Hemoglobin A1c levels and 1-year mortality in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.

Background: In this study, we investigated whether different levels of hemoglobin A1c (HbA1c) are associated with different short-term and 1-year mortality rates among diabetic patients undergoing percutaneous coronary intervention. Patients & methods: Clinical events including in-hospital, 1-month and 1-year mortality were compared between three groups based on HbA1c levels of patients (I: ≤5.6%, II: 5.7-6.4%, III: ≥6.5%). Results: Among 165 diabetic individuals, patients with abnormal HbA1c levels (≥6.5%) experienced significantly higher hospitalization days (7.65 ± 1.64 days) compared with those with normal HbA1c (4.94 ± 0.97 days) (p < 0.0001). In-hospital mortality was significantly higher in group III (14.5%) and II (5.5%) compared with group I (0%) (p = 0.008). Conclusion: HbA1c levels may be a reliable predictor of short-term clinical events in diabetic patients.

Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars).

BACKGROUND: We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting. METHODS: The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect. RESULTS: During December 2015-December 2016, a total of 4415 participants aged 50-75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4-4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups. CONCLUSIONS: The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level. TRIAL REGISTRATION NUMBER: NCT03459560.

Management of Anterior Urethral Stricture: A Survey of Contemporary Practice of Iranian Urologists.

PURPOSE: To evaluate Iranian urologists' approach to urethral stricture and assess how often they select open urethroplasty over minimally invasive procedures. MATERIAL AND METHODS: This cross-sectional observational study was conducted via www. SURVEY: porsline.ir among members of the Iranian urologists' community. The urologists were contacted via email and social media applications (e.g., WhatsApp, Telegram), and data, including their demographic information and years of practice, as well as questions related to their attitude towards the management of urethral stricture, were collected. RESULTS: A total number of 376 patients were included in the current survey. The specialty of reconstructive urology was selected by less than 2% (n=5) as their field of interest. Only 6.64% (n=25) of the urologists stated that they received adequate training for management of urethral stricture. Only about 5% (n=19), believed that according to scientific resources, chose open urethroplasty as the initial management. Almost 94% (n=353) did not perform any urethroplasties during the past year and about 0.2% (n=2) performed more than 20 open urethroplasties. For diagnosing urethral stricture, almost 99% of them chose RUG+VCUG, 72% chose urethrocystoscopy, and 69% chose uroflowmetry in the third place. For evaluation of urethroplasty postoperative outcomes, 76% (n=269) used RUG+VCUG, 15% (n=56) used Rigid Cystoscopy, and 8% (n=29) used Flexible Cystoscopy, Conclusion: Iranian urologists prefer minimally invasive procedures for treating urethral stricture, similar to other countries. This lack of urologists' interest in open urethroplasty is greatly due to poor training during the residency years and little experience with urethral strictures. Therefore, further considerations in order to improve urologists' knowledge and expertise for management of urethral stricture is recommended.

Takotsubo Cardiomyopathy and Autoimmune Disorders: A Systematic Scoping Review of Published Cases.

Introduction: Takotsubo cardiomyopathy (TCM) features transient left ventricular apical dysfunction or ballooning. The underlying mechanism remains elusive; however, evidence suggests the role of different physical and psychological stressors. We systematically reviewed patients presenting with TCM and autoimmunity to explore the link between the two conditions. Methods: We applied the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) to report this review. Using keywords related to autoimmune/immune-mediated diseases and TCM, we searched PubMed, Scopus, and WOS in March 2022. The final results were added to a data extraction sheet. Data were analyzed by SPSS version 26.0. Results: Our search yielded 121 studies, including 155 patients. Females were considerably predominant. Most patients had a history of autoimmune disease, and almost a third had a history of cardiovascular disease. Dyspnea and chest pain were the most common chief complaints. More than 70% of patients had experienced physical stress. Myasthenia gravis, systemic lupus erythematosus, and multiple sclerosis were the most frequently reported autoimmune diseases. Conclusion: There were similarities in age and sex compared to classic TCM. TCM should be considered as a differential diagnosis for ACS, especially in patients with a positive background of autoimmunity. A precise reporting system is required for further studies.

