Publications by authors named "Fabrizio DʼAscenzo"

361 Publications

IVUS-guided decision-making in acute coronary syndrome after resuscitated cardiac arrest.

Int J Cardiovasc Imaging 2021 Feb 22. Epub 2021 Feb 22.

Department of Cardiology, University of Turin, Turin, Italy.

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http://dx.doi.org/10.1007/s10554-021-02184-5DOI Listing
February 2021

Atrial fibrillation in patients with COVID-19. Usefulness of the CHADS-VASc score: an analysis of the international HOPE COVID-19 registry.

Rev Esp Cardiol (Engl Ed) 2021 Jan 13. Epub 2021 Jan 13.

Servicio de Cardiología, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Introduction And Objectives: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2. Atrial fibrillation (AF) is common in acute situations, where it is associated with more complications and higher mortality.

Methods: Analysis of the international HOPE registry (NCT04334291). The objective was to assess the prognostic information of AF in COVID-19 patients. A multivariate analysis and propensity score matching were performed to assess the relationship between AF and mortality. We also evaluated the impact on mortality and embolic events of the CHADS-VASc score in these patients.

Results: Among 6217 patients enrolled in the HOPE registry, 250 had AF (4.5%). AF patients had a higher prevalence of cardiovascular risk factors and comorbidities. After propensity score matching, these differences were attenuated. Despite this, patients with AF had a higher incidence of in-hospital complications such as heart failure (19.3% vs 11.6%, P=.021) and respiratory insufficiency (75.9% vs 62.3%, P=.002), as well as a higher 60-day mortality rate (43.4% vs 30.9%, P=.005). On multivariate analysis, AF was independently associated with higher 60-day mortality (hazard ratio, 1.234; 95%CI, 1.003-1.519). CHADS-VASc score acceptably predicts 60-day mortality in COVID-19 patients (area ROC, 0.748; 95%CI, 0.733-0.764), but not its embolic risk (area ROC, 0.411; 95%CI, 0.147-0.675).

Conclusions: AF in COVID-19 patients is associated with a higher number of complications and 60-day mortality. The CHADS-VASc score may be a good risk marker in COVID patients but does not predict their embolic risk.
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http://dx.doi.org/10.1016/j.rec.2020.12.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836821PMC
January 2021

Response to: Angiography versus FFR-guided coronary artery bypass grafting.

Catheter Cardiovasc Interv 2021 Feb 7. Epub 2021 Feb 7.

Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Torino, Italy.

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http://dx.doi.org/10.1002/ccd.29542DOI Listing
February 2021

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

Eur Heart J 2021 Jan 28. Epub 2021 Jan 28.

Newcastle University and Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.
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http://dx.doi.org/10.1093/eurheartj/ehaa1070DOI Listing
January 2021

European position paper on the management of patients with patent foramen ovale. Part II - Decompression sickness, migraine, arterial deoxygenation syndromes and select high-risk clinical conditions.

EuroIntervention 2021 01 28. Epub 2021 Jan 28.

S. Filippo Neri Hospital ASL Roma 1, Rome, Italy.

Patent foramen ovale (PFO) is implicated in the pathogenesis of a number of medical conditions but to date only one official position paper related to left circulation thromboembolism has been published. This interdisciplinary paper, prepared with the involvement of eight European scientific societies, reviews the available evidence and proposes a rationale for decision making for other PFO-related clinical conditions. In order to guarantee a strict evidence-based process, we used a modified grading of recommendations, assessment, development, and evaluation (GRADE) methodology. A critical qualitative and quantitative evaluation of diagnostic and therapeutic procedures was performed, including assessment of the risk/benefit ratio. The level of evidence and the strength of the position statements were weighed and graded according to predefined scales. Despite being based on limited and observational or low-certainty randomised data, a number of position statements were made to frame PFO management in different clinical settings, along with suggestions for new research avenues. This interdisciplinary position paper, recognising the low or very low certainty of existing evidence, provides the first approach to several PFO-related clinical scenarios beyond left circulation thromboembolism and strongly stresses the need for fresh high-quality evidence on these topics.
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http://dx.doi.org/10.4244/EIJ-D-20-00785DOI Listing
January 2021

Machine learning-based prediction of adverse events following an acute coronary syndrome (PRAISE): a modelling study of pooled datasets.

Lancet 2021 01;397(10270):199-207

Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza, Turin, Italy; Cardiology, Department of Medical Sciences, University of Turin, Turin, Italy.

Background: The accuracy of current prediction tools for ischaemic and bleeding events after an acute coronary syndrome (ACS) remains insufficient for individualised patient management strategies. We developed a machine learning-based risk stratification model to predict all-cause death, recurrent acute myocardial infarction, and major bleeding after ACS.

Methods: Different machine learning models for the prediction of 1-year post-discharge all-cause death, myocardial infarction, and major bleeding (defined as Bleeding Academic Research Consortium type 3 or 5) were trained on a cohort of 19 826 adult patients with ACS (split into a training cohort [80%] and internal validation cohort [20%]) from the BleeMACS and RENAMI registries, which included patients across several continents. 25 clinical features routinely assessed at discharge were used to inform the models. The best-performing model for each study outcome (the PRAISE score) was tested in an external validation cohort of 3444 patients with ACS pooled from a randomised controlled trial and three prospective registries. Model performance was assessed according to a range of learning metrics including area under the receiver operating characteristic curve (AUC).

