Recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) guidelines highlighted some concerns about the randomized clinical trials (RCTs) comparing ...transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) for aortic stenosis. Quantification of these biases has not been previously performed.
To assess whether randomization protects RCTs comparing TAVI and SAVR from biases other than nonrandom allocation.
A systematic review of the literature between January 1, 2007, and June 6, 2022, on MEDLINE, Embase, and Cochrane Central Register of Controlled Trials was performed. Specialist websites were also checked for unpublished data.
The study included RCTs with random allocation to TAVI or SAVR with a maximum 5-year follow-up.
Data extraction was performed by 2 independent investigators following the PRISMA guidelines. A random-effects meta-analysis was used for quantifying pooled rates and differential rates between treatments of deviation from random assigned treatment (DAT), loss to follow-up, and receipt of additional treatments.
The primary outcomes were the proportion of DAT, loss to follow-up, and patients who were provided additional treatments and myocardial revascularization, together with their ratio between treatments. The measures were the pooled overall proportion of the primary outcomes and the risk ratio (RR) in the TAVI vs SAVR groups.
The search identified 8 eligible trials including 8849 participants randomly assigned to undergo TAVI (n = 4458) or SAVR (n = 4391). The pooled proportion of DAT among the sample was 4.2% (95% CI, 3.0%-5.6%), favoring TAVI (pooled RR vs SAVR, 0.16; 95% CI, 0.08-0.36; P < .001). The pooled proportion of loss to follow-up was 4.8% (95% CI, 2.7%-7.3%). Meta-regression showed a significant association between the proportion of participants lost to follow-up and follow-up time (slope, 0.042; 95% CI, 0.017-0.066; P < .001). There was an imbalance of loss to follow-up favoring TAVI (RR, 0.39; 95% CI, 0.28-0.55; P < .001). The pooled proportion of patients who had additional procedures was 10.4% (95% CI, 4.4%-18.5%): 4.6% (95% CI, 1.5%-9.3%) in the TAVI group and 16.5% (95% CI, 7.5%-28.1%) in the SAVR group (RR, 0.27; 95% CI, 0.15-0.50; P < .001). The imbalance between groups also favored TAVI for additional myocardial revascularization (RR, 0.40; 95% CI, 0.24-0.68; P < .001).
This study suggests that, in RCTs comparing TAVI vs SAVR, there are substantial proportions of DAT, loss to follow-up, and additional procedures together with systematic selective imbalance in the same direction characterized by significantly lower proportions of patients undergoing TAVI that might affect internal validity.
IntroductionTo examine the impact of the COVID-19 pandemic on mortality, we estimated excess all-cause mortality in 24 countries for 2020 and 2021, overall and stratified by sex and age.MethodsTotal, ...age-specific and sex-specific weekly all-cause mortality was collected for 2015–2021 and excess mortality for 2020 and 2021 was calculated by comparing weekly 2020 and 2021 age-standardised mortality rates against expected mortality, estimated based on historical data (2015–2019), accounting for seasonality, and long-term and short-term trends. Age-specific weekly excess mortality was similarly calculated using crude mortality rates. The association of country and pandemic-related variables with excess mortality was investigated using simple and multilevel regression models.ResultsExcess cumulative mortality for both 2020 and 2021 was found in Austria, Brazil, Belgium, Cyprus, England and Wales, Estonia, France, Georgia, Greece, Israel, Italy, Kazakhstan, Mauritius, Northern Ireland, Norway, Peru, Poland, Slovenia, Spain, Sweden, Ukraine, and the USA. Australia and Denmark experienced excess mortality only in 2021. Mauritius demonstrated a statistically significant decrease in all-cause mortality during both years. Weekly incidence of COVID-19 was significantly positively associated with excess mortality for both years, but the positive association was attenuated in 2021 as percentage of the population fully vaccinated increased. Stringency index of control measures was positively and negatively associated with excess mortality in 2020 and 2021, respectively.ConclusionThis study provides evidence of substantial excess mortality in most countries investigated during the first 2 years of the pandemic and suggests that COVID-19 incidence, stringency of control measures and vaccination rates interacted in determining the magnitude of excess mortality.
The prevalence of spinal deformities increases with age, affecting between 30% and 68% of the elderly population (ages ≥65). The reported prevalence of complications associated with surgery for ...spinal deformities in this population ranges between 37% and 71%. Given the wide range of reported complication rates, the decision to perform surgery remains controversial.
A comprehensive search was conducted using PubMed, Embase, and Cochrane to identify studies reporting complications for spinal deformity surgery in the elderly population. Pooled prevalence estimates for individual complication types were calculated using the random-effects model.
