Publications by authors named "Antonio Leone"

274 Publications

The Role of Serial Radiographs in Diagnosing Diabetic Foot Bone Osteomyelitis.

Mediterr J Hematol Infect Dis 2022 1;14(1):e2022055. Epub 2022 Jul 1.

Department of Radiological and Hematological Sciences, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 1, 00168 Rome, Italy.

Background And Objective: Diagnosing diabetes-related foot osteomyelitis is sometimes a challenge for clinicians since it may occur without local or systemic signs of infection. Thus, the primary purpose of this article was to evaluate the role of progressive radiographic changes in diagnosing diabetic foot osteomyelitis.

Materials And Methods: A retrospective review of databases of our Institution was performed to identify all long-standing diabetic foot patients who underwent two radiographic examinations spaced no more than five weeks apart and a subsequent magnetic resonance (MR) examination from November 2015 to November 2020. A total of 46 patients (32 men, 14 women; mean age, 57.3 years) were identified.

Results: serial radiographs showed 89% sensitivity, 38% specificity, 80% diagnostic accuracy, 87% positive predictive value (PPV), 43% negative predictive value (NPV) to diagnose osteomyelitis (P value < 0,05). Bone destruction was the most reliable radiographic sign with 89% sensitivity, 88% specificity, 89% diagnostic accuracy, 97% PPV, 64% NPV (P value < 0,05).

Conclusion: Progressive bony changes detected by serial radiographs are a useful tool to diagnose diabetic foot osteomyelitis.
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http://dx.doi.org/10.4084/MJHID.2022.055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266704PMC
July 2022

Transcatether Aortic Valve Implantation to Treat Degenerated Surgical Bioprosthesis: Focus on the Specific Procedural Challenges.

Front Cardiovasc Med 2022 31;9:895477. Epub 2022 May 31.

Institute of Cardiology Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Actually transcatheter aortic valve implantation within failed surgically bioprosthetic valves (VIV-TAVI) is an established procedure in patients at high risk for repeat surgical aortic valve intervention. Although less invasive than surgical reintervention, VIV-TAVI procedure offers potential challenges, such as higher rates of prosthesis-patient mismatch and coronary obstruction. Thus, optimal procedural planning plays an important role to minimize the risk of procedure complications. In this review, we describe the key points of a VIV-TAVI procedure to optimize outcomes and reduce the risk of procedure complications.
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http://dx.doi.org/10.3389/fcvm.2022.895477DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9194080PMC
May 2022

Clinical impact of the extent of jeopardized myocardium in patients undergoing transcatheter aortic valve intervention.

Rev Esp Cardiol (Engl Ed) 2022 Jun 9. Epub 2022 Jun 9.

Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Dipartimento di Scienze Cardiovascolari, Università Cattolica del Sacro Cuore, Rome, Italy.

Introduction And Objectives: Coronary artery disease (CAD) is found in 30%-50% of patients with severe aortic stenosis (AS) undergoing treatment. The best management of CAD in AS patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear. We investigated the clinical impact of the extent of jeopardized myocardium in patients with concomitant CAD and severe AS treated by TAVI.

Methods: Consecutive patients who underwent TAVI procedures at our hospital were identified. In the presence of CAD, the myocardium jeopardized before TAVI was graded using the British Cardiovascular Intervention Society (BCIS) jeopardy score (JS). The study population was divided in 3 groups: patients without concomitant CAD (no-CAD), patients with CAD and BCIS-JS ≤ 4 (CAD BCIS-JS ≤ 4) and patients with concomitant CAD and BCIS-JS> 4 (CAD BCIS-JS> 4). The primary study endpoint was major adverse cardiovascular and cerebrovascular events (MACCE).

Results: A total of 403 patients entered the study: 223 no-CAD, 94 CAD BCIS-JS ≤ 4 and 86 CAD BCIS-JS> 4. At> 3 months of follow-up [range 104-3296 days], patients without CAD and CAD patients with BCIS-JS ≤ 4 had better survival free from MACCE compared with those with less extensive revascularization (BCIS-JS> 4) (P=.049). This result was driven by a significant reduction in death (P=.031). On multivariate analysis, residual BCIS-JS ≤ 4 and NYHA class III-IV independently predicted MACCE.

Conclusions: In patients with concomitant CAD and severe AS, the extent of jeopardized myocardium before TAVI impacts on clinical outcomes.
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http://dx.doi.org/10.1016/j.rec.2022.05.020DOI Listing
June 2022

Clinical Impact of Heart Team Decisions for Patients With Complex Valvular Heart Disease: A Large, Single-Center Experience.

J Am Heart Assoc 2022 06 27;11(11):e024404. Epub 2022 May 27.

Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italia.

