Meta‐analysis of cryoballoon ablation versus antiarrhythmic drugs as initial therapy for symptomatic atrial fibrillation

BackgroundThe optimal first‐line approach for patients with symptomatic atrial fibrillation (AF) remains unclear. We compared the efficacy and safety of cryoballoon ablation (CBA) and antiarrhythmic drugs (AADs) in the initial management of symptomatic AF.HypothesisCBA is superior to AAD as initial therapy for symptomatic AF.MethodsWe searched the EMBASE, PubMed, and Cochrane Library databases for randomized controlled trials (RCTs) that compared CBA with AAD as first‐line treatment for AF from the date of database establishment until March 18, 2021. The risk ratio (RR) with a 95% confidence interval (CI) was used as a measure of treatment effect.ResultsThree RCTs that enrolled 724 patients in total were included in this meta‐analysis. Majority of the patients were relatively young and had paroxysmal AF. CBA was associated with a significant reduction in the recurrence of atrial arrhythmia compared with AAD therapy, with low heterogeneity (RR, 0.59; 95% CI, 0.49–0.71; p < .00001; I ²  = 0%). There was a significant difference in the rate of symptomatic atrial arrhythmia recurrence (RR, 0.44; 95% CI, 0.29–0.65; p < .0001; I ²  = 0%); however, the rate of serious adverse events was similar between the two treatment groups (RR: 1.18; 95% CI: 0.71–1.97, p = .53; I ² = 0%). Transient phrenic nerve palsy occurred in four patients after the CBA procedure.ConclusionThe current meta‐analysis suggests that CBA is more effective than AAD as initial therapy in patients with symptomatic paroxysmal AF. Serious iatrogenic adverse events are uncommon in CBAs.     

Mediterranean dietary pattern,inflammation and endothelial function: A systematic review and meta-analysis of intervention trials

BackgroundHigh adherence to a Mediterranean diet (MD) is associated with reduced all-cause and cardiovascular mortality risk. To our knowledge, there is no systematic review and meta-analysis of randomized controlled trials that has compared the effects of an MD on outcomes of endothelial function and inflammation.Methods and resultsLiterature search was performed using the electronic databases MEDLINE, EMBASE, and the Cochrane Trial Register. Inclusion criteria were: randomized controlled trials, 19 + years of age, and minimum intervention period of 12 weeks. Study specific weighted mean differences (WMD) were pooled using a random effect model. Seventeen trials including 2300 subjects met the objectives. MD regimens resulted in a significantly more pronounced increase in flow mediated dilatation [WMD: 1.86%, 95% CI 0.23 to 3.48, p = 0.02; I² = 43%], and adiponectin [WMD: 1.69 μg/ml, 95% CI 0.27 to 3.11, p = 0.02; I² = 78%], while high-sensitive C reactive protein [WMD: −0.98 mg/l, 95% CI −1.48 to −0.49, p < 0.0001; I² = 91%], interleukin-6 [WMD: −0.42 pg/ml, 95% CI −0.73 to −0.11, p = 0.008; I² = 81%], and intracellular adhesion molecule-1 [WMD: −23.73 ng/ml, 95% CI −41.24 to −6.22 p = 0.008; I² = 34%] turned out to be significantly more decreased.ConclusionThe results of the present meta-analysis provide evidence that an MD decreases inflammation and improves endothelial function.     

A systematic review and meta‐analysis of the impact of the left atrial appendage closure on left atrial function

BackgroundLeft atrial (LA) appendage closure (LAAC) is effective in patients with atrial fibrillation who are not candidates for long‐term anticoagulation. However, the impact of LAAC on LA function is unknown. The aim of this study is to evaluate the impact of LAAC on atrial function.MethodsThis meta‐analysis was conducted according to Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. A search strategy was designed to utilize PubMed/Medline, EMBASE, and Google scholar for studies showing the effect of LAAC on the LA function from inception to November 20, 2021. The standardized mean difference (SMD) was calculated from the means and standard deviations.ResultsOf 247 studies initially identified, 8 studies comprising 260 patients were included in the final analysis. There was a significant increase in LA emptying fraction following LAAC compared with preoperative function (SMD: 0.53; 95% confidence interval [CI]: 0.04–1.01; p = .03; I ² = 75%). In contrast, there were no significant differences in LA volume (SMD: −0.07; 95% CI: −0.82–0.69; p = .86; I ² = 92%) peak atrial longitudinal strain (SMD: 0.50; 95% CI: −0.08–1.08; p = .09; I ² = 89%), peak atrial contraction strain (SMD: 0.38; 95% CI: −0.22–0.99; p = .21; I ² = 81%), strain during atrial contraction (SMD: −0.24; 95% CI: −0.61–0.13; p = .20; I ² = 0%), strain during ventricular systole (SMD: 0.47; 95% CI: −0.32–1.27; p = .24; I ² = 89%), strain during ventricular diastole (SMD: 0.09; 95% CI: −0.32–0.51; p = .66; I ² = 65%).ConclusionLAAC is associated with improvement in the left atrial emptying fraction, but did not significantly influence other parameters.     

