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Background: Data regarding the mean resident time (RT) after left main (LM) bifurcation stenting are scant. In the present study we performed a patient-specific computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in LM patients treated with single-or double stenting techniques., Methods: Patients were identified after reviewing the local Optical Coherence Tomography (OCT) scans database. Overall, 27 patients (mean age 65.5 ± 12.4, 21 males) [10 patients treated with provisional cross-over stenting, 7 with the double kissing crush (DK crush) and 10 with the nano-inverted T (NIT) technique, respectively] with isolated and significant LM bifurcation disease were analyzed., Results: After LM bifurcation stenting, the NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and provisional cross-over stenting. Moreover, the mean RT resulted lower after NIT compared to provisional or DK crush. During the diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional., Conclusion: The present OCT-derived CFD analysis revealed that, in patients with complex bifurcation LM disease, the provisional approach resulted in lower WSS values, while double stenting techniques, especially the NIT technique, resulted in a marked reduction of average RT compared to the provisional approach., Condensed Abstract: In the present study we performed a patient-specific Optical coherence tomography (OCT)-based computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in 27 patients treated with provisional cross-over stenting, DK crush and Nano-inverted-T (NIT) stenting. The NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and Provisional. The mean RT resulted lower in NIT compared to Provisional or DK crush. During the entire diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the entire LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional., Competing Interests: Declaration of competing interest None of the authors have conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Percutaneous coronary interventions (PCI) of bifurcation lesions poses a technical challenge with a high complication rate. Kissing balloon inflation (KBI) and proximal optimization technique (POT) are used to correct bifurcation carina after stenting. However, both may still lead to uncomplete strut apposition to the side branch (SB) lateral wall. Proposed herein, is a new stent-optimization technique following bifurcation stenting consisting of a combination of POT and KBI called proximal optimization with kissing balloon inflation (POKI)., Methods: Bench and in-vivo evaluations were performed. For the bench visualization bifurcated silicone mock vessel was used. The POKI technique was simulated using a 3.5 mm POT balloon. For the in-vivo evaluation patients with angiographic bifurcation lesions in a native coronary artery with diameter ≥ 2.5 mm and ≤ 4.5 mm, SB diameter ≥ 2.0 mm, and percentage diameter stenosis (%DS) more than 50% in the main vessel (MV) were included. Provisional stenting was the default strategy., Results: In total 41 vessels were evaluated. The target vessel was left main in 9 (22.0%) patients, left anterior descending artery - in 26 (63.4%), left circumflex artery - in 4 (9.8%) and right coronary artery - in 2 (4.9%). The predominant type of bifurcation was Medina 1-1-1 (61.8%). Baseline proximal MV DS% was 60.0 ± 23.7%, distal MV DS% - 58.8 ± 28.9% and SB DS% 53.0 ± 32.0%. The application of POKI was feasible in 41 (100%) of the vessels. Post-PCI residual DS at proximal MV was 11.5 ± 15.4%, distal MV - 6.6 ± 9.3%, and SB - 22.9 ± 28.5%. Both procedural and angiographic success was 100%., Conclusions: POKI is a novel stent-optimization technique for bifurcation lesions. It showed excellent feasibility and success rate both in bench and in-vivo evaluation.