Background A multidisciplinary approach might be pivotal for the management of patients with valvular heart disease (VHD), but clinical outcome data are lacking. Methods and Results At our institution, since 2014, internal guidelines recommended heart team consultations for patients with VHD. The clinical/echocardiographic characteristics, treatment recommendations, performed treatment, and early clinical outcomes of consecutive, hospitalized patients with VHD undergoing heart team evaluation were collected. Surgical risk was prospectively assessed by the EuroSCORE II and STS-PROM. The primary end point of the study was early mortality. A total of 1004 patients with VHD with high clinical complexity (mean age, 75 years; mean EuroSCORE II, 9.4%; mean STS-PROM, 5.6%; 48% ischemic heart disease; 29% chronic kidney disease, 9% oncologic/hematologic diseases) were enrolled. The heart team recommended an interventional treatment for 807 (80%) patients and conservative management for 197 (20%) patients. Management crossovers occurred in only 5% of patients. The recommended intervention was cardiac surgery for 230 (23%) patients, percutaneous treatment in 516 (51%) patients, and hybrid treatment in 61 (6%) patients. Early mortality occurred in 24 patients (2.4%) and was independently predicted by aortic stenosis, left ventricular ejection fraction, pulmonary artery systolic pressure, and conservative management recommendation. In patients referred to treatment, observed early mortality (1.7%) was significantly lower (<0.001) than expected on the bases of both the STS-PROM (5.2%) and EuroSCORE II (9.7%). Conclusions Within the limitations of its single-center and observational design, the present study suggests that heart team-based management of patients with complex VHD is feasible and allows referral to a wide spectrum of interventions with promising early clinical results.
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http://dx.doi.org/10.1161/JAHA.121.024404DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9238748PMC
June 2022

Predictive models in SMA II natural history trajectories using machine learning: A proof of concept study.

PLoS One 2022 5;17(5):e0267930. Epub 2022 May 5.

Pediatric Neurology, Università Cattolica del Sacro Cuore, Rome, Italy.

It is known from previous literature that type II Spinal Muscular Atrophy (SMA) patients generally, after the age of 5 years, presents a steep deterioration until puberty followed by a relative stability, as most abilities have been lost. Although it is possible to identify points of slope indicating early improvement, steep decline and relative stabilizations, there is still a lot of variability within each age group and it's not always possible to predict individual trajectories of progression from age only. The aim of the study was to develop a predictive model based on machine learning using an XGBoost algorithm for regression and report, explore and quantify, in a single centre longitudinal natural history study, the influence of clinical variables on the 6/12-months Hammersmith Motor Functional Scale Expanded score prediction (HFMSE). This study represents the first approach to artificial intelligence and trained models for the prediction of individualized trajectories of HFMSE disease progression using individual characteristics of the patient. The application of this method to larger cohorts may allow to identify different classes of progression, a crucial information at the time of the new commercially available therapies.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0267930PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9070873PMC
May 2022

Safety and prognostic relevance of acetylcholine testing in patients with stable myocardial ischaemia or myocardial infarction and non-obstructive coronary arteries.

EuroIntervention 2022 Apr 4. Epub 2022 Apr 4.

Department of Cardiovascular Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Background: Intracoronary provocation testing with acetylcholine (ACh) is crucial for the diagnosis of functional coronary alterations in patients with suspected myocardial ischaemia and non-obstructive coronary arteries.

Aims: Our intention was to assess the safety and predictive value for major adverse cardiovascular and cerebrovascular events (MACCE) in patients presenting with ischaemia with non-obstructive coronary arteries (INOCA) or with myocardial infarction with non-obstructive coronary arteries (MINOCA).

Methods: We prospectively enrolled consecutive INOCA or MINOCA patients undergoing intracoronary ACh provocation testing.

Results: A total of 317 patients were enrolled: 174 (54.9%) with INOCA and 143 (45.1%) with MINOCA. Of these, 185 patients (58.4%) had a positive response to the ACh test. Complications during ACh provocative testing were all mild and transient and occurred in 29 (9.1%) patients, with no difference between patients with positive or negative responses to ACh testing, nor between INOCA and MINOCA patients. A history of paroxysmal atrial fibrillation, moderate/severe diastolic dysfunction and a higher QT dispersion at baseline electrocardiogram were independent predictors of complications. MACCE occurred in 30 patients (9.5%) during a median follow-up of 22 months. The incidence of MACCE was higher among patients with a positive ACh test (24 [13.0%] vs 6 [4.5%], p=0.017), and a positive ACh test was an independent predictor of MACCE.

Conclusions: ACh provocation testing is associated with a low risk of mild and transient complications, with a similar prevalence in both INOCA and MINOCA patients. Importantly, ACh provocation testing can help to identify patients at higher risk of future clinical events, suggesting a net clinical benefit derived from its use in this clinical setting.
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http://dx.doi.org/10.4244/EIJ-D-21-00971DOI Listing
April 2022

An inter- and intra-rater agreement assessment of a novel classification of pyogenic spinal infections.

Eur Spine J 2022 02 10;31(2):448-453. Epub 2022 Jan 10.

Department of Orthopedic Surgery, School of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.

Purpose: Pola et al. described a clinical-radiological classification of pyogenic spinal infections (PSI) based on magnetic resonance imaging (MRI) features including vertebral destruction, soft tissue involvement, and epidural abscess, along with the neurological status. We performed an inter- and intra-observer agreement evaluation of this classification.

Methods: Complete MRI studies of 80 patients with PSI were selected and classified using the scheme described by Pola et al. by seven evaluators. After a four-week interval, all cases were presented to the same assessors in a random sequence for repeat assessment. We used the weighted kappa statistics (wκ) to establish the inter- and intra-observer agreement.

