Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry.

OBJECTIVE: We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation. STUDY DESIGN: The study was a prospective, observational, multicentre, single-arm registry. STUDY SETTINGS: The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021. STUDY PARTICIPANTS: A total of 1904 patients with symptomatic coronary artery disease (age ≥18 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled. PRIMARY AND SECONDARY OUTCOMES MEASURE: The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2/C lesion defined as per ACC/AHA (American College of Cardiology/American Heart Association) lesion classification and long coronary lesions (>20 mm). RESULTS: A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20±11.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2/C lesions (1832 lesions) and 985 had long coronary lesions (>20 mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2/C lesion, and 2.7% and 0.3% in long coronary lesions (>20 mm) subgroups, respectively. at 12 months follow-up. CONCLUSION: The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis. TRIAL REGISTRATION NUMBER: ISRCTN39751665 (https://doi.org/10.1186/ISRCTN39751665).

Safety and Effectiveness of a Novel Microcatheter in Coronary Chronic Total Occlusions-The BIOMICS Study.

Background: Chronic total occlusion (CTO) remains the most complex anatomical subset of lesions in percutaneous coronary intervention (PCI), often requiring advanced techniques and technologies, including the use of microcatheters. Methods: The BIOMICS study is a premarket first-in-human prospective, multicenter, open-label, single-arm trial investigating the safety and efficacy of a novel coronary microcatheter (BioMC, Biosensors International) in 100 patients with symptoms of ischemia undergoing elective CTO-PCI. The primary efficacy end point of the study was device success defined according to the CTO-ARC (Chronic Total Occlusion Academic Research Consortium) criteria namely the ability of the microcatheter to successfully facilitate placement of a guide wire beyond the occluded coronary segment. The primary safety end point was the incidence of in-hospital cardiac death or myocardial infarction at hospital discharge. Results: Hundred patients were recruited between March 2022 and January 2023. The primary efficacy end point was achieved in 75% of patients (95% CI, 65.3%-83.1%; P < .0001 for superiority compared to the prespecified performance goal of 54%). The primary safety end point of in-hospital cardiac death or myocardial infarction was observed in 2% of the patients. There were no study device-related coronary perforations or device failures. Conclusions: The use of a novel coronary microcatheter during CTO-PCI was associated with a high device success and an excellent safety profile.

Complex percutaneous coronary intervention in patients unable to undergo coronary artery bypass grafting during the COVID-19 pandemic: insights from the UK-ReVasc Registry.

OBJECTIVES: Cardiac surgery for coronary artery disease was dramatically reduced during the first wave of the COVID-19 pandemic. Many patients with disease ordinarily treated with coronary artery bypass grafting (CABG) instead underwent percutaneous coronary intervention (PCI). We sought to describe 12-month outcomes following PCI in patients who would typically have undergone CABG. METHODS: Between March 1 and July 31, 2020, patients who received revascularization with PCI when CABG would have been the primary choice of revascularization were enrolled in the prospective, multicenter UK-ReVasc Registry. We evaluated the following major adverse cardiovascular events at 12 months: all-cause mortality, myocardial infarction, repeat revascularization, stroke, major bleeding, and stent thrombosis. RESULTS: A total of 215 patients were enrolled across 45 PCI centers in the United Kingdom. Twelve-month follow up data were obtained for 97% of the cases. There were 9 deaths (4.3%), 5 myocardial infarctions (2.4%), 12 repeat revascularizations (5.7%), 1 stroke (0.5%), 3 major bleeds (1.4%), and no cases of stent thrombosis. No difference in the primary endpoint was observed between patients who received complete vs incomplete revascularization (residual SYNTAX score £ 8 vs > 8) (P = .22). CONCLUSIONS: In patients with patterns of coronary disease in whom CABG would have been the primary therapeutic choice outside of the pandemic, PCI was associated with acceptable outcomes at 12 months of follow-up. Contemporary randomized trials that compare PCI to CABG in such patient cohorts may be warranted.

The limited antegrade subintimal tracking technique to retrieve a trapped rotablator burr: a case report.

Background: Burr entrapment is a rare, but potentially serious complication of rotablation. This report describes the percutaneous options available for Rota burr retrieval. Case summary: A 62-year-old Caucasian man with stable angina presented for percutaneous coronary intervention. Attempted rotablation with a 1.75 mm burr resulted in Rota burr entrapment, in the heavily calcified proximal right coronary artery. A chronic total occlusion angioplasty technique (limited antegrade subintimal tracking) was successfully used to remove the trapped Rota burr, by enabling subintimal dilatation to externally crush plaque and dislodge the burr. The angioplasty procedure was then completed using the wire that had a short subintimal passage, before re-entering the true lumen. Discussion: The mechanism for Rota burr entrapment, in this case, was initiating rotablation on the heavily calcified lesion and not more proximal to allow a pecking motion. The learning points are (i) to start the rotablator several millimetres proximal to the actual lesion, and (ii) if unable to wire alongside a trapped Rota burr in the true lumen, then subintimal crossing and balloon dilatation in the subintimal space may work to dislodge the burr.

