Publications by authors named "Giuseppe Biondi-Zoccai"

845 Publications

The operation of carotid endarterectomy: is it an effective method of treatment of arterial hypertension?

Panminerva Med 2022 Jun 28. Epub 2022 Jun 28.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University, Rome, Italy.

Aim: To establish the relationship between AH and hemodynamically significant atherosclerotic stenosis of carotid bifurcation and study the effect of carotid endarterectomy (CEA) on the course of AH.

Materials And Methods: In our investigation we included 320 patients: 243 (75,9%) men and 77 (24,1%), the mean age - 59,6 ± 8,2. All patients underwent CEA operation. Patients were divided into groups: I (320) - before CEA surgery and AH; II (320) - the same patients after CEA operation. All patients underwent laboratory tests, ECG, chest X-ray, ultrasound of the kidneys, thyroid gland, computer tomography (CT) of adrenal glands, of the brain, echocardiography, ultrasound or angiography of the renal arteries. Before and after the CEA, there were made Doppler ultrasound of brachiocephalic arteries, 24 hours blood pressure (BP) monitoring. Additional visits were made by 73 patients in 3, 6 and 12 months after the CEA.

Results: Most of the patients had significant decrease of BP in the postoperative period, which was observed in 257 (80,3%) patients on days 2-7, in 58 (18,1%) - did not change significantly, and only 5 (1,6%) had the increasing of BP. In 29 (39,7%) patients 1 year after CEA, there was no need to use antihypertensive therapy due for the normalization of BP after the surgery.

Conclusions: It is necessary to highlight the cerebrovascular AH into a separate form of the secondary AH. The CEA has prominent, stable anti-hypertensive effect on these patients.
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http://dx.doi.org/10.23736/S0031-0808.21.04608-5DOI Listing
June 2022

Emergency department cardiovascular disease encounters and associated mortality in patients with cancer: A study of 20.6 million records from the USA.

Int J Cardiol 2022 Jun 22. Epub 2022 Jun 22.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Keele University, UK; Department of Cardiology, Thomas Jefferson University Philadelphia, PA, USA; Institute of Population Health, University of Manchester, UK. Electronic address:

Background: there is limited data on Emergency department (ED) cardiovascular disease (CVD) presentations and outcomes amongst cancer patients.

Objectives: The present study aimed to describe the clinical characteristics, prevalence, and clinical outcomes of the most common cardiovascular ED admissions in patients with cancer.

Methods: All ED encounters with a primary CVD diagnosis from the US Nationwide Emergency Department Sample between January 2016 to December 2018 were stratified by cancer type as well as metastatic status. Multivariable logistic regression was performed to determine the adjusted odds ratios of in-hospital mortality in different groups.

Results: From a total of 20,737,247 ED encounters with a primary CVD diagnosis, cancer was present in 3.4%. In patients with cancer the most common CVDs were DVT/PE (20%), hypertensive heart or kidney disease (14.7%), and AF/flutter (11.2%). The distribution of CVDs varied by cancer type, with AF/flutter most common in patients with lung cancer, AMI most common in patients with prostate cancer, heart failure most common in those with haematological malignancies, and patients with colorectal cancer having the greatest frequency of DVT/PE. Cancer status was independently associated with significantly higher risk of mortality in almost all CVD categories, consistent across all the cancer types, amongst which lung cancer patients had the highest risk of mortality across all CVD categories, except intracranial haemorrhage and hypertensive crisis.

Conclusions: Cardiovascular presentations to the ED varied by cancer subtype. Across all cancer subtypes, patients presenting with cardiovascular presentations carried a significantly increased risk of mortality compared to patients with no cancer.
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http://dx.doi.org/10.1016/j.ijcard.2022.06.053DOI Listing
June 2022

Progressive stages of dysmetabolism are associated with impaired biological features of human cardiac stromal cells mediated by the oxidative state and autophagy.

J Pathol 2022 Jun 25. Epub 2022 Jun 25.

Department of Medical Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy.

