Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial.

BACKGROUND: Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding. METHODS: The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100 units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100 units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2 to 5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. CONCLUSIONS: Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation. CLINICAL TRIALS REGISTRATION NUMBER: The study protocol is registered at ClinicalTrials.gov, identifier NCT05305612.

Computed tomographic characteristics of congenital coronary artery fistulas in an adult population.

BACKGROUND: Coronary artery fistulas (CAFs) are usually congenital coronary artery anomalies of termination. AIMS: This study aimed to assess the prevalence, anatomic characteristics, and clinical significance of CAFs detected by computed tomography (CT) in an adult population. METHODS: We performed 45 817 CT examinations in 39 066 subjects between 2008 and 2020. The electronic database was manually checked using specific keywords to identify patients with CAFs. The CT characteristics of CAFs were evaluated. CAF was defined as clinically significant if it was the most plausible cause of myocardial infarction, infective endocarditis, heart failure, death during follow-up, hospitalization, or if it required either percutaneous or surgical intervention. RESULTS: Of 39 066 patients, 56 CAFs were detected in 42 subjects (20 men, 47.6%) with a prevalence of 0.11%. Most CAFs originated from the right coronary artery (RCA) (48.2%) and drained into the pulmonary artery (PA) (58.9%). CAFs terminating in the PA were more frequently multiple (P <0.001) and tortuous (P <0.001) as compared to CAFs without PA drainage. Clinically significant CAFs, identified in 7 of 42 patients, were more common in younger (P = 0.03) and male (P = 0.04) subjects and had larger lumen area and diameter at the site of origin (P = 0.03, P = 0.03, respectively). CONCLUSIONS: In the unselected adult population undergoing coronary CT angiography, the RCA and the PA are the most common sites of origin and termination of CAFs, respectively. CAFs draining into the PA are more often multiple and tortuous. Clinically meaningful CAFs are larger and most frequently detected in younger and male patients.

Transcatheter interventions for left-sided valvular heart disease complicated by cardiogenic shock: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the Association for Acute Cardiovascular Care (ACVC) and the ESC Working Group on Cardiovascular Surgery.

Valvular heart disease (VHD) is one of the most frequent causes of heart failure (HF) and is associated with poor prognosis, particularly among patients with conservative management. The development and improvement of catheter-based VHD interventions have broadened the indications for transcatheter valve interventions from inoperable/high-risk patients to younger/lower-risk patients. Cardiogenic shock (CS) associated with severe VHD is a clinical condition with a very high risk of mortality for which surgical treatment is often deemed a prohibitive risk. Transcatheter valve interventions might be a promising alternative in this setting given that they are less invasive. However, supportive scientific evidence is scarce and often limited to small case series. Current guidelines on VHD do not contain specific recommendations on how to manage patients with both VHD and CS. The purpose of this clinical consensus statement, developed by a group of international experts invited by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Scientific Documents and Initiatives Committee, is to perform a review of the available scientific evidence on the management of CS associated with left-sided VHD and to provide a rationale and practical approach for the application of transcatheter valve interventions in this specific clinical setting.

Pericoronary adipose tissue density is increased in patients with recent spontaneous coronary dissection.

OBJECTIVE: Inflammatory activity is one of the potential mechanisms of spontaneous coronary artery dissection (SCAD). Recently, the pericoronary adipose tissue attenuation (PCAT) derived from CT angiography (CTA) has been established as a method for measuring vascular inflammation. We aimed to characterise the pancoronary and vessel-specific PCAT in patients with and without recent SCAD. METHODS: The study comprised patients with SCAD referred to a tertiary centre between 2017 and 2022 who underwent CTA and were compared with individuals with no prior SCAD. PCAT was analysed on end-diastolic CTA reconstructions along proximal 40 mm of all major coronary vessels as well as the SCAD-related vessel. We analysed 48 patients with recent SCAD (median 6.1 (IQR 3.5-14.9) months since SCAD, 95.8% female) and 48 patients in the group without SCAD. RESULTS: Pancoronary PCAT was higher in patients with SCAD compared with those without SCAD (-80.6±7.9 vs -85.3 HU±6.1, p=0.002). Vessel-specific PCAT in patients with SCAD compared with patients without SCAD was higher for both the RCA (-80.9±9.5 vs -87.1±6.9 HU, p=0.001) and the LCA (-80.3±7.8 vs -83.4±7.2 HU, p=0.04). In patients with SCAD, PCAT of the SCAD-related vessel was not significantly different from averaged PCAT of unaffected vessels (-81.2±9.2 vs -80.6±7.6, p=0.74). There was no association between PCAT and the interval from SCAD to CTA. CONCLUSIONS: Patients with recent SCAD have higher PCAT compared with patients without SCAD, suggesting an increased perivascular inflammatory activity. This association is not restricted to the dissected vessel.

