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Background and Objective: Primary hyperoxaluria (PH), a rare autosomal recessive disorder, results in defective metabolism of oxalate, leading to increased oxalate levels. Oxalobacter formigenes (O. formigenes) is a nonpathological anaerobic bacterium that uses oxalate for its survival and thus decreases the plasma oxalate levels. We aimed to use randomized controlled trials (RCTs) to evaluate the efficacy of O. formigenes in treating PH. Methods: A literature review was conducted for synthesizing the evidence from RCTs on Scopus, Web of Science, Embase, PubMed, and CENTRAL until January 2023. The outcomes were pooled using mean difference (MD) for continuous data and odds ratios (OR) for dichotomous data along with confidence interval (CI). The systematic review is registered with Prospero ID CRD42023404421. Results: We included five RCTs with 208 patients. The pooled analysis did not favor O. formigenes over placebo in reducing the plasma oxalate levels (MD: −0.00 mmol/day; 95% CI: [ − 0.01–0.00]; P = 0.06). Similar results were observed for urinary oxalate levels (MD: −0.01 mmol/day; 95% CI: [ − 0.12–0.10]; P = 0.86). There were no significant adverse events (OR: 0.44; 95% CI: [0.14–1.39]; P = 0.16) or serious adverse events (OR: 0.80; 95% CI: [0.29–2.25]; P = 0.67). Conclusion: O. formigenes was ineffective in reducing the serum and urine oxalate levels in patients with PH but has an acceptable safety profile. As PH is a relatively rare disease and few patients consent for the trials, stringent protocols are required in the future to achieve data accuracy pertinent for making conclusive recommendations on the efficacy of O. formigenes in patients with PH. [ABSTRACT FROM AUTHOR]

Background and objective: Plasma is a critical element in hemostatic resuscitation post-injury, and its prompt administration within the prehospital setting may reduce the complications resulting from hemorrhage and shock. Our objective is to assess the efficacy and safety of prehospital plasma infusion in patients susceptible to hemorrhagic shock. Methods: We conducted our study by aggregating randomized controlled trials (RCTs) sourced from PubMed, EMBASE, Scopus, Web of Science, and Cochrane CENTRAL up to January 29, 2023. Quality assessment was implemented using the Cochrane RoB 2 tool. Our study protocol is registered in PROSPERO under ID: CRD42023397325. Results: Three RCTs with 760 individuals were included. There was no difference between plasma infusion and standard care groups in 24-h mortality (P = 0.11), 30-day mortality (P = 0.12), and multiple organ failure incidences (P = 0.20). Plasma infusion was significantly better in the total 24-h volume of PRBC units (P = 0.03) and INR on arrival (P = 0.009). For all other secondary outcomes evaluated (total 24-h volume of packed FFP units, total 24-h volume of platelets units, massive transfusion, vasopressor need during the first 24 h, any adverse event, acute lung injury, transfusion reaction, and sepsis), no significant differences were observed between the two groups. Conclusion: Plasma infusion in trauma patients at risk of hemorrhagic shock does not significantly affect mortality or the incidence of multiple organ failure. However, it may lead to reduced packed red blood cell transfusions and increased INR at hospital arrival. [ABSTRACT FROM AUTHOR]

