Vascular Closure Devices For Axillary Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery. MATERIALS AND METHODS: MEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed: technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data. RESULTS: Of 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows: technical success 84.8% (95% confidence interval [CI]: 78%-89.7%, I2=60.4%), hematoma 7.9% (95% CI: 5.8%-10.6%, I2=0%), dissection 3.1% (95% CI: 1.3%-7.3%, I2=0%), pseudoaneurysm 2.7% (95% CI: 1.3%-5.7%, I2=0%), infection <1% (95% CI: 0%-5.7%, I2=20.5%), and local neurological complications 2.7% (95% CI: 1.7%-4.4%, I2=0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR]: 0.87 per 1 French (Fr) increase in sheath size, 95% CI: 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR]: 1.21 per 1 Fr increase sheath size, 95% CI: 1.04-1.40, p=0.013). CONCLUSIONS: Off-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications. CLINICAL IMPACT: Safe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site.

The Use of Vascular Closure Devices for Brachial Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To estimate the rates of technical success and adverse events of vascular closure devices (VCDs) in the brachial artery and compare the rates of adverse events with manual compression. MATERIALS AND METHODS: MEDLINE and Embase were searched for observational studies examining VCDs in the brachial artery. Meta-analyses were performed using random effects for the following outcomes: (a) technical success, (b) hematoma at the access site, (c) pseudoaneurysm, (d) local neurological adverse events, and (e) total number of adverse events. A pairwise meta-analysis compared VCD with manual compression for the outcomes of hematoma and the total number of adverse events. RESULTS: Of 1,761 eligible records, 16 studies including 510 access sites were included. Primary procedures performed were peripheral arterial disease interventions, percutaneous coronary intervention, and endovascular thrombectomy for ischemic stroke. The technical success rate was 93% (95% CI, 87%-96%; I2 = 47%). Data on the following adverse events were obtained via meta-analysis: (a) hematoma, 9% (5%-15%; I2 = 54%); (b) stenosis or occlusion at access site, 3% (1%-14%; I2 = 51%); (c) infection, 0% (0%-5%; I2 = 0%); (d) pseudoaneurysm, 4% (1%-13%; I2 = 61%); (e) local neurological adverse events, 5% (2%-13%; I2 = 54%); and (f) total number of adverse events, 15% (10%-22%; I2 = 51%). Angio-Seal success rate was 96% (93%-98%; I2 = 0%), whereas the ExoSeal success rate was 93% (69%-99%; I2 = 61%). When comparing VCD and manual compression, there was no difference in hematoma formation (relative risk, 0.75; 95% CI, 0.35-1.63; I2 = 0%; P = .47) or the total number of adverse events (relative risk, 0.75; 95% CI, 0.35-1.58; I2 = 76%; P = .45). CONCLUSIONS: Despite being off-label, studies suggest that VCDs in the brachial artery have a high technical success rate. There was no significant difference in adverse events between VCDs and manual compression in the brachial artery.

Blue vs white light for transurethral resection of non-muscle-invasive bladder cancer: an abridged Cochrane Review.

OBJECTIVES: To assess the effects of blue-light (BL)-enhanced transurethral resection of bladder tumour (TURBT) compared to white-light (WL)-based TURBT in the treatment of non-muscle-invasive bladder cancer (NMIBC). METHODS: Based on a published protocol, we performed a systematic search of multiple databases from their inception to March 2021. We included randomized controlled trials (RCTs) comparing blue-light (BL) TURBT to white-light (WL) TURBT. Our meta-analysis was based on a random-effects model. We assessed the quality of evidence on a per-outcome basis according to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach. RESULTS: We included 16 RCTs involving a total of 4325 participants in this review. BL TURBT may reduce the risk of disease recurrence over time (hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.54-0.81; low-certainty evidence) depending on baseline risk. For participants with low-, intermediate- and high-risk NMIBC, this corresponded to 48 (66 fewer to 27 fewer), 109 (152 fewer to 59 fewer) and 147 (211 fewer to 76 fewer) fewer recurrences per 1000 participants when compared to WL TURBT, respectively. BL TURBT may also reduce the risk of disease progression over time (HR 0.65, 95% CI 0.50-0.84; low-certainty evidence) depending on baseline risk. For participants with low-, intermediate- and high-risk NMIBC, this corresponded to 1 (1 fewer to 0 fewer), 17 (25 fewer to 8 fewer), and 56 (81 fewer to 25 fewer) fewer progressions per 1000 participants when compared to WL TURBT, respectively. CONCLUSIONS: Our findings suggest a favourable impact of BL TURBT on the risk of disease recurrence and progression; however, whether this risk reduction is clinically relevant greatly depends on the baseline risk of patients. We did not find an increase in severe surgical complications with BL cystoscopy, and we did not find any trial evidence on other, non-surgical adverse events.

Uterine Artery Embolization for Pedunculated Subserosal Fibroids: A Systematic Review and Meta-Analysis.

