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Response to cardiac resynchronisation therapy in men and women: a secondary analysis of the SMART-AV randomised controlled trial

BMJ Open. 2021 Oct 27;11(10):e049017. doi: 10.1136/bmjopen-2021-049017.

ABSTRACT

OBJECTIVES: There is a controversy about whether both sexes’ response to cardiac resynchronisation therapy (CRT) is similar. We aimed to assess a causal effect of sex on CRT response.

DESIGN: Secondary analysis of a randomised controlled trial (RCT) data. Doubly robust augmented-inverse-probability-weighted (AIPW) estimation of sex effect on CRT response.

SETTING: The SmartDelay Determined Atrioventricular (AV) Optimisation (SMART-AV) RCT.

PARTICIPANTS: The SMART-AV RCT enrolled New York Heart Association class III-IV patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≤35% despite optimal medical therapy and QRS duration ≥120 ms, in sinus rhythm. After exclusion of those with missing outcome or covariates, 741 participants (age 66±11 years; 33% female; 78% white; LVEF 28%±9%; 58% ischaemic cardiomyopathy; 75% left bundle branch block; left ventricular end-systolic volume index (LVESVI) 65±30 mL/m2) were included.

INTERVENTIONS: Implanted CRT defibrillator with randomly assigned AV delay as either (1) fixed at 120 ms, or (2) echocardiography-determined, or (3) SmartDelay algorithm-programmed.

OUTCOME: A composite of freedom from death and HF hospitalisation and a >15% reduction in LVESVI at 6 month post-CRT was the endpoint.

RESULTS: The primary endpoint was met by 337 patients (45.5%); 134 were women (55.6% response) and 203 were men (40.6% response); p<0.0001. After conditioning for 33 covariates that included baseline demographic, clinical, ECG, echocardiographic and biomarker characteristics, known predictors of CRT response, logistic regression showed a higher probability for composite CRT response for women versus men (OR 1.79; 95% CI 1.08 to 2.98; p<0.0001), whereas AIPW estimation showed no difference in CRT response (average treatment effect 0.88; 95% CI 0.41 to 1.89; p=0.739). After removing colliders from the model, both logistic regression (OR 1.00; 95% CI 0.69 to 1.44) and AIPW (ATE 1.06; 95% CI 0.96 to 1.16) reported similar results.

CONCLUSIONS: Both sexes’ response to CRT is similar. Sex differences in HF substrate, treatment and comorbidities explain sex disparities in CRT outcomes.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier; NCT00677014.

PMID:34706949 | DOI:10.1136/bmjopen-2021-049017

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Cohort study of intervened functionally univentricular heart in England and Wales (2000-2018)

Heart. 2021 Oct 27:heartjnl-2021-319677. doi: 10.1136/heartjnl-2021-319677. Online ahead of print.

ABSTRACT

OBJECTIVE: Given the paucity of long-term outcome data for complex congenital heart disease (CHD), we aimed to describe the treatment pathways and survival for patients who started interventions for functionally univentricular heart (FUH) conditions, excluding hypoplastic left heart syndrome.

METHODS: We performed a retrospective cohort study using all procedure records from the National Congenital Heart Diseases Audit for children born in 2000-2018. The primary outcome was mortality, ascertained from the Office for National Statistics in 2020.

RESULTS: Of 53 615 patients, 1557 had FUH: 55.9% were boys and 67.4% were of White ethnic groups. The largest diagnostic categories were tricuspid atresia (28.9%), double inlet left ventricle (21.0%) and unbalanced atrioventricular septal defect (AVSD) (15.2%). The ages at staged surgery were: initial palliation 11.5 (IQR 5.5-43.5) days, cavopulmonary shunt 9.2 (IQR 6.0-17.1) months and Fontan 56.2 (IQR 45.5-70.3) months. The median follow-up time was 10.8 (IQR 7.0-14.9) years and the 1, 5 and 10-year survival rates after initial palliation were 83.6% (95% CI 81.7% to 85.4%), 79.4% (95% CI 77.3% to 81.4%) and 77.2% (95% CI 75.0% to 79.2%), respectively. Higher hazards were present for unbalanced AVSD HR 2.75 (95% CI 1.82 to 4.17), atrial isomerism HR 1.75 (95% CI 1.14 to 2.70) and low weight HR 1.65 (95% CI 1.13 to 2.41), critical illness HR 2.30 (95% CI 1.67 to 3.18) or acquired comorbidities HR 2.71 (95% CI 1.82 to 4.04) at initial palliation.