Efficacy of exercise training-based cardiac rehabilitation programmes after transcatheter aortic valve implantation: A systematic review and meta-analysis.

Background: The beneficial effects of exercise training-based cardiac rehabilitation (CR) in different cardiac conditions have been previously studied. In this meta-analysis, we focused on the potential impact of CR on patients undergoing transcatheter aortic valve implantation (TAVI). Methods: Multiple databases were searched in a systematic approach to find the eligible studies. All the studies investigating the potential impact of exercise training-based CR programmes on exercise capacity and health-related quality of life in patients undergoing TAVI were retrieved. The primary endpoint of interest was 6-min walk test (6MWT). The pooled standardized mean difference (SMD) and 95 % confidence interval (CI) were measured to compare the improvement or worsening the endpoints using a random- or fixed-effects model, as appropriate. Results: A total of eleven studies (685 patients) were considered eligible for quantitative synthesis. The results showed that performing exercise training-based CR after TAVI is associated with significant improvement in 6MWT (SMD 0.59, 95 % CI (0.48; 0.71), p < 0.01), Barthel index (SMD 0.73, 95 % CI (0.57; 0.89), p < 0.01), 12-item Short Form (SF-12) physical (SMD 0.30, 95 % CI (0.08; 0.52), p < 0.01) and mental (SMD 0.27, 95 % CI (0.05; 0.49), p = 0.02) survey scores, and hospital anxiety and depression scale - depression (HADS-D) score (SMD -0.26, 95 % CI (-0.42; -0.10), p < 0.01). Conclusion: Performing exercise training-based CR following TAVI has significant benefits regarding physical capacity and health-related quality of life irrespective of the programme duration.

Clinical outcomes of optical coherence tomography versus conventional angiography guided percutaneous coronary intervention: A meta-analysis.

BACKGROUND: Performing optical coherence tomography (OCT) as a guide for percutaneous coronary intervention (PCI) compared to conventional coronary angiography has been the subject of the recent cohorts and randomized trials. However, clear evidence demonstrating its superiority is still controversial. METHODS: We performed a thorough search in digital databases to find the relevant observational studies and randomized trials comparing OCT and angiography in patients undergoing PCI. A random-effects meta-analysis was undertaken comparing clinical outcomes to generate an odds ratio (OR) with a corresponding 95% confidence interval (CI). Subgroup analyzes were performed based on study design, underlying cardiac condition, and complexity of cases. RESULTS: A total of 21 studies (10 RCTs and 11 observational studies) with 11,163 participants (5319: OCT and 5844: angiography group) were included for quantitative synthesis. Performing OCT was associated with lower odds of all-cause (OR (95% CI) = 0.56 (0.48; 0.67)) and cardiac mortality (OR (95% CI) = 0.47 (0.35; 0.63)), major adverse cardiovascular events (OR (95% CI) = 0.60 (0.48; 0.76)), myocardial infarction (OR (95% CI) = 0.79 (0.64; 0.97)), and stent thrombosis (OR (95% CI) = 0.61 (0.39; 0.96)) compared to the angiography group. Other clinical outcomes were similar between the studied groups. The outperformance of OCT was more evident in observational studies and the ones with PCI on complex lesions. CONCLUSION: Performing OCT prior to PCI is associated with better clinical outcomes compared to angiography alone based on contemporary evidence. Future well-designed randomized trials are needed to confirm the findings of this meta-analysis.

Ablation versus medical therapy for patients with atrial fibrillation: An updated meta-analysis.

