Publications by authors named "Marcello Galvani"

76 Publications

In- and out-of-hospital mortality for myocardial infarction during the first wave of the COVID-19 pandemic in Emilia-Romagna, Italy: A population-based observational study.

Lancet Reg Health Eur 2021 Apr 2;3:100055. Epub 2021 Mar 2.

Cardiology Unit, Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, Italy.

Background: The COVID-19 pandemic has put several healthcare systems under severe pressure. The present analysis investigates how the first wave of the COVID-19 pandemic affected the myocardial infarction (MI) network of Emilia-Romagna (Italy).

Methods: Based on Emilia-Romagna mortality registry and administrative data from all the hospitals from January 2017 to June 2020, we analysed: i) temporal trend in MI hospital admissions; ii) characteristics, management, and 30-day mortality of MI patients; iii) out-of-hospital mortality for cardiac cause.

Findings: Admissions for MI declined on February 22, 2020 (IRR -19.5%, 95%CI from -8.4% to -29.3%,  = 0.001), and further on March 5, 2020 (IRR -21.6%, 95%CI from -9.0% to -32.5%,  = 0.001). The return to pre-COVID-19 MI-related admission levels was observed from May 13, 2020 (IRR 34.3%, 95%CI 20.0%-50.2%, <0.001). As compared to those before the pandemic, MI patients admitted during and after the first wave were younger and with fewer risk factors. The 30-day mortality remained in line with that expected based on previous years (ratio observed/expected was 0.96, 95%CI 0.84-1.08). MI patients positive for SARS-CoV-2 were few (1.5%) but showed poor prognosis (around 5-fold increase in 30-day mortality). In 2020, the number of out-of-hospital cardiac deaths was significantly higher (ratio observed/expected 1.17, 95%CI 1.08-1.27). The peak was reached in April.

Interpretation: In Emilia-Romagna, MI hospitalizations significantly decreased during the first wave of the COVID-19 pandemic. Management and outcomes of hospitalized MI patients remained unchanged, except for those with SARS-CoV-2 infection. A concomitant increase in the out-of-hospital cardiac mortality was observed.

Funding: None.
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http://dx.doi.org/10.1016/j.lanepe.2021.100055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8454529PMC
April 2021

Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2): a multinational, multicentre, single-arm, phase 4 trial.

Lancet Haematol 2021 Sep 4;8(9):e627-e636. Epub 2021 Aug 4.

Internal and Subintensive Medicine Department, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.

Background: Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. This is a particular patient category for whom optimal treatment (anticoagulant treatment, reperfusion strategies, and duration of hospitalisation) is currently unknown. We investigated whether treatment of acute intermediate-risk pulmonary embolism with parenteral anticoagulation for a short period of 72 h, followed by a switch to a direct oral anticoagulant (dabigatran), is effective and safe.

Methods: We did a multinational, multicentre, single-arm, phase 4 trial at 42 hospitals in Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain. Adult patients (aged ≥18 years) with symptomatic intermediate-risk pulmonary embolism, with or without deep-vein thrombosis, were enrolled. Patients received parenteral low-molecular-weight or unfractionated heparin for 72 h after diagnosis of pulmonary embolism before switching to oral dabigatran 150 mg twice per day following a standard clinical assessment. The primary outcome was recurrent symptomatic venous thromboembolism or pulmonary embolism-related death within 6 months. The primary and safety outcomes were assessed in the intention-to-treat population. The study was terminated early, as advised by the data safety and monitoring board, following sample size adaptation after the predefined interim analysis on Dec 18, 2018. This trial is registered with the EU Clinical Trials Register (EudraCT 2015-001830-12) and ClinicalTrials.gov (NCT02596555).

Findings: Between Jan 1, 2016, and July 31, 2019, 1418 patients with pulmonary embolism were screened, of whom 402 were enrolled and were included in the intention-to-treat analysis (median age was 69·5 years [IQR 60·0-78·0); 192 [48%] were women and 210 [52%] were men). Median follow-up was 217 days (IQR 210-224) and 370 (92%) patients adhered to the protocol. The primary outcome occurred in seven (2% [upper bound of right-sided 95% CI 3]; p<0·0001 for rejecting the null hypothesis) patients, with all events occurring in those with intermediate-high-risk pulmonary embolism (seven [3%; upper bound of right-sided 95% CI 5] of 283). At 6 months, 11 (3% [95% CI 1-5]) of 402 patients had at least one major bleeding event and 16 (4% [2-6]) had at least one clinically relevant non-major bleeding event; the only fatal haemorrhage occurred in one (<1%) patient before the switch to dabigatran.

Interpretation: A strategy of early switch from heparin to dabigatran following standard clinical assessment was effective and safe in patients with intermediate-risk pulmonary embolism. Our results can help to refine guideline recommendations for the initial treatment of acute intermediate-risk pulmonary embolism, optimising the use of resources and avoiding extended hospitalisation.

Funding: German Federal Ministry of Education and Research, University Medical Center Mainz, and Boehringer Ingelheim.
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http://dx.doi.org/10.1016/S2352-3026(21)00203-9DOI Listing
September 2021

[Timing of coronary angiography in the 2020 ESC guidelines on non-ST-elevation acute coronary syndromes: when guidelines are not helpful].

G Ital Cardiol (Rome) 2021 Apr;22(4):336

U.O. Cardiologia, Ospedale G.B. Morgagni, Azienda USL della Romagna, Forlì.

