Publications by authors named "Filippo Russo"

74 Publications

An external validation of the Candiolo nomogram in a cohort of prostate cancer patients treated by external-beam radiotherapy.

Radiat Oncol 2021 May 5;16(1):85. Epub 2021 May 5.

Department of Radiation Oncology, University of Torino, Città della Salute e della Scienza Hospital, Turin, Italy.

Background: the aim of this study is to perform an external validation for the Candiolo nomogram, a predictive algorithm of biochemical and clinical recurrences in prostate cancer patients treated by radical Radiotherapy, published in 2016 on the journal "Radiation Oncology".

Methods: 561 patients, treated by Radiotherapy with curative intent between 2003 and 2012, were classified according to the five risk-classes of the Candiolo nomogram and the three risk-classes of the D'Amico classification for comparison. Patients were treated with a mean prostatic dose of 77.7 Gy and a combined treatment with Androgen-Deprivation-Therapy in 76% of cases. The end-points of the study were biochemical-progression-free-survival (bPFS) and clinical-Progression-Free-Survival (cPFS). With a median follow-up of 50 months, 56 patients (10%) had a biochemical relapse, and 30 patients (5.4%) a clinical progression. The cases were divided according to D'Amico in low-risk 21%, intermediate 40%, high-risk 39%; according to Candiolo very-low-risk 24%, low 37%, intermediate 24%, high 10%, very-high-risk 5%. Statistically, the Kaplan-Meier survival curves were processed and compared using Log-Rank tests and Harrell-C concordance index.

Results: The 5-year bPFS for the Candiolo risk-classes range between 98 and 38%, and the 5-year cPFS between 98 and 50% for very-low and very-high-risk, respectively. The Candiolo nomogram is highly significant for the stratification of both bPFS and cPFS (P < 0.0001), as well as the D'Amico classification (P = 0.004 and P = 0.001, respectively). For the Candiolo nomogram, the C indexes for bPFS and cPFS are 75 and 80%, respectively, while for D'Amico classification they are 64 and 69%, respectively. The Candiolo nomogram can identify a greater number of patients with low and very-low-risk prostate cancer (61% versus 21% according to D'Amico) and it better picks out patients with high and very-high-risk of recurrence, equal to only 15% of the total cases but subject to 48% (27/56) of biochemical relapses and 63% (19/30) of clinical progressions.

Conclusions: the external validation of the Candiolo nomogram was overall successful with C indexes approximately 10% higher than the D'Amico control classification for bPFS and cPFS. Therefore, its clinical use is justified in prostate cancer patients before radical Radiotherapy. Trial registration Retrospectively registered.
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http://dx.doi.org/10.1186/s13014-021-01814-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097839PMC
May 2021

Diagnostic Accuracy of Single-plane Biparametric and Multiparametric Magnetic Resonance Imaging in Prostate Cancer: A Randomized Noninferiority Trial in Biopsy-naïve Men.

Eur Urol Oncol 2021 Apr 20. Epub 2021 Apr 20.

Department of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.

Background: Urological guidelines recommend multiparametric magnetic resonance imaging (mpMRI) in men with a suspicion of prostate cancer (PCa). The resulting increase in MRI demand might place health care systems under substantial stress.

Objective: To determine whether single-plane biparametric MRI (fast MRI) workup could represent an alternative to mpMRI in the detection of clinically significant (cs) PCa.

Design, Setting, And Participants: Between April 2018 and February 2020, 311 biopsy-naïve men aged ≤75 yr with PSA ≤15 ng/ml and negative digital rectal examination were randomly assigned to 1.5-T fast MRI (n = 213) or mpMRI (n = 98).

Intervention: All MRI examinations were classified according to Prostate Imaging-Reporting and Data System (PI-RADS) version 2. Men scored PI-RADS 1-2 underwent 12-core standard biopsy (SBx) and those with PI-RADS 4-5 on fast MRI or PI-RADS 3-5 on mpMRI underwent targeted biopsy in combination with SBx. Equivocal cases on fast MRI (PI-RADS 3) underwent mpMRI and then biopsy according to the findings.

Outcome Measurements And Statistical Analysis: The primary outcome was to compare the detection rate of csPCa in both study arms, setting a 10% difference for noninferiority. The secondary outcome was to assess the role of prostate-specific antigen density (PSAD) in ruling out men who could avoid biopsy among those with equivocal findings on fast MRI.

Results And Limitations: The overall MRI detection rate for csPCa was 23.5% (50/213; 95% confidence interval [CI] 18.0-29.8%) with fast MRI and 32.7% (32/98; 95% CI 23.6-42.9%) with mpMRI (difference 9.2%; p = 0.09). The reproducibility of the study could have been affected by its single-center nature.

Conclusions: Fast MRI followed by mpMRI in equivocal cases is not inferior to mpMRI in the detection of csPCa among biopsy-naïve men aged ≤75 yr with PSA ≤15 ng/ml and negative digital rectal examination. These findings could pave the way to broader use of MRI for PCa diagnosis.