Sodium–glucose cotransporter inhibitors as add-on therapy in addition to insulin for type 1 diabetes mellitus: A meta-analysis of randomized controlled trials

Aims/IntroductionSeveral clinical trials reported the effects of sodium–glucose cotransporter (SGLT) inhibitors in type 1 diabetes patients. This meta‐analysis aimed to assess the efficacy and safety of SGLT inhibitors in type 1 diabetes patients.Materials and MethodsRelevant studies were identified in the PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure and Wan Fang databases through 1 April 2020. Differences were expressed as the 95% confidence interval (CI) or weighted mean difference (WMD) for continuous outcomes, and risk ratio (RR) for discontinuous outcomes.ResultsA total of 13 RCTs with 7,962 cases were included. SGLT inhibitors reduced the fasting plasma glucose level (WMD −1.320 mmol/L, 95% CI −1.609 to −1.031, P < 0.001), glycated hemoglobin level (WMD −0.386%, 95% CI −0.431 to −0.342, P < 0.001) and daily total insulin dose (WMD −5.403, 95% CI −7.218 to −3.859, P < 0.001). However, higher risks of diabetic ketoacidosis (RR 5.042, 95% CI 3.160–8.046, P < 0.001), urinary tract infections (RR 1.259, 95% CI 1.034–1.533,P = 0.022) and genital infections (RR 2.995, 95% CI 1.953–4.594, P < 0.001) were associated with SGLT inhibitors, but SGLT inhibitors did not increase the hypoglycemia risk (RR 0.980, 95% CI 0.840–1.144,P = 0.799). In subgroup analysis, with a significant reduction of fasting plasma glucose, glycated hemoglobin and daily insulin doses, SGLT1/2 inhibitor did not increase genitourinary tract infections compared with a placebo.ConclusionsSGLT2 and SGLT1/2 inhibitors can improve glycemic control in patients with type 1 diabetes.     

The effect of flaxseed supplementation on body weight and body composition: a systematic review and meta‐analysis of 45 randomized placebo‐controlled trials

Flaxseed consumption may be inversely associated with obesity; however, findings of available randomized controlled trials (RCTs) are conflicting. The present study aimed to systematically review and analyse RCTs assessing the effects of flaxseed consumption on body weight and body composition. PubMed, Medline via Ovid, SCOPUS, EMBASE and ISI Web of Sciences databases were searched up to November 2016. Mean changes in body composition indices including body weight, body mass index (BMI) and waist circumference were extracted. Effect sizes were expressed as weighted mean difference (WMD) and 95% confidence intervals (CI). Heterogeneity between studies was assessed with the I² test. Publication bias and subgroup analyses were also performed. The quality of articles was assessed via the Jadad scale. A total of 45 RCTs were included. Meta‐analyses suggested a significant reduction in body weight (WMD: ?0.99 kg, 95% CI: ?1.67, ?0.31, p = 0.004), BMI (WMD: ?0.30 kg m^?2, 95% CI: ?0.53, ?0.08, p = 0.008) and waist circumference (WMD: ?0.80 cm, 95% CI: ?1.40, ?0.20, p = 0.008) following flaxseed supplementation. Subgroup analyses showed that using whole flaxseed in doses ≥30 g d^?1, longer‐term interventions (≥12 weeks) and studies including participants with higher BMI (≥ 27 kg m^?2) had positive effects on body composition. Whole flaxseed is a good choice for weight management particularly for weight reduction in overweight and obese participants.     