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http://dx.doi.org/10.1714/3574.35582DOI Listing
April 2021

[Periprocedural management of anticoagulation therapy and in-hospital outcomes in patients with warfarin indication undergoing percutaneous coronary intervention. Data from the WAR-STENT registry].

G Ital Cardiol (Rome) 2021 Jan;22(1):62-67

Dipartimento Cardiovascolare - AUSL Romagna, U.O.C. Cardiologia, Ospedale S. Maria delle Croci, Ravenna.

Background: In patients with an indication for oral anticoagulation (OAC) with warfarin, the management of OAC peri-procedure of percutaneous coronary intervention (PCI) is still not fully defined. To investigate clinical practice and outcomes associated with continuation vs interruption of OAC, with or without bridging with low-molecular-weight heparin (LMWH), we examined the database of the observational, prospective, multicenter Italian WAR-STENT registry.

Methods: The WAR-STENT registry was conducted in 2008-2010 in 37 Italian centers and included 411 consecutive patients in 157 of whom the peri-procedural international normalized ratio (INR) value was available. In relation to the continuation vs interruption of OAC, patients were divided into group 1 (n = 106) and group 2 (n = 51) respectively, and compared.

Results: The basal characteristics of the two groups were similar. The most frequent indication for OAC was atrial fibrillation and for PCI acute coronary syndromes, respectively. The pre-procedural mean value of INR was significantly different in group 1 vs group 2 (2.3 ± 0.4 vs 1.5 ± 0.2; p <0.001), while the use of antithrombotic drugs did not differ, except for LMWH which, albeit limited to only 14% of cases, was used significantly more frequently in group 2 (14% vs 2%; p=0.006). The radial approach was used significantly more often in group 1 vs group 2 (72% vs 45%; p=0.002). The in-hospital incidence of major bleeding complications was similar in groups 1 and 2 (4% vs 8%; p=0.27), as well as the occurrence of major adverse cardio-cerebrovascular events, including cardiovascular death, non-fatal myocardial infarction, re-revascularization of the treated vessel, stent thrombosis, stroke and venous thromboembolism (6% vs 6%; p=0.95). There was a tendency towards a higher incidence of minor access-site bleeding complications in group 1 patients treated by the femoral route.

Conclusions: In unselected patients with an indication for OAC with warfarin and undergoing PCI, the continuation vs interruption of OAC (essentially without LMWH bridging) strategies appears similar in terms of efficacy and safety. In consideration of the superior convenience, peri-procedural continuation of OAC should therefore generally be preferred, with the possible exception of patients in whom the femoral approach is required for the procedure.
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http://dx.doi.org/10.1714/3502.34884DOI Listing
January 2021

Clinical governance programme in patients with acute coronary syndrome: design and methodology of a quality improvement initiative.

Open Heart 2020 12;7(2)

UO Cardiologia, Azienda Ospedaliero Universitaria di Ferrara Arcispedale Sant'Anna, Cona, Italy.

Introduction: Despite the availability of diverse evidence-based diagnostic and treatment options, many patients with acute coronary syndrome (ACS) still fail to receive effective, safe and timely diagnoses and therapies. The Association of Acute CardioVascular Care of the European Society of Cardiology has proposed and retrospectively validated a set of ACS-specific quality indicators. Combining these indicators with the principles of clinical governance-a holistic, patient-centred approach intended to promote continuous quality improvement-we designed the clinical governance programme in patients with ACS.

Methods And Analysis: This is a multicentre quality improvement initiative exploring multiple dimensions of care, including diagnosis, therapy, patient satisfaction, centre organisation and efficiency in all comers patients with ACS.The study will enrol ≈ 5000 patients prospectively (ie, at the time of the first objective qualifying ACS criterion) with a 1-year follow-up. Consecutive inclusion will be promoted by a simplified informed consent process and quantified by the concordance with corresponding hospital administrative records using diagnosis-related group codes of ACS.Coprimary outcome measures are (1) timely reperfusion in patients with ST-elevation ACS and (2) optimal medical therapy at discharge in patients with confirmed acute myocardial infarction. Secondary outcomes broadly include multiple indicators of the process of care. Clinical endpoints (ie, death, myocardial infarction, stroke and bleeding) will be adjudicated by a clinical event committee according to predefined criteria.

Ethics And Dissemination: The study has been approved by local ethics committee of all study sites. As a quality improvement initiative and to promote consecutive inclusion of the population of interest, a written informed consent will be requested only to patients who are discharged alive. Dissemination will be actively promoted by (1) the registration site (ClinicalTrials.Gov ID NCT04255537), (2) collaborations with investigators through open data access and sharing.
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http://dx.doi.org/10.1136/openhrt-2020-001415DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768950PMC
December 2020

Early Resolution of Heyde's Syndrome following Transcatheter Aortic Valve Replacement.

Semin Thromb Hemost 2021 Feb 23;47(1):102-104. Epub 2020 Dec 23.

Cardiology Unit, Morgagni-Pierantoni Hospital, Forlì, Italy.

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http://dx.doi.org/10.1055/s-0040-1718871DOI Listing
February 2021

Gender differences in acute coronary syndromes patterns during the COVID-19 outbreak.

Am J Cardiovasc Dis 2020 15;10(4):506-513. Epub 2020 Oct 15.

Coronary Care Unit and Catheterization laboratory, A.O.U. Maggiore della Carità Novara, Italy.

