Browsing by Author "Burzotta, Francesco (7003405739)"

Coronary bifurcations exhibit localised turbulent flow and an enhanced propensity for atherothrombosis, platelet deposition and plaque rupture. Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with an increased risk of thrombotic events. Such risk is modulated by anatomical complexity, intraprocedural factors and pharmacological therapy. There is no consensus on the appropriate PCI strategy or the optimal regimen and duration of antithrombotic treatment in order to decrease the risk of ischaemic and bleeding complications in the setting of coronary bifurcation. A uniform therapeutic approach meets a clinical need. The present initiative, promoted by the European Bifurcation Club (EBC), involves opinion leaders from Europe, America, and Asia with the aim of analysing the currently available evidence. Although mainly derived from small dedicated studies, substudies of large trials or from authors' opinions, an algorithm for the optimal management of patients undergoing bifurcation PCI, developed on the basis of clinical presentation, bleeding risk, and intraprocedural strategy, is proposed here. © Europa Digital & Publishing 2021. All rights reserved.

Background: In patients with complex coronary bifurcation lesions undergoing percutaneous coronary intervention (PCI), various 2-stent techniques might be utilised. The Visible Heart Laboratories (VHL) offer an experimental environment where PCI results can be assessed by multimodality imaging. Aims: We aimed to assess the post-PCI stent configuration achieved by 2-stent techniques in the VHL and to evaluate the procedural factors associated with suboptimal results. Methods: Bifurcation PCI with 2-stent techniques, performed by expert operators in the VHL on explanted beating swine hearts, was studied. The adopted bifurcation PCI strategy and the specific procedural steps applied in each procedure were classified according to Main, Across, Distal, Side (MADS)-2 and to their adherence to the European Bifurcation Club (EBC) recommendations. Microcomputed tomography (micro-CT) was used to assess the post-PCI stent configuration. The primary endpoint was “suboptimal stent implantation”, defined as a composite of stent underexpansion (<90%), side branch ostial area stenosis >50% and the gap between stents. Results: A total of 82 PCI with bifurcation stenting were assessed, comprised of 29 crush, 25 culotte, 28 T/T and small protrusion (TAP) techniques. Suboptimal stent implantation was observed in as many as 53.7% of the cases, regardless of baseline anatomy or the stenting strategy. However, less frequent use of the proximal optimisation technique (POT; p=0.015) and kissing balloon inflations (KBI; p=0.027) and no adherence to EBC recommendations (p=0.004, p multivariate=0.006) were significantly associated with the primary endpoint. Conclusions: Commonly practised bifurcation 2-stent techniques may result in imperfect stent configurations. More frequent use of POT/KBI and adherence to expert recommendations might reduce the occurrence of post-PCI suboptimal stent configurations. © Europa Digital & Publishing 2023. All rights reserved.

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients. © 2022 The Authors

The Bifurcation Academic Research Consortium (Bif-ARC) project originated from the need to overcome the paucity of standardization and comparability between studies involving bifurcation coronary lesions. This document is the result of a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focused on bifurcation lesions in Europe, the United States, and Asia. This consensus provides standardized definitions for bifurcation lesions; the criteria to judge the side branch relevance; the procedural, mechanistic, and clinical endpoints for every type of bifurcation study; and the follow-up methods. Considering the complexity of bifurcation lesions and their evaluation, detailed instructions and technical aspects for site and core laboratory analysis of bifurcation lesions are also reported. The recommendations included within this consensus will facilitate pooled analyses and the effective comparison of data in the future, improving the clinical relevance of trials in bifurcation lesions, and the quality of care in this subset of patients. © 2022 The Author(s). Published by Elsevier Inc. on behalf of American College of Cardiology and Europa Digital & Publishing.