PURPOSE: To provide a comprehensive overview of the literature assessing the safety and efficacy of uterine artery embolization (UAE) for patients with pedunculated subserosal fibroids. MATERIALS AND METHODS: MEDLINE and Embase databases were searched without language or publication type restrictions for observational studies to estimate safety (adverse events) and efficacy (devascularization, fibroid volume reduction, and uterine volume reduction) outcomes. Case reports were included to qualitatively report adverse events. Meta-analysis was performed for single proportions and mean changes with random-effects modeling. RESULTS: Of 98 eligible articles, 11 studies were included in the final analysis. Of the adverse events detailed in these cases, 5 events were mild, 2 were moderate (torsion of pedunculated fibroid requiring laparoscopic myomectomy and persistent bleeding after embolization requiring hysterectomy), and 1 was severe (fibroid necrosis causing bowel obstruction requiring bowel resection and hysterectomy). There were no deaths reported in the literature. The pooled risk of adverse events was 1.7% (95% confidence interval [CI], 0.29%-9.2%; 4 of 181; I2 = 0%). The pooled devascularization rate was 75.9% (95% CI, 62.4%-85.6%; 140 of 189; I2 = 75%) at 3.91 months of follow-up. The percent volume reduction of the dominant pedunculated fibroid was 38.6% (95% CI, 33.0%-44.2%; I2 = 0%) at 4.3 months of follow-up. The percent uterine volume reduction was 36.7% (95% CI, 30.3%-43.0%; I2 = 47%) at 3.5 months of follow-up. CONCLUSIONS: UAE for pedunculated subserosal fibroids has a low risk of adverse events and effectively reduces fibroid and uterine size.

Pre-treatment with antiarrhythmic drugs for elective electrical cardioversion of atrial fibrillation: a systematic review and network meta-analysis.

AIMS: Our objective was to compare the efficacy of pre-treatment with different classes of anti-arrhythmic drugs (AADs) in patients with atrial fibrillation (AF) undergoing electrical cardioversion. METHODS AND RESULTS: We performed a systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) comparing different AADs in patients with AF undergoing electrical cardioversion. We grouped AADs into five network nodes: no treatment or rate control, Class Ia, Class Ic, Class III, and amiodarone. Outcomes were (i) acute restoration and (ii) maintenance of sinus rhythm. We searched MEDLINE and EMBASE from inception until June 2020. We used Python 3.8.3 and R 3.6.2 for data analysis. We evaluated the overall certainty of evidence with the GRADE framework. We included 28 RCTs. Compared with no treatment or rate control, Class III AADs [odds ratio (OR): 2.41; 95% credible interval (CrI): 1.37 to 4.62, high certainty] and amiodarone (OR: 2.58; 95% CrI: 1.54 to 4.37, high certainty) improved restoration of sinus rhythm. Amiodarone improved long-term maintenance of sinus rhythm when compared with no treatment or rate control (OR: 5.37; 95% CrI: 4.00-7.39, high certainty), Class Ic (OR: 1.89; 95% CrI: 1.05-3.45, moderate certainty) and Class III AADs (OR: 2.19; 95% CrI: 1.39-3.26, high certainty). CONCLUSION: Before electrical cardioversion of AF, treatment with Class III AADs or amiodarone improves the acute restoration of sinus rhythm. Amiodarone is most likely to improve the maintenance of sinus rhythm after electrical cardioversion, but Class Ic and Class III AADs are also effective.

A survey of cardiac surgeons to evaluate the use of sutureless aortic valve replacement in Canada.

BACKGROUND: Sutureless aortic valve replacement (SuAVR) is gaining popularity for the treatment of aortic stenosis. We aimed to describe Canadian cardiac surgeons' practice patterns and perceptions regarding SuAVR. METHODS: Content experts (clinicians and methodologists) developed the survey. Domains in the questionnaire include: respondent characteristics, factors influencing the decision to implant a SuAVR, barriers to SuAVR use, and interest in participating in a trial. RESULTS: A total of 66 cardiac surgeons (median duration of practice: 15 years; range 8-20 years) from 18 hospitals across Canada responded to the survey for a response rate of 84%. Surgeons reported that the following patient characteristics increased the likelihood they would choose SuAVR: hostile root (73%), small annular size (55%), high Society of Thoracic Surgery risk score (42%), older age (40%), to support minimally invasive surgery (25%) and redo-operation (23%). The following patient characteristics made surgeons less likely to pursue SuAVR: young age (73%), low STS score (40%), and large annular size (30%). Reported barriers to SuAVR use included: cost (33%), permanent pacemaker risk (27%) and uncertain durability (12%). Of respondents, 73% were interested in participating in a randomized controlled trial comparing SuAVR with transcatheter aortic valve replacement. CONCLUSIONS: The primary reasons for surgeons selecting SuAVR were high surgical risk and anatomical challenges. Cost is a primary factor limiting SuAVR use.

Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis.

TOPIC: To evaluate the safety and efficacy of transepithelial corneal cross-linking in comparison with the established epithelium-off technique for corneal ectasia. CLINICAL RELEVANCE: Considerable debate exists regarding whether transepithelial and epithelium-off cross-linking are comparable in their safety and efficacy. METHODS: We searched 16 electronic databases, including Medline, Embase, Web of Science, and the grey literature, current to July 8, 2020, for randomized controlled trials comparing transepithelial and epithelium-off cross-linking for corneal ectasia. We excluded studies evaluating cross-linking for nonectatic indications, as well as non-randomized controlled trials. Our primary outcome was the change in maximal keratometry (Kmax) at 12 months after cross-linking, and we considered additional topographic, visual, and safety outcomes. We summarized our analyses by calculating weighted mean differences (MDs) with associated 95% confidence intervals (CIs) for continuous outcomes and relative risks (RRs) with corresponding 95% CIs for dichotomous outcomes. We conducted trial sequential analysis to determine whether the required information size was met for each outcome. The quality of individual trials was evaluated using the Cochrane Collaboration's risk of bias assessment tool, and the evidence was assessed at an outcome level using the Grading of Recommendations Assessment, Development, and Evaluation methodology. RESULTS: Twelve studies totaling 966 eyes were eligible. A significant difference was found between transepithelial and epithelium-off cross-linking groups in the change in Kmax at 12 months (MD, 0.75; 95% CI, 0.23-1.28; P = 0.004; primary outcome) and at longest follow-up (MD, 1.20; 95% CI, 0.62-1.77; P < 0.001; secondary outcome) after treatment. No significant difference was found between the 2 groups when examining uncorrected distance visual acuity (MD, 0.04; 95% CI, -0.06 to 0.14; P = 0.386) or corrected distance visual acuity (MD, 0.01; 95% CI, -0.06 to 0.09; P = 0.732). Transepithelial cross-linking was associated with significantly fewer complications than the epithelium-off approach (RR, 0.22; 95% CI, 0.06-0.79; P = 0.020), although it was associated with an increased rate of disease progression at 12 months after treatment (RR, 4.49; 95% CI, 1.24-16.25; P = 0.022). The required information size was met for our primary outcome and trial sequential analysis supported the conventional meta-analysis. The quality of evidence was rated as moderate using the Grading of Recommendations Assessment, Development, and Evaluation methodology. DISCUSSION: The efficacy of transepithelial cross-linking remains inferior to the epithelium-off approach, although it is significantly safer.