Results: The inter-observer agreement was substantial considering the main categories (wκ = 0.77; 0.71-0.82), but moderate considering the subtypes (wκ = 0.51; 0.45-0.58). The intra-observer agreement was substantial considering the main types (wκ = 0.65; 0.59-0.71), and moderate considering the subtypes (wκ = 0.58; 0.54-0.63).

Conclusion: The agreement at the main type level indicates that this classification allows adequate communication and may be used in clinical practice; at the subtypes level, the agreement is only moderate.
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http://dx.doi.org/10.1007/s00586-021-07077-8DOI Listing
February 2022

Predictors of fractional flow reserve/instantaneous wave-free ratio discordance: impact of tailored diagnostic cut-offs on clinical outcomes of deferred lesions.

J Cardiovasc Med (Hagerstown) 2022 02;23(2):106-115

Città della Salute e della Scienza, University of Turin, Turin.

Background: Patient-related and lesion-related factors may influence instantaneous wave-free ratio (iFR)/fractional flow reserve (FFR) concordance, potentially affecting the safety of revascularization deferral.

Methods: Consecutive patients with at least an intermediate coronary stenosis evaluated by both iFR and FFR were retrospectively enrolled. The agreement between iFR and FFR at their diagnostic cut-offs (FFR 0.80, iFR 0.89) was assessed. Predictors of discordance were assessed using multivariate analyses. Tailored iFR cut-offs according to predictors of discordance best matching an FFR of 0.80 were identified. The impact of reclassification according to tailored iFR cut-offs on major cardiovascular events (MACE: cardiovascular death, myocardial infarction or target-lesion revascularization) among deferred lesions was investigated.

Results: Two hundred and ninety-nine intermediate coronary stenosis [FFR 0.84 (0.78-0.89), iFR 0.91 (0.87-0.95), 202 left main/left anterior descending (LM/LAD) vessels, 67.6%] of 260 patients were studied. Discordance rate was 23.4% (n = 70, 10.7% iFR-negative discordant, 12.7% iFR-positive discordant). Predictors of discordance were LM/LAD disease, multivessel disease, non-ST-elevation myocardial infarction, smoking, reduced eGFR and hypertension. Lesion reclassification with tailored iFR cut-offs based on patient-level predictors carried no prognostic value among deferred lesions. Reclassification according to lesion location, which was entirely driven by LM/LAD lesions (iFR cut-offs: 0.93 for LM/LAD, 0.89 for non-LM/LAD), identified increased MACE among lesions deferred based on a negative FFR, between patients with a positive as compared with a negative iFR (19.4 vs. 6.1%, P = 0.044), whereas the same association was not observed with the conventional 0.89 iFR cut-off (15 vs. 8.6%, P = 0.303).

Conclusion: Tailored vessel-based iFR cut-offs carry prognostic value among FFR-negative lesions, suggesting that a one-size-fit-all iFR cut-off might be clinically unsatisfactory.
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http://dx.doi.org/10.2459/JCM.0000000000001264DOI Listing
February 2022

10-Year Clinical, Functional, and X-ray Follow-Up Evaluation of a Novel Posterior Percutaneous Screw-Rod Instrumentation Technique for Single-Level Pyogenic Spondylodiscitis.

Trop Med Infect Dis 2021 Sep 1;6(3). Epub 2021 Sep 1.

Department of Orthopaedics, A.O.U. "Vanvitelli" University Hospital, "Luigi Vanvitelli" University, Via del Sole 10, 80138 Naples, Italy.

Medical treatment with antibiotic therapy remains the mainstay of treatment for pyogenic spondylodiscitis (PS). Nevertheless, orthopaedic treatment is also very important in relieving pain, preventing neurological damage, and avoiding development of spinal deformities (e.g., scoliosis, kyphosis) due to spinal instability. Rigid thoracolumbosacral orthosis (TLSO) bracing is often needed in patients with PS, and average duration of treatment of 3 to 4 months. However, TLSO bracing can be poorly tolerated and limit ability of the patient to go back to a normal life. In 2004 our group developed an alternative surgical treatment to TLSO bracing by percutaneous posterior screw-rod bridge instrumentation of the infected level. This treatment allows early and free mobilization of the patients and is associated with faster recovery, lower pain scores and improved quality of life as previously reported. Herein, we report the clinical outcome of the first 3 patients who have completed the 10 years follow-up mark after the procedure. A case report is also described and details of the procedure are provided.
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http://dx.doi.org/10.3390/tropicalmed6030159DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8482233PMC
September 2021

Systemic Mastocytosis: Radiological Point of View.

Mediterr J Hematol Infect Dis 2021 1;13(1):e2021056. Epub 2021 Sep 1.

Department of Radiological and Hematological Sciences, Università Cattolica del Sacro Cuore, Largo A. Gemelli 1, 00168 Rome, Italy.