To investigate the effect of ablation compared to medical therapy on clinical outcomes of patients with atrial fibrillation (AF). PubMed, Scopus, Embase, and Web of Science databases were searched using ablation, medical treatment, AF, and related words. The effect of ablation and medical therapy was sought to be gathered on stroke or transitional ischemic attack, mortality, hospitalization, recurrence of AF, progression of AF, and left ventricular ejection fraction. Analyses were performed using R software. 31 studies (the results of 27 randomized controlled trials), compromising an overall 6965 patients (Ablation, n = 3643; Medical treatment, n = 3322) were reviewed in our study, revealed that catheter ablation would result in substantial benefits for patients with AF without significant difference in serious adverse events compared to medical management (Risk Ratio: 0.92, [95% Confidence Interval (CI), 0.64-1.33]). Catheter ablation in patients with AF significantly resulted in a 29% reduction in all-cause mortality (RR: 0.71, [95% CI, 0.57-0.88]), a 57% reduction in hospitalization (RR: 0.43, [95% CI, 0.27-0.67]), a 53% reduction in AF recurrence (RR: 0.47, [95% CI, 0.36-0.61]), and a dramatic reduction, 89%, in progression of paroxysmal to persistent AF (RR: 0.11, [95% CI, 0.02-0.65]); also associated with a remarkable improvement in their left ventricular ejection fraction (LVEF) (Mean Difference, MD: 6.84%, [95% CI, 3.27-10.42]) compared to medical therapy. Our study showed that ablation may be superior to medical therapy in patients with AF regarding AF recurrence, mortality, LVEF improvement, hospitalization, and AF progression outcomes.

Sex-Specific Differences in Clinical Outcomes in Patients With Coronary Bifurcation Lesions.

Coronary bifurcation lesions are frequent challenging findings during percutaneous coronary intervention (PCI). Contemporary evidence has explored the potential sex-specific differences in patients undergoing PCI. In the present meta-analysis, we compared clinical outcomes of patients undergoing bifurcation PCI between women and men. Using the random-effects method, we compared the clinical outcomes of patients with a coronary bifurcation lesion following PCI between women and men. The results were reported using relative risk (RR) and 95% confidence interval (CI). Baseline comorbidities and mean age were compared between the 2 studied groups. Four observational studies comprising 30,684 patients (8898 women and 21,786 men) were included in the meta-analysis. Women were significantly older than men with a relatively higher prevalence of baseline comorbidities. After using adjusted data from 2 out of 4 available studies, performing PCI for bifurcation lesions in women was not associated with an increased risk of mortality (RR 1.33, 95% CI, 0.78-2.29), myocardial infarction (RR 1.22, 95% CI, 0.41-3.61), target lesion revascularization (RR 1.06, 95% CI, 0.40-2.81), stent thrombosis (RR 0.99, 95% CI, 0.09-10.52), and stroke (RR 1.19, 95% CI, 0.64-2.22). Women were at higher risk of major bleeding compared to male counterparts (RR 2.23, 95% CI, 1.73-2.89). The present study showed no difference in the risk of adverse clinical outcomes except the risk of bleeding between genders with coronary bifurcation lesions. Future studies with adjustment of age and baseline comorbidities are needed to confirm these findings.

Effect of once versus twice intracoronary injection of allogeneic-derived mesenchymal stromal cells after acute myocardial infarction: BOOSTER-TAHA7 randomized clinical trial.

