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Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies.

ABSTRACT: Aim of the present analysis was to collect and pool all available data currently in the literature regarding outcomes and complications of all approved TAVR prosthesis and to assess the transition from first to next generation TAVR devices by directly comparing both in regard of procedure related complications. Transcatheter aortic valve replacement is a well established treatment modality in patients with severe aortic stenosis deemed to be inoperable or at unacceptable risk for open heart surgery. First generation prostheses were associated with a high rate of peri-procedural complications like paravalvular regurgitation, valve malpositioning, vascular complications and conduction disorders. Refinement of the available devices incorporate features to address the limitations of the first-generation devices. A PRISMA checklist-guided systematic review and meta-analysis of prospective observational studies, national and device specific registries or randomized clinical trials was conducted. Studies were identified by searching PUBMED, SCOPUS, Cochrane Central Register of Controlled Trials and LILACs from January 2000 to October 2017. We extracted and pooled data on both mortality and complications from 273 studies for twelve different valves prostheses in a total of 68,193 patients. In second generation prostheses as compared to first generation devices, we observed a significant decrease in mortality (1.47?±?1.73% vs. 5.41?±?4.35%; p?

SUBMITTER: Winter MP

PROVIDER: S-EPMC7511292 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies.

Winter Max-Paul MP Bartko Philipp P Hofer Felix F Zbiral Martin M Burger Achim A Ghanim Bahil B Kastner Johannes J Lang Irene M IM Mascherbauer Julia J Hengstenberg Christian C Goliasch Georg G

Scientific reports 20200923 1

Aim of the present analysis was to collect and pool all available data currently in the literature regarding outcomes and complications of all approved TAVR prosthesis and to assess the transition from first to next generation TAVR devices by directly comparing both in regard of procedure related complications. Transcatheter aortic valve replacement is a well established treatment modality in patients with severe aortic stenosis deemed to be inoperable or at unacceptable risk for open heart surg ...[more]

PMID: 32968104

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Project description:BackgroundCommunity-acquired pneumonia (CAP) is a leading cause of morbidity and mortality. CAP can trigger acute cardiac events. We sought to determine the incidence of major cardiac complications in CAP patients to characterize the magnitude of this problem.Methods and findingsTwo investigators searched MEDLINE, Scopus, and EMBASE for observational studies of immunocompetent adults with clinical and radiological evidence of CAP that reported any of the following: overall cardiac complications, incident heart failure, acute coronary syndromes (ACS), or incident cardiac arrhythmias occurring within 30 days of CAP diagnosis. At a minimum, studies had to establish enrolment procedures and inclusion and exclusion criteria, enroll their patients sequentially, and report the incidence of cardiac complications as a function of their entire cohorts. Studies with focus on nosocomial or health care-associated pneumonia were not included. Review of 2,176 citations yielded 25 articles that met eligibility and minimum quality criteria. Seventeen articles (68%) reported cohorts of CAP inpatients. In this group, the pooled incidence rates for overall cardiac complications (six cohorts, 2,119 patients), incident heart failure (eight cohorts, 4,215 patients), acute coronary syndromes (six cohorts, 2,657 patients), and incident cardiac arrhythmias (six cohorts, 2,596 patients), were 17.7% (confidence interval [CI] 13.9-22.2), 14.1% (9.3-20.6), 5.3% (3.2-8.6), and 4.7% (2.4-8.9), respectively. One article reported cardiac complications in CAP outpatients, four in low-risk (not severely ill) inpatients, and three in high-risk inpatients. The incidences for all outcomes except overall cardiac complications were lower in the two former groups and higher in the latter. One additional study reported on CAP outpatients and low-risk inpatients without discriminating between these groups. Twelve studies (48%) asserted the evaluation of cardiac complications in their methods but only six (24%) provided a definition for them. Only three studies, all examining ACS, carried out risk factor analysis for these events. No study analyzed the association between cardiac complications and other medical complications or their impact on other CAP outcomes.ConclusionsMajor cardiac complications occur in a substantial proportion of patients with CAP. Physicians and patients need to appreciate the significance of this association for timely recognition and management of these events. Strategies aimed at preventing pneumonia (i.e., influenza and pneumococcal vaccination) in high-risk populations need to be optimized. Further research is needed to understand the mechanisms underlying this association, measure the impact of cardiac complications on other CAP outcomes, identify those patients with CAP at high risk of developing cardiac complications, and design strategies to prevent their occurrence in this population.

