Serial Morphological and Functional Assessment of Drug-Eluting Balloon for In-Stent Restenotic Lesions Mechanisms of Action Evaluated With Angiography, Optical Coherence Tomography, and Fractional Flow Reserve

ObjectivesThis study sought to elucidate the underlying mechanism through which drug-eluting balloons (DEB) restore coronary blood flow, by assessing the coronary vessel before, immediately after, and at 6-month follow-up with angiography, optical coherence tomography (OCT), and fractional flow reserve (FFR).BackgroundIn-stent restenosis (ISR) treatment remains challenging. Drug-eluting balloons have been shown to be a valid treatment option in several studies. These studies focused on efficiency of the device, whereas the mechanisms of action of DEB in ISR treatment have not been investigated.MethodsIn this prospective, single-center observational study, patients with ISR were treated with a second-generation DEB. Serial angiographic, OCT, and FFR measurements were performed before and after the procedure, as well as at 6-month follow-up.ResultsTwenty-five patients were assigned to DEB treatment, with an angiographic and device success of 100% and 92%, respectively. Late luminal loss was 0.01 ± 0.43 mm. Median percent changes [interquartile range] between pre-and post-procedure, and post-procedure and follow-up were, respectively: lumen volume 75.1% increase [43.7 to 115.0], and 8% increase [−14.0 to 25.8]; stent volume 23.7% increase [15.5 to 40.0], and −1.2% decrease [−6.9 to 5.9]; and neointimal volume −14.4% decrease [−29.2 to −9.5], and −15.8% decrease [−38.1 to 28.3]. The FFR gradient along the treated stent (difference in FFR between the distal and the proximal stent edge) was 0.37 ± 0.18 pre-procedure, 0.06 ± 0.04 post-procedure, and 0.05 ± 0.05 at follow-up. In all post-procedural OCT images, intrastent dissections were seen, which were sealed at follow-up OCT.ConclusionsDEB restore coronary blood flow by means of a short-term mechanical effect, causing an increase in lumen and stent volumes and compression of neointimal hyperplasia (with intra-stent dissections). Due to the local drug effect, patency persists and may even improve at follow-up, with further increase in lumen volume, decrease in neointimal volume, and complete sealing of neointimal dissections

Расчет электромагнитного поля в электронных модулях с использованием интеграла Зоммерфельда

Излагается подход с использованием интеграла Зоммерфельда. Метод позволяет избежать интегрирования в комплексной области и снизить объем вычислений по сравнению с известными методами

140 Impact of TAVI with the Edwards-SAPIEN endoprosthesis on mitral regurgitation: results of a serial echocardiography assessment

PurposeThe impact of transcatheter aortic valve implantation (TAVI) on mitral regurgitation (MR) is controversial. Two recent publications have reported improvement in MR grades following implantation of the Edwards-SAPIEN endoprosthesis. These findings were not replicated with the Core-Valve. The time course of improvement in MR grades with the Edwards-SAPIEN valve has not been described on an individual patient basis and the potential mechanisms of benefit are unclear. The aim of this study was to assess the acute and intermediate changes in MR severity after TAVI with the Edwards-SAPIEN endoprosthesis.MethodsEchocardiography was performed in 22 consecutive patients before and after treatment, and at 1 month follow-up. MR was assessed by color flow mapping and was graded as none, mild, moderate, or severe. MR was defined as organic or functional.ResultsThe aortic valve area increased from pretreatment 0.72cm2 to post-treatment 1.87cm2 and postdischarge 1.81cm2 (P<0.0001). Before intervention MR was present in 73% of the patients. It was mild, moderate, or severe in 36% (n=8), 32% (n=7), and 4% (n=1) respectively. MR was defined as organic in 6 patients (27%) and functional in 10 patients (45%). Compared to baseline, MR grades improved by 1 month (p for trend=0.01). This benefit was secondary to a reduction in regurgitation grades in 50% of patients with an MR at baseline (n=6), while no worsening was observed in the other patients with an MR (n=6) and no occurrence of MR was observed in patients without MR (n=6). A trend for a greater improvement in MR grade was observed in patients with functional MR (n=7, − 1.00) compared to those with an organic MR (n=5, − 0.294; p=0.10).ConclusionIn consecutive patients with a successful implantation of an Edwards-SAPIEN valve a significant improvement in MR was observed. This benefit was secondary to an improvement in 50% of patients with an MR and no worsening in the others

