Kissing Balloon Inflation Research Articles

Abstract 4137144: Return to Cath Lab: Chest Pain Resolution after Right Coronary Artery Chronic Total Occlusion Intervention

Introduction: Subacute stent thrombosis (ST) is related to high rates of cardiac reinfarction. We present a case of reinfarction from ST. The patient’s chest pain (CP) was not alleviated with initial revascularization of his left circumflex (LCx) ST, requiring PCI to his right coronary artery (RCA) chronic total occlusion (CTO). This is a novel approach to CTO PCI which is traditionally a non-urgent procedure. Case: A 53-year-old male with a history of coronary artery disease and surgical turndown presented to the ED with CP. Two weeks prior he had impella guided LM bifurcation PCI with DES and ramus intermedius (RI) angioplasty (PTA) but was nonadherent to clopidogrel. He had a BP of 127/85, HR of 65, and was on room air. Exam was unremarkable. His EKG was in sinus rhythm with S-T depressions ~1mm in leads V1-V4 concerning for posterior infarction. HS-troponin (HST) was 60. Angiography (CA) showed thrombotic occlusion of his LCx DES (Fig 1a) and an RCA CTO (Fig 1c). Optical coherence tomography (OCT) revealed DES struts overlying the ostial LCx concerning for mechanical deformation from carinal shift. OCT guided PTA and laser thrombectomy (LT) of the LCx led to TIMI-3 Flow. LT and kissing balloon inflation (BI) was performed on the LAD and LCx to reshape the carina. HST peaked at 116,012. He had CCS Class IV CP despite medical therapy and returned for re-look CA with TIMI-3 flow in the left-sided circulation without thrombus (Fig 1b). He had PCI to his distal RCA CTO with two DES and TIMI-3 flow in the RCA (Fig 1d). He did not have recurrence of CP. Discussion: Bifurcation PCI leads to challenges from anatomic reconfiguration, metallic DES deformity, and changes in blood flow leading to increased risk of distal ST. This patient’s CA demonstrated LM DES material overlying the LCx from carinal shifting which likely led to interrupted flow dynamics. His LCx ST was partly due to this stasis and his clopidogrel nonadherence. Despite PCI of his LCx his CP remained with poor collateral flow from the left circulation. While CTO procedures are typically done non urgently, emergent intervention on our patient’s RCA CTO led to complete resolution of his CP and clear benefit for symptomatic management.

OSDOKINA crush technique for the management of side branch ostial lesion ISTANBOL study

Abstract Background Isolated ostial bifurcation lesions (Medina type 0.0.1) represent <20% of coronary bifurcation lesions. Percutaneous coronary intervention (PCI) of this subset of lesions is challenging for the interventional cardiologist because of the technical difficulty and potential risk of serious complications. Purposes Recently, we devised a new technique, called the OSDOKINA crush technique, for the treatment of Medina type 0.0.1 coronary bifurcation lesions. The aim of this study was to evaluate the technical feasibility, safety and short-term and midterm procedural and clinical results achieved with OSDOKINA crush technique for Medina type 0.0.1 coronary bifurcation lesions. Materials and Methods Between September 2020 and January 2024, we included 49 patients who had Medina type 0,0,1 coronary bifurcation lesions. The vessel size had to be ≥2.5 mm by visual estimation on coronary angiography. Demographic, clinical and lesion characteristics of the cases were recorded. Quantitative coronary angiography analyses were performed using dedicated bifurcation angiographic software. Procedural success was defined as successful implantation of the stent into the target lesion, causing a final residual stenosis ≤30%. Major adverse cardiac events(MACE) were defined as cardiac death, myocard infarction and target lesion revascularisation. All patients were followed up to twelve months after the intervention. Results The lesion localisations were the ostium of diagonal branch in 19 (38.7%), ostium of the obtuse marginalis branch in 17 (34.6%), ostium of right posterior descending or right posterolateral branch in 13 (26.7%). SB RVD, SB lesion length and SB diameter stenosis by QCA were 2.65±0.35 mm, 9.4±3.9 mm, and 79.8±12.6, respectively. SB predilatation was applied in all cases. In 1 patient (2.1%), a stent had to be placed in the main branch using the double-kissing mini crush technique due to flow-limiting dissection that developed after the second kissing balloon inflation. Considering all cases, the angiographic success rate was 97.9% (n: 48). All patients had 12-month follow-up results. Acute myocardial infarction occurred in 1 patient (2.1%) due to side branch stent thrombosis. No patient had main branch revascularization. Cardiac or non-cardiac death was not observed. Cumulative MACE was 2.1%(n:1). Conclusion The OSDOKINA crush technique has excellent acute results and midterm clinical outcomes in the management of Medina type 0.0.1 coronary bifurcation lesions. Multicenter studies with large patient groups are needed.