CONCLUSION: Although treatment pathways for FUH are complex and variable, nearly 8 out of 10 children survived to 10 years. Longer-term analyses of outcome based on diagnosis (rather than procedure) can inform parents, patients and clinicians, driving practice improvements for complex CHD.

PMID:34706904 | DOI:10.1136/heartjnl-2021-319677

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Equity of geographical access to public health facilities in Nepal

BMJ Glob Health. 2021 Oct;6(10):e006786. doi: 10.1136/bmjgh-2021-006786.

ABSTRACT

INTRODUCTION: Geographical accessibility is important against health equity, particularly for less developed countries as Nepal. It is important to identify the disparities in geographical accessibility to the three levels of public health facilities across Nepal, which has not been available.

METHODS: Based on the up-to-date dataset of Nepal formal public health facilities in 2021, we measured the geographical accessibility by calculating the travel time to the nearest public health facility of three levels (ie, primary, secondary and tertiary) across Nepal at 1×1 km2 resolution under two travel modes: walking and motorised. Gini and Theil L index were used to assess the inequality. Potential locations of new facilities were identified for best improvement of geographical efficiency or equality.

RESULTS: Both geographical accessibility and its equality were better under the motorised mode compared with the walking mode. If motorised transportation is available to everyone, the population coverage within 5 min to any public health facilities would be improved by 62.13%. The population-weighted average travel time was 17.91 min, 39.88 min and 69.23 min and the Gini coefficients 0.03, 0.18 and 0.42 to the nearest primary, secondary and tertiary facilities, respectively, under motorised mode. For primary facilities, low accessibility was found in the northern mountain belt; for secondary facilities, the accessibility decreased with increased distance from the district centres; and for tertiary facilities, low accessibility was found in most areas except the developed areas like zonal centres. The potential locations of new facilities differed for the three levels of facilities. Besides, the majority of inequalities of geographical accessibility were from within-province.

CONCLUSION: The high-resolution geographical accessibility maps and the assessment of inequality provide valuable information for health resource allocation and health-related planning in Nepal.

PMID:34706879 | DOI:10.1136/bmjgh-2021-006786

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Body composition and osteoporotic fracture using anthropometric prediction equations to assess muscle and fat masses

J Cachexia Sarcopenia Muscle. 2021 Oct 27. doi: 10.1002/jcsm.12850. Online ahead of print.

ABSTRACT

BACKGROUND: Obesity is protective of bone health; however, abdominal obesity is associated with a higher fracture risk. Little is known about whether body composition protects or adversely affects osteoporotic fractures because of practical issues regarding assessment tools. This study aimed to evaluate the association of predicted body composition with fracture risk to determine the distinctive and differing effects of muscle or fat mass on bone health outcomes in the general population.

METHODS: This population-based, longitudinal cohort study used 2009-2010 Korean National Health Insurance Service data and follow-up data from 1 January 2011 to 31 December 2013, to determine the incidence of osteoporotic fracture (total, spine, and non-spine) defined using the International Classification of Diseases, Tenth Revision codes. The study participants were aged ≥50 years (men, 158 426; women, 131 587). The predicted lean body mass index (pLBMI), appendicular skeletal muscle index (pASMI), and body fat mass index (pBFMI) were used to assess body composition, using anthropometric prediction equations.

RESULTS: Over a 3 year follow-up, we identified 2350 and 6175 fractures in men and women, respectively. The mean age of the participants was 60.2 ± 8.3 and 60.7 ± 8.4 years in men and women, respectively. In a multivariable-adjusted Cox proportional hazards regression model, increasing pLBMI or pASMI was significantly associated with a decreased risk of total fractures in men and women. When comparing individuals in the lowest pLBMI and pASMI (reference groups), men with the highest pLBMI and pASMI had adjusted hazard ratios of 0.63 [95% confidence interval (CI) 0.47-0.83] and 0.62 (95% CI 0.47-0.82), and women with the highest pLBMI and pASMI had adjusted hazard ratios of 0.72 (95% CI 0.60-0.85) and 0.71 (95% CI 0.60-0.85), respectively, for total fractures. The pBFMI had no significant association with total fractures in men or women. Regarding sex-specific or site-specific differences, the protective effects of the pLBMI and pASMI on fractures were greater in men and reduced the risk of spinal fractures. An increased pBFMI was associated with an increased risk of spinal fractures in women.

