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The comparative effectiveness of transradial (TRA) compared with transfemoral (TFA) access in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear.Among 8404 ACS patients in the Minimising Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX (MATRIX)-Access trial, 5233 underwent noncomplex (TRA: n = 2590; TFA: n = 2643) and 1491 complex (TRA: n = 777; TFA: n = 714) PCI. Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding (net adverse cardiovascular events [NACE]) at 30 days.Rates of 30-day MACE (HR 0.94, 95% CI 0.72-1.22) or NACE (HR 0.89, 95% CI 0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary end points were lower (HR 0.84, 95% CI 0.70-1.00; HR 0.83, 95% CI 0.70-0.98; respectively) with TRA among noncomplex PCI patients, with negative interaction testing (PAmong ACS patients, PCI complexity did not affect the comparative efficacy and safety of TRA vs TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.

BACKGROUND The occurrence of acute kidney injury (AKI) among patients with acute coronary syndrome (ACS) undergoing invasive management is associated with worse outcomes. However, the prognostic implications of transient or in-hospital persistent AKI may differ. OBJECTIVES The aim of this study was to evaluate the prognostic implications of transient or in-hospital persistent AKI in patients with ACS. METHODS In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial, 203 subjects were excluded because of incomplete information or end-stage renal disease, with a study population of 8,201 patients. Transient and persistent AKI were defined as renal dysfunction no longer or still fulfilling the AKI criteria (>0.5 mg/dL or a relative >25% increase in creatinine) at discharge, respectively. Thirty-day coprimary outcomes were the out-of-hospital composite of death, myocardial infarction, or stroke (major adverse cardiovascular events [MACE]) and net adverse cardiovascular events (NACE), defined as the composite of MACE or Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS Persistent and transient AKI occurred in 750 (9.1%) and 587 (7.2%) subjects, respectively. After multivariable adjustment, compared with patients without AKI, the risk for 30-day coprimary outcomes was higher in patients with persistent AKI (MACE: adjusted HR: 2.32; 95% CI: 1.48-3.64; P < 0.001; NACE: adjusted HR: 2.29; 95% CI: 1.48-3.52; P < 0.001), driven mainly by all-cause mortality (adjusted HR: 3.43; 95% CI: 2.03-5.82; P < 0.001), whereas transient AKI was not associated with higher rates of MACE or NACE. Results remained consistent when implementing the KDIGO (Kidney Disease Improving Global Outcomes) criteria. CONCLUSIONS Among patients with ACS undergoing invasive management, in-hospital persistent but not transient AKI was associated with higher risk for 30-day MACE and NACE. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox [MATRIX]; NCT01433627).

Aims Left atrial appendage (LAA) membranes are rare congenital anomalies. Those involving the appendage orifice may obstruct its emptying flows, thus promoting blood stasis and clot formation. However, the epidemiology of LAA membranes has never been studied and a correlation with appendage thrombosis has never been proved. Very few case reports described LAA membranes, therefore, their frequency and clinical significance are not known. Moreover, their presence and degree are of crucial importance in planning LAA percutaneous closure, a procedure whose indication is evolving, and whether their presence can represent technical issues during the device implantation is not known. This study aimed to evaluate the incidence and the clinical significance of LAA membranes. Methods and results A population of 6030 consecutive transoesophageal echo (TOE) studies has been retrospectively reviewed in order to find those patients in whom an LAA membrane has been found. A literature research has been performed to review previous described cases. Among 6030 TOE cases, an LAA membrane has been described in 6 (prevalence of 1/1000). In one case, the membrane was associated to a severe LAA hypoplasia and in another case to an LAA thrombus (these represent the first cases ever described). All patients had an atrial fibrillation (AF) history and two were in AF during the TOE exam. Conclusion LAA membranes are rare congenital abnormalities occasionally discovered during a TOE exam, frequently in patients affected by AF. In half of the cases, they obstruct the LAA flow, thus theoretically pre-disposing to clot formation. They may be rarely associated to an appendage hypoplasia. During a TOE exam, cardiac imagers should always rule out their presence.

Contrast-induced acute kidney injury (CI-AKI) is prognostically relevant in invasive cardiological and radiological procedures. The administration of sodium bicarbonate has controversial effects. It has been hypothesised that bicarbonate is ineffective when unable to achieve adequate urine alkalinisation.We tested the hypothesis that alkaline urine status with oral or intravenous (i.v.) bicarbonate on top of hydration alone prevents CI-AKI.In a prospective, randomised, parallel-group, open-label trial, we compared 1) saline hydration alone (n=81); 2) i.v. bicarbonate (n=82); and 3) oral bicarbonate (n=78), in patients with chronic kidney disease (CKD) scheduled for the intra-arterial administration of contrast medium. The primary endpoint was the incidence of CI-AKI according to alkaline urine status achieved immediately before angiography. Secondary endpoints were the mean change of urine pH up to the time of angiography and the incidence of CI-AKI in the three groups.The incidence of CI-AKI was not significantly different in the three treatment arms (20% in the hydration group, 21% in the oral bicarbonate group and 22% in the i.v. bicarbonate group; p=0.94). Patients achieving a pH6 before angiography (n=145) had a significantly lower incidence of CI-AKI compared with the others (n=96; odds ratio [OR] 0.48, 95% confidence interval [CI]: 0.25-0.90; p=0.023, primary study hypothesis). The proportion of patients achieving a pH6 was higher in the i.v. and oral bicarbonate groups compared with hydration alone.Urinary pH before administration of contrast medium is an inverse correlate of CI-AKI incidence, and bicarbonate is superior to hydration alone in achieving urinary alkalinisation. Since, however, bicarbonate did not reduce the incidence of CI-AKI, we conclude that urinary pH is a marker and not a mediator of CI-AKI (ClinicalTrials.gov: NCT02980003).

