Efficacy and Safety of a Polytetrafluoroethylene Membrane Wrapped a Single Layer of Sirolimus-Eluting Stent in a Porcine Coronary Perforation Model.

Background: Covered stents are effective in treating coronary artery perforation (CAP), however, the high rate of immediate device deployment failure and in-stent restenosis have limited the application of the currently covered stents. Methods: We designed a covered stent system consisting of a single layer of drug-eluting stent and a layer of polytetrafluoroethylene (PTFE) membrane wrapped at the outer layer of the stent. The immediate sealing effect of our novel covered stent was observed by using an Ellis type III CAP model. The device's success was defined as its ability to seal the perforation, assessed by visual estimation and final thrombolysis in myocardial infarction (TIMI) 3 flow. The antiproliferative effect was evaluated in 12 swine, which were randomly assigned to treatment (sirolimus-eluting covered stents) and control (bare metal covered stents) groups. Coronary angiography and optical coherence tomography (OCT) were performed at index procedure, 1- and 6-month after stent implantation. All swine were sacrificed for histopathological analyses at 6-month. Results: The device success rate was 100%. All swine were alive at 6-month follow-up. At 1-month, the treatment group had a larger minimal luminal diameter (MLD) (1.89 ± 0.29 mm vs. 0.63 ± 0.65 mm, p = 0.004) and lower late luminal loss (LLL) (0.47 ± 0.15 mm vs. 1.80 ± 0.34 mm, p < 0.001) compared with control group. At 6-month, the treatment group had a numerically higher MLD (0.94 ± 0.75 mm vs. 0.26 ± 0.46 mm; p = 0.230) and lower LLL (1.43 ± 0.85 mm vs. 2.17 ± 0.28 mm; p = 0.215) compared with control group. Histological analyses revealed the mean plaque area was lower in the treatment group (2.99 ± 0.81 mm 2 vs. 4.29 ± 0.77 mm 2 , p = 0.035) than in the control group. No in-stent thrombosis was observed in either group. Conclusions: In the porcine model of coronary perforation, the PTFE membrane wrapped sirolimus-eluting stent showed a high device success rate in sealing the perforation. The drug-eluting covered stent demonstrated a relatively sustained antiproliferative effect up to 6 months post-implantation.

[Changed accumulation of active ingredient in different localities and growth period of Hemsleya zhejiangensis (Cucurbitaceae)].

In this paper, the content of moisture, ethanol-soluble extractives, total saponins and polysaccharide of different tuber samples of Hemsleya zhejiangensis, from different localities, years and seasons, were detected based upon Chinese Pharmacopoeia 2010 version. The samples of roots, stems and leaves in summer were detected as well. The results are mainly as follows. (1)With tuber quality increasing, the content of total saponins increased and then decreased. The individual quality of tubers getting 594.06 g, the content of total saponins reached the peak. (2) The content of active ingredients in different localities was significantly different, and the population of Wuyanling had the maximum content of total saponins and polysaccharide. (3) The content of active ingredients revealed stability between the years 2012 and 2013, but the content of polysaccharide was significantly different. The content in 2012 was higher than that of 2013. (4) The content of active ingredients reached the peak in autumn, which was the best harvest season. (5) Among different component content detection of nutritional organs, tubers had the maximum content of ethanol-soluble extractives, total saponins and polysaccharide. Leaves also contained higher content of ethanol-soluble extractives and total saponins than roots and stems. All of these provide theoretical basis for plant, harvest and production of H. zhejiangensis, which is an endemic, rare, and endangered medicinal plants.

A novel biodegradable polymer-coated sirolimus-eluting stent: 1-year results of the HELIOS registry.

BACKGROUND: The HELIOS stent is a sirolimus-eluting stent with a biodegradable polymer and titanium oxide film as the tie-layer. The study aimed to evaluate the safety and efficacy of HELIOS stent in a real-world setting. METHODS: The HELIOS registry is a prospective, multicenter, cohort study conducted at 38 centers across China between November 2018 and December 2019. A total of 3060 consecutive patients were enrolled after application of minimal inclusion and exclusion criteria. The primary endpoint was target lesion failure (TLF), defined as a composite of cardiac death, non-fatal target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 1-year follow-up. Kaplan-Meier methods were used to estimate the cumulative incidence of clinical events and construct survival curves. RESULTS: A total of 2998 (98.0%) patients completed the 1-year follow-up. The 1-year incidence of TLF was 3.10% (94/2998, 95% closed interval: 2.54-3.78%). The rates of cardiac death, non-fatal target vessel MI and clinically indicated TLR were 2.33% (70/2998), 0.20% (6/2998), and 0.70% (21/2998), respectively. The rate of stent thrombosis was 0.33% (10/2998). Age ≥60 years, diabetes mellitus, family history of coronary artery disease, acute myocardial infarction at admission, and device success were independent predictors of TLF at 1 year. CONCLUSION: The 1-year incidence rates of TLF and stent thrombosis were 3.10% and 0.33%, respectively, in patients treated with HELIOS stents. Our results provide clinical evidence for interventional cardiologists and policymakers to evaluate HELIOS stent. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03916432.

Influence of Different Segmentations on the Diagnostic Performance of Pericoronary Adipose Tissue.