TCT-558 Repeat Proximal Optimization Technique Following Kissing Balloon Inflation in Percutaneous Coronary Interventions for Left Main Coronary Bifurcation Lesions: Insights From Intravascular Ultrasound

TCT-558 Repeat Proximal Optimization Technique Following Kissing Balloon Inflation in Percutaneous Coronary Interventions for Left Main Coronary Bifurcation Lesions: Insights From Intravascular Ultrasound

Technological Advances Are Associated With Better Clinical Outcomes of Percutaneous Coronary Intervention inPatients With Unprotected Left MainDisease.

Few large-scale studies have evaluated the effectiveness of percutaneous coronary intervention (PCI) technological advances in the treatment of patients with unprotected left main coronary artery disease (LM-CAD). We aim to identify independent factors that affect the prognosis of PCI in patients with unprotected LM-CAD and to assess the impact of PCI technological advances on long-term clinical outcomes. A total of 4512 consecutive patients who underwent unprotected LM-CAD PCI at Fuwai Hospital from 2004 to 2016 were enrolled. Multivariable Cox proportional hazards model was used to identify which techniques can independently affect the incidence of major adverse cardiac events (MACEs; a composite of cardiac death, myocardial infarction, or target vessel revascularization). The incidence of 3-year MACEs was 9.0% (406/4512). Four new PCI techniques were identified as the independent protective factors of MACEs, including second-generation drug-eluting stents (hazard ratio [HR], 0.61 [95% CI, 0.37-0.99]), postdilatation (HR, 0.75 [95% CI, 0.59-0.94]), final kissing balloon inflation (HR, 0.78 [95% CI, 0.62-0.99]), and using intravascular ultrasound (HR, 0.78 [95% CI, 0.63-0.97]). The relative hazard of 3-year MACEs was reduced by ≈50% with use of all 4 techniques compared with no technique use (HR, 0.53 [95% CI, 0.32-0.87]). PCI technological advances including postdilatation, second-generation drug-eluting stent, final kissing balloon inflation, and intravascular ultrasound guidance were associated with improved clinical outcomes in patients who underwent unprotected LM-CAD PCI.

Coronary bifurcation lesion treatment with the BioMime™ Branch sirolimus-eluting coronary side-branch stent system: A single-center experience

BackgroundCoronary bifurcation lesions (CBL) comprise 15 %–20 % of percutaneous coronary procedures and remain a challenge despite advances in stent and interventional techniques. The BioMime™ Branch sirolimus-eluting coronary side-branch stent (BBSES) is specifically designed for CBL treatment in conjunction with a standard drug-eluting stent (DES). We report the first single-center experience of treating complex CBL with the novel BBSES. MethodsThis is a retrospective, single-center study involving consecutive prospectively identified patients who underwent treatment of true CBL with the BBSES. The protocol included BBSES+DES implantation in the CBL and simultaneous final kissing balloon inflation. ResultsFifty-eight CBL were treated in 58 consecutive patients (89.6 % men, mean age 69.0 ± 9.5 years) presenting primarily with stable angina (84.4 %) and true (Medina 1,1,1,) CBL. Procedural success was 100 % without major adverse cardiac events (MACE). At a median follow-up of 18 months, one sudden death was reported that was accounted as possible late stent thrombosis. One patient had spontaneous myocardial infarction due to subacute thrombosis of a DES implanted in the main vessel proximally to the BBSES before the index procedure. Another patient was hospitalized for atrial fibrillation. ConclusionsThis is the first clinical experience to date of true CBL treatment with the BBSES demonstrating high procedural success, no in-hospital MACE and sustained clinical results at a median follow-up of 18 months.