Patient Summary: A faster MRI (magnetic resonance imaging) protocol with no contrast agent and fewer scan sequences for examination of the prostate is not inferior to the typical MRI approach in the detection of clinically significant prostate cancer. If our findings are confirmed in other studies, fast MRI could represent a time-saving and less invasive examination for men with suspicion of prostate cancer. This trial is registered at ClinicalTrials.gov as NCT03693703.
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http://dx.doi.org/10.1016/j.euo.2021.03.007DOI Listing
April 2021

Multiparametric magnetic resonance imaging-targeted prostate biopsy: present and future of the prostate cancer diagnostic pathway.

Minerva Urol Nephrol 2021 02;73(1):128-129

Department of Radiology, IRCCS Candiolo Cancer Institute - FPO, Candiolo, Turin, Italy.

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http://dx.doi.org/10.23736/S2724-6051.21.04341-1DOI Listing
February 2021

Covid-19 and gender: lower rate but same mortality of severe disease in women-an observational study.

BMC Pulm Med 2021 Mar 20;21(1):96. Epub 2021 Mar 20.

Department of Health and Social Care Professions, ASST Papa Giovanni XXIII, Bergamo, Italy.

Background: Gender-related factors might affect vulnerability to Covid-19. The aim of this study was to describe the role of gender on clinical features and 28-day mortality in Covid-19 patients.

Methods: Observational study of Covid-19 patients hospitalized in Bergamo, Italy, during the first three weeks of the outbreak. Medical records, clinical, radiological and laboratory findings upon admission and treatment have been collected. Primary outcome was 28-day mortality since hospitalization.

Results: 431 consecutive adult patients were admitted. Female patients were 119 (27.6%) with a mean age of 67.0 ± 14.5 years (vs 67.8 ± 12.5 for males, p = 0.54). Previous history of myocardial infarction, vasculopathy and former smoking habits were more common for males. At the time of admission PaO/FiO was similar between men and women (228 [IQR, 134-273] vs 238 mmHg [150-281], p = 0.28). Continuous Positive Airway Pressure (CPAP) assistance was needed in the first 24 h more frequently in male patients (25.7% vs 13.0%; p = 0.006). Overall 28-day mortality was 26.1% in women and 38.1% in men (p = 0.018). Gender did not result an independent predictor of death once the parameters related to disease severity at presentation were included in the multivariable analysis (p = 0.898). Accordingly, the Kaplan-Meier survival analysis in female and male patients requiring CPAP or non-invasive ventilation in the first 24 h did not find a significant difference (p = 0.687).

Conclusion: Hospitalized women are less likely to die from Covid-19; however, once severe disease occurs, the risk of dying is similar to men. Further studies are needed to better investigate the role of gender in clinical course and outcome of Covid-19.
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http://dx.doi.org/10.1186/s12890-021-01455-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7980742PMC
March 2021

Intravascular Ultrasound-Guided Coronary Lithotripsy Treatment of In-Stent Restenosis in Saphenous Venous Graft.

J Invasive Cardiol 2021 Feb;33(2):E141-E142

Interventional Cardiology Unit, IRCCS San Raffaele Hospital, Milan, Italy.

To the best of our knowledge, this is the first description of intravascular-ultrasound guided coronary lithotripsy on saphenous vein graft because of severely calcific in-stent restenosis, showing good result without procedural complications.
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February 2021

Noninvasive Ventilatory Support of COVID-19 Patients Outside the Intensive Care Units (WARd-COVID).

Ann Am Thorac Soc 2021 Jan 4. Epub 2021 Jan 4.

Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy, Department of Anesthesia and Intensive Care Unit, Pavia, Italy.

Rationale: Treatment with non-invasive ventilation (NIV) in COVID-19 is frequent. Shortage of Intensive care unit (ICU) beds led clinicians to deliver NIV also outside intensive care units (ICUs). Data about the use of NIV in COVID-19 is limited.

Objective: To describe the prevalence and clinical characteristics of patients with COVID-19 treated with NIV outside the ICUs. To investigate the factors associated with NIV failure (need for intubation or death).

Methods: In this prospective single day observational study, we enrolled adult COVID-19 patients, treated with NIV outside the ICU from thirty-one hospitals in Lombardy, Italy.

Results: We collected data on demographic, clinical characteristics, ventilatory management and patients' outcome. Of 8753 COVID-19 patients present in the hospitals on the study day, 909 (10%) were receiving NIV outside the ICU. 778/909 (85%) patients were treated with Continuous Positive Airway Pressure (CPAP), delivered by helmet in 617 (68%). NIV failed in 300 patients (37.6%), while 498 (62.4%) were discharged alive without intubation. Overall mortality was 25%. NIV failure occurred in 152/284 (53%) patients with a PaO2/FiO2 ratio < 150 mmHg. Higher C-reactive protein, lower PaO2/FiO2, and platelet counts were independently associated with increased risk of NIV failure.