Background The coronary sinus (CS) Reducer can be considered for the treatment of refractory angina in patients unsuitable for coronary revascularization, but its effect can be influenced by the significant heterogeneity in the anatomy of the cardiac venous system. Case summary We report the case of a 70-year-old woman with recurrent episodes of rest angina refractory to optimal medical therapy [Canadian Cardiovascular Society (CCS) Class IV] and inducible ischaemia in a large myocardial territory. Given the diffuse and peripheral nature of the coronary disease, the patient was considered ineligible for percutaneous or surgical revascularization and she was regarded as a good candidate for a CS occluder. Since coronary venous angiography showed the middle cardiac vein (MCV) to be at least as relevant as the CS, successful implantation of two devices, one in the CS and the second in the MCV, was performed. At 6-month follow-up, the patient reported a significant improvement in angina, resulting in a reduction of the CCS class from Grades IV to III. Discussion In patients affected by refractory angina and regarded as good candidates for Reducer implantation, a thorough comprehension of the cardiac venous pathway drainage is of pivotal importance to guarantee the therapeutic success of the procedure. In this patient, since the CS and the MCV seemed to contribute equally to coronary venous drainage, Reducer implantation in both vessels allowed to obtain a significant improvement of symptoms. The clinical effectiveness of this strategy needs to be validated in randomized clinical trials.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile. During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding of the cardiac anatomy. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other contiguous anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region. This article is protected by copyright. All rights reserved.

Background Although oral P2Y12 inhibitors are key in the management of patients with non-ST elevation acute coronary syndrome (NSTE-ACS), the optimal timing of their administration is not well defined. Objective to compare downstream and upstream oral P2Y12 inhibitors administration strategies in NSTE-ACS patients undergoing invasive management. Methods We performed a randomized, adaptive, open-label, multi-center, clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention (PCI) were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was superiority of the downstream over the upstream strategy on the combination of efficacy and safety events (net clinical benefit). Results We randomized 1449 patients to downstream or upstream oral P2Y12 inhibitor administration. A prespecified stopping rule for futility at interim analysis led the trial to be stopped. The rate of the primary endpoint, a composite of death due to vascular causes, non-fatal myocardial infarction or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4 and 5 bleedings through day 30, did not differ significantly between the downstream and upstream groups (Absolute Risk Reduction (ARR%) -0.46 [-2.90; 1.90]).These results were confirmed among patients undergoing PCI (72% of population) and regardless of the timing of coronary angiography (within or after 24 hours from enrolment). Conclusions Downstream and upstream oral P2Y12 inhibitors administration strategies were associated with low incidence of ischemic and bleeding events and minimal numerical difference of event rates between treatment groups. These findings led to premature interruption of the trial and suggest the unlikelihood of enhanced efficacy of one strategy over the other. [Funded by the Italian Society of Interventional Cardiology (SICI-GISE)]

Ultrasound (US)-guided axillary vein cannulation is effective and safe during cardiac implantable electronic devices (CIEDs). It is a reasonable alternative to other techniques in order to shorten procedural time and decrease perioperative complications. However, in this context, the short-axis (out-of-plane) visualization to guide the vein puncture is the most used technique. The aim of our study is to describe a single-center experience with the US long-axis (in-plane) technique defining predictors of unsuccessful puncture attempts and failure to axillary vein cannulation in a cohort of patients undergoing CIEDs procedures. From November 2017 to June 2019, consecutive patients undergoing CIEDs procedures were enrolled in the study. US-guided long axis (in-plane) view to guide axillary vein cannulation was used in all subjects. Unsuccessful puncture attempts (UAs) and complete failures to cannulate the vein were collected for each procedure. All patients were evaluated on a daily basis until hospital discharge and at 1-month follow up visit. Among 119 subjects (M: F = 75:44), mean age was 79 ± 9 years, mean BMI 25.7 ± 4.3 kg/m2, and mean BSA 1.74 ± 0.4 m2. We placed 95 pacemakers (32 single-, 61 dual-, and 2 triple-chamber) and 20 ICDs (7 single, 6 dual, 7 triple chambers). An upgrade from dual-chamber to triple-chamber device was carried out with the addition of a new lead in 3 patients. During a system revision, one new electrode was implanted. The overall leads inserted were 204. There were 33 initial unsuccessful attempts in 22/119 patients. US-guided axillary access was finally successful in 94.9% of patients (113/119). In the other cases (6/119), cephalic vein was isolated or blinded subclavian puncture was performed. Interestingly, at univariate analysis, an increasing BMI and BSA, male sex, and anticoagulant therapy were predictors of unsuccessful attempts or failure to cannulate the vein with US. Among those subjects, the multivariate logistic regression showed significant correlations only between BMI and unsuccessful attempts: odds ratio (OR) = 1.16, p = 0.009 [95% CI = 1.04–1.31], and BMI with failure to cannulate the vein: OR = 1.21, p = 0.03 [95%CI = 1.01–1.45]. The receiver operating characteristic (ROC) curves individuated the best BMI value cutoff point at 27 kg/m2 (area under the curve [AUC]: 68.6%) having a sensitivity of 63.6% and a specificity of 66.5% for unsuccessful puncture attempts; a BMI value of 28 kg/m2 (AUC 74.9%) had a sensitivity of 66.7% and a specificity of 66.7% for failure to cannulate the vein with the US-guided approach. Axillary vein long-axis (in-plane) US-guided cannulation during CIEDs implantation is characterized by a high success rate (94.9%). An elevated BMI is significantly related to unsuccessful puncture attempts or failure to cannulation. The higher is the BMI, the more are the chances to have difficult vein puncture or cannulation failure and to switch from US-guided approach to another technique.