The everolimus eluting Synergy MegatronTM drug-eluting stent platform: Early outcomes from the European Synergy MegatronTM Implanters' Registry.

BACKGROUND: The Synergy MegatronTM is an everolimus-drug eluting stent that may offer advantages in the treatment of aorto-ostial disease and large proximal vessels. AIMS: To report the short- to medium-term clinical outcomes from the European Synergy MegatronTM Implanters' Registry. METHODS: This registry was an investigator-initiated study conducted at 14 European centers. The primary outcome was target lesion failure (TLF), defined as the composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularisation. RESULTS: Five hundred seventy-five patients underwent PCI with MegatronTM between 2019 and 2021. Patients were 69 ± 12 years old, 26% had diabetes mellitus, 24% had moderate-severe left ventricular impairment and 59% presented with an acute coronary syndrome. 15% were deemed prohibitively high risk for surgical revascularisation. The target vessel involved the left main stem in 55%, the ostium of the RCA in 13% and was a true bifurcation (Medina 1,1,1) in 50%.  At 1 year, TLF was observed in 40 patients, with 26 (65%) occurring within the first 30 days. The cumulative incidence of TLF was 4.5% at 30 days and 8.6% (95% CI 6.3-11.7) at 1 year. The incidence of stent thrombosis was 0.5% with no late stent thromboses. By multivariate analysis, the strongest independent predictors of TLF were severe left ventricular impairment (HR 3.43, 95% CI: 1.67-6.76, p < 0.001) and a target vessel involving the left main (HR 4.00 95% CI 1.81-10.15 p = 0.001). CONCLUSIONS: Use of the Synergy MegatronTM everolimus eluting stent in a 'real-world' setting shows favorable outcomes at 30 days and 1 year.

The Utility of CT Coronary Angiography in Chronic Total Occlusion Percutaneous Coronary Intervention.

Chronic total occlusion (CTO) of the coronary arteries is a relatively common finding in routine coronary angiography. Of late, there has been considerable improvement in the success rate of percutaneous intervention for coronary CTO, attributed to technological advancement and skills development. CT coronary angiogram (CTCA) is a simple, non-invasive, and cost-effective test that aids in the diagnosis and management of coronary artery disease, including CTOs. The development of multi-slice CT and the use of 3D volume rendering images has revolutionised the diagnostic abilities of CTCA, with improvements in imaging quality and detailed anatomical and morphological characterisation of the plaque disease. In CTO percutaneous intervention, CTCA is used in pre-procedural planning, applying scoring systems to predict the likely success of the intervention as well as the post-procedural evaluation and follow-up. This review examines the different uses of CTCA in CTO intervention, its impact on successful recanalisation and the areas for future consideration.

Follow-up optical coherence tomography to evaluate circumflex ostium after fenestration of left main Papyrus covered stent: a case report.

Background: Left main (LM) perforations necessitating a covered stent risk sacrificing the side branch. The lost side branch can be promptly recovered by fenestration of the covered stent, using a stiff wire. However, it is unclear whether subsequent balloon angioplasty of the recovered side branch ostium is sufficient to preserve side branch patency. We report the longer-term patency of the circumflex (LCx) ostium after LM covered stenting. Case summary: A 78-year-old lady, with stable angina, presented for elective angiography. Percutaneous coronary intervention of the left anterior descending (LAD) artery to LM was complicated by a distal LM perforation. A covered stent across the LM sealed the perforation but resulted in acute occlusion of the LCx. The LCx was rescued by fenestration of the covered stent with a stiff wire, followed by balloon angioplasty to the LCx ostium. At follow-up, the angina had resolved. However, follow-up angiography demonstrated a new severe stenosis at the LCx ostium, with remnants of the polyurethane membrane seen protruding into the LCx ostium on optical coherence tomography. Therefore, the LCx ostium was stented, using the reverse Culotte technique. Conclusion: This case demonstrates that stenting the LCx ostium should be considered after covered stent implantation from LM to LAD, because balloon angioplasty of the LCx ostium may not provide a durable result in this scenario.

Transcoronary electrophysiological parameters in patients undergoing elective and acute coronary intervention.