Cardiac stromal cells (CSCs) are the main players in fibrosis. Dysmetabolic conditions (metabolic syndrome - MetS, and type 2 diabetes - DM2) are strong pathogenetic contributors to cardiac fibrosis. Moreover, modulation of the oxidative state (OxSt) and autophagy is a fundamental function affecting the fibrotic commitment of CSCs, that are adversely modulated in MetS/DM2. We aimed to characterize CSCs from dysmetabolic patients, and to obtain a beneficial phenotypic setback from such fibrotic commitment by modulation of OxSt and autophagy. CSCs were isolated from 38 patients, stratified as MetS, DM2, or controls. Pharmacological modulation of OxSt and autophagy was obtained by treatment with trehalose and NOX4/NOX5 inhibitors (TREiNOX). Flow-cytometry and RT-qPCR analyses showed significantly increased expression of myofibroblasts markers in MetS-CSCs at baseline (GATA4, ACTA2, THY1/CD90) and after starvation (COL1A1, COL3A1). MetS- and DM2-CSCs displayed a paracrine profile distinct from control cells, as evidenced by heatmap analysis of 30 secreted cytokines, with significant reduction in VEGF and endoglin confirmed by ELISA. DM2-CSCs showed significantly reduced support to endothelial cells in angiogenic assays, and significantly increased H O release and NOX4/5 expression levels. Autophagy impairment after starvation (reduced ATG7 and LC3-II proteins) was also detectable in DM2-CSCs. TREiNOX treatment significantly reduced ACTA2, COL1A1, COL3A1, and NOX4 expression in both DM2- and MetS-CSCs, as well as GATA4 and THY1/CD90 in DM2, all versus control cells. Moreover, TREiNOX significantly increased VEGF release by DM2-CSCs, and VEGF and endoglin release by both MetS- and DM2-CSCs, also recovering the angiogenic support to endothelial cells by DM2-CSCs. In conclusion, DM2 and MetS worsen microenvironmental conditioning by CSCs. Appropriate modulation of autophagy and OxSt in human CSCs appears to restore these features, mostly in DM2-CSCs, suggesting a novel strategy against cardiac fibrosis in dysmetabolic patients. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1002/path.5985DOI Listing
June 2022

Air pollution and cardiovascular risk: is it time to change guidelines?

Open Heart 2022 Jun;9(1)

UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Latina, Lazio, Italy.

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http://dx.doi.org/10.1136/openhrt-2022-001961DOI Listing
June 2022

Cardiovascular meta-analyses: fool's gold or gold for fools?

Eur Heart J 2022 Jun 17. Epub 2022 Jun 17.

Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA, USA.

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http://dx.doi.org/10.1093/eurheartj/ehac312DOI Listing
June 2022

Individualised prognosis in out-of-hospital cardiac arrest: The case for P-ROSC in Asian people.

EClinicalMedicine 2022 Jun 12;48:101446. Epub 2022 May 12.

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, Latina 04100, Italy.

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http://dx.doi.org/10.1016/j.eclinm.2022.101446DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112103PMC
June 2022

Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.

J Transl Med 2022 Jun 15;20(1):270. Epub 2022 Jun 15.

Pauley Heart Center, Department of Internal Medicine, Virginia Commonwealth University, Pauley Heart Center, Richmond, VA, USA.

Background: Heart failure (HF) is a global leading cause of mortality despite implementation of guideline directed therapy which warrants a need for novel treatment strategies. Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.

Method: We designed a single center, randomized, placebo controlled, double-blind phase II randomized clinical trial. One hundred and two adult patients hospitalized within 2 weeks of discharge due to acute decompensated HF with reduced ejection fraction (HFrEF) and systemic inflammation (high sensitivity of C-reactive protein > 2 mg/L) will be randomized in 2:1 ratio to receive anakinra or placebo for 24 weeks. The primary objective is to determine the effect of anakinra on peak oxygen consumption (VO) measured at cardiopulmonary exercise testing (CPX) after 24 weeks of treatment, with placebo-corrected changes in peak VO at CPX after 24 weeks (or longest available follow up). Secondary exploratory endpoints will assess the effects of anakinra on additional CPX parameters, structural and functional echocardiographic data, noninvasive hemodynamic, quality of life questionnaires, biomarkers, and HF outcomes.