COVID-19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID-19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019-nCoV infection accessing in cath-lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).

Aims Contrast-induced acute kidney injury (CI-AKI) after coronary angiography and percutaneous interventions (PCI) impacts on hospitalization duration and mortality. Pre-procedural hydration is the sole strategy currently recommended for preventing CI-AKI. The role of sodium bicarbonate (SB) although attractive, since urine alkalinization suppresses the production of reactive oxygen species, is still controversial, and the optimal dosing to attain adequate urine alkalinization is still undefined. The PrevenTion of contrast-inducEd nephropathy with urine alkalinization (TEATE) study was a prospective 3-centre 3-arm single-blind randomized controlled trial testing the hypothesis that adequate urine alkalinization is associated with CI-AKI prevention. Secondary endpoints were the efficacy of SB vs. saline in achieving adequate urine alkalinization and reducing the incidence of CI-AKI compared with saline. Methods and results Patients candidate to coronary angiography and/or PCI with moderate-to-severe chronic kidney disease [eGFR of 15–60 ml/min/1.73 m2, by the Modification of Diet in Renal Disease Study equation (MDRD)] were randomly assigned to saline hydration (control), oral SB or i.v. SB. The study protocol was registered (ClinicalTrials.gov NCT02980003). We evaluated urinary pH at the time of hospitalization, immediately before coronary angiography and 24–48 h after angiography. According to urine pH immediately before the procedure, patients were divided in two groups above or below a pH cut-off of 6. We enrolled a total of 241 patients: 81 were randomly assigned to the control group, 82 to i.v. SB and 78 to oral SB. Patients achieving a urinary pH > 6 before angiography had a lower incidence of CI-AKI (46%) than patients with urinary pH ≤ 6 (54%) [OR = 0.48 (95% CI: 0.25–0.9), P = 0.023]. The number of patients with urine pH > 6 was higher in both the i.v. (71%) and the oral SB (65%) groups compared to the hydration-only group (44%, P = 0.004). We found however no difference in the incidence of CI-AKI in the three treatment arms (20% in hydration alone, 21% in oral SB group and 22% in i.v. SB group) (P = 0.94). Subgroup analyses according to basal urine pH and eGFR ranges failed to identify statistically significant differences in the development of CI-AKI according to treatment allocation. Conclusions Urinary pH before the administration of contrast medium is an inverse correlate of CI-AKI incidence, and SB is superior to hydration alone in achieving urinary alkalinization. Since, however, SB did not reduce the incidence of CI-AKI, we conclude that urinary pH is a marker and not a mediator of CI-AKI.

Atrial fibrillation (AF) is the most prevalent form of cardiac arrhythmia. It is often related to diverse pathological conditions affecting the atria and leading to remodeling processes including collagen accumulation, fatty infiltration, and amyloid deposition. All these events generate atrial fibrosis, which contribute to beget AF. In this scenario, cardiac imaging appears as a promising noninvasive tool for monitoring the presence and degree of LA fibrosis and remodeling. The aim of this review is to comprehensively examine the bench mechanisms of atrial fibrosis moving, then to describe the principal imaging techniques that characterize it, such as cardiac magnetic resonance (CMR) and multidetector cardiac computed tomography (MDCT), in order to tailor atrial fibrillation ablation to each individual.

We report a case of cardiogenic shock due to severe aortic stenosis in a 55-year-old patient with a congenital unicuspid aortic valve (UAV). An emergent aortic valvuloplasty was performed in the spoke catheterization laboratory which allowed to achieve transient stabilization of the hemodynamic parameters and to move the patient to the nearest hub hospital with on-site cardiac surgery. Since the surgical risk of an aortic valve replacement was deemed too high, a transcatheter procedure was performed with implantation of a self-expandable prosthesis. The final result was suboptimal due to a moderate residual paravalvular leak, but the patient experienced rapid recovery and was discharged 10 days after the procedure. Just a few cases of transcatheter aortic valve replacement due to severe aortic stenosis in UAV have been described but, to the best of our knowledge, this is the first one in a clinical setting of cardiogenic shock. Although the gold standard treatment for UAV is surgical intervention, this case demonstrates that the transcatheter procedure is feasible and may play a role as a bridge to definitive surgical replacement.

Ventricular tachycardia and premature ventricular complexes (PVCs) arising from right ventricular outflow tract (RVOT) are the most common type of ventricular arrhythmias (VAs) in patients without structural heart disease. Radiofrequency ablation is now the gold standard of treatment in this setting due to high efficacy rates and optimal safety profile [2] During the last few years, the pulmonary valve (PV) and the pulmonary artery (PA) have attracted much attention as reliable sites of origin of RVOT-type arrhythmias. In the mean while intracardiac echocardiogram (ICE) has undoubtedly improved our understanding and approach to manage these arrhythmias accurately characterizing the PV and its contiguous structures. Aim of this paper is to provide an illustrated step-by-step guide on how to use ICE with the CARTOSOUND module to visualize and reconstruct 3D shell of the RV, the PV, as well of other anatomical structures (i.e., the aortic valve and coronary arteries) to perform aware and safe ablation in this region. A new reconsideration of the existent classification of these VAs is also provided.