BACKGROUND: Mesenchymal stromal cell (MSC) transplantation can improve the left ventricular ejection fraction (LVEF) after an acute myocardial infarction (AMI). Transplanted MSCs exert a paracrine effect, which might be augmented if repeated doses are administered. This study aimed to compare the effects of single versus double transplantation of Wharton's jelly MSCs (WJ-MSCs) on LVEF post-AMI. METHODS: We conducted a single-blind, randomized, multicenter trial. After 3-7 days of an AMI treated successfully by primary PCI, 70 patients younger than 65 with LVEF < 40% on baseline echocardiography were randomized to receive conventional care, a single intracoronary infusion of WJ-MSCs, or a repeated infusion 10 days later. The primary endpoint was the 6-month LVEF improvement as per cardiac magnetic resonance (CMR) imaging. RESULTS: The mean baseline EF measured by CMR was similar (~ 40%) in all three groups. By the end of the trial, while all patients experienced a rise in EF, the most significant change was seen in the repeated intervention group. Compared to the control group (n = 25), single MSC transplantation (n = 20) improved the EF by 4.54 ± 2%, and repeated intervention (n = 20) did so by 7.45 ± 2% when measured by CMR imaging (P < 0.001); when evaluated by echocardiography, these values were 6.71 ± 2.4 and 10.71 ± 2.5%, respectively (P < 0.001). CONCLUSIONS: Intracoronary transplantation of WJ-MSCs 3-7 days after AMI in selected patients significantly improves LVEF, with the infusion of a booster dose 10 days later augmenting this effect. TRIAL REGISTRATION: Trial registration: Iranian Registry of Clinical Trials, IRCT20201116049408N1. Retrospectively Registered 20 Nov. 2020, https://en.irct.ir/trial/52357.

The impact of antihypertensive treatment of mild to moderate hypertension during pregnancy on maternal and neonatal outcomes: An updated meta-analysis of randomized controlled trials.

Currently, there is controversy regarding the treatment of pregnant patients with mild hypertension (blood pressure 140-159/90-109 mm Hg). While guidelines do not recommend this treatment, results from recent clinical trials are supportive of the treatment. This meta-analysis aimed to clarify if active treatment of mild hypertension during pregnancy results in better maternal and fetal outcomes. All of the potentially eligible randomized controlled trials were retrieved through a systematic database search investigating the impact of pharmacological treatment in mild hypertensive patients on maternal, fetal, and neonatal outcomes. Relative risk (RR) and 95% confidence interval (CI) were calculated using a random-effects model. Data from 12 trials comprising 4461 pregnant women diagnosed with mild to moderate hypertension (2395 in the intervention group and 2066 in the control group) were extracted for quantitative synthesis. Antihypertensive treatment was associated with better outcomes in seven out of the 19 analyzed outcomes: Severe hypertension (RR = 0.53; 95% CI = [0.38;0.75]), preeclampsia (RR = 0.71; 95% CI = [0.54; 0.93]), placental abruption (RR = 0.48; 95% CI = [0.26; 0.87]), changes in electrocardiogram (RR = 0.43; 95% CI = [0.25; 0.72]), renal impairment (RR = 0.42; 95% CI = [0.34; 0.51]), pulmonary edema (RR = 0.46; 95% CI = [0.25; 0.84]), and neonatal mortality (RR = 0.72; 95% CI = [0.57; 0.92]). The primary safety outcome of small for gestational age was not different between the treatment group and the control group (RR = 1.12; 95% CI = [0.80; 1.57]). The results of this meta-analysis are in favor of the beneficial impact of pharmacological treatment of mild hypertension on both maternal and neonatal outcomes and without significant adverse events for the fetus.

Preventive Effect of Bone Marrow Mononuclear Cell Transplantation on Acute Myocardial Infarction-Induced Heart Failure: A Meta-analysis of Randomized Controlled Trials.