Discussion: The current trial will assess the effects of IL-1 blockade with anakinra for 24 weeks on cardiorespiratory fitness in patients with recent hospitalization due to acute decompensated HFrEF.

Trial Registration: The trial was registered prospectively with ClinicalTrials.gov on Jan 8, 2019, identifier NCT03797001.
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http://dx.doi.org/10.1186/s12967-022-03466-9DOI Listing
June 2022

Is Smoking Cessation the Best Intervention Ever to Prevent Heart Failure?

J Am Coll Cardiol 2022 Jun;79(23):2306-2309

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; IRCCS NEUROMED, Pozzilli, Italy.

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http://dx.doi.org/10.1016/j.jacc.2022.04.006DOI Listing
June 2022

Percutaneous vs surgical axillary access for transcatheter aortic valve implantation: the TAXI registry.

Panminerva Med 2022 May 30. Epub 2022 May 30.

Clinica Montevergine, GVM Care & Research, Mercogliano, Italy.

Background: Transcatheter aortic valve implantation (TAVI) is an established management strategy for severe aortic valve stenosis. Percutaneous axillary approach for TAVI holds the promise of improving safety without jeopardizing effectiveness in comparison to surgical access. We aimed at appraising the comparative effectiveness of percutaneous vs surgical axillary approaches for TAVI.

Methods: We performed an international retrospective observational study using de-identified details on baseline, procedural, and 1-month follow-up features. Valve Academic Research Consortium (VARC)-3 criteria were applied throughout. Outcomes of interest were clinical events up to 1 month of follow-up, compared with unadjusted and propensity score-adjusted analyses.

Results: A total of 432 patients were included, 189 (43.8%) receiving surgical access, and 243 (56.2%) undergoing percutaneous access. Primary hemostasis failure was more common in the percutaneous group (13.2% vs 4.2%, p<0.001), leading to more common use of covered stent implantation (13.2% vs 3.7%, p<0.001). Irrespectively, percutaneous access was associated with shorter hospital stay (-2.6 days [95% confidence interval: -5.0; -0.1], p=0.038), a lower risk of major adverse events (a composite of death, myocardial infarction, stroke, type 3 bleeding, and major access-site related complication; odds ratio=0.44 [0.21; 0.95], p=0.036), major access-site non-vascular complications (odds ratio=0.21 [0.06; 0.77], p=0.018), and brachial plexus impairment (odds ratio=0.16 [0.03; 0.76], p=0.021), and shorter hospital stay (-2.6 days [-5.0; -0.1], p=0.038).

Conclusions: Percutaneous axillary access provides similar or better results than surgical access in patients undergoing TAVI with absolute or relative contraindications to femoral access.
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http://dx.doi.org/10.23736/S0031-0808.22.04750-4DOI Listing
May 2022

The relationship between mortality and daily number of steps in type 2 diabetes.

Panminerva Med 2022 May 30. Epub 2022 May 30.

Research and Development Department SCOR, Paris, France -

Background: Physical activity (PA) is an established modifiable factor for the prevention of cardiovascular disease. Our objective was to assess the association of PA with mortality rates in a national sample of patients with diabetes.

Methods: We analyzed a nationally representative sample from The National Health and Nutrition Examination Survey (NHANES, periods 2003-2004 and 2005-2006) that used Physical Activity Monitors. Individuals were matched for BMI, number of steps/ per day and age. Three groups were created: subjects with less than 5000/steps per day (low), 5000-7500/steps per day (moderate) and more than 7500/steps per day (high levels of physical activity). All-cause mortality was ascertained through December 2015.

Results: A sample of 3,072 individuals (1018 with diabetes) was analyzed. Patients with diabetes had 30% increased risk of mortality of all causes (RR: 1,298, 95% CI [1,162-1,451], p< 0,001), Higher levels of physical activity (> 7500 steps/day) provided similar relative risk for subjects with diabetes compared to their controls [RR:1,256 (95% CI 0,910-1,732)]. In a Poisson model adjusted for sex, history of previous cardiovascular event or cancer, ethnicity, Hb1ac, SBP, and total cholesterol to HDL ratio, patients with diabetes and moderate or high PA had an associated 44% to 80% lower risk of all-cause mortality compared to those with low PA.

