Objectives. To investigate outcome with selective, clopidogrel-based therapies vs conventional tr... more Objectives. To investigate outcome with selective, clopidogrel-based therapies vs conventional treatment in patients undergoing percutaneous coronary intervention (PCI), especially for acute coronary syndrome. Background. Safety and efficacy of alternative, selective, clopidogrel-based therapies after PCI are not robustly established. Methods. We performed a study-level meta-analysis on six randomized trials investigating selective clopidogrel-based therapies (three on unguided de-escalation, N=3,473; three on guided clopidogrel therapy, N=7,533). Control groups received ticagrelor or prasugrel treatment. Main endpoints were major bleeding, any bleeding, major adverse cardiovascular events (MACE) and net clinical endpoint. Results. The incidence of major bleeding and MACE was similar in the selective, clopidogrel-based therapy vs conventional treatment arm (OR 0·72, 95% CI 0·51-1·01, p=0·06; OR 0·93, 0·72-1·20, p=0·58; respectively). The rates of any bleeding were lower in the selec...
Figure 1 of the Appendix. Diagram showing balancing of main clinical variables included in the Pr... more Figure 1 of the Appendix. Diagram showing balancing of main clinical variables included in the Propensity Score matching model.<br> ICD= implantable cardiac defibrillator; MI= myocardial infarction; OAC= oral anticoagulant; PAD= peripheral artery disease; PM= pacemaker<br> Figure 2 of the Appendix. Histogram of Propensity Score matching results by different oral anticoagulation strategy.
Permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI) has emerged... more Permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI) has emerged as a relevant issue, being more frequent than after surgery and the progressive shift towards low-risk patients stressed the importance to reduce the risk of complications that could impact patient’s long-term prognosis. Long-term right ventricular pacing has been related to an increased risk of electromechanical asynchrony, negative left-ventricular remodelling, atrial fibrillation and heart failure, but there is a lack of evidence regarding the prognostic impact on TAVI patients. The aim of this international multicentre study is to assess the impact of right ventricular pacing on prognosis of TAVI patients undergone pacemaker implantation after the procedure due to conduction disorders. All the consecutive patients with severe aortic stenosis treated with TAVI and subsequently underwent pacemaker implantation in each participating centre were enrolled. Patients were divided into two ...
There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagula... more There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) versus vitamin K antagonist anticoagulants (VKAs) in patients with atrial fibrillation (AF) undergoing cardiac implantable electronic device (CIED) intervention. Our aim was to evaluate whether NOACs have a safety benefit even in terms of fewer hemorrhagic complications at the site of CIED implant. Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, and monocentric investigation. Primary endpoint was the incidence of post-intervention pocket hematoma. A total of 311 patients were enrolled, 146 on NOACs, and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC versus 13.3% in the VKA group (p = 0.002). Primary outcome-free survival at 30-days was 96.6% in patients on NOACs and 86.0% in those on VKAs (p = 0.019). Multivariate analysis, adjusted by propensity-score calculation of inverse-...
Left ventricular noncompaction (LVNC) is a rare congenital cardiomyopathy thought to be caused by... more Left ventricular noncompaction (LVNC) is a rare congenital cardiomyopathy thought to be caused by arrest of normal endomyocardial morphogenesis. A 33-year-old male, smoker, dyslipidemic not on medical therapy, with family history for sudden cardiac death (SCD) presented to the ER for chest pain radiated to the left arm, unrelated to exertion. The physical examination was within normal limits. Blood tests showed increased cardiac enzymes levels (Troponin I hs 49 308.7 ng/l). The EKG showed STE in the anterior leads and diffuse ventricular repolarization anomalies, suggestive of anterior STEMI. The patient underwent coronary catheterization, with evidence of anomalous origin of the Cx from the RCA and critical stenosis on the proximal LAD, treated with PPCI and implantation of a DES with good angiographic result. The patient was transferred to the Cardiac Intensive Care Unit. TTE showed moderate LV dilatation, severe LV dysfunction (EF 30%) with apical, septal and anterior wall akines...