PURPOSE: Heart failure (HF) is a major complication of acute myocardial infarction (AMI). Transplantation of bone marrow mononuclear cells (BM-MNC) in the setting of AMI has been proposed as a means for myocardial tissue regeneration. Several trials have explored the outcomes of these cells on surrogate end points such as left ventricular ejection fraction (LVEF) in patients with AMI. However, the data regarding the clinical efficacy are infrequent. Here, we performed a meta-analysis investigating the effect of BM-MNCs injection on the rate of hospitalization for HF in the long-term follow-up period. METHODS: PubMed, Scopus, and Cochrane databases were queried with various combinations of keywords through May 2, 2022. A random-effects meta-analysis was performed to calculate risk ratio (RR) and 95% confidence interval (CI) of hospitalization for HF, all-cause mortality, and stroke rate. Subgroup analyses for hospitalization based on time and cell dose were performed. RESULTS: A total of 2150 patients with AMI across 22 trials were included for quantitative synthesis. At long-term follow-up, AMI patients treated with an intracoronary injection of BM-MNCs were less likely to be hospitalized for heart failure compared to the control group receiving standard treatment (RR = 0.54, 95% CI = [0.37; 0.78], p = 0.002). There was no association between BM-MNC therapy and all-cause mortality (RR = 0.69, 95% CI = [0.47; 1.01], p = 0.05) and stroke (RR = 1.12, 95% CI= [0.24; 5.21], p = 0.85). CONCLUSION: Autologous injection of BM-MNC in the setting of AMI may be associated with decreased risk of hospitalization of heart failure in the long term. However, its effect on all-cause mortality and stroke rate is questionable.

Protective effects of Panax ginseng against doxorubicin-induced cardiac toxicity in patients with non-metastatic breast cancer: A randomized, double-blind, placebo-controlled clinical trial.

INTRODUCTION: Anthracycline-based chemotherapy increases the risk of cancer therapeutics-related cardiac dysfunction. Recently, evidences from in vitro experiments and animal studies have shown that ginsenosides may exert cardiovascular protection against cancer therapeutics-related cardiac dysfunction. Here, we aimed to evaluate this effect in a clinical situation. METHODS: In this randomized, double-blind, placebo-controlled clinical trial, women with non-metastatic breast cancer whose left ventricular ejection fraction was ≥ 50% were randomly assigned in 1:1 ratio to receive ginseng (1 g/day) or placebo besides standard chemotherapy. Echocardiographic measurements were performed at baseline, after the fourth, and eighth chemotherapy cycles. High-sensitive cardiac troponin I was assessed at baseline and after the 4th cycle. The primary endpoint of the study was change in left ventricular ejection fraction. Cancer therapeutics-related cardiac dysfunction was defined as a drop in left ventricular ejection fraction of ≥ 10% from baseline. RESULTS: Results from 30 patients were included in the final analysis (15 patients in each group). In the intervention and control groups, left ventricular ejection fraction was dropped from 62.0 ± 0.9% to 60.7 ± 1.0% (difference = -1.3 ± 1.1%) and from 63.27 ± 1.1% to 58.0 ± 1.3% (difference = -5.27 ± 0.8%), respectively (difference = 3.97%, p = 0.006) at the end of the fourth cycle of chemotherapy. After the eighth cycle of chemotherapy, the mean left ventricular ejection fraction was increased by 0.8 ± 1.3% from baseline in the intervention group, whereas the placebo group experienced a reduction of -7.3 ± 1.4% (difference = 8.1%, p-value < 0.001). None of the patients in the ginseng group in comparison to 1(6.7%, p-value = 0.5) and 5 (33.3%, p-value = 0.02) patients in the placebo group developed cancer therapeutics-related cardiac dysfunction after the fourth and eighth cycles, respectively. High-sensitive cardiac troponin I levels were not significantly different between groups. CONCLUSIONS: Prophylactic ginseng supplementation may protect against doxorubicin-induced early cancer therapeutics-related cardiac dysfunction and early decline in left ventricular ejection fraction in breast cancer patients.

Impacts of opium addiction on patterns of angiographic findings in patients with acute coronary syndrome.