Mechanical or biologic prostheses for mitral valve replacement: A systematic review and meta‐analysis

Either a mechanical or bioprosthetic valve is used in patients undergoing mitral valve replacement (MVR). However, the optimal mitral prosthesis remains controversial. The aim of this meta‐analysis was thus to compare outcomes between mechanical mitral valve replacement (MVRm) and bioprosthetic mitral valve replacement (MVRb) for MVR patients. We searched Embase, PubMed, Web of Science, and Cochrane Library databases from January 1, 2000 to October 31, 2021 for studies that directly compared surgical outcomes of MVRm and MVRb. A total of 22 studies with 35 903 patients were included in the meta‐analysis (n = 23 868 MVRm and n = 12 035 MVRb). The MVRm group displayed lower long‐term all causes mortality (HR, 0.84; 95% confidence interval [CI]: 0.77−0.91; p < .0001; I² = 51%), and fewer mitral reoperation (hazard ratio [HR]: 0.34; 95% CI: 0.23−0.50; p < .00001; I² = 74%) than MVRb group. However, the MVRm group was associated with a greater risk of major bleeding events (HR: 1.21; 95% CI: 1.14−1.29; p < .00001; I² = 0%), stroke and systemic embolism (HR: 1.20; 95% CI: 1.10−1.32; p < .0001; I² = 0%) in matched or adjusted data. No significant difference was observed between MVRm and MVRb on operative mortality in matched/adjusted group (risk ratios: 0.83; 95% CI: 0.66−1.05; p = .12; I² = 0%). The results were consistent with patients aged under 70 years old. Patients who received a MVRm is associated with 16% lower risk of long‐term mortality and 66% lower risk of mitral reoperation, but 20% greater risk of stroke or systemic embolism, 21% greater risk of major bleeding compared with MVRb in matched/adjusted studies group, which were consistent to patients younger than the age of 70 years who underwent MVR.     

Association between subjective well-being and exceptional longevity in a longevity town in China: a population-based study

To examine the associations of cognitive and emotional facets (measured by life satisfaction [LS], positive affect [PA], negative affect [NA], and affect balance [AB]) of subjective well-being (SWB) with exceptional longevity (EL), we conducted a population-based study with 463 EL individuals (95+, EL group) recruited from a longevity town of Rugao, China (N = 755, with a response rate of 71.6 %), and 926 elderly individuals (60–69, elderly/control group). The population-based controls were sampled from the resident registry according to the gender ratio of the EL group. We found that the EL group had significantly higher levels of LS (30.74 vs. 28.93), PA (3.91 vs. 3.67), and AB (7.89 vs. 7.40) and a lower level of NA (1.02 vs. 1.27) than the elderly group. Multivariate logistic regression analysis revealed that higher levels of LS, PA, AB, and NA were significantly associated with EL, with odds ratios (ORs) of 1.98 (95 % CI, 1.36–2.89), 2.35 (95 % CI, 1.59–3.48), 2.56 (95 % CI, 1.75–3.75), and 0.50 (95 % CI, 0.33–0.74), respectively. Stratification analysis showed that the associations were significant in the healthy subsample, with the following ORs: LS = 2.31, PA = 2.53, AB = 3.05, and NA = 0.39. In conclusion, SWB, with high cognitive and emotional facets, was associated with EL in the healthy Rugao population. The findings imply that interventions that aim to improve elderly individuals’ SWB may promote their quality of life and, ultimately, EL.     

Effects of acute bouts of endurance exercise on retinal vessel diameters are age and intensity dependent

Alterations of retinal vessel diameters are associated with increased cardiovascular risk. We aimed to investigate changes in retinal vessel diameters in response to acute dynamic exercise of different intensities and whether these changes are age dependent. Seventeen healthy seniors (median (IQR) age 68 (65, 69) years) and 15 healthy young adults (median (IQR) age 26 (25, 28) years) first performed a maximal treadmill test (MTT) followed by a submaximal treadmill test (SMTT) and a resting control condition in randomised order. Central retinal arteriolar (CRAE) and central retinal venular (CRVE) diameter equivalents were measured before as well as 5 (t₅) and 40 (t₄₀) minutes after exercise cessation using a static retinal vessel analyser. Both exercise intensities induced a significant dilatation in CRAE and CRVE at t₅ compared to the control condition (P < 0.001). At t₄₀, the mean increase in CRAE and CRVE was greater for MTT compared to that for SMTT (CRAE 1.7 μm (95 % confidence interval (CI) −0.1, 3.6; P = 0.061); CRVE 2.2 μm (95 % CI 0.4, 4.1; P = 0.019)). However, the estimated difference at t₅ between seniors and young adults in their response to MTT compared to SMTT was 5.3 μm (95 % CI 2.0, 8.5; P = 0.002) for CRAE and 4.1 μm (95 % CI −0.4, 8.6; P = 0.076) for CRVE. Wider arteries and veins after maximal versus submaximal exercise for seniors compared to young adults suggest that myogenic vasoconstriction in response to exhaustive exercise may be reduced in seniors. Age-related loss of vascular reactivity has clinical implications since the arteriolar vasoconstriction protects the retinal capillary bed from intraluminal pressure peaks.