Although oral P2YThe purpose of this study was to compare downstream and upstream oral P2YWe performed a randomized, adaptive, open-label, multicenter clinical trial. Patients were randomly assigned to receive pre-treatment with ticagrelor before angiography (upstream group) or no pre-treatment (downstream group). Patients in the downstream group undergoing percutaneous coronary intervention were further randomized to receive ticagrelor or prasugrel. The primary hypothesis was the superiority of the downstream versus the upstream strategy on the combination of efficacy and safety events (net clinical benefit).We randomized 1,449 patients to downstream or upstream oral P2YDownstream and upstream oral P2Y

The joint occurrence of atrial fibrillation (AF) and an acute coronary syndrome (ACS) entails a three-dimensional - cardioembolic, coronary and hemorrhagic - risk. Triple antithrombotic therapy (TAT), i.e., oral anticoagulation (OAC) on top of dual antiplatelet therapy (DAPT), has been the default strategy for such patients until recently. Due to the high hemorrhagic burden of TAT, several dual antithrombotic therapy (DAT) regimens, i.e., OAC plus a single antiplatelet agent, have been proposed in randomized trials with the aim of improving safety without hampering efficacy. Current guidelines and consensus documents still leave here, however, OAC as an undisputed cornerstone. Such documents do not sufficiently distinguish between the ischemic risk due to ACS treated with stenting and the one due to AF, which may dissociate in some patients and definitely have a different time course. The possibility of postponing the introduction of OAC in such conditions, rather taking advantage of the use of newer P2Y12 inhibitors prasugrel and ticagrelor, is not currently sufficiently contemplated in contemporary documents. We here question the claimed lack of alternatives to the "anticoagulant always and immediately" approach in most such patients, propose some risk simulations, claim that skipping anticoagulation in the presence of modern DAPT for one month after an ACS in the context of a high bleeding risk and a high coronary risk is a valuable, currently unlisted option, and raise the need of a proper trial on this controversial issue.

Background The optimal timing to administer a P2Y12 inhibitor in patients presenting with a non-ST elevation acute coronary syndrome remains a topic of debate. Pretreatment with ticagrelor before coronary anatomy is known as a widely adopted strategy. However, there is poor evidence on how this compares with administration of a P2Y12 inhibitor after defining coronary anatomy (i.e., downstream administration). Moreover, there are limited head-to-head comparisons of the two P2Y12 inhibitors—ticagrelor and prasugrel—currently recommended by the guidelines. Study design DUBIUS is a phase 4, multicenter, parallel-group, double randomized study conducted in NSTE-ACS patients designed to compare a pretreatment strategy (including only ticagrelor) versus a downstream strategy (including prasugrel or ticagrelor) and to compare downstream prasugrel with downstream ticagrelor. A total of 2520 patients will be randomly assigned to pretreatment with ticagrelor or to no pretreatment. The PCI group of the downstream arm will be further randomized to receive prasugrel or ticagrelor. The two primary hypotheses are that the downstream strategy is superior to the upstream strategy and that downstream ticagrelor is non-inferior to downstream prasugrel, both measured by the incidence of a composite efficacy and safety endpoint of death from vascular causes, non-fatal MI, or non-fatal stroke, and Bleeding Academic Research Consortium (BARC) type 3, 4, and 5 bleedings. Conclusions The DUBIUS study will provide important evidence related to the benefits and risks of pretreatment with ticagrelor compared with a strategy of no pretreatment. Moreover, the clinical impact of using downstream ticagrelor compared with downstream prasugrel will be assessed. Trial registration ClinicalTrials.gov NCT02618837. Registered on 1 December 2015.

Background Ticagrelor is a reversibly binding, direct-acting, oral, P2Y12 antagonist used for the prevention of atherothrombotic events in patients with coronary artery disease (CAD). Ticagrelor blocks adenosine reuptake through the inhibition of equilibrative nucleoside transporter 1 (ENT-1) on erythrocytes and platelets, thereby facilitating adenosine-induced physiological responses such as an increase in coronary blood flow velocity. Meanwhile, adenosine plays an important role in triggering ischemic preconditioning through the activation of the A1 receptor. Therefore, an increase in ticagrelor-enhanced adenosine bioavailability may confer beneficial effects through mechanisms related to preconditioning activation and improvement of coronary microvascular dysfunction. Methods To determine whether ticagrelor can trigger ischemic preconditioning and influence microvascular function, we designed this prospective, open-label, pilot study that enrolled patients with stable multivessel CAD requiring staged, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI). Participants will be randomized in 1:1 ratios either to ticagrelor (loading dose (LD) 180 mg, maintenance dose (MD) 90 mg bid) or to clopidogrel (LD 600 mg, MD 75 mg) from 3 to 1 days before the scheduled PCI. The PCI operators will be blinded to the randomization arm. The primary endpoint is the delta (difference) between ST segment elevations (in millimeters, mm) as assessed by intracoronary electrocardiogram (ECG) during the two-step sequential coronary balloon inflation in the culprit vessel. Secondary endpoints are 1) changes in coronary flow reserve (CFR), index of microvascular resistance (IMR), and FFR measured in the culprit vessel and reference vessel at the end of PCI, and 2) angina score during inflations. This study started in 2018 with the aim of enrolling 100 patients. Based on the rate of negative FFR up to 30% and a drop-out rate up to 10%, we expect to detect an absolute difference of 4 mm among the study arms in the mean change of ST elevation following repeated balloon inflations. All study procedures were reviewed and approved by the Ethical Committee of the Catholic University of Sacred Heart. Discussion Ticagrelor might improve ischemia tolerance and microvascular function compared to clopidogrel, and these effects might translate to better long-term clinical outcomes. Trial registration EudraCT No. 2016–004746-28. No. NCT02701140. Trial status Information provided in this manuscript refers to the definitive version (n. 3.0) of the study protocol, dated 31 October 2017, and includes all protocol amendments. Recruitment started on 18 September 2018 and is currently ongoing. The enrollment is expected to be completed by the end of 2019. Trial sponsor Fondazione Policlinico Universitario A. Gemelli – Roma, Polo di Scienze Cardiovascolari e Toraciche, Largo Agostino Gemelli 8, 00168 Rome, Italy.