Randomized comparison between 3-month Cre8 DES vs. 1-month Vision/Multilink8 BMS neointimal coverage assessed by OCT evaluation: The DEMONSTRATE study

AbstractBackgroundIt has been hypothesized that incomplete endothelialization and delayed vascular healing may trigger stent thrombosis events after drug-eluting stent (DES) implantation. We aimed to demonstrate non-inferiority in terms of neointimal coverage of novel Cre8 DES at 3months, compared to Vision/Multilink8 Bare Metal Stent (BMS) at 1month.MethodsThe ranDomizEd coMparisOn betweeN novel Cre8 DES and BMS to assess neoinTimal coveRAge by OCT Evaluation (DEMONSTRATE) was a multicenter, randomized, parallel group study. Thirty-eight patients undergoing angioplasty of de-novo coronary lesion were randomized to Cre8 (19) or Vision/Multilink8 (19) stent placement at 6 OCT-experienced centers. Primary end-point was the Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of <30%, determined by OCT at 3 and 1months for Cre8 and Vision/Multilink8, respectively. Percentage of uncovered/malapposed stent struts, neointimal growth and thickness were the main secondary end-points.ResultsThe primary end-point of RUTTS score <30% occurred in 99.8% (899/901) of Cre8 struts and in 99.6% (1116/1121) of Vision/Multilink8 struts (difference 0.2, CI 95% −0.2 to 0.6, p for noninferiority <0.001). The percentage of uncovered/malapposed struts was comparable (0.36±0.64 vs. 0.12±0.24, p=0.145) in the two study groups, while both neointimal percentage area (8.46±5.29 vs. 19.84±15.93, p<0.001) and thickness (0.07±0.04 vs. 0.16±0.12, p<0.001) were significantly reduced by Cre8 stent.ConclusionsThe Cre8 DES at 3months has comparable strut coverage to Vision/Multilink8 BMS at 1month while preserving a greater efficacy in neo-intima formation reduction. Further studies to assess clinical implication of these Cre8 characteristics are warranted

Comparison of the Sapien 3 versus the ACURATE neo valve system: A propensity score analysis

Objectives: To compare the outcomes of transfemoral ACURATE neo (NEO) and Sapien 3 (S3) patients in terms of device success and clinical safety outcomes using a propensity score analysis. Background: Differences in clinical outcomes between the latest-generation balloon-expandable S3 and self-expanding NEO in a “real-world transfemoral TAVI population” are still unclear. Methods: We compared up to 6 months clinical outcomes using a propensity s

Reproducibility of computed tomography angiography data analysis using semiautomated plaque quantification software: Implications for the design of longitudinal studies

Reproducibility of the quantitative assessment of atherosclerosis by computed tomography coronary angiography (CTCA) is paramount for the design of longitudinal studies. The purpose of this study was to assess the inter- and intra-observer reproducibility using semiautomated CT plaque analysis software in symptomatic individuals. CTCA was performed in 10 symptomatic patients after percutaneous treatment of the culprit lesions and was repeated after 3 years. The plaque quantitative analysis was performed in untreated vessels with mild-tomoderate atherosclerosis and included geometrical and compositional characteristics using semiautomated CT plaque analysis software. A total of 945 matched crosssections from 21 segments were analyzed independently by a second reviewer to assess inter-observer variability; the first observer repeated all the analyses after 3 months to assess intra-observer variability. The observer variability was also compared to the absolute plaque changes detected over time. Agreement was evaluated by Bland-Altman analysis and co