Comparison of Proximal Optimisation with Kissing Inflation Technique with Kissing Balloon Inflation for Treatment of Coronary Bifurcations

Comparison of Proximal Optimisation with Kissing Inflation Technique with Kissing Balloon Inflation for Treatment of Coronary Bifurcations

Optimal Percutaneous Treatment Approach to Unprotected Ostial Left Anterior Descending Artery Disease: A Meta-Analysis and Systematic Review

The optimal management strategy for significant unprotected ostial left anterior descending artery (LAD) disease remains undefined. Merits of the two most common percutaneous approaches are considered in this quantitative synthesis. A meta-analysis was performed to compare ostial stenting (OS) and crossover stenting (CS) in the treatment of unprotected ostial LAD stenosis. The primary outcome is the disparity in target lesion revascularisation (TLR). The Mantel-Haenszel method was employed with random effect model, chosen a priori to account for heterogeneity among the included studies. Seven studies comprising 1,181 patients were included in the analyses. Of these, 482 (40.8%) patients underwent CS. Overall, there was a statistically significant trend in favour of CS (odds ratio 0.51, 95% confidence interval 0.30-0.86, p=0.01) with respect to the rate of TLR at follow-up. This remained true when TLR involving the left circumflex artery (LCx) was considered, even when there was a greater need for unintended intervention to the LCx during the index procedure (odds ratio 6.68, 95% confidence interval: 1.69-26.49, p=0.007). Final kissing balloon inflation may reduce the need for acute LCx intervention. Imaging guidance appeared to improve clinical outcomes irrespective of approach chosen. In the percutaneous management of unprotected ostial LAD disease, CS into the left main coronary artery (LMCA) appeared to reduce future TLR. Integration of intracoronary imaging was pivotal to procedural success. The higher incidence of unintended LCx intervention in the CS arm may be mitigated by routine final kissing balloon inflation, although the long-term implication of this remains unclear. In the absence of randomised trials, clinicians' discretion remains critical.

The impact of the bifurcation angle for the Nano-Crush two-stent coronary bifurcation technique on long-term outcomes in a real-world clinical population

AimThis study aims to assess the direct impact of bifurcation angle (BA) on immediate procedural outcomes and patient prognosis post-Nano-Crush stenting for coronary bifurcation lesions. MethodsA retrospective analysis was conducted for all consecutive patients treated with the Nano-Crush technique across two high-volume interventional centers from January 2020 to October 2022. Primary endpoint: comparison of target lesion failure rate in two cohorts based on bifurcation angle (<70° vs. ≥70°), with secondary endpoints including side branch ostium coverage, rate of successful final kissing balloon inflation (FKBI), need for conversion to another technique, and procedure length. ResultsBaseline demographics included 71 patients in the BA<70° group and 49 in the BA≥70° group, with well-balanced characteristics. Angiographic characteristics revealed similar trends, including anatomic and morphological lesion characteristics (referencing Syntax score, Medina classification, and presence of calcifications). Both groups predominantly had complex coronary disease, with a baseline mean Syntax score of 24.18 ± 8.19 in the BA<70° group and 23.91 ± 7.29 in the BA≥70° group, respectively. A dedicated debulking device for lesion preparation was used in 25.35 % of patients in the first group and in 28.57 % of patients in the second group.The primary endpoint occurred in 5.63 % of patients in the BA<70° group and in 4.08 % of patients in the BA≥70° group (P = 0.7014) after ≥ 2 years of clinical follow-up. Angiographic success was achieved in 100 % of both groups, with procedural time averaging 74.99 ± 25.55 min in the BA≥70° and 76.94 ± 27.81 min in the BA<70° (P = 0.6922). The rate of successful final kissing balloon inflation was 98.59 % in the BA<70° group and 95.91 % in the BA≥70° group (P = 0.3566). The mean contrast volume was 189.54 ± 73.74 ml in BA<70° and 168.9 ± 62.77 ml in BA≥70° (P = 0.1126). Clinical follow-ups at 30 days and 2 years revealed similar outcomes and complications for each group, as summarized in Table 3. ConclusionsOur results demonstrate that the bifurcation angle does not significantly impact long-term clinical outcomes or procedural parameters, such as side branch ostium coverage, conversion to a modified DK Crush technique, FKBI success rate, and procedure length. These findings suggest that the Nano-Crush technique can be a viable option for bifurcation lesions, irrespective of the bifurcation angle, achieving optimal side branch ostium coverage while preventing excessive protrusion into the main vessel.