Management of coronary artery disease in patients undergoing transcatheter aortic valve implantation. A clinical consensus statement from the European Association of Percutaneous Cardiovascular Interventions in collaboration with the ESC Working Group on Cardiovascular Surgery.

Significant coronary artery disease (CAD) is a frequent finding in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), and the management of these two conditions becomes of particular importance with the extension of the procedure to younger and lower-risk patients. Yet, the preprocedural diagnostic evaluation and the indications for treatment of significant CAD in TAVI candidates remain a matter of debate. In this clinical consensus statement, a group of experts from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery aims to review the available evidence on the topic and proposes a rationale for the diagnostic evaluation and indications for percutaneous revascularisation of CAD in patients with severe aortic stenosis undergoing transcatheter treatment. Moreover, it also focuses on commissural alignment of transcatheter heart valves and coronary re-access after TAVI and redo-TAVI.

Clinical use of intracoronary imaging modalities in Poland. Expert opinion of the Association of Cardiovascular Interventions of the Polish Cardiac Society.

The article presents the most common, current indications for the use of intravascular invasive imag-ing diagnostic techniques, i.e. intravascular ultrasound and optical coherence tomography in Polish invasive cardiology centers. The application of the above-mentioned techniques in the diagnosis of stenosis of the left main coronary artery, optimization of stent implantation procedures, treatment of calcified lesions, and other clinically important issues are discussed.

Efficacy and safety of coronary computed tomography angiography in patients with a high clinical likelihood of obstructive coronary artery disease.

BACKGROUND: The CAT-CAD trial showed that coronary computed tomography angiography (CTA) in patients with a high prevalence of coronary artery disease (CAD) and indications for invasive coronary angiography (ICA) reduces the number of patients undergoing ICA by two-thirds and nearly eradicates non-actionable ICAs. However, the long-term benefits of this non-invasive strategy remain unknown. AIMS: To evaluate the long-term efficacy and safety of a non-invasive strategy employing coronary CTA vs. ICA as the first-line imaging test in stable patients with a high clinical likelihood of obstruc-tive CAD. METHODS: The long-term outcomes were evaluated for 36 months following randomization and included the efficacy outcome (analyzed as the composite of major adverse cardiovascular events (MACE): all-cause death, acute coronary syndrome, unplanned coronary revascularization, urgent hospitalization for a cardiovascular reason, a stroke) and the safety outcome (analyzed as a cumulative incidence of serious adverse events). RESULTS: One hundred and twenty participants at a mean age of 60.6 (7.9) years (female, 35.0%) were randomized with an allocation ratio of 1:1 to coronary CTA and direct ICA as the first-line anatomical test for suspected obstructive CAD. There were no significant differences between both diagnostic strategies neither in terms of the long-term efficacy (MACE occurrence: 15.5% in coronary CTA group vs. 16.7% in ICA group; log-rank P = 0.89) nor the long-term safety (cumulative number of serious adverse events: 36 vs. 38; P = 0.79, respectively). CONCLUSIONS: Long-term follow-up of the randomized CAT-CAD trial confirms that the strategy employing coronary CTA is an effective and safe, non-invasive, outpatient-based alternative to ICA for patients with a high clinical likelihood of obstructive CAD.

Percutaneous tricuspid edge-to-edge repair - patient selection, imaging considerations, and the procedural technique. Expert opinion of the Working Group on Echocardiography and Association of CardioVascular Interventions of the Polish Cardiac Society.

Tricuspid regurgitation (TR) is a common acquired valvular heart disease (VHD). TR has progressive character and is associated with impaired long-term survival in both symptomatic and asymptomatic subjects. Despite this knowledge, the overall number of tricuspid valve surgeries is very low worldwide and many patients with clear indications for intervention are left untreated. The development of less invasive transcatheter techniques may offer new treatment options in this growing population of patients. Out of various percutaneous methods proposed, tricuspid edge-to-edge repair has recently gained considerable attention. The article summarizes available data regarding this new treatment method.

Mechanisms, Prevention and Treatment of Saphenous Vein Graft Disease.

Saphenous vein grafts are imperfect yet indispensable conduits commonly used for coronary artery bypass grafting. Their degeneration ultimately leading to occlusion results from the pathological response of the vein to altered blood rheology and several types of vascular injury. Surgical techniques minimizing vessel damage, and prolonged antiplatelet and lipid-lowering treatment are established methods of mitigating the degeneration process hence preventing graft occlusions. Percutaneous interventions in degenerated vein grafts carry high risk of embolization, periprocedural myocardial infarction and restenosis. Thus, native vessel should be the preferred treatment target in case of graft failure whenever technically feasible.

Visually Estimated RESOLVE Score Based on Coronary Computed Tomography to Predict Side Branch Occlusion in Percutaneous Bifurcation Intervention.