Background: The optimal final optimization technique to be used in patients after Cross Over Left main stenting remainsdebatable., Aim: We evaluate the impact of the post-optimization technique (POT), kissing balloon (KB) and the POT-side-POT techniques on both cardiovascular mortality and event-free survival in patients receiving left main (LM) cross-over stenting for an isolated/distal bifurcation LM disease., Methods: Clinical and instrumental records of 128 consecutive patients (102 males, mean age 73.39 ± 9.54 years old) with isolated distal/bifurcation LM disease and bypass surgery contraindications or refusal enrolled to receive LM cross-over stenting between the 1st January 2012 and the 1st January 2017 at two institutions: the Rovigo General Hospital (Rovigo, Italy) and the Alexandrovka Hospital University School of Medicine (Sofia, Bulgaria). Patients has been divided into three groups (POT, KB and POT-side-POT) according the optimal final optimization technique used while the 5-year cardiovascular mortality has been evaluated using the log-rank (Mantel-Cox) analysis., Results: Baseline angiographic characteristics of the LM disease were mostly equivalent among the three groups. Over a global follow-up of 61.03 ± 0.92 months, the rates of target vessel revascularization, acute myocardial infarction, and stent thrombosis, were not different among groups. Patients treated with POT had a slightly better long-term survival., Conclusions: None of these optimization techniques appeared to have clearly better long-term outcomes after LM Cross-over stenting in our retrospective study. POT resulted in a slightly better survival compared to Pot-sid-POT and KB., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: We assess the mid-term outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (Nano-Crush) technique in large complex coronary bifurcation., Background: Complex bifurcations have been suggested to be better approached by a planned double stent technique., Methods: Two hundred and five consecutive patients (107 males and 98 females) referred for large complex coronary bifurcation percutaneous coronary interventions were enrolled. The technique was also evaluated by both a bench test with a silicon tubes phantom resembling a coronary bifurcation and a computed fluid dynamic (CFD) analysis., Results: Left main bifurcation accounted for 40.9% of cases (84 patients). Mean angles between main branch (MB) and side branch (SB) were 63.6 ± 21.3°. SB intravascular ultrasound-calculated MSA was 5.6 ± 1.5 mm 2 . Clinical follow-up was available for 100% of patients and at a mean follow-up of 16.2 ± 6.7 months 8 deaths, all due to cardiovascular reason, (3.9%, 4 patients for stroke, two for heart failure, one after surgical aortic valve substitution, and one after acute massive pulmonary embolism) and no presumptive stent thrombosis or target vessel induced ischemia were observed. Angiographic follow-up was available in 108 patients (52.7%) and showed a very low significant restenosis (5 patients, 4.6%). Bench study and CFD evaluation suggested a complete coverage of the SB ostium with a very high strut-free area at the SB., Conclusions: The revascularization of complex large coronary bifurcation disease using the Nano-crush technique appeared promising thanks to the favorable fluid dynamic profile, complete coverage of the SD ostium, and very small metal amount at the carina., (© 2018 Wiley Periodicals, Inc.)

Background: Results of regular drug-eluting stents (rDESs) in bifurcation treatment are not optimal. The aim of the Polish Bifurcation Optimal Stenting I (POLBOS I) trial was to compare bifurcation treatment with any rDES vs the dedicated bifurcation paclitaxel-eluting stent BiOSS Expert (Balton, Poland). The second aim was to study the effect of final kissing balloon (FKB) inflation on clinical outcomes., Methods: Between October 2010 and January 2013 patients with stable coronary artery disease or non-ST-elevation acute coronary syndrome were assigned 1:1 to 1 of 2 treatment strategies: BiOSS Expert stent or rDES implantation. Coronary angiography was performed at 12 months. The primary end point was a composite of cardiac-related death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months., Results: The BiOSS Expert was implanted in 120 patients (49.4%), and an rDES was implanted in 123 patients. The target vessel was the left anterior descending (LAD) artery (52% vs 70%) followed by the left main stem (LMS) coronary artery (22% vs 15%). In the rDES group, 38.2% received paclitaxel-eluting stents. There were 3 stent implantation failures (2 in the rDES group and 1 in the BiOSS Expert group). Side branch treatment with an rDES was required in 10% of cases in both groups. At 12 months, the incidence of cumulative major adverse cardiovascular events (MACE) was similar in both groups: 13.3% vs 12.2% (P = 0.7). The TLR rate was significantly higher in the BiOSS Expert group compared with the rDES group (11.5% vs 7.3%; P = 0.02). Significantly lower rates of restenosis were observed in FKB subgroups of both the BiOSS Expert (8.1% vs 13.2%; P < 0.05) and rDES groups (4.9% vs 9.5%; P < 0.05)., Conclusions: MACE rates were comparable between the 2 groups; however, the TLR rate was higher in the BiOSS Expert group. A more aggressive protocol yielded better angiographic and clinical outcomes., (Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess prospectively the effectiveness and safety profile of distal left main stem (LMS) stenosis treatment with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®., Background: Angioplasty of distal LMS stenosis is always a high-risk procedure, and optimal treatment is uncertain., Methods: This was a prospective international 2-center study, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) or stable angina with distal left main stenosis. All patients were treated with the dedicated bifurcation stent BiOSS Expert®. Provisional T-stenting was the obligatory strategy. Angiographic control was performed after 12 months. The primary end-point was cumulative rate of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. Angiographic end-points included late lumen loss, percent diameter stenosis, and binary restenosis rate., Results: A total of 54 patients with distal LMS stenosis were enrolled. Seven patients (13%) were enrolled during NSTE-ACS, 77.8% were hypertensive, 27.8% were diabetic, 51.9% had previous MI, 53.7% underwent prior percutaneous coronary intervention, and 16.7% coronary artery bypass graft. The mean SYNTAX score was 21.52 ± 6.50. The device success rate was 100%. The mean BiOSS Expert stent parameters were as follows: 4.07 ± 0.26 mm × 3.36 ± 0.26 mm × 16.61 ± 1.72 mm and in side branch the other stent (classical drug-eluting stent) was implanted in 25.9% of cases. The overall TLR was 9.3%. There were no death, stent thrombosis, or acute MI. In the univariate regression analysis, the only factor associated with higher risk for TLR was the SYNTAX score value., Conclusions: The dedicated bifurcation stent BiOSS Expert® proved to be a feasible device, with promising safety and long-term clinical effectiveness in the treatment of distal LMS stenosis., (© 2014, Wiley Periodicals, Inc.)

