Explore the vast range of titles available.

Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products. The aim of the present preclinical trial was to investigate a novel DCB coated with 6 μg Ptx/mm2 in a porcine model. The current study investigated a DCB with a novel, modified iopromide based matrix with 6 μg Ptx/mm2. Drug transfer to the vessel wall of peripheral arteries was compared with a dose of 3 μg Ptx/mm2 and two fully overlapping DCB with 3 μg Ptx/mm2, each. Ptx concentration in the vessel wall after drug transfer was about twice as high for balloons with 6 μg/mm2 (1957±1472 μg/g) and two overlapping DCB with 3 μg Ptx/mm2, each (1287±619 μg/g) compared to a single balloon with 3 μg Ptx/mm2, (787±738 μg/g), with statistical significant differences for 1x6 μg/mm2 vs. 1x3 μg/mm2 (p = 0.017) but not for 2x3 μg/mm2 vs. 1x3 μg/mm2 (p = 0.184) and 1x6 μg/mm2 vs. 2x3 μg/mm2 (p = 0.178). The proportion of residual Ptx on balloon after treatment was similar for all groups between 6±1% and 10±3% of dose on balloon. The dose of 6 μg Ptx/mm2 was successfully as well as reproducibly coated on conventional balloon catheters. Increased Ptx on balloons resulted in increased drug concentration in the vessel wall. A single balloon with 6 μg Ptx/mm2 seems to provide double dose compared to 3 μg Ptx/mm2, facilitates the procedure, and may reduce medico-economic cost compared to the use of two standard DCB.

Long diseased vessel segments of peripheral arteries may display irregular shapes with different diameters. The aim of this study was to investigate inhibition of neointimal proliferation in porcine peripheral vessels with different diameters covered by one single hyper-compliant drug-coated balloon (HCDCB), compared to conventional drug-coated balloons (DCB), each selected according to the respective vessel diameter. Neointimal proliferation was stimulated in proximal and distal segments of the peripheral arteries by balloon overstretch and stent implantation. Inhibition of neointimal proliferation by one single HCDCB was compared to two vessel diameter-adjusted DCB per artery and to one single uncoated hyper-compliant balloon (HCB). Sixteen HCB, 16 HCDCB, and 32 DCB were used in 16 arteries each. Quantitative angiography (QA), optical coherence tomography (OCT) and histology showed a similar anti-restenotic effect for one HCDCB compared to two vessel diameter-adjusted DCB in narrow distal and wider proximal segments (QA diameter stenosis: 18.7±12.3% vs. 22.8±15.5%, p = 0.535; OCT area stenosis: 21.4±11.6% vs. 23.6±12.3%, p = 0.850; histomorphometry diameter stenosis: 27.5±7.1% vs. 26.9±8.0%, p = 0.952) and indicated significant inhibition of neointimal proliferation by HCDCB vs. uncoated HCB (QA diameter stenosis: 18.7±12.3% vs. 30.3±16.7%, p = 0.008; OCT area stenosis: 21.4±11.6% vs. 34.7±16.0%, p = 0.004; histomorphometry diameter stenosis: 27.5±7.1% vs. 32.5±8.5%, p = 0.038). HCDCB were found to be similar effective as DCB in inhibiting neointimal proliferation in vessel segments with different diameters. One single long HCDCB may allow for treatment of segments with variable diameters, and thus, replace the use of several vessel diameter-adjusted DCB.

In a randomized trial, 154 patients with femoropopliteal-artery disease who were undergoing angioplasty were assigned to treatment with a paclitaxel-coated angioplasty balloon, an uncoated balloon with paclitaxel dissolved in the contrast medium, or an uncoated balloon without paclitaxel (control treatment). Late lumen loss, restenosis at 6 months, and target-lesion revascularization at 6, 12, and 24 months were significantly reduced with the paclitaxel-coated balloon but not with paclitaxel-containing contrast medium. In patients with femoropopliteal-artery disease who were undergoing angioplasty, late lumen loss, restenosis at 6 months, and target-lesion revascularization at 6, 12, and 24 months were significantly reduced with a paclitaxel-coated balloon but not with paclitaxel-containing contrast medium. Percutaneous transluminal angioplasty for revascularization of the superficial femoral artery has an initial technical success rate of more than 95%. 1 However, restenosis occurs in 40 to 60% of the treated segments after 6 to 12 months 2 – 4 ; these rates are much higher than restenosis rates in other vascular beds, such as the coronary and renal arteries. 5 Stenting is more effective than balloon angioplasty for preventing restenosis in the coronary circulation, but a benefit of stenting in the vessels of the lower extremities remains to be confirmed. 6 – 9 Several other attempts to increase long-term patency in peripheral vascular disease have . . .