Radiological diagnosis of systemic mastocytosis (SM) can be hard to establish. This difficulty is mainly due to the variable radiological features involving many organ systems (e.g., respiratory, cardiovascular, lympho-reticular, digestive systems, and most commonly skin), and above all, to the broad spectrum of skeletal findings. Skeletal involvement is the most common and prominent imaging feature in patients with SM and represents a prognostic factor as it may entail an aggressive course of the disease. Diagnosis, largely established by histological evaluation of a bone marrow trephine biopsy, supplemented by imaging modalities such as radiography, CT, and magnetic resonance imaging, requires a team approach between the hematologist, radiologist, and pathologist. The general radiologist needs to be familiar with the imaging findings because they may be the first to suggest the correct diagnosis. The primary purpose of this review article was to equip clinicians with pertinent radiological semiotics by presenting relevant radiological features that assist early diagnosis and selection of an effective treatment.
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http://dx.doi.org/10.4084/MJHID.2021.056DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8425380PMC
September 2021

Physiological assessment after percutaneous coronary intervention: the hard truth.

Panminerva Med 2021 Dec 6;63(4):519-528. Epub 2021 Sep 6.

Dipartimento di Scienze Cardiovascolari, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy -

Physiologically guided revascularization, using fractional flow reserve (FFR) or instantaneous wave free ratio (iFR) has been demonstrated to be associated with better long-term outcomes compared to an angiographically-guided strategy, mainly avoiding inappropriate coronary stenting and its associated adverse events. On the contrary, the role of invasive physiological assessment after percutaneous coronary intervention (PCI) is much less well established. However, a large body of evidence suggests that a relevant proportion of patients undergoing PCI with a satisfying angiographic result show instead a suboptimal functional product with a potentially negative prognostic impact. For this reason, many efforts have been focused to identify interventional strategies to physiologically optimize PCI. Measuring the functional result after as PCI, especially when performed after a physiological assessment, implies that the operator is ready to accept the hard truth of an unsatisfactory physiological result despite angiographically optimal and, consequently, to optimize the product with some additional effort. The aim of this review was to bridge this gap in knowledge by better defining the paradigm shift of invasive physiological assessment, from a simple tool for deciding whether an epicardial stenosis must be treated, to a thoroughly physiological approach to PCI with the suggestion of a practical flow chart.
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http://dx.doi.org/10.23736/S0031-0808.21.04363-9DOI Listing
December 2021

No blossom for fractional flow reserve in FLOWER-MI.

Eur Heart J 2021 08;42(31):2971-2972

Department of Cardiovascular and Pulmonary Sciences, Fondazione Policlinico Gemelli-IRCCS, Catholic University School of Medicine, Largo A. Gemelli, Rome 8-00168, Italy.

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http://dx.doi.org/10.1093/eurheartj/ehab425DOI Listing
August 2021

Interplay Between Myocardial Bridging and Coronary Spasm in Patients With Myocardial Ischemia and Non-Obstructive Coronary Arteries: Pathogenic and Prognostic Implications.

J Am Heart Assoc 2021 07 14;10(14):e020535. Epub 2021 Jul 14.

Department of Cardiovascular Medicine Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy.

Background Myocardial bridging (MB) may represent a cause of myocardial ischemia in patients with non-obstructive coronary artery disease (NOCAD). Herein, we assessed the interplay between MB and coronary vasomotor disorders, also evaluating their prognostic relevance in patients with myocardial infarction and non-obstructive coronary arteries (MINOCA) or stable NOCAD. Methods and Results We prospectively enrolled patients with NOCAD undergoing intracoronary acetylcholine provocative test. The incidence of major adverse cardiac events, defined as the composite of cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina, was assessed at follow-up. We also assessed angina status using Seattle Angina Questionnaires summary score. We enrolled 310 patients (mean age, 60.6±11.9; 136 [43.9%] men; 169 [54.5%] stable NOCAD and 141 [45.5%] MINOCA). MB was found in 53 (17.1%) patients. MB and a positive acetylcholine test coexisted more frequently in patients with MINOCA versus stable NOCAD. MB was an independent predictor of positive acetylcholine test and MINOCA. At follow-up (median, 22 months; interquartile range, 13-32), patients with MB had a higher rate of major adverse cardiac events, mainly driven by a higher rate of hospitalization attributable to angina, and a lower Seattle Angina Questionnaires summary score (all <0.001) compared with patients without MB. In particular, the group of patients with MB and a positive acetylcholine test had the worst prognosis. Conclusions Among patients with NOCAD, coronary spasm associated with MB may predict a worse clinical presentation with MINOCA and a higher rate of hospitalization attributable to angina at long-term follow-up with a low rate of hard events.
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http://dx.doi.org/10.1161/JAHA.120.020535DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483499PMC
July 2021

Broadening the phenotypic spectrum of Beta3GalT6-associated phenotypes.

Am J Med Genet A 2021 10 23;185(10):3153-3160. Epub 2021 Jun 23.