Findings: The PRAISE score showed an AUC of 0·82 (95% CI 0·78-0·85) in the internal validation cohort and 0·92 (0·90-0·93) in the external validation cohort for 1-year all-cause death; an AUC of 0·74 (0·70-0·78) in the internal validation cohort and 0·81 (0·76-0·85) in the external validation cohort for 1-year myocardial infarction; and an AUC of 0·70 (0·66-0·75) in the internal validation cohort and 0·86 (0·82-0·89) in the external validation cohort for 1-year major bleeding.

Interpretation: A machine learning-based approach for the identification of predictors of events after an ACS is feasible and effective. The PRAISE score showed accurate discriminative capabilities for the prediction of all-cause death, myocardial infarction, and major bleeding, and might be useful to guide clinical decision making.

Funding: None.
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http://dx.doi.org/10.1016/S0140-6736(20)32519-8DOI Listing
January 2021

Incidence, Management, Immediate and Long-Term Outcome of Guidewire and Device Related Grade III Coronary Perforations (from G3CAP - Cardiogroup VI Registry).

Am J Cardiol 2021 Mar 30;143:37-45. Epub 2020 Dec 30.

Interventional Cardiology Unit, San Luigi Gonzaga University Hospital (Orbassano) and Rivoli Infermi Hospital (Rivoli), Turin, Italy.

Ellis grade III coronary artery perforations (G3-CAP) remain a life-threatening complication of percutaneous coronary intervention (PCI), with high morbidity and mortality and lack of consensus regarding optimal treatment strategies. We reviewed all PCIs performed in 10 European centers from 1993 to 2019 recording all G3-CAP along with management strategies, in-hospital and long-term outcome according to Device-related perforations (DP) and Guidewire-related perforations (WP). Among 106,592 PCI (including 7,773 chronic total occlusions), G3-CAP occurred in 311 patients (0.29%). DP occurred in 194 cases (62.4%), more commonly in proximal segments (73.2%) and frequently secondary to balloon dilatation (66.0%). WP arose in 117 patients (37.6%) with chronic total occlusions guidewires involved in 61.3% of cases. Overall sealing success rate was 90.7% and usually required multiple maneuvers (80.4%). The most commonly adopted strategies to obtain hemostasis were prolonged balloon inflation (73.2%) with covered stent implantation (64.4%) in the DP group, and prolonged balloon inflation (53.8%) with coil embolization (41%) in the WP group.  Procedural or in-hospital events arose in 38.2% of cases: mortality was higher after DP (7.2% vs 2.6%, p = 0.05) and acute stent thrombosis 3-fold higher (3.1% vs 0.9%, p = 0.19). At clinical follow-up, median 2 years, a major cardiovascular event occurred in one-third of cases (all-cause mortality 8.2% and 7.1% respectively, without differences between groups). In conclusion, although rare and despite improved rates of adequate perforation sealing G3-CAP cause significant adverse events. DP and WP result in different patterns of G3-CAP and management strategies should be based on this classification.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.041DOI Listing
March 2021

Underlying heart diseases and acute COVID-19 outcomes.

Cardiol J 2020 Dec 21. Epub 2020 Dec 21.

HOSPITAL CLINICO SAN CARLOS, Prof Martin Lagos, sn, 28040 Madrid, Spain.

Background: The presence of any underlying heart condition could influence outcomes during the coronavirus disease 2019 (COVID-19).

Methods: The registry HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19, NCT04334291) is an international ambispective study, enrolling COVID-19 patients discharged from hospital, dead or alive.

Results: HOPE enrolled 2798 patients from 35 centers in 7 countries. Median age was 67 years (IQR: 53.0-78.0), and most were male (59.5%). A relevant heart disease was present in 682 (24%) cases. These were older, more frequently male, with higher overall burden of cardiovascular risk factors (hypertension, dyslipidemia, diabetes mellitus, smoking habit, obesity) and other comorbidities such renal failure, lung, cerebrovascular disease and oncologic antecedents (p < 0.01, for all). The heart cohort received more corticoids (28.9% vs. 20.4%, p < 0.001), antibiotics, but less hydroxychloroquine, antivirals or tocilizumab. Considering the epidemiologic profile, a previous heart condition was independently related with short-term mortality in the COX multivariate analysis (1.62; 95% CI 1.29-2.03; p < 0.001). Moreover, heart patients needed more respiratory, circulatory support, and presented more in-hospital events, such heart failure, renal failure, respiratory insufficiency, sepsis, SIRS and clinically relevant bleedings (all, p < 0.001), and mortality (39.7% vs. 15.5%; p < 0.001).

