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Carlo Di Mario - Top 30 Publications

Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure with Preserved Ejection Fraction: the Critical Play Off between a 'Pure' Patient Phenotype and the Generalizability of Trial Findings.

To investigate the effect of the different eligibility criteria used by phase III clinical studies in heart failure with preserved ejection fraction (HFpEF) on patient selection, phenotype and survival.

Bioresorbable Vascular Scaffolds as a Treatment Option for Left Main Lesions.

Percutaneous Intervention for Concurrent Chronic Total Occlusions in Patients With STEMI: We Should EXPLORE More!

12 months outcomes after Bioresorbable Vascular Scaffold implantation in Patients with Acute Coronary Syndromes. Data from the European Multicentre GHOST-EU Extended Registry.

We report on the mid-term outcomes of patients undergoing percutaneous coronary intervention with bioresorbable vascular scaffolds (BVS) for the treatment of acute coronary syndromes (ACS) and compare with those of patients with stable coronary artery disease (sCAD).

Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI.

Background Coronary revascularization guided by fractional flow reserve (FFR) is associated with better patient outcomes after the procedure than revascularization guided by angiography alone. It is unknown whether the instantaneous wave-free ratio (iFR), an alternative measure that does not require the administration of adenosine, will offer benefits similar to those of FFR. Methods We randomly assigned 2492 patients with coronary artery disease, in a 1:1 ratio, to undergo either iFR-guided or FFR-guided coronary revascularization. The primary end point was the 1-year risk of major adverse cardiac events, which were a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization. The trial was designed to show the noninferiority of iFR to FFR, with a margin of 3.4 percentage points for the difference in risk. Results At 1 year, the primary end point had occurred in 78 of 1148 patients (6.8%) in the iFR group and in 83 of 1182 patients (7.0%) in the FFR group (difference in risk, -0.2 percentage points; 95% confidence interval [CI], -2.3 to 1.8; P<0.001 for noninferiority; hazard ratio, 0.95; 95% CI, 0.68 to 1.33; P=0.78). The risk of each component of the primary end point and of death from cardiovascular or noncardiovascular causes did not differ significantly between the groups. The number of patients who had adverse procedural symptoms and clinical signs was significantly lower in the iFR group than in the FFR group (39 patients [3.1%] vs. 385 patients [30.8%], P<0.001), and the median procedural time was significantly shorter (40.5 minutes vs. 45.0 minutes, P=0.001). Conclusions Coronary revascularization guided by iFR was noninferior to revascularization guided by FFR with respect to the risk of major adverse cardiac events at 1 year. The rate of adverse procedural signs and symptoms was lower and the procedural time was shorter with iFR than with FFR. (Funded by Philips Volcano; DEFINE-FLAIR number, NCT02053038 .).

Bioresorbable Everolimus-Eluting Vascular Scaffold for Long Coronary Lesions: A Subanalysis of the International, Multicenter GHOST-EU Registry.

The authors sought to investigate 1-year outcomes in patients treated with bioresorbable everolimus-eluting vascular scaffolds (BVS) for "long coronary lesions."

Predilation, sizing and post-dilation scoring in patients undergoing everolimus-eluting bioresorbable scaffold implantation for prediction of cardiac adverse events: development and internal validation of the PSP score.

The aim of the study was to develop a scoring model to evaluate the quality of bioresorbable vascular scaffold (BVS) implantation and determine the model's usefulness in predicting adverse cardiac events.

Effects of renal denervation on vascular remodelling in patients with heart failure and preserved ejection fraction: A randomised control trial.

To assess the effect of renal denervation (RDT) on micro- and macro-vascular function in patients with heart failure with preserved ejection fraction (HFpEF).

Left atrial appendage occlusion: Fighting the "dark side" of atrial fibrillation.

Everolimus Eluting Bioresorbable Vascular Scaffold for Treatment of Complex Chronic Total Occlusions.

Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study is to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO).

Instantaneous wave-free ratio to guide coronary revascularization: physiological framework, validation and differences with fractional flow reserve.