Project description:IntroductionTo date, it is unclear what the clinical benefit of cement augmentation in fixation for trochanteric fractures is. The aim of this meta-analysis is to compare cement augmentation to no augmentation in fixation of trochanteric femur fractures in the elderly patients (>65 years) following low energy trauma.MethodsPubMed/Medline/Embase/CENTRAL/CINAHL were searched for both randomized clinical trials (RCT) and observational studies comparing both treatments. Effect estimates were pooled across studies using random effects models. Subgroup analysis was performed stratified by study design (RCTs and observational studies). The primary outcome is overall complication rate. Secondary outcomes include re-operation rate, mortality, operation duration, hospital stay, general quality of life, radiologic measures and functional hip scores.ResultsA total of four RCT's (437 patients) and three observational studies (293 patients) were included. The effect estimates of RCTs were equal to those obtained from observational studies. Cement augmentation has a significantly lower overall complication rate (28.3% versus 47.2%) with an odds ratio (OR) of 0.3 (95%CI 0.1-0.7). The occurrence of device/fracture related complications was the largest contributing factor to this higher overall complication rate in the non-augmented group (19.9% versus 6.0%, OR 0.2, 95%CI 0.1-0.6). Cement augmentation also carries a lower risk for re-interventions (OR 0.2, 95%CI 0.1-0.7) and shortens the hospital stay with 2 days (95%CI -2.2 to -0.5 days). The mean operation time was 7 minutes longer in the augmented group (95%CI 1.3-12.9). Radiological scores (lag screw/blade sliding mean difference -3.1mm, 95%CI -4.6 to -1.7, varus deviation mean difference -6.15°, 95%CI; -7.4 to -4.9) and functional scores (standardized mean difference 0.31, 95%CI 0.0-0.6) were in favor of cement augmentation. Mortality was equal in both groups (OR 0.7, 95%CI 0.4-1.3) and cement related complications were rare.ConclusionCement augmentation in fixation of trochanteric femoral fractures leads to fewer complications, re-operations and shorter hospital stay at the expense of a slightly longer operation duration. Cementation related complications occur rarely and mortality is equal between treatment groups. Based on these results, cement augmentation should be considered for trochanteric fractures in elderly patients.

Project description:BackgroundAlthough oral opioid agonist therapies (OATs), buprenorphine and methadone, are effective first-line treatments, OAT remains largely underutilized due to low retention rates and wide variation across programs. This rapid review therefore sought to summarize the retention rates reported by randomized controlled trials (RCTs) and controlled observational study designs that compared methadone to buprenorphine (or buprenorphine-naloxone).MethodsWe searched four electronic databases (EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials, CINAHL, up to April 2018) for RCTs and controlled observational studies that compared oral fixed-dose methadone to buprenorphine versus methadone (or buprenorphine-naloxone). Data were extracted separately for two different definitions of retention in treatment: (1) length of time retained in the study and (2) presence on the final day of a study. Separate random effects meta-analyses were performed for RCTs and controlled observational studies. Data from controlled observational studies where retention was measured as the length of time retained in the study were not amenable to meta-analysis.ResultsAmong 7603 studies reviewed, 10 RCTs and 3 observational studies met inclusion criteria (n = 5065) and compared fixed-dose oral buprenorphine with methadone. Across studies, the average retention rate was highly variable (RCTs: buprenorphine 20.0-82.5% and methadone 30.7-83.8%; observational studies: buprenorphine 20.2-78.3% and methadone 48.3-74.8%). For time period retained in the study, we observed no significant difference in treatment retention for buprenorphine versus methadone in RCTs (standardized mean difference [SMD] = - 0.07; 95% CI - 0.35-0.21, p = 0.63; quality of evidence: low). For presence on the final study day, we observed no significant difference between buprenorphine and methadone treatment retention in RCTs (risk ratio [RR] = 0.89; 95% CI 0.73-1.08, p = 0.24; quality of evidence: low) and controlled observational studies (RR = 0.75; 95% CI 0.36-1.58, p = 0.45).ConclusionMeta-analysis of existing RCTs suggests retention in oral fixed-dose opioid agonist therapy with methadone appears to be generally equal to buprenorphine (or buprenorphine-naloxone), with wide variation across studies. Similarly, a meta-analysis of three controlled observational studies indicated no difference in treatment retention although there was significant heterogeneity among the included studies. The length of follow-up did not appear to affect the retention rate.Systematic review registrationPROSPERO CRD42018104452 .

Dataset Information

Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies.

Publications

Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies.

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