Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study.

BACKGROUND: Diabetes mellitus is an independent predictor of adverse clinical events after drug-eluting stent implantation. OBJECTIVES: The objective of this study is to evaluate the long-term clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in diabetic versus non-diabetic patients. METHODS: A total of 2077 "all comers," including 440 (21.2%) diabetic patients and 1637 (78.8%) non-diabetic patients, were prospectively enrolled in the CREATE study at 59 centers in four countries. The recommended antiplatelet regimen was clopidogrel and aspirin for 6 months followed by chronic aspirin therapy. The primary outcome was the rate of major adverse cardiac events (MACE), defined as a composite of cardiac death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR). RESULTS: Diabetic patients had higher risks of all-cause death (8.2% vs. 3.4%, P < 0.001) and cardiac death (4.1% vs. 1.4%, P < 0.001) compared with non-diabetic patients at 4 years. The rates of non-fatal MI (0.2% vs. 0.9%, P = 0.218), TLR (2.0% vs. 2.8%, P = 0.357), MACE (5.9% vs. 4.4%, P = 0.227), and overall stent thrombosis (1.6% vs. 1.6%, P = 0.932) were not significantly different between diabetic and non-diabetic patients. A landmark analysis showed that prolonged clopidogrel therapy (>6 months) was not beneficial in reducing the cumulative hazards of MACE either in diabetic or non-diabetic patients (log rank P = 0.810). CONCLUSIONS: Biodegradable polymer-based sirolimus-eluting stents for the treatment of diabetic patients had a similar clinical event rate at 4 years compared with non-diabetic patients, except for a higher mortality rate.

Transvenous left bundle branch pacing during cardiac surgery: A case report.

Left bundle branch pacing (LBBP) was a promising physiological pacing method, which could prevent or treat heart failure. We reported a young woman with severe valvular disease and heart failure receiving LBBP under direct vision and without x-ray assistance during cardiac surgery. To the best of our knowledge, this was the first case report of this type of pace maker implantation.

His-Purkinje system pacing reduced tricuspid regurgitation in patients with persistent atrial fibrillation after left-sided valve surgery.

Background & objective: Tricuspid regurgitation after left-sided valve surgery was a common and difficult problem. Atrial fibrillation was considered to be an important etiology of tricuspid regurgitation. His-Purkinje system pacing (HPSP) was a physiological pacing method, which could prevent and treat heart failure and might reduce tricuspid regurgitation. Our study aimed to investigate the effect of HPSP on tricuspid regurgitation in patients with persistent atrial fibrillation after left-sided valve surgery. Methods: This study was a retrospective study. The 3-year patient review focused on those who underwent permanent cardiac pacemaker implantation of HPSP after mitral valve and/or aortic valve replacement from Jan 1st, 2019 to Jan 1st, 2022. HPSP included His bundle pacing (HBP) or left bundle branch pacing (LBBP). Clinical data collected included electrocardiogram, pacing parameters, ultrasonic cardiogram parameters and chest x-ray at implantation and 3-month follow up. Univariate and multivariate linear regression analysis of tricuspid regurgitation velocity were performed. Results: A total of 44 patients was retrospectively reviewed. Eight patients who had undergone implantation of HPSP after left-sided heart valve replacement were enrolled in the study. All patients had persistent atrial fibrillation. Three of them received HBP and five underwent LBBP. At 3-month follow-up, the tricuspid regurgitation grade was significantly lower than that before implantation (P = 0.007). The tricuspid regurgitation velocity significantly decreased (317 ± 74 cm/s vs. 261 ± 52 cm/s, P = 0.022) and tricuspid valve pressure gradient (PG) reduced (42 ± 21 mmHg vs. 28 ± 10 mmHg, P = 0.040). The cardiothoracic ratio of patients was significantly lower than that before implantation (0.61 ± 0.08 vs. 0.64 ± 0.09, P = 0.017). The NYHA classification of patients also improved (P = 0.013). In multivariate liner regression analysis, the pacing ratio (ß = 0.736, P = 0.037) was an independent determinant of tricuspid regurgitation velocity variation. Conclusion: HPSP might reduce tricuspid regurgitation and improve cardiac function in patients with persistent atrial fibrillation after left-sided valve surgery.

Accuracy of non-gated low-dose non-contrast chest CT with tin filtration for coronary artery calcium scoring.