Conclusions: The use of NIV outside the ICUs, in COVID-19 was common, with a predominant use of helmet CPAP, with a rate of success greater than 60% and close to 75% in full treatment patients. C-reactive protein, PaO2/FiO2, platelet counts were independently associated with increased risk of NIV failure. Clinical trial registered with ClinicalTrials.gov (NCT04382235).
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http://dx.doi.org/10.1513/AnnalsATS.202008-1080OCDOI Listing
January 2021

Self-expanding transcatheter aortic valve infolding: Current evidence, diagnosis, and management.

Catheter Cardiovasc Interv 2020 Dec 14. Epub 2020 Dec 14.

Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background: Prosthetic valve infolding is a rare but severe complication of transcatheter aortic valve implantation (TAVI) with self-expanding valves. However, currently available clinical data are limited and fragmented.

Objectives: This report aims to provide a comprehensive overview of this complication focusing on predisposing factors, clinical presentation, diagnostic findings, treatment and clinical outcomes.

Methods: A systematic review of the literature was performed to identify cases of infolding occurring during TAVI with self-expanding valves published until August 2020. These data were pooled with all the retrospectively identified infolding cases occurred at San Raffaele Scientific Institute between December 2014 and August 2020.

Results: A total of 34 cases were included. Among patients with available data, 38% received a first-generation CoreValve, and 62% a second-generation Evolut R (82%) or Evolut PRO (18%). Infolding occurred mostly with ≥29-mm valves (94%). Predisposing factors included resheathing of a second-generation valve (82%), heavy calcification of the native valve (65%), lack of predilatation (16%), Sievers type-1 bicuspid aortic valve (11%), and improper valve loading (5%). Infolding resulted in severe PVL causing hemodynamic instability (29%) or cardiac arrest (12%). Postdilatation was the treatment strategy in 68%, while prosthesis replacement with a new device in 23% of cases. Device success rate was 82%. Death and stroke occurred in 3% and 12% of cases.

Conclusions: Prosthetic valve infolding is typically observed after resheathing of a large-size self-expanding TAVI. When infolding is timely diagnosed, prosthesis removal and replacement should be pursued. Further studies are required to precisely define predisposing factors to prevent this complication.
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http://dx.doi.org/10.1002/ccd.29432DOI Listing
December 2020

At the peak of COVID-19 age and disease severity but not comorbidities are predictors of mortality: COVID-19 burden in Bergamo, Italy.

Panminerva Med 2021 Mar 27;63(1):51-61. Epub 2020 Nov 27.

Unit of Quality Management, ASST Papa Giovanni XXIII, Bergamo, Italy.

Background: Findings from February 2020, indicate that the clinical spectrum of COVID-19 can be heterogeneous, probably due to the infectious dose and viral load of SARS-CoV-2 within the first weeks of the outbreak. The aim of this study was to investigate predictors of overall 28-day mortality at the peak of the Italian outbreak.

Methods: Retrospective observational study of all COVID-19 patients admitted to the main hospital of Bergamo, from February 23 to March 14, 2020.

Results: Five hundred and eight patients were hospitalized, predominantly male (72.4%), mean age of 66±15 years; 49.2% were older than 70 years. Most of patients presented with severe respiratory failure (median value [IQR] of PaO2/FiO2: 233 [149-281]). Mortality rate at 28 days resulted of 33.7% (N.=171). Thirty-nine percent of patients were treated with continuous positive airway pressure (CPAP), 9.5% with noninvasive ventilation (NIV) and 13.6% with endotracheal intubation. 9.5% were admitted to Semi-Intensive Respiratory Care Unit, and 18.9% to Intensive Care Unit. Risk factors independently associated with 28-day mortality were advanced age (≥78 years: odds ratio [OR], 95% confidence interval [CI]: 38.91 [10.67-141.93], P<0.001; 70-77 years: 17.30 [5.40-55.38], P<0.001; 60-69 years: 3.20 [1.00-10.20], P=0.049), PaO2/FiO2<200 at presentation (3.50 [1.70-7.20], P=0.001), need for CPAP/NIV in the first 24 hours (8.38 [3.63-19.35], P<0.001), and blood urea value at admission (1.01 [1.00-1.02], P=0.015).

Conclusions: At the peak of the outbreak, with a probable high infectious dose and viral load, older age, the severity of respiratory failure and renal impairment at presentation, but not comorbidities, are predictors of 28-day mortality in COVID-19.
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http://dx.doi.org/10.23736/S0031-0808.20.04063-XDOI Listing
March 2021

Impact of optical coherence tomography findings on clinical outcomes in ST-segment elevation myocardial infarction patients: a MATRIX (Minimizing Adverse Hemorrhagic Events by Trans-radial Access Site and angioX) OCT sub-study.

Int J Cardiovasc Imaging 2021 Apr 22;37(4):1143-1150. Epub 2020 Nov 22.