Of 5,586 articles, 14 met inclusion criteria. Fourteen complication types were reported, with at least 2 studies for each complication with the following pooled prevalence: reoperation (prevalence 19%; 95% CI, 9-36%; 107 patients); hardware failure (11%; 95% CI, 5-25%; 52 patients); infection (7%; 95% CI, 4-12%; 262 patients); pseudarthrosis (6%; 95% CI, 3-12%; 149 patients); radiculopathy (6%; 95% CI, 1-33%; 116 patients); cardiovascular event (5%; 95% CI, 1-32%; 121 patients); neurological deficit (5%; 95% CI, 2-15%; 248 patients); deep vein thrombosis (3%; 95% CI, 1-7%; 230 patients); pulmonary embolism (3%; 95% CI, 1-7%; 210 patients); pneumonia (3%; 95% CI, 1-11%; 210 patients); cerebrovascular or stroke event (2%; 95% CI, 0-9%; 85 patients); death (2%; 95% CI, 1-9%; 113 patients); myocardial infarction (2%; 95% CI, 1-6%; 210 patients); and postoperative hemorrhage (1%; 95% CI, 0-10%; 85 patients).
Most complication types following spinal deformity surgery in the elderly had prevalence point estimates of <6%, while all were at least ≤19%. Additional studies are needed to further explore composite prevalence estimates and prevalence associated with traditional surgical approaches as compared to minimally-invasive procedures in the elderly.
Objective: To compare the mortality associated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with non–ST elevation acute coronary syndrome ...(NSTE-ACS). Methods: We searched publications from PubMed, Embase, Web of Science, and the Cochrane Library from inception until December 23, 2020. All randomized clinical trials (RCTs) and observational studies comparing all-cause mortality after treatment with CABG versus PCI for patients with NSTE-ACS with minimum follow-up of 6 months were included. Restricted mean survival time (RMST) differences from RCTs and adjusted RMST differences from observational studies were computed by reconstructing time-to-event data from published Kaplan–Meier curves. Extracted hazard ratios (HRs) were also assessed as a secondary analysis. Results: Our systematic review included an individual participant data analysis of 3 RCTs and 8 observational studies. A meta-regression showed a significant association between log-transformed HRs and duration of follow-up (−0.009 95% confidence interval (CI), −0.002 to −0.016 log-HR per 1-year longer follow-up; P = .037), suggesting a violation of the proportional hazard assumption. Analysis of 6 studies with available RMST data showed a significant inverse association between adjusted RMST differences and cutoff years (slope, −0.028 95% CI, −0.042 to −0.013 year difference per 1-year longer cutoff; P < .005), suggesting a longer survival benefit in the CABG arm compared with the PCI arm with longer follow-up. Conclusions: There was a trend toward a benefit of CABG compared with PCI in the longer follow-up in patients with NSTE-ACS. A large, well-designed RCT with longer follow-up is needed to obtain definitive evidence on this topic.
Abstract Objectives To assess the predictive performance of cervical length measurement at presentation and 24 h later in women with symptoms of preterm labour. Study design Cervical length was ...measured transvaginally at presentation and 24 hours later in 122 women presenting with threatened preterm labour between 23 and 33 + 6 gestational weeks. Results Six women delivered within 1 week of presentation. The sensitivity and specificity of a cervical length <15 mm at admission for delivery within one week was 83.3 and 95.8%, respectively. A reduction of >20% in cervical length 24 h after admission predicted 50% of preterm deliveries within 1 week, with a specificity of 92.7%; in combination with cervical length at presentation it did not improve the prediction. The same was observed for birth before 32 weeks ( N = 9) and birth before 35 weeks ( N = 15). Conclusions Women with threatened preterm labour and a cervical length of <15 mm at presentation are at high risk of delivering preterm. Cervical change in the following 24 hours does not seem to improve the prediction.
Background and Purpose- Digital subtraction angiography has been used as the gold standard to confirm successful aneurysmal obliteration after aneurysm clipping procedures using titanium or cobalt ...alloy clips. Computed tomographic angiography is a newer, less invasive imaging technique also used to confirm successful aneurysmal obliteration; however, its use compared with digital subtraction angiography remains controversial. Methods- A comprehensive literature search was conducted on Pubmed, EMBASE, and Cochrane databases through November 6, 2017, for studies that evaluated postclipping aneurysm obliteration with both computed tomographic angiography and digital subtraction angiography. Pooled sensitivity, specificity, positive likelihood ratio (LR+), and negative likelihood ratio (LR-) were calculated using the bivariate random-effects model. Results- Out of 6916 studies, 13 studies met inclusion criteria for this meta-analysis. A total of 510 patients with 613 aneurysms were included. Compared with digital subtraction angiography, which detected 87 residual aneurysms, computed tomographic angiography detected 58 resulting in a pooled sensitivity of 69% (95% CI, 54%-81%) and a pooled specificity of 99% (95% CI, 97%-99%). This corresponded to LR+ of 55.5 (95% CI, 23.6-130.9) and LR- of 0.31 (95% CI, 0.20-0.48). Univariate meta-regression revealed that the pooled sensitivity was worse in prospective designs ( P interaction <0.05), and the pooled specificity was better in higher-quality studies and for postoperative aneurysm diameters of <2 mm ( P interaction <0.001 for both). Conclusions- This meta-analysis revealed that computed tomographic angiography had a favorable LR+ but not a favorable LR-. Thus, this imaging modality may be applicable to rule in, but not rule out, residual aneurysms after clipping.
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