Cognitive behavioral therapy for the treatment of insomnia in patients with cardiovascular diseases: a meta-analysis with GRADE analysis.

Insomnia, as a difficulty in initiating and maintaining sleep, coupled with cardiovascular diseases (CVDs) increase the risk of aggravate daytime symptoms, mortality, and morbidity. Cognitive behavioral therapy (CBT) is thought to have a significant impact on insomnia treatment, but in patients with CVDs, there is a paucity of data. To provide a comprehensive appraisal on the impact of CBT on the treatment of insomnia in patients with CVDs. We searched Ovid, Scopus, Web of science, and Cochrane central, to randomized controlled trials (RCTs) from inception till November 2022. Outcomes of interest were insomnia severity index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep efficiency (SE), Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS), and sleep disorders questionnaire (SDQ). Pooled data were analyzed using mean difference (MD) with its 95% confidence interval (CI) in a random effect model using STATA 17 for Mac. Nine RCTs comprising 365 patients were included in the analysis. CBT significantly reduced scores of ISI (MD = - 3.22, 95%  CI - 4.46 to - 1.98, p < 0.001), PSQI (MD = - 2.33, 95%  CI - 3.23 to - 1.44, p < 0.001), DBAS (MD = - 0.94, 95%  CI - 1.3 to - 0.58, p < 0.001), SDQ (MD = - 0.38, 95%  CI - 0.56 to - 0.2, p < 0.001). Also, it increased the score of SE (MD = 6.65, 95% CI 2.54 to 10.77, p < 0.001). However, there was no difference in terms of ESS. CBT is an easy and feasible intervention with clinically significant improvement in insomnia symptoms. Further large-volume studies are needed to assess sustained efficacy.

Efficacy and Safety of Intranasal Fentanyl in Pediatric Emergencies: A Systematic Review and Meta-analysis.

BACKGROUND: Intranasal fentanyl (INF) has gained popularity in pediatric emergency departments (EDs) as an effective alternative to intravenous morphine for treating acute moderate to severe pain. Intranasal fentanyl eliminates the need for invasive access, making it advantageous for patients with minor injuries. Our study aims to provide a comprehensive evaluation of the available evidence regarding the effectiveness and safety of INF administration in pediatric emergency wards, particularly compared with other treatment options described in the literature. METHODS: A thorough search strategy identified randomized controlled trials assessing INF in the pediatric emergency ward. Eligible studies were independently screened, and relevant data were extracted. The analysis used pooled risk ratio (RR) for dichotomous outcomes and the standardized mean difference (SMD) for continuous ones. Randomized controlled trials' quality was assessed using the Cochrane Risk of Bias Assessment Tool 2. RESULTS: In our study, 8 randomized controlled trials involving 806 patients, INF demonstrated superior effectiveness in reducing pain compared with other comparators at the 15- to 20-minute mark (SMD, -0.23; 95% confidence interval, -0.37 to -0.08; P = 0.002). However, no significant differences were found at the 30- and 60-minute time points (SMDs, -0.16; 95% CI, -0.50, 0.19; P = 0.37; and -0.16; 95% CI, -0.50 to 0.19; P = 0.78) except when excluding one study to resolve heterogeneity at the 30-minute mark (RR, -0.02; 95% CI, -0.24 to 0.20; P = 0.87). Intranasal fentanyl also exhibited a better adverse outcome profile, with a lower risk of total adverse events and nausea/vomiting (RR, 0.66; 95% CI, 0.48-0.91; P = 0.01; and RR, 0.43; 95% CI, 0.30-0.63; P > 0.001) compared with other analgesics. However, no significant differences were observed for dizziness and hallucination (RR, 0.43; 95% CI, 0.30-0.63; P = 0.68; and RR, 0.43; 95% CI, 0.30-0.63; P = 0.35). CONCLUSIONS: Our study assessed the effectiveness of INF compared with other analgesics in pain reduction. Intranasal fentanyl demonstrated superior pain reduction at the 15- to 20-minute point but showed no significant differences at 30 and 60 minutes. Intranasal fentanyl also had a more favorable adverse event profile, with a lower risk of nausea and vomiting than other analgesics. However, no significant differences were observed in dizziness and hallucination between the groups.

Safety and efficacy of extended versus standard interval dosing of natalizumab in multiple sclerosis patients: a systematic review and meta-analysis.