Swiss Cardiovascular Center, University of Bern, Bern, Switzerland.

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 1 year. 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 (< 4.5mm), dissection (> 200 µm in width and < 5 mm from stent segment), malapposition (> 200 µm 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 < 4.5mm (16.1%, p < 0.001) and a greater thrombus burden within stent (56.7%, p = 0.042). The overall 30 day and 1 year 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 30 days 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.
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http://dx.doi.org/10.1007/s10554-020-02098-8DOI Listing
April 2021

Haemodynamic characteristics of COVID-19 patients with acute respiratory distress syndrome requiring mechanical ventilation. An invasive assessment using right heart catheterization.

Eur J Heart Fail 2020 12 7;22(12):2228-2237. Epub 2020 Dec 7.

Cardiovascular Department, ASST Papa Giovanni XXIII, Bergamo, Italy.

Aims: Interstitial pneumonia due to coronavirus disease 2019 (COVID-19) is often complicated by severe respiratory failure. In addition to reduced lung compliance and ventilation/perfusion mismatch, a blunted hypoxic pulmonary vasoconstriction has been hypothesized, that could explain part of the peculiar pathophysiology of the COVID-19 cardiorespiratory syndrome. However, no invasive haemodynamic characterization of COVID-19 patients has been reported so far.

Methods And Results: Twenty-one mechanically-ventilated COVID-19 patients underwent right heart catheterization. Their data were compared both with those obtained from non-mechanically ventilated paired control subjects matched for age, sex and body mass index, and with pooled data of 1937 patients with 'typical' acute respiratory distress syndrome (ARDS) from a systematic literature review. Cardiac index was higher in COVID-19 patients than in controls [3.8 (2.7-4.5) vs. 2.4 (2.1-2.8) L/min/m , P < 0.001], but slightly lower than in ARDS patients (P = 0.024). Intrapulmonary shunt and lung compliance were inversely related in COVID-19 patients (r = -0.57, P = 0.011) and did not differ from ARDS patients. Despite this, pulmonary vascular resistance of COVID-19 patients was normal, similar to that of control subjects [1.6 (1.1-2.5) vs. 1.6 (0.9-2.0) WU, P = 0.343], and lower than reported in ARDS patients (P < 0.01). Pulmonary hypertension was present in 76% of COVID-19 patients and in 19% of control subjects (P < 0.001), and it was always post-capillary. Pulmonary artery wedge pressure was higher in COVID-19 than in ARDS patients, and inversely related to lung compliance (r = -0.46, P = 0.038).

Conclusions: The haemodynamic profile of COVID-19 patients needing mechanical ventilation is characterized by combined cardiopulmonary alterations. Low pulmonary vascular resistance, coherent with a blunted hypoxic vasoconstriction, is associated with high cardiac output and post-capillary pulmonary hypertension, that could eventually contribute to lung stiffness and promote a vicious circle between the lung and the heart.
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http://dx.doi.org/10.1002/ejhf.2058DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753704PMC
December 2020

Supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease: the LIRA method.

Int J Cardiol 2020 Oct 28;317:144-151. Epub 2020 May 28.

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

Background: Recent evidence shows that THV prostheses anchoring occurs at the raphe-level, known as LIRA plane, in raphe-type bicuspid aortic valve (BAV) disease. The purpose of this study was to evaluate the application of a novel supra-annular sizing method, known as Level of Implantation at the RAphe (LIRA) method, to optimize transcatheter heart valve (THV) prosthesis sizing in raphe-type BAV disease.

Methods And Results: The LIRA method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to January 2020 in our centre. THV prostheses were sized on the basis of baseline CT scan perimeters at the LIRA plane and at the virtual basal ring. In case of discrepancy between the two plane measurements, the plane with the smallest perimeter was considered the reference for prosthesis sizing. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. 20 patients (mean patient age 81 ± 5.4 years, 70% males) were identified as having a raphe-type BAV disease at pre-procedural CT scans and were implanted with different types of THV prostheses. The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, no moderate-severe paravalvular leak and low transprosthetic gradient (residual mean gradient of 8.2 ± 2.9 mm Hg).

Conclusions: Supra-annular sizing according to the LIRA method appeared to be safe with a high device success. The application of the LIRA method might optimize THV prosthesis sizing in patients with raphe-type BAV disease.
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http://dx.doi.org/10.1016/j.ijcard.2020.05.076DOI Listing
October 2020

Assessment of residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing bivalirudin versus unfractionated heparin infusion: The MATRIX (minimizing adverse hemorrhagic events by transradial access site and angioX) OCT study.

Catheter Cardiovasc Interv 2020 11 28;96(6):1156-1171. Epub 2019 Dec 28.

Swiss Cardiovascular Center Bern, University of Bern, Bern, Switzerland.

