internally. RESULTS: In the training cohort, four independent variables were associated with unfavorable outcome: hemodynamic instability (2 pts), involvement of the small bowel (1 pt), paper-thin wall pattern (3 pts), no stratified enhancement pattern (1 pt). The score was used to categorize patients into low risk (score: 0, 1), high risk (score: 2-3), and very high risk (score: 4-7) groups with sensitivity and specificity of 97% and 67%, respectively, and a good discriminating capability, with a C-statistic of 0.94. Internal and external validation showed good discrimination capability (C-statistics of 0.9 and 0.84, respectively). CONCLUSION: A simple risk score can stratify patients into three distinct prognosis groups, which can optimize patient management. CLINICAL TRIAL NUMBER: NCT04662268 KEY POINTS: • Simple scoring system predicting the risk of severe ischemic colitis • First study to include CT findings to the clinical and biological data used to determine a severity score.

Thoracoscopic Versus Open Lobectomy After Induction Therapy for Nonsmall Cell Lung Cancer: New Study Results and Meta-analysis.

INTRODUCTION: The use of video-assisted thoracoscopic surgery (VATS) lobectomy has become a mainstay of modern thoracic surgery practice and the technique of choice for resection of early-stage lung cancers. However, the benefits of VATS following induction therapy are yet to be clarified. This study aims to assess whether VATS lobectomy achieves similar perioperative and oncologic outcomes compared to thoracotomy for nonsmall cell lung cancer after induction therapy. METHODS: We retrospectively reviewed the outcomes of 72 patients who underwent lung lobectomy after induction therapy in our institution from January 2017 to January 2020. Subsequently, we carried out a comprehensive literature search and pooled our results with available data from previously published studies to perform a meta-analysis. RESULTS: VATS was associated with reduced intraoperative blood loss (P = 0.05) and less perioperative complications (P = 0.04) in our local institution. The meta-analysis comprised nine studies. A total of 943 patients underwent VATS and 2827 patients underwent open lobectomy. VATS was associated with significant shorter surgery duration (P < 0.0001), shorter chest-tube drainage duration (P < 0.0001), and shorter hospital stays (P < 0.0001). Furthermore, there was significantly less perioperative complications (P = 0.006) and less intraoperative blood loss (P = 0.036) in the VATS group. However, there were no significant differences in 3-y overall survival and 3-y disease-free survival rates. CONCLUSIONS: In some selected patients undergoing induction therapy, VATS lobectomy could achieve equivalent perioperative outcomes to thoracotomy but evidence is lacking on oncologic outcomes. Further trials with a focus on oncologic outcomes and longer follow-up are required.

Discomfort improvement for critically ill patients using electronic relaxation devices: results of the cross-over randomized controlled trial E-CHOISIR (Electronic-CHOIce of a System for Intensive care Relaxation).

PURPOSE: To assess the impact of different electronic relaxation devices on common stressful patient symptoms experienced in intensive care unit (ICU). METHODS: Sixty critically ill patients were enrolled in four relaxation sessions using a randomized cross-over design: standard relaxation (TV/radio), music therapy (MUSIC-CARE©), and two virtual reality systems using either real motion pictures (DEEPSEN©) or synthetic motion pictures (HEALTHY-MIND©). The goal was to determine which device was the best to reduce overall patient discomfort intensity (0-10 Numeric Rating Scale (NRS); primary endpoint). Secondary endpoints were specific stressful symptoms (pain, anxiety, dyspnea, thirst, and lack of rest feeling) and stress response measured by Analgesia/Nociception Index (ANI). Multivariate mixed-effect analysis was used, taking into account patient characteristics and multiple measurements. RESULTS: Fifty patients followed the full research protocol, and ten patients did at least one research planned session of relaxation. HEALTHY-MIND© was associated with a significant decrease in overall discomfort, the primary endpoint (median NRS = 4[2-6] vs. 2[0-5]; p = 0.01, mixed-effect model), accompanied by a significant decrease in stress response (increase in ANI, secondary endpoint; p < 0.01). Regarding other secondary endpoints, each of the two virtual reality systems was associated with a decrease in anxiety (p < 0.01), while HEALTHY-MIND© was associated also with a decrease in pain (p = 0.001) and DEEPSEN© with a decrease in lack of rest (p = 0.01). Three incidents (claustrophobia/dyspnea/agitation) were reported among 109 virtual reality sessions. Cybersickness was rare (NRS = 0[0-0]). CONCLUSION: Electronic relaxation therapy is a promising, safe, and effective non-pharmacological solution that can be used to improve overall discomfort in alert and non-delirious ICU patients. Its effectiveness depends on technical characteristics (virtual reality using a synthetic imagined world versus a real world or music therapy alone without virtual reality), as well as the type of symptoms.