Long-term outcomes of sacral neuromodulation for lower urinary tract dysfunction: A 23-year experience.

AIMS: To evaluate the long-term outcomes of sacral neuromodulation (SNM), and patient characteristics that may predict long-term success or complications. METHODS: A single-center retrospective cohort study was performed of all patients who underwent SNM testing and implantation. Outcome results, resolution of symptoms, and device removal were reported. Multivariable logistic regression was used to identify predictors of success. Cox proportional hazards model was used to identify predictors for device removal. RESULTS: Four hundred and thrity four patients underwent SNM test phase of which 241 (median age 48.0 years, 91.7% [221/241] female) had device implantation and were followed up for median [range] time of 4.0 (3 months-20.5 years) years. Multivariable logistic regression showed that male gender (odds ratio: 0.314; 95% confidence interval: 0.164-0.601, p = .0005) was independently associated with decreased peripheral nerve evaluation success. At final follow-up for patients who originally had device implantation, median (interquartile range) percent of symptoms resolution of all patients was 60.0% (0%-90%) and 69.3% (167/241) had SNM successful outcomes. Cox proportional hazards model showed no difference for time to SNM device removal with respect to patient age, gender, or diagnosis. 69.3% (167/241) patients had at least 1 surgical re-intervention. The most common reason at first surgical re-intervention was lead change only (26.3%, 44/167). CONCLUSION: SNM is a minimally invasive procedure with good long-term success rates. There is a high revision rate but overall, SNM has a good safety profile and excellent long-term outcomes.

Blue versus white light for transurethral resection of non-muscle invasive bladder cancer.

BACKGROUND: Disease recurrence and progression remain major challenges in the treatment of non-muscle invasive bladder cancer (NMIBC). Blue light-enhanced transurethral resection of bladder cancer (TURBT) is an approach to improve staging and achieve a complete resection of NMIBC. OBJECTIVES: To assess the effects of blue light-enhanced TURBT compared to white light-based TURBT in the treatment of NMIBC. SEARCH METHODS: We searched several medical literature databases, including the Cochrane Library, MEDLINE, and Embase, as well as trial registers, including ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. We performed a comprehensive search with no restrictions on language of publication or publication status until March 2021. SELECTION CRITERIA: We included randomized controlled trials using blue light versus white light TURBT. Included participants had a high level of suspicion based on imaging or 'visible diagnosis' for primary urothelial carcinoma of the bladder or recurrent urothelial carcinoma of the bladder upon cytoscopy. We excluded studies in which blue light was used in a surveillance setting.  DATA COLLECTION AND ANALYSIS: Two review authors independently performed data extraction and risk of bias assessment. Our primary outcomes were time to disease recurrence, time to disease progression, and serious surgical complications. Secondary outcomes were time to death from bladder cancer, any adverse events, and non-serious complications. We rated the certainty of evidence using the GRADE approach. MAIN RESULTS: We included 16 randomized controlled trials involving a total of 4325 participants in the review. The studies compared blue light versus white light TURBT for treatment of NMIBC.  Primary outcomes Blue light TURBT may reduce the risk of disease recurrence over time (hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.54 to 0.81; low-certainty evidence) depending on baseline risk. For participants with low-, intermediate-, and high-risk NMIBC, this corresponded to 48 (66 fewer to 27 fewer), 109 (152 fewer to 59 fewer), and 147 (211 fewer to 76 fewer) fewer recurrences per 1000 participants when compared to white light TURBT, respectively.  Blue light TURBT may also reduce the risk of disease progression over time (HR 0.65, 95% CI 0.50 to 0.84; low-certainty evidence) depending on baseline risk. For participants with low-, intermediate-, and high-risk NMIBC, this corresponded to 1 (1 fewer to 0 fewer), 17 (25 fewer to 8 fewer), and 56 (81 fewer to 25 fewer) fewer progressions per 1000 participants when compared to white light TURBT, respectively. Blue light TURBT may have little or no effect on serious surgical complications (risk ratio (RR) 0.54, 95% CI 0.14 to 2.14; low-certainty evidence). This corresponded to 10 fewer (19 fewer to 25 more) surgical complications per 1000 participants with blue light TURBT.  Secondary outcomes Blue light TURBT may have little or no effect on the risk of death from bladder cancer over time (HR 0.55, 95% CI 0.19 to 1.61; low-certainty evidence). This corresponded to 22 deaths per 1000 participants with white light TURBT and 10 fewer (17 fewer to 13 more) deaths per 1000 participants with blue light TURBT.   We are very uncertain how blue light TURBT affects the outcome adverse events of any grade (RR 1.09, 95% CI 0.88 to 1.33; low-certainty evidence).  No analysis was possible for the outcome non-serious surgical complications, as it was not reported by any of the included studies. AUTHORS' CONCLUSIONS: Blue light-enhanced TURBT for the treatment of non-muscle invasive bladder cancer compared to white light-based TURBT may reduce the risk of disease recurrence and disease progression over time depending on baseline risk. There may be little or no effect on serious surgical complications. The certainty of evidence for our findings was low, meaning that future studies are likely change to the reported estimates of effect. Frequent issues that led to downgrading of the certainty of the evidence were study limitations, inconsistency, and imprecision.

Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis.

PURPOSE: Cardiogenic shock carries high morbidity and mortality. The purpose of this review was to determine the safety and efficacy of pulmonary artery catheterization (PAC) in adult patients hospitalized with cardiogenic shock. SOURCE: We performed a systematic review and meta-analysis of observational studies and randomized controlled trials comparing PAC vs no PAC in cardiogenic shock. We searched MEDLINE, EMBASE, Cochrane CENTRAL, and grey literature. We screened articles, abstracted data, and evaluated risk of bias in duplicate. We pooled data using a random-effects model and evaluated the quality of evidence using the GRADE framework. Outcomes of interest were mortality, length of stay, and procedural complications. PRINCIPAL FINDINGS: We identified 19 eligible observational studies (≥ 2,716,287 patients) and no randomized controlled trials; 14 studies were at high risk of bias (lack of adjustment for prognostic variables and/or co-interventions). When pooling adjusted results, PAC was associated with improved survival to hospital discharge (relative risk [RR], 0.77; 95% confidence interval [CI], 0.64 to 0.91, I2 = 98%; very low-quality evidence) and at longest available follow-up (RR, 0.72; 95% CI, 0.60 to 0.87; I2 = 99%; very low-quality evidence). Unadjusted length of stay was 3.5 days longer (95% CI, 1.49 to 5.54; I2 = 100%; very low-quality evidence) with PAC. Procedural complications were inconsistently reported. CONCLUSIONS: Very low-quality observational evidence suggests PAC use in patients with cardiogenic shock is associated with lower mortality. Overall, these results support consideration of PAC for hemodynamic assessment in cardiogenic shock. Prospective randomized clinical trials are needed to further characterize the role of PAC in this population.

RéSUMé: OBJECTIF: Le choc cardiogénique entraîne une morbidité et une mortalité élevées. Le but de cette revue était de déterminer la sécurité et l'efficacité de l'utilisation d'un cathétérisme de l'artère pulmonaire (CAP) chez des patients adultes hospitalisés en choc cardiogénique. SOURCES: Nous avons réalisé une revue systématique et une méta-analyse d'études observationnelles et d'études randomisées contrôlées comparant l'utilisation vs la non-utilisation de CAP pour le traitement d'un choc cardiogénique. Nous avons effectué des recherches dans les bases de données MEDLINE, EMBASE, Cochrane CENTRAL et dans la littérature grise. Nous avons examiné les articles, résumé les données et évalué le risque de biais à deux reprises. Nous avons regroupé les données à l'aide d'un modèle à effets aléatoires et évalué la qualité des données probantes en nous appuyant sur le système GRADE. Les issues d'intérêt étaient la mortalité, la durée de séjour et les complications procédurales. CONSTATATIONS PRINCIPALES: Nous avons identifié 19 études observationnelles admissibles (≥ 2 716 287 patients) et aucune étude randomisée contrôlée; 14 études comportaient un risque élevé de biais (absence d'ajustement sur les variables pronostiques et/ou les interventions concomitantes). En regroupant les résultats ajustés, le CAP a été associé à une meilleure survie jusqu'au congé de l'hôpital (risque relatif [RR], 0,77; intervalle de confiance [IC] à 95 %, 0,64 à 0,91, I2 = 98 %; données probantes de très faible qualité) et jusqu'au point de suivi disponible rapporté le plus lointain dans le temps (RR, 0,72; IC 95 %, 0,60 à 0,87; I2 = 99 %; données probantes de très faible qualité). La durée de séjour non ajustée était 3,5 jours plus longue (IC 95 %, 1,49 à 5,54; I2 = 100 %; données probantes de très faible qualité) avec un CAP. Les complications procédurales n'étaient par rapportées de manière uniforme. CONCLUSION: Des données observationnelles de très faible qualité suggèrent que l'utilisation d'un CAP chez des patients en choc cardiogénique est associée à une réduction de la mortalité. Dans l'ensemble, ces résultats suggèrent de considérer le CAP pour l'évaluation hémodynamique en cas de choc cardiogénique. Des études cliniques randomisées prospectives sont nécessaires pour mieux caractériser le rôle du CAP dans cette population.

What Is the Relative Effectiveness of the Various Surgical Treatment Options for Distal Radius Fractures? A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.