Opium is one of the most abused substances in the Middle East. The effects of opium use on coronary artery disease (CAD) are a matter of debate. This study aimed to assess the association between opium use and angiographic findings as well as the complexity of CAD in patients with acute coronary syndrome (ACS) diagnosis. In this case-control study, all patients admitted for coronary angiography from 2019 to 2020 were evaluated. After applying the eligibility criteria, they were categorized into two groups opium and non-opium based on their history of opium use. Both groups were matched regarding the demographic features. The prevalence, location, and severity of obstruction of the vessels were compared between the non-opium and opium groups. The SYNTAX score was also calculated and compared between the two groups. The scores ≤ 22 are considered low risk and the higher scores are a non-low risk. P value < 0.05 is considered significant. A total of 170 patients with a mean age of 61.59 ± 9.07 years were finally enrolled in our study. Regarding the severity of vascular involvement, there was a significant difference between the non-opium and opium groups in LAD (P = 0.025), and PLV (P = 0.018) vessels. From the location points of view of obstructive coronary artery involved segments, only in the PDA (P = 0.006), and LCX (P = 0.004) vessels, a significant difference was observed. Moreover, 47.1% of opium and 30.6% of non-opium use group were in the non-low risk SYNTAX score classification which is a statistically significant difference between these two groups (P value = 0.048). Opium, as an independent risk factor for cardiovascular diseases, can have specific effects on angiographic findings in patients with acute coronary syndrome. Likewise, the complexity of CAD in opium users who undergo percutaneous coronary intervention is significantly higher.

Global longitudinal strain for detection of cardiac iron overload in patients with thalassemia: a meta-analysis of observational studies with individual-level participant data.

BACKGROUND: Although cardiac magnetic resonance (CMR) is the most reliable tool for assessment of CIO in patients with thalassemia, it is not always readily available. Recent studies have explored the potential of GLS as an alternative for diagnosis of CIO. We aimed to investigate the efficacy of global longitudinal strain (GLS) for detection of cardiac iron level (CIO). METHODS: We searched SCOPUS, MEDLINE, and Embase to identify the studies which used GLS for assessment of CIO. We searched for individual participant data (IPD) in eligible studies to perform ROC curve analysis. CMR with a T2* cut-off value of 20 ms was considered as the gold standard. A meta-analysis was performed and the risk of bias was assessed using the JBI Checklist. RESULTS: A total of 14 studies with 789 thalassemia patients (310 and 430 with and without CIO respectively and 49 with undetermined condition) were considered eligible for meta-analysis. IPDs of 405 participants were available. GLS was significantly lower in patients with CIO (-17.5 ± 2.7%) compared to those without CIO (-19.9 ± 2.3%; WMD = 1.6%, 95% CI = [0.76-2.4], p = 0.001, I2 = 77.1%) and to normal population (-20.61 ± 2.26%; WMD = 2.2%, 95% CI = [0.91-3.5], p = 0.001, I2 = 83.9%). A GLS < -19.5% could predict CIO with 92.8% sensitivity and 34.63% specificity (AUC = 0.659, 95% CI = [0.6-0.72], p-value < 0.0001). A GLS value < -6% has 100% positive predictive and ≥ -24.5% has 100% negative predictive values for detection of CIO. CONCLUSIONS: According to our study, GLS is a strong predictor of CIO and when CMR is not available, it may be a useful screening method for identification of CIO in thalassemia patients.

Transplantation of mesenchymal stem cells for prevention of acute myocardial infarction induced heart failure: study protocol of a phase III randomized clinical trial (Prevent-TAHA8).

BACKGROUND: Results from recent clinical trials on bone marrow mononuclear cell (BM-MNC) transplantation show that this intervention can help reduce the incidence of heart failure (HF) after acute myocardial infarction (AMI). However, no study has evaluated the effect of the transplantation of mesenchymal stem cells (MSCs) on a clinical endpoint such as HF. METHODS: This single-blinded, randomized, multicenter trial aims to establish whether the intracoronary infusion of umbilical cord-derived Wharton's jelly MSCs (WJ-MSCs) helps prevent HF development after AMI. The study will enroll 390 patients 3 to 7 days following AMI. Only patients aged below 65 years with impaired LV function (LVEF < 40%) will be included. They will be randomized (2:1 ratio) to either receive standard care or a single intracoronary infusion of 107 WJ-MSCs. The primary outcome of this study is the assessment of HF development during long-term follow-up (3 years). DISCUSSION: Data will be collected until Nov 2024. Thereafter, the analysis will be conducted. Results are expected to be ready by Dec 2024. We will prepare and submit the related manuscript following the CONSORT guidelines. This study will help determine whether or not the infusion of intracoronary WJ-MSCs in patients with AMI will reduce the incidence of AMI-induced HF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05043610 , Registered on 14 September 2021 - retrospectively registered.