Hydroxyethyl Starch for Fluid Management in Patients Undergoing Major Abdominal Surgery: A Systematic Review With Meta-analysis and Trial Sequential Analysis.

BACKGROUND: In critically ill patients, warnings about a risk of death and acute kidney injury (AKI) with hydroxyethyl starch (HES) solutions have been raised. However, HES solutions may yet have a role to play in major abdominal surgery. This meta-analysis and trial sequential analysis (TSA) aimed to investigate the effect of HES intravascular volume replacement on the risk of AKI, intraoperative blood transfusion, and postoperative intra-abdominal complications compared to crystalloid intravascular volume replacement. METHODS: In this meta-analysis and TSA, we searched for randomized controlled trials (RCTs) comparing intraoperative HES intravascular volume replacement to crystalloid intravascular volume replacement in adult patients undergoing major abdominal surgery. Primary outcome was 30-day AKI, defined as a binary outcome according to Kidney Disease Improving Global Outcomes (KDIGO) criteria, combining stages 1, 2, and 3 into an AKI category versus no AKI category (stage 0). Secondary outcomes included rates of intraoperative blood transfusion and postoperative intra-abdominal complications. We used random effects models to calculate summary estimates. We used relative risk (RR) as summary measure for dichotomous outcomes, with corresponding 95% confidence intervals (CIs) for the primary outcome (P value <.05 was considered statistically significant) and 99% CI after Bonferroni correction for the secondary outcomes (P value <.01 was considered statistically significant). RESULTS: Seven RCTs including 2398 patients were included. HES intravascular volume replacement was not associated with an increased risk of 30-day AKI (RR = 1.22, 95% CI, 0.94-1.59; P = .13), when compared to crystalloid intravascular volume replacement. According to TSA, this analysis was underpowered. HES intravascular volume replacement was associated with higher rates of blood transfusion (RR = 1.57 99% CI, 1.10-2.25; P = .001), and similar rates of postoperative intra-abdominal complications (RR = 0.76 99% CI, 0.57-1.02; P = .02). CONCLUSIONS: In this meta-analysis to focus on HES intravascular volume replacement in major abdominal surgery, HES intravascular volume replacement was not associated with a higher risk of 30-day AKI when compared to crystalloid intravascular volume replacement. However, CI and TSA do not exclude harmful effects of HES intravascular volume replacement on the renal function.

Shear Wave Elastography, a New Tool for Diaphragmatic Qualitative Assessment: A Translational Study.

Rationale: Prolonged mechanical ventilation is often associated with either a decrease (known atrophy) or an increase (supposed injury) in diaphragmatic thickness. Shear wave elastography is a noninvasive technique that measures shear modulus, a surrogate of tissue stiffness and mechanical properties. Objectives: To describe changes in shear modulus (SM) during the ICU stay and the relationship with alterations in muscle thickness. To perform a comprehensive ultrasound-based characterization of histological and force production changes occurring in the diaphragm. Methods: Translational study using critically ill patients and mechanically ventilated piglets. Serial ultrasound examination of the diaphragm collecting thickness and SM was performed in both patients and piglets. Transdiaphragmatic pressure and diaphragmatic biopsies were collected in piglets. Measurements and Main Results: We enrolled 102 patients, 88 of whom were invasively mechanically ventilated. At baseline, SM was 14.3 ± 4.3 kPa and diaphragm end-expiratory thickness was 2.0 ± 0.5 mm. Decrease or increase by more than 10% from baseline was reported in 86% of the patients for thickness and in 92% of the patients for SM. An increase in diaphragmatic thickness during the stay was associated with a decrease in SM (ß = -9.34 ± 4.41; P = 0.03) after multivariable analysis. In the piglet sample, a decrease in SM over 3 days of mechanical ventilation was associated with loss of force production, slow and fast fiber atrophy, and increased lipid droplets accumulation. Conclusions: Increases in diaphragm thickness during critical illness is associated with decreased tissue stiffness as demonstrated by shear wave ultrasound elastography, consistent with the development of muscle injury and weakness. Clinical trial registered with www.clinicaltrials.gov (NCT03550222).

Elective late open conversion after endovascular aneurysm repair is associated with comparable outcomes to primary open repair of abdominal aortic aneurysms.