BACKGROUND: Multiple sclerosis (MS) is a chronic inflammatory, immune-mediated disease affecting the central nervous system. Natalizumab, an FDA-approved monoclonal antibody for MS, has been explored for its off-label extended interval dosing (EID), suggesting a potential reduction in the risk of progressive multifocal leukoencephalopathy (PML) compared to standard interval dosing (SID). Our objective was to assess the efficacy and safety of EID in comparison to SID for natalizumab treatment in patients with MS. METHODS: We searched PubMed, Embase, WOS, Scopus, Ovid, Science Direct, Clinical trials.gov, and Cochrane Library. Our assessed outcomes were clinical relapses, MRI activity, change in expanded disability status scale [EDSS], and the risk of PML. The EID group was defined as 5 to 8 weeks [EID (Q5-8W)]. The analysis was conducted using RevMan ver. 5.4. The effect estimates were presented as a risk ratio [RR] or mean difference with 95% confidence intervals [CI] using SID group as the reference for comparisons. RESULTS: Fourteen studies met our inclusion criteria: 2 RCTs, 1 switched single-arm trial, and 12 observational studies. No significant differences were found in all efficacy outcomes of interest. Risk of clinical relapses [RR = 0.90, (95%CI 0.80, 1.02)], risk of new or newly enlarging T2 hyperintense MRI lesions [RR = 0.78, (95%CI 0.59, 1.04)], risk gadolinium enhancing lesions [RR = 1.30, (95%CI 0.98, 1.72)], change in EDSS [MD = 0.09 (95%CI - 0.57, 0.76)], risk of PML [RR = 1.09, 95%CI (0.24, 4.94)]. CONCLUSION: In summary, our meta-analysis indicates that natalizumab maintains its effectiveness under extended interval dosing [up to 8 weeks], presenting comparable risks for clinical relapses, MRI lesions, EDSS, and PML. Caution is advised given study limitations and heterogeneity. Robust conclusions necessitate well-designed high-quality prospective studies.

Efficacy of flattening filter-free beams with the acuros XB algorithm in thoracic spine stereotactic body radiation therapy.

This study aimed to determine the dosimetric value of flattening filter-free (FFF) beams compared to flattening filter (FF) beams using different algorithms in the treatment planning of thoracic spine stereotactic body radiation therapy (SBRT). A total of 120 plans were created for 15 patients using the Anisotropic Analytical Algorithm (AAA) and the Acuros External Beam (AXB) algorithm with FF and FFF beams at 6 MV and 10 MV energies. Various dosimetric parameters were evaluated, including target coverage, dose spillage, and organs-at-risk sparing of the spinal cord and esophagus. Treatment delivery parameters, such as the monitor units (MUs), modulation factors (MFs), beam-on time (BOT), and dose calculation time (DCT), were also collected. Significant differences were observed in the dosimetric parameters when AXB was used for all energies (P < 0.05). 6 XFFF energy was the best option for target coverage, dose spillage, and organs-at-risk sparing. In contrast, dosimetric parameters had no significant difference when using the AAA. The AAA and AXB calculations showed that the 6 XFFF beam had the shortest DCT. The treatment delivery parameters indicated that 10 XFF beam required the fewest MUs and MFs. In addition, the 10 XFFF beam demonstrated the shortest BOT. For effective treatment of the thoracic spine using SBRT, it is recommended to use the 10 XFFF beam because of the short BOT. Moreover, the AXB algorithm should be used because of its accurate dose calculation in regions with tissue heterogeneity.

Safety and feasibility of rotational atherectomy (RA) versus conventional stenting in patients with chronic total occlusion (CTO) lesions: a systematic review and meta-analysis.

BACKGROUND AND AIM: Interventional cardiologists face challenges in managing chronic total occlusion (CTO) lesions, with conflicting results when comparing rotational atherectomy (RA) to conventional PCI. This meta-analysis aims to provide a critical evaluation of the safety and feasibility of RA in CTO lesions. METHODS: PubMed, Scopus, Web of Science, Ovid, and Cochrane central library until April 2023 were searched for relevant studies. MACE was our primary outcomes, other outcomes were all cause of death, cardiac death, MI, and TVR. Also, we reported angiographic outcomes as technical success, procedural success, and procedural complications in a random effect model. The pooled data was analyzed using odds ratio (OR) with its 95% CI using STATA 17 MP. RESULTS: Seven studies comprising 5494 patients with a mean follow-up of 43.1 months were included in this meta-analysis. Our pooled analysis showed that RA was comparable to PCI to decrease the incidence of MACE (OR = 0.98, 95% CI [0.74 to 1.3], p = 0.9). Moreover, there was no significant difference between RA and conventional PCI in terms of other clinical or angiographic outcomes. CONCLUSION: Our study showed that RA had comparable clinical and angiographic outcomes as conventional PCI in CTO lesions, which offer interventional cardiologists an expanded perspective when addressing calcified lesions. PROSPERO REGISTRATION: CRD42023417362.