Background: Little data supports using tacrolimus versus cyclosporin for immunosuppression concerning acute rejection and bronchiolitis obliterans syndrome/Chronic Lung Allograft Dysfunction CLAD complications following lung transplantation (LTx). Our goal was to evaluate the use of tacrolimus versus cyclosporine in preventing these complications after LTx. Methods: We included randomized controlled trials (RCTs) by searching PubMed, Web of Science, SCOPUS, and Cochrane through January 10th, 2024. We pooled dichotomous data using the risk ratio (RR) and continuous data using the mean difference (MD) with a 95% confidence interval (CI). Results: We included Four RCTs with a total of 677 patients. Tacrolimus was significantly associated with decreased risk of acute rejection (RR: 1.21, 95% CI [1.03, 1.42], I2 = 25%, P = 0.02) compared with cyclosporine, bronchiolitis obliterans syndrome/CLAD (RR: 1.87, 95% CI [1.26, 2.77], I2 = 52%, P = 0.002), and treatment withdrawal (RR: 3.11, 95% CI [2.06, 4.70], I2 = 0%, P = < 0.00001). However, tacrolimus significantly increased the risk of new-onset diabetes (RR: 0.33, 95% CI [0.12, 0.91], I2 = 0%, P = 0.03), and kidney dysfunction (RR: 0.79, 95% CI [0.66, 0.93], I2 = 0%, P = 0.006). In contrast, there was no difference in the incidence of all-cause mortality (RR: 91, 95% CI [0.68, 1.22], I2 = 0%, P = 0.53), arterial hypertension (RR: 2.40, 95% CI [0.41, 14.21], I2 = 92%, P = 0.33), and new cancer (RR: 1.57, 95% CI [0.79, 3.10], I2 = 4%, P = 0.20). Conclusion: Tacrolimus has decreased acute rejection episodes and CLAD rate than cyclosporine, but it increased the risk of new-onset diabetes and kidney dysfunction. [ABSTRACT FROM AUTHOR]

Background: Intermittent ambulatory levosimendan administration has been shown in several small randomized controlled trials to benefit patients with advanced heart failure, preventing heart failure rehospitalization and mortality. We aim to investigate the totality of high-quality evidence regarding the efficacy and safety of intermittent levosimendan in advanced heart failure patients. Methods: Up to September 2023, we systematically reviewed the randomized controlled trials indexed in PubMed, Embase Cochrane, SCOPUS, and Web of Science. We used mean difference (MD) to estimate the continuous outcomes, and risk ratio (RR) for the dichotomous outcomes with a 95% confidence interval (CI), using the random-effects model. Ultimately, a trial sequential analysis was employed to enhance the reliability of our findings and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework for certainty leveling. Results: Fifteen randomized controlled trials with 1181 patients were included. Intermittent levosimendan was significantly associated with an improved left ventricular ejection fraction compared with placebo (MD 6.39 [95% CI 3.04–9.73], P = 0.002; I2 = 75, P = 0.0005), with cumulative z-score of change after ≤ 1 week passing the monitoring boundaries, favoring the levosimendan, but did not cross the required information size. Additionally, levosimendan reduced the all-cause mortality rate (RR 0.60 [95% CI 0.40–0.90], P = 0.01; I2 = 9, P = 0.36). However, we found no difference between levosimendan and placebo in all-cause rehospitalization rate (RR 0.75 [95% CI 0.46–1.22], P = 0.25; I2 = 70, P = 0.04), event-free survival rate (RR 0.97 [95% CI 0.72–1.30], P = 0.84; I2 = 63, P = 0.03), or any adverse event (RR 1 [95% CI 0.73–1.37], P = 1.00, I2 = 0%, P = 0.70). Conclusion: In patients with advanced heart failure, intermittent levosimendan significantly improved left ventricular ejection fraction, brain natriuretic peptide values, and all-cause mortality rate. Levosimendan use is not associated with a change in rehospitalization or event-free survival. Registration: PROSPERO identifier number (CRD42023487838). [ABSTRACT FROM AUTHOR]