CONCLUSIONS: An increased pLBMI or pASMI was significantly associated with decreased total osteoporotic fracture risk; however, the pBFMI showed no statistically significant association. Muscle mass was more important than fat mass in preventing future osteoporotic fractures based on anthropometric prediction equations.

PMID:34706399 | DOI:10.1002/jcsm.12850

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Is anterior subcapital shortening osteotomy a reliable and reproducible technique in the treatment of severe slipped capital femoral epiphysis?

Orthop Traumatol Surg Res. 2021 Oct 24:103132. doi: 10.1016/j.otsr.2021.103132. Online ahead of print.

ABSTRACT

INTRODUCTION: Proximal femoral shortening osteotomies are becoming the treatment of choice for severe slipped capital femoral epiphysis (SCFE) to reduce the risk of femoroacetabular impingement. The reported rates of complication seem reasonable, but these are single-operator series with surgeons highly experienced in this technique. The purpose of this study was to assess how surgeon experience impacted the outcomes of anterior subcapital shortening osteotomy (ASSO) in severe SCFE.

HYPOTHESIS: The hypothesis was that ASSO is a reproducible technique that is accessible to junior surgeons.

MATERIALS AND METHODS: All ASSOs performed for severe SCFE (slip angle >40°) between 2015 and 2019 were retrospectively reviewed. All osteotomies were performed by surgeons with less than 4 years’ experience (senior residents), who were trained by a senior surgeon experienced in this technique (Group 1). The incidence of femoral head avascular necrosis (AVN) and complications were analyzed and compared to a historical control cohort (Group 2).

RESULTS: A total of 62 SCFEs (37 unstable and 25 stable) were analyzed. Both groups had similar demographic data and SCFE characteristics. The mean operative times were statistically comparable in both groups. The rates of AVN in unstable SCFEs and in the overall series were comparable in both groups (18.9% vs. 13.3%, P =.55 and 12.9% vs. 9.7%, P =.60). These rates were comparable in the stable forms (4.0% vs. 5.4%; P = 1). However, the preoperative MRI in Group 1 showed that 42.8% of unstable hips that developed AVN were already hypoperfused before surgery. The overall rate of complication showed no significant difference between the 2 groups (26% vs. 17%, P =.16).

DISCUSSION: Although ASSO is a technically demanding procedure, it is reliable and reproducible. The main risk factor for developing AVN remains the unstable nature of SCFE and not the surgeon’s experience. It can be performed by trained junior surgeons, but not in an emergency setting, with the possibility of assistance from a more experienced surgeon.

LEVEL OF EVIDENCE: IV; retrospective case study.

PMID:34706290 | DOI:10.1016/j.otsr.2021.103132

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Reflected near-infrared light versus bite-wing radiography for the detection of proximal caries: a multicenter prospective clinical study conducted in private practices

J Dent. 2021 Oct 24:103861. doi: 10.1016/j.jdent.2021.103861. Online ahead of print.

ABSTRACT

OBJECTIVES: The aim of the present prospective multicenter clinical study was to compare the detection of proximal caries with near-infrared light reflection (NILR) versus bitewing radiography (BWR).

MATERIALS AND METHODS: Intraoral scans were performed on 100 patients in five dental clinics using an intraoral scanner (iTero Element 5D, Align Technology, Tempe, AZ, USA) that includes a near-infrared light source (850nm) and sensor. Reflected near-infrared light images of posterior teeth were used by the individual dentists to detect proximal caries and the results were compared to the BWRs. In a total of 3499 proximal surfaces of molars and premolars which were examined 223 carious lesions were detected by BWR while NILR detected 549 carious lesions. Caries detection using both methods was also done by an expert team of five dentists, highly experienced in NILR image interpretation, who used the same sets of clinically-obtained data. Sensitivity, specificity, and accuracy were calculated for caries detection by both the dentists and the expert team. Fifty-nine of the detected carious lesions were clinically treated and the observations during caries excavation were compared with those done with NILR and BWR. Statistical analysis to compare between NILR and BWR diagnosis was performed using non-parametric two-sided McNemar’s Chi-Square test with the significance level set at p<0.05. Kappa coefficients were calculated to assess the level of agreement between the two caries detection methods.

RESULTS: Accuracy of NILR detection of early enamel lesions was 88% and that of carious lesions involving the dentino-enamel junction (DEJ) was 97%. Accuracy was found to be higher at 96% and 99%, respectively, when the same data were examined by the expert team. Direct observation during caries-excavation treatment suggested that NILR detected early enamel lesions that were not detectable with BWR alone.