A comprehensive guide on the optimal timing of PCI in the setting of acute coronary syndrome: An updated meta-analysis.

BACKGROUND: Invasive revascularization is recommended for cohorts of patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTE-ACS). However, the optimal timing of invasive revascularization is still controversial and no defined consensus is established. We aim to give a comprehensive appraisal on the optimal timing of invasive strategy in the heterogenous population of ACS. METHODS: Relevant studies were assessed through PubMed, Scopus, Web of science, and Cochrane Library from inception until April 2023. Major adverse cardiovascular events (MACE) and all-cause mortality were our primary outcomes of interest, other secondary outcomes were cardiac death, TVR, MI, repeat revascularization, recurrent ischemia, and major bleeding. The data was pooled as odds ratio (OR) with its 95% confidence interval (CI) in a random effect model using STATA 17 MP. RESULTS: A total of 26 studies comprising 21,443 patients were included in the analysis. Early intervention was favor to decrease all-cause mortality (OR = 0.79, 95% CI: 0.64 to 0.98, p = 0.03), when compared to delayed intervention. Subgroup analysis showed that early intervention was significantly associated with all-cause mortality reduction in only NSTE-ACS (OR = 0.83, 95% CI [0.7 to 0.99], p = 0.04). However, there was no significant difference between early and delayed intervention in terms of MACE, cardiac death, TVR, MI, repeat revascularization, recurrent ischemia, and major bleeding. CONCLUSION: An early intervention was associated with lower mortality rates compared to delayed intervention in NSTE-ACS with no significant difference in other clinical outcomes. PROSPERO registration: CRD42023415574.

Drug-coated balloons versus drug-eluting stents in patients with acute myocardial infarction undergoing percutaneous coronary intervention: an updated meta-analysis with trial sequential analysis.

BACKGROUND: Drug-coated balloons (DCBs) are an established strategy for coronary artery disease. However, the new generation drug-eluting stent (DES) is recommended for patients with Acute myocardial infarction (AMI) for coronary artery revascularization. Our aim is to provide a comprehensive appraisal of the efficacy of DCBs in patients with AMI undergoing PCI. METHODS: We searched the WOS, PubMed, Scopus, and Cochrane CENTRAL till March 2023, for studies that compared DCBs versus DES in patients with AMI undergoing PCI. We used a random-effects model to compare major adverse cardiac events (MACE), cardiac death, all-cause death, myocardial infarction, target lesion revascularization (TLR), stent thrombosis, Late lumen Loss (LLL), and minimum lumen diameter (MLD) between the two groups. RESULTS: Thirteen studies comprising 2644 patients were included. The pooled OR showed non-inferiority of DCB over DES in terms of MACE (OR = 0.89, 95% CI [0.57 to 1.40], p = 0.63). When we defined MACE as a composite of cardiac death, MI, and TLR; the pooled OR favored DCB over DES (OR = 0.50, 95% CI [0.28 to 0.9], p = 0.02). Moreover, DCB was not inferior to DES in terms of all-cause mortality (OR = 0.88, 95% CI: 0.43 to 1.8, p = 0.73), cardiac mortality, (OR = 0.59, 95% CI: 0.22 to 1.56, p = 0.29), MI (OR = 0.88, 95% CI: 0.34 to 2.29, p = 0.79), stent thrombosis (OR = 1.21, 95% CI: 0.35 to 4.23, p = 0.76), TLR (OR = 0.9, 95% CI: 0.43 to 1.93, p = 0.8), LLL (MD = -0.6, 95% CI: -0.3 to 0.19, p = 0.64), or MLD (MD = -0.4, 95% CI: -0.33 to 0.25, p = 0.76). CONCLUSION: Our meta-analysis indicated that DCB intervention was not inferior to DES in the PCI setting in patients with AMI, and can be recommended as a feasible strategy in AMI. PROSPERO REGISTRATION: CRD42023412757.

Short- and Long-term Outcomes of Percutaneous Coronary Interventions in Chronic and Non-chronic Total Occlusions: A Meta-analysis of 690,123 Patients.