Background: Pulsed‐field ablation (PFA) has emerged as an innovative alternative to radiofrequency (RF) and cryoablation because it selectively targets myocardial tissue. Thus, we aim to estimate the efficacy and safety of PFA versus thermal ablation for atrial fibrillation (AF) ablation. Methods: A systematic review and meta‐analysis were retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL through September 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: CRD42023480321 Results: We included 17 studies with a total of 2255 patients. PFA was significantly associated with a decreased incidence of AF recurrence (RR: 0.66 with 95% CI [0.51, 0.87], p =.003). However, there was no significant difference between PFA and thermal ablation in arrhythmia recurrence (RR: 0.92 with 95% CI [0.74, 1.46], p =.42). PFA was significantly associated with decreased total procedure time (MD: −15.15 with 95% CI [−20.23, −10.07], p <.00001), decreased heart rate change (MD: −7.39 with 95% CI [−12.16, −2.62], p =.002), decreased phrenic nerve palsy (RR: 0.38 with 95% CI [0.15, 0.98], p =.05), and reduced esophageal lesions (RR: 0.09 with 95% CI [0.01, 0.69], p =.02). On the contrary, PFA was significantly associated with increased pericardial tamponade (RR: 6.14 with 95% CI [1.43, 26.33], p =.01). Conclusion: PFA was significantly associated with decreased AF recurrence, total procedure time, heart rate change, phrenic nerve palsy, esophageal lesion, and increased incidence of pericardial tamponade compared with thermal ablation. [ABSTRACT FROM AUTHOR]

Purpose: The role of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in managing cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM) is evolving. This meta-analysis seeks to explore the influence of SGLT2i on the recurrence of atrial fibrillation (AF) following catheter ablation (CA) in individuals with T2DM qualitatively and quantitatively. Methods: A comprehensive literature search was conducted in electronic databases. Studies meeting predefined criteria were included. Individual patient data (IPD) were used from reconstructed time-to-event data to estimate hazard ratios (HRs) and 95% confidence intervals for AF recurrence. IPD meta-analysis was followed by a direct meta-analysis to assess the risk of AF recurrence. Results: A total of five studies [one randomized controlled trial (RCT) and four cohort studies] were included in this study, and five studies were included in the qualitative analysis, while four studies comprising 1043 patients with T2DM were included in the quantitative analysis. The pooled Kaplan–Meier curve based on reconstructed data showed a significantly lower risk of AF recurrence in the SGLT2i group compared with all antidiabetic drugs (log-rank P = 0.00011) and dipeptidyl-peptidase IV inhibitors (DPP4i) (log-rank P = 0.01). Cox regression analysis showed consistent results. Direct meta-analysis showed that SGLT2i, compared with all antidiabetic medications (HR 0.57, 95% CI [0.44, 0.73], I2) and DPP4i (HR 0.41, 95% CI [0.24, 0.70], I2), was associated with a lower risk of AF recurrence. Conclusions: SGLT2i are associated with a reduced risk of AF recurrence after CA in patients with T2DM. These results suggest that SGLT2i is promising in improving clinical outcomes for this population. [ABSTRACT FROM AUTHOR]

Objective: Posterior left atrial wall isolation (PWI) plus traditional pulmonary vein isolation (PVI) has been proposed as a promising intervention to decrease atrial fibrillation (AF) recurrence. We aim to investigate the efficacy and safety of adding PWI to the traditional PVI in patients with AF. Methods: A systematic review and meta‐analysis was conducted using synthesizing randomized controlled trials (RCTs) retrieved by systematically searching PubMed, Web of Science, SCOPUS, EMBASE, and Cochrane through June 14, 2023. We used Stata version 17 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), with a 95% confidence interval (CI) (PROSPERO ID: CRD42023446227). Results: We included 11 RCTs with a total number of 1534 patients. Combined ablation with PWI + PVI was not associated with any significant difference over PVI only regarding the recurrence of clinical AF (RR: 0.86 with 95% CI [0.70–1.06]), all atrial arrhythmia (RR: 0.93 with 95% CI [0.82–1.07]), nonatrial fibrillation arrhythmia (RR: 1.22 with 95% CI [0.97–1.53]), early AF (RR: 0.89 with 95% CI [0.62–1.27]), and antiarrhythmic drugs at discharge (RR: 0.83 with 95% CI [0.67–1.04]). However, it was associated with increased total ablation duration (minutes) (MD: 12.58 with 95% CI [6.80–18.37]) and total procedure duration (minutes) (MD: 16.77 with 95% CI [9.63–23.91]), without any significant difference regarding adverse events (RR: 1.05 with 95% CI [0.63–1.74]). Conclusion: While the pooled data from PWI + PVI using point‐by‐point radiofrequency did not suggest a benefit in the recurrence of various atrial arrhythmias compared to PVI alone, PWI+PVI using direct posterior wall ablation, especially with cryoballoon, demonstrated a significant reduction in recurrence of AF/atrial arrhythmias. Also, PWI + PVI significantly increased the ablation and total procedure durations. [ABSTRACT FROM AUTHOR]