Introduction: Coronary Bifurcation lesions are technically more challenging and Bifurcation percutaneous coronary intervention (PCI) remains a challenge with unpredictable and sub-optimal clinical and angiographic results. Drug-Coated Balloons (DCB) are emerging devices in the field of coronary intervention with promising results that may overcome some of drug eluting stents limitations and may have potential advantages in complex bifurcation PCI. Areas covered: We have performed a re-appraisal about the issues with current bifurcation PCI techniques and the use of DCB in the treatment of Bifurcation lesions. Several studies performed utilizing DCB are described and critically appraised. Over the recent years, there have been tremendous developments in the DCB technology, lesion preparation, clinical experience, and clinical data during bifurcation PCI. The current review describes the advances in the DCB technology, pharmacokinetics, role of excipients, and optimization of the technique. Special emphasis in lesion preparation and potential pathway of using DCB in bifurcation PCI is proposed. Expert opinion: Although different proof of concept and pilot studies have shown promising results in treatment of bifurcation lesions with DCB, larger randomized trials and/or international consensus papers are required to enable worldwide translation of this idea to clinical practice. © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Introduction: Coronary Bifurcation lesions are technically more challenging and Bifurcation percutaneous coronary intervention (PCI) remains a challenge with unpredictable and sub-optimal clinical and angiographic results. Drug-Coated Balloons (DCB) are emerging devices in the field of coronary intervention with promising results that may overcome some of drug eluting stents limitations and may have potential advantages in complex bifurcation PCI. Areas covered: We have performed a re-appraisal about the issues with current bifurcation PCI techniques and the use of DCB in the treatment of Bifurcation lesions. Several studies performed utilizing DCB are described and critically appraised. Over the recent years, there have been tremendous developments in the DCB technology, lesion preparation, clinical experience, and clinical data during bifurcation PCI. The current review describes the advances in the DCB technology, pharmacokinetics, role of excipients, and optimization of the technique. Special emphasis in lesion preparation and potential pathway of using DCB in bifurcation PCI is proposed. Expert opinion: Although different proof of concept and pilot studies have shown promising results in treatment of bifurcation lesions with DCB, larger randomized trials and/or international consensus papers are required to enable worldwide translation of this idea to clinical practice. © 2020 Informa UK Limited, trading as Taylor & Francis Group.

Background: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison. Methods: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice. Results: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques (“provisional” and “inverted provisional”) and (b) 2-stent techniques (“T/TAP,” “culotte,” and “DK-crush”). Conclusions: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice. © 2020 Wiley Periodicals LLC.

Background: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. Aim: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. Methods: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). Results: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). Conclusion: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. Clinical Trial Registration: ClinicalTrials.gov Identifier NCT02497014. © 2023 Wiley Periodicals LLC.

Coronary artery bifurcation lesions comprise approximately 15-20% of all percutaneous coronary interventions (PCI) and constitute a complex lesion subgroup. Intravascular optical coherence tomography (OCT) is a promising adjunctive tool for guiding coronary bifurcation with its unrivalled high resolution. Compared to angiography, intravascular OCT has a clear advantage in that it depicts ostial lesion(s) in bifurcation without the misleading two-dimensional appearance of conventional angiography such as overlap and foreshortening. In addition, OCT has the ability to reconstruct a bifurcation in three dimensions and to assess the side branch ostium from 3D reconstruction of the main vessel pullback, which can be applied to ensure the optimal recrossing position of the wire after main vessel stenting. Recently, online co-registration of OCT and angiography became widely available, helping the operator to position a stent in precise landing zones, reducing the risk of geographic miss. Despite these technological advances, the currently available clinical data are based mainly on observational studies with a small number of patients; there is little evidence from randomised trials. The joint working group of the European Bifurcation Club and the Japanese Bifurcation Club reviewed all the available literature regarding OCT use in bifurcation lesions and here provides recommendations on OCT guiding of coronary interventions in bifurcation lesions. © Europa Digital & Publishing 2019.