Acute and long-term results of percutaneous coronary intervention of bifurcation lesions with the dedicated Bioss Lim C stent: the Italian BIfurcation Observational Spontaneous Study (IBIOSS).

Percutaneous coronary intervention (PCI) for bifurcation lesions still represents a clinical challenge. The Bioss Lim C is a dedicated device for bifurcation lesions, features a tapered shape and large cells, and thus appears as a promising adjunct to the current interventional cardiologists' armamentarium. We aimed at conducting a prospective multicenter study focusing on early and long-term results after Bioss Lim C implantation for true coronary bifurcation lesions. Patients with true bifurcation lesions in whom Bioss Lim C implantation was attempted were enrolled in four Italian centers. An explicit bifurcation management approach was recommended, leaving however the choice between one- vs. two-stent strategies at operator's discretion. Acute and long-term results were systematically appraised, focusing on an acute composite of complex side branch (SB) rewiring, SB pinching, or SB occlusion (primary efficacy endpoint), as well as major adverse events (MACE, i.e. death, myocardial infarction [MI], or target vessel revascularization [TVR]), individual components of MACE, and stent thrombosis. A total of 207 patients were included, with age of 67.3±10.8 years, and 40 (19.3%) women. The target lesion was located in the left main in 48 (23.2%) patients, whereas proximal reference vessel diameter was 3.69±0.48 mm, and lesion length 20.3±3.4 mm. According to the Medina classification, most patients (60 [30.9%]) had 1-1-1 lesions. Drug-eluting stent implantation in the SB was carried out in 19 (9.3%) subjects, and kissing balloon inflation was used in 67 (32.5%). The primary efficacy endpoint occurred in 27 (13.0%), with side branch (SB) occlusion in two (1.0%), SB pinching in 23 (11.1%), and complex SB rewiring in six (2.9%), and was most frequent in patients with lower body mass index or dyslipidemia. After 24.1±19.5 months, MACE were adjudicated in 23 (11.1%) subjects, with death in 10 (4.8%), MI in six (2.9%), and TVR in seven (3.4%), as well as stent thrombosis in one (0.5%). This study supports a wider adoption of the Bioss Lim C dedicated bifurcation device, thanks to the favorable acute results as well as long-term clinical outcomes, as well as its versatility for the stenting strategy provisionally or eventually adopted by operators.

Longitudinal outcomes of final kissing balloon inflation in coronary bifurcation lesions treated with a single stent

BackgroundFinal kissing balloon inflation (FKBI) is a percutaneous coronary intervention (PCI) technique that is considered mandatory to improve outcomes in two-stent strategies, but its use in single-stent bifurcation PCI remains controversial.MethodsIn this retrospective cohort study, we identified patients with coronary bifurcation lesions treated with one stent from January 2012 to March 2021 at a single academic medical center. Incidence rates per 1,000 patient-years (IR1000) were calculated for the outcomes of all-cause mortality, myocardial infarction (MI), stent thrombosis (ST), target lesion revascularization (TLR), coronary artery bypass graft (CABG), and cardiac readmission between patients who received FKBI and those who did not over a median follow up of 2.3 years. Studied outcomes were adjusted for all baseline clinical and procedural characteristics.ResultsThis study included 893 consecutive patients of which 256 received FKBI and 637 did not. The IR1000 for MI were 51.1 and 27.6 for patients who received FKBI and patients who did not, respectively (adjusted HR = 2.44, p = 0.001). The IR1000 for death were 31.2 and 52.3 for patients who received FKBI and patients who did not, respectively (adjusted HR = 0.68, p = 0.141). The incidence rates of ST, TLR, CABG, and cardiac readmissions were similar between patients who received FKBI and those who did not.ConclusionsThese results suggest that performing FKBI in a one-stent technique was associated with higher rates of myocardial infarction, particularly in the first 6 months, and no difference in death, ST, TLR, CABG, and cardiac readmission rates.