Objective: The study investigated the accuracy of coronary artery calcium scores (CACS) and the potential for reducing radiation dose using non-gated low-dose non-contrast chest computed tomography (CT) scanning with tin filtration for one-stop screening of the lungs and heart. Methods: A prospective study was conducted,193 Patients received two scans for determining CACS, including an ECG-gated CT at 120 kV (ECG-gated CT), followed by a non-gated low-dose chest CT using 100 kV with tin filtration (non-gated Sn100 kV-LDCT). The Agatston score (AS), risk stratification, and radiation dose were compared between the scan types. Results: There was good consistency in the AS from both an ECG-gated CT and a non-gated low-dose chest CT scan, which had a high correlation (r = 0.970). The Kappa value of risk stratification of the two scan types was 0.549. The area under the ROC curve (AUC) of the CACS was used to develop a new risk stratification standard for non-gated Sn100 kV-LDCT evaluation of CACS. In comparison to the CACS measured by ECG-gated CT, non-gated Sn100 kV-LDCT had an AUC of 0.951 and an optimal critical value of 4.6 in the low-risk category. The AUC of low-medium risk was 0.966, and the optimal critical value was 41.2. The AUC of the medium-high risk category was 0.968, and the optimal critical value was 230. The consistency in CACS measured by ECG-gated CT and non-gated Sn100 kV-LDCT had a Kappa value of 0.831. The Effective dose (ED) of non-gated Sn100 kV-LDCT and ECG-gated CT was 0.056 ± 0.017 mSv and 0.685 ± 0.455 mSv, respectively (p < 0.05). Conclusion: The Agatston score of CACS using non-gated low-dose chest CT was accurate, but there was an underestimation in risk stratification. This study developed a new risk stratification standard for non-gated Sn100 kV-LDCT evaluation of CACS, which is in closer agreement with CACS derived from ECG-gated CT scans.

Effect of angiotensin receptor-neprilysin inhibitor on atrial electrical instability in atrial fibrillation.

Background and objective: Around 33.5 million patients suffered from atrial fibrillation (AF), causing complications and increasing mortality and disability rate. Upstream treatment for AF is getting more popular in clinical practice in recent years. The angiotensin receptor-neprilysin inhibitor (ARNI) is one of the potential treatment options. Our study aimed to investigate the effect of ARNI on atrial electrical instability and structural remodeling in AF. Methods: Our research consisted of two parts - a retrospective real-world clinical study and an animal experiment on calmness to verify the retrospective founding. In the retrospective study, we reviewed all patients (n = 110) who had undergone the first AF ablation from 1 August 2018 to 1 March 2022. Patients with ARNI (n = 36) or angiotensin II receptor antagonist (ARB) (n = 35) treatment were enrolled. Their clinical data, ultrasound cardiogram (UCG) and Holter parameters were collected before radiofrequency catheter ablation (RFCA) as baseline and at 24-week follow-up. Univariate and multivariate logistic regression analysis were performed. In the animal experiment, we established an AF model (n = 18) on canines by rapid atrial pacing. After the successful procedure of pacing, all the 15 alive beagles were equally and randomly assigned to three groups (n = 5 each): Control group, ARB group, and ARNI group. UCG was performed before the pacing as baseline. Physiological biopsy, UCG, and electrophysiological study (EPS) were performed at 8-week. Results: Clinical data showed that the atrial arrhythmia rate at 24-week was significantly lower in ARNI group compared to ARB group (P < 0.01), and ARNI was independently associated with a lower atrial arrhythmia rate (P < 0.05) at 24-week in multivariate regression logistic analysis. In the animal experiment, ARNI group had a higher atrial electrical stability score and a shorter AF duration in the EPS compared to Control and ARB group (P < 0.05). In the left atrium voltage mapping, ARNI group showed less low voltage and disordered zone compared to Control and ARB group. Compared to Control group, right atrium diameter (RAD), left ventricle end-diastolic volume index (LVEDVI), E/A, and E/E' were lower in ARNI group (P < 0.05) at the 8-weeks follow-up, while left atrium ejection fraction (LAEF) and left ventricle ejection fraction (LVEF) were higher (P < 0.01). Compared to ARB group, LVEF was higher in ARNI group at the 8-week follow-up (P < 0.05). ARB and ARNI group had a lower ratio of fibrotic lesions in the left atrium tissues compared to Control group (P < 0.01), but no difference was found between the ARB and the ARNI group. Conclusion: ARNI could reduce atrial electrical instability in AF in comparison with ARB in both retrospective study and animal experiment.

Follicular thyroid carcinoma presenting with multiple skull metastases on CT and MRI: A case report and literature review.

Although the incidence of thyroid carcinoma has increased in recent years, follicular thyroid carcinoma with bone metastasis as the first symptom remains rare. Here, we report a case of occult follicular thyroid carcinoma in a 65-year-old female patient admitted to hospital with cerebrovascular disease. Computed tomography findings suggested a diagnosis of meningioma; however, magnetic resonance imaging results showed multiple skull bone destruction with soft tissue masses on the left side of the skull. After surgical resection, the pathology results revealed skull metastasis of follicular thyroid carcinoma. We present this case not only because of the diagnostic challenge it posed, but also because the patient had multiple skull metastases from follicular thyroid carcinoma.

