Transannular patch repair of tetralogy of Fallot with or without monocusp valve reconstruction: a meta-analysis

Background Tetralogy of Fallot (TOF) is one of the most common cyanotic congenital heart diseases. Pulmonary regurgitation is the most common and severe comorbidity after transannular patch (TAP) repair of TOF patients. It has not been confirmed whether a TAP repair with monocusp valve reconstruction would benefit TOF patients in perioperative period compared to those without monocusp valve reconstruction. The purpose of the study is to review and analyze all clinical studies that have compared perioperative outcomes of TOF patients undergoing TAP repair with or without monocusp valve reconstruction and conduct a preferable surgery. Methods Eligible studies were identified by searching the electronic databases. The year of publication of studies was restricted from 2000 till present. The primary outcome was perioperative mortality, and secondary outcomes included cardiopulmonary bypass time, aortic cross-clamp time, ventilation duration, ICU length of stay, hospital length of stay, perioperative right ventricular outflow tract (RVOT) pressure gradient, and moderate or severe pulmonary regurgitation (PR). The meta-analysis and forest plots were drawn using Review Manager 5.3. Statistically significant was considered when p-value ≤ 0.05. Results Eight studies were included which consisted of 8 retrospective cohort study and 2 randomized controlled trial. The 10 studies formed a pool of 526 TOF patients in total, in which are 300 undergoing TAP repair with monocusp valve reconstruction (monocusp group) compared to 226 undergoing TAP repair without monocusp valve reconstruction (non-monocusp group). It demonstrated no significant differences between two groups in perioperative mortality (OR = 0.69, 95% CI 0.20–2.41, p = 0.58). It demonstrated significant differences in perioperative cardiopulmonary bypass time (minute, 95% CI 17.93–28.42, p < 0.00001), mean length of ICU stay (day, 95% CI − 2.11–0.76, p < 0.0001), and the degree of perioperative PR (OR = 0.03, 95% CI 0.010.12, p < 0.00001). Significant differences were not found in other secondary outcomes. Conclusion Transannular patch repair with monocusp valve reconstruction have significant advantages on decreasing length of ICU stay and reducing degree of PR for TOF patients. Large, multicenter, randomized, prospective studies which focuse on perioperative outcomes and postoperative differences based on long-term follow-up between TAP repair with and without monocusp valve reconstruction are needed.

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial

Background The effectiveness of blood flow restriction training (BFR) in elderly with knee osteoarthritis (OA) is comparable to performing high-intensity protocols (70 to 80% of 1 RM [repetition maximum]) that are known to be effective for improving the muscle strength of knee extensors, with the advantage of generating less particular rating of perceived exertion and pain immediately after training. However, despite being a promising alternative, little is known about the best way to apply the BFR, such as level of pressure and combination or not with other therapeutic modalities. The purpose of this study is to evaluate whether different levels of blood flow restriction with low load (BFR + LL) and no load (BFR + rest) are non-inferior to high-intensity resistance exercise (HIRE+BFRplacebo) for pain reduction in patients with knee OA. Methods/design This clinical trial is a non-inferiority, five-arm, randomized, active-controlled, single trial which will be carried out in 165 patients of both sexes with knee OA, aged 50 years and older. Participants will be randomly allocated into 5 exercise groups (40% of BFR + LL; 80% of BFR + LL; 40% of BFR + rest; 80% BFR + rest, and HIRE+BFR placebo). A mixed linear model will be used to examine the effect of group-by-time interaction on pain intensity on the WOMAC subscale (primary outcome) and on disease severity, physical functional data, balance data, quality of life, global perceived effect scale, and muscle strength (secondary outcomes). Participants will be analyzed for intention-to-treat, and the statistical assessor blinded to the groups. The collection of outcomes 72 h after completion of the 16 weeks of interventions will be the primary measurement point. Follow-up secondary timepoints will be collected at 20, 28, 40, 52, and 64 weeks after the end of interventions, except for pain during the training, which will be measured immediately at the end of each session. Only the comparison of the primary outcome between the HIRE group with each BFR group will be analyzed in the non-inferiority framework, the other comparisons between the BFR groups for the primary outcome, and all secondary outcomes will be interpreted in the superiority framework. Discussion The results of this clinical trial can point out more clearly to ways to optimize the BFR training with the minimum of pain immediately after training, which will allow the offer of an effective and more adherent strengthening training to patients with knee OA. Trial registration Registro Brasileiro de Ensaios Clínicos, RBR-93rx9q. Registered on 23 July 2020. Version 1.0.