Double kissing inflation outside the stent versus jailed balloon technique for coronary bifurcation lesions

Abstract Background Side branch (SB) occlusion remains challenging in percutaneous coronary intervention (PCI) for bifurcation lesions even in the era of jailed balloon technique (JBT). Our previous single-arm study introduced a novel method to protect SB named double kissing inflation outside the stent (DKo), which features twice inflation of the protective balloon kissing with the stent balloon and post-dilation balloon. Objective To confirm whether DKo can protect SB better than JBT in a large sample of bifurcation lesions. Methods This retrospective, single-center cohort study enrolled 875 consecutive patients underwent bifurcation PCI either in DKo (n=209) or JBT group (n=666). The primary endpoint was transient SB loss after removal of the protective balloon. The secondary endpoints included rates of SB rewiring, final kissing balloon inflation (FKBI), SB stenting, final SB loss, and peri-procedural myocardial infarction (PMI). Results Transient SB loss occurred in only 1 patient (0.5%) in DKo but 32 patients (4.8%) in JBT (p&amp;lt;0.005). Transient loss in JBT group was triggered by rewiring (n=21), post-dilation (n=8) and severe dissection (n=3). DKo caused lower rates of rewiring (0.5% vs. 13.8%, p&amp;lt;0.001), FKBI (0.5% vs. 7.7%, p&amp;lt;0.001) and PMI (0.5% vs. 2.9%, p=0.045). SB stenting and final SB loss showed a lower tendency in DKo [0% vs. 0.8%, p=0.21; 0% vs. 1.2%, p=0.11]. DKo was the only protector against transient SB loss [odds ratio=0.08, 95% confidence interval (0.01-0.59), p=0.013]. Conclusion DKo protects SB better than JBT in PCI for bifurcation lesions. Randomized controlled studies are required to confirm the long-term benefit.

Impact of coronary bifurcation angle on stent malapposition in a randomized comparison between proximal optimization technique followed by side branch dilatation and kissing balloon inflation.

The impact of coronary bifurcation angle (BA) on incomplete stent apposition (ISA) after crossover stenting followed by side branch (SB) intervention has not been established. A total of 100 crossover stentings randomly treated with proximal optimization technique followed by short balloon dilation in the SB (POT-SBD group, 48 patients) and final kissing balloon technique (KBT group, 52 patients) were analyzed in the PROPOT trial. Major ISA with maximum distance>400μm and its location was determined using optical coherence tomography before SB intervention and at the final procedure. The BA was defined as the angle between the distal main vessel and SB. Optimal POT was determined when the difference in stent volume index between the proximal and distal bifurcation was greater than the median value (0.86mm3/mm) before SB intervention. Major ISA was more frequently observed in the POT-SBD than in the KBT group (35% versus 17%, p<0.05). In the POT-SBD group, worsening ISA after SBD was prominent at the distal bifurcation. The BA was an independent predictor of major ISA (odds ratio 1.04, 95% confidence interval 1.00-1.07, p<0.05) with a cut-off value of 59.5° (p<0.05). However, the cases treated with optimal POT in the short BA (<60°) indicated the lowest incidence of major ISA. In the KBT group, BA had no significant impact. A wide BA has a potential risk for the occurrence of major ISA after POT followed by SBD in coronary bifurcation stenting.

DES Selection for Left Main and Coronary Bifurcation Stenting.

Coronary bifurcation lesions present a challenging lesion subset regarding procedural complexity and worse patient outcomes as compared to simple lesions. Drug eluting stents (DES), as the current standard of care for percutaneous myocardial revascularization, have tubular design and uniform diameter, and therefore, need to be subjected to a standardized set of procedural modifications, to optimally fit and reconstruct underlying bifurcation anatomy. Since contemporary DES have various design platforms, with diverse mechanical properties, we must be aware of the device's favorable characteristics and limitations, to ensure maximal procedural safety and success. This is especially true for bifurcation lesion stenting, during which device integrity will often be eventually tested by undergoing specific procedural steps, such as proximal balloon optimization, kissing-balloon inflations, or even intentional stent crushing. In this review we address the design characteristics of contemporary DES, their bifurcation-specific experimental testing data, and reported clinical results, in an attempt to provide relevant information and help in device selection for bifurcation stenting procedures.