OBJECTIVE: Three of four patients with infrarenal abdominal aortic aneurysm are now treated with endovascular aneurysm repair (EVAR). The incidence of secondary procedures and surgical conversions is increasing for a population theoretically unfit for open surgery. The indications and outcomes of late open surgical conversions after EVAR in a high-volume tertiary vascular unit are reported. METHODS: This retrospective single-center study includes all patients who underwent a late open conversion between January 1996 and July 2018. Data were collected from records on patient demographics, operative indications, surgical strategy, perioperative outcomes, and medium-term survival. RESULTS: Sixty-two consecutive patients (88.7% male) with a mean age of 77.5 years are included. The median duration since index EVAR was 38.5 months; 65% of stent grafts requiring late open conversion had suprarenal fixation. Indications included 22.6% type IA, 16.1% type IB, and 45.2% type II endoleaks; 12.9% graft thrombosis; and 14.5% endoprosthesis infection. Complete endograft explantation was performed in 37.1% of patients and a partial explantation in 54.8%, whereas 8.1% of stent grafts were wholly preserved in situ. Overall 30-day mortality was 12.9% (n = 8) in the cohort and 2.7% for elective patients. The all-cause morbidity rate was 40.1%, and the median length of hospital stay was 9 days. After follow-up of 28.4 months (range, 1.8-187.3 months), all-cause survival was 58.8%. Avoidance of aortic clamping (P = .006) and elective procedures (P = .019) were associated with a significant reduction in the length of hospital stay. Moreover, the 30-day mortality (P = .002), occurrence of postoperative renal dysfunction (P = .004), and intestinal ischemia (P = .017) were increased in the emergency setting. Excluding cases with rupture or infection, survival estimates were 97%, 97%, and 71% at 1 year, 2 years, and 5 years, respectively. CONCLUSIONS: Technically more complex than primary open surgery, late open conversion is a procedure that generates an acceptable perioperative risk when it is performed in a high-volume aortic surgical center. Elective open conversion is associated with excellent early and late outcomes. Endograft preservation strategies decrease perioperative morbidity.

Efficacy of a long-term pulmonary rehabilitation maintenance program for COPD patients in a real-life setting: a 5-year cohort study.

BACKGROUND: Pulmonary rehabilitation (PR) improves exercise capacity, health-related quality of life (HRQoL) and dyspnea in chronic obstructive pulmonary disease (COPD) patients. Maintenance programs can sustain the benefits for 12 to 24 months. Yet, the long-term effects (> 12 months) of pragmatic maintenance programs in real-life settings remain unknown. This prospective cohort study assessed the yearly evolution in the outcomes [6-min walking distance (6MWD), HRQoL, dyspnea] of a supervised self-help PR maintenance program for COPD patients followed for 5 years. The aim was to assess the change in the outcomes and survival probability for 1 to 5 years after PR program discharge in COPD patients following a PR maintenance program supported by supervised self-help associations. METHODS: Data were prospectively collected from 144 COPD patients who followed a pragmatic multidisciplinary PR maintenance program for 1 to 5 years. They were assessed yearly for 6MWD, HRQol (VQ11) and dyspnea (MRC). The 5-year survival probability was compared to that of a control PR group without a maintenance program. A trajectory-based cluster analysis identified the determinants of long-term response. RESULTS: Maintenance program patients showed significant PR benefits at 4 years for 6MWD and VQ11 and 5 years for MRC. The 5-year survival probability was higher than for PR patients without PR maintenance. Two clusters of response to long-term PR were identified, with responders being the less severe COPD patients. CONCLUSIONS: This study provides evidence of the efficacy of a pragmatic PR maintenance program in a real-life setting for more than 3 years. In contrast to short-term PR, long-term PR maintenance appeared more beneficial in less severe COPD patients.

Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study.

BACKGROUND: For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term. METHODS: The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS. RESULTS: 1484 patients were included in the analysis (72.2% male, median age 67 years (IQ25-75: 60-74), initial Apnea-Hypopnea-Index (AHI) of 39 (31-56)/h, residual AHIflow was 1.9 (0.9-4) events/h), CPAP-treatment lasted 4.4 (2.0-9.7) years, CPAP-usage was 6.8 (5.5-7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043). CONCLUSION: In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring. Trial registration InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).

Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial.

BACKGROUND: Pectoral nerve blocks have been proposed for analgesia during and after breast cancer surgery, but data are conflicted in aesthetic breast surgery. This trial tested the primary hypothesis that adding a preincisional pectoral nerve block is superior to systemic multimodal analgesic regimen alone for pain control after breast augmentation surgery. A second hypothesis is that rescue opioid consumption would be decreased with a long-lasting effect for both outcomes during the following days. METHODS: Seventy-three adult female patients undergoing aesthetic breast augmentation surgery under general anesthesia were randomly allocated to receive a pectoral nerve block versus no block. Both groups received standard care with protocolized multimodal analgesia alone including systematic acetaminophen and nonsteroidal anti-inflammatory drugs. The primary outcome measure was the maximal numerical rating scale in the first 6 h after extubation. Secondary outcomes included intraoperative remifentanil consumption and from extubation to day 5: maximal numerical rating scale, postoperative cumulative opioid consumption and postoperative opioid side effects, and patient satisfaction recorded at day 5. RESULTS: The maximal numerical rating scale score in the first 6 h was lower in the pectoral nerve block group compared with the control group (3.9 ± 2.5 vs. 5.2 ± 2.2; difference: -1.2 [95% CI, -2.3 to -0.1]; P = 0.036). The pectoral nerve block group had a lower maximal numerical rating scale between days 1 and 5 (2.2 ± 1.9 vs. 3.2 ± 1.7; P = 0.032). The cumulative amount of overall opioids consumption (oral morphine equivalent) was lower for the pectoral nerve block group from hour 6 to day 1 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 31.5] mg, P = 0.006) and from days 1 to 5 (0.0 [0.0 to 21.0] vs. 21.0 [0.0 to 51] mg, P = 0.002). CONCLUSIONS: Pectoral nerve block in conjunction with multimodal analgesia provides effective perioperative pain relief after aesthetic breast surgery and is associated with reduced opioid consumption over the first 5 postoperative days.