Center for Rare Diseases and Birth Defects, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Biallelic mutations in B3GALT6, coding for a galactosyltransferase involved in the synthesis of glycosaminoglycans (GAGs), have been associated with various clinical conditions, causing spondyloepimetaphyseal dysplasia with joint laxity type 1 (SEMDJL1 or SEMDJL Beighton type), Al-Gazali syndrome (ALGAZ), and a severe progeroid form of Ehlers-Danlos syndrome (EDSSPD2). In the 2017 Ehlers-Danlos syndrome (EDS) classification, Beta3GalT6-related disorders were grouped in the spondylodysplastic EDSs together with spondylodysplastic EDSs due to B4GALT7 and SLC39A13 mutations. Herein, we describe a patient with a previously unreported homozygous pathogenic B3GALT6 variant resulting in a complex phenotype more severe than spondyloepimetaphyseal dysplasia with joint laxity type 1, and having dural ectasia and aortic dilation as additionally associated features, further broadening the phenotypic spectrum of the Beta3GalT6-related syndromes. We also document the utility of repeating sequencing in patients with uninformative exomes, particularly when performed by using "first generations" enrichment capture methods.
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http://dx.doi.org/10.1002/ajmg.a.62399DOI Listing
October 2021

Impact of coronary stenting on top of medical therapy and of inclusion of periprocedural infarctions on hard composite endpoints in patients with chronic coronary syndromes: a meta-analysis of randomized controlled trials.

Minerva Cardiol Angiol 2021 May 4. Epub 2021 May 4.

IRCCS Ospedale Policlinico San Martino, Italian IRCCS Cardiovascular Network, Genoa, Italy -

Background: Composite endpoints are pivotal when assessing rare outcomes over relatively short follow-ups. Most randomized controlled trials (RCTs) comparing percutaneous coronary intervention (PCI) with stent implantation to optimal medical therapy (OMT) in chronic coronary syndromes (CCS) patients included both hard and soft outcomes in their primary endpoint, with periprocedural myocardial infarctions (MIs) systematically allocated to the PCI arm. We metaanalysed the above RCTs for composite hard endpoints, with and without periprocedural MIs.

Methods: This study is registered in PROSPERO CRD42020166754 and follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane Collaboration reporting. Patients had inducible ischemia, no left main disease nor severe left ventricular dysfunction.

Results: Six RCTs involving 10,751 patients followed for a mean of 4.4 years were included. PCI+OMT versus OMT alone was associated with no difference in the two co-primary composite endpoints of all-cause death/MI/stroke and cardiovascular death/MI including all-MIs (IRR 0.99; 95% CI 0.90-1.08 and IRR 0.95; 95% CI 0.83-1.08 respectively). After inclusion of spontaneous rather than all-MIs (i.e., excluding periprocedural MIs), the odds showed benefit of PCI+OMT for both co-primary endpoints (IRR 0.88; 95% CI 0.80-0.97, P<0.01 and IRR 0.81; 95% CI 0.69-0.95, P=0.01 respectively) with numbers needed to treat of 42 in both cases.

Conclusions: Among CCS patients with inducible myocardial ischemia without severely reduced ejection fraction or left main disease, adding PCI to OMT reduces hard composite outcomes only after exclusion of periprocedural MIs. Continued efforts to define periprocedural MIs reproducibly, to assess their prognostic relevance and to prevent them are warranted.
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http://dx.doi.org/10.23736/S2724-5683.21.05645-3DOI Listing
May 2021

Intracoronary bolus of glycoprotein IIb/IIIa inhibitor as bridging or adjunctive strategy to oral P2Y12 inhibitor load in the modern setting of STEMI.

Minerva Cardiol Angiol 2021 Apr 7. Epub 2021 Apr 7.

Dipartimento di Scienze Cardiovascolari e Toraciche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Background: In the acute management of ST-elevation myocardial infarction (STEMI), glycoprotein IIb/IIIa inhibitors (GPIs) bolus not followed by intravenous infusion is potentially advantageous given their fast onset and offset of action, but clinical evidence in a contemporary setting is limited.

Methods: We collected data from consecutive STEMI patients admitted to the cardiac catheterization laboratory of the Fondazione Policlinico Universitario A. Gemelli from October 2017 to September 2019.

Results: Out of 423 consecutive STEMI patients, 297 met the inclusion and exclusion criteria and were included in the study. Of them, 107/297 (36%) received an intracoronary GPI bolus-only during primary percutaneous coronary intervention (PPCI) not followed by intravenous infusion and 190/297 (64%) received standard antithrombotic therapy. Of the 107 GPI-treated, 22/107 (21%) had P2Y12 inhibitor pre-treatment (adjunctive strategy) and 85/107 (79%) did not (bridging strategy). During hospital staying, there was no difference in the primary safety endpoint of TIMI major+minor bleeding (p=0.283), TIMI major (p=0.267) or TIMI minor (p=0.685) bleeding between groups. No stroke event occurred in the GPI group. Despite patients receiving GPI having a significantly higher intraprocedural ischemic burden, no significant differences were found in the efficacy outcomes between groups. Consistent findings were observed for patients receiving GPIs bolus before (bridging strategy) or after (adjunctive strategy) P2Y12 inhibitors, compared to those receiving standard therapy. Multivariate logistic regression analyses did not find any independent predictors significantly associated to the primary and secondary composite endpoints.

Conclusions: In a contemporary real-world population of STEMI patients undergoing PPCI, the use of intracoronary GPIs bolus-only in selected patients at high ischemic risk is safe and could represent a useful antithrombotic strategy both in those pre-treated and in those naïve to P2Y12 inhibitors.
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http://dx.doi.org/10.23736/S2724-5683.21.05669-6DOI Listing
April 2021

Under-deployment of extra-large drug-eluting stent: an adapted provisional technique for selected patients with distal lesions in large left main.