Conclusions: An underlying heart disease is an adverse prognostic factor for patients suffering COVID-19. Its presence could be related with different clinical drug management and would benefit from maintaining treatment with angiotensin converting enzyme inhibitors or angiotensin receptor blockers during in-hospital stay. Trial Numbers: NCT04334291/ EUPAS34399.
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http://dx.doi.org/10.5603/CJ.a2020.0183DOI Listing
December 2020

Prognostic Impact of Hyponatremia and Hypernatremia in COVID-19 Pneumonia. A HOPE-COVID-19 (Health Outcome Predictive Evaluation for COVID-19) Registry Analysis.

Front Endocrinol (Lausanne) 2020 30;11:599255. Epub 2020 Nov 30.

Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.

Dysnatremia is associated with increased mortality in patients with community-acquired pneumonia. SARS-COV2 (Severe-acute-respiratory syndrome caused by Coronavirus-type 2) pneumonia can be fatal. The aim of this study was to ascertain whether admittance dysnatremia is associated with mortality, sepsis, or intensive therapy (IT) in patients hospitalized with SARS-COV2 pneumonia. This is a retrospective study of the HOPE-COVID-19 registry, with data collected from January 1 through April 31, 2020. We selected all hospitalized adult patients with RT-PCR-confirmed SARS-COV2 pneumonia and a registered admission serum sodium level (SNa). Patients were classified as hyponatremic (SNa <135 mmol/L), eunatremic (SNa 135-145 mmol/L), or hypernatremic (SNa >145 mmol/L). Multivariable analyses were performed to elucidate independent relationships of admission hyponatremia and hypernatremia, with mortality, sepsis, or IT during hospitalization. Four thousand six hundred sixty-four patients were analyzed, median age 66 (52-77), 58% males. Death occurred in 988 (21.2%) patients, sepsis was diagnosed in 551 (12%) and IT in 838 (18.4%). Hyponatremia was present in 957/4,664 (20.5%) patients, and hypernatremia in 174/4,664 (3.7%). Both hyponatremia and hypernatremia were associated with mortality and sepsis. Only hyponatremia was associated with IT. In conclusion, hyponatremia and hypernatremia at admission are factors independently associated with mortality and sepsis in patients hospitalized with SARS-COV2 pneumonia.

Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04334291, NCT04334291.
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http://dx.doi.org/10.3389/fendo.2020.599255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7734292PMC
January 2021

Fractional flow reserve guided versus angiographic guided surgical revascularization: A meta-analysis.

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

Division of Cardiology, Department of Cardiovascular and Thoracic, Città della Salute e della Scienza Hospital and University of Turin, Turin, Italy.

Background: Clinical benefits of FFR (Fraction Flow Reserve) driven CABG (Coronary Artery Bypass Graft) remain to be established.

Methods: All randomized controlled trials (RCTs) and observational studies with multivariable adjustement were included. MACE (Major Adverse Cardiac Events) was the primary end point, while its single components (death, myocardial infarction, and total vessel revascularization [TVR]) along with number of anastomoses, on pump procedures and graft occlusion at angiographic follow-up were the secondary ones. Each analysis was stratified for RCTs versus observational studies.

Results: Four studies (two RCTs and two observational) were included, enrolling 983 patients, 542 angio-guided and 441 FFR-guided. Mean age was 68.45 years, 79% male, with a mean EuroSCORE I of 2.7. Coronary lesions were located in 37% of patients in the left anterior descending artery, 32% in the circumflex artery, and 26% in the right coronary artery. After a mean follow-up of 40 months, risk of MACE did not differ (OR 0.86 [0.63-1.18]) as that of all cause death (OR 0.86 [0.59-1.25]), MI (OR 0.57 [0.30-1.11]) and TVR (OR 1.10 [0.65-1.85]). FFR-driven CABG reduced on-pump procedures (OR 0.58 [0.35-0.93]) and number of anastomoses (-0.40 [-0.80: -0.01]) while incidence of graft occlusion at follow-up did not differ (OR 0.59 [0.30-1.15], all CI 95%).

Conclusion: Fraction flow reserve driven CABG reduced the number of anastomoses and of on-pump procedures without increasing risk of MACE and without reducing graft occlusion at angiographic follow-up. ID CRD42020211945.
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http://dx.doi.org/10.1002/ccd.29427DOI Listing
December 2020

"Predictors of pacemaker implantation after TAVI according to kind of prosthesis and risk profile: a systematic review and contemporary meta-analysis".

Eur Heart J Qual Care Clin Outcomes 2020 Dec 8. Epub 2020 Dec 8.

Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital and University of Turin, Italy.

Background: Permanent pacemaker implantation (PPI) may be required after transcatheter aortic valve implantation (TAVI). Evidence on PPI prediction has largely been gathered from high risk patients receiving first generation valve implants.

Objectives: We undertook a meta-analysis of the existing literature to examine the incidence and predictors of PPI after TAVI according to generation of valve, valve type and surgical risk.

Methods: We made a systematic literature search for studies with ≥100 patients reporting the incidence and adjusted predictors of PPI after TAVI. Subgroup analyses examined these features according to generation of valve, specific valve type and surgical risk.

