scholarly journals Outcomes of Cardiac Contractility Modulation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Ramy Mando ◽  
Akshay Goel ◽  
Fuad Habash ◽  
Marwan Saad ◽  
Karam Ayoub ◽  
...  

Background. Cardiac contractility modulation (CCM) is a device therapy for systolic heart failure (HF) in patients with narrow QRS. We aimed to perform an updated meta-analysis of the randomized clinical trials (RCTs) to assess the efficacy and safety of CCM therapy. Methods. We conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) between January 2001 and June 2018. Outcomes of interest were peak oxygen consumption (peak VO2), 6-Minute Walk Distance (6MWD), Minnesota Living with Heart Failure Questionnaire (MLHFQ), HF hospitalizations, cardiac arrhythmias, pacemaker/ICD malfunctioning, all-cause hospitalizations, and mortality. Data were expressed as standardized mean difference (SMD) or odds ratio (OR). Results. Four RCTs including 801 patients (CCM n = 394) were available for analysis. The mean age was 59.63 ± 0.84 years, mean ejection fraction was 29.14 ± 1.22%, and mean QRS duration was 106.23 ± 1.65 msec. Mean follow-up duration was six months. CCM was associated with improved MLWHFQ (SMD -0.69, p = 0.0008). There were no differences in HF hospitalizations (OR 0.76, p = 0.12), 6MWD (SMD 0.67, p = 0.10), arrhythmias (OR 1.40, p = 0.14), pacemaker/ICD malfunction/sensing defect (OR 2.23, p = 0.06), all-cause hospitalizations (OR 0.73, p = 0.33), or all-cause mortality (OR 1.04, p = 0.92) between the CCM and non-CCM groups. Conclusions. Short-term treatment with CCM may improve MLFHQ without significant difference in 6MWD, arrhythmic events, HF hospitalizations, all-cause hospitalizations, and all-cause mortality. There is a trend towards increased pacemaker/ICD device malfunction. Larger RCTs might be needed to determine if the CCM therapy will be beneficial with longer follow-up.

Author(s):  
Reagan F. Cabahug ◽  
Gina L. Montalan ◽  
Irma P. Yape ◽  
Maria Christina M. Laurenciana

Objective: To update Sagar et.al. systematic review and meta-analysis on exercise-based rehabilitation for heart failure. Methods: A systematic review and meta-analysis of randomized clinical trials on exercised-based cardiac rehabilitation. MEDLINE, OVID and cross references were searched for RCTs published between February 2013 up to August 2018. Trials with at least 6 months follow up were included if exercise training program alone or as a component of comprehensive cardiac rehabilitation was compared with groups without exercise prescription. Results: A total of 11,989 patients were included in the 43 randomized clinical trials predominantly with reduced EF and NYHA class ll -lll. Exercise training program prescription in heart failure patients reduced the all-cause mortality (RR=0.76; 95%CI= 0.66, 0.87; P= 0.001), all cause hospitalization after 12 months (RR=0.70; 95% CI= 0.52, 0.96; P= 0.02) rehospitalization due to heart failure (RR= 0.49; 95% CI= 0.44, 0.55; P= <0.0001) and improvement in quality-of-life scores (RR= -0.36; 95% CI= -0.58, -0.14; P= 0.002). Among these health quality related outcomes, the all-cause mortality and the hospitalization admission after 12 months follow up showed a significant association with exercise therapy program, particularly on exercise setting(p=0.026) and exercise dose (p=0.013), respectively, as revealed by the univariate meta-regression results. Conclusion: This study has shown that exercise therapy either in center or home based has benefited heart failure patients in reducing the risk of all-cause mortality up to 12 months, hospital admission up 12 months, and has given a better quality of life. The new studies included have further strengthened the findings of previous studies that an exercise therapy program provides benefit to heart failure patients, either as an “alone” intervention or together with a cardiac rehabilitation program; and that the setting and dose of an exercise therapy program provide significant contribution to a reduced risk in all-cause mortality and hospitalization after 12 months follow up, respectively.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Cathrine Axfors ◽  
Perrine Janiaud ◽  
Andreas M. Schmitt ◽  
Janneke van’t Hooft ◽  
Emily R. Smith ◽  
...  