Determining the optimal treatment strategy for revascularization of coronary artery stenosis involves the use of fractional flow reserve (FFR). To improve the low clinical uptake of physiological lesion assessment to guide revascularization, the instantaneous wave-free period (iFR) was proposed as a simpler alternative to FFR that does not require adenosine administration. iFR is calculated as the ratio of blood pressure distal and proximal to a coronary artery stenosis during the diastolic wave- free period. The wave-free period is a part of the cardiac cycle where generation of new pressure wavefronts does not occur and resting microvascular resistance is relatively minimized. iFR indicates the hemodynamic severity of a stenosis, by assessing the extent to which the epicardial stenosis depletes the microcirculatory, autoregulatory reserve. The introduction of iFR and the potential to assess hemodynamic stenosis severity without the need for administration of potent vasodilators such as adenosine, sparked an interesting debate about the fundamentals of human coronary physiology. Outcomes of two randomized clinical trials investigating iFR are pending. These studies are designed to evaluate whether iFR guided revascularisation is non-inferior to an FFR guided approach. The purpose of this review article is to discuss the physiological concepts underlying iFR, examine the existing validation studies and discuss the advantages and disadvantages of iFR as compared to FFR.

Calcium: A predictor of interventional treatment failure across all fields of cardiovascular medicine.

In this substudy of the ADAPT-DES trial Généreux et al. compared two years outcomes according to the presence or absence of coronary artery calcification (CAC) as assessed by coronary angiography. Coronary calcification was an independent predictor of interventional treatment failure and a higher incidence of both ischemic events and bleeding. The cohort with CAC was older with a higher prevalence of risk factors and comorbidities and an increased anatomical complexity of the target lesions, explaining only in part the worse outcome of the CAC population that persisted at multivariate analysis. Incomplete expansion and poor stent apposition, more frequent in calcified lesions, are predictive of target lesion failure and late stent thrombosis. The main limitation of the study is the use of angiography for CAC assessment with a likely major underestimation of CAC burden. Intravascular imaging might also help for a more accurate quantification of the CAC burden and characteristics, selecting the lesions in need of a calcium modification with atherectomy or lithotripsy before stent implantation.

Intracoronary Imaging.

The year in cardiology 2016: coronary interventions.

Immediate and 12-Month Outcomes of Ischemic Versus Nonischemic Functional Mitral Regurgitation in Patients Treated With MitraClip (from the 2011 to 2012 Pilot Sentinel Registry of Percutaneous Edge-To-Edge Mitral Valve Repair of the European Society of Cardiology).

In literature, there are limited data comparing ischemic mitral regurgitation (I-MR) versus nonischemic MR regarding outcomes after percutaneous "edge-to-edge" repair. We aimed to describe the early and 12-month results after MitraClip device implantation regarding the 2 etiologies. From January 2011 to December 2012, the Transcatheter Valve Treatment Sentinel Pilot Registry included 452 patients with MR who underwent MitraClip procedure in 25 centers across Europe. The prevalent etiology was I-MR (235 patients, 52.0%). I-MR group had a significantly higher proportion of men (74.9 vs 59.9%, p <0.001) and surgical risk (logistic EuroSCORE 24.8 ± 18.2 vs 18.8 ± 16.3, p <0.001). Acute procedural success was high (96%) and similar between groups (p = 0.48). Patients with I-MR required a higher, albeit not significant, number of clips to reduce MR (p = 0.08). Inhospital mortality was low (2.0%) without significant differences between etiologies. The estimated 1-year mortality and rehospitalization rates were 15.0% and 25.8%, respectively, without significant differences between groups. Paired echocardiographic data showed a persistent improvement of MR at 1 year in both etiologies. Despite a significant overall reverse atrial remodeling after clip, there were no significant changes in left ventricular volumes. In conclusion, this large independent cohort showed that percutaneous "edge-to-edge" therapy was associated with early- and long-term improvement of MR severity and functional condition both in patients with I-MR and nonischemic MR. There were no significant differences between the 2 etiologies regarding survival and freedom from rehospitalization due to heart failure at the 1-year follow-up.

Feasibility of cardiovascular magnetic resonance derived coronary wave intensity analysis.

Wave intensity analysis (WIA) of the coronary arteries allows description of the predominant mechanisms influencing coronary flow over the cardiac cycle. The data are traditionally derived from pressure and velocity changes measured invasively in the coronary artery. Cardiovascular magnetic resonance (CMR) allows measurement of coronary velocities using phase velocity mapping and derivation of central aortic pressure from aortic distension. We assessed the feasibility of WIA of the coronary arteries using CMR and compared this to invasive data.

Conquering CTO revascularisation: the summit is near with 90% of the ascent behind us.

Coronary covered stents.

Covered stents offer an effective bail-out strategy in vessel perforations, are an alternative to surgery for the exclusion of coronary aneurysms, and have a potential role in the treatment of friable embolisation-prone plaques. The aim of this manuscript is to offer an overview of currently available platforms and to report results obtained in prior studies.