BACKGROUND: Many acceptable treatment options exist for distal radius fractures (DRFs); however, a simultaneous comparison of all methods is difficult using conventional study designs. QUESTIONS/PURPOSES: We performed a network meta-analysis of randomized controlled trials (RCTs) on DRF treatment to answer the following questions: Compared with nonoperative treatment, (1) which intervention is associated with the best 1-year functional outcome? (2) Which intervention is associated with the lowest risk of overall complications? (3) Which intervention is associated with the lowest risk of complications requiring operation? METHODS: Ten databases were searched from inception to July 25, 2019. Search and analysis reporting adhered to Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Included studies were English-language RCTs that assessed at least one surgical treatment arm for adult patients with displaced DRFs, with less than 20% loss to follow-up. We excluded RCTs reporting on patients with open fractures, extensive bone loss, or ipsilateral upper extremity polytrauma. Seventy RCTs (n = 4789 patients) were included. Treatments compared were the volar locking plate, bridging external fixation, nonbridging external fixation, dynamic external fixation, percutaneous pinning, intramedullary fixation, dorsal plating, fragment-specific plating, and nonoperative treatment. Subgroup analyses were conducted for intraarticular fractures, extraarticular fractures, and patients with an average age greater than 60 years. Mean (range) patient age was 59 years (56 to 63) and was similar across all treatment groups except for dynamic external fixation (44 years) and fragment-specific plating (47 years). Distribution of intraarticular and extraarticular fractures was approximately equal among the treatment groups other than that for intramedullary fixation (73% extraarticular), fragment-specific plating (66% intraarticular) [13, 70], and dorsal plating (100% intraarticular). Outcomes were the DASH score at 1 year, total complications, and reoperation. The minimum clinically important different (MCID) for the DASH score was set at 10 points. The analysis was performed using Bayesian methodology with random-effects models. Rank orders were generated using surface under the cumulative ranking curve values. Evidence quality was assessed using Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methodology. Most studies had a low risk of bias due to randomization and low rates of incomplete follow-up, unclear risk of bias due to selective reporting, and high risk of bias due to lack of patient and assessor blinding. Studies assessing bridging external fixation and/or nonoperative treatment arms had a higher overall risk of bias while studies with volar plating and/or percutaneous pinning treatment arms had a lower risk of bias. RESULTS: Across all patients, there were no clinically important differences in terms of the DASH score at 1 year; although differences were found, all were less than the MCID of 10 points. Volar plating was ranked the highest for DASH score at 1 year (mean difference -7.34 [95% credible interval -11 to -3.7) while intramedullary fixation, with low-quality evidence, also showed improvement in DASH score (mean difference -7.75 [95% CI -14.6 to -0.56]). The subgroup analysis revealed that only locked volar plating was favored over nonoperative treatment for patients older than 60 years of age (mean difference -6.4 [95% CI -11 to -2.1]) and for those with intraarticular fractures (mean difference -8.4 [95% CI -15 to -2.0]). However, its clinical importance was uncertain as the MCID was not met. Among all patients, intramedullary fixation (odds ratio 0.09 [95% CI 0.02 to 0.84]) and locked volar plating (OR 0.14 [95% CI 0.05 to 0.39]) were associated with a lower complication risk compared with nonoperative treatment. For intraarticular fractures, volar plating was the only treatment associated with a lower risk of complications than nonoperative treatment (OR 0.021 [95% CI < 0.01 to 0.50]). For extraarticular fractures, only nonbridging external fixation was associated with a lower risk of complications than nonoperative treatment (OR 0.011 [95% CI < 0.01 to 0.65]), although the quality of evidence was low. Among all patients, the risk of complications requiring operation was lower with intramedullary fixation (OR 0.06 [95% CI < 0.01 to 0.85) than with nonoperative treatment, but no treatment was favored over nonoperative treatment when analyzed by subgroups. CONCLUSION: We found no clinically important differences favoring any surgical treatment option with respect to 1-year functional outcome. However, relative to the other options, volar plating was associated with a lower complication risk, particularly in patients with intraarticular fractures, while nonbridging external fixation was associated with a lower complication risk in patients with extraarticular fractures. For patients older than 60 years of age, nonoperative treatment may still be the preferred option because there is no reliable evidence showing a consistent decrease in complications or complications requiring operation among the other treatment options. Particularly in this age group, the decision to expose patients to even a single surgery should be made with caution. LEVEL OF EVIDENCE: Level I, therapeutic study.

Outflow cannula position for left ventricular assist device: A propensity score-matched study.

OBJECTIVE: The clinical consequences of alternative outflow cannula positioning in patients undergoing left ventricular assist device implantation are unknown. We evaluated clinical outcomes in patients who underwent implantation with the outflow cannula implanted from the right side into the ascending aorta versus the left side of the pericardium. METHODS: Fifty consecutive patients with terminal left heart failure underwent implantation using the Medtronic Heartware Ventricular Assist Device at Toronto General Hospital. Patients were divided between left and right outflow cannula positioning during implantation where anastomosis occurred in the ascending aorta. Propensity score matching using exact matching on the following pre-specified covariates: Interagency Registry for Mechanically Assisted Circulatory Support score, previous cardiac surgery, and preoperative inotrope use. RESULTS: Fifty consecutive patients (25 left implantation and 25 right implantation) were included in the unmatched cohort and 45 patients (25 left implantation and 20 right implantation) were included in the matched cohort. No significant differences in baseline demographics. Pump thrombosis occurred in 10% (n = 2) receiving right-sided implantation and 8% (n = 2) with left implantation (p = 1.00). Postoperative stroke occurred in 10% (2/20) with right implantation and 16% (4/25) with left implantation (p = .88). No difference in 1-year mortality between right 20% (5/25) and left 25% (5/20) implantation (p = .97). CONCLUSION: No observed difference in mortality when adjusting for competing risk of heart transplantation. There was also no difference in stroke, pump thrombosis, driveline infection. Larger studies are required to confirm these findings. These preliminary data support the use of left-sided anastomoses to facilitate subsequent re-entry during heart transplantation.

Outcomes of sutureless aortic valve replacement versus conventional aortic valve replacement and transcatheter aortic valve replacement, updated systematic review, and meta-analysis.