Purpose: To investigate the association of the degree of stent expansion, as assessed by optical coherence tomography (OCT), following stent implantation, and clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients. Methods: STEMI patients from the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study were selected; Clinical outcomes were collected through 1year. Stent expansion index is a minimum stent area (MSA) divided by average lumen area (average of proximal and distal reference lumen area). The following variables were measured: MSA (< 4.5mm2), dissection (> 200µm in width and < 5mm from stent segment), malapposition (> 200µm distance of stent from vessel wall), a thrombus (area > 5% of lumen area) were compared. Results: A total of 151 patients were included; after excluding patients with suboptimal OCT quality, the population with available OCT was classified into 2 groups: under–expanded < 90% (N = 72, 51%) and well–expanded ≥ 90% (N = 67, 49%). In the well–expanded group, a significant number of the proximal vessels had a lumen area < 4.5mm2 (16.1%, p < 0.001) and a greater thrombus burden within stent (56.7%, p = 0.042). The overall 30day and 1year major adverse cardiovascular event (MACE) rates were 5% and 6.1%, respectively. Conclusion: Irrespective of the degree of stent expansion, the OCT findings, in STEMI patients, and the MACE at 30days and one year follow up was low; further, well–expanded stents led to a more significant residual thrombotic burden within the stent but seemed to have insignificant clinical impact. Acknowledged stent optimization criteria, traditionally related to worse outcomes in stable patients, do not seem to be associated with worse outcomes in this STEMI population.

The combination of atrial fibrillation (AF) and acute coronary syndrome (ACS) is a complex situation in which a three-dimensional risk—cardioembolic, coronary, and hemorrhagic—has to be carefully managed. Triple antithrombotic therapy (TAT) is burdened with a high risk of serious bleeding, while dual antithrombotic therapy with an anticoagulant (DAT) likely provides only suboptimal coronary protection early after stent implantation. Moreover, TAT precludes the advantages provided by the use of the latest and more potent P2Y12 inhibitors in ACS patients. Here, we aimed to simulate and compare the expected coronary, cardioembolic, and hemorrhagic outcomes offered by DAT, TAT, or modern dual antiplatelet therapy (DAPT) with aspirin plus one of the latest P2Y12 inhibitors in AF patients early after an ACS. The comparison of numbers needed to treat to prevent major adverse events with the various antithrombotic regimens suggests that AF–ACS patients at high ischemic and hemorrhagic risk and at moderately low embolic risk (CHA2DS2VASc score 2–4) might safely withhold anticoagulation after revascularization for one month taking advantage of a modern DAPT, with a favorable risk-to-benefit ratio. In conclusion, this strategy, not sufficiently addressed in recent European and North American guidelines or consensus documents, adds to the spectrum of treatment options in these difficult patients; it might be the best choice in a substantial number of patients; and should be prospectively tested in a randomized controlled trial.

BACKGROUND Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up. OBJECTIVES To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI). METHODS Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI. RESULTS 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm2 in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057). CONCLUSIONS The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.

Intravascular administration of iodinated contrast media is an essential tool for the imaging of blood vessels and cardiac chambers, as well as for percutaneous coronary and structural interventions. Along with the spreading of diagnostic and interventional procedures, the increasing incidence of contrast-induced nephropathy (CIN) has become an important and prognostically relevant problem. CIN is thought to be largely dependent on oxidative damage, and is a considerable cause of renal failure, being associated with prolonged hospitalization and significant morbidity/mortality. The most effective treatment strategy of this serious complication remains prevention, and several preventive measures have been extensively investigated in the last few years.Preprocedural hydration is the best-known and mostly accepted strategy. The administration of sodium bicarbonate has controversial effects, and is likely to be ineffective when the infused dose is unable to achieve adequate urine alkalinization. Since alkaline pH suppresses the production of free radicals, increasing urine pH would be an attractive goal for CIN prevention.In a prospective randomized controlled, open-label clinical trial we will test the hypothesis that urine alkalinization with either oral or intravenous bicarbonate on top of hydration alone is the main determinant of CIN prevention (primary endpoint) in a population of patients with moderate or severe chronic kidney disease scheduled for coronary angiography and/or angioplasty. If we then demonstrate nonsignificant differences in urine alkalinization and incidence of CIN between the two bicarbonate groups (secondary endpoint), a practical implication will be that oral administration is preferable for practical reasons over the administration of intravenous bicarbonate.

Background: The avascular region of the fibrous body between the mitral and aortic valves, named mitral-aortic intervalvular fibrosa (MAIVF), is often involved in the periaortic diffusion of infective endocarditis (IE), resulting in abscess or pseudoaneurysm formation. The early recognition of these life-threatening complications is of crucial importance, as urgent surgical correction is necessary. In the first stages of the abscess formation, the only sign is an increased thickness of the MAIVF. To the best of our knowledge, normal transesophageal echocardiography (TEE) examination reference values for MAIVF thickness has not yet been established. The aim of the study was to define the normal ranges of MAIVF thickness in a population of healthy adults who underwent a TEE examination. Materials and Methods: A population of consecutive adult patients who underwent a TEE examination was enrolled in the study. Measurement was performed in short-axis (SAX) and long-axis (LAX) views. Mean-2 standard deviations (mean-2SDs) and 5%, 10%, 90%, and 95% confidence intervals were evaluated. A comparison with MAIVF thickness in patients affected by aortic IE complicated by abscess formation was performed, and receiver operating characteristic (ROC) curves were constructed to achieve the optimal cutoff value of normality. Results: A total of 477 consecutive Caucasian adult patients were enrolled (mean age: 69 years, range: 27–93 years). Mean-2SD MAIVF measurement in SAX view was 0.325 cm (95% confidence interval [CI]: 0.319–0.330 cm) and in LAX view was 0.340 cm (95% CI: 0.334–0.346 cm). Computed tomography–MAIVF mean measurement (±2SD) was 0.237 cm (95% CI: 0.110–0.340 cm). ROC curves showed that a cutoff SAX value measurement of 0.552 (area under the curve [AUC]: 95.2%) had a sensibility of 88.2% and a specificity of 92.4%; a LAX measurement value of 0.623 (AUC: 93.3%) had a sensibility of 82.7% and a specificity of 85.7%. The multivariate analysis showed no significant correlation between MAIVF thickness, age, and sex. Conclusion: In healthy patients, MAIVF thickness should not exceed 0.600 cm. Above these values, the suspicion of a periaortic abscess formation should be raised. MAIVF increased thickness may be an early sign of perivalvular diffusion requiring an urgent endocarditis team evaluation.