Prognostic value of various markers in recovery from peripartum cardiomyopathy: a systematic review and meta-analysis.

AIMS: The aetiology of peripartum cardiomyopathy (PPCM) is still not clear, and it is unknown who would recover from PPCM. In this meta-analysis, for the first time, we aimed to explore the prognostic value of potential baseline factors that may help predict recovery in patients with PPCM. METHODS: A systematic approach following the Meta-analysis of Observational Studies in Epidemiology guideline was taken by using appropriate keywords in PubMed, Scopus, and Embase databases. Studies that had compared different clinical and paraclinical markers at the time of diagnosis related to cardiovascular function between recovered and non-recovered patients with PPCM were included. To find potential predictors of recovery, the odds ratio (OR) was calculated for different parameters using the random-effects model. RESULTS: Eighteen cohort studies including 1047 patients with PPCM were enrolled. Six markers out of the 11 potentially eligible markers were associated with PPCM recovery. Baseline echocardiographic parameters [left ventricular ejection fraction (LVEF) (OR = 4.84 [2.53; 9.26]), left ventricular end-diastolic diameter (OR = 3.67 [2.58; 5.23]), left ventricular end-systolic diameter (OR = 3.99 [2.27; 7.02]), and fractional shortening (OR = 6.14 [1.81; 20.85])] were strong predictors of PPCM recovery. Systolic blood pressure (OR = 2.16 [1.38; 3.38]) and diastolic blood pressure (OR = 2.06 [1.07; 3.96]) at diagnosis were also associated with recovery. CONCLUSIONS: Patients with PPCM who have a higher baseline LVEF, lower left ventricular diameters, and higher blood pressure levels have a greater chance to recover from PPCM.

Major cardiovascular events after bone marrow mononuclear cell transplantation following acute myocardial infarction: an updated post-BAMI meta-analysis of randomized controlled trials.

BACKGROUND: The effect of bone marrow-derived mononuclear cells (BM-MNCs) after acute myocardial infarction (AMI) on myocardial function indices such as left ventricular ejection fraction has been widely studied. However, the effect of this intervention on major adverse cardiovascular events (MACE) was not the principal purpose of most investigations and its role is unclear. The aim of this study was to investigate the possible long-term clinical efficacy of BM-MNCs on MACE after AMI. METHODS: A comprehensive search was conducted through electronic databases for potentially eligible randomized trials investigating the impact of BM-MNC therapy following acute MI on clinical outcomes. Risk of bias of the eligible studies was assessed using the Cochrane Collaboration's tool. The effect of treatment was displayed by risk ratio (RR) and its 95% confidence interval (CI) using random-effects model. RESULTS: Initial database searching found 1540 records and 23 clinical trials with a total of 2286 participants eligible for meta-analysis. Injection of BM-MNCs was associated with lower risk of composite end points of hospitalization for congestive heart failure (CHF), re-infarction, and cardiac-related mortality (91/1191 vs. 111/812, RR = 0.643, 95% CI = 0.489 to 0.845, p = 0.002). This effect was derived from both reduction of CHF (47/1220 vs. 62/841, RR = 0.568, 95% CI = 0.382 to 0.844, p = 0.005) and re-infarction rate (23/1159 vs. 30/775, RR = 0.583, 95% CI = 0.343 to 0.991, p = 0.046), but not cardiac-related mortality (28/1290 vs. 31/871, RR = 0.722, 95% CI = 0.436 to 1.197, p = 0.207). CONCLUSION: This is the first meta-analysis focused on the cardiovascular outcomes of stem cell therapy after AMI and it revealed that transplantation of BM-MNCs may reduce composite endpoint of hospitalization for CHF, re-infarction, and cardiac related mortality driven mainly by reducing reinfarction and hospitalization for heart failure rates but not cardiovascular mortality.