BACKGROUND The optimal pharmacological therapy after transcatheter aortic valve implantation (TAV... more BACKGROUND The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) remains uncertain. We compared efficacy and safety of various antiplatelet and anticoagulant approaches after TAVI by a network meta-analysis. METHODS A total of 14 studies (both observational and randomized) were considered, with 24,119 patients included. Primary safety endpoint was the incidence of any bleeding complications during follow-up. Secondary safety endpoint was major bleeding. Efficacy endpoints were stroke, myocardial infarction and cardiovascular mortality. A frequentist network meta-analysis was conducted with a random-effects model. The following strategies were compared: dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT), oral anticoagulation (OAC), OAC+SAPT. Mean follow-up was 15 months. RESULTS In comparison to DAPT, SAPT was associated with a 44% risk reduction of any bleeding (OR, 0.56 [95% CI, 0.39-0.80]). SAPT was ranked as the safest strategy...
A pro-thrombotic milieu and a higher risk of thrombotic events were observed in patients with Cor... more A pro-thrombotic milieu and a higher risk of thrombotic events were observed in patients with CoronaVirus disease-19 (COVID-19). Accordingly, recent data suggested a beneficial role of low molecular weight heparin (LMWH), but the optimal dosage of this treatment is unknown. We evaluated the association between prophylactic vs. intermediate-to-fully anticoagulant doses of enoxaparin and in-hospital adverse events in patients with COVID-19. We retrospectively included 436 consecutive patients admitted in three Italian hospitals. Outcome according to the use of prophylactic (4000 IU) vs. higher (> 4000 IU) daily dosage of enoxaparin was evaluated. The primary end-point was in-hospital death. Secondary outcome measures were in-hospital cardiovascular death, venous thromboembolism, new-onset acute respiratory distress syndrome (ARDS) and mechanical ventilation. A total of 287 patients (65.8%) were treated with the prophylactic enoxaparin regimen and 149 (34.2%) with a higher dosing re...
Patients with Coronavirus Disease-2019 (COVID‐19) have haemostatic dysfunction and are at higher ... more Patients with Coronavirus Disease-2019 (COVID‐19) have haemostatic dysfunction and are at higher risk of thrombotic complications. Although age is a major risk factor for outcome impairment in COVID-19, its impact on coagulative patterns here is still unclear. We investigated the association of Endogenous Thrombin Potential (ETP) with thrombotic and haemorrhagic events according to different ages in patients admitted for COVID-19. A total of 27 patients with COVID‐19-related pneumonia, without need for intensive care unit admission or mechanical ventilation at hospital presentation, and 24 controls with non-COVID-19 pneumonia were prospectively included. ETP levels were measured on admission. Patients were evaluated for major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke, transient ischemic attack, venous thromboembolism) and bleeding complications [according to Bleeding Academic Research Consortium (BARC) definition] during in-hospital sta...
The International Journal of Cardiovascular Imaging
Cardiac magnetic resonance imaging (CMRI) represents the main imaging modality for diagnosing acu... more Cardiac magnetic resonance imaging (CMRI) represents the main imaging modality for diagnosing acute myocarditis. However, its limited availability could entail missing or delayed diagnosis. A reduction of left ventricular global longitudinal strain (LV GLS) by speckle tracking echocardiography (STE) correlates with amount of oedema in acute myocarditis and here may be early detected. Aim was to evaluate the diagnostic and prognostic role of 3-layers LV GLS in patients with acute myocarditis. Out of 122 patients with suspected acute myocarditis, a total of 86 consecutive patients with CMRI-confirmed acute myocarditis admitted in two Italian institutions were retrospectively screened. Exclusion criteria were met in 29 patients because of poor acoustic window or missing data. A total of 57 patients were then included. Clinical characteristics, laboratory examinations, transthoracic echocardiography data and STE parameters were collected early after hospitalization. In the study populat...