Background: Mortality from acute coronary syndromes (ACS) is strictly related to early management. As female patients usually experience longer delays before diagnosis and treatment, we assessed whether women were more affected by the dramatic drop in hospital admissions for ACS during the Covid-19 pandemic.

Methods: We performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in Northern Italy comparing men and women data. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: the corresponding period during the previous year (February 20 to March 31, 2019) and the earlier period during the same year (January 1 to February 19, 2020). Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression.

Results: Of the 547 patients who were hospitalized for ACS during the study period, only 127 (23%) were females, accounting for a mean of 3.1 admissions per day, while ACS hospitalized males were 420, with a mean of 10.2 admissions per day. There was a significant decrease driven by a similar reduction in ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis in both sexes compared to the control periods. A trend toward a greater reduction in admitted females was shown in the intra-year control period (46% admission reduction in females vs 37% in males, with females accounting for 26% of ACS, P=0.10) and a significant reduction when compared to the previous year control period (40% admission reduction in females vs 23% in males, with females accounting for 28% of ACS, P=0.03), mainly related to Unstable Angina diagnosis.

Conclusion: The Covid-19 pandemic period closed the gap between men and women in ACS, with similar rates of reduction of hospitalized STEMI and NSTEMI and a trend toward greater reduction in UA admission among women. Furthermore, many typical differences between males and females regarding ischemic heart disease presentations and vessel distribution were leveled.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7675165PMC
October 2020

[Early invasive strategy (<24 h) in high-risk non-ST-elevation acute coronary syndrome: when the guideline recommendations need to be contextualized].

G Ital Cardiol (Rome) 2020 Nov;21(11):835-846

U.O.C. Cardiologia, Ospedale Maggiore, Azienda AUSL di Bologna, Bologna.

The advantages of an early invasive strategy in non-ST-elevation acute coronary syndromes (NSTE-ACS) are well documented. Less clear is the ideal time to perform it (within 24 h, within 72 h, or during hospitalization after positive non-invasive testing for ischemia). In particular, the class IA recommendation for coronary angiography within 24 h in patients with high-risk NSTE-ACS is controversial. Randomized clinical trials and meta-analyses show neutral effects on mortality, while significant positive results are observed only for secondary outcomes (mainly ischemic recurrences). Favorable effects on major cardiovascular events are reported only in the subgroup analysis of a single randomized trial (TIMACS) or in several trials included in the meta-analyses. Thus, these results are far from conclusive and should stimulate new randomized clinical studies to support them. In fact, the logistical implications that this recommendation implies deserve stronger evidence. It is clear that all patients with NSTE-ACS, especially if high-risk, should have the opportunity to undergo a coronary angiogram during hospitalization. However, in the real world, the strict timeline of the international guidelines may be difficult to follow. Therefore, indications that take into account resource availability and the organizational context should be developed. Several regional indications suggest that even in high-risk patients the 24 h time limit for the invasive strategy should not be mandatory, but timing of angiography should be calibrated on clinical presentation and logistical resources, without any a priori automatism.
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http://dx.doi.org/10.1714/3455.34438DOI Listing
November 2020

Electrocardiographic features of 431 consecutive, critically ill COVID-19 patients: an insight into the mechanisms of cardiac involvement.

Europace 2020 12;22(12):1848-1854

Cardiological Center, University of Ferrara, Italy.

Aims: Our aim was to describe the electrocardiographic features of critical COVID-19 patients.

Methods And Results: We carried out a multicentric, cross-sectional, retrospective analysis of 431 consecutive COVID-19 patients hospitalized between 10 March and 14 April 2020 who died or were treated with invasive mechanical ventilation. This project is registered on ClinicalTrials.gov (identifier: NCT04367129). Standard ECG was recorded at hospital admission. ECG was abnormal in 93% of the patients. Atrial fibrillation/flutter was detected in 22% of the patients. ECG signs suggesting acute right ventricular pressure overload (RVPO) were detected in 30% of the patients. In particular, 43 (10%) patients had the S1Q3T3 pattern, 38 (9%) had incomplete right bundle branch block (RBBB), and 49 (11%) had complete RBBB. ECG signs of acute RVPO were not statistically different between patients with (n = 104) or without (n=327) invasive mechanical ventilation during ECG recording (36% vs. 28%, P = 0.10). Non-specific repolarization abnormalities and low QRS voltage in peripheral leads were present in 176 (41%) and 23 (5%), respectively. In four patients showing ST-segment elevation, acute myocardial infarction was confirmed with coronary angiography. No ST-T abnormalities suggestive of acute myocarditis were detected. In the subgroup of 110 patients where high-sensitivity troponin I was available, ECG features were not statistically different when stratified for above or below the 5 times upper reference limit value.

Conclusions: The ECG is abnormal in almost all critically ill COVID-19 patients and shows a large spectrum of abnormalities, with signs of acute RVPO in 30% of the patients. Rapid and simple identification of these cases with ECG at hospital admission can facilitate classification of the patients and provide pathophysiological insights.
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http://dx.doi.org/10.1093/europace/euaa258DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543398PMC
December 2020

Transcatheter aortic valve implantation for severe pure aortic regurgitation due to active aortitis.

Catheter Cardiovasc Interv 2021 04 31;97(5):950-954. Epub 2020 Aug 31.

Unità Operativa di Cardiologia, Ospedale GB Morgagni, Forlì, Italy.