Background Mechanical thrombectomy has been shown to reduce thrombus burden and pulmonary artery pressure (PAP) and to improve right ventricular (RV) function in patients with high-risk or intermediate-high-risk pulmonary embolism (PE). As hemodynamic data after mechanical thrombectomy for PE are scarce, we aimed to assess the hemodynamic effects of mechanical thrombectomy in acute PE with right heart overload. Methods In this prospective, open-label study, patients with acute symptomatic, computed tomography-documented PE with signs of right heart overload underwent mechanical thrombectomy using the FlowTriever System. Right heart catheterization was performed immediately before and after thrombectomy and after three months. Transthoracic echocardiography was performed before thrombectomy, discharge, and at three months. This analysis was done after 20 patients completed three months of follow-up. Results Twenty-nine patients (34% female) underwent mechanical thrombectomy, of which 20 completed three months follow-up with right heart catheterization. Most patients were at high (17%) or intermediate-high (76%) risk and had bilateral PE (79%). Before thrombectomy, systolic PAP (sPAP) was severely elevated (mean 51.3 ± 11.6 mmHg). Mean sPAP dropped by -15.0 mmHg (95% confidence interval [CI]: -18.9 to -11.0; p < 0.001) immediately after the procedure and continued to decrease from post-thrombectomy to three months (-6.4 mmHg, 95% CI: -10-0 to -2.9; p = 0.002). RV/left ventricular (LV) ratio immediately reduced within two days by -0.37 (95% CI: -0.47 to -0.27; p < 0.001). The proportion of patients with a tricuspid annular plane systolic excursion (TAPSE)/sPAP ratio < 0.31 mm/mmHg decreased from 28% at baseline to 0% before discharge and at three months (p = 0.007). There were no procedure-related major adverse events. Conclusions Mechanical thrombectomy for acute PE was safe and immediately reduced PAP and improved right heart function. The reduction in PAP was maintained at three months follow-up.

BackgroundAtrial fibrillation (AF) represents a frequent complication in patients after interventional closure of patent foramen ovale (PFO). We aimed to compare the incident rate and risk of AF between Amplatzer PFO and GORE (Helex and CARDIOFORM Septal Occluder) device by analyzing the data from randomized trials.MethodsWe included all randomized studies which reported the rate of AF after PFO closure using Amplatzer or GORE occluder in patients suffering cryptogenic stroke and compared the risk of AF between the two devices. PubMed and Cochrane library were searched for eligible studies published until July 2020.ResultsRate of all cases of incident AF from randomized trials with Amplatzer in the interventional group was 3.93% (30/763) vs. 1.46% (11/751) in the respective medical group (RR of 2.57, 95% CI 1.31–5.03, p = 0.006). The incidence of incident AF from randomized trial with GORE device was 6.57% (29/441) vs. 0.44% (1/223) in the respective medical group (RR of 14.66, 95% CI 2.01–106.95, p = 0.008). The p for interaction between the two devices regarding risk of AF was 0.10.ConclusionsThe results suggest lower risk expressed by lower rate of incident AF after PFO closure using Amplatzer PFO Occluder when compared with GORE Occluder. However, these findings are derived from secondary analyses and should be scrutinized using appropriate screening tool for AF following PFO closure in adequately powered randomized clinical trial with a head-to-head design that compares the two devices.

Objectives Data on side-branch (SB) ostial effect after drug-coated balloon (DCB) treatment in the context of de novo coronary bifurcation lesions are limited. We aimed to investigate the angiographic outcomes of SB ostium after DCB treatment compared with drug-eluting stents (DESs) implantation in the main vessel (MV) or optimal medical therapy (OMT) for the treatment of de novo coronary bifurcation lesions. Methods Serial angiographic changes in the SB ostium were compared between DCB, DES, and medication alone for MV treatment. Δ value was calculated by subtracting the follow-up value from the pre-procedure value. Results A total of 132 bifurcation lesions were included for analysis (44 lesions in DCB group; 38 lesions in DES group; 50 lesions in OMT group). The minimal lumen diameter (MLD) of SB ostium showed an increase at follow-up in the DCB group, whereas a decrease was observed in both the DES and OMT groups (ΔMLD: −0.16 ± 0.45 mm for DCB group vs. 0.50 ± 0.52 mm for DES group vs. 0.08 ± 0.38 mm for OMT group, p  < 0.001). The diameter stenosis (DS) of SB ostium showed a marked decrease at follow-up in the DCB group, in contrast to an increase observed in both the DES and OMT groups (ΔDS: 8.01 ± 18.96% for DCB group vs. −18.68 ± 18.60% for DES group vs. −2.05 ± 14.58% for OMT group, p  < 0.001). Conclusions In de novo coronary bifurcation lesions, DCB treatment on the MV demonstrated favorable angiographic outcomes in the SB ostium at 6–9 month follow-up compared to DES implantation or OMT.