Clinical outcome data of patients discharged after Coronavirus disease 2019 (COVID-19) are limite... more Clinical outcome data of patients discharged after Coronavirus disease 2019 (COVID-19) are limited and no study has evaluated predictors of cardiovascular prognosis in this setting. Our aim was to assess short-term mortality and cardiovascular outcome after hospitalization for COVID-19. A prospective cohort of 296 consecutive patients discharged after COVID-19 from two Italian institutions during the first wave of the pandemic and followed up to 6 months was included. The primary endpoint was all-cause mortality. The co-primary endpoint was the incidence of the composite outcome of major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, myocardial infarction, stroke, pulmonary embolism, acute heart failure, or hospitalization for cardiovascular causes). The mean follow-up duration was 6 ± 2 months. The incidence of all-cause death was 4.7%. At multivariate analysis, age was the only independent predictor of mortality (aHR 1.08, 95% CI 1.01–1.16). MACCE occurre...
Introduction. The clinical course of Coronavirus Disease 2019 (COVID-19) is highly heterogenous, ... more Introduction. The clinical course of Coronavirus Disease 2019 (COVID-19) is highly heterogenous, ranging from asymptomatic to fatal forms. The identification of clinical and laboratory predictors of poor prognosis may assist clinicians in monitoring strategies and therapeutic decisions. Materials and Methods. In this study, we retrospectively assessed the prognostic value of a simple tool, the complete blood count, on a cohort of 664 patients ( F 260; 39%, median age 70 (56-81) years) hospitalized for COVID-19 in Northern Italy. We collected demographic data along with complete blood cell count; moreover, the outcome of the hospital in-stay was recorded. Results. At data cut-off, 221/664 patients (33.3%) had died and 453/664 (66.7%) had been discharged. Red cell distribution width (RDW) ( χ 2 10.4; p < 0.001 ), neutrophil-to-lymphocyte (NL) ratio ( χ 2 7.6; p = 0.006 ), and platelet count ( χ 2 5.39; p = 0.02 ), along with age ( χ 2 87.6; p < 0.001 ) and gender ( χ 2 17.3; p &...
Background During the COVID-19 outbreak, cardiovascular imaging, especially transoesophageal echo... more Background During the COVID-19 outbreak, cardiovascular imaging, especially transoesophageal echocardiography (TOE), may expose healthcare personnel to virus contamination and should be performed only if strictly necessary. On the other hand, transthoracic echocardiography (TTE) and TOE represent the first-line imaging exams for the diagnosis of infective endocarditis (IE). To date, this is the first case of COVID-19 complicated by IE. Case summary We present the case of a 57-year-old man with severe COVID-19 pneumonia requiring mechanical ventilation. During the intensive care unit (ICU) stay, he developed fever and positive haemocoltures for methicillin-resistant Staphylococcus aureus infection. TTE did not identify endocardial vegetations. TOE was then performed and outlined IE of the aortic valve on the non-coronary cusp. Antibiotic therapy was given with progressive resolution of the septic state and improvement of inflammatory signs. After 30 days of ICU stay, the patient was ...
Clinical features and natural history of coronavirus disease 2019 (COVID-19) differ widely among ... more Clinical features and natural history of coronavirus disease 2019 (COVID-19) differ widely among different countries and during different phases of the pandemia. Here, we aimed to evaluate the case fatality rate (CFR) and to identify predictors of mortality in a cohort of COVID-19 patients admitted to three hospitals of Northern Italy between March 1 and April 28, 2020. All these patients had a confirmed diagnosis of SARS-CoV-2 infection by molecular methods. During the study period 504/1697 patients died; thus, overall CFR was 29.7%. We looked for predictors of mortality in a subgroup of 486 patients (239 males, 59%; median age 71 years) for whom sufficient clinical data were available at data cut-off. Among the demographic and clinical variables considered, age, a diagnosis of cancer, obesity and current smoking independently predicted mortality. When laboratory data were added to the model in a further subgroup of patients, age, the diagnosis of cancer, and the baseline PaO2/FiO2...