BACKGROUND: Sutureless aortic valve replacement (SuAVR) is an alternative to surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This study compares the effectiveness of SuAVR to SAVR and TAVR. METHODS: We searched MEDLINE and EMBASE from inception to July 2021 for studies evaluating SuAVR, SAVR, and TAVR in adults with aortic stenosis. We performed screening, full-text assessment, data collection, and risk of bias evaluation independently and in duplicate. We evaluated risk of bias using by Cochrane and CLARITY's tools, and certainty in evidence using the GRADE framework. Data were pooled using a random-effects model. RESULTS: We identified one randomized and 78 observational studies (n = 60,689; SuAVR vs. SAVR = 39,171, vs. TAVR = 21,518). All studies were at high or unclear risk of bias, with very-low certainty in effect estimates. Compared to TAVR, SuAVR demonstrates no significant difference in mortality at 30-days (odds ratio [OR]: 0.52, 95% confidence interval [CI: 0.85, 1.16], I2 = 0%), but decreased odds at 2-years (OR: 0.39, 95% CI [0.17, 0.88], I2 = 0%). SuAVR also reduced odds of mild paravalvular regurgitation (OR: 0.11, 95% CI [0.06, 0.21], I2 = 50%). Compared to SAVR, SuAVR was associated with a similar mortality at 30-days (OR: 0.99, 95% CI [0.85, 1.16], I2 = 0%) and 2-years (OR: 0.99, 95% CI [0.43-2.30], I2 = 7%). SuAVR significantly increased odds of permanent pacemaker implantation (OR: 2.5, 95% CI [2.25, 2.77], I2 = 0%). Pooled effect estimates were consistent with results from the randomized trial comparing SuAVR and SAVR. CONCLUSION: Based on very-low quality evidence, SuAVR is associated with similar short- and midterm outcomes compared to TAVR and SAVR. Comparative randomized data with long-term follow-up are required to clarify the role of SuAVR.

Expertise-based design in surgical trials: a narrative review.

Randomized controlled trials (RCTs) are the most robust study design for evaluating the safety and efficacy of a therapeutic intervention. However, their internal validity are at risk when evaluating surgical interventions. This review summarizes existing expertise- based trials in surgery and related methodological concepts to guide surgeons performing this work. We provide caseloads required to reach the learning curve for various surgical interventions and report criteria for expertise from published and unpublished expertise-based trials. In addition, we review design and implementation concepts of expertise-based trials, including recruitment of surgeons, crossover, ethics, generalizability, sample size and definitions for learning curve. Several RCTs have used an expertise-based design. We found that the majority of definitions used for expertise were vague, heterogeneous, and inconsistent across trials evaluating the same surgical intervention. Statistical methods exist to adjust for the learning curve; however, there is limited guidance. We developed the following criteria for surgical expertise for future trials: 1) decide on the proxy to be used for the learning curve, and 2) assess eligible surgeons by comparing their performance to the previously defined expertise criteria.

Modes of bioprosthetic valve failure: a narrative review.

PURPOSE OF REVIEW: A thorough understanding of the modes of bioprosthetic valve failure is critical as clinicians will be facing an increasing number of patients presenting with failed bioprostheses in coming years. The purpose of this article is to review modes of bioprosthestic valve degeneration, their management, and identify gaps for future research. RECENT FINDINGS: Guidelines recommend monitoring hemodynamic performance of prosthetic valves using serial echocardiograms to determine valve function and presence of valve degeneration. Modes of bioprosthetic valve failure may be categorized as structural degeneration (calcification, tears, fibrosis, flail), nonstructural degeneration (pannus), thrombosis, and endocarditis. Calcification is the most common form of structural valve degeneration. Predictors of bioprosthetic valve failure include valves implanted in the mitral position, younger age, and type of valve (porcine versus bovine pericardial). Failed bioprosthetic valves are managed with either redo surgical replacement or transcatheter valve-in-valve implantation. SUMMARY: Several modes of bioprosthetic valve failure exist, which vary based on patient, implant position, and valve characteristics. Further research is required to characterize factors associated with early failure to delay structural valve degeneration and improve patient prognosis.

Alpha-blockers after shock wave lithotripsy for renal or ureteral stones in adults.