Effect of Acupuncture on Artery Elasticity for Atherosclerosis: A Randomized Controlled Trial

Background Atherosclerosis (AS) is a chronic arterial disease. Atherosclerosis related diseases, like myocardial infarctions (MI) and strokes have the highest mortality and disability rate. However, limited evidence verified the effects of acupuncture on arterial stiffness for subclinical atherosclerosis. We hypothesized that acupuncture could improve arterial stiffness in subclinical atherosclerosis and resist plaque progression. The aim of this study is to assess the effect of acupuncture on arterial elasticity via ultrafast pulse wave velocity (ufPWV) and explore the effect of acupuncture on lipid level and platelet function for subclinical atherosclerosis patients.MethodsThis was a randomized parallel controlled trial included 44 patients. Patients were assigned in a 1:1 ratio to acupuncture group and sham acupuncture group. Patients completed 24 treatments in total within 12 weeks of intervention. The primary outcome was ultrafast pulse wave velocity (ufPWV) assessed after every 4-weeks treatment; the secondary outcomes were carotid intima-media thickness (cIMT), blood lipid levels, fibrinogen (FIB) and blood platelet. Intention-to-treat (ITT) principle was applied and data sets were analyzed using SPSS 20.0 software.ResultsAmong the 44 randomly assigned patients, changes of right-side BS value in TA group (0.841) at week 12 were greater than SA group (-0.189), with a mean difference of 1.030 (95% CI, 0.320, 1.739; P=0.006). Similar results were observed in right-side ES, left-side BS, left-side ES at week 12. As to secondary outcomes, compared with SA group(1.08mm), the TA group(0.98mm) showed a significant decline in mean of left-side IMT at week 12. (Z= -2.118; P=0.034). There were no serious adverse events.ConclusionsAmong patients with Carotid intima-media thickening, both-side carotids arterial elasticity is significantly improved after 12-week acupuncture compared with sham acupuncture. The effects of acupuncture are more noticeable at week 12 during end-systole.Trial registrationThe trial was registered at http://www.chictr.org.cn (NO. ChiCTR1900025551, 31/08/2019)

No Difference between Spinal Anesthesia with Hyperbaric Ropivacaine and Intravenous Dexmedetomidine Sedation with and without Intrathecal Fentanyl: A Randomized Noninferiority Trial

To enhance the duration of single-shot spinal anesthesia, intrathecal fentanyl and intravenous dexmedetomidine are widely used as adjuvants to local anesthetics. This noninferiority trial evaluated whether hyperbaric ropivacaine alone can produce a noninferior duration of sensory block in comparison to hyperbaric ropivacaine with intrathecal fentanyl in patients under dexmedetomidine sedation. Methods. Fifty patients scheduled for elective lower limb surgery under spinal anesthesia were randomly assigned in a double-blind fashion to receive either hyperbaric ropivacaine 15 mg (Group R) or hyperbaric ropivacaine 15 mg with intrathecal fentanyl 20 μg (Group RF). Intravenous dexmedetomidine (1 μg/kg for 10 min, followed by 0.5 μg/kg/h) was administered in both groups. The primary outcome of this study was the time to two-dermatomal regression of sensory block. The noninferiority margin for the mean difference was −10 min. Characteristics of the block, intraoperative and postoperative side effects, postoperative pain score, and analgesic consumption were assessed as secondary outcomes. Results. There was no difference in the two-dermatomal regressions of sensory block between the two groups (Group R 70.4 ± 10.2 min, Group RF 71.2 ± 12.4 min, p = 0.804) with a mean difference of 0.8 min (−7.2 to 5.6, 95% confidence interval). Thus, the noninferiority of hyperbaric ropivacaine alone was established. There were no significant differences in the secondary outcomes between the two groups. Conclusions. Under intravenous dexmedetomidine sedation, the duration of spinal anesthesia with hyperbaric ropivacaine alone was noninferior to that of hyperbaric ropivacaine with intrathecal fentanyl. This suggests that addition of intrathecal fentanyl to hyperbaric ropivacaine may not be necessary in patients receiving intravenous dexmedetomidine.

Effects of a home-based physical training and activity promotion program in community-dwelling older persons with cognitive impairment after discharge from rehabilitation: A randomized controlled trial

