Doukky, Rami

Purpose We sought to investigate the association between left-sided prosthetic valve dysfunction and gastrointestinal (GI) bleeding. Methods In a retrospective cohort of patients with left-sided prostheses, we identified those who experienced one or more GI bleeds. The latest or chronologically closest echocardiogram to the GI bleed was analyzed by a blinded investigator for prosthetic valve dysfunction. Results Among 334 unique patients, 166 had aortic prostheses, 127 had mitral prostheses, and 41 had both. A total of 58 (17.4%) subjects had GI bleeding events. Patients in the “GI Bleed” group had higher mean ejection fraction (56±14% vs. 49±15%; P = 0.003) and higher prevalence of hypertension, end-stage renal disease, and liver cirrhosis compared to the “No GI Bleed” group. There was a higher prevalence of moderate or severe prosthetic valve regurgitation in the GI Bleed vs. No GI Bleed group (8.6% vs. 2.2%; P = 0.027). Moderate or severe prosthetic valve regurgitation was independently associated with GI bleeding (odds ratio, 6.18; 95% confidence interval, 1.27-30.05; P = 0.024), after adjusting for ejection fraction, hypertension, end-stage renal disease and liver cirrhosis. Paravalvular regurgitation was associated with a higher incidence of GI bleeding compared to transvalvular regurgitation (35.7% vs. 11.9%; P = 0.044). The prevalence of prosthetic valve stenosis was similar between the GI Bleed and No GI Bleed groups (6.9% vs. 5.8%; P = 0.761). Conclusion In a cohort of patients with predominantly surgically placed prosthetic valves, moderate to severe left-sided prosthetic valve regurgitation was independently associated with GI bleeding.

Background: Efficacy of an intervention is commonly evaluated using P values, in addition to effect size measures such as absolute risk reduction, relative risk reduction, and numbers needed to treat. However, these measures are not always intuitive to clinicians. The fragility index (FI) is a more intuitive number that can facilitate interpretation but can only be used with binary outcomes. FI is the minimum number of patients who must be moved from the nonevent group to the event group to turn a significant result nonsignificant. In this retrospective analysis, we assessed the robustness of cardiovascular randomized controlled trials (RCTs), which report a positive (statistically significant) primary outcome by using the FI. Methods and Results: We searched Medline from 2007 to 2017 to identify cardiovascular RCTs published in 6 high impact journals ( The Lancet , New England Journal of Medicine , Journal of the American Medical Association , Circulation , Journal of the American College of Cardiology and European Heart Journal ). Only RCTs with sample sizes >500 and a 2-by-2 factorial design or dichotomous primary outcomes were selected. FI was calculated using a defined approach. Among the cohort of 123 RCTs that met inclusion criteria, median FI was 13 (interquartile range, 5–26). In 28 trials (22.8%), FI ranged between 1 and 4. In 37 trials (30.1%), number of patients lost to follow-up was higher than the FI. Pharmaceutical interventions had higher FI compared with other interventions, FI=19 (7–52; P =0.002). Median FI varied according to subspecialty (electrophysiology=2; heart failure=11; interventional cardiology=8; P =0.020) and multiregional RCTs had higher FI=22 (12–53.25; P =0.023). FI did not differ based on risk of bias indicators, funding, or publication year. Conclusions: Considerable variations in FI were observed among cardiovascular trials, suggesting the need for careful interpretation of results, particularly when number of patients lost to follow-up exceeds FI.

AbstractIntroduction:Patients with end‐stage renal disease (ESRD) experience frequent hemodialysis (HD) complications. Intradialytic hypotension (IDH) is a common complication presenting in approximately between 20 and 50% of HD sessions. Available interventions such as volume replacement or vasoactive medications are associated with significant side effects.Intermittent pneumatic compression (IPC) has been proposed as a feasible intervention for the prevention of IDH, treatment of peripheral arterial disease and venous ulcers. These devices apply intermittent pressure to the legs improving arterial blood flow, mobilization of pooled blood with an increase in venous return increasing the effective circulatory volume.Our goal was to identify the published clinical evidence on whether IPC has a circulatory benefit and is it well‐tolerated among patients receiving HD.Methods:We conducted a systematic review to identify studies assessing the efficacy and safety of IPC in patients with ESRD. Our primary outcome was IDH. Secondary outcomes such as HD comfort, ultrafiltration volume, and physical activity were collected. No restrictions where used and we included all observational and interventional studies. Two reviewers performed screening and study quality assessment.Findings:We included seven studies. Out of the seven studies, five addressed IDH, and the rest were included for secondary outcomes such as physical capacity and HD comfort. In one randomized crossover trial comparing exercise against IPC, 21 patients were randomized to 3 different arms (no intervention, cycling, IPC) a decrease in the rates of IDH with IPC was described (43%, 38%, and 24% respectively P = 0.014). The smaller studies corroborated these results. All studies where at high risk of bias.Discussion:IPC might offer significant benefits for patients undergoing HD not limited to prevention of IDH but also improvement of hemodialysis comfort and physical capacity. However, our results should be interpreted in the context of its limitations.

Background: In the busy world of cardiovascular medicine, abstracts may be the only part of a publication that clinicians read. Therefore, it is critical for abstracts to accurately reflect article content. The extended CONSORT (Consolidated Standards of Reporting Trials) Statement for Abstracts was developed to ensure high abstract quality. However, it is unknown how often adherence to CONSORT guidelines occurs among cardiovascular journals. Methods and Results: We searched MEDLINE for randomized controlled trials published in 3 major cardiovascular journals ( Circulation, Journal of the American College of Cardiology , and European Heart Journal ) from 2011 to 2017. Post hoc, interim, and cost-effective analyses of randomized controlled trials were excluded. Two independent investigators extracted the data using a prespecified data collection form and a third investigator adjudicated the data. The primary outcome was frequency of subcategory adherence to CONSORT guidelines. A total of 478 abstracts were included in the analysis. Approximately half of the abstracts (53%; 255/478; 95% CI, 49%–57%) identified the article as randomized in the title. All abstracts detailed the interventions for both study groups (100%) and 81% (95% CI, 78%–85%) reported trial registration. Methodological quality reporting was relatively low: 9% (45/478; 95% CI, 6%–12%) described participant eligibility criteria with settings for data collection, 43% (204/478; 95% CI, 39%–47%) reported details of blinding, and <1% (4/478; 95% CI, 0%–2%) reported allocation concealment. Approximately 60% (301/478; 95% CI, 59%–67%) of the included abstracts provided primary outcome results while 55% (262/478; 95% CI, 51%–60%) reported harms or adverse effects. Conclusions: There is a high prevalence of nonadherence to CONSORT guidelines among leading cardiovascular journals. Efforts by editors, authors, and reviewers should be made to increase adherence and promote transparent and unbiased presentation of study results.