Objectives: Restenosis after drug eluting stent (DES) implantation in the distal/bifurcation left main (DBLM) remains challenging to manage. The aim of this study was to assess the in-stent restenosis (ISR) after DES implantation in DLM and to evaluate current management strategy., Methods: The medical records of patients referred for LM distal/bifurcation percutaneous coronary interventions (PCI) from the same Cardiology Unit in the January 2007 to December 2012 period were reviewed for PCI technique, stent type, restenosis type, restenosis treatment and management (CABG, balloon angioplasty only, alternative DES implant, drug eluting balloon angioplasty)., Results: Fourteen patients (5 females, mean age 75.1±8.3years) out of 89 (15.7%) having undergone a percutaneous coronary interventions on DBLM with DES, developed restenosis (everolimus stents in 10 patients, zotarolimus stents in 4 patients). Technique used at the first implant included stenting of the main branch in 4 patients, culottes stenting in 6 patients and T-stent in 4 patients. The mean time elapsed from the first angioplasty and ISR intervention was 7.6±3.6months. Restenosis treatments included: implantation of a different DES (in 3 patients), implantation of a bare-metal stent (in 2 patients), simple balloon angioplasty (in 4 patients), and drug-eluting balloon (5 patients). At 6-month angiographic control second restenosis rate was 14.2%. After a mean follow-up of 38.5±24.4months the target vessel revascularization was 14.3%: surgery was the final choice in two patients due to recurrent restenosis. Incidence of major adverse cardiac event was 28.5%., Conclusions: The occurrence of restenosis after DBLM following DES implantation is not frequent but remains difficult to manage. In our small anecdotal series, all the different strategies including implantation of different DES, balloon angioplasty, bare-metal stent implantation and drug-eluting balloon angioplasty appeared equally effective in maintaining arterial patency., (Copyright © 2014 Elsevier Inc. All rights reserved.)

A 55-year-old male underwent paclitaxel-eluting stent implantation in a bifurcation lesion of his left anterior descending artery (LAD) during an episode of unstable angina in 2008. A late in-stent restenosis developed 15 months after implantation of the drug-eluting stent (DES) and was treated with paclitaxel eluting balloon. Two months later, during angiography for functional assessment of the significance of lesions in the circumflex artery, an aneurysm at the place of drug-eluting balloon (DEB) inflation was observed. The patient was left on double antiplatelet therapy and scheduled for clinical observation after 3 months and control coronary angiography after 6 months for aneurysm progression follow-up., (Copyright © 2012 Wiley Periodicals, Inc.)