BACKGROUND: Shock wave lithotripsy (SWL) is a widely used method to treat renal and ureteral stone. It fragments stones into smaller pieces that are then able to pass spontaneously down the ureter and into the bladder. Alpha-blockers may assist in promoting the passage of stone fragments, but their effectiveness remains uncertain.  OBJECTIVES: To assess the effects of alpha-blockers as adjuvant medical expulsive therapy plus usual care compared to placebo and usual care or usual care alone in adults undergoing shock wave lithotripsy for renal or ureteral stones. SEARCH METHODS: We performed a comprehensive literature search of the Cochrane Library, the Cochrane Database of Systematic Reviews, MEDLINE, Embase, several clinical trial registries and grey literature for published and unpublished studies irrespective of language. The date of the most recent search was 27 February 2020. SELECTION CRITERIA: We included randomized controlled trials of adults undergoing SWL. Participants in the intervention group had to have received an alpha-blocker as adjuvant medical expulsive therapy plus usual care. For the comparator group, we considered studies in which participants received placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion/exclusion, and performed data abstraction and risk of bias assessment. We conducted meta-analysis for the identified dichotomous and continuous outcomes using RevManWeb according to Cochrane methods using a random-effects model. We judged the certainty of evidence on a per outcome basis using GRADE. MAIN RESULTS: We included 40 studies with 4793 participants randomized to usual care and an alpha-blocker versus usual care alone. Only four studies were placebo controlled. The mean age of participants was 28.6 to 56.8 years and the mean stone size prior to SWL was 7.1 mm to 13.2 mm. The most widely used alpha-blocker was tamsulosin; others were silodosin, doxazosin, terazosin and alfuzosin.  Alpha-blockers may improve clearance of stone fragments after SWL (risk ratio (RR) 1.16, 95% confidence interval (CI) 1.09 to 1.23; I² = 78%; studies = 36; participants = 4084; low certainty evidence). Based on the stone clearance rate of 69.3% observed in the control arm, an alpha-blocker may increase stone clearance to 80.4%. This corresponds to 111 more (62 more to 159 more) participants per 1000 clearing their stone fragments. Alpha-blockers may reduce the need for auxiliary treatments after SWL (RR 0.67, 95% CI 0.45 to 1.00; I² = 16%; studies = 12; participants = 1251; low certainty evidence), but also includes the possibility of no effect. Based on a rate of auxiliary treatments in the usual care arm of 9.7%, alpha-blockers may reduce the rate to 6.5%. This corresponds 32 fewer (53 fewer to 0 fewer) participants per 1000 undergoing auxiliary treatments. Alpha-blockers may reduce major adverse events (RR 0.60, 95% CI 0.46 to 0.80; I² = 0%; studies = 7; participants = 747; low certainty evidence). Major adverse events occurred in 25.8% of participants in the usual care group; alpha-blockers would reduce this to 15.5%. This corresponds to 103 fewer (139 fewer to 52 fewer) major adverse events per 1000 with alpha-blocker treatment. None of the reported major adverse events appeared drug-related; most were emergency room visits or rehospitalizations. Alpha-blockers may reduce stone clearance time in days (mean difference (MD) -3.74, 95% CI -5.25 to -2.23; I² = 86%; studies = 14; participants = 1790; low certainty evidence). We found no evidence for the outcome of quality of life. For those outcomes for which we were able to perform subgroup analyses, we found no evidence of interaction with stone location, stone size or type of alpha-blocker. We were unable to conduct an analysis by lithotripter type. The results were also largely unchanged when the analyses were limited to placebo controlled studies and those in which participants explicitly only received a single SWL session. AUTHORS' CONCLUSIONS: Based on low certainty evidence, adjuvant alpha-blocker therapy following SWL in addition to usual care may result in improved stone clearance, less need for auxiliary treatments, fewer major adverse events and a reduced stone clearance time compared to usual care alone. We did not find evidence for quality of life. The low certainty of evidence means that our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.

Bedside Optic Nerve Ultrasonography for Diagnosing Increased Intracranial Pressure: A Systematic Review and Meta-analysis.

Background: Optic nerve ultrasonography (optic nerve sheath diameter sonography) has been proposed as a noninvasive, quick method for diagnosing increased intracranial pressure. Purpose: To examine the accuracy of optic nerve ultrasonography for diagnosing increased intracranial pressure in children and adults. Data Sources: 13 databases from inception through May 2019, reference lists, and meeting proceedings. Study Selection: Prospective optic nerve ultrasonography diagnostic accuracy studies, published in any language, involving any age group or reference standard. Data Extraction: 3 reviewers independently abstracted data and performed quality assessment. Data Synthesis: Of 71 eligible studies involving 4551 patients, 61 included adults, and 35 were rated as having low risk of bias. The pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of optic nerve ultrasonography in patients with traumatic brain injury were 97% (95% CI, 92% to 99%), 86% (CI, 74% to 93%), 6.93 (CI, 3.55 to 13.54), and 0.04 (CI, 0.02 to 0.10), respectively. Respective estimates in patients with nontraumatic brain injury were 92% (CI, 86% to 96%), 86% (CI, 77% to 92%), 6.39 (CI, 3.77 to 10.84), and 0.09 (CI, 0.05 to 0.17). Accuracy estimates were similar among studies stratified by patient age, operator specialty and training level, reference standard, sonographer blinding status, and cutoff value. The optimal cutoff for optic nerve sheath dilatation on ultrasonography was 5.0 mm. Limitation: Small studies, imprecise summary estimates, possible publication bias, and no evaluation of effect on clinical outcomes. Conclusion: Optic nerve ultrasonography can help diagnose increased intracranial pressure. A normal sheath diameter measurement has high sensitivity and a low negative likelihood ratio that may rule out increased intracranial pressure, whereas an elevated measurement, characterized by a high specificity and positive likelihood ratio, may indicate increased intracranial pressure and the need for additional confirmatory tests. Primary Funding Source: None. (PROSPERO: CRD42017055485).

Midterm results after St Jude Medical Epic porcine xenograft for aortic, mitral, and double valve replacement.

BACKGROUND: The aim of this study was to evaluate the results after stented porcine xenograft implantation (Epic, SJM, St Paul, MN) with Linx anticalcification treatment in elderly patients at our high-volume tertiary care center. METHODS: A total of 3825 patients undergoing aortic (AVR = 2441), mitral (MVR = 892), or double valve (DVR = 492) replacement between 11/2001 and 12/2017 with Epic xenografts were evaluated. Outcomes were assessed by reviewing the prospectively acquired hospital database results, and regular annual follow-up information was acquired from questionnaires or telephone interviews. RESULTS: For patients undergoing AVR, MVR, DVR, age at surgery were 76.4 ± 6, 71.2 ± 9, 72.9 ± 8 years; active endocarditis was an indication for valve surgery in 4.5%, 20.7%, 19.7%; and the predicted median (interquartile range [IQR]) mortality risk (EuroSCORE II) was 5.2% (3.1%-9.4%), 7.5% (3.9%-16.2%), 9.9% (6.0%-19.6%), respectively. Median follow-up was 3.04 (IQR: 0.18-5.21). Thirty-day survival was 91.2% ± 0.6%, 87.6% ± 0.1.1%, 84.7% ± 1.6%; and 10-year survival was 56.7% ± 1.0%, 59.4% ± 2.5%, 50.45% ± 3.1%, respectively. Patients who underwent MVR versus AVR were at significant increased risk for reoperation for endocarditis (adjusted odds ratio; 2.2, 95% confidence interval; 1.29-3.7; P = .003). There was no significant difference in all-cause mortality at midterm in AVR vs MVR in the matched cohort (P = .85). CONCLUSIONS: Implantation of the Epic stented porcine xenograft is associated with acceptable survival and freedom from valve-related complications or reoperation due to structural valve disease at midterm follow-up.