Aortitis is an uncommon systemic inflammatory disease affecting the aorta and its main branches. Severe aortic regurgitation (AR) represents a fearsome complication of aortitis and is associated with an increased mortality rate. Surgical aortic valve replacement represents the only treatment choice for these patients. However, it is associated with a higher risk of medium to long-term complications such as prosthetic valve detachment. This is the first reported case where severe AR secondary to aortitis was managed with transcatheter aortic valve implantation (TAVI). TAVI was safe and effective in this clinical setting and may be considered a viable alternative to high-risk surgery in these complex patients.
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http://dx.doi.org/10.1002/ccd.29249DOI Listing
April 2021

Multimodality Imaging of Purulent Pericarditis: Hints to Speed up Diagnosis and Promote Healing.

J Invasive Cardiol 2020 Mar;32(3):E79-E80

Cardiovascular Department ASL Romagna via Forlanini 34, 47121 Forlì, Italy.

Purulent pericarditis is rare and usually associated with pneumonia, bacteremia, immunosuppression, and thoracic surgery. A timely diagnostic pericardiocentesis with dedicated maneuvers to improve the effectiveness of drainage and pericardial fibrinolytic rinsing can improve prognosis and prevent a surgical pericardiectomy. Imaging offers useful clues for a more aggressive approach.
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March 2020

[The ISAR-REACT 5 trial: is there a winner between prasugrel and ticagrelor in acute coronary syndromes?]

G Ital Cardiol (Rome) 2020 03;21(3):171-174

Divisione di Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia.

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http://dx.doi.org/10.1714/3306.32764DOI Listing
March 2020

Integration of the Universal Definition of Myocardial Infarction into administrative data: still a long way to run.

Authors:
Marcello Galvani

J Cardiovasc Med (Hagerstown) 2020 01;21(1):40-41

UOC Cardiologia, Ospedale Morgagni, Forlì, Unità di Ricerca Cardiovascolare, Fondazione Sacco, Forlì, Italy.

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http://dx.doi.org/10.2459/JCM.0000000000000915DOI Listing
January 2020

Bleeding Risk Scores and Scales of Frailty for the Prediction of Haemorrhagic Events in Older Adults with Acute Coronary Syndrome: Insights from the FRASER study.

Cardiovasc Drugs Ther 2019 10;33(5):523-532

Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Via Aldo Moro 8, 44124, Cona, Fe, Italy.

Purpose: Hitherto, no study has yielded important information on whether the scales of frailty may improve the ability to discriminate the risk of haemorrhages in older adults admitted to hospital for acute coronary syndrome (ACS). The aim of this study is to investigate whether frailty scales would predict the 1-year occurrence of haemorrhagic events and if they confer a significant incremental prognostic value over the bleeding risk scores.

Methods: The present study involved 346 ACS patients aged ≥ 70 years enrolled in the FRASER study. Seven different scales of frailty and PARIS, PRECISE-DAPT and BleeMACS bleeding risk scores were available for each patient. The outcomes were the 1-year BARC 3-5 and 2 bleeding events.

Results: Adherence to antiplatelet treatment at 1, 6 and 12 months was 98%, 87% and 78%, respectively. At 1-year, 14 (4%) and 30 (9%) patients presented BARC 3-5 and 2 bleedings, respectively. Bleeding risk scores and four scales of frailty (namely Short Physical Performance Battery, Columbia, Edmonton and Clinical Frailty Scale) significantly discriminated the occurrence of BARC 3-5 events. The addition of the scales of frailty to bleeding risk scores did not lead to a significant improvement in the ability to predict BARC 3-5 bleedings. Neither the bleeding risk scores nor the scales of frailty predicted BARC 2 bleedings.

Conclusions: Both the bleeding risk scores and the scales of frailty predicted BARC 3-5 haemorrhages. However, integrating the scales of frailty with the bleeding risk scores did not improve their discriminative ability.

Clinical Trial Registration: www.clinicaltrials.gov: NCT02386124.
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http://dx.doi.org/10.1007/s10557-019-06911-yDOI Listing
October 2019

The Assessment of Scales of Frailty and Physical Performance Improves Prediction of Major Adverse Cardiac Events in Older Adults with Acute Coronary Syndrome.

J Gerontol A Biol Sci Med Sci 2020 05;75(6):1113-1119

Department of Medical Science, University of Ferrara, Italy.

Background: The number of older adults admitted to hospital for acute coronary syndrome (ACS) has increased worldwide. The aim of this study was to determine which scale of frailty or physical performance provides incremental improvements in risk stratification of older adults after ACS.

Methods: A prospective cohort of 402 older (≥70 years) ACS patients were enrolled. Data about baseline characteristics, Global Registry of Acute Coronary Events (GRACE), and Thrombolysis in Myocardial Infarction (TIMI) risk scores were collected. Before hospital discharge, seven scales of frailty and physical performance were measured. The 1-year occurrence of adverse events (cardiac death, reinfarction, and cerebrovascular accident [MACCE] and all-cause mortality) was recorded.

Results: Out of the 402 patients, 43 (10.5%) had a MACCE and 35 (8.7%) died. Following adjustment for confounding factors, scales of frailty and physical performance were associated with adverse events. Among the scales, the addition of short physical performance battery (SPPB) produced the highest incremental value over the initial model generated by baseline characteristics both for MACCE (ΔC-statistic 0.043, p = .04; integrated discrimination improvement (IDI) 0.054, p = .001; net reclassification improvement (NRI) 0.752, p < .001) and all-cause mortality (ΔC-statistic 0.063, p = .02; IDI 0.061, p < .001; NRI 1.022, p < .001). The addition of SPPB scale on top of GRACE or TIMI risk scores led to a considerable improvement in the prediction of MACCE and all-cause mortality (about 15% and 20%, respectively).