Minerva Cardiol Angiol 2021 Mar 11. Epub 2021 Mar 11.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia.

Background: In provisional technique, main vessel (MV) drug-eluting stent (DES) diameter is usually selected according to distal MV to reduce carina shift. Proximal optimization technique (POT) is used to expand the DES in the proximal MV. Occasionally, the size discrepancy between left main (LM) and left anterior descending artery (LAD) may be huge and this may cause stent malapposition and poor vessel wall coverage in large-sized LM. Recently, some manufactures designed extra-large DES to treat large vessels.

Methods: We developed an "adapted" provisional strategy based on underdeployment of extralarge DES in case of major size mismatch between LM and proximal LAD. Bench tests were realized in appropriately designed LM bifurcation model using an extra-large DES (Onyx XL, Medtronic, Santa Rosa, USA). This technique was adopted when such "rare" anatomy was found in our clinical practice.

Results: At bench test, Onyx XL 4.5 mm stent reaches 3.8 mm at 5-6 atmospheres, with favourable stent deformation achieved after POT, kissing balloon and re-POT. This technique was performed in 10 patients undergoing unprotected LM stenting with large LM and major mismatch toward LAD. Angiographic success was achieved in all cases and optical coherence tomography assessment was performed in 5 patients revealing optimal stent result. After a follow-up of 557 days (range: 90-1369 days), clinical course was uneventful in all treated patients.

Conclusions: Underdeployment of extra-large DES is a technical option that can be considered to optimize the provisional stenting technique in selected patients with major diameter mismatch between large-sized LM and LAD.
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http://dx.doi.org/10.23736/S2724-5683.21.05545-6DOI Listing
March 2021

Corrigendum to '3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study' [Injury 51S3 (2020) S28 - S33].

Injury 2021 Apr 13;52(4):1103. Epub 2021 Feb 13.

Department of Orthopaedics, A. Gemelli University Hospital Foundation IRCCS, Catholic University, Rome, Italy.

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http://dx.doi.org/10.1016/j.injury.2021.02.011DOI Listing
April 2021

The role of chronic obstructive pulmonary disease in acute coronary syndrome patients: a critical risk factor for lipid plaque burden?

Minerva Cardiol Angiol 2021 Dec 11;69(6):735-737. Epub 2021 Jan 11.

Unit of Intensive Care, Hemodynamics, and Cardiology, S. Maria Goretti Hospital, Latina, Italy.

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http://dx.doi.org/10.23736/S2724-5683.20.05555-3DOI Listing
December 2021

Systemic mastocytosis revisited with an emphasis on skeletal manifestations.

Radiol Med 2021 Apr 26;126(4):585-598. Epub 2020 Nov 26.

Department of Radiological and Hematological Sciences Fondazione, Policlinico Universitario A. Gemelli, IRCCS Università Cattolica del Sacro Cuore, Largo A. Gemelli, 100168, Rome, Italy.

Systemic mastocytosis (SM) is a rare form of mastocytosis that can affect various organ systems. Bone involvement is the most common and prominent imaging feature in patients with SM regardless of the subtype. Furthermore, bone involvement is a prognostic factor as it may entail an aggressive course of the disease. Diagnosis is established by bone marrow biopsy complemented by imaging modalities such as radiography, CT, and magnetic resonance (MR) imaging. The radiographic and CT appearances are that of sclerotic, lytic, or mixed patterns with focal or diffuse distribution, involving primarily the axial skeleton and the ends of the long bones. Bone marrow infiltration is best recognized on MR imaging. Osteoporosis is common in SM; thus, a bone mineral density measurement at lumbar spine and proximal femur by dual-energy X-ray absorptiometry should be obtained. Imaging plays a huge part in the diagnostic process; when skeletal imaging findings are carefully interpreted and correlated with clinical features, they can lead to the suspicion of SM. The primary aims of this review article were to focus on the role of imaging in detection and characterization of skeletal patterns of SM and to discuss relevant clinical features that could facilitate prompt and correct diagnosis.
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http://dx.doi.org/10.1007/s11547-020-01306-8DOI Listing
April 2021

Prognostic impact of FFR/contrast FFR discordance.

Int J Cardiol 2021 03 10;327:40-44. Epub 2020 Nov 10.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; Università Cattolica del Sacro Cuore, Roma, Italy.

Background: Contrast fractional flow reserve (cFFR) is a relatively new tool for the assessment of intermediate coronary artery stenosis and represents a reliable surrogate of FFR with the advantage of potentially simplifying functional evaluation. We aimed to compare the incidence of major adverse cardiac events (MACE) in patients undergoing functional evaluation with both FFR and cFFR based on the results of the two indexes.

Method And Result: We retrospectively analyzed outcomes in 488 patients who underwent functional evaluation with FFR and cFFR. Patients were divided into four groups using the cutoff values of 0.80 for FFR and 0.85 for cFFR: -/- (n = 298), +/+ (n = 134), -/+(n = 31) and +/- (n = 25). All patients were treated according to FFR value. MACE rate was assessed in each group, including death, myocardial infarction and urgent target vessel revascularization (TVR). Mean follow-up time was 22 ± 15 months. Incidence of MACE at follow-up was 8.3% in FFR-/cFFR-, 14.0% in FFR+/cFFR+, 16.0% in FFR-/cFFR+ and 8.0% in FFR+/cFFR- without a significant difference amongst the 4 groups (p = 0.2). Nevertheless, a significant difference in the rate of TVR comparing FFR-/cFFR- (n = 17) and FFR-/cFFR+ (n = 5) was found at 24 months (5.7% vs 16.0%; p = 0.027).