Stenting the unprotected left main coronary artery- mid-term outcomes of the observational registry

Abstract Background New imaging modalities such as IVUS had improved results of Stenting of the unprotected left main coronary artery (UPLM). The results of stenting UPLM without these new modalities but with meticulous care need to be studied more. Methods This prospective and retrospective study was performed in multiple local centers. The local ethics committee approved the study, and the patients signed informed consent. In addition, the local heart team, including a cardiac surgeon, was consulted for a joint decision agreement. In the last five years, one hundred twenty patients with left main disease &amp;gt;50% were subjected to stenting with drug- eluted stents.All patients were subjected to detailed history taking with particular emphasis on acute coronary syndrome, angina duration, class, previous coronary interventions, and medications. In addition, 12 lead ECGs were revised with an evaluation of ST/T changes and any old infarction. An echocardiographic examination was done on all patients. Relevant laboratory tests were done.Risk assessment was calculated for every patient, including Euro SCORE and Syntax score. Patient selection: Consecutive patients arriving for primary Stenting or acute coronary episode were included. Medications: All patients received clopidogrel and aspirin before the planned procedure. Anticoagulation with unfractionated heparin in a dose of 10000 IU was given at the beginning of the PCI. Post PCI, all patients received B blockers, ACE inhibitors, statins, and dual antiplatelets in the guidelines recommended doses. Calcification was assessed by angiographic imaging only. We estimated the vessel diameter as 2/3 diameter of the branches. PCI technique: A steerable guidewire was advanced in LAD, followed by PCI with pre-dilatation or direct Stenting according to the operator’s discretion. One or two stent strategy was utilized according to the situation of the lesions. Results 92 patients (77.3%) presented with ACS, of which 65 patients (54.6%) had no Previous Intervention, and 27 patients (22.7%) had a previous PCI. Left ventricular ejection fraction significantly correlates with the complication at six months follow-up; all 16 patients with reported complications (100%) had baseline LVEF of &amp;lt;40% (P-value = 0.023). Syntax score 11 patients (55%) with a high score of more than 32 had adverse events, P = 0.004. Residual syntax shows a less significant correlation with a mean value of 7.3 in the complication group vs. 4.9 in the other group (P = 0.016). Final kissing balloon inflation shows no statistically significant difference. Conclusions PCI in UPLM is a safe, feasible option with a high technical success rate and acceptable outcome at follow-up, even without the utilization of IVUS

Clinical prognostic value of a novel quantitative flow ratio from a single projection in patients with coronary bifurcation lesions treated with the provisional approach.

A novel quantitative flow ratio (μQFR) for bifurcated coronary vessels, derived from a single projection, has been recently reported. Provisional stenting is effective for most bifurcation lesions. However, the clinical value of the side branch (SB) μQFR in patients with coronary bifurcation lesions undergoing provisional stenting remains unclear. This study aims to determine the clinical predictive value of the SB μQFR after provisional stenting in patients with coronary bifurcation lesions. Between June 2015 and May 2018, 288 patients with true coronary bifurcation lesions who underwent a provisional approach without SB treatment (including predilation, kissing balloon inflation or stenting) were classified by an SB μQFR <0.8 (n=65) and ≥0.8 (n=223) groups. The primary endpoint was the three-year composite of target vessel failure (TVF), including cardiac death, target vessel myocardial infarction (TVMI), and revascularisation (TVR). Three years after the procedures, there were 43 (14.9%) TVFs, with 19 (29.2%) in the SB μQFR <0.8 and 24 (10.8%) in the SB μQFR ≥0.8 groups (adjusted hazard ratio [HR] 2.45, 95% confidence interval [CI] 1.39-5.54; p=0.003), mainly driven by increased TVMI (16.9% vs 5.4%, adjusted HR 3.29, 95% CI: 1.15-6.09; p=0.030) and TVR (15.4% vs 2.2%, adjusted HR 6.39, 95% CI: 2.04-13.48; p=0.007). Baseline diameter stenosis at the ostial SB and SB lesion length were the two predictors of an SB μQFR <0.8 immediately after stenting the main vessel, whereas previous percutaneous coronary intervention and an SB μQFR <0.8 were the two independent factors of 3-year TVF. An SB μQFR <0.8 immediately after the provisional approach is strongly associated with clinical events. Further randomised studies with large patient populations are warranted.