Imaging strategies for patients with suspicion of uncomplicated colic pain: diagnostic accuracy and management assessment.

OBJECTIVE: Compare different imaging scenarios in the diagnosis of uncomplicated renal colic due to urolithiasis (URCU). MATERIALS AND METHODS: A total of 206 prospectively included patients had been admitted with suspected URCU and had undergone abdominal plain film (APF), US and unenhanced CT after clinical STONE score evaluation. CT was the reference standard. We assessed sensitivity (Se), specificity (Spe) and Youden index for colic pain diagnosis, percentage of patients managed by urologic treatment with stone identified, percentage of alternative diagnoses (AD) and exposure to radiation, according to single imaging approaches, strategies driven by patient characteristics and conditional imaging strategies after APF and US. RESULTS: One hundred (48.5%) patients had a final diagnosis of URCU and 19 underwent urologic treatment. The conditional strategy, i.e. CT in patients who had no stone identified at US, had a perfect sensitivity and specificity. This enabled diagnosis of all stones requiring urology management while decreasing the number of CT exams by 22%. The strategy whereby CT was used when there was neither direct or indirect APF + US finding of colic pain nor alternative diagnoses in patients with a STONE score ≥ 10 had a sensitivity of 0.95 and a specificity of 0.99, identified 84% of stones managed by urologic treatment and decreased the number of CT examinations by 76%. CONCLUSION: In patients with clinical findings consistent with URCU, the use of ultrasound as first-line imaging modality, with CT restricted to patients with negative US and a STONE score ≥ 10, led to a sensitivity and specificity of above 95%, identified 84% of stones requiring urological management and reduced the number of CT scans needed by fourfold. KEY POINTS: • For diagnosis, the use of APF + US as first-line imaging, with CT restricted to patients with both a normal APF + US and a STONE score ≥ 10, provides both a sensitivity and specificity superior or equal to 95% and reduces the number of CT scans necessary by fourfold. • For management, the use of APF + US as first-line imaging, with CT restricted to patients with both a normal APF + US and a STONE score ≥ 10, maintains a 84% stone identification rate in urology-treated patients.

Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial.

BACKGROUND: Nerve damage can occur after peripheral nerve block (PNB). Ultrasound guidance does not eliminate the risk of intraneural injection or nerve injury. Combining nerve stimulation and injection pressure (IP) monitoring with ultrasound guidance has been suggested to optimize needle tip location in PNB. In this prospective observational study, we hypothesized that measured pairs of IP and minimum intensity of stimulation (MIS) might differentiate successive needle tip locations established by high-resolution ultrasound during PNB. METHODS: For this exploratory study, 240 observations for 40 ultrasound-guided PNBs were studied in 28 patients scheduled for orthopedic surgery. During the progression of the needle to the nerve observed by ultrasonography, the IP was measured continuously using a computerized pressure-sensing device with a low flow rate of solution. Stimulation thresholds and electrical impedance were obtained by an impedance analyzer coupled to the nerve stimulator at 6 successive needle positions. The median (quartile) or mean (95% confidence interval [CI]) was reported. A mixed model analysis was used, and the sample was also explored using a classification and regression tree (CART) algorithm. RESULTS: Specific combinations of IP and MIS were measured for subcutaneous, epimysium contact, intramuscular, nerve contact (231 mm Hg [203-259 mm Hg] and 1.70 mA [1.38-2.02 mA]), intraneural location (188 mm Hg [152-224 mm Hg] and 0.58 mA [0.46-0.70 mA]), and subparaneural location (47 mm Hg [41-53 mm Hg] and 1.35 mA [1.09-1.61 mA]). The CART algorithm shows that the optimal subparaneural needle tip position might be defined by the lowest pressure (<81.3 mm Hg) and MIS (<1.5 mA) cutoffs. CONCLUSIONS: Our exploratory study evaluated concepts to generate hypotheses. The combinations of IP and MIS might help the physician during a PNB procedure. A low IP and low MIS might confirm a subparaneural location, and a high IP and a low MIS might be an alert for the intraneural location of the needle tip.