Abstract Background Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of the weight in the meta-analysis. Conclusions Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.


2021 ◽  
pp. 1-8
Author(s):  
Huiyang Li ◽  
Peng Zhou ◽  
Yikai Zhao ◽  
Huaichun Ni ◽  
Xinping Luo ◽  
...  

Abstract Objective: The aim of this meta-analysis was to investigate the association between malnutrition assessed by the controlling nutritional status (CONUT) score and all-cause mortality in patients with heart failure. Design: Systematic review and meta-analysis. Settings: A comprehensively literature search of PubMed and Embase databases was performed until 30 November 2020. Studies reporting the utility of CONUT score in prediction of all-cause mortality among patients with heart failure were eligible. Patients with a CONUT score ≥2 are grouped as malnourished. Predictive values of the CONUT score were summarized by pooling the multivariable-adjusted risk ratios (RR) with 95 % CI for the malnourished v. normal nutritional status or per point CONUT score increase. Participants: Ten studies involving 5196 patients with heart failure. Results: Malnourished patients with heart failure conferred a higher risk of all-cause mortality (RR 1·92; 95 % CI 1·58, 2·34) compared with the normal nutritional status. Subgroup analysis showed the malnourished patients with heart failure had an increased risk of in-hospital mortality (RR 1·78; 95 % CI 1·29, 2·46) and follow-up mortality (RR 2·01; 95 % CI 1·58, 2·57). Moreover, per point increase in CONUT score significantly increased 16% risk of all-cause mortality during the follow-up. Conclusions: Malnutrition defined by the CONUT score is an independent predictor of all-cause mortality in patients with heart failure. Assessment of nutritional status using CONUT score would be helpful for improving risk stratification of heart failure.


2019 ◽  
Vol 26 (5) ◽  
pp. 600-612 ◽  
Author(s):  
Krystal Dinh ◽  
Alexandra M. Limmer ◽  
Sharath C. V. Paravastu ◽  
Shannon D. Thomas ◽  
Michael H. Bennett ◽  
...  

Purpose: To report the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon. Materials and Methods: A systematic review and meta-analysis of randomized controlled trials were performed to investigate the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access (last search date February 28, 2019). The primary endpoint was all-cause mortality. This analysis included 8 studies comparing paclitaxel-coated balloon (PCB) angioplasty (n=327) and PTA (n=331) in the treatment of failing dialysis access. None investigated paclitaxel-coated stents. Mortality data were pooled using a random effects model. Statistical heterogeneity was evaluated with a chi-square test and the I2 statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: At the pooled mean follow-up of 13.5 months (median 12, range 6–24) all-cause mortality was similar in the PCB group (13.8%) compared with PTA (11.2%; RR 1.26, 95% CI 0.85 to 1.89, p=0.25; I2=0%). Subgroup analysis, stratified according to length of follow-up, confirmed that there were no statistically significant differences in mortality at short- and midterm follow-up [6-month (8 studies): 5.2% vs 4.8%, RR 1.24, 95% CI 0.62 to 2.47, p=0.55; 12-month (6 studies): 6.3% vs 6.0%, RR 1.06, 95% CI 0.43 to 2.63, p=0.90; and 24-month (3 studies): 19.0% vs 13.5%, RR 1.38, 95% CI 0.90 to 2.12, p=0.14). Conclusion: The analysis found no difference in short- to midterm mortality among patients treated with a drug-coated balloon compared with PTA. With proven benefit and no evidence of harm, the authors recommend ongoing use of PCB for the failing dialysis access.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Mohan Satish ◽  
Raviteja Guddeti ◽  
Florian Wenzl ◽  
Ryan Walters ◽  
Venkata M Alla