Conclusion: cFFR is accurate in predicting FFR and consequently reliable in guiding coronary revascularization. In the rare case of discordance, while FFR+/cFFR- patients show a prognosis similar to FFR-/cFFR- patients, FFR-/cFFR+ patients show a prognosis similar to FFR+/cFFR+ patients.
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http://dx.doi.org/10.1016/j.ijcard.2020.11.011DOI Listing
March 2021

ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study.

J Cardiovasc Med (Hagerstown) 2021 Mar;22(3):175-179

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Aims: The ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) study investigates the safety and efficacy of Edoxaban administered via PEG in patients with atrial fibrillation and a clinical indication for a long-term anticoagulation.

Design: In this prospective, single-centre observational study, 12 PEG-treated patients with indication to anticoagulation will receive edoxaban via PEG and will be followed up to 6 months. Plasma antifactor Xa activity and edoxaban concentrations will be assessed. Thromboembolic (ischaemic stroke, systemic embolism, venous thromboembolism) and bleeding events (Bleeding Academic Research Consortium and Thrombolysis in Myocardial Infarction) will be recorded at 1 and 6 months.

Preliminary Results: A retrospective analysis of five atrial fibrillation cases undergoing PEG implantation at our Institution who received edoxaban via PEG showed plasma anti-FXa levels at a steady state of 146 ± 15 ng/ml, without major adverse event at a mean follow-up of 6 months.

Conclusion: ORIGAMI prospectively investigates PEG-administration of edoxaban in PEG-treated patients requiring long-term anticoagulation. Our preliminary retrospective data support this route of DOAC administration.

Clinicaltrialsgov Identifier: NCT04271293.
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http://dx.doi.org/10.2459/JCM.0000000000001142DOI Listing
March 2021

Thoracic spine fracture associated with an extradural lipoma: Case report and systematic review of the literature.

Orthop Rev (Pavia) 2020 Jun 26;12(Suppl 1):8684. Epub 2020 Jun 26.

UOC Chirurgia Vertebrale.

Isolated extradural lipoma (IEL), not associated to spinal dysraphisms, is a rare condition. Frequently IEL was confused with much more frequent diffuse lipomatosis. The lesion can be completely asymptomatic and occasionally diagnosed with magnetic resonance (MR) imaging. This paper describes a case of a patient with an axial compression fracture of the thoracic spine associated with an extradural lipoma. We also performed a systematic review of the pertinent literature in order to retrieve the key information regarding: the diagnosis, the clinical features and the treatment.
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http://dx.doi.org/10.4081/or.2020.8684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7459376PMC
June 2020

3D - Navigated percutaneous screw fixation of pelvic ring injuries - a pilot study.

Injury 2020 Aug 10;51 Suppl 3:S28-S33. Epub 2020 Jul 10.

Department of Orthopaedics, A. Gemelli University Hospital Foundation IRCCS, Catholic University, Rome, Italy.

Introduction: Screw fixation of pelvic ring fractures is a common, but demanding procedure and navigation techniques were introduced to increase the precision of screw placement. The purpose of this case series is to demonstrate a lower screw malposition rate using percutaneous fixation of pelvic ring fractures and sacroiliac dislocations guided by navigation system based on 3D-fluoroscopic images compared to traditional imaging techniques and to evaluate the functional outcomes of this innovative procedure.

Patient And Methods: 10 cases of disrupted pelvic ring lesions treated in our hospital from February 2018 to December 2018 were included for closed reduction and percutaneous screw fixation of using with O-Arm and the acquisition by the Navigator. Preoperative assessment was performed on the patients by means of X Ray imaging and CT scan. Routine CT was carried out on third postoperative day to evaluate screw placement. Measures of radiation exposure were extracted directly from reports provided by system. Quality of life was evaluated by SF 36-questionnaire 6 months after surgery.

Results: 12 iliosacral- and 2 ramus pubic-screws were inserted. In post-operative CT-scans the screw position was assessed and graded using the score described by Smith. No wound infection or iatrogenic neurovascular damage were observed. No re-operations were performed. The exposure to radiation is, for the patient, slightly greater than that resulting from the use of traditional fluoroscopic systems, while it is naught for the surgical team, which at the time of image acquisition is located outside the room.

Discussion And Conclusion: The execution of an intraoperative 3D-fluoroscopic scan can on its own suffice as a post-operative control examination since its accuracy is similar to that of the post-operative CT. The use of a navigated 3d fluoroscopy exposes the patient to an amount of radiation slightly greater than that of traditional fluoroscopy, but the dose is lower than a CT examination. For the operating team, exposure to radiation is naught. 3D-fluoroscopic navigation is a safe tool providing high accuracy of percutaneous screw placement for pelvic ring fractures. Finally, despite the small cohort of patients studied, the excellent results obtained regarding the patients' quality of life and the absence of complications allow us to look positively at the future of this technique, which needs further studies and improvement.
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http://dx.doi.org/10.1016/j.injury.2020.07.025DOI Listing
August 2020

Radiological evaluation of fusion patterns after lateral lumbar interbody fusion: institutional case series.