Configuration of two-stent coronary bifurcation techniques in explanted beating hearts: the MOBBEM study.

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. 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. 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 acomposite of stent underexpansion (<90%), side branch ostial area stenosis >50% and the gap between stents. Atotal 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. 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.

A multi-device robotic-assisted PCI system: a proof-of concept study for left main bifurcation stenting with culotte technique in a porcine model

Background and purpose: Robotic-assisted percutaneous coronary intervention (PCI) has been increasingly used for simple lesion. For complex lesions, extensive manual intervention is still required. This study aims to verify the stability and safety of this robot system in complex lesion under fifth-generation (5G) network before clinical trial. Methods: We developed a robotic system that allows simultaneous remote control of multiple devices using a 5G wireless network. The key feature of the system is a bionic thumb along with two-bionic forefingers. The system was tested in eight pigs (six over 18.3 km and two over 1,100 km). Two stents were placed in the left main bifurcation using the culotte technique. All procedures, barring device loading onto the robot system, including manipulation of the guiding catheter, wire adjustments, stent or balloon positioning, and notably the final kissing step, were conducted remotely. Results: The rate of procedure success was 100%, with no device-related complications. In comparison to short-distance remote control, the delay with long-distance remote control was minimal (90.9 ± 1.5 vs. 81.5 ± 2.7 ms for command data transmission; 163.2 ± 1.3 vs. 161.0 ± 1.4 ms for image transmission). The procedure time was shorter when using two pairs versus a single pair of bionic fingers (104.3 ± 10.2 vs. 126.0 ± 3.9 min), primarily due to less time needed for device loading and exchange (33.1 ± 4.2 vs. 56.1 ± 4.0 min). Conclusions: With the 5G network, long distance was not a significant barrier for robotic-assisted PCI for chronic total occlusion. A design of the independent bionic finger module enabled final kissing balloon inflation with reduced requirement for manual intervention. Whether the system could be used beyond left main bifurcation lesions requires further investigation.

Serial changes of the side-branch ostial area after single crossover stenting with kissing-balloon inflation

PurposeWe aimed to investigate the serial change of the side-branch ostial area (SBOA) depended on the wire-position before Kissing-balloon inflation (KBI) in the single-stent strategy for bifurcation lesions separately in the left main coronary artery (LMCA) and in non-LMCA.MethodsPatients who underwent a single-stent KBI for a bifurcation lesion and had OCT images at the timing of the rewiring, at the post-procedure, and at the 9-month follow-up were extracted from the 3D-OCT Bifurcation Registry, which is a multicenter-prospective registry of patients with a percutaneous coronary intervention for a bifurcation lesion under OCT guidance. The SBOA was measured by dedicated software, and the rewiring position at the side-branch ostium after crossover stenting was assessed by three-dimensional-optical coherence tomography (3D-OCT). The optimal rewiring was defined as link-free-type and distal rewiring. The relationship between the optimal rewiring and the serial change of the SBOA was investigated separately in LMCA and non-LMCA cases.ResultsWe examined 75 bifurcation lesions (LMCA, n = 35; non-LMCA, n = 40). The serial changes of the SBOA with the optimal rewiring were not significantly different regardless of LMCA and non-LMCA (LMCA:3.96 to 3.73 mm2, p = 0.38; non-LMCA:2.16 to 2.21 mm2, p = 0.98), whereas the serial changes of the SBOA with the sub-optimal rewiring were significantly reduced (LMCA:6.75 to 5.54 mm2, p = 0.013; non-LMCA:2.28 mm2 to 2.09 mm2, p = 0.024). There was no significant difference in clinical events between the optimal and sub-optimal rewiring group regardless of the LMCA and non-LMCA.ConclusionThe side-branch ostial area dilated with the optimal rewiring position in a bifurcation lesion treated with single crossover stenting and kissing-balloon inflation was preserved regardless of whether the bifurcation was in the LMCA or a non-LMCA.