Background Older people with cognitive impairment (CI) are at high risk for mobility limitations and adverse outcomes after discharge from geriatric rehabilitation settings. Study aim was to estimate the effects of a specifically designed home-based physical training and activity promotion program on physical capacity, different aspects of physical activity (PA), and psychosocial status. Methods Patients with mild-to-moderate CI (Mini-Mental State Examination [MMSE]: 17-26 points) discharged home after rehabilitation were included in this randomized, double-blind, placebo-controlled trial with a 12-week intervention and 12-week follow-up period. The intervention group performed a CI-specific, autonomous, home-based strength, balance and walking training supported by tailored motivational strategies to foster training adherence and promote PA. The control group participated in an unspecific motor placebo activity. Primary outcomes were physical capacity (Short Physical Performance Battery [SPPB]) and PA (sensor-based activity time). Results Among 118 randomized participants (82.3±6.0 years) with CI (MMSE: 23.3±2.4) and high levels of multi-morbidity, those participants undergoing home-based training demonstrated superior outcomes to the control group in SPPB (mean difference between groups 1.9 points; 95%-CI: 1.0-2.8; p&lt;.001), with persistent benefits over the follow-up (1.3 points; 95%-CI: 0.4-2.2; p&lt;.001). There were no differences in PA across any time points. Among secondary outcomes, fear of falling and activity avoidance behavior were reduced in the intervention group at all time points, life-space mobility improved short-term. Conclusions Study results demonstrate clinically important benefits of an individually tailored autonomous physical training and activity promotion program on physical capacity and secondary outcomes in different domains in a vulnerable, multi-morbid population.

Improving smoking cessation after myocardial infarction by systematically implementing evidence-based treatment methods

We compared the odds of smoking cessation at 2-months post-myocardial infarction (MI), before and after implementing routines optimizing use of evidence-based smoking cessation methods, with start during admission. The following routines were implemented at six Swedish hospitals: cardiac rehabilitation nurses offering smokers consultation during admission, optimizing nicotine replacement therapy and varenicline prescription, and contacting patients by telephone during the 1st week post-discharge. Using logistic regression, odds for smoking cessation at 2-months before (n smokers/n admitted = 188/601) and after (n = 195/632) routine implementation were compared. Secondary outcomes included adherence to implemented routines and assessing the prognostic value of each routine on smoking cessation. After implementation, a larger proportion of smokers (65% vs. 54%) were abstinent at 2-months (OR 1.60 [1.04–2.48]). Including only those counselled during admission (n = 98), 74% were abstinent (2.50 [1.42–4.41]). After implementation, patients were more often counselled during admission (50% vs. 6%, p < 0.001), prescribed varenicline (23% vs. 7%, p < 0.001), and contacted by telephone post-discharge (18% vs. 2%, p < 0.001). Being contacted by telephone post-discharge (adjusted OR 2.74 [1.02–7.35]) and prescribed varenicline (adjusted OR 0.39 [0.19–0.83]) predicted smoking cessation at 2-months. In conclusion, readily available methods for aiding smoking cessation can be implemented effectively in routine practice, with beneficial effects for post-MI patients.

CO2 laser-assisted sclerectomy surgery in the treatment of open-angle glaucoma in Chinese patients

Purpose To evaluate the efficacy and safety of CO2-Laser Assisted Sclerectomy Surgery (CLASS) with 5-fluorouracil (5-FU) in treating open-angle glaucoma (OAG) in Chinese patients. Methods: This was a retrospective, uncontrolled, interventional case series. All patients from 2016 to 2017 who received CLASS were recruited in this study. The primary outcome was the change in intraocular pressure (IOP) and the number of IOP-lowering medications over a 12-month follow-up period. Adverse events were evaluated as secondary outcomes. Results: Data were collected from forty-two eyes of 31 patients. The average preoperative IOP was 31.33 ± 7.60mmHg. The mean percentage of IOP reduction from baseline at postoperative months (POM) 1, 3, 6, 9, and, 12 were 48.1% ± 24.6%, 51.4% ± 19.3%, 51.2% ± 17.2%, 50.9% ± 15.0%, 49.2% ± 16.3%, respectively (all P < 0.001). The number of glaucoma medications decreased from a baseline of 3.02 ± 0.81 to 0.05 ± 0.22, 0.10 ± 0.37, 0.12 ± 0.40, 0.17 ± 0.44, and 0.24 ± 0.58 at POM 1, 3, 6, 9, and 12, respectively (all P < 0.001). At POM 1, 3, 6, 9, and 12, complete success rates were 66.7%, 73.8%, 76.2%, 69.1%, and 71.4%, respectively. At POM 1, 3, 6, 9, and 12, qualified success rates were 71.4%, 82.0%, 85.3%, 83.3%, and 90.5%, respectively. Major postoperative complications include peripheral iris synechia, iris incarceration, and anterior chamber shallowing. Conclusions: CLASS with 5-FU shows safety and efficacy for decreasing IOP and the number of IOP-lowering medications over a 12-month follow-up period. It could be an alternative treatment for patients with OAG.