Aims: Dedicated bifurcation stents seem to be the most promising solution for treating bifurcations. The aim of our study was to present the 12 months results of a new dedicated stent for coronary bifurcation lesions -the paclitaxel-eluting stent- BiOSS® Expert (Bifurcation Optimisation Stent System, Balton, Warsaw, Poland)., Methods and Results: Sixty-three patients with 65 lesions were enrolled in the registry. Forty-six % of the patients were classified as NSTEMI or unstable angina, 27% were diabetics, 30% had previous myocardial infarction and 48% had a history of previous revascularisation. In addition, hypertension and dyslipidaemia were the most common risk factors (58% and 40%). Sixty-five stents were successfully implanted (100% device success rate). The analysis of 30 days follow-up for 63 patients revealed good clinical results showing lack of death, target lesion revascularisation procedures (TLR) and target vessel revascularisation procedures (TVR). There were six (9,5%) cases of in-hospital raised troponin, however, only one showed an additional increase in CK-MB levels and was qualified as non-Q myocardial infarction (MI). There was a need for percutaneous coronary intervention (PCI) in a non-index vessel in one patient due to exertional angina. The analysis of 12-month follow-up for 63 patients revealed good clinical results. There were two (3.2%) cases of death (three and 10 months after index procedure). The first patient, in good physical shape, drowned, while the second was found dead by his family. There were no incidents of MI or stroke in the rest of the population. At 12 months there were seven (10.8% per lesion; 11.1% per patient) cases of TLR and nine (13.8% per lesion; 14.3% per patient) TVR. There were also 15 (23.8%) cases of PCI on vessels not related to BiOSS® Expert stent implantation., Conclusions: Our registry showed that bifurcation treatment with a single dedicated paclitaxel-eluting bifurcation stent, BiOSS® Expert is feasible and successful. The long-term clinical results are satisfactory in this high-risk patient population.

Aims: The optimal treatment strategy for coronary bifurcation lesions is still unknown. The BiOSS Lim stents (Bifurcation Optimisation Stent System) is a novel dedicated bifurcation stent introduced over a single wire in to the main vessel, covered with biodegradable polymer and sirolimus. It has wider proximal and narrower distal parts. The aim of the study was to assess applicability of the the BiOSS Lim stent in a porcine coronary model., Methods and Results: A total of 14 BiOSS Lims were implanted in normal non-atherosclerotic porcine coronary bifurcations of 14 animals (six stents for 28 days, eight stents for 90 days) using 1.1:1.0 stent-to-artery ratio. Stent geometry and morphology were evaluated by Faxitron imagery (Faxitron Bioptics, LLC, IL, USA). Vascular effects were assessed based on angiographic and histological analysis. Analysis of Faxitron images revealed no major abnormalities except two struts fractures at the place of connection between the mid-portion and proximal wider part of the stent. Histomorphometry showed decreased area stenosis and intimal thickness at 90 days compared with the 28 days cohort. The inflammatory scores were low (<1) at both time points and struts endothelialisation was completed at 28 days., Conclusions: The novel BiOSS Lim stent demonstrates good short- and mid-term vascular effects in a porcine coronary bifurcation model.

Background and Aim: Bifurcation lesions are relatively frequently encountered in everyday interventional practice. Stenting of the vessel chosen to be main (usually the larger one) frequently leads to stenosis at the ostium of the side branch (SB) and compromises its flow (side branch compromise--SBC). The relative dependence of main and side branch diameters, based on the concept of carina displacement of stent struts, was examined in a cohort of patients with bifurcation stenting., Methods: We accept that the basic mechanism for SBC after stent placement in the parent vessel is carina shifting from expanded stent struts. The ostial SB minimal lumen diameter (MLD), percentage diameter stenosis (%DS) at maximal and calculated actual carina displacement, as well as distal limb diameter (DLD) in the main branch were calculated and compared with actually observed values., Results: A group of 55 consecutive patients with acceptable quality angiograms formed the study population. General patient characteristics were similar to other bifurcation studies. Left anterior descending artery was predominantly treated in 73% of patients. There was worsening SB ostial stenosis after stent implantation (%DS increase from 48%+/-23% to 69%+/-21%, p <0.001) and final improvement because of kissing balloon inflation or SB postdilatation (post vs. final-69+/-21% and 53+/-25%, p<0.001). Stent implantation causes straightening of the main vessel, evident from a significant increase in angle C (pre- 148 degrees +/-19 degrees vs. 156 degrees +/-16 degrees after stenting, p=0.007). Relations between observed and predicted values for main branch DLD and %DS demonstrated a good correlation between predicted and observed values (for DLD r=0.66, p<0.001, and for %DS r=0.53, p <0.001). There was an excellent fit of regression lines between theoretical predictions and actual measurements for side branches (MLD r=0.91, p<0.001, %DS r=0.89, p<0.001)., Conclusions: Carina displacement from stent struts is a major mechanism governing changes in coronary bifurcations after main vessel stenting. Improvement in the ostium of the side branch causes shifting back of the carina and a decrease of main vessel diameter. The long-term consequences of this phenomenon are not currently known.