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The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS registered Expert and BiOSS registered LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert registered (paclitaxel) and BiOSS LIM registered (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert registered 11 patients, BiOSS LIM registered 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS registered LIM group, 54.5% vs 73.9% (P<0.05) and 0% vs 39.1% (P<0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS registered Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM registered group comparing with the BiOSS Expert registered group there was lower neointima burden in the whole stent (24.7 plus or minus 7.5% vs 19.4 plus or minus 8.6%, P<0.05) as well as in main vessel (22.8 plus or minus 5.6% vs 16.9 plus or minus 6.1%, P<0.05) and main branch (36.1 plus or minus 6.5% vs 27.6 plus or minus 8.7%, P<0.05), but not at the level of bifurcation (15.1 plus or minus 3.8% vs 13.6 plus or minus 5.4%, P=NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 plus or minus 0.09 mm vs 0.32 plus or minus 0.14 mm, P<0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 plus or minus 3.9% vs 18.9 plus or minus 4.45%, P<0.05) as well as at the bifurcation site (12.6 plus or minus 4.1% vs 14.1 plus or minus 2.4%, P<0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM registered stents than in BiOSS Expert registered stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.

The aim of this study was to analyze the difference in neointima pattern assessed by intravascular ultrasound (IVUS) between two dedicated bifurcation stents, BiOSS® Expert and BiOSS® LIM at 12-month follow-up. This manuscript reports IVUS findings obtained from the analysis of patients enrolled into first-in-man registries initially assessing the BiOSS Expert® (paclitaxel) and BiOSS LIM® (sirolimus) stents. Quantitative angiographic analysis was performed pre, post-stenting, and at follow-up. IVUS examination was performed at 12 months. There were analyzed 34 cases (BiOSS Expert® 11 patients, BiOSS LIM® 23 patients). Procedural characteristics in the two groups were similar, except for rates of main vessel predilatation and FKB/POT, which were higher in BiOSS® LIM group, 54.5 % vs 73.9 % (P < 0.05) and 0 % vs 39.1 % (P < 0.05), respectively. When comparing late lumen loss (LLL) for both stents there were significantly bigger values for main vessel and main branch in the BiOSS® Expert group, but not in side branch. Intravascular ultrasound examination showed that in the BiOSS LIM® group comparing with the BiOSS Expert® group there was lower neointima burden in the whole stent (24.7 ± 7.5 % vs 19.4 ± 8.6 %, P < 0.05) as well as in main vessel (22.8 ± 5.6 % vs 16.9 ± 6.1 %, P < 0.05) and main branch (36.1 ± 6.5 % vs 27.6 ± 8.7 %, P < 0.05), but not at the level of bifurcation (15.1 ± 3.8 % vs 13.6 ± 5.4 %, P = NS). In addition, we found that final kissing balloon/proximal optimization technique (FKB/POT) was associated with significantly smaller value of LLL in main vessel (0.24 ± 0.09 mm vs 0.32 ± 0.14 mm, P < 0.05), which in IVUS analysis resulted in smaller neointima burden in main vessel (13.7 ± 3.9 % vs 18.9 ± 4.45 %, P < 0.05) as well as at the bifurcation site (12.6 ± 4.1 % vs 14.1 ± 2.4 %, P < 0.05). The obtained results suggest that neointima proliferation was the largest in main branches of both stents assessed in quantitative angiography (LLL) as well as in IVUS (neointima burden) and the neointima increase was smaller in BiOSS LIM® stents than in BiOSS Expert® stents. Moreover, the middle part of the stent seems to not to be associated with excessive neointima proliferation and more aggressive protocol of implantation with the use FKB/POT seems to decrease this process.

The aim of this study was to analyze the mechanisms of lumen enlargement in bifurcation lesions, as assessed by intravascular ultrasound (IVUS), after percutaneous treatment with classic provisional “T” stenting with conventional drug-eluting stents (DES) versus bifurcation dedicated BiOSS ® (Balton, Warsaw, Poland) stent. In this prospective study between Jan and Dec/11, 32 patients with single de novo coronary bifurcation lesions suitable for treatment with BiOSS stents were randomized (1:1). IVUS method included pre- and post-procedure analysis in the parent vessel. Vessel, lumen and plaque cross-sectional areas were determined at the target lesion [minimum lumen area (MLA) site], proximal limb, distal limb, and “window”—defined as the segment between the carina (flow divider) and the vessel wall at the level of the side branch inflow. All lesions were treated with provisional approach and only 1 case in BiOSS group had a stent implanted in the side branch. Angiographic and IVUS results including MLA at the target site and proximal/distal references were similar. However, mean window length—largest diameter within the window, was similar at baseline, but BiOSS measured significantly longer at postprocedure (2.21 ± 0.37 vs. 1.76 ± 0.52 mm, p  = 0.01). In addition, the magnitude of changes in vessel (27 ± 24 % vs. 9 ± 10 %, p  = 0.01) and plaque (2 ± 26 % vs. −2 ± 26 %, p  = 0.02) areas at the window were significantly different for DES versus BiOSS groups, respectively. The contribution of vessel extension for lumen enlargement represented 54 versus 43 %, 130 versus 46 %, 98 versus 80 % and 51 versus 19 % of the result achieved at the proximal limb, window, distal limb and MLA sites for DES versus BiOSS, respectively; as for plaque re-distribution, results were 36 versus 57 %, −30 versus 54 %, 2 versus 20 %, and 49 versus 81 %, at the proximal limb, window, distal limb and MLA sites, respectively. These results suggest different mechanisms of lumen enlargement comparing conventional DES versus BiOSS dedicated bifurcation stent, which can impact side branch compromise during procedure.