Purification, characterization and anti-tumor activity of a pectic-type polysaccharide isolated from Ficus pandurata H.

A homogeneous polysaccharide (FP2) with 83.3 kDa molecular weight was obtained from the aerial parts of Ficus pandurata H. (Moraceae) by Sevag, anion-exchange chromatography and gel-filtration chromatography. On the basis of composition analysis, infrared spectra (IR) and nuclear magnetic resonance (NMR) experiments, FP2 is a linear pectin with a main chain composed of →4)-α-D-GalpA-(1→. We investigated the anti-proliferative activity and its underlying mechanism of FP2 in HeLa cancer cells, using MTT assay and western blot analysis, respectively. Treatment with FP2 in HeLa cancer cells showed anti-proliferation effect and up-regulated the expression levels of caspase-3 and cleaved-PARP. IC50 values were 31.50 and 22.62 µg/ml for 24 h and 48 h, respectively. FP2 has potential of antitumor possibly due to apoptosis induction mediated through caspase-3 activation and cleavage of PARP. The results suggest that FP2 may be a promising plant polysaccharide targeting for anticancer therapy through activating the apoptotic pathway.

Innovated formulation of TCM pangolin scales to develop a nova therapy of rheumatoid arthritis.

Pangolin scale (PS) is a traditional Chinese medicine (TCM) for treating rheumatic arthritis (RA), and diverse medicinal formulations and therapeutic properties of PS have proved great potential to supplement conventional treatments in integrative medicine-based strategies. However, few studies have investigated how different PS formulations can impact the management of RA. Herein, we developed an innovative formulation of PS processed with vinegar (PSP) and evaluated it by comparing with the traditional decoction of PS (PSD) and non-steroidal anti-inflammatory drug (NASID) (i.e., meloxicam) in a RA Sprague Dawley rat model, which is induced with a complete Freund's adjuvant (CFA). The anti-inflammatory activities were evaluated by paw edema measurement, arthritic score, histopathological examination, pro-inflammatory cytokines (IL-1ß and TNF-α) production and the whole blood viscosity. PSP treatments (249.0 mg/kg.bw) from day 14-42 alleviated paw edema (P < 0.001), arthritic index (score 0-1.5) and the inflammatory cell infiltration in the ankle joint, which may be attributed to inhibiting the production of TNF-α (P < 0.01) and IL-1ß (P < 0.05) in the serum. Although PSP is with fewer efficacies than meloxicam, it outperformed traditional formulation PSD (830 mg/kg.bw) in all above mentioned metrics. Furthermore, PSP exhibited a unique effect on reducing whole blood viscosity (P < 0.05) unobserved in meloxicam intervention. The present study demonstrates that PSP showed more efficient anti-inflammatory activity than PSD in CFA-induced RA rats, possibly due to the presence of higher levels of active ingredients. Thus, PSP may be a promising therapy for anti-inflammation in RA and can be integrated with conventional treatments, particularly for long-term RA management in an integrative treatment strategy.

Serum potassium levels and mortality of patients with acute myocardial infarction: A systematic review and meta-analysis of cohort studies.

BACKGROUND: The evidence of current epidemiological studies investigating the association between serum potassium levels and mortality of acute myocardial infarction (AMI) patients is controversial and inadequate. DESIGN: Systematic review and meta-analysis. METHODS: Two researchers independently searched the PubMed, EMBASE and Web of Science databases to identify observational studies published prior to 31 October 2017. Similarly, two researchers separately extracted data and any differences were resolved by discussion. Pooled relative risks and 95% confidence intervals (CIs) were computed with an inverse variance-weighted random-effects model. Heterogeneity among studies was assessed with the I2 statistic. RESULTS: Seven cohort studies were included for analysis. Compared with the reference group (3.5 to <4.0 mEq/L), the pooled relative risks of mortality were 1.15 (95% CI = 1.00-1.32), 1.09 (95% CI = 0.97-1.24), 1.42 (95% CI = 1.19-1.70) and 1.85 (95% CI = 1.39-2.47) for AMI patients with a potassium level of<3.5, 4.0 to <4.5, 4.5 to <5.0, and ≥5.0 mEq/L, respectively. For admission and post-admission potassium, although J-shaped associations were also indicated, non-significant results were observed for AMI patients with potassium levels of <3.5 mEq/L when compared with the reference group. Notably, in subgroup analyses of study characteristics, stratified by study quality, geographic location, type of outcome, number of cases, type of AMI, and adjustment for potential confounders, the findings were broadly consistent across strata. CONCLUSIONS: These findings indicate that both lower (<3.5 mEq/L) and higher (≥4.5 mEq/L) serum potassium levels are associated with an increased risk of mortality of patients with AMI.

Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents.

BACKGROUND: The residual drug carriers on drug-eluting stents (DES) surfaces are considered to be one of the most significant reasons causing late thrombosis. There is no documented data currently available on the safety/benefit profile beyond 6 months of EXCEL stent, a novel sirolimus-eluting stent with biodegradable polymer coating, in treating patients with coronary artery disease (CHD). OBJECTIVE: To evaluate the long-term efficacy and safety of EXCEL stent on treating CHD patients. METHODS: Between February and March 2006, a consecutive cohort of complex patients treated with the EXCEL stent was prospectively enrolled in this single-center registry. Antiplatelet protocol was 6-month dual antiplatelet therapy with clopidogrel and aspirin followed by aspirin alone indefinitely. The primary outcome was major adverse cardiac events (MACE) at 12 months. Secondary outcomes included in-segment and in-stent late lumen loss and binary restenosis rate measured by quantitative coronary angiography (QCA) analysis at 8 months postindex PCI procedure. RESULTS: A total of 100 patients with 153 lesions were included in this analysis. Most lesions (83.0%) were classified as complex (B2/C). At 12 months, four patients (4.0%) experienced MACE, which were four target-lesion revascularizations due to in-stent restenosis (ISR). All patients received follow-up up to 24 +/- 0.4 months and no cardiac death, MI, and in-stent thrombosis occurred during the 6 months of dual antiplatelet therapy or the subsequent 15 months of aspirin treatment alone. QCA analysis of 112 lesions from 75 patients showed 3.6% (4/112) in-stent lesion restenosis, 5.4% (6/112) in-segment lesion restenosis, 0.12 +/- 0.34 mm in-stent late lumen loss, and 0.08 +/- 0.35 mm in-segment late lumen loss. CONCLUSIONS: In this single-center experience with complex patients and lesions, the EXCEL stent implantation with 6-month dual antiplatelet treatment proved to markedly reduce the incidence of 24-month ISR and MACE. These preliminary findings require further validation by large scale, randomized trials.

Age-related reduction of adaptive brain response during semantic integration is associated with gray matter reduction.

While aging is associated with increased knowledge, it is also associated with decreased semantic integration. To investigate brain activation changes during semantic integration, a sample of forty-eight 25-75 year-old adults read sentences with high cloze (HC) and low cloze (LC) probability while functional magnetic resonance imaging was conducted. Significant age-related reduction of cloze effect (LC vs. HC) was found in several regions, especially the left middle frontal gyrus (MFG) and right inferior frontal gyrus (IFG), which play an important role in semantic integration. Moreover, when accounting for global gray matter volume reduction, the age-cloze correlation in the left MFG and right IFG was absent. The results suggest that brain structural atrophy may disrupt brain response in aging brains, which then show less brain engagement in semantic integration.

Phytochemical Compositions and Antioxidant and Anti-Inflammatory Activities of Crude Extracts from Ficus pandurata H. (Moraceae).

Background. Ficus pandurata H. (Moraceae) is widely used in traditional Chinese medicine as a healthy food condiment or a medicine for treatment of various diseases including inflammation. Objective. The purpose of the present study is to investigate the phytochemical compositions and antioxidant and anti-inflammatory activities of crude water (FPW) and ethanolic extracts (FPE) from Ficus pandurata H. Methods. Phytochemical compositions were identified by a high-performance liquid chromatography-electrospray ionization-mass spectrometry method (HPLC-ESI-MS). The antioxidant activities were evaluated by diphenylpicrylhydrazyl (DPPH) and hydroxyl radical assays, and the anti-inflammatory activities were evaluated by paw edema and levels of inflammatory mediator TNF- α and PGE2 in monosodium urate (MSU) crystal-induced rats. Results. Six compounds were identified by HPLC-MS method, and abundance of phenolics was found in FPE. The FPE showed concentration-dependent-significant scavenging of DPPH and hydroxyl radicals with IC50 values 118.4 and 192.9 µ g/mL, respectively. The FPE treatment significantly inhibited the paw edema and the production of TNF- α and PGE2 in MSU crystal-induced rats. Conclusion. The FPE exerted stronger antioxidant and anti-inflammatory activities which may be attributed to its high phenolic content.

Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes.

OBJECTIVES: This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice. BACKGROUND: It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events. METHODS: Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy. RESULTS: The average duration of clopidogrel treatment was 199.8 +/- 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 +/- 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment. CONCLUSIONS: This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578).