Electronic supplementary material

The online version of this article (doi:10.1007/s11357-014-9650-3) contains supplementary material, which is available to authorized users.     

Bone mineral density in patients with early rheumatoid arthritis treated with corticosteroids

The aim of this study was to evaluate the bone mineral density (BMD) in patients with early rheumatoid arthritis (RA) prior to and 6 months after adding low-dose corticosteroid (CS) treatment. Adult patients (>21 years old) with early RA (symptom duration <1 year) and severe joint pain under maximal dose of nonsteroidal anti-inflammatory drugs (NSAIDS) were started on low-dose prednisone (10 mg/day). Patients were evaluated after 1, 3, and 6 months. Disease activity measures including swollen and tender joint count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were documented, and the dose of prednisone was adjusted according to the level of pain at each visit. BMD of the femoral neck (FN) and lumbar spine (LS) was measured using dual energy X-ray absorptiometry prior to and 6 months after starting CS treatment. Calcium supplements, vitamin D, bisphosphonates, or hormonal therapy that may affect BMD were not permitted during the study. Twenty patients were eligible and 16 completed the study; 75% were female. The mean age was 47.2±12 years and mean duration of symptoms was 7±2 months. The mean BMD at the FN prior to and 6 months after starting CS treatment were 0.8080 g/cm²±0.1145 and 0.8242 g/cm²±0.1122, respectively (p=0.04). The mean BMD at the LS prior to and 6 months after starting CS treatment were 0.9429 g/cm²±0.1406 and 0.9490 g/cm²±0.1277, respectively (p=0.423). There was a significant correlation between the mean change of BMD at the FN and mean change of tender joint count (p=0.01), ESR (p=0.008), and CRP (p=0.006) but not with swollen joint count (p=0.099). However, there was no correlation between the change of BMD at the FN or LS and the change of any of the disease activity measures of every patient. Also, no correlation was seen between the cumulative dose of CS and the change in BMD. BMD increases significantly at the FN in early RA patients 6 months after adding low-dose CS to the treatment.     

Metformin treatment is associated with an increase in bone mineral density in type 2 diabetes mellitus patients in China: A retrospective single center study

AimsTo investigate the association between metformin and bone mineral density (BMD) in a large cohort of Chinese patients with type 2 diabetes mellitus (T2DM).MethodsA total of 11,458 T2DM patients aged ≥40 years were included. Information on demographic, anthropometric and clinical characteristics was collected from medical records. BMD at lumbar spine (LS), femoral neck (FN), and total hip(TH) was assessed by dual-energy X-ray absorptiometry.ResultsOverall prevalence of osteopenia and osteoporosis was 37.4% and 10.3%, and was lower in patients on metformin (34.6% vs 38.3% and 7.1% vs 11.3%, both p < 0.001). Patients who had a lower BMI, older age, and lower estimated glomerular filtration rate (eGFR), had more osteoporosis, lower BMD (osteoporosis or osteopenia), and a lower T-score at LS, FN and TH. Metformin use and male sex was associated with a higher BMD. Metformin treatment was also independently associated with higher T-score at LS, FN and TH (β values of 0.120, 0.082 and 0.108; all p <0.001), and lower odds ratio of osteoporosis (OR = 0.779, 95%CI: 0.648–0.937, p = 0.008) or low BMD (OR = 0.834, 95%CI: 0.752 - 0.925, p = 0.001). However, when analyzed by sex, this association of a lower odds ratio for osteoporosis with metformin was only significant in women (OR= 0.775, 95% CI: 0.633–0.948; p = 0.013).ConclusionsMetformin treatment was associated with a higher T-score and a lower odds ratio of osteopenia and osteoporosis, especially in the female population, independent of age, BMI, and eGFR.     