Background Manual thrombus aspiration and local drug delivery of abciximab have been proposed as a strategy to reduce thrombus burden during percutaneous coronary intervention in patients with ST elevation myocardial infarction; however, the effectiveness of these approaches, is uncertain. In this COCTAIL II substudy, we compared the effect of these strategies on prestenting and poststenting thrombus burden assessed by optical coherence tomography. Patients and methods COCTAIL II trial enrolled patients with ST elevation myocardial infarction randomized to intralesion (IL, by the ClearWay catheter) versus intracoronary (IC, by the guide catheter) abciximab bolus with or without aspiration thrombectomy (AT). The following parameters were used to quantify atherothrombotic burden: thrombus volume (TVol), maximum thrombus area (TA), and thrombus burden (TB). Primary endpoint was the comparison of prestenting TVol after the use of local drug delivery (group IL+IL abciximab plus AT) versus nonlocal drug delivery (group IC abciximab plus AT+IC). Results The final population consisted of 59 patients undergoing both prestenting and poststenting optical coherence tomography assessment. The amount of thrombus was not significantly different in the groups with local drug delivery of abciximab versus nonlocal drug delivery in both prestenting (TVol: 18.87±26.70 vs. 19.02±18.45; TB: 26.73±12.8 vs. 25.18±13.25; and maximum TA: 59.25±18.84 vs. 53.34±19.30) and poststenting (TVol: 8.46±9.15 vs. 8.05±6.81; TB: 6.68±3.54 vs. 6.24±3.66; and maximum TA: 15.47±7.61 vs. 16.52±11.55) evaluations. A good correlation between thrombus measurements after thrombus removal techniques and intrastent thrombus was observed. Conclusion Either local drug delivery of abciximab or manual thrombus aspiration showed comparable results in terms of prestenting and poststenting thrombus burden removal.

Perioperative management of antithrombotic therapy in patients treated with coronary stents undergoing surgery remains poorly defined. Importantly, surgery represents a common reason for premature treatment discontinuation, which is associated with an increased risk in mortality and major adverse cardiac events. However, maintaining antithrombotic therapy to minimize the incidence of perioperative ischemic complications may increase the risk of bleeding complications. Although guidelines provide some recommendations with respect to the perioperative management of antithrombotic therapy, these have been largely developed according to the thrombotic risk of the patient and a definition of the hemorrhagic risk specific to each surgical procedure, key to defining the trade-off between ischemia and bleeding, is not provided. These observations underscore the need for a multidisciplinary collaboration among cardiologists, anesthesiologists, hematologists and surgeons to reach this goal. The present document is an update on practical recommendations for standardizing management of antithrombotic therapy management in patients treated with coronary stents (Surgery After Stenting 2) in various types of surgery according to the predicted individual risk of thrombotic complications against the anticipated risk of surgical bleeding complications. Cardiologists defined the thrombotic risk using a "combined ischemic risk" approach, while surgeons classified surgeries according to their inherent hemorrhagic risk. Finally, a multidisciplinary agreement on the most appropriate antithrombotic treatment regimen in the perioperative phase was reached for each surgical procedure.

Objectives This study sought to assess whether transradial access (TRA) compared with transfemoral access (TFA) is associated with consistent outcomes in male and female patients with acute coronary syndrome undergoing invasive management. Background There are limited and contrasting data about sex disparities for the safety and efficacy of TRA versus TFA for coronary intervention. Methods In the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) program, 8,404 patients were randomized to TRA or TFA. The 30-day coprimary outcomes were major adverse cardiovascular and cerebrovascular events (MACCE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACCE or major bleeding. Results Among 8,404 patients, 2,232 (26.6%) were women and 6,172 (73.4%) were men. MACCE and NACE were not significantly different between men and women after adjustment, but women had higher risk of access site bleeding (male vs. female rate ratio [RR]: 0.64; p = 0.0016), severe bleeding (RR: 0.17; p = 0.0012), and transfusion (RR: 0.56; p = 0.0089). When comparing radial versus femoral, there was no significant interaction for MACCE and NACE stratified by sex (p int = 0.15 and 0.18, respectively), although for both coprimary endpoints the benefit with TRA was relatively greater in women (RR: 0.73; p = 0.019; and RR: 0.73; p = 0.012, respectively). Similarly, there was no significant interaction between male and female patients for the individual endpoints of all-cause death (p int = 0.79), myocardial infarction (p int = 0.25), stroke (p int = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (p int = 0.45). Conclusions Women showed a higher risk of severe bleeding and access site complications, and radial access was an effective method to reduce these complications as well as composite ischemic and ischemic or bleeding endpoints.