The use of percutaneous coronary intervention (PCI) in patients with chronic total occlusion (CTO) is still a subject of debate, with conflicting outcomes reported in different studies when compared to non-CTO lesions. This meta-analysis aims to clarify the clinical outcomes of PCI in CTO cases compared to non-CTO lesions, both in the short and long-term. PubMed, Scopus, Web of Science, Ovid, and Cochrane Central were searched until March 2023 for relevant studies addressing short- and long-term outcomes of PCI in CTO vs non-CTO lesions. Dichotomous data were pooled as odds ratio (OR) with its 95% confidence interval (CI) in a random Der-Simonian lair effect model using STATA 17 MP. Eight studies with a total of 690,123 patients were included. In terms of short-term outcomes, CTO PCI was associated with higher rates of vessel perforation (OR = 2.16, 95% CI: 1.31-3.57) and cardiac tamponade (OR = 5.19, 95% CI: 4.29-6.28). Additionally, CTO PCI showed lower rates of procedural success (OR = 0.84, 95% CI: 0.73-0.96). Moreover, in the long-term, CTO PCI had higher rates of MACE (OR = 1.02, 95% CI: 1.01-1.04), however, it showed lower rates of cardiac death (OR = 0.61, 95% CI: 0.38-0.98), with no significant difference in other reported outcomes. Our findings underscore the challenges and adverse outcomes associated with using PCI to treat CTO lesions in the short term. This suggests that interventional cardiologists should carefully evaluate the risks and benefits before proceeding with PCI in CTO lesions.

Posterior pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: a systematic review and meta-analysis of 25 randomised controlled trials.

BACKGROUND: Atrial fibrillation (AF) associated with postoperative pericardial effusion is the most commonly reported adverse event after cardiac surgery. AIMS: We aimed to determine the role of posterior pericardiotomy in preventing postoperative AF (POAF). METHODS: We searched PubMed, Scopus, Web of Science, Ovid, and EBSCO from inception until 30 June 2022. We included randomised clinical trials (RCTs) that compared posterior pericardiotomy (PP) versus control (no PP) in patients undergoing cardiac surgery. The primary endpoint was the incidence of POAF after cardiac surgery. The secondary endpoints were supraventricular arrhythmias, early/late pericardial effusion, pericardial tamponade, pleural effusion, length of hospital/intensive care unit stay, intra-aortic balloon pump use, revision surgery for bleeding, and mortality. RESULTS: Twenty-five RCTs comprising 4,467 patients were included in this systematic review and meta-analysis. The overall incidence rate of POAF was 11.7% in the PP group compared with 23.67% in the no PP or control group, with a significant decrease in the risk of POAF following PP (odds ratio [OR] 0.49, 95% confidence interval [CI]: 0.38-0.61). Compared with the control group, the risk of supraventricular tachycardia (OR 0.66, 95% CI: 0.43-0.89), early pericardial effusion (OR 0.32, 95% CI: 0.22-0.46), late pericardial effusion (OR 0.15, 95% CI: 0.09-0.25), and pericardiac tamponade (OR 0.18, 95% CI: 0.10-0.33) were lower in the PP group. CONCLUSIONS: PP is an effective intervention for reducing the risk of POAF after cardiac surgery. Also, PP is economically efficient in terms of decreasing the length of hospital stay.

Oncoplastic versus conventional breast-conserving surgery in breast cancer: a pooled analysis of 6941 female patients.

BACKGROUND: Breast cancer is the most prevalent cancer in women. In the past few years, surgical interventions for breast cancer have experienced massive changes from radical excision to conserving approaches. In this study, we aim to compare the two breast surgery interventions, including conventional breast-conserving surgery (CBCS) versus oncoplastic breast-conserving surgery (OPBCS). METHODS: We searched on PubMed, Web of Science (WOS), Scopus, Embase, and Cochrane till 2 October 2021. All relevant randomized controlled trials (RCTs) and observational studies were included. The data were extracted and pooled using Review Manager software (RevMan 5.4). RESULTS: The pooled meta-analysis of the included studies showed that OPBCS was significantly superior to CBCS in most of the outcomes. Re-excision significantly favoured CBCS (RR = 0.49, 95% CI [0.37, 0.63], P < 0.00001). However, local recurrence (RR = 0.55, 95% CI [0.27, 1.09], P = 0.09), close surgical margins (RR = 0.37, 95% CI [0.14, 1.00], P = 0.05) and end up to the risk of mastectomy (RR = 0.73, 95% CI [0.54, 97], P = 0.06) showed no significant difference between both techniques. Notably, while performing a sensitivity analysis, other outcomes as local recurrence, significantly showed favourable results towards OPBCS. In terms of safety outcomes, there was no significant difference between OPBCS and CBCS. CONCLUSION: We recommend the oncoplastic approach rather than the conventional one in females with breast cancer. Re-excision rates showed better results following OPBCS.

Demographic and treatment risk factors of cancer-specific mortality among children and adolescent leukemia patients: a population-based study.