BACKGROUND: Current evidence on the long-term outcome and its determinants in patients with unprotected left main trifurcation (LMT) treated with percutaneous coronary intervention (PCI) is based on small-sized studies. We aimed to assess the clinical, anatomical and procedural factors impacting long-term clinical outcomes of patients with LMT treated by PCI. METHODS: We conducted a multicenter retrospective study on consecutive patients with unprotected LMT in stable or acute coronary settings who underwent PCI with drug-eluting-stent implantation. Primary endpoint was major adverse cardiovascular events (MACE), defined as composite of all-cause death, myocardial infarction, and target lesion revascularization. LMT lesions complexity was graded according to a modified Medina LMT score, which, together with standard criteria of >50% stenosis in any of the branches, included the presence of disease extent >5 mm in the two major side-branches. RESULTS: A total of 103 patients were analyzed, mean age 67.5 years, 37.9% with diabetes mellitus, 47.6% presenting with acute coronary syndrome, 8.7% in cardiogenic shock, with a mean SYNTAX Score of 28.1. Procedural success (angiographic success without in-hospital MACE) was achieved in 99 patients (96.1%). During 3-year follow-up, 18 patients (17.9%) experienced MACE, mainly due to target lesion revascularization (TLR), which occurred in 12 patients (11.9%). At multivariable analysis, modified Medina LMT score was the only independent predictor of MACE (HR 1.538 [1.081-2.189], P=0.017). CONCLUSIONS: PCI in patients with LMT is associated with a high procedural success rate and acceptable long-term clinical outcomes. Baseline LMT lesion complexity, assessed by an original modified Medina LMT score, is an independent driver of long-term clinical outcomes. © 2024 EDIZIONI MINERVA MEDICA.

In some cases it is critical to clinically perform coronary bifurcation stenting to minimize the potential risk for restenosis and/or stent thrombosis. The European Bifurcation Club (EBC) has provided guidelines for optimally performing such procedures. Yet, sometimes such procedures do not go as planned, and in some cases bailout procedures are required. Here we utilized Visible Heart® (VH) methodologies and multimodal visualizations to better understand each step for optimally performed T and small protrusion (TAP) procedures, as well as those in which complications occurred. These studies were performed within reanimated swine hearts in which endoscopes, fluoroscopy, and optical coherence tomography (OCT) could readily be used. Additionally, because these procedures were performed in reanimated hearts, one could intentionally cause complications, so to perform bailout procedures. Finally, following these procedures each specimen was micro CT scanned, and high resolution computational models (~40 microns) were reconstructed of the final outcomes. © 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

The 2023 European Bifurcation Club (EBC) meeting took place in Warsaw in October, and the latest evidence for the use of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to optimise percutaneous coronary interventions (PCI) on coronary bifurcation lesions (CBLs) was a major focus. The topic generated deep discussions and general appraisal on the potential benefits of IVUS and OCT in PCI procedures. Nevertheless, despite an increasing recognition of IVUS and OCT capabilities and their recognised central role for guidance in complex CBL and left main PCI, it is expected that angiography will continue to be the primary guidance modality for CBL PCI, principally due to educational and economic barriers. Mindful of the restricted access/adoption of intracoronary imaging for CBL PCI, the EBC board decided to review and describe a series of tips and tricks which can help to optimise angiography-guided PCI for CBLs. The identified key points for achieving an optimal angiography-guided PCI include a thorough analysis of pre-PCI images (computed tomography angiography, multiple angiographic views, quantitative coronary angiography vessel estimation), a systematic application of the technical steps suggested for a given selected technique, an intraprocedural or post-PCI use of stent enhancement and a low threshold for bailout use of intravascular imaging. © 2024 Europa Group. All rights reserved.

The 15th European Bifurcation Club (EBC) meeting was held in Barcelona in October 2019. It facilitated a renewed consensus on coronary bifurcation lesions (CBL) and unprotected left main (LM) percutaneous interventions. Bifurcation stenting techniques continue to be refined, developed and tested. It remains evident that a provisional approach with optional side branch treatment utilising T, T and small protrusion (TAP) or culotte continues to provide flexible options for the majority of CBL patients. Debate persists regarding the optimal treatment of side branches, including assessment of clinical significance and thresholds for bail-out treatment. In more complex CBL, especially those involving the LM, adoption of dedicated two-stent techniques should be considered. Operators using such techniques have to be fully familiar with their procedural steps and should acknowledge associated limitations and challenges. When using two-stent techniques, failure to perform a final kissing inflation is regarded as a technical failure, since it may jeopardise clinical outcome. The development of novel technical tools and drug regimens deserves attention. In particular, intracoronary imaging, bifurcation simulation, drug-eluting balloon technology and tailored antiplatelet therapy have been identified as promising tools to enhance clinical outcomes. In conclusion, the evolution of a broad spectrum of bifurcation PCI components has resulted from studies extending from bench testing to randomised controlled trials. However, further advances are still needed to achieve the ambitious goal of optimising the clinical outcomes for every patient undergoing PCI on a CBL. © Europa Digital & Publishing 2021.