Conclusions: The assessment of the physical performance with SPPB scale before hospital discharge increases the ability to predict adverse events in older ACS patients and may be useful in the clinical decision-making process.

Clinical Trial Registration: www.clinicaltrials.gov NCT02386124.
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http://dx.doi.org/10.1093/gerona/glz123DOI Listing
May 2020

Cardiac Arrest in a 31-Year-Old Man With Noonan Syndrome.

J Invasive Cardiol 2019 02;31(2):E40

Cardiology Unit, Morgagni-Pierantoni Hospital, Cardiovascular Department AUSL Romagna, via Forlanini 34, 47121 Forlì, Italy.

A 31-year-old man with Noonan syndrome who suffered an out-of-hospital cardiac arrest presented at our institution with severe postanoxic coma (Glasgow coma scale 3), but normalized electrocardiogram and stable hemodynamics. Coronary angiography documented a giant right coronary artery supplying collateral flow to the left coronary artery, which presented a left main functional occlusion.
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February 2019

[The CULPRIT-SHOCK trial].

G Ital Cardiol (Rome) 2018 Dec;19(12):672-675

U.O.C. Cardiologia, Ospedale G.B. Morgagni, Forlì - Fondazione Cardiologica "Myriam Zito Sacco", Forlì.

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http://dx.doi.org/10.1714/3027.30250DOI Listing
December 2018

Rapid rule-out of suspected acute coronary syndrome in the Emergency Department by high-sensitivity cardiac troponin T levels at presentation.

Intern Emerg Med 2019 04 29;14(3):403-410. Epub 2018 Nov 29.

Dipartimento Cardio-vascolare, Presidio Ospedaliero Morgagni-Pierantoni, AUSL della Romagna, Via C Forlanini 34, 47121, Forlì, FC, Italy.

The reliability of initial high-sensitivity cardiac troponin T (hs-cTnT) under limit-of-detection in ruling-out short- and long-term acute coronary events in subjects for suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is not definitely settled. In a retrospective chart review analysis, 1001 subjects with hs-cTnT ≤ 14 ng/L out of 4053 subjects with hs-cTnT measured at Emergency Department (ED) presentation were recruited. The main outcome measure is fatal or non-fatal myocardial infarction (MI) within 30 days; secondary outcomes are MI or major acute coronary events (MACE) as a combination of MI or re-hospitalization for unstable angina within 1 year. In subjects with hs-cTnT < 5 ng/L [32.6% of cases, mean age 63 years (interquartile range 23)], no cases (0%, NPV 100%) had MI within 30 days, 2 cases (0.6%, NPV 99.4%) MI at 1-year, and 11 cases (3.4%, NPV 96.6%) MACE at 1-year. Patients with hs-cTnT < 5 ng/L would have benefited from a shortened decision (9.30 h and 53% overnight ED stay saved). Hs-cTnT < 5 ng/L is confirmed as safe for patients and comfortable for physicians in ruling out MI or MACE both at short and long term, suggesting that a sizable number of patients can be rapidly discharged without unnecessary diagnostic tests and ED observation.
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http://dx.doi.org/10.1007/s11739-018-1996-6DOI Listing
April 2019

[Rescue thrombolytic therapy for the treatment of ST-elevation myocardial infarction after unsuccessful primary percutaneous coronary intervention in a patient with coronary artery aneurysm].

G Ital Cardiol (Rome) 2018 Sep;19(9):514-518

U.O. Cardiologia, Ospedale Morgagni-Pierantoni, Forlì - Unità di Ricerca Cardiovascolare, Fondazione Cardiologica Myriam Zito Sacco, Forlì.

The recommended treatment for ST-segment elevation myocardial infarction (STEMI) is primary percutaneous coronary intervention (pPCI). However, in a non-negligible proportion of patients, pPCI is ineffective and the cardiologist must face the decision of how to achieve optimal myocardial reperfusion. Although the possibility of a rescue fibrinolytic strategy has not been evaluated yet in this clinical setting, it is a viable alternative to emergency cardiac surgery. We here report the case of a 60-year-old STEMI patient presenting with a coronary anatomy unsuitable for percutaneous mechanical revascularization, characterized by marked dilation and tortuosity of the proximal and middle epicardial segments. After pPCI failure, the administration of recombinant tissue-type plasminogen activator allowed us to obtain reperfusion as shown by clinical outcome, ST-segment resolution and subsequent angiographic study. No indication was given to further percutaneous or surgical revascularization. The long-term pharmacological management of these patients represents a challenge for the clinician, also considering the available data on the use of new antiplatelet and anticoagulant molecules and their possible associations.
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http://dx.doi.org/10.1714/2951.29671DOI Listing
September 2018

Reperfusion in STEMI patients: still a role for cardioprotection?

Minerva Cardioangiol 2018 Aug 28;66(4):452-463. Epub 2018 Mar 28.

Unit of Cardiology, Morgagni Hospital, Azienda USL della Romagna, Forlì, Italy.