Radiol Med 2021 Feb 11;126(2):250-257. Epub 2020 Jul 11.

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Introduction: There is no consensus on how to evaluate segmental fusion after lateral lumbar interbody fusion (LLIF). Bone bridges (BB) between two contiguous vertebra are reported as pathognomonic criteria for anterior fusion. However, to the best of our knowledge, there are no radiological investigations on zygapophyseal joints (ZJ) status after LLIF. The aim of this radiological study was to investigate the different fusion patterns after LLIF.

Materials And Methods: This is a retrospective single-centre radiological study. Patients who underwent LLIF and posterior percutaneous screw fixation for degenerative spondylolisthesis, on a single lumbar level, were considered for eligibility. Complete radiological data and a minimum follow-up of 1 year were the inclusion criteria. Intervertebral BB were investigated for evaluating anterior fusion and ZJ ankylotic degeneration was evaluated according Pathria et al., as a matter of proof of posterior fusion and segmental immobilization.

Results: Seventy-four patients were finally included in the present study. Twelve months after surgery, intervertebral BB were recognized in 58 segments (78.3%), whereas ZJ Pathria grade was I in 8 (10.8%) patients, II in 15 (20.3%) and III in 51 (68.9%) that were considered posteriorly fused. The overlapping rate between anteriorly and posteriorly fused segments was 72.4% (42 segments), whereas 10 (13.5%) did not achieve any fusion, anterior or posterior, and 6 (8.1%) were posteriorly fused only.

Conclusions: Our results seem to suggest that anterior fusion is not sufficient to achieve segmental immobilization. Further properly designed investigations are needed to investigate eventual clinical-radiological correlations.
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http://dx.doi.org/10.1007/s11547-020-01252-5DOI Listing
February 2021

Post PCI FFR: More questions than answers?

Int J Cardiol 2020 10 4;317:42-43. Epub 2020 Jul 4.

Dipartimento di Scienze Cardiovascolari Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italia. Electronic address:

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http://dx.doi.org/10.1016/j.ijcard.2020.06.058DOI Listing
October 2020

Usefulness of sheathless guiding catheters in patients with upper extremity vascular anomalies: Sheathless catheters in upper vascular anomalies.

AsiaIntervention 2020 Jul 20;6(1):43-49. Epub 2020 Jul 20.

Institute of Cardiology, Fondazione Policlinico Universitario A. Gemelli IRCSS, Rome, Italy.

Aims: The transradial approach (TRA) reduces hospitalisation and access-site complications as compared to the transfemoral approach. Nevertheless, the TRA technical failure rate is significantly higher compared to the transfemoral approach. The high failure rate of TRA is due to a series of factors. In particular, a wide range of anatomic vascular variants hindering procedural success may be present in patients undergoing TRA procedures.

Methods And Results: In our retrospective observational study, 1,596 consecutive patients with upper limb vascular anomalies underwent TRA between January 2006 and July 2017. We evaluate the usefulness of the sheathless guiding catheter system (SG) as compared to the conventional guiding catheter (CG). The primary study endpoint was the "procedural success" defined as successful transradial procedure (both selective cannulation of the coronary ostium in the diagnostic procedure and successful stent delivery in the interventional procedure) without access change. All SG procedures were successful, whereas only 1,274 (86%) CG procedures were successfully performed (p=0.0001). At multivariable analysis, age (p=0.001) and sheathless catheter use (p=0.001) were independent predictors of procedural success.

Conclusions: The sheathless GC is a safe and useful system not only for small radial access but also in the presence of upper vascular anomalies and it can be used in PCI and diagnostic procedures.
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http://dx.doi.org/10.4244/AIJ-D-19-00024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8525726PMC
July 2020

Diabetic Foot Infections: The Diagnostic Challenges.

J Clin Med 2020 Jun 8;9(6). Epub 2020 Jun 8.

Diabetic Foot Unit, Department of Systems Medicine, University of Rome Tor Vergata, 00133 Rome, Italy.

Diabetic foot infections (DFIs) are severe complications of long-standing diabetes, and they represent a diagnostic challenge, since the differentiation between osteomyelitis (OM), soft tissue infection (STI), and Charcot's osteoarthropathy is very difficult to achieve. Nevertheless, such differential diagnosis is mandatory in order to plan the most appropriate treatment for the patient. The isolation of the pathogen from bone or soft tissues is still the gold standard for diagnosis; however, it would be desirable to have a non-invasive test that is able to detect, localize, and evaluate the extent of the infection with high accuracy. A multidisciplinary approach is the key for the correct management of diabetic patients dealing with infective complications, but at the moment, no definite diagnostic flow charts still exist. This review aims at providing an overview on multimodality imaging for the diagnosis of DFI and to address evidence-based answers to the clinicians when they appeal to radiologists or nuclear medicine (NM) physicians for studying their patients.
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http://dx.doi.org/10.3390/jcm9061779DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7355769PMC
June 2020
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