INTRODUCTION: Percutaneous coronary intervention is performed routinely in the management of myocardial infarction with obstructive coronary disease, but intervention to arteries supplying nonviable myocardium may be harmful. It is important therefore to establish myocardial viability, and there is an unmet need in current clinical practice for real time viability assessment to aid in decision making. Transcoronary pacing to assess myocardial electrophysiological parameters may be a novel viability assessment technique which could be used in this regard. METHODS: Coronary intervention was carried out according to standard departmental procedure with standard equipment. An exchange length coronary guidewire was passed into both target and reference coronary vessels and an over-the-wire balloon or microcatheter was used to insulate the guidewire and allow electrophysiological parameters to be assessed. Readings were obtained from all major epicardial vessels and substantial branches. At each position, an intracoronary electrocardiogram was recorded, and R wave amplitude was measured. Transcoronary pacing was then performed to establish threshold and impedance for each myocardial segment. A viability cardiac MRI scan was performed for each patient. A standard segmental model was used to determine viability in each segment using an 'infarct score' based on degree of late gadolinium enhancement. Studies were reported blinded to the electrical parameters obtained from the coronary guidewire. The primary outcome was the relationship between pacing threshold and myocardial segment infarct score. Secondary outcomes included the relationship between segmental infarct score and R wave height, and between segmental infarct score and pacing impedance. Data were collected on the feasibility of studying the coronary segments as well as safety. RESULTS: Sixty-five patients presenting with stable coronary artery disease or acute coronary syndromes to Leeds General Infirmary between September 2019 and August 2021 were included in the study. Electrophysiological parameters from segments with an infarct score of zero were obtained, with wide variances seen, with no significant difference in impedance or threshold in any territory. There was a significant difference in sensitivity for segments in the right coronary artery territory for both elective and acute patients. This likely relates to reduced myocardial mass in these territories. No significant association between infarct score and sensitivity, impedance or threshold were seen. CONCLUSION: This study has established intracoronary electrophysiological parameters in both normal myocardium and areas of myocardial scar. No reliable association was seen between impedance, threshold or R wave amplitude and degree of myocardial viability, contrasting with prior findings from our group and others. More work is therefore required to fully understand the role of transcoronary pacing in this setting.

Imaging Real-Time Coronary Anatomy Using a Three-Dimensional Electrophysiology Mapping System.

The aim of this study is to evaluate the feasibility of creating fast three-dimensional maps of coronary arteries and to develop a bipolar coronary guidewire in vitro and determine whether it can be localised accurately within the model.A total of five patients were recruited, and EnSite Precision was utilised to create 3D coronary anatomy. A water bath to accommodate a 3D-printed coronary model was developed to test the performance of the bipolar angioplasty wire.Successful guidewire localisation and 3D reconstruction of coronary anatomy were achieved in all the cases. No complications. The bipolar wire was able to collect point clouds, and localisation of the distal tip was excellent when tested in the water bath.Our study demonstrates the feasibility and safety of utilising EAMS to collect coronary anatomy. Real-time tracking with a bipolar catheter is accurate when tested in vitro.

Fractional Flow Reserve versus Angiography-Guided Management of Coronary Artery Disease: A Meta-Analysis of Contemporary Randomised Controlled Trials.

Background and Aims: Randomised controlled trials (RCTs) comparing outcomes after fractional flow reserve (FFR)-guided versus angiography-guided management for obstructive coronary artery disease (CAD) have produced conflicting results. We investigated the efficacy and safety of an FFR-guided versus angiography-guided management strategy among patients with obstructive CAD. Methods: A systematic electronic search of the major databases was performed from inception to September 2022. We included studies of patients presenting with angina or myocardial infarction (MI), managed with medications, percutaneous coronary intervention, or bypass graft surgery. A meta-analysis was performed by pooling the risk ratio (RR) using a random-effects model. The endpoints of interest were all-cause mortality, MI and unplanned revascularisation. Results: Eight RCTs, with outcome data from 5077 patients, were included. The weighted mean follow up was 22 months. When FFR-guided management was compared to angiography-guided management, there was no difference in all-cause mortality [3.5% vs. 3.7%, RR: 0.99 (95% confidence interval (CI) 0.62−1.60), p = 0.98, heterogeneity (I2) 43%], MI [5.3% vs. 5.9%, RR: 0.93 (95%CI 0.66−1.32), p = 0.69, I2 42%], or unplanned revascularisation [7.4% vs. 7.9%, RR: 0.92 (95%CI 0.76−1.11), p = 0.37, I2 0%]. However, the number patients undergoing planned revascularisation by either stent or surgery was significantly lower with an FFR-guided strategy [weighted mean difference: 14 (95% CI 3 to 25)%, p =< 0.001]. Conclusion: In patients with obstructive CAD, an FFR-guided management strategy did not impact on all-cause mortality, MI and unplanned revascularisation, when compared to an angiography-guided management strategy, but led to up to a quarter less patients needing revascularisation.