Results: We obtained data from 43 studies, encompassing 29,113 patients. PPI rates ranged from 6.7% - 39.2% in individual studies with a pooled incidence of 19% (95% CI 16-21). Independent predictors for PPI were age (OR 1.05; 95% CI: 1.01-1.09), left bundle branch block (LBBB) (OR: 1.45; 95% CI: 1.12 to 1.77), right bundle branch block (RBBB) (OR: 4.15; 95% CI: 3.23 to 4.88), implantation depth (OR: 1.18; 95% CI: 1.11 to 1.26) and self-expanding valve prosthesis (OR 2.99; 95% CI: 1.39-4.59). Among subgroups analyzed according to valve type, valve generation and surgical risk, independent predictors were RBBB, self-expanding valve type, first degree atrioventricular block and implantation depth.

Conclusions: The principle independent predictors for PPI following TAVI are age, RBBB, LBBB, self-expanding valve type and valve implantation depth. These characteristics should be taken into account in pre-procedural assessment to reduce PPI rates. PROSPERO ID CRD42020164043.
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http://dx.doi.org/10.1093/ehjqcco/qcaa089DOI Listing
December 2020

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.

Division of Cardiology, A.O.U Città della Salute e della Scienza di Torino Turin, 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

Mortality risk assessment in Spain and Italy, insights of the HOPE COVID-19 registry.

Intern Emerg Med 2020 Nov 9. Epub 2020 Nov 9.

Hospital Clínico San Carlos, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Prof Martin Lagos St., 28040, Madrid, Spain.

Recently the coronavirus disease (COVID-19) outbreak has been declared a pandemic. Despite its aggressive extension and significant morbidity and mortality, risk factors are poorly characterized outside China. We designed a registry, HOPE COVID-19 (NCT04334291), assessing data of 1021 patients discharged (dead or alive) after COVID-19, from 23 hospitals in 4 countries, between 8 February and 1 April. The primary end-point was all-cause mortality aiming to produce a mortality risk score calculator. The median age was 68 years (IQR 52-79), and 59.5% were male. Most frequent comorbidities were hypertension (46.8%) and dyslipidemia (35.8%). A relevant heart or lung disease were depicted in 20%. And renal, neurological, or oncological disease, respectively, were detected in nearly 10%. Most common symptoms were fever, cough, and dyspnea at admission. 311 patients died and 710 were discharged alive. In the death-multivariate analysis, raised as most relevant: age, hypertension, obesity, renal insufficiency, any immunosuppressive disease, 02 saturation < 92% and an elevated C reactive protein (AUC = 0.87; Hosmer-Lemeshow test, p > 0.999; bootstrap-optimist: 0.0018). We provide a simple clinical score to estimate probability of death, dividing patients in four grades (I-IV) of increasing probability. Hydroxychloroquine (79.2%) and antivirals (67.6%) were the specific drugs most commonly used. After a propensity score adjustment, the results suggested a slight improvement in mortality rates (adjusted-OR 0.88; 95% CI 0.81-0.91, p = 0.005; adjusted-OR 0.94; 95% CI 0.87-1.01; p = 0.115). COVID-19 produces important mortality, mostly in patients with comorbidities with respiratory symptoms. Hydroxychloroquine could be associated with survival benefit, but this data need to be confirmed with further trials. Trial Registration: NCT04334291/EUPAS34399.
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http://dx.doi.org/10.1007/s11739-020-02543-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649104PMC
November 2020

Angiographic control versus ischaemia-driven management of patients undergoing percutaneous revascularisation of the unprotected left main coronary artery with second-generation drug-eluting stents: rationale and design of the PULSE trial.

Open Heart 2020 10;7(2)

Department of Medical Sciences, Division of Cardiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.

Background: The role of planned angiographic control (PAC) over a conservative management driven by symptoms and ischaemia following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with second-generation drug-eluting stents remains controversial. PAC may timely detect intrastent restenosis, but it is still unclear if this translated into improved prognosis.

Methods And Analysis: PULSE is a prospective, multicentre, open-label, randomised controlled trial. Consecutive patients treated with PCI on ULM will be included, and after the index revascularisation patients will be randomised to PAC strategy performed with CT coronary after 6 months versus a conservative symptoms and ischaemia-driven follow-up management. Follow-up will be for at least 18 months from randomisation. Major adverse cardiovascular events at 18 months (a composite endpoint including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina, stent thrombosis) will be the primary efficacy outcome. Secondary outcomes will include any unplanned target lesion revascularisation (TLR) and TLR driven by PAC. Safety endpoints embrace worsening of renal failure and bleeding events. A sample size of 550 patients (275 per group) is required to have a 80% chance of detecting, as significant at the 5% level, a 7.5% relative reduction in the primary outcome.

Trial Registration Number: NCT04144881.
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http://dx.doi.org/10.1136/openhrt-2020-001253DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7597506PMC
October 2020

Reduction in heart failure hospitalization rate during coronavirus disease 19 pandemic outbreak.

ESC Heart Fail 2020 Oct 23. Epub 2020 Oct 23.

Department of Clinical, Internal, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, Rome, 00161, Italy.