Apolipoprotein E-related all-cause mortality in hospitalized elderly patients

The most common apolipoprotein E (APOE) allelic variation is implicated in many age-related diseases and human longevity with controversial findings. We investigated the effect of APOE gene polymorphism on all-cause mortality in elderly patients taking into consideration the functional disability, cognitive impairment, malnutrition, and the occurrence of common age-related diseases. APOE genotypes were determined in 2,124 geriatric hospitalized patients (46.5% men and 53.5% women; mean age, 78.2 ± 7.1 years; range, 65–100 years). At hospital admission, all patients underwent a comprehensive geriatric assessment to evaluate functional disability, cognitive status, nutritional status, and comorbidity. The main and secondary diagnoses at hospital discharge were also recorded. Mortality status was evaluated in all patients after a maximum follow-up of 5 years (range, from 1.26 to 5.23 years; median, 2.86 years). During the study period, 671 patients died (32.0%). At hospital admission, these patients showed a significant higher prevalence of cardiovascular diseases (56.3% vs 53.4%; p = 0.007), neoplasias (32.3% vs 13.7%; p < 0.001), and lower prevalence of neurodegenerative diseases (17.7% vs 20.7%; p < 0.001) than survived patients. Moreover, they also showed an higher prevalence of disability (52.0% vs 25.6%; p < 0.001), cognitive impairment (31.0% vs 18.8%; p < 0.001), and malnutrition (74.0% vs 46.1%; p < 0.001) than survived patients. In the overall study population, the APOE ε2 allele was significantly associated to neurodegenerative diseases (odds ratio = 0.59; 95% confidence interval (CI), 0.37–0.94). No significant association between the APOE polymorphism and disability, malnutrition, co-morbidity status, and with all-cause mortality was observed. In patients with cardiovascular diseases, however, a decreased risk of all-cause mortality was found in the ε2 allele carriers (hazard ratio = 0.56; 95% CI, 0.36–0.88). In this population, APOE allele variants might play a role on cardiovascular disease-related mortality.     

Efficacy and safety of baroreflex activation therapy for treatment of resistant hypertension: a systematic review and meta-analysis

To provide definite evidence for the anti-hypertensive benefit of Baroreflex Activation Therapy (BAT) for resistant hypertension, we performed a systematic review and meta-analysis to evaluate the efficacy and safety of BAT. Electronic searches were conducted in PubMed, EMBASE, The Cochrane Library and Web of Science. Two reviewers independently determined the eligibility of studies and extracted the data. The quality of all included studies was evaluated by the use of the Newcastle Ottawa Scale (NOS). Disagreements were settled through discussion. Twelve studies, included one randomized clinical trials (RCTs) and eleven prospective studies were eligible for qualitative analysis and five prospective studies were selected for meta-analysis. The data of analysis showed office systolic blood pressure (SBP)(WMD = ?24.01, 95% CI = ?28.65 to ?19.36, P= 0.753I² = 0.0%) and diastolic blood pressure (DBP)(WMD = ?12.53, 95% CI = ?15.82 to ?9.24,P = 0.893,I² = 0.893) decreased by BAT treatment.The effect on SBP was both significant in the Barostim neo TM device (WMD = ?22.49, 95% CI = ?29.13 to 15.84, P= 0.443; I² = 0.0%) and Rheos System (WMD = 25.46, 95% CI = ?31.96 to ?18.96, P= 0.703; I² = 0.0%). Our study found office BP were significantly decreased by BAT treatment, but available evidence is limited by risk of bias, small sample size, and few RCTs. Thus, there is presently insufficient evidence to fully evaluate the efficacy and safety of BAT for Patients with Resistant Hypertension. Additional high-quality RCT research with long-term follow-up is required.     

Fluoroscopy usage in contemporary interventional electrophysiology: Insights from a European registry