Objective: To investigate the influence of different segmentations on the diagnostic performance of pericoronary adipose tissue (PCAT) CT attenuation and radiomics features for the prediction of ischemic coronary artery stenosis. Methods: From June 2016 to December 2018, 108 patients with 135 vessels were retrospectively analyzed in the present study. Vessel-based PCAT was segmented along the 40 mm-long proximal segments of three major epicardial coronary arteries, while lesion-based PCAT was defined around coronary lesions. CT attenuation and radiomics features derived from two segmentations were calculated and extracted. The diagnostic performance of PCAT CT attenuation or radiomics models in predicting ischemic coronary stenosis were also compared between vessel-based and lesion-based segmentations. Results: The mean PCAT CT attenuation was -75.7 ± 9.1 HU and -76.1 ± 8.1 HU (p = 0.395) for lesion-based and vessel-based segmentations, respectively. A strong correlation was found between vessel-based and lesion-based PCAT CT attenuation for all cohort and subgroup analyses (all p < 0.01). A good agreement for all cohort and subgroup analyses was also detected between two segmentations. The diagnostic performance was comparable between vessel-based and lesion based PCAT CT attenuation in predicting ischemic stenosis. The radiomics features of PCAT based on vessel or lesion segmentation can both adequately identify the ischemic stenosis. However, no significant difference was detected between the two segmentations. Conclusions: The quantitative evaluation of PCAT can be reliably measured both from vessel-based and lesion-based segmentation. Furthermore, the radiomics analysis of PCAT may potentially help predict hemodynamically significant coronary artery stenosis.

A Randomized Comparison of the Healing Response Between the Firehawk Stent and the Xience Stent in Patients With ST-Segment Elevation Myocardial Infarction at 6 Months of Follow-Up (TARGET STEMI OCT China Trial): An Optical Coherence Tomography Study.

Background: The healing response of the Firehawk stent in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear. Aim: We compared the vascular healing of a biodegradable polymer sirolimus-eluting stent (Firehawk) vs. a durable polymer everolimus-eluting stent (Xience) at 6 months after percutaneous coronary intervention (PCI) in patients with STEMI. Methods: In this prospective, multicenter, randomized, non-inferiority study, patients within 12 h of STEMI onset were randomized in a ratio of 1:1 to receive Firehawk or Xience stents. Optical coherence tomography (OCT) follow-up was performed 6 months after the index procedure and assessed frame by frame. The primary endpoint was the neointimal thickness (NIT) at 6 months evaluated by OCT. The safety endpoint was target lesion failure (TLF) at 12 months. Results: The Firehawk stent was non-inferior to the Xience stent in terms of the neointimal thickness (73.03 ± 33.30 µm vs. 78.96 ± 33.29 µm; absolute difference: -5.94 [one-sided 95% lower confidence bound: -23.09]; P non-inferiority < 0.001). No significant difference was observed between the Firehawk and Xience groups regarding the percentage of uncovered struts (0.55 [0.08, 1.32]% vs. 0.40 [0.21, 1.19]%, P = 0.804), the percentage of malapposed struts (0.17 [0.00, 1.52]% vs. 0.17 [0.00, 0.69]%, P = 0.662), and the healing score (1.56 [0.23, 5.74] vs. 2.12 [0.91, 3.81], P = 0.647). At 12 months, one patient in the Firehawk group experienced a clinically indicated target lesion revascularization. No other TLF events occurred in both groups. Independent risk factors of the NIT included body mass index, hyperlipidemia, B2/C lesions, thrombus G3-G5, thrombus aspiration, and postdilation pressure. Conclusion: In patients with STEMI, Firehawk was non-inferior to Xience in vascular healing at 6 months. Both stents exhibited nearly complete strut coverage, moderate neointimal formation, and minimal strut malapposition. Clinical Trial Number: NCT04150016.

Left main bronchus as a guide for individualized transseptal puncture using a conventional fluoroscopic approach in cryoballoon ablation of atrial fibrillation.

OBJECTIVE: Although imaging modalities, such as transesophageal and intracardiac echocardiography, have helped to improve the safety of atrial transseptal puncture (TSP), fluoroscopy is still traditionally and widely used in TSP. The aim of the present study was to evaluate an individual knack for TSP during cryoballoon ablation of atrial fibrillation (AF) under fluoroscopy. METHODS: Through the prospective study of 72 cases of patients with paroxysmal or persistent AF admitted for cryoablation in our center, 46 cases using a puncture site toward the bifurcation of the left main bronchus (LMB group) and 26 cases using an anterior-inferior puncture site (AI group) were included in the study. The acute pulmonary vein (PV) isolation success rate, single-procedure success rate, and time-to-effect (TTE) between the two groups were analyzed. RESULTS: All PVs were identified and successfully isolated, and there are no differences in the two groups. However, the mean TTE was shorter in the LMB group than in the AI group. Moreover, a higher single-procedure success rate was observed in the LMB group. CONCLUSION: The bifurcation of the LMB can be clearly evaluated in each patient under fluoroscopy and is an anatomical landmark for the location of the left PV. TSP guided by the LMB is a new practical method for choosing individualized transseptal sites for catheter ablation of AF, which can help to shorten TTE and procedure time.