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 mm 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.
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http://dx.doi.org/10.1002/ccd.28661DOI Listing
November 2020

Comparison of intra-procedural vs. post-stenting prolonged bivalirudin infusion for residual thrombus burden in patients with ST-segment elevation myocardial infarction undergoing: the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) OCT study.

Eur Heart J Cardiovasc Imaging 2019 Dec;20(12):1418-1428

Swiss Cardiovascular Center Bern, Bern University Hospital, Freiburgstrasse 8, Bern, Switzerland.

Aims: To compare prolonged bivalirudin infusion vs. an intra-procedural only bivalirudin infusion administration in subjects with ST-segment elevation myocardial infarction (STEMI) regarding residual stent strut thrombosis.

Methods And Results: Multivessel STEMI patients undergoing primary percutaneous coronary intervention (PPCI) and scheduled for a staged percutaneous coronary intervention (PCI) before hospital discharge were selected among those allocated to either prolonged bivalirudin or intra-procedural only bivalirudin infusion in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of PPCI and 4-5 days thereafter during staged intervention. The predefined endpoint was the percentage difference in the number of stent cross-sections with a thrombotic area >5% at the end of PPCI and at the time of staged PCI (ΔThCS). Between September 2013 and November 2015, 137 were randomized to either intra-procedural only bivalirudin infusion (N = 64) or prolonged bivalirudin (N = 73) at 16 European sites. Mean stent area, minimum lumen area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The difference in the proportion of frames with percent thrombotic area >5% (ΔTh > 5%) were -7.7 (-22.1 to 5.1) in the intra-procedural bivalirudin infusion group and -8.8 (-23.1 to 2.6) in the prolonged infusion group (P = 0.994). Time from index to follow-up OCT imaging and the infarct vessel artery did not affect this OCT-based endpoint.

Conclusion: A strategy of prolonged bivalirudin infusion after PPCI did not reduce residual stent strut thrombosis when compared with intra-procedural only bivalirudin infusion administration (funded by The Medicines Company and Terumo; MATRIX ClinicalTrials.gov number, NCT01433627).
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http://dx.doi.org/10.1093/ehjci/jez040DOI Listing
December 2019

Post-Procedural Bivalirudin Infusion at Full or Low Regimen in Patients With Acute Coronary Syndrome.

J Am Coll Cardiol 2019 02;73(7):758-774

Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address:

Background: The value of prolonged bivalirudin infusion after percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients with or without ST-segment elevation remains unclear.

Objectives: The purpose of this study was to assess efficacy and safety of a full or low post-PCI bivalirudin regimen in ACS patients with or without ST-segment elevation.

Methods: The MATRIX program assigned bivalirudin to patients without or with a post-PCI infusion at either a full (1.75 mg/kg/h for ≤4 h) or reduced (0.25 mg/kg/h for ≤6 h) regimen at the operator's discretion. The primary endpoint was the 30-day composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (composite of all-cause death, myocardial infarction, or stroke, or major bleeding).

Results: Among 3,610 patients assigned to bivalirudin, 1,799 were randomized to receive and 1,811 not to receive a post-PCI bivalirudin infusion. Post-PCI full bivalirudin was administered in 612 (ST-segment elevation myocardial infarction [STEMI], n = 399; non-ST-segment elevation acute coronary syndromes [NSTE-ACS], n = 213), whereas the low-dose regimen was administered in 1,068 (STEMI, n = 519; NSTE-ACS, n = 549) patients. The primary outcome did not differ in STEMI or NSTE-ACS patients who received or did not receive post-PCI bivalirudin. However, full compared with low bivalirudin regimen remained associated with a significant reduction of the primary endpoint after multivariable (rate ratio: 0.21; 95% CI: 0.12 to 0.35; p < 0.001) or propensity score (rate ratio: 0.16; 95% CI: 0.09 to 0.26; p < 0.001) adjustment. Full post-PCI bivalirudin was associated with improved outcomes consistently across ACS types compared with the no post-PCI infusion or heparin groups.

Conclusions: In ACS patients with or without ST-segment elevation, the primary endpoint did not differ with or without post-PCI bivalirudin infusion but a post-PCI full dose was associated with improved outcomes when compared with no or low-dose post-PCI infusion or heparin (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX [MATRIX]; NCT01433627).
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http://dx.doi.org/10.1016/j.jacc.2018.12.023DOI Listing
February 2019

Radiological Wheeler staging system: a retrospective cohort analysis to improve the local staging of prostate cancer with multiparametric MRI.

Minerva Urol Nefrol 2019 Jun 17;71(3):264-272. Epub 2019 Jan 17.

Department of Urology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Turin, Italy.

Background: The knowledge of tumor location and extension can allow a modulated radical prostatectomy in order to minimize positive surgical margins and reduce functional morbidity after surgery in patients with prostate cancer (PCa). Multiparametric (mp) magnetic resonance imaging (MRI) could allow the assessment of tumor extension and of its relationship with external structures. Aim of this study is to propose a new radiological Wheeler (rW) staging system applied to mp-MRI, based on the pathologic staging system (pW) for the local assessment of PCa.