Aims: The recent coronavirus disease 19 (COVID-19) pandemic outbreak forced the adoption of restraint measures, which modified the hospital admission patterns for several diseases. The aim of the study is to investigate the rate of hospital admissions for heart failure (HF) during the early days of the COVID-19 outbreak in Italy, compared with a corresponding period during the previous year and an earlier period during the same year.

Methods And Results: We performed a retrospective analysis on HF admissions number at eight hospitals in Italy throughout the study period (21 February to 31 March 2020), compared with an inter-year period (21 February to 31 March 2019) and an intra-year period (1 January to 20 February 2020). The primary outcome was the overall rate of hospital admissions for HF. A total of 505 HF patients were included in this survey: 112 during the case period, 201 during intra-year period, and 192 during inter-year period. The mean admission rate during the case period was 2.80 admissions per day, significantly lower compared with intra-year period (3.94 admissions per day; incidence rate ratio, 0.71; 95% confidence interval [CI], 0.56-0.89; P = 0.0037), or with inter-year (4.92 admissions per day; incidence rate ratio, 0.57; 95% confidence interval, 0.45-0.72; P < 0.001). Patients admitted during study period were less frequently admitted in New York Heart Association (NYHA) Class II compared with inter-year period (P = 0.019). At covariance analysis NYHA class was significantly lower in patients admitted during inter-year control period, compared with patients admitted during case period (P = 0.014).

Conclusions: Admissions for HF were significantly reduced during the lockdown due to the COVID-19 pandemic in Italy.
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http://dx.doi.org/10.1002/ehf2.13043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754919PMC
October 2020

COVID-19 pandemic and infarctions: another call to reorganise our healthcare systems.

Heart 2020 12 21;106(23):1786-1787. Epub 2020 Oct 21.

Division of Cardiology, Department of Medical Sciences, Città della Salute e della Scienza, University of Turin, Torino, Italy.

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http://dx.doi.org/10.1136/heartjnl-2020-317981DOI Listing
December 2020

Reply to "Re-intervention for failed surgical aortic bioprosthesis: Remaining questions on long term outcomes and selection of patients".

Int J Cardiol 2021 Mar 11;326:155. Epub 2020 Oct 11.

Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital, University of Turin, Italy.

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http://dx.doi.org/10.1016/j.ijcard.2020.10.023DOI Listing
March 2021

Antecedent Administration of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II Receptor Antagonists and Survival After Hospitalization for COVID-19 Syndrome.

J Am Heart Assoc 2020 11 7;9(22):e017364. Epub 2020 Oct 7.

Baylor University Medical Center Dallas TX.

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) utilizes the angiotensin-converting enzyme-2 (ACE-2) receptor to enter human cells. Angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor antagonists (ARB) are associated with ACE-2 upregulation. We hypothesized that antecedent use of ACEI/ARB may be associated with mortality in coronavirus disease 2019 (COVID-19). Methods and Results We used the Coracle registry, which contains data of patients hospitalized with COVID-19 in 4 regions of Italy, and restricted analyses to those ≥50 years of age. The primary outcome was in-hospital mortality. Among these 781 patients, 133 (17.0%) used an ARB and 171 (21.9%) used an ACEI. While neither sex nor smoking status differed by user groups, patients on ACEI/ARB were older and more likely to have hypertension, diabetes mellitus, and congestive heart failure. The overall mortality rate was 15.1% (118/781) and increased with age (<0.0001). The crude odds ratios (ORs) for death for ACEI users and ARB users were 0.98, 95% CI, 0.60-1.60, =0.9333, and 1.13, 95% CI, 0.67-1.91, =0.6385, respectively. After adjusting for age, hypertension, diabetes mellitus, and congestive heart failure, antecedent ACEI administration was associated with reduced mortality (OR, 0.55; 95% CI, 0.31-0.98, =0.0436); a similar, but weaker trend was observed for ARB administration (OR, 0.58; 95% CI, 0.32-1.07, =0.0796). Conclusions In those aged ≥50 years hospitalized with COVID-19, antecedent use of ACEI was independently associated with reduced risk of inpatient death. Our findings suggest a protective role of renin-angiotensin-aldosterone system inhibition in patients with high cardiovascular risk affected by COVID-19.
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http://dx.doi.org/10.1161/JAHA.120.017364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763715PMC
November 2020

Excess all-cause mortality during COVID-19 outbreak: potential role of untreated cardiovascular disease.

Minerva Cardioangiol 2020 Sep 30. Epub 2020 Sep 30.

Division of Cardiology, Department of Medical Sciences, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has rapidly spread globally. Due to different testing strategies, under-detection of positive subjects and COVID-19-related-deaths remains common. Aim of this analysis was to assess the real impact of COVID-19 through the analysis of 2020 Italian all-cause mortality data compared to historical series.

Methods: We performed a retrospective analysis of 2020 and 2015-2019 all-cause mortality data released by the Italian National Institute for Statistics (ISTAT) for the time period 'January 1 - March 21'. This preliminary sample included 1,084 Italian municipalities showing at least 10 deaths during the above-mentioned timeframe and an increase in mortality of more than 20% as compared to the previous five years (2015-2019), with a resulting coverage of 21% of Italian population. The difference between 2020 observed and expected deaths (mean of weekly deaths in 2015-2019) was computed, together with mortality rate ratio (MRR) for each of the four weeks following detection of the first autochthonous COVID-19 case in Italy (23 February, 2020 - 21 March, 2020), as well as for this entire timeframe. Subgroup analysis by age groups was also performed.