Objectives. To investigate outcome with selective, clopidogrel-based therapies vs conventional tr... more Objectives. To investigate outcome with selective, clopidogrel-based therapies vs conventional treatment in patients undergoing percutaneous coronary intervention (PCI), especially for acute coronary syndrome. Background. Safety and efficacy of alternative, selective, clopidogrel-based therapies after PCI are not robustly established. Methods. We performed a study-level meta-analysis on six randomized trials investigating selective clopidogrel-based therapies (three on unguided de-escalation, N=3,473; three on guided clopidogrel therapy, N=7,533). Control groups received ticagrelor or prasugrel treatment. Main endpoints were major bleeding, any bleeding, major adverse cardiovascular events (MACE) and net clinical endpoint. Results. The incidence of major bleeding and MACE was similar in the selective, clopidogrel-based therapy vs conventional treatment arm (OR 0·72, 95% CI 0·51-1·01, p=0·06; OR 0·93, 0·72-1·20, p=0·58; respectively). The rates of any bleeding were lower in the selec...
Figure 1 of the Appendix. Diagram showing balancing of main clinical variables included in the Pr... more Figure 1 of the Appendix. Diagram showing balancing of main clinical variables included in the Propensity Score matching model.<br> ICD= implantable cardiac defibrillator; MI= myocardial infarction; OAC= oral anticoagulant; PAD= peripheral artery disease; PM= pacemaker<br> Figure 2 of the Appendix. Histogram of Propensity Score matching results by different oral anticoagulation strategy.
Permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI) has emerged... more Permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI) has emerged as a relevant issue, being more frequent than after surgery and the progressive shift towards low-risk patients stressed the importance to reduce the risk of complications that could impact patient’s long-term prognosis. Long-term right ventricular pacing has been related to an increased risk of electromechanical asynchrony, negative left-ventricular remodelling, atrial fibrillation and heart failure, but there is a lack of evidence regarding the prognostic impact on TAVI patients. The aim of this international multicentre study is to assess the impact of right ventricular pacing on prognosis of TAVI patients undergone pacemaker implantation after the procedure due to conduction disorders. All the consecutive patients with severe aortic stenosis treated with TAVI and subsequently underwent pacemaker implantation in each participating centre were enrolled. Patients were divided into two ...
There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagula... more There are no data on procedure-related bleeding outcome with non-vitamin K antagonist anticoagulants (NOACs) versus vitamin K antagonist anticoagulants (VKAs) in patients with atrial fibrillation (AF) undergoing cardiac implantable electronic device (CIED) intervention. Our aim was to evaluate whether NOACs have a safety benefit even in terms of fewer hemorrhagic complications at the site of CIED implant. Consecutive AF patients receiving NOACs or VKAs at the time of CIED procedure were included in this observational, retrospective, and monocentric investigation. Primary endpoint was the incidence of post-intervention pocket hematoma. A total of 311 patients were enrolled, 146 on NOACs, and 165 on VKAs. The incidence of pocket hematoma was 3.4% in the NOAC versus 13.3% in the VKA group (p = 0.002). Primary outcome-free survival at 30-days was 96.6% in patients on NOACs and 86.0% in those on VKAs (p = 0.019). Multivariate analysis, adjusted by propensity-score calculation of inverse-...
Left ventricular noncompaction (LVNC) is a rare congenital cardiomyopathy thought to be caused by... more Left ventricular noncompaction (LVNC) is a rare congenital cardiomyopathy thought to be caused by arrest of normal endomyocardial morphogenesis. A 33-year-old male, smoker, dyslipidemic not on medical therapy, with family history for sudden cardiac death (SCD) presented to the ER for chest pain radiated to the left arm, unrelated to exertion. The physical examination was within normal limits. Blood tests showed increased cardiac enzymes levels (Troponin I hs 49 308.7 ng/l). The EKG showed STE in the anterior leads and diffuse ventricular repolarization anomalies, suggestive of anterior STEMI. The patient underwent coronary catheterization, with evidence of anomalous origin of the Cx from the RCA and critical stenosis on the proximal LAD, treated with PPCI and implantation of a DES with good angiographic result. The patient was transferred to the Cardiac Intensive Care Unit. TTE showed moderate LV dilatation, severe LV dysfunction (EF 30%) with apical, septal and anterior wall akines...