Atraumatic versus conventional lumbar puncture needles: a systematic review and meta-analysis.

BACKGROUND: Atraumatic needles have been proposed to lower complication rates after lumbar puncture. However, several surveys indicate that clinical adoption of these needles remains poor. We did a systematic review and meta-analysis to compare patient outcomes after lumbar puncture with atraumatic needles and conventional needles. METHODS: In this systematic review and meta-analysis, we independently searched 13 databases with no language restrictions from inception to Aug 15, 2017, for randomised controlled trials comparing the use of atraumatic needles and conventional needles for any lumbar puncture indication. Randomised trials comparing atraumatic and conventional needles in which no dural puncture was done (epidural injections) or without a conventional needle control group were excluded. We screened studies and extracted data from published reports independently. The primary outcome of postdural-puncture headache incidence and additional safety and efficacy outcomes were assessed by random-effects and fixed-effects meta-analysis. This study is registered with the International Prospective Register of Systematic Reviews, number CRD42016047546. FINDINGS: We identified 20 241 reports; after exclusions, 110 trials done between 1989 and 2017 from 29 countries, including a total of 31 412 participants, were eligible for analysis. The incidence of postdural-puncture headache was significantly reduced from 11·0% (95% CI 9·1-13·3) in the conventional needle group to 4·2% (3·3-5·2) in the atraumatic group (relative risk 0·40, 95% CI 0·34-0·47, p<0·0001; I2=45·4%). Atraumatic needles were also associated with significant reductions in the need for intravenous fluid or controlled analgesia (0·44, 95% CI 0·29-0·64; p<0·0001), need for epidural blood patch (0·50, 0·33-0·75; p=0·001), any headache (0·50, 0·43-0·57; p<0·0001), mild headache (0·52, 0·38-0·70; p<0·0001), severe headache (0·41, 0·28-0·59; p<0·0001), nerve root irritation (0·71, 0·54-0·92; p=0·011), and hearing disturbance (0·25, 0·11-0·60; p=0·002). Success of lumbar puncture on first attempt, failure rate, mean number of attempts, and the incidence of traumatic tap and backache did not differ significantly between the two needle groups. Prespecified subgroup analyses of postdural-puncture headache revealed no interactions between needle type and patient age, sex, use of prophylactic intravenous fluid, needle gauge, patient position, indication for lumbar puncture, bed rest after puncture, or clinician specialty. These results were rated high-quality evidence as examined using the grading of recommendations assessment, development, and evaluation. INTERPRETATION: Among patients who had lumbar puncture, atraumatic needles were associated with a decrease in the incidence of postdural-puncture headache and in the need for patients to return to hospital for additional therapy, and had similar efficacy to conventional needles. These findings offer clinicians and stakeholders a comprehensive assessment and high-quality evidence for the safety and efficacy of atraumatic needles as a superior option for patients who require lumbar puncture. FUNDING: None.

Pre- and post-treatment with amiodarone for elective electrical cardioversion of atrial fibrillation: a systematic review and meta-analysis.

AIMS: Clinicians frequently pre-treat patients with amiodarone to increase the efficacy of electrical cardioversion for atrial fibrillation (AF). Our objective was to determine the precise effects of amiodarone pre- and post-treatment on conversion efficacy and sinus rhythm maintenance. METHODS AND RESULTS: We conducted a systematic review and meta-analysis of trials comparing pre- and post-treatment for electrical cardioversion with amiodarone vs. no therapy on (i) acute restoration and (ii) maintenance of sinus rhythm after 1 year. We searched MEDLINE and EMBASE from inception to July 2018 for randomized controlled trials. We evaluated the risk of bias for individual studies with the Cochrane tool and overall quality of evidence with the GRADE framework. We identified eight eligible studies (n = 1012). Five studies were deemed to have unclear or high risk of selection bias. We found the evidence to be of high quality based on GRADE. Treatment with amiodarone (200-800 mg daily for 1-6 weeks pre-cardioversion; 0-200 mg daily post-cardioversion) was associated with higher rates of acute restoration [relative risk (RR) 1.22, 95% confidence interval (CI) 1.07-1.39, P = 0.004, n = 1012, I2 = 65%] and maintenance of sinus rhythm over 13 months (RR 4.39, 95% CI 2.99-6.45, P < 0.001, n = 695, I2 = 0%). The effects of amiodarone for acute restoration were maintained when considering only studies at low risk of bias (RR 1.22, 95% CI 1.10-1.36, P < 0.001, n = 572, I2 = 0%). Adverse effects were typically non-serious, occurring in 3.4% (6/174) of subjects receiving amiodarone. CONCLUSION: High-quality evidence demonstrated that treatment with amiodarone improved the restoration and maintenance of sinus rhythm after electrical cardioversion of AF. Short-term amiodarone was well-tolerated.