Results: Overall MRR was 1.79 [1.75-1.84], with an observed excess mortality of 8,750 individuals in the investigated sample, which in itself outweighs Italian Civil Protection report of only 4,825 COVID-19-related deaths across Italy, as of March 21. Subgroup analysis did not show any difference in mortality rate in '0-14 years' age group, while MRRs were significantly increased in older age groups, in particular in patients >75 years (MRR 1.84 [1.79-1.89]). In addition, week-by-week analysis showed a progressive increase in MRR during this period, peaking in the last week (15 March, 2020 - 21 March, 2020) with an estimated value of 2.65 [2.53-2.78].

Conclusions: The analysis of all-cause mortality data in Italy indicates that reported COVID-19-related deaths are an underestimate of the actual death toll. All-cause death should be seen as the epidemiological indicator of choice to assess the real mortality impact exerted by SARS-CoV-2, given that it also best reflects the toll on frail patient subsets (eg the elderly or those with cardiovascular disease).
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http://dx.doi.org/10.23736/S0026-4725.20.05349-9DOI Listing
September 2020

Mortality Risk Assessment Using CHA(2)DS(2)-VASc Scores in Patients Hospitalized With Coronavirus Disease 2019 Infection.

Am J Cardiol 2020 12 28;137:111-117. Epub 2020 Sep 28.

Cardiovascular Diseases Unit, Department of Medical Sciences, Le Scotte Hospital, University of Siena, Siena, Italy. Electronic address:

Early risk stratification for complications and death related to Coronavirus disease 2019 (COVID-19) infection is needed. Because many patients with COVID-19 who developed acute respiratory distress syndrome have diffuse alveolar inflammatory damage associated with microvessel thrombosis, we aimed to investigate a common clinical tool, the CHA(2)DS(2)-VASc, to aid in the prognostication of outcomes for COVID-19 patients. We analyzed consecutive patients from the multicenter observational CORACLE registry, which contains data of patients hospitalized for COVID-19 infection in 4 regions of Italy, according to data-driven tertiles of CHA(2)DS(2)-VASc score. The primary outcomes were inpatient death and a composite of inpatient death or invasive ventilation. Of 1045 patients in the registry, 864 (82.7%) had data available to calculate CHA(2)DS(2)-VASc score and were included in the analysis. Of these, 167 (19.3%) died, 123 (14.2%) received invasive ventilation, and 249 (28.8%) had the composite outcome. Stratification by CHA(2)DS(2)-VASc tertiles (T1: ≤1; T2: 2 to 3; T3: ≥4) revealed increases in both death (8.1%, 24.3%, 33.3%, respectively; p <0.001) and the composite end point (18.6%, 31.9%, 43.5%, respectively; p <0.001). The odds ratios for mortality and the composite end point for T2 patients versus T1 CHA(2)DS(2)-VASc score were 3.62 (95% CI:2.29 to 5.73,p <0.001) and 2.04 (95% CI:1.42 to 2.93, p <0.001), respectively. Similarly, the odds ratios for mortality and the composite end point for T3 patients versus T1 were 5.65 (95% CI:3.54 to 9.01, p <0.001) and 3.36 (95% CI:2.30 to 4.90,p <0.001), respectively. In conclusion, among Italian patients hospitalized for COVID-19 infection, the CHA(2)DS(2)-VASc risk score for thromboembolic events enhanced the ability to achieve risk stratification for complications and death.
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http://dx.doi.org/10.1016/j.amjcard.2020.09.029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7521434PMC
December 2020

Health Outcome Predictive Evaluation for COVID 19 international registry (HOPE COVID-19), rationale and design.

Contemp Clin Trials Commun 2020 Dec 23;20:100654. Epub 2020 Sep 23.

Hospital Clínico San Carlos, Madrid, Spain.

The disease produced by the new coronavirus known as SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2), named COVID-19 (Coronavirus Disease-2019) has recently been classified as a pandemic by the World Health Organization (WHO). However, scarce clinical data is available and generally limited to the Chinese population due to the first cases were identified in Wuhan (Hubei, China).This article describes the rationale and design of the HOPE COVID-19 (Health Outcome Predictive Evaluation for COVID 19) registry (ClinicalTrials.gov Identifier: NCT04334291). With an ambispective cohort design, eligible patients are those discharged, deceased or alive, from any hospital center with a confirmed diagnosis or a COVID-19 high suspicion. With a current recruitment of more than 7000 cases, in 46 hospitals in 8 countries, since it is not possible to estimate the sample size based on literature reports, the investigators will try to get the maximum numbers of patients possible. The study primary objective is all cause mortality and aims to characterize the clinical profile of patients infected in order to develop a prognostic clinical score allowing, rapid logistic decision making. As secondary objectives, the analysis of other clinical events, the risk-adjusted influence of treatments and previous comorbidities of patients infected with the disease will be performed.The results of HOPE COVID-19 will contribute to a better understanding of this condition. We aim to describe the management of this condition as well as the outcomes in relation to the therapy chosen, in order to gain insight into improving patient care in the coming months.