BackgroundFluoroscopy has been an essential part of every electrophysiological procedure since its inception. However, till now no clear standards regarding acceptable x‐ray exposure nor recommendation how to achieve them have been proposed.HypothesisCurrent norms and quality markers required for optimal clinical routine can be identified.MethodsCenters participating in this Europe‐wide multicenter, prospective registry were requested to provide characteristics of the center, operators, technical equipment as well as procedural settings of consecutive cases.ResultsTwenty‐five centers (72% university clinics, with a mean volume of 526 ± 348 procedures yearly) from 14 European countries provided data on 1788 cases [9% diagnostic procedures (DP), 38% atrial fibrillation (AF) ablations, 44% other supraventricular (SVT) ablations, and 9% ventricular ablations (VT)] conducted by 95 operators (89% male, 41 ± 7 years old).Mean dose area product (DAP) and time was 304 ± 608 cGy*cm², 3.6 ± 4.8 minutes, 1937 ± 608 cGy*cm², 15.3 ± 15.5 minutes, 805 ± 1442 cGy*cm², 10.6 ± 10.7 minutes, and 1277 ± 1931 cGy*cm², 10.4 ± 12.3 minutes for DP, AF, SVT, and VT ablations, respectively. Seven percent of all procedures were conducted without any use of fluoroscopy.Procedures in the lower quartile of DAP were performed more frequently by female operators (OR 1.707, 95%CI 1.257‐2.318, P = .001), in higher‐volume center (OR 1.001 per one additional procedure, 95%CI 1.000‐1.001, P = .002), with the use of 3D‐mapping system (OR 2.622, 95%CI 2.053‐3.347, P < .001) and monoplane x‐ray system (OR 2.945, 95%CI 2.149‐4.037, P < .001).ConclusionExposure to ionizing radiation varies widely in daily practice for all procedure. Significant opportunities for harmonization of exposure toward the lower range has been identified.     

Masked and white coat hypertension,the double trouble of large arteries: A systematic review and meta‐analysis

Arterial damage of large arteries, addressed as c‐f PWV, is recognized as independent predictor for future cardiovascular disease. The aim of this study was to systematically investigate the association of the four hypertension phenotypes with carotid‐femoral pulse wave velocity (c‐f PWV), in untreated patients. PubMed and Cochrane Library were searched to identify studies comparing c‐f PWV levels between normotensives, sustained hypertensives, white‐coat hypertensives (WCH), and masked hypertensives (MH). Meta‐analysis was performed to compare the difference c‐f PWV levels between these groups. Newcastle‐Ottawa quality assessment scale for cross‐sectional studies was used to assess study quality. MH and WCH patients had significantly increased c‐f PWV values compared to the normotensive groups (d = 0.96 m/s, 95% CI: 0.49‐1.42; I2 = 85%, P < .01 for MH and d = 0.85 m/s, 95% CI: 0.48‐1.22; I2 = 89%, for WCH). Moreover, the sustained hypertensive population was found to have significantly increased values of c‐f PWV compared to MH (d = −0.70 m/s, 95% CI: −0.87 to −0.54; I2 = 12%, P = .33) but not compared to WCH population (d = −0.75 m/s, 95% CI: −1.52‐0.02; I ² = 96%,). Finally, there was no significant difference between MH and WCH population (d = 0.06 m/s, 95% CI: −1.04 to 1.15; I ² = 96%,). MH and WCH population may have increased values of c‐f PWV compared to the normotensive group. These results demonstrate that these phenotypes are not clinically innocent, in the untreated population.     

Effectiveness and safety of NER1006 versus standard bowel preparations: A meta-analysis of randomized phase-3 clinical trials

BackgroundA 1 L PEG-based preparation for colonoscopy (NER1006) has been recently developed.AimsWe conducted a meta-analysis of randomized controlled trials (RCTs) to explore the effectiveness and safety of NER1006 versus traditional preparations.MethodsPubMed/Medline and Embase were systematically searched through January 2020 for phase-3 RCTs comparing NER1006 versus standard preparations.ResultsThree RCTs (1879 participants) met the inclusion criteria and were included. The analysis showed a higher cleansing success for NER1006 compared standard preparations (OR=1.28; 95% CI 1.00–1.62; p = 0.047, I²=0%) as well as a greater high-quality cleansing of the right colon (OR=2.13; 95% CI 1.16–3.94; p = 0.015, I²=76.0%) when assessed by the Harefield Cleansing Scale (HCS).The pooled estimate of the NER1006 effect on ADR showed a higher, although not significant, ADR of the right colon (OR=1.19; 95% CI 0.73–1.92; p = 0.485, I²=53%). When considering the impact of NER1006 on mild to moderate treatment-emergent adverse events (TEAEs), we observed a significant pooled estimate of TEAEs (OR=2.31; 95% CI 1.82–2.94; p<0.001, I²=0%).ConclusionsWhen compared to traditional preparations, NER1006 showed a better overall cleansing of the colon as well as a greater high-quality cleansing of the right colon, with comparable ADR. A higher incidence of mild to moderate TEAEs was observed for NER1006, in the absence of serious adverse events.     