The Degree of Stent Apposition Measured by Stent Enhancement at the Level of the Side Branch as a Novel Predictor of Procedural Success in Left Main PCI.

Stent enhancement techniques allow adequate visualization of stent deformation or incomplete stent expansion at the ostium of the side branch. Measuring the stent enhancement side branch length (SESBL) could reflect procedural success in terms of optimal stent expansion and apposition with better long-term outcomes. A longer SESBL may reflect a better stent apposition at the polygon of confluence and at the side branch (SB) ostium. We evaluated 162 patients receiving the left main (LM) provisional one-stent technique and measured the SESBL, dividing them into two groups: SESBL≤ 2.0 mm and SESBL > 2.0 mm. The mean SESBL was 2.0 ± 1.2 mm. More than half of the bifurcations had both main and side branch lesions (Medina 1-1-1) (84 patients, 51.9%) and the length of the SB disease was 5.2 ±1.8 mm. Kissing balloon inflation (KBI) was performed in 49 patients (30.2%). During follow-up (12 months), there was a significantly higher rate of cardiac death in the SESBL ≤ 2.0 mm group (p = 0.02) but no significant difference in all major adverse cardiovascular events (MACEs) (p = 0.7). KBI did not influence the outcomes (p = 0.3). Suboptimal SESBL is positively correlated with worse outcomes and SB compromise. This novel sign could aid the LM operator to assess the level of stent expansion at the ostium of the SB in the absence of intracoronary imaging.

Clinical Characteristics and Outcomes following Percutaneous Coronary Intervention in Unprotected Left Main Disease: A Single-Center Study

Background: Hemodynamically significant unprotected left main (LM) coronary artery disease is a high-risk clinical condition because of the large area of myocardium at risk, and it requires prompt revascularization. Percutaneous coronary intervention (PCI) is an appropriate alternative to coronary artery bypass grafting (CABG) for revascularization of unprotected LM disease in patients with low-to-intermediate anatomic complexity or when the patient refuses CABG after adequate counseling by the heart team. Methods: We retrospectively evaluated 201 patients receiving left main (LM) provisional one-stent or two-stent procedures, and we assessed the clinical characteristics and outcomes of patients undergoing unprotected LM PCI. Results: The mean age was 66.5 ± 9.9 years, and 72% were male. The majority of the subjects presented several cardiovascular risk factors, among which arterial hypertension (179 patients, 89.5%) and dyslipidemia (173 patients, 86.5%) were the most frequent. Out of all patients, 162 (81.8%) underwent revascularization by using the one-stent technique, while the two-stent technique was used in 36 patients (18.2%). The median value of fractional flow reserve (FFR) of the side branch was 0.9 [0.85-0.95], and 135 patients (67.1%) showed a value of FFR > 0.8. One hundred nine patients (54.2%) had a stent enhancement side branch length (SESBL) > 2, with median values of 2.5 mm2 [2.1-3]. Regarding angiographic parameters, the LM area as assessed by intravascular ultrasound (IVUS) or optical coherence tomography (OCT) and the grade of stenosis as assessed by quantitative coronary angiography (QCA) were similar between groups. However, patients who required revascularization by using the two-stent technique presented more frequently with intermediate rather than low SYNTAX scores (69.4% vs. 28.4%, p < 0.0001). Also, the same group required kissing balloon inflation (KBI) more frequently (69.4% vs. 30%, p < 0.001). There were no differences regarding the success of revascularization between the use of the one-stent or two-stent technique. FFR was able to predict a SESBL > 2 mm. The cut-off value for FFR to afford the highest degree of sensitivity (74.5%) and specificity (47%) for a SESBL > 2 was >0.86, indicating a moderate accuracy (AUC = 0.61, 95% CI 0.525-0.690, p = 0.036). Conclusions: Unprotected left main PCI is a safe and effective revascularization option amongst a complex and morbid population. There were no differences regarding the success of revascularization between the use of the one-stent or two-stent technique, and there was no significant impact of KBI on side branch FFR measurements but lower side branch FFR values were correlated with angiographic side branch compromise.