Leukemia is the 15th most commonly diagnosed cancer and the 11th leading cause of cancer mortality. The high mortality rate of leukemia could be attributed to numerous factors. Therefore, we aimed to identify the demographic and treatment risk factors influencing mortality among patients diagnosed with leukemia. Patients' data from 1975 to 2016 were collected from the Surveillance, Epidemiology, and End Results (SEER) database. We used the Person's chi-square test to examine the associations among the categorical variables. Kaplan-Meier and Cox regression were applied for univariate and multivariate analyses. Standardized mortality ratios were utilized to compare the mortality rates of leukemia patients and the general US population. We carried out the statistical analysis using SPSS software. A total of 18,880 patients with leukemia were studied. The leukemia incidence was increased in children than in adolescents. Acute lymphoid leukemia (ALL) was the most common type diagnosed among children and adolescents: 10,331 and 4112 patients, respectively. All mortality ratios were significantly higher in leukemia patients compared to the US population. The risk of mortality among leukemia patients was higher among adolescents, females, Black, urban areas with a 20,000 population, and patients not receiving chemotherapy. In contrast, the mortality risk was decreased in patients with higher family incomes, those not treated with radiation, and diagnosed from 2000 to 2016. In conclusion, Leukemia's incidence increases with time. Adolescents, males, Black, in some urban areas, and patients who have not received chemotherapy had the highest mortality risk among leukemia patients.

Quantifying inter- and intra-fraction variations of breast cancer radiotherapy with skin dose measurements.

Aim. The aim of the current study was to compare between the deep inspiration breath-hold (DIBH) technique and free-breathing (FB) method in the treatment delivery uncertainty of breast cancer radiotherapy using skin dose measurements.Methods. In a prospective manner, eighty patients were randomly selected for skin dose measurements, and they were assigned to two groups. DIBH (40 patients) and FB (40 patients). The systematic inter-fraction dose variation was quantified using the mean percentage error (MPE) between the average measured total dose per session in three consecutive sessions and the corresponding calculated point dose from the treatment planning system. The random inter-fraction dose variation was quantified using the standard deviation (SD) of the dose delivered by the medial or lateral tangential fields, or the total session dose in the three sessions (SDMT, SDLT, or SDtotal, respectively). While the random intra-fraction dose variation was quantified using the SD of the dose difference between the medial and lateral tangential fields in three consecutive sessions (SDMT-LT).Results. There was no statistically significant difference in MPE between the DIBH and FB groups (p = 0.583). Moreover, the mean SDtotaland SDMTof the DIBH group were significantly lower than that of the FB group (2.75 ± 2.33 cGy versus 4.45 cGy ± 4.33, p = 0.048) and (1.94 ± 1.63 cGy versus 3.76 ± 3.42 cGy, p = 0.007), respectively. However, there was no significant difference in the mean SDLTand SDMT-LTbetween the two groups (p > 0.05).Conclusion. In addition to the advantage of reducing the cardiopulmonary radiation doses in left breast cancer, the DIBH technique could reduce the treatment delivery uncertainty compared to the FB method due to the significant reduction in the random inter-fraction dose variations.

The necessity of using deep inspiration breath-hold in the radiotherapy of left breast cancer patients who undergo the UK FAST trial.

AIM: The purpose of the current study was to compare between deep inspiration breath-hold (DIBH) and free-breathing (FB) method in the setup reproducibility and to perform a dosimetric comparison between both methods in left-sided breast cancer patients who undergo the UK FAST trial. MATERIALS AND METHODS: The online matching correction data were retrospectively collected for 50 patients treated with the FAST trial. They were equally divided into DIBH and FB groups to compare between both methods in the setup reproducibility and create the appropriate planning target volume (PTV) margin. Ten patients out of the fifty were scanned in DIBH and FB to perform a dosimetric comparison with the strict acceptance criteria of the FAST trial. RESULTS: All heart dosimetric parameters of the DIBH was significantly lower than that of FB (p < 0.001), and the lung V30% of DIBH plans was significantly lower than FB plans (p = 0.03). There was no statistically significant difference between the two methods in the other organs at risk doses. To fulfill the heart and lung constraints in FB plans, the PTV V90% was reduced by 3.4%, and three plans would not attain the PTV acceptance criteria. There was no significant difference between the systematic or random setup errors between both methods except the left-right random shift was significantly lower in DIBH cases (p = 0.004). The calculated PTV margins were (4 mm, 3 mm, and 4 mm) for DIBH group, and (5 mm, 6 mm, and 8 mm) for FB group in the anterior-posterior, superior-inferior, and left-right shifts, respectively. CONCLUSION: It is highly warranted to treat left-sided breast cancer patients with the DIBH technique when the UK FAST trial is employed for treatment.