Feasibility of facilitated antegrade dissection with Stingray-based re-entry for coronary chronic total occlusions with previously stented graft-to-native-vessel anastomoses.

Facilitated antegrade dissection re-entry (F-ADR) is a technique described for treating post coronary artery bypass surgery chronic total occlusions (CTO) when there is flush occlusion of the distal cap of the CTO at the vein graft anastomosis. In this scenario retrograde access is usually impossible and if antegrade wiring fails, F-ADR is then the best option. Following antegrade dissection past the anastomosis, a balloon is delivered via the vein graft and inflated in the native vessel distal to the anastomosis to facilitate re-entry using a Stingray catheter. However, the applicability and outcome of this technique have not been described in cases where the graft to native vessel anastomosis has previously been stented. We report a case series of successful CTO recanalization using F-ADR across stented graft-native vessel anastomoses.

Safety and efficacy of interrupting dual antiplatelet therapy one month following percutaneous coronary intervention: a meta-analysis of randomized controlled trials.

Very short duration of dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) has recently attracted a lot of attention with the introduction of newer generations stents. This is appealing, especially in patients at high bleeding risk. However, none of the trials were powered for the individual ischemic and bleeding endpoints. All randomised controlled trials (RCTs) investigating one-month versus routine duration of DAPT in patients undergoing PCI and reporting outcomes from the time of cessation of DAPT (1 month) to 1 year were eligible for inclusion in the meta-analysis. The pooled risk ratios (RR) with their 95% confidence interval (CI) were calculated with the random-effects model using the Mantel-Haenszel method. Four RCTs involving 26,576 patients were included in this meta-analysis. Cessation of DAPT after 1 month was associated with significantly less major bleeding [RR 0.70, 95%CI (0.51-0.95), P = 0.02, heterogeneity (I2) = 42%]. There was no statistically significant difference in all-cause mortality [RR 0.84 (95%CI 0.69-1.03), P = 0.10, I2 = 0%] and stroke [RR 0.71 (95%CI 0.45-1.13), P = 0.15, I2 = 42%] when compared to routine duration of DAPT. There was also no difference in myocardial infarction (MI) [RR 1.12 (95%CI 0.91-1.39), P = 0.28, I2 = 0%], and definite or probable stent thrombosis [RR 1.49 (95%CI 0.92-2.41), P = 0.11, I2 = 0%] with cessation of DAPT after 1 month. Cessation of DAPT 1 month after PCI was associated with significantly less major bleeding, but there was no difference in the rate of all-cause mortality, stroke, MI and stent thrombosis.

British Cardiovascular Intervention Society Consensus Position Statement on Out-of-hospital Cardiac Arrest 2: Post-discharge Rehabilitation.

Out-of-hospital cardiac arrest (OHCA) is a major public health issue that poses significant challenges both in immediate management and long-term follow-up. Survivors of OHCA often experience a combination of complex medical, physical and psychological needs that have a significant impact on quality of life. Guidelines suggest a multi-dimensional follow-up to address both physical and non-physical domains for survivors. However, it is likely that there is substantial unwarranted variation in provision of services throughout the UK. Currently, there is no nationally agreed model for the follow-up of OHCA survivors and there is an urgent need for a set of standards and guidelines in order to ensure equal access for all. Accordingly, the British Cardiovascular Interventional Society established a multi-disciplinary working group to develop a position statement that summarises the most up-to-date evidence and provides guidance on essential and desirable services for a dedicated follow-up pathway for survivors of OHCA.

British Cardiovascular Interventional Society Consensus Position Statement on Out-of-Hospital Cardiac Arrest 1: Pathway of Care.

Out-of-hospital cardiac arrest (OHCA) affects 80,000 patients per year in the UK; despite improvements in care, survival to discharge remains lower than 10%. NHS England and several societies recommend all resuscitated OHCA patients be directly transferred to a cardiac arrest centre (CAC). However, evidence is limited that all patients benefit from transfer to a CAC, and there are significant organisational, logistic and financial implications associated with such change in policies. Furthermore, there is significant variability in interventional cardiovascular practices for OHCA. Accordingly, the British Cardiovascular Interventional Society established a multidisciplinary group to address variability in practice and provide recommendations for the development of cardiac networks. In this position statement, we recommend: the formal establishment of dedicated CACs; a pathway of conveyance to CACs; and interventional practice to standardise our approach. Further research is needed to understand the role of CACs and which interventions benefit patients with OHCA to support wide-scale changes in networks of care across the UK.