Conclusions: The subgroup of patients with diabetes and high PA had no excess of mortality compared to the general population. PA can reduce the gap for all-cause mortality, used as an index of cardiovascular fitness and a clinical tool for the assessment of mortality risk.
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http://dx.doi.org/10.23736/S0031-0808.22.04732-2DOI Listing
May 2022

Juvenile myocardial infarction: Sex matters.

Int J Cardiol 2022 Aug 23;361:18-19. Epub 2022 May 23.

Cardiovascular Interventional Operative Unit, Presidio Ospedaliero Pineta Grande, Castel Volturno, Caserta, Italy; Operative Unit of Hemodynamics, Casa di Salute Santa Lucia, San Giuseppe Vesuviano, Naples, Italy.

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http://dx.doi.org/10.1016/j.ijcard.2022.05.046DOI Listing
August 2022

De-escalation of dual antiplatelet therapy: will we ever get to the right method?

J Cardiovasc Pharmacol 2022 May 16. Epub 2022 May 16.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

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http://dx.doi.org/10.1097/FJC.0000000000001304DOI Listing
May 2022

Impact of pre-existing vascular disease on clinical outcomes in patients with non-ST-segment myocardial infarction: a nationwide cohort study.

Eur Heart J Qual Care Clin Outcomes 2022 May 16. Epub 2022 May 16.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, United Kingdom (UK).

Aims: Little is known about the outcomes and processes of care of patients with non ST-segment myocardial infarction (NSTEMI) who present with 'polyvascular' disease.

Methods And Results: We analysed 287,279 NSTEMI patients using the Myocardial Infarction National Audit Project (MINAP) registry. Clinical characteristics and outcomes were analysed according to history of affected vascular bed; coronary artery disease (CAD), cerebrovascular disease (CeVD) and peripheral vascular disease (PVD), with comparison to a historically disease-free control group; comprising 167,947 patients (59%). After adjusting for demographics and management, polyvascular disease was associated with increased likelihood of major adverse cardiovascular events (MACE) (CAD OR: 1.06, 95% CI: 1.01-1.12, P = 0.02) (CeVD OR: 1.19, 95% CI: 1.12-1.27, P<0.001) (PVD OR: 1.22, 95% CI: 1.13-1.33, P<0.001) and in-hospital mortality (CeVD OR: 1.24, 95% CI: 1.16-1.32, P<0.001) (PVD OR: 1.33, 95% CI: 1.21-1.46, P<0.001). Patients without vascular disease were less frequently discharged on statins (PVD 88%, CeVD 86%, CAD 90% and control 78%), and those with moderate (ejection fraction (EF) 30-49%) or severe left ventricular systolic dysfunction (LVSD) (EF<30%), were less frequently discharged on angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) (CAD 82%, CeVD 77%, PVD 77%, control 74%). Patients with polyvascular disease were less likely to be discharged on dual antiplatelet therapy (DAPT) (PVD 78%, CeVD 77%, CAD 80%, control 87%).

Conclusion: Polyvascular disease patients had a higher incidence of in-hospital mortality and MACE. Patients with no history of vascular disease were less likely to receive statins or ACE inhibitors/ARBs, but more likely to receive DAPT.
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http://dx.doi.org/10.1093/ehjqcco/qcac026DOI Listing
May 2022

Transcatheter aortic valve implantation with the novel-generation Navitor device: Procedural and early outcomes.

Catheter Cardiovasc Interv 2022 May 12. Epub 2022 May 12.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.
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http://dx.doi.org/10.1002/ccd.30179DOI Listing
May 2022

Transcatheter Aortic Valve Replacement for Mixed Aortic Valve Disease: A Propensity Score-Adjusted Analysis From the RISPEVA Registry.

J Invasive Cardiol 2022 Jun 6;34(6):E419-E427. Epub 2022 May 6.