Neuroprotective strategies with circulatory arrest in open aortic surgery – A meta-analysis

Objective Deep hypothermic circulatory arrest (DHCA) in aortic surgery is associated with morbidity and mortality despite evolving strategies. With the advent of antegrade cerebral perfusion (ACP), moderate hypothermic circulatory arrest (MHCA) was reported to have better outcomes than DHCA. There is no standardised guideline or consensus regarding the hypothermic strategies to be employed in open aortic surgery. Meta-analysis was performed comparing DHCA with MHCA + ACP in patients having aortic surgery. Methods A systematic review of the literature was undertaken. Any studies with DHCA versus MHCA + ACP in aortic surgeries were selected according to specific inclusion criteria and analysed to generate summative data. Statistical analysis was performed using STATS Direct. The primary outcomes were hospital mortality and post-operative stroke. Secondary outcomes were cardiopulmonary bypass time (CPB), post-operative blood transfusion, length of ICU stay, respiratory complications, renal failure and length of hospital stay. Subgroup analysis of primary outcomes for Arch surgery alone was also performed. Results Fifteen studies were included with a total of 5869 patients. There was significantly reduced mortality (Pooled OR = +0.64, 95% CI = +0.49 to +0.83; p = 0.0006) and stroke rate (Pooled OR = +0.62, 95% CI = +0.49 to +0.79; p < 0.001) in the MHCA group. MHCA was associated significantly with shorter CPB times, shorter duration in ICU, less pulmonary complications, and reduced rates of sepsis. There was no statistical difference between the two groups in terms of circulatory arrest times, X-Clamp times, total operation duration, transfusion requirements, renal failure and post-op hospital stay. Conclusion MHCA + ACP are associated with significantly better post-operative outcomes compared with DHCA for both mortality and stroke and majority of the secondary outcomes.

Multiple secondary outcome analyses: precise interpretation is important

Analysis of multiple secondary outcomes in a clinical trial leads to an increased probability of at least one false significant result among all secondary outcomes studied. In this paper, we question the notion that that if no multiplicity adjustment has been applied to multiple secondary outcome analyses in a clinical trial, then they must necessarily be regarded as exploratory. Instead, we argue that if individual secondary outcome results are interpreted carefully and precisely, there is no need to downgrade our interpretation to exploratory. This is because the probability of a false significant result for each comparison, the per-comparison wise error rate, does not increase with multiple testing. Strong effects on secondary outcomes should always be taken seriously and must not be dismissed purely on the basis of multiplicity concerns.

Evaluation of a novel therapeutic education programme for people with alcohol use disorder in France: a mixed-methods intervention study protocol (ETHER)

Background ETHER (“Education THEérapeutique pour la Réduction des dommages en alcoologie” or Therapeutic education for alcohol-related harm reduction) is a multicentre community-based mixed-methods study, which aims to evaluate the effectiveness of the innovative therapeutic patient education (TPE) programme ‘Choizitaconso’ in a sample of French people with alcohol use disorder (people with AUD). Choizitaconso teaches people with AUD psychosocial skills to help them (re)establish controlled drinking and reduce alcohol-related harms. Recruitment started in October 2019. We present here the protocol of the ETHER study. Methods ETHER’s quantitative component involves a 6-month controlled intervention study which evaluates Choizitaconso’s effectiveness by comparing 30 people with AUD following the programme with a control group of 60 people with AUD not enrolled in it, using a questionnaire co-constructed by the research team and members of the people with AUD community. Thirty-four alcohol-related harms are assessed and summed to provide an individual measure of the ‘harm burden’ from consuming alcohol (primary outcome). Secondary outcomes are anticipated and internalized stigma, alcohol consumption measures, craving for alcohol, coping strategies, health-related quality of life, self-confidence to control or abstain from drinking, treatment self-regulation, anxiety and depressive symptoms, alcohol-related neuropsychological impairments, and capabilities (a measure of wellbeing in adults). Data will be collected in face-to-face and phone-based interviews at enrolment and 6 months later. Linear regression models will be used to assess the impact of the TPE programme on changes in the primary and secondary outcomes, while adjusting for other correlates and confounders. The study’s qualitative component comprises semi-structured interviews with 16 people with AUD who have already completed the TPE programme at least 6 months before the interview. Qualitative interviews will be analysed using thematic analysis. Results and conclusions ETHER is the first evaluation study of an innovative TPE programme specifically designed to reduce alcohol-related harms and reach controlled drinking in France. The involvement of the people with AUD community in selecting which experienced and perceived alcohol-related harms to measure ensures that ETHER will provide healthcare staff and researchers with a relevant set of harm reduction criteria for use in future research. Finally, ETHER will provide scientific justification for implementing novel alcohol-related harm reduction approaches and champion controlled drinking as a therapeutic goal. Trial registration ClinicalTrials.gov, NCT03954054. Registered 17 May 2019—Prospectively registered, https://clinicaltrials.gov/ct2/show/NCT03954054?cond=alcohol&cntry=FR&city=Marseille&draw=1&rank=1.