Ischemic heart disease remains a leading cause of death worldwide, responsible for an estimated 17.5 million deaths in 2012. Mortality from ST-elevation myocardial infarction STEMI have decreased over the last 3 decades. However, despite the success of reperfusion therapy by primary percutaneous coronary intervention (PPCI) or thrombolysis, STEMI is still of significant concern. A recent patient-level meta-analysis emphasized the pivotal importance of infarct size within 1 month after PPCI as a determinant of all-cause mortality and hospitalization for heart failure at 1 year. Although timely and complete reperfusion is the most effective way of limiting infarct size (IS) and subsequent ventricular remodeling, reperfusion per se adds an additional component of irreversible injury to the myocardium (known as ischemia/reperfusion injury, IRI), and the coronary circulation and it contributes to final infarct size. The prevention and treatment of lethal IRI and coronary microvascular dysfunction pose a continued and formidable barrier to successful myocardial perfusion as opposed to establishing patency of the epicardial infarct-related artery (IRA), and in this context the need for additional cardioprotective strategies to reduce IS and coronary microvascular dysfunction remains the 'last frontier' of reperfusion therapy.
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http://dx.doi.org/10.23736/S0026-4725.18.04680-7DOI Listing
August 2018

High-sensitivity troponin in emergency room practice: pros and cons.

J Cardiovasc Med (Hagerstown) 2018 Feb;19 Suppl 1:e68-e71

Cardiology Unit, Cardiovascular Department ASL Romagna, GB Morgagni Hospital - Forlì, Forlì, Italy.

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http://dx.doi.org/10.2459/JCM.0000000000000604DOI Listing
February 2018

Switching from clopidogrel to prasugrel to protect early invasive treatment in acute coronary syndromes: Results of the switch over trial.

Int J Cardiol 2018 Mar 27;255:8-14. Epub 2017 Dec 27.

Unità Operativa di Cardiologia, Morgagni Hospital, Forlì, Italy; Unità di Ricerca Cardiovascolare, Fondazione Cardiologica "Sacco", Forlì, Italy.

Background: Clopidogrel is used to pretreat patients with non-ST elevation acute coronary syndromes (NSTE-ACS), but prasugrel provides better platelet inhibition with improved outcome. However, switching from clopidogrel at the time of percutaneous coronary intervention (PCI) remains incompletely defined. Our aim was to compare the pharmacodynamic (PD) effects of 3 prasugrel loading doses (LDs; G1:10mg, G2: 30mg, and G3: 60mg) before PCI. A fourth group, continuing clopidogrel, served as control (G4).

Methods: 100 clopidogrel-pretreated patients were enrolled and blood collected before PCI, 30min, 1, 2, 4, 6, 24 and 48h thereafter. Platelet inhibition was measured by vasodilator-stimulated phosphoprotein phosphorylation (VASP) and Verify-Now assays. The end-points (EP) was the difference of PD effect at 4h between G3 and G4 (primary EP) with hierarchic evaluation between G2 and G1 versus G4 (secondary EP). A mixed-design ANOVA statistic was used to compare the four group scores over time.

Results: Baseline characteristics were balanced across the groups. Only patients receiving 60 and 30mg prasugrel LDs showed a rapid (<1h) and significant (p<0.001) platelet inhibition up to 48h after PCI·The primary EP was met by G3 (p<0.0001), but also G2 scored different (p<0-001) from G4 at 4h after PCI. Similar findings were observed with Verify-Now. No differences in 30-day clinical outcomes were observed across groups.

Conclusions: Switching NSTE-ACS patients before PCI to prasugrel 60 or 30mg LDs determined a better and faster platelet inhibition than continuing clopidogrel, while PCI it is still underway.
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http://dx.doi.org/10.1016/j.ijcard.2017.12.055DOI Listing
March 2018

Patients with non-ST segment elevation acute coronary syndromes managed without coronary revascularization: A population needing treatment improvement.

Int J Cardiol 2017 Oct;245:35-42

Division of Cardiology, San Giovanni Evangelista Hospital, Tivoli, Rome, Italy.

NSTE-ACS patients are a heterogeneous population, with different clinical features and prognosis. A large proportion of them is medically managed, without any revascularization. In the EYSHOT and FAST-MI registries such patients were 40% and 35%, respectively. These patients are at higher risk of adverse cardiovascular events and have a worse prognosis compared with those receiving revascularization. Medically managed NSTE-ACS patients consist of different subgroups: those not undergoing coronary angiography, those without significant coronary artery disease, and those with coronary stenoses not referred to revascularization. Patients with NSTE-ACS for whom a conservative strategy without coronary angiogram is planned must be very carefully selected. In patients with comorbidities, frailty, or advanced age, a careful balance between benefits and risks is needed to choice the management strategy (perform or not coronary angiography and/or revascularization), as evidence-based medicine data are lacking in the setting of frailty and comorbidities. In this decisional process, it should be also taken into consideration the role of coronary anatomy in risk stratification and treatment guidance. NSTE-ACS patients managed without revascularization less frequently receive guideline-recommended pharmacological treatment. Dual antiplatelet therapy (DAPT) is recommended for 12months also in medically managed patients, after careful balancing of ischemic and bleeding risk. In these patients it is mandatory to optimize pharmacological treatment, including antiplatelet therapy, to improve outcome. In NSTE-ACS medically managed, the proportion of patients discharged with DAPT should be increased in comparison with current practice, and the use of ticagrelor in place of clopidogrel should be considered in selected patients.
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http://dx.doi.org/10.1016/j.ijcard.2017.05.066DOI Listing
October 2017

Data on administration of cyclosporine, nicorandil, metoprolol on reperfusion related outcomes in ST-segment Elevation Myocardial Infarction treated with percutaneous coronary intervention.

Data Brief 2017 Oct 18;14:197-205. Epub 2017 Jul 18.