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Piazza G. Cesare 11, Bari, Italy.

Background: The differential outcomes between pure/predominant aortic stenosis (AS) and mixed aortic valve disease (MAVD) in patients undergoing transcatheter aortic valve implantation (TAVI) are still debated.

Objective: To evaluate the comparative clinical outcomes of patients with MAVD and AS undergoing TAVI using data from the RISPEVA registry.

Methods: A total of 3263 patients were included. Of the 3263 patients, 656 with concomitant moderate/severe aortic regurgitation constituted the MAVD group and 2607 constituted the AS cohort. Primary endpoints were 30-day mortality and 1-year survival. Postprocedural paravalvular regurgitation (PPVR), cerebrovascular events, bleeding, and vascular complications were assessed at 30 days.

Results: In the overall population, 30-day mortality in the MAVD group was higher than in AS patients (4.3% vs 2.6%;P=.02); however, no differences were detected after propensity-score matching (4.1% vs 3.5%; P=.62). One-year survival was comparable between MAVD and AS patients in both unmatched and matched cohorts. Left ventricular ejection fraction, pulmonary artery systolic pressure, and PPVR, but not baseline MAVD, were predictors of 30-day mortality. The incidence of PPVR was higher in the MAVD group vs the AS group; this difference was not confirmed in patients implanted with a balloon-expandable device.

Conclusion: MAVD per se did not negatively affect patients' prognoses, but appears to identify a more complex cohort of patients with a worse clinical and functional status, probably referred to TAVI in a later stage of the disease. Patients with MAVD had a greater propensity to develop PPVR, which is a known predictor of worse outcome; this tendency seems to be mitigated by the implantation of balloon-expandable valves.
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June 2022

TAVI-CT score to evaluate the anatomic risk in patients undergoing transcatheter aortic valve implantation.

Sci Rep 2022 05 9;12(1):7612. Epub 2022 May 9.

Unità Operativa di Interventistica Cardiovascolare, Pineta Grande Hospital, Castel Volturno, Italy.

Transcatheter aortic valve implantation (TAVI) requires thorough preprocedural planning with non-invasive imaging, including computed tomography (CT). The plethora of details obtained with thoraco-abdominal CT represents a challenge for accurate and synthetic decision-making. We devised and tested a comprehensive score suitable to summarize CT exams when planning TAVI. An original comprehensive scoring system (TAVI-CT score) was devised, including details on cardiac, aortic, iliac and femoral artery features. The score was applied to a prospectively collected series of patients undergoing TAVI at our institution, driving decision making on access and prosthesis choice. Different TAVI-CT score groups were compared in terms of procedural success, acute complications, and early clinical outcomes. We included a total of 200 undergoing TAVI between February 2020 and May 2021, with 74 (37.0%) having a low (0-2) TAVI-CT score, 50 (25.0%) having a moderate (3) TAVI-CT score, and 76 (38.0%) having a high (≥ 4) TAVI-CT score. Male gender was the only non-CT variable significantly associated with the TAVI-CT score (p = 0.001). As expected, access choice differed significantly across TAVI-CT scores (p = 0.009), as was device choice, with Portico more favored and Allegra less favored in the highest TAVI-CT score group (p = 0.036). Acute outcomes were similar in the 3 groups, including device and procedural success rates (respectively p = 0.717 and p = 1). One-month follow-up showed similar rates of death, myocardial infarction, stroke, and bleeding, as well as of a composite safety endpoint (all p > 0.05). However, vascular complications were significantly more common in the highest TAVI-CT score group (p = 0.041). The TAVI-CT score is a simple scoring system that could be routinely applied to CT imaging for TAVI planning, if the present hypothesis-generating findings are confirmed in larger prospective studies.
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http://dx.doi.org/10.1038/s41598-022-11788-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9085825PMC
May 2022

Challenges of redo cardiac surgery: forewarned is forearmed?

J Cardiovasc Med (Hagerstown) 2022 05;23(5):335-337

IRCCS NEUROMED, Pozzilli.