Background and Objectives Provisional and culotte are the most commonly used techniques in left main (LM) stenting. The impact of different post-dilation techniques on fluid dynamic of LM bifurcation has not been yet investigated. The aim of this study is to evaluate, by means of computational fluid dynamic analysis (CFD), the impact of different post-dilation techniques including proximal optimization technique (POT), kissing balloon (KB), POT-Side-POT and POT–KB-POT, 2-steps Kissing (2SK) and Snuggle Kissing balloon (SKB) on flow dynamic profile after LM provisional or culotte stenting. Methods We considered an LM-LCA-LCX bifurcation reconstructed after reviewing 100 consecutive patients (mean age 71.4 ± 9.3 years, 49 males) with LM distal disease. The diameters of LAD and LCX were modelled according to the Finnet’s law as following: LM 4.5 mm, LAD 3.5 mm, LCX 2.75 mm, with bifurcation angle set up at 55°. Xience third-generation stent (Abbot Inc., USA) was reconstructed and virtually implanted in provisional/cross-over and culotte fashion. POT, KB, POT-side-POT, POT-KB-POT, 2SK and SKB were virtually applied and analyzed in terms of the wall shear stress (WSS). Results Analyzing the provisional stenting, the 2SK and KB techniques had a statistically significant lower impact on the WSS at the carina, while POT seemed to obtain a neutral effect. In the wall opposite to the carina, the more physiological profile has been obtained by KB and POT with higher WSS value and smaller surface area of the lower WSS. In culotte stenting, at the carina, POT-KB-POT and 2SK had a very physiological profile; while at the wall opposite to the carina, 2SK and POT–KB-POT decreased significantly the surface area of the lower WSS compared to the other techniques. Conclusion From the fluid dynamic point of view in LM provisional stenting, POT, 2SK and KB showed a similar beneficial impact on the bifurcation rheology, while in LM culotte stenting, POT-KB-POT and 2SK performed slightly better than the other techniques, probably reflecting a better strut apposition.

The aim of this study was to analyze the mechanisms of lumen enlargement in bifurcation lesions, as assessed by intravascular ultrasound (IVUS), after percutaneous treatment with classic provisional \"T\" stenting with conventional drug-eluting stents (DES) versus bifurcation dedicated BiOSS^sup ^ (Balton, Warsaw, Poland) stent. In this prospective study between Jan and Dec/11, 32 patients with single de novo coronary bifurcation lesions suitable for treatment with BiOSS stents were randomized (1:1). IVUS method included pre- and post-procedure analysis in the parent vessel. Vessel, lumen and plaque cross-sectional areas were determined at the target lesion [minimum lumen area (MLA) site], proximal limb, distal limb, and \"window\"--defined as the segment between the carina (flow divider) and the vessel wall at the level of the side branch inflow. All lesions were treated with provisional approach and only 1 case in BiOSS group had a stent implanted in the side branch. Angiographic and IVUS results including MLA at the target site and proximal/distal references were similar. However, mean window length--largest diameter within the window, was similar at baseline, but BiOSS measured significantly longer at postprocedure (2.21 ± 0.37 vs. 1.76 ± 0.52 mm, p = 0.01). In addition, the magnitude of changes in vessel (27 ± 24 % vs. 9 ± 10 %, p = 0.01) and plaque (2 ± 26 % vs. -2 ± 26 %, p = 0.02) areas at the window were significantly different for DES versus BiOSS groups, respectively. The contribution of vessel extension for lumen enlargement represented 54 versus 43 %, 130 versus 46 %, 98 versus 80 % and 51 versus 19 % of the result achieved at the proximal limb, window, distal limb and MLA sites for DES versus BiOSS, respectively; as for plaque re-distribution, results were 36 versus 57 %, -30 versus 54 %, 2 versus 20 %, and 49 versus 81 %, at the proximal limb, window, distal limb and MLA sites, respectively. These results suggest different mechanisms of lumen enlargement comparing conventional DES versus BiOSS dedicated bifurcation stent, which can impact side branch compromise during procedure.[PUBLICATION ABSTRACT]

Background: Detailed anatomic variants of the interatrial septum in patients with right-to-left shunt and contribution of specific anatomies to the risk of ischaemic recurrences has not yet been comprehensively classified. Objective: To report a classification of the anatomic variants of the interatrial septum as observed by intracardiac echocardiography and its correlation with clinical and functional characteristics. Methods: We retrospectively reviewed the medical and instrumental data of 520 consecutive patients (mean age 44±15. 5 years, 355 women) who had over a 10-year period undergone intracardiac echocardiography and right-to-left shunt catheter-based closure. The four main features used to analyse were: (a) diameter of the oval fossa, (b) presence and length of the channel, (c) presence and degree of atrial septal aneurysm, and (d) rim thickness. The presence of Eustachian valve was also tabulated. Results: The combinations of interatrial septum anatomical features were classified into six main anatomical subgroups. Recurrent embolism, multiple ischaemic foci on brain magnetic resonance imaging, high grade shunt, and permanent shunt before transcatheter closure procedure were associated with type 2, type 4, and type 6. Type 4 anatomical subtype (OR 4.1, 1.5–8 [95% CI], p<0.001) and type 2+presence of Eustachian valve (OR 4.3, 1.6–9 [95% CI], p<0.001) were the strongest predictors of recurrent ischaemic events before transcatheter closure. Conclusion: Our study showed that interatrial septum anatomy greatly differs among patients with right-to-left shunt, as well as the risk of ischaemic recurrences in different anatomies.