Clinical Trial Registration: ClinicalTrials.gov. Unique identifier: NCT04334291.
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http://dx.doi.org/10.1016/j.conctc.2020.100654DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7510540PMC
December 2020

Inpatient Mortality According to Level of Respiratory Support Received for Severe Acute Respiratory Syndrome Coronavirus 2 (Coronavirus Disease 2019) Infection: A Prospective Multicenter Study.

Crit Care Explor 2020 Sep 18;2(9):e0220. Epub 2020 Sep 18.

Baylor Heart and Vascular Institute, Dallas, TX.

Objectives: To describe patients according to the maximum degree of respiratory support received and report their inpatient mortality due to coronavirus disease 2019.

Design: Analysis of patients in the Coracle registry from February 22, 2020, to April 1, 2020.

Setting: Hospitals in the Piedmont, Lombardy, Tuscany, and Lazio regions of Italy.

Patients: Nine-hundred forty-eight patients hospitalized for coronavirus disease 2019.

Interventions: None.

Measurements And Main Results: Among 948 patients, 122 (12.87%) received invasive ventilation, 637 (67.19%) received supplemental oxygen only, and 189 (19.94%) received no respiratory support. The median (quartile 1-quartile 3) age was 65 years (54-76.59 yr), and there was evidence of differential respiratory treatment by decade of life ( = 0.0046); patients greater than 80 years old were generally not intubated. There were 606 men (63.9%) in this study, and they were more likely to receive respiratory support than women ( < 0.0001). The rate of in-hospital death for invasive ventilation recipients was 22.95%, 12.87% for supplemental oxygen recipients, and 7.41% for those who received neither ( = 0.0004). A sensitivity analysis of the 770 patients less than 80 years old revealed a lower, but similar mortality trend (18.02%, 8.10%, 5.23%; = 0.0008) among the 14.42%, 65.71%, and 19.87% of patients treated with mechanical ventilation, supplemental oxygen only, or neither. Overall, invasive ventilation recipients who died were significantly older than those who survived (median age: 68.5 yr [60-81.36 yr] vs 62.5 yr [55.52-71 yr]; = 0.0145).

Conclusions: Among patients hospitalized for coronavirus disease 2019, 13% received mechanical ventilation, which was associated with a mortality rate of 23%.
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http://dx.doi.org/10.1097/CCE.0000000000000220DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505344PMC
September 2020

Short term outcomes of Impella in cardiogenic shock: A review and meta-analysis of observational studies.

Int J Cardiol 2021 Feb 22;324:44-51. Epub 2020 Sep 22.

Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.

Introduction: The clinical impact of invasive hemodynamic support with Impella in patients with cardiogenic shock (CS) remains to be defined.

Method: Only studies including patients treated with Impella in CS were selected. The primary endpoint was short term mortality, while secondary endpoints were major vascular complications and major bleeding.

Results: 17 studies and 3933 patients were included in the analysis. Median age was 61.9 (IQR 59.2-63.5) years, CS was mainly related to acute coronary syndrome (ACS): 79.6% (IQR 75.1-79.6). Thirty-day mortality was 47.8% (CI 43.7-52%). Based on metaregression analysis, the Impella 5.0 (point estimate -0.006, 95% CI -0.01 - - 0.02, p < 0.01) and the Impella CP (point estimate -0.007, 95% CI -0.01 - - 0.03, p < 0.01) devices were related to a higher survival rate, whereas the Impella 2.5 was not. Furthermore, a correlation with reduced mortality was found when Impella was initiated in CS not complicated by cardiac arrest (CA), and before revascularization, (point estimate 0.01, 95% CI 0.002-0.02, p < 0.01 and point estimate -0.02, 95% CI 0.023-0.01, p < 0.001 respectively). The vascular complication and major bleeding rate were 7.4% (95% CI 5.6-9.6%) and 15.2% (95% CI 10.7-21%) respectively, and were associated with older age and comorbidities, while the implantation of an Impella CP/2.5 L was associated with fewer complications.

Conclusions: Despite the use of Impella the 30 day mortality of CS still remains high. Our data suggest that the use of an Impella CP, initiation of Impella prior to PCI and in patients without cardiac arrest was correlated with outcome improvements.
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http://dx.doi.org/10.1016/j.ijcard.2020.09.044DOI Listing
February 2021

Comparison of antithrombotic strategies in patients with cryptogenic stroke and patent foramen ovale: an updated meta-analysis.

Cardiovasc Drugs Ther 2020 Sep 12. Epub 2020 Sep 12.

Stroke Unit and Division of Cardiovascular Medicine, University of Perugia, S. Maria della Misericordia Hospital, Perugia, Italy.

Purpose: Patients with patent foramen ovale (PFO) and cryptogenic ischemic stroke (CS) are at risk for stroke recurrence. The optimal antithrombotic strategy in patients who undergo medical management is still debated.