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http://dx.doi.org/10.2459/JCM.0000000000001315DOI Listing
May 2022

Heart Failure After ST-Elevation Myocardial Infarction: Beyond Left Ventricular Adverse Remodeling.

Curr Probl Cardiol 2022 Apr 20:101215. Epub 2022 Apr 20.

Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, USA. Electronic address:

ST-segment elevation myocardial infarction (STEMI) remains a significant source of morbidity and mortality worldwide. Despite advances in treatment leading to a significant reduction in the early complications and in-hospital mortality, a significant proportion of STEMI survivors develop heart failure (HF) at follow-up. The classic paradigm of HF after STEMI is one characterized by left ventricular adverse remodeling (LVAR) and encompasses the process of regional and global structural and functional changes that occur in the heart as a consequence of loss of viable myocardium, increased wall stress and neurohormonal activation, and results in HF with reduced ejection fraction (HFrEF). More recently, however, with further improvements in the treatment of STEMI the incidence and entity of LVAR appear to be largely reduced, yet the risk for HF following STEMI is not abolished and remains substantial, identifying a new paradigm by which patients with STEMI present with HF and preserved EF (HFpEF) characterized by reduction of diastolic or systolic reserve independent of LVAR.
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http://dx.doi.org/10.1016/j.cpcardiol.2022.101215DOI Listing
April 2022

Severe infrarenal aortic neck angulation alone may not be a predictor of adverse outcomes in the medium term following endovascular aortic aneurysm repair.

J Cardiovasc Surg (Torino) 2022 04;63(2):237-239

Department of Vascular and Endovascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK -

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http://dx.doi.org/10.23736/S0021-9509.21.11997-4DOI Listing
April 2022

Sodium-Glucose Cotransporter Inhibitors Reduce Mortality and Morbidity in Patients With Heart Failure: Evidence From a Meta-Analysis of Randomized Trials.

Am J Ther 2021 Nov 24;29(2):e199-e204. Epub 2021 Nov 24.

Department of Medicine, Center for Integrated Research and Unit of Drug Sciences, University Campus Bio-Medico, Rome, Italy.

Background: Recent trials demonstrated the clinical efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients with heart failure (HF), regardless of the presence or absence of type 2 diabetes. These data may allow the use of this innovative drug class in clinical routine for treating these patients.

Study Question: We aimed at further clarifying the role of SGLT2i in patients with diagnosis of HF, capitalizing on pooled sample size and heightened power for clinically relevant safety and efficacy outcomes.

Data Sources: We conducted a systematic search of PubMed, reference lists of relevant articles, and Medline database from inception until March 1, 2021.

Study Design: This meta-analysis was completed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched for randomized trials that evaluated the cardiovascular effects of SGLT2i in patients with HF. Three investigators independently assessed study eligibility, extracted the data, and assessed risk of bias. Hazard ratios and 95% confidence intervals (CIs) were pooled and meta-analyzed using a random-effect model. Numbers needed to treat (NNT) with the relative 95% CIs were also calculated. The primary outcome was a composite of HF hospitalization or an urgent visit for worsening HF and cardiovascular death.

Results: Three trials were included in the study. Overall, treatment with SGLT2i was associated with a lower risk of the primary composite outcome [hazard ratios 0.73, 95% CI (0.67-0.80), NNT = 11.3]. Similarly, there was a significantly reduced risk of cardiovascular death, all-cause death, HF hospitalization and need for urgent treatment for HF, and HF hospitalization.

Conclusions: Therefore, the available evidence supports the routine use of these drugs as standard-of-care, also given the highly favorable NNTs.
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http://dx.doi.org/10.1097/MJT.0000000000001452DOI Listing
November 2021

Impact of the Gastrointestinal Tract Microbiota on Cardiovascular Health and Pathophysiology.

J Cardiovasc Pharmacol 2022 Apr 6. Epub 2022 Apr 6.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 79, 04100 Latina, Italy.