Coronary bifurcations are involved in 15-20% of all percutaneous coronary interventions (PCI) and remain one of the most challenging lesions in interventional cardiology in terms of procedural success rate as well as long-term cardiac events. The optimal management of bifurcation lesions is, despite a fast growing body of scientific literature, the subject of considerable debate. The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field, and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, compact meeting, dedicated to bifurcations, which brings together physicians, engineers, biologists, physicists, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement which reflects the unique opportunity of combining the opinions of interventional cardiologists with the opinions of a large variety of other scientists on bifurcation management. The present 11th EBC consensus document represents the summary of the up-to-date EBC consensus and recommendations. It points to the fact that there is a multitude of strategies and approaches to bifurcation stenting within the provisional strategy and in the different two-stent strategies. The main EBC recommendation for PCI of bifurcation lesions remains to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. The consensus document covers a moving target. Much more scientific work is needed in non-left main (LM) and LM bifurcation lesions for continuous improvement of the outcome of our patients. © Europa Digital & Publishing 2016. All rights reserved.

The European Bifurcation Club recommends an approach to a bifurcation stenosis which involves careful assessment, planning and a sequential provisional approach. In the minority of lesions where two stents are required, careful deployment and optimal expansion are essential to achieve a long-term result. © Europa Digital & Publishing 2019. All rights reserved.

The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field of coronary artery bifurcation interventions and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, two-day compact meeting, dedicated to bifurcations, which brings together physicians, pathologists, engineers, biologists, physicists, mathematicians, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement that reflects the unique opportunity of combining the opinion of interventional cardiologists with the opinion of a large variety of other scientists on bifurcation management. A series of consensus sessions dedicated to specific topics, to strengthen the consensus debates and focus the discussions, was introduced at this year's meeting. The sessions comprise an intensive overview of the present literature, a pro and con debate and a voting system, to guide the consensus-building process. The present document represents the summary of the up-to-date EBC consensus and recommendations from the 12th annual EBC meeting in 2016 in Rotterdam. © Europa Digital & Publishing 2018.

The 2017 European Bifurcation Club (EBC) meeting was held in Porto (Portugal) and allowed a multidisciplinary international faculty to review and discuss the latest data collected in the field of coronary bifurcation interventions. In particular, the topic of percutaneous coronary intervention (PCI) on left main coronary artery (LM) disease was highlighted as a contemporary priority. Herein, we summarise the key LM anatomy features, the diagnostic modalities and available data that are relevant for a patient's procedural management. Since the clinical outcomes of patients undergoing PCI on LM disease may depend on both PCI team organisation and PCI performance, the optimal catheterisation laboratory set-up and the rationales for device and technique selection are critically reviewed. The best lesion preparation modalities, the different DES implantation technique choices and the strategies to be considered during PCI on unprotected LM for optimal PCI results are reviewed step by step. © Europa Digital & Publishing 2018.

Monotherapy with a potent P2Y12 receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).

Background: The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in non-left main true bifurcations. Aims: This study aimed to investigate the 5-year clinical results of the EBC TWO Trial. Methods: A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation. Results: The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34). Conclusions: In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. © Europa Digital & Publishing 2023. All rights reserved.

The T and small protrusion (TAP) technique is a modification of provisional T-stenting aimed at optimising "bail-out" SB stent implantation in bifurcated coronary lesions treated using the "provisional" approach. The main strengths of the TAP stenting technique are: compatibility with 6 Fr guiding catheters, full coverage of the side branch ostium, and facilitation of final kissing balloon inflation. The main drawback of TAP is related to the creation of a single layer stent strut neocarina of variable length. In this paper, we review the technical aspects which should be considered in order to achieve TAP stenting successfully in the case of "bail-out" need for side branch stenting. Furthermore, we report the technical details which may help in the practice of TAP stenting in complex bifurcated lesions with the anticipated high probability of requiring double stenting. Although no large trial has investigated this technique, the clinical results reported so far look promising. © 2015 Europa Digital & Publishing. All rights reserved.