Effect of Treatment with Colchicine after Acute Coronary Syndrome on Major Cardiovascular Events: A Systematic Review and Meta-Analysis of Clinical Trials.

Aim: Colchicine as an anti-inflammatory drug might be effective in the treatment of atherosclerosis, an inflammatory-based condition. The aim of this systematic review and meta-analysis was to evaluate the impact of colchicine on acute coronary syndrome (ACS). Methods: We searched SCOPUS, PubMed, and Web of Science up to September 27, 2020. All clinical trials which evaluated the effect of colchicine on ACS patients and reported high-sensitivity C-reactive protein (hs-CRP) serum level or gastrointestinal (GI) adverse events with at least 5-day follow-up or death, myocardial infarction (MI), and stroke with at least 30-day follow-up as outcomes were included. Results: Finally, seven publications were analyzed. The results of our study revealed that colchicine has a marginally significant effect on hs-CRP attenuation. Furthermore, colchicine manifested promising results by declining the risk of stroke by 70%. However, MI and primary composite endpoint did not differ between the colchicine and noncolchicine groups. Although colchicine did not significantly increase GI adverse events in the pooled analysis, the dose-dependent effect was detected. Low-dose consumption can avoid GI side effects of colchicine. Conclusion: Colchicine has shown some molecular and clinical promising results in ACS patients. The lack of effect of colchicine on MI and all-cause mortality can be partly attributed to the limitations of previous studies. Since colchicine is an inexpensive and easy-to-access drug that has shown to be safe in low-dose regimens in the clinical setting; it would be worthy that future large-scale well-designed clinical trials address this issue by resolving the limitations of previous investigations.

Comparing the effect of bone marrow mono-nuclear cells with mesenchymal stem cells after acute myocardial infarction on improvement of left ventricular function: a meta-analysis of clinical trials.

BACKGROUND: The effect of transplantation of bone-marrow mononuclear cells (BM-MNCs) and mesenchymal stem cells (MSCs) on ejection fraction (LVEF) has been studied in patients with acute myocardial infarction (AMI) in clinical trials. This raises the question that which type of cell may help improve LVEF better in AMI patients. No meta-analysis of clinical trials has yet addressed this question. METHODS: Electronic databases were searched thoroughly to find eligible trials on the effects of transplantation of BM-MNCs and MSCs in patients with AMI. The primary outcome was improvement in LVEF. Data were synthesized using random-effects meta-analysis. For maximizing the credibility of subgroup analysis, we used the instrument for assessing the Credibility of Effect Modification of Analyses (ICEMAN) for meta-analyses. RESULTS: A total of 36 trials (26 on BM-MNCs and 10 on MSCs) with 2489 patients (1466 were transplanted [1241 with BM-MNCs and 225 with MSCs] and 1023 as controls) were included. Both types of cells showed significant improvements in ejection fraction in short-term follow-up (BM-MNCs: WMD = 2.13%, 95% CI = 1.23 to 3.04, p < 0.001; MSCs: WMD = 3.71%, 95% CI = 2.32 to 5.09, p < 0.001), and according to ICEMAN criteria, MSCs are more effective. For selected population of patients who received stem cell transplantation in early course after AMI (less than 11 days), this effect was even more pronounced (BM-MNC: WMD = 3.07%, 95% CI = 1.97 to 4.17, p < 0.001, I2 = 40.7%; MSCs: WMD = 5.65%, 95% CI = 3.47 to 7.84, p < 0.001, I2 = 84.6%). CONCLUSION: Our results showed that transplantation of MSCs after AMI might increase LVEF more than BM-MNCs; also, based on ICEMAN, there was likely effect modification between subgroups although uncertainty still remained.