Bioresorbable magnesium scaffolds are a promising future treatment option for coronary artery stenosis, especially for young adults. Due to the degradation of these scaffolds (<1 year), long-term device-related clinical events could be reduced compared to treatments with conventional drug eluting stents. First clinical trials indicate a return of vasomotion after one year, which may be associated with improved long-term clinical outcomes. However, even after decades of development, the degradation process, ideal degradation time and biological response in vivo are still not fully understood. The present study investigates the in vivo degradation of magnesium scaffolds in the coronary arteries of pigs influenced by different strut thicknesses and the presence of antiproliferative drugs. Due to high 3D image contrast of synchrotron-based micro-CT with phase contrast (SR-μCT), a qualitative and quantitative evaluation of the degradation morphology of magnesium scaffolds was obtained. For the segmentation of the μCT images a convolutional network architecture (U-net) was exploited, demonstrating the huge potential of merging high resolution SR-μCT with deep learning (DL) supported data analysis. In total, 30 scaffolds, made of the rare earth alloy Resoloy®, with different strut designs were implanted into the coronary arteries of 10 domestic pigs for 28 days using drug-coated or uncoated angioplasty balloons for post-dilatation. The degradation morphology was analyzed using scanning electron microscopy, energy dispersive x-ray spectroscopy and SR-μCT. The data from these methods were then related to data from angiography, optical coherence tomography and histology. A thinner strut size (95 vs. 130 μm) and the presence of paclitaxel indicated a slower degradation rate at 28 d in vivo, which positively influences the late lumen loss (0.5 and 0.6 mm vs. 1.0 and 1.1 mm) and recoil values (0 and 1.7% vs. 6.1 and 22%).

Aims Drug-coated balloon catheters (DCB) are a new clinical treatment modality for coronary and peripheral artery disease. The goal of the consensus group is to develop recommendations for the clinical use of DCB based on randomized clinical trials and the best available clinical evidence. The present paper gives an update on the recommendations against the background of a variety of new data published since the first paper was presented. Methods and results The general concept of our recommendations for the coronary use of DCB includes the preparation of the lesion to facilitate drug delivery and to estimate the need for stent implantation, especially after relevant dissections. Lesion preparation includes conventional angioplasty. In more complex lesions, additional treatments and imaging or functional measurements are helpful. In case of no flow-limiting dissection and an acceptable but not stent-like primary result, DCB use without additional stent implantation may be considered. The proposed advantages of the DCB only concept over a direct stent approach include reduced restenosis rates in indications where DES show limited efficacy, the reduction of DAPT especially in patients with contraindications for prolonged DAPT, and the option of leaving no foreign object behind resulting in vascular restoration with potentially plaque regression instead of neo-atherosclerosis. Conclusions DCB allow for local drug delivery in endovascular therapy leaving no permanent implant behind.

By comparison, the primary endpoint in the drug-coated balloon group of the DEBUT trial occurred in only 4% of cases after 1 year,6 hence fewer events than those reported for drug-coated stents (LEADERS FREE trial)4 or drug-eluting stents (SENIOR trial).5 Notably, this benefit of drug-coated balloons over bare metal stents was maintained up to 3 years, mainly driven by cardiac mortality and myocardial infarction. To date, drug-coated balloon therapy has only been recommended for the treatment of coronary in-stent restenosis.3 This indication is widely accepted since the use of a paclitaxel-coated balloon avoids an additional stent layer and might reduce the probability of death or myocardial infarction in the long term.7 For the majority of interventional cardiologists, however, it is still difficult to accept treating a lesion primarily without a stent. The aim is to reach an acceptable primary result (ie, no occurrence of a flow limiting dissection [type C or higher] or a residual stenosis of maximum 30%); otherwise, the implantation of a drug-eluting stent is recommended.10 In the DEBUT trial, the crossover rate to stenting before randomisation was only 5%.6 Dr P Marazzi/Science Photo Library Despite the limitations of the DEBUT trial, such as using bare metal stents as a control group and the medium sample size, it is an important contribution to the clinical evidence of drug-coated balloon therapy.

Introduction In BASKET-SMALL 2, drug-coated balloons (DCB) were non-inferior to drug-eluting stents (DES) in de-novo stenosis of small coronary vessels (≤ 2.75 mm) regarding clinical endpoints up to 36 months. Aim: In the present subgroup analysis, we aimed to analyze the effect of the two treatment strategies in different vessel sizes. Material and methods Patients were analyzed according to the size of the device used (small > 2.5 mm vs. very small ≤ 2.5 mm). The primary endpoint was major adverse cardiac events (MACE), while secondary endpoints were target vessel revascularization (TVR), non-fatal myocardial infarction, cardiac death, and all-cause mortality, all at 36 months. Interactions for the different groups were assessed with Cox regression analysis. Results Overall, 758 patients were enrolled in this analysis, of which 437 (58%) had very small vessel disease. There were similar results in both treatment groups for the primary endpoint in both small and very small vessels (DCB vs DES, MACE at 3 years in small vessels HR = 1.31, 95% CI: 0.74–2.32, p = 0.355, and very small vessels HR = 0.82, 95% CI: 0.49–1.39, p = 0.468). Second generation paclitaxel-eluting stents showed significantly higher rates for MACE (p = 0.041), TVR (p = 0.004) and non-fatal myocardial infarction (p = 0.036) compared to DCB in very small coronary arteries at 3 years, while results were similar in small coronary arteries. Conclusions Efficacy and safety of DCB are similar irrespective of vessel size. However, there is a beneficial effect of DCB over paclitaxel-eluting stents regarding TVR, non-fatal myocardial infarction and MACE that is most pronounced in very small coronary arteries.