Introduction: Due to shared risk factors and pathophysiology, atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) frequently coexist. However, the prognostic implications of AF in HFpEF are unclear with conflicting data. Herein, we conducted a systematic review and meta-analysis to assess the impact of concomitant AF on cardiovascular outcomes in patients with HFpEF. Methods: PubMed, Scopus, and Google Scholar were comprehensively searched through May 7th, 2020 for studies comparing outcomes of HFpEF patients with and without AF. Outcomes assessed were all-cause mortality and a composite of HF hospitalization or cardiovascular (CV) mortality. Data from selected studies were abstracted and pooled using a random-effects meta-analysis to calculate odds ratios (ORs) and 95% confidence intervals [CIs] for each of the outcomes. Results: Our final analysis included 10 studies with 27,440 HFpEF patients (43.2% with AF). AF was associated with significantly increased risk of all-cause mortality (OR 1.37 [1.17-1.61], p < 0.001, Fig. 1A), HF hospitalization or CV mortality (OR 1.66 [1.16-2.36], p = 0.005, Fig. 1B), and HF hospitalization alone (OR 1.34 [1.03-1.76], p = 0.03, Fig. 1C). However, AF was not associated with excess risk of CV mortality alone (OR 1.10 [0.79-1.52], p = 0.57, Fig. 1D). Conclusions: In patients with HFpEF, concomitant AF is associated with an increased risk of all-cause mortality and HF hospitalization. Further research into the mechanisms and interventions to mitigate this excess risk is necessary.


2021 ◽  
Author(s):  
Mohammad Ali Omrani ◽  
Amin Salehi-Abargouei ◽  
Behrooz Heydari ◽  
Nazgol Kermanshahi ◽  
Fatemeh Joukar ◽  
...  

Abstract BackgroundThis systematic review and meta-analysis aimed to assess the efficacy of the Ivermectin/Doxycycline combination for the treatment of coronavirus disease 2019 (COVID-19).MethodsWe searched PubMed, Web of Science, Scopus, ClinicalTrials.gov, and Google Scholar from database inception to August 26, 2021 for relevant studies. We included studies reporting at least one of the outcomes of interest: all-cause mortality; time to clinical recovery; hospital stay and viral clearance. The logarithm of risk ratios or mean differences and their corresponding standard errors for each outcome were pooled using a random-effects model. The risk of bias was assessed using the Cochrane Collaboration's tool for randomized clinical trials and the Newcastle-Ottawa Scale for cohort studies.ResultsFour randomized clinical trials and one prospective study involving 789 patients, including 399 in the Ivermectin/Doxycycline group and 390 in the control group, were enrolled. The all-cause mortality rate of patients with COVID-19 in the Ivermectin/Doxycycline group was 0.79% (2/253), which was lower than in the control group (3.6%; 9/250). However, the difference was not statistically significant (Log risk ratio=-1.288; 95% CI:-2.671, 0.096; P = 0.068; I2 = 0%). The effect of Ivermectin/Doxycycline on time to clinical recovery was found to be significant (Difference in means =-2.427 days; 95% CI:-4.033, -0.820; P = 0.003, I2 = 91.475%). There is no significant effect of Ivermectin/Doxycycline on hospital stay (Difference in means =-0.379 days; 95% CI:-1.965, 1.208; P = 0.640, I2 = 91.95%) and time to negative PCR or viral clearance (Difference in means =-0.768 days; 95% CI:-1.550, 0.013; P = 0.054, I2 = 91.48%).DiscussionBased on low-quality evidence, this meta-analysis showed that Ivermectin/Doxycycline combination is accompanied with shorter time of clinical recovery in COVID-19 patients. However, it did not reduce all-cause mortality, viral clearance, and hospital stay significantly. Not only the number of the studies are limited but also they ranked methodologically medium to low with limited participants. To assess the exact effective dose and efficacy of this combination therapy, high-quality and large-scale randomized clinical trials are needed.OtherThis study was registered in Prospero (registration number: CRD42021272400). The authors declare they have no competing financial interests.


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