PURPOSE: The quantitative RESOLVE (Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion) score derived from coronary computed tomography angiography (coronary CTA) was developed as a noninvasive and accurate prediction tool for side branch (SB) occlusion in coronary bifurcation intervention. We aimed to determine the ability of a visually estimated CTA-derived RESOLVE score (V-RESOLVE score) to predict SB occlusion in coronary bifurcation intervention. MATERIALS AND METHODS: The present study included 363 patients with 400 bifurcation lesions. CTA-derived V-RESOLVE score was derived and compared with the quantitative CTA-derived RESOLVE score. The scoring systems were divided into quartiles, and classified as the high-risk and non-high-risk groups. SB occlusion was defined as any decrease in thrombolysis in myocardial infarction flow grade after main vessel stenting. RESULTS: In total, 28 SB occlusions (7%) occurred. The concordance between visual and quantitative CTA analysis showed poor to excellent agreement (weighted κ range: 0.099 to 0.867). The area under the receiver operating curve for the prediction of SB occlusion was significantly higher for the CTA-derived V-RESOLVE score than for quantitative CTA-derived RESOLVE score (0.792 vs. 0.709, P=0.049). The total net reclassification index was 42.7% (P=0.006), and CTA-derived V-RESOLVE score showed similar capability to discriminate between high-risk group (18.6% vs. 13.8%, P=0.384) and non-high-risk group (3.8% vs. 4.9%, P=0.510) as compared with quantitative CTA-derived RESOLVE score. CONCLUSIONS: Visually estimated CTA-derived V-RESOLVE score is an accurate and easy-to-use prediction tool for the stratification of SB occlusion in coronary bifurcation intervention.

Noncalcified plaque burden quantified from coronary computed tomography angiography improves prediction of side branch occlusion after main vessel stenting in bifurcation lesions: results from the CT-PRECISION registry.

OBJECTIVES: To assess the incremental value of quantitative plaque features measured from computed tomography angiography (CTA) for predicting side branch (SB) occlusion in coronary bifurcation intervention. METHODS: We included 340 patients with 377 bifurcation lesions in the post hoc analysis of the CT-PRECISION registry. Each bifurcation was divided into three segments: the proximal main vessel (MV), the distal MV, and the SB. Segments with evidence of coronary plaque were analyzed using semi-automated software allowing for quantitative analysis of coronary plaque morphology and stenosis. Coronary plaque measurements included calcified and noncalcified plaque volumes, and corresponding burdens (respective plaque volumes × 100%/vessel volume), remodeling index, and stenosis. RESULTS: SB occlusion occurred in 28 of 377 bifurcation lesions (7.5%). The presence of visually identified plaque in the SB segment, but not in the proximal and distal MV segments, was the only qualitative parameter that predicted SB occlusion with an area under the curve (AUC) of 0.792. Among quantitative plaque parameters calculated for the SB segment, the addition of noncalcified plaque burden (AUC 0.840, p = 0.003) and low-density plaque burden (AUC 0.836, p = 0.012) yielded significant improvements in predicting SB occlusion. Using receiver operating characteristic curve analysis, optimal cut-offs for noncalcified plaque burden and low-density plaque burden were > 33.6% (86% sensitivity and 78% specificity) and > 0.9% (89% sensitivity and 73% specificity), respectively. CONCLUSIONS: CTA-derived noncalcified plaque burden, when added to the visually identified SB plaque, significantly improves the prediction of SB occlusion in coronary bifurcation intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03709836 registered on October 17, 2018.

Comparison of myocardial tissue reperfusion of inferior wall and a right ventricle among patients after primary angioplasty for an inferior myocardial infarction with right ventricular infarction.

BACKGROUND: Impaired myocardial tissue reperfusion affects prognosis of patients with ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) and can be identified by ST-segment analysis. To date, evaluation of the myocardial tissue reperfusion of the right ventricle (RV) among the patients treated with PCI for inferior STEMI with right ventricular infarction (RVI) has not been made yet. METHODS: Patients with inferior STEMI were screened for RVI. Tissue reperfusion was evaluated by maximal residual ST-segment deviation post PCI, independently for the RV and for inferior wall. Myocardial injury was assessed by the peak creatine kinase-mb (CK-MB) value. RESULTS: Among 456 patients with inferior STEMI, concomitant RVI occurred in 153 (33.5%) subjects (59.86±10.35 years old, 71.9% females). Tissue reperfusion of LV was present in 75 (49%), whereas 55 (35.9%) had both successful LV and RV reperfusion. Among 97 (63.4%) with successful tissue reperfusion of RV, 55 (56.7%) had associated successful tissue reperfusion of inferior wall. Adequate LV reperfusion was accompanied by RV in over 73.3% of patients (P=0.006). Mean peak CK-MB was lower in the group with adequate versus impaired RV tissue-perfusion (197±143 vs. 305±199 U/L, P=0.021 respectively). CONCLUSIONS: Impaired reperfusion of RV is observed in more than one third of inferior STEMIs with RVI and is not strictly associated with impaired reperfusion of inferior wall and clinical or angiographic variables, therefore ST-segment analysis for RV is mandatory.