Unità Operativa di Cardiologia, Ospedale GB Morgagni, Forlì, Italy.

Mortality and morbidity in patients with ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) are still high [1]. A huge amount of the myocardial damage is related to the mitochondrial events happening during reperfusion [2]. Several drugs directly and indirectly targeting mitochondria have been administered at the time of the PCI and their effect on fatal (all-cause mortality, cardiovascular (CV) death) and non fatal (hospital readmission for heart failure (HF)) outcomes have been tested showing conflicting results [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16]. Data from 15 trials have been pooled with the aim to analyze the effect of drug administration versus placebo on outcome [17]. Subgroup analysis are here analyzed: considering only randomized clinical trial (RCT) on cyclosporine or nicorandil [3], [4], [5], [9], [10], [11], excluding a trial on metoprolol [12] and comparing trial with follow-up length <12 months versus those with longer follow-up [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16]. This article describes data related article titled "Clinical Benefit of Drugs Targeting Mitochondrial Function as an Adjunct to Reperfusion in ST-segment Elevation Myocardial Infarction: a Meta-Analysis of Randomized Clinical Trials" [17].
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http://dx.doi.org/10.1016/j.dib.2017.07.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5537426PMC
October 2017

Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction: A meta-analysis of randomized clinical trials.

Int J Cardiol 2017 Oct 13;244:59-66. Epub 2017 Jun 13.

Unità Operativa di Cardiologia, Ospedale GB Morgagni, Forlì, Italy.

Aims: To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion.

Methods: Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo. Odds ratios (OR) were computed from individual studies and pooled with random-effect meta-analysis.

Results: Fifteen studies were identified involving 5680 patients. When compared with placebo, drugs targeting mitochondrial component/pathway were not associated with significant reduction of cardiovascular and all-cause mortality (OR 0.9, 95% CI 0.7-1.17 and OR 0.92, 95% CI 0.69-1.23, respectively). However, these agents significantly reduced hospital admission for heart failure (HF) (OR 0.64; 95% CI 0.45-0.92) and increased left ventricular ejection fraction (LVEF) (OR 1.44; 95% CI 1.15-1.82). After analysis for subgroups according to the mechanism of action, drugs with direct/selective action did not reduce any outcome. Conversely, those with indirect/unspecific action showed a significant effect on cardiovascular mortality (0.65, 95% CI 0.46-0.92), all-cause mortality (OR 0.69, 95% CI 0.52-0.92), hospital readmission for HF (OR 0.41, 95% CI 0.28-0.6) and LVEF (OR 1.49, 95% CI 1.09-2.05).

Conclusions: Administration of drugs targeting mitochondrial function in STEMI patients undergoing primary PCI appear to have no effect on mortality, but may reduce hospital readmission for HF. The drugs with a broad-spectrum mechanism of action seem to be more effective in reducing adverse events.
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http://dx.doi.org/10.1016/j.ijcard.2017.06.040DOI Listing
October 2017

[Patients with non-ST-elevation acute coronary syndrome managed without coronary revascularization: an undertreated population].

G Ital Cardiol (Rome) 2016 Oct;17(10):816-826

S.C. Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia.

Non-ST-elevation acute coronary syndromes (NSTE-ACS) represent one of the most common clinical presentations of ischemic heart disease. Patients with NSTE-ACS are a heterogeneous population, with different clinical features and prognosis. A significant proportion of this population is medically managed, without any revascularization. In the Italian EYESHOT and French FAST-MI registries, patients managed with a conservative strategy were 40% and 35%, respectively. NSTE-ACS patients not undergoing coronary revascularization are at higher risk of adverse cardiovascular events and have a worse prognosis, including short- and long-term mortality, compared with those receiving revascularization. Patients with NSTE-ACS medically managed consist of three different subgroups: those not undergoing coronary angiography, those receiving coronary angiography and without significant coronary artery disease, and those with significant coronary artery disease at angiography but not receiving revascularization. Patients presenting with NSTE-ACS for whom a conservative strategy without coronary angiography is planned should be selected very carefully and coronary angiography should not be denied because of the lack of on-site cath-lab facilities. In addition, advanced age alone, in the absence of severe comorbidities or frailty, should not be considered as a reason for denying coronary angiography and, in general, optimal treatment. Given that evidence-based data are lacking, a careful balance between benefits and risks is needed in the decision to perform or not coronary angiography and/or revascularization in patients with important comorbidities, or frailty, or advanced age. In this decisional process, it should be also taken into consideration the role of coronary anatomy in risk stratification and treatment guidance.NSTE-ACS patients managed without revascularization less frequently receive guideline-recommended pharmacological treatment. Dual antiplatelet therapy is recommended for 12 months also in medically managed patients, after careful balance of ischemic and bleeding risk. Indeed, in this group of patients it is mandatory to optimize pharmacological treatment, including antiplatelet therapy, in order to improve clinical outcome. In NSTE-ACS not undergoing revascularization, the proportion of patients discharged with dual antiplatelet therapy should be increased in comparison to current clinical practice, and the use of ticagrelor instead of clopidogrel should be considered in selected patients.
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http://dx.doi.org/10.1714/2464.25800DOI Listing
October 2016

The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program: rational and design of a multicenter prospective study.

Aging Clin Exp Res 2017 Oct 28;29(5):895-903. Epub 2016 Oct 28.

Department of Medical Science, University of Ferrara, Ferrara, Italy.