Abstract: The microbiota of the gastrointestinal tract (GIT) is an extremely diverse community of microorganisms, and their collective genomes (microbiome) provide a vast arsenal of biological activities, in particular enzymatic ones, which are far from being fully elucidated. The study of the microbiota (and the microbiome) is receiving great interest from the biomedical community as it carries the potential to improve risk-prediction models, refine primary and secondary prevention efforts, and also design more appropriate and personalized therapies, including pharmacological ones. A growing body of evidence, though sometimes impaired by the limited number of subjects involved in the studies, suggests that GIT dysbiosis, i.e. the altered microbial composition, has an important role in causing and/or worsening cardiovascular disease (CVD). Bacterial translocation as well as the alteration of levels of microbe-derived metabolites can thus be important to monitor and modulate, because they may lead to initiation and progression of CVD, as well as to its establishment as chronic state. We hereby aim to provide readers with details on available resources and experimental approaches that are used in this fascinating field of biomedical research, and on some novelties on the impact of GIT microbiota on CVD.
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http://dx.doi.org/10.1097/FJC.0000000000001273DOI Listing
April 2022

Comparison of Different Stenting Techniques in Left Main Bifurcation Disease: Evidence From a Network Meta-Analysis.

J Invasive Cardiol 2022 04;34(4):E334-E342

Department of Cardiology, Hartcentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp, Belgium.

Objectives: We aimed to assess which bifurcation technique performs best in unprotected left-main (LM) percutaneous coronary intervention (PCI).

Background: Provisional stenting was considered the preferred technique for LM bifurcation PCI due to the supposed lower risks of thrombosis and restenosis. However, recent studies showed potential advantages of double kissing (DK)-crush technique over the other strategies.

Methods: We performed a frequentist network meta-analysis comparing different stenting techniques in the setting of LM bifurcation. PubMed, Embase, the Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov were searched. Both randomized clinical trials and non-randomized clinical trials were considered eligible for inclusion. Incidence rate ratios (IRRs) were computed using a random-effects model for death, cardiac death, myocardial infarction, target-vessel revascularization, target-lesion revascularization, and stent thrombosis, including 95% confidence intervals (CIs).

Results: A total of 10 studies (2364 patients) were included. Compared with provisional stenting, DK-crush was associated with fewer cardiac deaths (IRR, 0.34; 95% CI, 0.17-0.70; P<.01), myocardial infarctions (IRR, 0.19; 95% CI, 0.08-0.44; P<.001), stent thromboses (IRR, 0.31; 95% CI, 0.14-0.69; P<.01), target-vessel revascularizations (IRR, 0.25; 95% CI, 0.14-0.46; P<.001), and target-lesion revascularizations (IRR, 0.25; 95% CI, 0.14-0.46; P<.001). DK-crush was also associated with a lower risk of myocardial infarction (IRR, 0.19; 95% CI, 0.05-0.76; P=.02) when compared with standard crush and lower risk of target-lesion revascularization when compared with culotte (IRR, 0.32; 95% CI, 0.12-0.83; P=.02) and crush (IRR, 0.07; 95% CI, 0.02-0.28; P<.001).

Conclusions: DK-crush is the best technique for unprotected LM bifurcation PCI.
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April 2022

Alex Plus Versus Xience Drug-Eluting Stents for Percutaneous Coronary Intervention in Routine Clinical Practice: A Propensity Score-Matched Analysis.

J Invasive Cardiol 2022 04;34(4):E319-E325

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.

Background: The next iteration of drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) has focused on bioresorbable polymers and thin struts. The Alex Plus DES is a new-generation sirolimus-eluting device with 70-μm cobalt chromium struts, a 5-μm bioresorbable polymer and a very small profile. Despite such favorable features, limited data are available to estimate the risk-benefit profile of Alex Plus. We aimed at comparing the effectiveness of Alex Plus in real-world practice.

Methods: Retrospective clinical data on patients treated with Alex Plus at our institutions were collected and clinical outcome data over follow-up were obtained, comparing them with those of subjects receiving Xience, a leading DES with permanent polymer.