BACKGROUND The optimal pharmacological therapy after transcatheter aortic valve implantation (TAV... more BACKGROUND The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) remains uncertain. We compared efficacy and safety of various antiplatelet and anticoagulant approaches after TAVI by a network meta-analysis. METHODS A total of 14 studies (both observational and randomized) were considered, with 24,119 patients included. Primary safety endpoint was the incidence of any bleeding complications during follow-up. Secondary safety endpoint was major bleeding. Efficacy endpoints were stroke, myocardial infarction and cardiovascular mortality. A frequentist network meta-analysis was conducted with a random-effects model. The following strategies were compared: dual antiplatelet therapy (DAPT), single antiplatelet therapy (SAPT), oral anticoagulation (OAC), OAC+SAPT. Mean follow-up was 15 months. RESULTS In comparison to DAPT, SAPT was associated with a 44% risk reduction of any bleeding (OR, 0.56 [95% CI, 0.39-0.80]). SAPT was ranked as the safest strategy...
A pro-thrombotic milieu and a higher risk of thrombotic events were observed in patients with Cor... more A pro-thrombotic milieu and a higher risk of thrombotic events were observed in patients with CoronaVirus disease-19 (COVID-19). Accordingly, recent data suggested a beneficial role of low molecular weight heparin (LMWH), but the optimal dosage of this treatment is unknown. We evaluated the association between prophylactic vs. intermediate-to-fully anticoagulant doses of enoxaparin and in-hospital adverse events in patients with COVID-19. We retrospectively included 436 consecutive patients admitted in three Italian hospitals. Outcome according to the use of prophylactic (4000 IU) vs. higher (> 4000 IU) daily dosage of enoxaparin was evaluated. The primary end-point was in-hospital death. Secondary outcome measures were in-hospital cardiovascular death, venous thromboembolism, new-onset acute respiratory distress syndrome (ARDS) and mechanical ventilation. A total of 287 patients (65.8%) were treated with the prophylactic enoxaparin regimen and 149 (34.2%) with a higher dosing re...
Patients with Coronavirus Disease-2019 (COVID‐19) have haemostatic dysfunction and are at higher ... more Patients with Coronavirus Disease-2019 (COVID‐19) have haemostatic dysfunction and are at higher risk of thrombotic complications. Although age is a major risk factor for outcome impairment in COVID-19, its impact on coagulative patterns here is still unclear. We investigated the association of Endogenous Thrombin Potential (ETP) with thrombotic and haemorrhagic events according to different ages in patients admitted for COVID-19. A total of 27 patients with COVID‐19-related pneumonia, without need for intensive care unit admission or mechanical ventilation at hospital presentation, and 24 controls with non-COVID-19 pneumonia were prospectively included. ETP levels were measured on admission. Patients were evaluated for major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke, transient ischemic attack, venous thromboembolism) and bleeding complications [according to Bleeding Academic Research Consortium (BARC) definition] during in-hospital sta...
The International Journal of Cardiovascular Imaging
Cardiac magnetic resonance imaging (CMRI) represents the main imaging modality for diagnosing acu... more Cardiac magnetic resonance imaging (CMRI) represents the main imaging modality for diagnosing acute myocarditis. However, its limited availability could entail missing or delayed diagnosis. A reduction of left ventricular global longitudinal strain (LV GLS) by speckle tracking echocardiography (STE) correlates with amount of oedema in acute myocarditis and here may be early detected. Aim was to evaluate the diagnostic and prognostic role of 3-layers LV GLS in patients with acute myocarditis. Out of 122 patients with suspected acute myocarditis, a total of 86 consecutive patients with CMRI-confirmed acute myocarditis admitted in two Italian institutions were retrospectively screened. Exclusion criteria were met in 29 patients because of poor acoustic window or missing data. A total of 57 patients were then included. Clinical characteristics, laboratory examinations, transthoracic echocardiography data and STE parameters were collected early after hospitalization. In the study populat...