Effect of dietary sodium restriction on blood pressure in type 2 diabetes: A meta-analysis of randomized controlled trials

AimsAlthough current guidelines recommend reduction of salt intake in patients with diabetes, the benefits of reducing salt intake in people with type 2 diabetes mellitus (T2DM) lack clear evidence. Therefore, we performed a meta-analysis of available randomized controlled trials (RCTs) of sodium restriction and blood pressure (BP) in patients with T2DM.Data synthesisWe performed a systematic search of the online databases that evaluated the effect of dietary sodium restriction on BP in patients with T2DM. Sodium intake was expressed by 24 h urinary sodium excretion (UNaV). Q statistics and I² were used to explore between-study heterogeneity. A random-effects model was used in the presence of significant heterogeneity; otherwise, a fixed-effects model was applied. Eight RCTs with 10 trials (7 cross-over and 3 parallel designs) were included in the meta-analysis. Compared with ordinary sodium intake, dietary sodium restriction significantly decreased UNaV (weighted mean difference, WMD: ?38.430 mmol/24 h; 95% CI: ?41.665 mmol/24 h to ?35.194 mmol/24 h). Sodium restriction significantly lowered systolic BP (WMD: ?5.574 mm Hg; 95% CI: ?8.314 to ?2.834 mm Hg; I² = 0.0%) and diastolic BP (WMD: ?1.675 mm Hg; 95% CI: ?3.199 to ?0.150 mm Hg; I² = 0.0%) with low heterogeneity among the studies. No publication bias was found from Begg's and Egger's tests.ConclusionsSodium restriction significantly reduces SBP and DBP in patients with T2DM.     

Non‐vitamin K oral anticoagulants versus vitamin K antagonists in post transcatheter aortic valve replacement patients with clinical indication for oral anticoagulation: A meta‐analysis

BackgroundCurrent guidelines recommend oral anticoagulation (OAC) following transcatheter aortic valve replacement (TAVR) in patients with clinical indication, but the optimal antithrombotic regimen remains uncertain. We aimed to compare the efficacy and safety of non‐vitamin K oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in patients undergoing TAVR with concomitant indication of OAC.HypothesisComparing with VKAs therapy, NOACs are similar in reducing the all‐cause mortality and major bleeding in post‐TAVR patients requiring OAC medication.MethodsWe searched the databases of PubMed, Embase, and Cochrane library databases to identify studies that investigated NOACs versus VKAs after TAVR in patients with another indication of OAC, which were published before 28th September 28, 2021. The effectiveness of outcomes was all‐cause mortality and stroke or systemic embolism, while the main safety outcome was major and/or life‐threatening bleeding. The hazard ratio (HR) with 95% confidence interval (CI) was used as a measure of treatment effect.ResultsOur search identified eight studies. We included 4947 post‐TAVR patients with another indication of OAC allocated to the NOAC (n = 2146) or VKA groups (n = 2801). There were no significant differences in the all‐cause mortality (HR: 0.91, 95% CI: 0.77–1.08, p = .29, I ² = 47%), stroke or systemic embolism (HR: 0.96, 95% CI: 0.68–1.37, p = .84, I ² = 0%), and major and/or life‐threatening bleeding (HR: 1.09, 95% CI: 0.89–1.32, p = .40, I ² = 30%) in both groups.ConclusionAmong post‐TAVR patients who required OAC therapy, NOACs therapy compared to VKAs is similar in reducing the all‐cause mortality, stroke or systemic embolism, and major and/or life‐threatening bleeding events.     

Impact of phytosterol supplementation on plasma lipoprotein(a) and free fatty acid (FFA) concentrations: A systematic review and meta-analysis of randomized controlled trials