Background: Frailty has become a high-priority issue in cardiovascular medicine because of the aging of cardiovascular patients. Simple and reproducible tools to assess frailty in elderly patients are clearly on demand. Their application may help physicians in the selection of invasive and medical treatments and in the timing and modality of the follow-up. The frailty in elderly patients receiving cardiac interventional procedures (FRASER) program is designed with the aim to validate the use of the short physical performance battery (SPPB) as prognostic tools in patients admitted to hospital for acute coronary syndrome (ACS).

Methods: The FRASER program is a multicenter prospective study involving 4 Italian cardiology units. The FRASER program enrolls only patients aged ≥70 years. The core of the FRASER program includes patients admitted to hospital for ACS. The aims are (1) to describe SPPB distribution before hospital discharge and (2) to investigate the prognostic role of SPPB score. The primary outcome is a composite of 1-year all-cause mortality and hospital readmission for any cause. Ancillary analyses will be focused on different study populations (patients hospitalized for arrhythmias or acute heart failure or symptomatic severe aortic stenosis) and on different tools to assess frailty (multidimensional prognostic index, clinical frailty score, grip strength).

Discussion: The FRASER program will fill critical gaps in the knowledge regarding the link between frailty, cardiovascular disease, interventional procedures and outcome and will help physicians in the generation of a more personalized risk assessment and in the identification of potential targets for interventions.
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http://dx.doi.org/10.1007/s40520-016-0662-yDOI Listing
October 2017

Sex-Related Outcomes in Elderly Patients Presenting With Non-ST-Segment Elevation Acute Coronary Syndrome: Insights From the Italian Elderly ACS Study.

JACC Cardiovasc Interv 2015 May;8(6):791-796

Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.

Objectives: This study sought to investigate sex-related differences in treatment and outcomes in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS).

Background: Female sex and older age are usually associated with worse outcome in NSTEACS. The Italian Elderly ACS study enrolled NSTEACS patients aged 75 years of age and older in a randomized trial comparing an early aggressive with an initially conservative strategy and in a registry of patients with ≥1 exclusion criteria of the trial.

Methods: We compared sexes in the pooled populations of the trial and registry.

Results: A total of 645 patients (313 from the trial and 332 from the registry), including 301 women (47%), were enrolled. Women were slightly older than men (82.1 ± 5.0 years vs. 81.2 ± 4.5 years; p = 0.02), had lower hemoglobin levels (12.5 ± 1.6 g/dl vs. 13.3 ± 1.9 g/dl; p < 0.001), and underwent fewer coronary revascularizations during the index admission (37.2% vs. 45.0%; p = 0.04). In-hospital adverse event rates were similar in both sexes; severe bleeding was uncommon (0.3% vs. 0%). The 1-year primary endpoint (composite of death, nonfatal myocardial infarction, disabling stroke, cardiac rehospitalization, and severe bleeding) occurred less often in women (27.6% vs. 38.7%; p < 0.01). Women not undergoing revascularization showed a 3-fold higher mortality, both in-hospital (8.5% vs. 2.7%; p = 0.05) and at 1 year (21.6% vs. 8.1%; p = 0.002).

Conclusions: Elderly women had a similar in-hospital outcome and better 1-year outcome compared with men. Coronary revascularization in women was associated with lower 1-year mortality, without an increase in severe bleeding. Elderly women with NSTEACS should always be considered for early revascularization.
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http://dx.doi.org/10.1016/j.jcin.2014.12.240DOI Listing
May 2015

Outcome of patients on oral anticoagulation undergoing coronary artery stenting: data from discharge to 12 months in the Warfarin and Coronary Stenting (WAR-STENT) Registry.

J Invasive Cardiol 2014 Nov;26(11):563-9

Division of Cardiology, Laboratory of Interventional Cardiology, Ospedale Maggiore, Largo Nigrisoli 2, 40133 Bologna, Italy.

Objectives: To obtain further, and more focused, information on the efficacy and safety of the antithrombotic regimens, including triple therapy (TT) of warfarin, aspirin, and clopidogrel; dual therapy (DT) of warfarin and single antiplatelet agent (aspirin or clopidogrel); and dual-antiplatelet therapy (DAPT) of aspirin and clopidogrel, prescribed to patients on oral anticoagulation (OAC) undergoing percutaneous coronary intervention with stent (PCI-S).

Background: The true efficacy and safety of TT, DT, and DAPT in OAC patients undergoing PCI-S is largely undefined.

Methods: We analyzed the database of the prospective, multicenter WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319), only including the post-discharge period.

Results: Of the 401 patients discharged alive from index hospitalization, 339 (85%), 20 (5%), and 42 (10%) were prescribed TT, DT, and DAPT, respectively. Throughout a mean follow-up of 368.3 ± 22.8 days, major adverse cardiovascular events (MACE) (including cardiovascular death, myocardial infarction, repeat revascularization, stent thrombosis, and thromboembolism), total bleeding, major bleeding, and combination of MACE plus total bleeding were comparable across the three treatment groups. The absolute rate of major bleeding with TT was 4%. The antithrombotic treatment actually ongoing at major bleeding was TT in 44%, DT in 50%, and DAPT in 6% of cases.

Conclusion: In the real-world population of OAC patients undergoing PCI-S in the WAR-STENT registry, the three antithrombotic regimens of TT, DT, and DAPT showed comparable efficacy and safety. Due to several limitations, our data cannot be considered conclusive in confuting the current recommendations to prescribe TT. Further properly designed and sized studies are warranted.
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November 2014
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