Methods: This retrospective single-center multi-reader study included consecutive patients with PCa and preoperative mp-MRI, who underwent non-nerve sparing radical prostatectomy. Three radiologists reported on all examinations and classified each selected lesion according to imaging criteria following rW. Whole-mount histological sections were used as the reference standard. An experienced pathologist classified the extent of prostatic capsular invasion of each PCa according to the pW. Each histological section was scanned for comparison with mp-MRI findings. The rate of PCa correctly classified by radiologists using the pW was assessed. To evaluate the accuracy of mp-MRI in the discrimination between T2 and T3 PCa, the AUC was computed.

Results: One-hundred and five patients with a total of 195 PCa foci were included in the study. 130/195 tumors with a clear overlap between mp-MRI and surgical specimens were selected. The sensitivity of the most experienced reader was lower than that of the other two readers (48.6% vs. 68.6% and 62.9%, P>0.09) while specificity and PPV were higher (95.8% vs. 79.0% and 57.9%, P<0.001; 81.0% vs. 54.6% and 35.5%, P<0.041; respectively). The AUC values for the most and the intermediate experienced readers in the detection of extracapsular extension were in the range 0.72-0.74.

Conclusions: The rW staging system has low accuracy in predicting each single pW class, while accuracy was over 80% for experienced readers in the identification of organ-confined (T2 stage class) tumors and non-organ confined cases (T3 stage class).
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http://dx.doi.org/10.23736/S0393-2249.19.03248-XDOI Listing
June 2019

Patent Foramen Ovale Closure Versus Medical Therapy in Cryptogenic Strokes and Transient Ischemic Attacks: A Meta-Analysis of Randomized Trials.

Angiology 2019 Apr 1;70(4):325-331. Epub 2018 Oct 1.

3 Department of Neurology and Stroke Unit, Niguarda Ca' Granda Hospital, Milan, Italy.

Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.
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http://dx.doi.org/10.1177/0003319718802635DOI Listing
April 2019

Radial versus femoral access and bivalirudin versus unfractionated heparin in invasively managed patients with acute coronary syndrome (MATRIX): final 1-year results of a multicentre, randomised controlled trial.

Lancet 2018 09 25;392(10150):835-848. Epub 2018 Aug 25.

Sahlgrenska University Hospital, Gothenburg, Sweden.

Background: The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme.

Methods: MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70-100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50-70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627.

Findings: Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80-1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78-0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83-1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81-1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84-1·16; p=0·90).

Interpretation: In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management.

Funding: Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.
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http://dx.doi.org/10.1016/S0140-6736(18)31714-8DOI Listing
September 2018

[Percutaneous treatment of coronary artery fistula: a tailored strategy is needed].

G Ital Cardiol (Rome) 2018 Mar;19(3):187-190

U.O.S.D. Cardiologia - Laboratorio di Emodinamica, Dipartimento di Emergenza, Rianimazione e Anestesia, ASST Lariana, Ospedale S. Anna, Como.

Coronary artery fistula (CAF) is a rare, abnormal connection between one or more coronary arteries and a cardiac chamber, or great vessel.We describe the case of a male patient with worsening effort angina referred for coronary angiography. The examination revealed the presence of a CAF between the proximal left anterior descending (LAD) and pulmonary arteries, with mid LAD subocclusive stenosis. Ad hoc PCI with stenting was performed in the mid LAD, followed by CAF embolization with coils and plugs. Angiography and computed tomography scan at follow-up showed complete CAF occlusion, stent patency, and normal flow reserve of the LAD. CAF treatment is indicated only for large or clinically significant symptomatic fistulas. Treatment strategy, technique and device choice should be tailored on CAF anatomical characteristics. In this case, our strategy was feasible, safe and successful with favorable long-term results.
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http://dx.doi.org/10.1714/2883.29077DOI Listing
March 2018

Bivalirudin or Heparin in Patients Undergoing Invasive Management of Acute Coronary Syndromes.

J Am Coll Cardiol 2018 03;71(11):1231-1242

Clinic of Cardiovascular Disease, IRCCS Policlinico San Martino, Genoa, Italy.

Background: Contrasting evidence exists on the comparative efficacy and safety of bivalirudin and unfractionated heparin (UFH) in relation to the planned use of glycoprotein IIb/IIIa inhibitors (GPIs).

Objectives: This study assessed the efficacy and safety of bivalirudin compared with UFH with or without GPIs in patients with acute coronary syndrome (ACS) who underwent invasive management.

Methods: In the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX) program, 7,213 patients were randomly assigned to receive either bivalirudin or UFH with or without GPIs at discretion of the operator. The 30-day coprimary outcomes were major adverse cardiovascular events (MACEs) (a composite of death, myocardial infarction, or stroke), and net adverse clinical events (NACEs) (a composite of MACEs or major bleeding).