Background and aimAlthough some earlier studies have indicated the effect of phytosterol (PS) supplementation on serum lipoprotein(a) (Lp(a)) and free fatty acid (FFA) concentration, findings are still conflicting. We aimed to assess the impact of PS supplementation on serum Lp(a) and FFA concentration through a systematic review and meta-analysis of available RCTs.Methods and resultsWe performed a systematic search of all available RCTs conducted up to 21 February 2019 in the following databases: PubMed, Scopus, and Cochrane. The choice of fixed- or random-effect model for analysis was determined according to the I² statistic. Effect sizes were expressed as weighted mean difference (WMD) and 95% confidence interval (CI). Pooling of 12 effect sizes from seven articles revealed a significant reduction of Lp(a) levels following PS supplementation (MD: ?0.025 mg/dl, 95% CI: ?0.045, ?0.004, p = 0.017) without significant heterogeneity among the studies (I² = 0.0%, p = 0.599). Also, PS supplementation significantly lowered FFA (MD: ?0.138 mg/dl, 95% CI: ?0.195, ?0.081, p = 0.000) without significant heterogeneity among the studies (I² = 0.0%, p = 0.911). The results for meta-regression and sensitivity analysis were not significant.ConclusionThe meta-analysis suggests that oral PS supplementation could cause a significant reduction in serum Lp(a) and FFA.     

Thermoregulation and fluid balance during a 30-km march in 60- versus 80-year-old subjects

The presence of impaired thermoregulatory and fluid balance responses to exercise in older individuals is well established. To improve our understanding on thermoregulation and fluid balance during exercise in older individuals, we compared thermoregulatory and fluid balance responses between sexagenarians and octogenarians during prolonged exercise. Forty sexagenarians (60 ± 1 year) and 36 octogenarians (81 ± 2 year) volunteered to participate in a 30-km march at a self-selected pace. Intestinal temperature (T_in) and heart rate were recorded every 5 km. Subjects reported fluid intake, while urine output was measured and sweat rate was calculated. Octogenarians demonstrated a lower baseline T_in and a larger exercise-induced increase in T_in compared to sexagenarians (1.2 ± 0.5 °C versus 0.7 ± 0.4 °C, p < 0.01), while maximum T_in tended to be higher in octogenarians (38.4 ± 0.4 °C versus 38.2 ± 0.3 °C, p = 0.09). Exercise intensity (70 ± 11 % versus 70 ± 9 %) and exercise duration (7 h 45 min ± 0 h 57 min versus 7 h 24 min ± 0 h 58 min) were not different between octogenarians and sexagenarians. Octogenarians demonstrated lower fluid intake (251 ± 97 mL/h versus 325 ± 125 mL/h, p = 0.01) and urine output (28 ± 22 mL/h versus 52 ± 40 mL/h, p < 0.01) compared to sexagenarians. Furthermore, the sweat rate tended to be lower (294 ± 150 mL/h versus 364 ± 148 mL/h, p = 0.07) in the octogenarian group. Sodium levels and plasma volume changes were not different between sexagenarians and octogenarians (all p > 0.05). These results suggest that thermoregulatory responses deteriorate with advancing age, while fluid balance is regulated appropriately during a 30-km walking march under moderate ambient conditions.     

Peripheral artery disease and clinical outcomes in patients with atrial fibrillation: A systematic review and meta‐analysis

BackgroundAtrial fibrillation (AF) is the most common cardiac rhythm disturbance and leads to morbidity and mortality. Peripheral artery disease (PAD) is associated with atherosclerotic risk factors and always classified as a vascular disease and deemed to be a bad complication of AF. In patients with AF, the risk and prognostic value of PAD have not been estimated comprehensively.HypothesisPAD is associated with all‐cause mortality, cardiovascular (CV) mortality, and other outcomes in patients with AF.MethodsWe searched PubMed, Embase, and Cochrane Library databases for prospective studies published before April 2021 that provided outcomes data on PAD in confirmed patients with AF. Heterogeneity was estimated using the I ² statistic. The fixed‐effects model was used for low to moderate heterogeneity studies, and the random‐effects model was used for high heterogeneity studies.ResultsEight prospective studies (Newcastle‐Ottawa score range, 7–8) with 39 654 patients were enrolled. We found a significant association between PAD and all‐cause mortality (hazard ratio [HR], 1.42; 95% confidence interval [CI], 1.25–1.62; p < .001), CV mortality (HR, 1.64; 95% CI, 1.32–2.05; p < .001) and MACE (HR, 1.75; 95% CI, 1.38–2.22; p < .001) in patients with AF. No significant relationship was found in major bleeding (HR, 1.22; 95% CI, 0.95–1.57; p = 0.118), myocardial infarction (MI) (HR, 2.07; 95% CI, 1.17–3.67; p = .038), and stroke (HR, 1.14; 95% CI, 0.87–1.50, p = 0.351).ConclusionsPAD is associated with an increased risk of all‐cause mortality, CV mortality, and MACE in patients with AF. However, no significant association was found with major bleeding, MI, and stroke.