Background and Objective: Despite the significant burden of Plasmodium falciparum (Pf) malaria and the licensure of two vaccines for use in infants and young children that are partially effective in preventing clinical malaria caused by Pf, a highly effective vaccine against Pf infection is still lacking. Live attenuated vaccines using Pf sporozoites as the immunogen (PfSPZ Vaccines) hold promise for addressing this gap. Here we review the safety and efficacy of two of the most promising PfSPZ approaches: PfSPZ Vaccine (radiation attenuated PfSPZ) and PfSPZ-CVac (chemo-attenuated PfSPZ). Methods: We conducted a systematic review and meta-analysis by searching PubMed, EMBASE, SCOPUS, CENTRAL, and WOS until 22nd December 2021. We included randomized controlled trials (RCTs) of these two vaccine approaches that measured protection against parasitaemia following controlled human malaria infection (CHMI) in malaria-naive and malaria-exposed adults or following exposure to naturally transmitted Pf malaria in African adults and children (primary outcome) and that also measured the incidence of solicited and unsolicited adverse events as indicators of safety and tolerability after vaccination (secondary outcome). We included randomized controlled trials (RCTs) that measured the detected parasitaemia after vaccination (primary outcome) and the incidence of various solicited and unsolicited adverse events (secondary outcome). The quality of the included RCTs using the Cochrane ROB 1 tool and the quality of evidence using the GRADE system were evaluated. We pooled dichotomous data using the risk ratio (RR) for development of parasitemia in vaccinees relative to controls as a measure of vaccine efficacy (VE), including the corresponding confidence interval (CI). This study was registered with PROSPERO (CRD42022308057). Results: We included 19 RCTs. Pooled RR favoured PfSPZ Vaccine (RR: 0.65 with 95% CI [0.53, 0.79], P = 0.0001) and PfSPZ-table (RR: 0.42 with 95% CI [0.27, 0.67], P = 0.0002) for preventing parasitaemia, relative to normal saline placebo. Pooled RR showed no difference between PfSPZ Vaccine and the control in the occurrence of any solicited adverse event (RR: 1.00 with 95% CI [0.82, 1.23], P = 0.98), any local solicited adverse events (RR: 0.73 with 95% CI [0.49, 1.08], P = 0.11), any systemic solicited adverse events (RR: 0.94 with 95% CI [0.75, 1.17], P = 0.58), and any unsolicited adverse event (RR: 0.93 with 95% CI [0.78, 1.10], P = 0.37). Conclusion: PfSPZ and PfSPZ-CVacs showed comparable efficacy. Therefore, they can introduce a promising strategy for malaria prophylaxis, but more large-scale field trials are required to sustain efficacy and yield clinically applicable findings. [ABSTRACT FROM AUTHOR]