CONCLUSIONS: Within the limitations of the present study, NILR was more sensitive than BWR in detecting early enamel lesions and comparable to BWR in detecting lesions that involved the DEJ.

CLINICAL RELEVANCE: Reflected near-infrared light images that are generated simultaneously with 3D intra-oral scanning may be used reliably for detection, screening, and monitoring of proximal caries, thus potentially minimizing the traditional use of ionizing radiation.

PMID:34706269 | DOI:10.1016/j.jdent.2021.103861

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Harnessing the Electronic Health Record to Actively Support Providers with Guideline-Directed Telemetry Use

Appl Clin Inform. 2021 Oct;12(5):996-1001. doi: 10.1055/s-0041-1736338. Epub 2021 Oct 27.

ABSTRACT

BACKGROUND: Overuse of cardiac telemetry monitoring (telemetry) can lead to alarm fatigue, discomfort for patients, and unnecessary medical costs. Currently there are evidence-based recommendations describing appropriate telemetry use, but many providers are unaware of these guidelines.

OBJECTIVES: At our multihospital health system, our goal was to support providers in ordering telemetry on acute care in accordance with evidence-based guidelines and discontinuing telemetry when it was no longer medically indicated.

METHODS: We implemented a multipronged electronic health record (EHR) intervention at two academic medical centers, including: (1) an order set requiring providers to choose an indication for telemetry with a recommended duration based on American Heart Association guidelines; (2) an EHR-generated reminder page to the primary provider recommending telemetry discontinuation once the guideline-recommended duration for telemetry is exceeded; and (3) documentation of telemetry interpretation by telemetry technicians in the notes section of the EHR. To determine the impact of the intervention, we compared number of telemetry orders actively discontinued prior to discharge and telemetry duration 1 year pre- to 1 year post-intervention on acute care medicine services. We evaluated sustainability at years 2 and 3.

RESULTS: Implementation of the EHR initiative resulted in a statistically significant increase in active discontinuation of telemetry orders prior to discharge: 15% (63.4-78.7%) at one site and 13% at the other (64.1-77.4%) with greater improvements on resident teams. Fewer acute care medicine telemetry orders were placed on medicine services across the system (1,503-1,305) despite an increase in admissions and the average duration of telemetry decreased at both sites (62 to 47 hours, p < 0.001 and 73 to 60, p < 0.001, respectively). Improvements were sustained 2 and 3 years after intervention.

CONCLUSION: Our study showed that a low-cost, multipart, EHR-based intervention with active provider engagement and no additional education can decrease telemetry usage on acute care medicine services.

PMID:34706394 | DOI:10.1055/s-0041-1736338

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Evaluation of Transbronchial Lung Cryobiopsy Freezing Time, Biopsy Size, Histological Quality, and Incidence of Complication: A Prospective Clinical Trial

Respiration. 2021 Oct 27:1-8. doi: 10.1159/000519279. Online ahead of print.

ABSTRACT

BACKGROUND: Transbronchial cryobiopsy (TBCB), a novel way of obtaining a specimen of lung tissue using a flexible cryoprobe, can obtain large lung biopsies without crush artifacts. The freezing time of TBCB was empirically selected from 3 to 7 s in the previous studies. However, no consensus has yet been reached regarding the optimal freezing time used in TBCB.

OBJECTIVES: The primary endpoint was biopsy size in different freezing times. The secondary endpoints included sample histological quality, diagnostic confidence, and complications in different freezing times.

METHODS: Patients who were suspected of DPLD requiring histopathological examination for further evaluation were enrolled in this study. Distinct biopsies were obtained by using different freezing times increased from 3 to 6 s sequentially. Samples were reviewed by 2 external expert pathologists.