Aims Recent frequency-domain optical coherence tomography studies showed that a complete removal of thrombotic materials is rarely achieved after percutaneous coronary interventions for ST segment elevation myocardial infarction. Residual intrastent thrombus can embolize distally leading to microcirculatory injury. The aim was to find a possible correlation between residual intrastent thrombus and angiographic indexes of myocardial reperfusion. Methods The population consisted of 128 ST segment elevation myocardial infarction patients enrolled in the COCTAIL II trial. Intrastent thrombus at optical coherence tomography was defined as the maximum percentage value of thrombus area (thrombus area/stent area × 100 in the cross-section with largest thrombus). A thrombus area of at least 16% (mean value) was considered indicative of high residual intrastent thrombus. The following angiographic indexes of myocardial reperfusion were evaluated: thrombolysis in myocardial infarction (TIMI) value, corrected TIMI frame count and myocardial blush grade. Results Angiographic and optical coherence tomography results are available in 119 patients: 64 had a maximum percentage value of thrombus area less than 16%, whereas the remaining 55 had a residual intrastent thrombus at least 16%. No differences were found regarding the microcirculatory indexes at baseline angiogram. After intervention, patients with intrastent thrombus less than 16% showed a significant improvement in the final TIMI value (2.87 ± 0.33 vs 2.67 ± 0.54; P = 0.014), final TIMI frame count (11.71 ± 4.58 vs 18.04 ± 17.32; P = 0.012) and a nonsignificant improvement in the final myocardial blush grade value (2.58 ± 0.58 vs 2.43 ± 0.76; P = 0.255). Conclusion Data obtained from this ancillary study of the COCTAIL II suggest that the presence of high residual intrastent thrombus in patients undergoing primary angioplasty is associated with worsened final microcirculatory indexes.

Background It remains unclear whether radial access (RA), compared with femoral access (FA), mitigates the risk of acute kidney injury (AKI). Objectives The authors assessed the incidence of AKI in patients with acute coronary syndrome (ACS) enrolled in the MATRIX-Access (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial. Methods Among 8,404 patients, 194 (2.3%) were excluded due to missing creatinine values, no or an incomplete coronary angiogram, or previous dialysis. The primary AKI-MATRIX endpoint was AKI, defined as an absolute (>0.5 mg/dl) or a relative (>25%) increase in serum creatinine (sCr). Results AKI occurred in 634 patients (15.4%) with RA and 712 patients (17.4%) with FA (odds ratio [OR]: 0.87; 95% confidence interval [CI]: 0.77 to 0.98; p = 0.0181). A >25% sCr increase was noted in 633 patients (15.4%) with RA and 710 patients (17.3%) with FA (OR: 0.87; 95% CI: 0.77 to 0.98; p = 0.0195), whereas a >0.5 mg/dl absolute sCr increase occurred in 175 patients (4.3%) with RA versus 223 patients (5.4%) with FA (OR: 0.77; 95% CI: 0.63 to 0.95; p = 0.0131). By implementing the Kidney Disease Improving Global Outcomes criteria, AKI was 3-fold less prevalent and trended lower with RA (OR: 0.85; 95% CI: 0.70 to 1.03; p = 0.090), with stage 3 AKI occurring in 28 patients (0.68%) with RA versus 46 patients (1.12%) with FA (p = 0.0367). Post-intervention dialysis was needed in 6 patients (0.15%) with RA and 14 patients (0.34%) with FA (p = 0.0814). Stratified analyses suggested greater benefit with RA than FA in patients at greater risk for AKI. Conclusions In ACS patients who underwent invasive management, RA was associated with a reduced risk of AKI compared with FA. (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627 )

Objective Revascularization of functionally non-significant stenoses in patients with stable coronary artery disease can safely be deferred as rate of adverse cardiovascular events is low. It is not clear whether fractional flow reserve (FFR) is just as accurate in acute coronary syndromes (ACS). The aim of this study is to assess the outcome of coronary lesions whose revascularization was deferred based on negative FFR values in subjects with ACS. Methods Patients with acute coronary syndrome and showing at least one coronary stenosis whose revascularization was deferred based on FFR value >0.80 were included in the study. The primary endpoint of the study was the rate of target lesion failure (TLF), a composite of cardiac events (cardiac death, myocardial infarction and any coronary revascularization) related to the initially deferred stenosis at three-year follow-up. Results A total of 319 patients (237 male), mean age 68 [59–74] years and 355 coronary lesions with deferred revascularization based on negative FFR values (0.88±0.05) were selected. The rate of TLF was 6% at 1-year, 9% at 2-year and 12% at 3-year follow-up. TLF was driven by a new acute coronary syndrome in 75% of cases. The median time interval from FFR assessment to TLF was 457 [138–868] days. Conclusions In patients with acute coronary syndrome, the rate of TLF of the initially deferred coronary stenoses is 12% at 3-year follow-up and TLF occurred because of a new ACS in three quarters of cases.

AIMS Bindarit (BND) is a selective inhibitor of monocyte chemotactic protein-1 (MCP-1/CCL2), which plays an important role in generating intimal hyperplasia. Our aim was to explore the efficacy and safety of bindarit in preventing restenosis following percutaneous coronary intervention. METHODS AND RESULTS A phase II, double-blind, multicentre randomised trial included 148 patients randomised into three arms (BND 600 mg, n=48; BND 1,200 mg, n=49; PLB, n=51). Bindarit was given following PCI and continued for 180 days. Monthly clinical follow-up and six-month coronary angiography were conducted. The primary endpoint was in-segment late loss; the main secondary endpoints were in-stent late loss and major adverse cardiovascular events. Efficacy analysis was carried out on two populations, ITT and PP. There were no significant differences in the baseline characteristics among the three treatment groups. In-segment and in-stent late loss at six months in BND 600, BND 1,200 and PLB were: (ITT 0.54 vs. 0.52 vs. 0.72; p=0.21), (PP 0.46 vs. 0.53 vs. 0.72; p=0.12) and (ITT 0.74 vs. 0.74 vs. 1.05; p=0.01), (PP 0.66 vs. 0.73 vs. 1.06; p=0.003), respectively. The MACE rates at nine months among treatment groups were 20.8% vs. 28.6% vs. 25.5% (p=0.54), respectively. CONCLUSIONS This was a negative study with the primary endpoint not being met. However, significant reduction in the in-stent late loss suggests that bindarit probably exerts a favourable action on the vessel wall following angioplasty. Bindarit was well tolerated with a compliance rate of over 90%. A larger study utilising a loading dose and targeting a specific patient cohort may demonstrate more significant results.