Results: Among 3,603 patients assigned to receive UFH, 781 (21.7%) underwent planned treatment with GPI before coronary intervention. Bailout use of GPIs was similar between the bivalirudin and UFH groups (4.5% and 5.4%) (p = 0.11). At 30 days, the 2 coprimary endpoints of MACEs and NACEs, as well as individual endpoints of mortality, myocardial infarction, stent thrombosis or stroke did not differ among the 3 groups after adjustment. Compared with the UFH and UFH+GPI groups, bivalirudin reduced bleeding, mainly the most severe bleeds, including fatal and nonaccess site-related events, as well as transfusion rates and the need for surgical access site repair. These findings were not influenced by the administered intraprocedural dose of UFH and were confirmed at multiple sensitivity analyses, including the randomly allocated access site.

Conclusions: In patients with ACS, the rates of MACEs and NACEs were not significantly lower with bivalirudin than with UFH, irrespective of planned GPI use. However, bivalirudin significantly reduced bleeding complications, mainly those not related to access site, irrespective of planned use of GPIs. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of AngioX [MATRIX]; NCT01433627).
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http://dx.doi.org/10.1016/j.jacc.2018.01.033DOI Listing
March 2018

Indication to pelvic lymph nodes dissection for prostate cancer: the role of multiparametric magnetic resonance imaging when the risk of lymph nodes invasion according to Briganti updated nomogram is <5.

Prostate Cancer Prostatic Dis 2018 04 22;21(1):85-91. Epub 2018 Feb 22.

Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, TO, Italy.

Background: The Briganti updated nomogram (BN) is the most popular predictive model aiming to predict the presence of lymph node invasion (LNI) in patients with prostate cancer (PCa), but it lacks information obtained by preoperative imaging. The primary aim of the study was to evaluate the role of multiparametric prostate magnetic resonance imaging (mp-MRI) in the indication to perform pelvic lymph nodes dissection (PLND) or not in patients with risk of LNI according to BN below 5%.

Methods: Since March 2012 and September 2016, 310 patients who underwent a preoperative mp-MRI for staging purpose and subsequent robot-assisted extended PLND (RAEPLND) were retrospectively evaluated. Mp-MRIs were prospectively analyzed by two experienced radiologists. The imaging parameters analyzed were the presence of extracapsular extension (ECE), seminal vesicles invasion (SVI) and predominant Gleason pattern 4 (pG4). All patients underwent RAEPLND by two experienced surgeons with a standardized technique. A dedicated uropathologist performed all pathological analysis. Univariate analysis and multivariate logistic regression analysis were used in order to identify the predictors of LNI in patients with PCa.

Results: In the overall population, 57 (18.4%) patients had histologically proven pN1 disease. 48/250 patients (19.2%) with a risk of LNI ≥5% as calculated by the BN were staged pN1 at final histopathological analysis. 9/60 patients (15.0%) with a risk of LNI <5% as calculated by BN, who underwent RAEPLND anyway according to the findings at mp-MRI, were staged pN1 at final histopathological analysis. At multivariate logistic regression analysis, all the three mp-MRI parameters were significant independent predictors of LNI after RAEPLND.

Conclusions: The role of mp-MRI seemed to be crucial in patients with a risk of LNI <5% as calculated by the BN. The presence of ECE, SVI, or pG4 at mp-MRI was found to be an independent predictor of LNI by itself.
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http://dx.doi.org/10.1038/s41391-017-0026-5DOI Listing
April 2018

Impact of Sex on Comparative Outcomes of Radial Versus Femoral Access in Patients With Acute Coronary Syndromes Undergoing Invasive Management: Data From the Randomized MATRIX-Access Trial.

JACC Cardiovasc Interv 2018 01;11(1):36-50

Department of Cardiology, Bern University Hospital, Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.

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 = 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 = 0.79), myocardial infarction (p = 0.25), stroke (p = 0.18), and Bleeding Academic Research Consortium type 3 or 5 (p = 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.
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http://dx.doi.org/10.1016/j.jcin.2017.09.014DOI Listing
January 2018

Acute Kidney Injury After Radial or Femoral Access for Invasive Acute Coronary Syndrome Management: AKI-MATRIX.

J Am Coll Cardiol 2017 May 11. Epub 2017 May 11.

Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. Electronic address:

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).
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http://dx.doi.org/10.1016/j.jacc.2017.02.070DOI Listing
May 2017

Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

Minerva Urol Nefrol 2018 Feb 11;70(1):9-21. Epub 2017 May 11.

Department of Urology, Vaudois University Hospital, Lausanne, Switzerland.

Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.
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http://dx.doi.org/10.23736/S0393-2249.17.02846-6DOI Listing
February 2018

Transradial versus transfemoral ancillary approach in complex structural, coronary, and peripheral interventions. Results from the multicenter ancillary registry: A study of the Italian Radial Club.