Long-term outcomes after Resolute zotarolimus-eluting stent implantation in patients with ST-segment elevation acute myocardial infarction: insights from the RESOLUTE All Comers Trial and the RESOLUTE Global Clinical Trial Program.

We examined long-term outcomes after implantation of the Resolute zotarolimus-eluting stent (R-ZES) in ST-segment elevation acute myocardial infarction (STEMI) patients.

Mechanisms of Myocardial Ischemia in Hypertrophic Cardiomyopathy: Insights From Wave Intensity Analysis and Magnetic Resonance.

Angina is common in hypertrophic cardiomyopathy (HCM) and is associated with abnormal myocardial perfusion. Wave intensity analysis improves the understanding of the mechanics of myocardial ischemia.

Utility of Intravascular Ultrasound in Percutaneous Revascularization of Chronic Total Occlusions: An Overview.

Intravascular ultrasound has been used for >20 years to guide percutaneous coronary intervention in different subsets of coronary lesions. During the last decade, the interest in percutaneous coronary intervention for chronic total occlusion (CTO) has increased dramatically, leading to high success rates. Failure of guidewire crossing is the most common reason for failed CTO attempts. Certain angiographic features, such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel, increase procedural difficulty. A better understanding of the behavior of the guidewire within the CTO segment may represent a key issue to achieve successful outcome. In this respect, intravascular ultrasound imaging might have potential roles in the recanalization of CTOs. In this paper, we focused on the usefulness and the applications of intravascular ultrasound imaging in percutaneous CTO recanalization, underlying its impact on clinical outcome.

Five-year outcomes of chronic total occlusion treatment with a biolimus A9-eluting biodegradable polymer stent versus a sirolimus-eluting permanent polymer stent in the LEADERS all-comers trial.

Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9â„¢-eluting stent (BES) with a sirolimus-eluting stent (SES).

Predictors of Bioresorbable Everolimus-Eluting Scaffold Failure at Intravascular Ultrasound Examination: Asymmetry Versus Expansion.

Bioresorbable vascular scaffold radial expansion and conformation compared to a metallic platform: insights from in vitro expansion in a coronary artery lesion model.

This study aimed to compare the acute expansion behaviour of a polymer-based bioresorbable scaffold and a second-generation metallic DES platform in a realistic coronary artery lesion model. Experimental mechanical data with conventional methods have so far shown little difference between metallic stents and currently available polymer-based bioresorbable scaffolds (BRS). Nevertheless, differences in acute results have been observed in clinical studies comparing BRS directly with metallic DES platforms.

Current bioresorbable scaffold technologies for treatment of coronary artery diseases: Do polymer and Magnesium platforms differ?

Impact of overlapping on 1-year clinical outcomes in patients undergoing everolimus-eluting bioresorbable scaffolds implantation in routine clinical practice: Insights from the European multicenter GHOST-EU registry.

Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown.

Absorb vs. DESolve: an optical coherence tomography comparison of acute mechanical performances.

The aim of the study was to compare retrospectively the acute mechanical performance of the Absorb vs. DESolve scaffolds in terms of appropriate deployment with OCT.

Guide extension, unmissable tool in the armamentarium of modern interventional cardiology. A comprehensive review.

Due to the aging population undergoing percutaneous coronary intervention (PCI), interventional cardiologists are confronted daily with treatment of lesions with complex anatomy. Despite improvements in stent devices and PCI techniques, these lesions remain a challenge in terms of procedural success. Guide-extensions (GE) are coaxial "mother and child" catheters employed to facilitate device delivery but they can be used in many different complex scenarios. A comprehensive review of the possible applications of GE and of the GuideLinerâ„¢ (GL), the most widely used GE device, is missing. We therefore aim to provide a comprehensive review of all the potential applications of the GL and other GE devices, describe its limitations as well as tips and tricks for successful usage of this GE catheter.

Bioresorbable Scaffold Thrombosis: Why BRS Size Matters.

The evolving landscape of oral anti-arrhythmic prescriptions for atrial fibrillation in England: 1998-2014.

An important decision in the management of patients with atrial fibrillation is whether to adopt a rate or rhythm control strategy. Options for the latter include oral membrane-active anti-arrhythmic drugs (AADs) or catheter ablation. Recent prescription trends may have been affected by the introduction of dronedarone and an increasing number of reports suggesting increased mortality in those taking AADs. We describe the trend in oral AAD prescriptions in England in the period 1998-2014.