Despite improvements in the treatment and prevention of risk factors (i.e. dyslipidemia), cardiovascular disease (CVD) remains one of the leading causes of morbidity and mortality in countries with a high degree of socio-economic development. As a matter of fact, in the last decades, several trials and meta-analysis highlighted the impact of treatments targeted to lowering cholesterol levels (particularly LDL-cholesterol) on outcomes of patients affected by CVD, both in terms of primary and secondary prevention. The main international CVD guidelines recommend lifestyle modifications and optimal lipid-lowering therapy in individuals with established CVD. The aim of the present document is to describe the dimension of the problem and the available therapies, offering a practical pharmacological flow-chart useful for accurate monitoring and intensive treatment of dyslipidemias in this patient population.

The radiation dose received by interventional cardiologists during their activity in the catheterization laboratory is a matter of concern in terms of possible deterministic and stochastic risk. At the same time, very often, the knowledge of the effect and consequences of radiation exposure in the interventional cardiology community is limited. This document endorsed by the Italian Society of Interventional Cardiology (SICI-GISE) provides recommendations for cardiologists' radiation protection. Radiation safety considerations dedicated to women and other staff personnel working in the catheterization laboratory are also discussed.

Introduction and objectives Bicuspid aortic valve (BAV) is the most common congenital malformation, with an estimated prevalence ranging from 0,48 to 2%. Most of the studies describe complications associated with BAV, including aortic stenosis and regurgitation, infective endocarditis and aortic dilation and dissection. Very few studies have been performed in the neonatal and paediatric age, most lacking in long-term follow up. The aim of our study was to explore the prevalence of BAV and the progression of aortic valve disease and aortic dilation in paediatric patients followed from January 1996 to August 2018. Methods A prospective collection of Congenital Heart Disease (CHD) diagnosed in the first year of life was performed in our institution from January 1996 to August 2018. Patients affected by BAV were then followed yearly. BAV morphology, aortic valve dysfunction and aortic dimensions were measured. Comparisons were performed between right-left cusp fusion (R-L) and right-non coronary cusp fusion (R-N), according to Shaefer's classification. Rate of change of the ascending aorta size over time was analyzed, and aortic size values were normalized as the number of standard deviations above or below the mean size expected for body surface area (z scores). Results A total of 35,310 live births were screened. Incidence rate of total CHD, including small ventricular septal defects and BAV was19,57%. Sixty had BAV (8,73% of CHD), with an incidence of 17/1,000 live births. Male/Female ratio was 1.4. A positive family history was present in 5 (8.3%). In 12 patients (24%) BAV was associated to other CHD (9 Aortic Coarctation, 1 Atrio-Ventricular Septal Defect, and in two cases a critical neonatal aortic stenosis). BAV was isolated in 48 cases (80%), with an incidence of 13.6/1.000 live births. According to Shaefer's classification the most common was type 1 (R-L), with Right to Left cusps fusion (R-L 76%, R-N 21% and L-N 3%). Among patients with isolated BAV, after a median follow up of 11 [1–21] years an aortic stenosis was observed in 5 patients (10.4%, none severe), an aortic insufficiency in 13 (27%, in one case severe). A dilated ascending aorta (z-score>2) was found in 11 patients (23%). An indication cardiac surgery due to severe aortic insufficiency was present in one case. No patient had indication for aortic aneurysm surgery. Conclusions Paediatric patients with isolated BAV warrant medical follow-up but progression towards severe valve dysfunction and/or dilation of the ascending aorta warranting cardiac surgery is very low.

Blood stasis is the main cause of left atrial thrombosis (LAT) in atrial tachyarrhythmias. The high-velocity flow inside the left atrium, due to mitral valve regurgitation, may prevent clot formation but the topic has never been investigated in large-scale studies. The aim of our study was to evaluate whether the presence and degree of mitral regurgitation have a protective role against LAT risk.A total of 1302 consecutive adult patients with paroxysmal or persistent atrial fibrillation or flutter undergoing cardioversion, submitted to transesophageal echocardiography, were retrospectively enrolled in the study. The study population was divided into three groups according to the mitral regurgitation degree: absent, mild-to-moderate and severe.Among 1302 patients enrolled in the study, patients without mitral regurgitation were 248 (19%), those with mild-to-moderate 970 (75%), whereas 84 had severe mitral regurgitation (6%). LAT incidence was significantly lower in patients with severe mitral regurgitation compared with those with mild-to-moderate (mitral regurgitation) (2.4 vs. 8.9%, P 0.05), and similar to subjects without mitral regurgitation (2.4%).Despite patients with severe regurgitation having clinical and echo characteristics predisposing to LAT (higher age, heart failure, higher atrial size, lower ventricular function) thrombosis prevalence was significantly lower than for those with mild-to-moderate mitral regurgitation. The percentage of LAT in severe mitral regurgitation cases was very low and similar to that of cases without regurgitation which were characterized by lower age, normal left ventricular function or other risk factors, reinforcing the hypothesis of a protecting role against atrial thrombosis of mitral regurgitation.