Catheter Cardiovasc Interv 2018 01 2;91(1):97-102. Epub 2017 May 2.

Interventional Cardiology, San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus, Milan, Italy.

Objectives: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions.

Background: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications.

Methods: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings.

Results: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients.

Conclusions: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc.
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http://dx.doi.org/10.1002/ccd.27087DOI Listing
January 2018

Impact of a risk-based follow-up in patients affected by gastrointestinal stromal tumour.

Eur J Cancer 2017 06 24;78:122-132. Epub 2017 Apr 24.

Sarcoma Unit, Division of Medical Oncology Candiolo Cancer Institute - FPO, IRCCS, Strada Provinciale 142, Km 3.95, 10060 Candiolo, TO, Italy; University of Torino, Department of Oncology, Regione Gonzole, 10, 10043 Orbassano, TO, Italy. Electronic address:

Background: Follow-up aims to precociously identify recurrences, metastases or treatment-related adverse events so as to undertake the appropriate therapy. Guidelines admit lack of knowledge on optimal surveillance schedule, but suggest follow-up based on experts' opinion and risk stratification. To identify the impact, if any, of regular follow-up, we interrogated our prospectively collected database whether early detection of recurrences affected both clinical management and, likely, the outcome.

Patients And Methods: We required information to be available on primary surgery and ≥3°years of follow-up for non-recurring patients. We analysed recurrence characteristics (asymptomatic versus symptomatic, low- versus high tumour burden) and computed tomography (CT) scan counts to detect one recurrence. Kaplan-Meier method estimated recurrence-free survival (RFS), post-recurrence progression-free survival (PR-PFS), and disease-specific overall survival (OS). Comparisons used Hazard ratios (HR) with 95% confidence intervals (CIs). Multivariate analyses employed the Cox proportional hazards model. All tests were two-sided.

Results: Between 01/2001 and 12/2012 we found 233 study-eligible patients. Estimated 5- and 10-year RFS were 61.8% and 50.4%, respectively. After a 68-month median follow-up, we observed 94 (40.3%) recurrences [73/94 (77.7%) asymptomatic versus 21/94 (22.3%) symptomatic and 45/94 (47.9%) low- versus 49/94 (52.1%) high tumour burden]. Multivariate analysis revealed that symptomatic and high tumour burden recurrences were highly predictive of both worse PR-PFS (HR:3.19, P < 0.001; HR:2.80, P = 0.003, respectively) and OS (HR:3.65, P < 0.001; HR:2.38, P = 0.026, respectively). Finally, 29 second (primary) cancers were detected during follow-up.

Conclusions: Regular follow-up detects recurrences at an earlier stage and may be associated with a better PR-PFS and OS for these patients. In the absence of randomised trials, these evidences support follow-up effort and cost.
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http://dx.doi.org/10.1016/j.ejca.2017.03.025DOI Listing
June 2017

Multiparametric magnetic resonance imaging of the prostate with computer-aided detection: experienced observer performance study.

Eur Radiol 2017 Oct 6;27(10):4200-4208. Epub 2017 Apr 6.

Department of Radiology at the Candiolo Cancer Institute, FPO, IRCCS, Strada Provinciale 142 km 3.95, 10060, Candiolo, Turin, Italy.

Objectives: To compare the performance of experienced readers in detecting prostate cancer (PCa) using likelihood maps generated by a CAD system with that of unassisted interpretation of multiparametric magnetic resonance imaging (mp-MRI).

Methods: Three experienced radiologists reviewed mp-MRI prostate cases twice. First, readers observed CAD marks on a likelihood map and classified as positive those suspicious for cancer. After 6 weeks, radiologists interpreted mp-MRI examinations unassisted, using their favourite protocol. Sensitivity, specificity, reading time and interobserver variability were compared for the two reading paradigms.

Results: The dataset comprised 89 subjects of whom 35 with at least one significant PCa. Sensitivity was 80.9% (95% CI 72.1-88.0%) and 87.6% (95% CI 79.8-93.2; p = 0.105) for unassisted and CAD paradigm respectively. Sensitivity was higher with CAD for lesions with GS > 6 (91.3% vs 81.2%; p = 0.046) or diameter ≥10 mm (95.0% vs 80.0%; p = 0.006). Specificity was not affected by CAD. The average reading time with CAD was significantly lower (220 s vs 60 s; p < 0.001).

Conclusions: Experienced readers using likelihood maps generated by a CAD scheme can detect more patients with ≥10 mm PCa lesions than unassisted MRI interpretation; overall reporting time is shorter. To gain more insight into CAD-human interaction, different reading paradigms should be investigated.

Key Points: • With CAD, sensitivity increases in patients with prostate tumours ≥10 mm and/or GS > 6. • CAD significantly reduces reporting time of multiparametric MRI. • When using CAD, a marginal increase of inter-reader agreement was observed.
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http://dx.doi.org/10.1007/s00330-017-4805-0DOI Listing
October 2017