Background: Clinical decision support systems (CDSS) have been utilized as a low-cost intervention to improve healthcare process measures. Thus, we aim to estimate CDSS efficacy to optimize adherence to oral anticoagulant guidelines in eligible patients with atrial fibrillation (AF). Methods: A systematic review and meta-analysis of randomized controlled trials (RCTs) retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL through August 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) with a 95% confidence interval (CI). PROSPERO ID: CRD42023471806. Results: We included nine RCTs with a total of 25,573 patients. There was no significant difference, with the use of CDSS compared to routine care, in the number of patients prescribed anticoagulants (RR: 1.06, 95% CI [0.98, 1.14], P = 0.16), the number of patients prescribed antiplatelets (RR: 1.01 with 95% CI [0.97, 1.06], P = 0.59), all-cause mortality (RR: 1.19, 95% CI [0.31, 4.50], P = 0.80), major bleeding (RR: 0.84, 95% CI [0.21, 3.45], P = 0.81), and clinically relevant non-major bleeding (RR: 1.05, 95% CI [0.52, 2.16], P = 0.88). However, CDSS was significantly associated with reduced incidence of myocardial infarction (RR: 0.18, 95% CI [0.06, 0.54], P = 0.002) and cerebral or systemic embolic event (RR: 0.11, 95% CI [0.01, 0.83], P = 0.03). Conclusion: We report no significant difference with the use of CDSS compared to routine care in anticoagulant or antiplatelet prescription in eligible patients with AF. CDSS was associated with a reduced incidence of myocardial infarction and cerebral or systemic embolic events. [ABSTRACT FROM AUTHOR]

Background: Transcranial direct current stimulation (tDCS) emerged as a potential modality for enhancing cognitive functions in patients with cognitive decline, including mild cognitive impairment (MCI). Our systematic review and meta-analysis aim to synthesize the available randomized controlled trials (RCTs) on the effects of tDCS on cognitive functions in patients with MCI. Methods: Our review protocol was registered on PROSPERO with ID: CRD42022360587. We conducted a systematic database search until September 2022. Standardized mean difference (SMD) and pooled effect size (ES) for robust variance estimation (RVE) method were used as effect estimates for our meta-analysis. Results: We included 11 RCTs with a total of 429 participants. The meta-analysis showed that, compared to sham groups, tDCS did not improve global functioning (measured by MOCA) (SMD = 0.02, CI = − 0.30 to 0.35; p = 0.88), memory domain (ES = 0.681, CI = − 2.15 to 3.51, p = 0.576), sustained attention (measured by TMT-A) (SMD = − 0.21, CI = − 0.52 to 0.10, p = 0.19), and executive function (measured by TMT-B) (SMD = − 0.53, CI = − 1.56 to 0.50, p = 0.20). Conclusion: Our meta-analysis found no significant effect of tDCS on cognitive functions in MCI patients, including effects on global functioning, memory, sustained attention, and executive function. Therefore, an important change to be tested in future studies is to look for a better combination with tDCS for patients with MCI. [ABSTRACT FROM AUTHOR]

Background: Paroxysmal supraventricular tachycardia (PSVT) treatment requires medically supervised intervention. Etripamil is a novel short-acting calcium channel blocker. Its intranasal spray formulation has a rapid onset of action and shows promise for the unsupervised treatment of PSVT. Objective: We aimed to evaluate the efficacy and safety of etripamil nasal spray for the acute conversion of PSVT. Methods: A systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching the PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane databases through to 1 December 2022. RevMan version 5.4 software was used to pool dichotomous outcomes using risk ratio (RR) presented with the corresponding confidence interval (CI). Results: Three RCTs with a total of 496 participants were included in our analysis. Etripamil was effective for PSVT conversion at 15 min (RR 1.84, 95% CI 1.37–2.48), 30 min (RR 1.86, 95% CI 1.42–2.44), and 60 min (RR 1.25, 95% CI 1.05–1.50) after drug administration; decreasing medical intervention-seeking (RR 0.58, 95% CI 0.37–0.90); and decreasing emergency room (ER) visits (RR 0.61, 95% CI 0.38–0.97). However, there was no difference at 300 min (RR 1.10, 95% CI 0.97–1.25) and it was associated with higher rates of adverse events (RR 3.17, 95% CI 2.15–4.69). Conclusion: Etripamil nasal spray was effective and well tolerated to induce PSVT termination for up to 60 min. Therefore, etripamil nasal spray constitutes a promising strategy for PSVT self-termination without medical supervision; however, further RCTs are required before endorsement in clinical practice. [ABSTRACT FROM AUTHOR]