Methods: We systematically searched the literature for studies that reported on cerebrovascular event recurrences and/or death in patients with PFO treated with oral anticoagulation (OAC) or antiplatelet therapy (APT) for secondary prevention of CS. The efficacy endpoints were stroke recurrence and the composite of stroke, transient ischemic attack or all-cause death. Major bleedings represented the safety endpoint.

Results: A total of 16 studies with 3953 patients (OAC = 1527, APT = 2426) were included. Weighted mean follow-up was 2.9 years. OAC was associated with a significant reduction in the risk of stroke compared with APT (RR 0.65; 95% CI 0.44-0.95; ARR 2%, NNT 49), while no difference was found regarding the composite outcome (RR 0.78; 95% CI 0.57-1.07) and the safety outcome (RR 1.57; 95% CI 0.85-2.90; p = 0.15).

Conclusions: OAC was more effective than APT in reducing the risk of stroke recurrence in patients with PFO and CS, without a significant increase in the risk of major bleedings. Our findings support the need for further randomized data focused on the comparison of antithrombotic strategies in this setting.
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http://dx.doi.org/10.1007/s10557-020-07068-9DOI Listing
September 2020

Usefulness of oral anticoagulation in patients with coronary aneurysms: Insights from the CAAR registry.

Catheter Cardiovasc Interv 2020 Sep 9. Epub 2020 Sep 9.

Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain.

Objectives: To assess the Usefulness of oral anticoagulation therapy (OAT) in patients with coronary artery aneurysm (CAA).

Background: Data on the most adequate antithrombotic CAA management is lacking.

Methods: Patients included in CAAR (Coronary Artery Aneurysm Registry, Clinical Trials.gov: NCT02563626) were selected. Patients were divided in OAT and non-OAT groups, according to anticoagulation status at discharge and 2:1 propensity score matching with replacement was performed. The primary endpoint of the analysis was a composite and mutual exclusive endpoint of myocardial infarction, unstable angina (UA), and aneurysm thrombosis (coronary ischemic endpoint). Net adverse clinical events, major adverse cardiovascular events, their single components, cardiovascular death, re-hospitalizations for heart failure, stroke, aneurysm thrombosis, and bleeding were the secondary ones.

Results: One thousand three hundred thirty-one patients were discharged without OAT and 211 with OAT. In the propensity-matched sample (390 patients in the non-OAT group, 195 patients in the OAT group), after 3 years of median follow-up (interquartile range 1-6 years), the rate of the primary endpoint (coronary ischemic endpoint) was significantly less in the OAT group as compared to non-OAT group (8.7 vs. 17.2%, respectively; p = .01), driven by a significant reduction in UA (4.6 vs. 10%, p < .01) and aneurysm thrombosis (0 vs. 3.1%, p = .03), along with a non-significant reduction in MI (4.1 vs. 7.7%, p = .13). A non-significant increase in bleedings, mainly BARC type 1 (55%), was found in the OAT-group (10.3% in the non-OAT vs. 6.2% in the OAT group, p = .08).

Conclusion: OAT decreases the composite endpoint of UA, myocardial infarction, and aneurysm thrombosis in patients with CAA, despite a non-significant higher risk of bleeding.
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http://dx.doi.org/10.1002/ccd.29243DOI Listing
September 2020

Electrocardiographic and clinical predictors for permanent pacemaker requirement after transcatheter aortic valve implantation: a 10-year single center experience.

J Cardiovasc Surg (Torino) 2020 Sep 4. Epub 2020 Sep 4.

Division of Cardiology, Department of Internal Medicine, University of Turin, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.

Background: Aim of this study is to identify clinical, electrocardiographic (ECG) and procedural predictors for permanent pacemaker (PPM) requirement after transaortic valve implantation (TAVI).

Methods: All consecutive patients with severe symptomatic aortic stenosis (SSAS) undergoing TAVI at our single centre were included in the study and prospectively followed. All patients had standard 12-leads ECGs recordings before and after TAVI and continuous ECG monitoring during hospital stay. Primary endpoint was to identify electrocardiographic predictors of PPM implantation after TAVI; secondary endpoint was to ascertain other clinical or procedure-related predictive factors of PPM need. PPM implantation was further arbitrarily divided into early and late one (beyond the 3rd day).

Results: Among the 431 patients undergoing TAVI between 2008 and 2018, 77 (18%) needed PPM implantation; 47 (11%) had an early procedure, and 30 (7%) a late implant. Pre-operative RBBB implies more than five-fold increase of the risk of PPM implantation (OR 5.19, CI 1.99 - 13.56, P=0.001), whereas the use of a selfexpandable prosthesis is associated with an almost three-fold increase of the risk (OR 2.60, CI 1.28 - 5.28, P=0.008). In the late PPM implantation subgroup, only the history of syncope retains a significant association with such an increased risk (OR 2.71, CI 1.09 - 6.75, P=0.032).

Conclusions: The need of a PPM in the individual TAVI patient is hardly predictable. However, the finding of pre-existing RBBB, the use of self-expandable prosthesis and history of syncope can individuate patients at increased risk.
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http://dx.doi.org/10.23736/S0021-9509.20.11342-9DOI Listing
September 2020