Clinical outcome data of patients discharged after Coronavirus disease 2019 (COVID-19) are limite... more Clinical outcome data of patients discharged after Coronavirus disease 2019 (COVID-19) are limited and no study has evaluated predictors of cardiovascular prognosis in this setting. Our aim was to assess short-term mortality and cardiovascular outcome after hospitalization for COVID-19. A prospective cohort of 296 consecutive patients discharged after COVID-19 from two Italian institutions during the first wave of the pandemic and followed up to 6 months was included. The primary endpoint was all-cause mortality. The co-primary endpoint was the incidence of the composite outcome of major adverse cardiac and cerebrovascular events (MACCE: cardiovascular death, myocardial infarction, stroke, pulmonary embolism, acute heart failure, or hospitalization for cardiovascular causes). The mean follow-up duration was 6 ± 2 months. The incidence of all-cause death was 4.7%. At multivariate analysis, age was the only independent predictor of mortality (aHR 1.08, 95% CI 1.01–1.16). MACCE occurre...
Introduction. The clinical course of Coronavirus Disease 2019 (COVID-19) is highly heterogenous, ... more Introduction. The clinical course of Coronavirus Disease 2019 (COVID-19) is highly heterogenous, ranging from asymptomatic to fatal forms. The identification of clinical and laboratory predictors of poor prognosis may assist clinicians in monitoring strategies and therapeutic decisions. Materials and Methods. In this study, we retrospectively assessed the prognostic value of a simple tool, the complete blood count, on a cohort of 664 patients ( F 260; 39%, median age 70 (56-81) years) hospitalized for COVID-19 in Northern Italy. We collected demographic data along with complete blood cell count; moreover, the outcome of the hospital in-stay was recorded. Results. At data cut-off, 221/664 patients (33.3%) had died and 453/664 (66.7%) had been discharged. Red cell distribution width (RDW) ( χ 2 10.4; p < 0.001 ), neutrophil-to-lymphocyte (NL) ratio ( χ 2 7.6; p = 0.006 ), and platelet count ( χ 2 5.39; p = 0.02 ), along with age ( χ 2 87.6; p < 0.001 ) and gender ( χ 2 17.3; p &...
Background During the COVID-19 outbreak, cardiovascular imaging, especially transoesophageal echo... more Background During the COVID-19 outbreak, cardiovascular imaging, especially transoesophageal echocardiography (TOE), may expose healthcare personnel to virus contamination and should be performed only if strictly necessary. On the other hand, transthoracic echocardiography (TTE) and TOE represent the first-line imaging exams for the diagnosis of infective endocarditis (IE). To date, this is the first case of COVID-19 complicated by IE. Case summary We present the case of a 57-year-old man with severe COVID-19 pneumonia requiring mechanical ventilation. During the intensive care unit (ICU) stay, he developed fever and positive haemocoltures for methicillin-resistant Staphylococcus aureus infection. TTE did not identify endocardial vegetations. TOE was then performed and outlined IE of the aortic valve on the non-coronary cusp. Antibiotic therapy was given with progressive resolution of the septic state and improvement of inflammatory signs. After 30 days of ICU stay, the patient was ...
Clinical features and natural history of coronavirus disease 2019 (COVID-19) differ widely among ... more Clinical features and natural history of coronavirus disease 2019 (COVID-19) differ widely among different countries and during different phases of the pandemia. Here, we aimed to evaluate the case fatality rate (CFR) and to identify predictors of mortality in a cohort of COVID-19 patients admitted to three hospitals of Northern Italy between March 1 and April 28, 2020. All these patients had a confirmed diagnosis of SARS-CoV-2 infection by molecular methods. During the study period 504/1697 patients died; thus, overall CFR was 29.7%. We looked for predictors of mortality in a subgroup of 486 patients (239 males, 59%; median age 71 years) for whom sufficient clinical data were available at data cut-off. Among the demographic and clinical variables considered, age, a diagnosis of cancer, obesity and current smoking independently predicted mortality. When laboratory data were added to the model in a further subgroup of patients, age, the diagnosis of cancer, and the baseline PaO2/FiO2...
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Papers by Enrico Spinoni