RESULTS: A total of 33 patients were enrolled, and 143 transbronchial cryobiopsies were taken in this trial. An average of 4.33 samples were taken from each patient. The mean biopsy size of different freezing times from 3 to 6 s was 9.10 ± 4.37, 13.23 ± 5.83, 16.26 ± 5.67, and 18.83 ± 7.50 mm2, respectively. A strong correlation between freezing time and biopsy size was observed (r = 0.99, p < 0.01). Statistically significant difference of biopsy size was detected in the freezing time of 3 s versus 4 s (p < 0.01) and 4 s versus 5 s (p = 0.02), but not in the freezing time of 5 s versus 6 s (p = 0.10). Overall bleeding in different freezing times from 3 to 6 s was 53.33%, 67.50%, 89.47%, and 77.14%, respectively. A significantly higher overall bleeding was observed when the freezing time exceeded 4 s (RR = 1.67, p < 0.01). Pneumothorax occurred in 4 cases (12.12%). One lethal case (3.03%) was noted 25 days after TBCB. Lung parenchyma was preserved well in all cryobiopsy samples. Thirty-one (93.94%) patients’ histopathological findings were identified as sufficient to establish a CRP diagnosis. There was no statistical difference in diagnostic confidence between different freezing times.

CONCLUSION: A longer freezing time was associated with a larger size of the biopsy sample but a higher risk of bleeding. The optimal transbronchial cryobiopsy freezing time is 3-4 s, which is easily achievable and provides an adequate biopsy size whilst creating a safety threshold from complications.

PMID:34706367 | DOI:10.1159/000519279

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French trends in carpal tunnel surgery: an online survey of members of the French Society for Surgery of the Hand

Hand Surg Rehabil. 2021 Oct 24:S2468-1229(21)00598-3. doi: 10.1016/j.hansur.2021.10.314. Online ahead of print.

ABSTRACT

Several surgical and anesthesia techniques are used in carpal tunnel surgery. The practices of members of the American Society for Surgery of the Hand and the Canadian Society of Plastic Surgery were recently published and compared. Because of the great difference in these practices, we investigated the practices of the members of the French Society for Surgery of the Hand and how they have changed. An online survey including 14 close-ended and 12 open-ended questions was sent by email to all 685 surgeons who were members of the French Society for Surgery of the Hand in July 2019. Data were analyzed using descriptive statistics. The survey was completed by 129 members (19%). The open approach was used by 56% of the surgeons (8% by standard open technique, 48% by minimally invasive open technique), endoscopic techniques by 40% and ultrasound-guided techniques by 4%. Most surgeons used regional anesthesia (69%) or local anesthesia (25%). Half of the surgeons (50%) would consider changing their surgical technique. Sixty-one percent were interested in ultrasound-guided techniques and 34% in endoscopic techniques. Almost half the surgeons (48%) would consider changing their anesthesia technique and 97% were interested in local anesthesia. Our study showed that the open approach and regional anesthesia were the most frequently used techniques but that an increase in endoscopic and ultrasound-guided techniques as well as local anesthesia techniques was likely.

PMID:34706303 | DOI:10.1016/j.hansur.2021.10.314

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Medication Use Reported by Individuals With Tinnitus Who Are Seeking Internet-Based Psychological Interventions

Am J Audiol. 2021 Oct 27:1-8. doi: 10.1044/2021_AJA-21-00062. Online ahead of print.

ABSTRACT

Purpose This study examined medication use by individuals with tinnitus who were seeking help for their tinnitus by means of a psychological intervention. Method This study used a cross-sectional survey design and included individuals with tinnitus enrolled in an Internet-based cognitive behavioral therapy trial (n = 439). Study participants provided demographic details, completed various structured questionnaires and provided details about the medications used. The self-reported medications were classified using the United States Pharmacopeial Medicare Model Guidelines v7.0. Results Current medication use was reported by 67% (n = 293) of the study participants. Those currently using medication were older; had consulted their primary care physician, had greater tinnitus severity, depression, anxiety, and insomnia when compared with those not reporting any current medication use. The top 10 medication used included cardiovascular agents (n = 162; 55.3%), antidepressants (n = 80; 27.3%), electrolytes/minerals/metals/vitamins (n = 70; 23.9%), respiratory tract/pulmonary agents (n = 62; 21.2%), anxiolytics (n = 59; 20.1%), hormonal agents/stimulant/replacement/modifying (thyroid; n = 45; 15.4%), gastrointestinal agents (n = 43; 14.7%), analgesics (n = 33; 11.3%), blood glucose regulators (n = 32; 10.9%), and anticonvulsants (n = 26; 8.87%). Some associations between type of medication used and demographic or tinnitus-related variables were noted especially for the cardiovascular agents, electrolytes/minerals/metals/vitamins, and anxiolytics. Conclusions This exploratory study indicated a large percentage of patients using medication and a range of medications. Further studies are required to assess the effects of such medications on the tinnitus percept and concurrent medication moderate treatment effects.

PMID:34706212 | DOI:10.1044/2021_AJA-21-00062