Results: A total of 100 patients (126 lesions) treated with Alex Plus and 753 subjects (1020 lesions) receiving Xience were included. Baseline and procedural features were largely similar in the 2 groups, with the notable exception of age, sex, and left circumflex coronary artery as the target vessel. Clinical follow-up showed that patients with Alex Plus had a significantly higher risk of major adverse clinical event (MACE), mainly driven by an excess in repeat PCI (hazard ratio, 4.81; 95% confidence interval, 2.83-8.20; P<.001). Even after propensity-score matching, Alex Plus was associated with an increased risk of MACE (P<.001).

Conclusions: Our clinical experience to date with Alex Plus has been disappointing, despite the favorable promises. Further improvements are likely needed in the Alex Plus DES, most likely in drug delivery, before this device is considered for routine clinical use in complex patients or lesions.
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April 2022

Cardiovascular scholarly challenges following the Russian invasion of Ukraine.

Minerva Cardiol Angiol 2022 Mar 28. Epub 2022 Mar 28.

Keele Cardiac Research Group, Keele University, Stoke-on-Trent, UK.

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http://dx.doi.org/10.23736/S2724-5683.22.06102-6DOI Listing
March 2022

Transcatheter aortic valve implantation in patients with age ≤70 years: experience from two leading structural heart disease centers.

Minerva Cardiol Angiol 2022 Mar 25. Epub 2022 Mar 25.

Department of Cardiac Surgery and Heart Transplantation, San Camillo Forlanini Hospital, Rome, Italy.

Background: Transcatheter aortic valve implantation (TAVI) is emerging a an appealing management strategy for patients with severe aortic stenosis at intermediate, high or exceedingly high risk, but its risk-benefit profile in younger patients is less certain. We aimed at exploring the outlook of patients aged 70 years or less and undergoing TAVI at 2 high-volume Italian institituions.

Methods: We retrospectively collected baseline, imaging, procedural and outcome features of patients with age ≤70 years in whom TAVI was attempted at participating centers between 2012 and 2021. Non-parametric tests and bootstrap resampling were used for inferential purposes.

Results: A total of 39 patients were included, out of >3,000 screened with heart team involvement and >1,500 receiving TAVI. Most common or relevant indications for TAVI were reduced life expectancy (eg cardiogenic shock or severe left ventricular systolic dysfunction), chronic obstructive pulmonary disease, morbid obesity, active or recent extra-cardiac cancer, porcelain aorta, neurologic disability, cirrhosis, or prior surgical aortic valve replacement, as well as extreme cachexia, and Hutchinson-Gilford progeria. At least two contemporary high-risk features were present in most cases. Transapical access was used in 5 (12.8%) cases, and a sheathless approach in 15 (38.5%). A variety of devices were used, including both balloon- and selfexpandable devices. Clinical outcomes were satisfactory, despite the high risk profile, at both shortand mid-term, with no in-hospital death, and 5.1% (95% confidence interval 0-12.8%) mortality at a median follow-up of 15 months (minimum 1; maximum 85). Notably, no case of significant valve deterioration requiring reintervention occurred.

Conclusions: In carefully selected patients with 70 years or less of age and prohibitive risk for surgery or reduced life expectancy, TAVI represents a safe option with a favorable mid-term survival and low rate of adverse events.
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http://dx.doi.org/10.23736/S2724-5683.22.06040-9DOI Listing
March 2022

A systematic review and meta-analysis of percutaneous coronary intervention compared to coronary artery bypass grafting in non-ST-elevation acute coronary syndrome.

Sci Rep 2022 03 24;12(1):5138. Epub 2022 Mar 24.

Department of Cardiothoracic Surgery, Friedrich-Schiller-University Jena, 101 Erlanger Allee, 07747, Jena, Germany.

Non-ST-elevation acute coronary syndrome (NSTE-ACS) affects millions of patients. Although an invasive strategy can improve survival, the optimal treatment [i.e., percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)] is not clear. We performed a meta-analysis of studies reporting outcomes between PCI and CABG in patients with NSTE-ACS. MEDLINE, EMBASE and Cochrane Library were assessed. The primary outcome was long-term mortality. Inverse variance method and random model were performed. We identified 13 observational studies (48,891 patients). No significant difference was found in the primary endpoint [CABG vs. PCI, incidence rate ratio (IRR) 0.93, 95% confidence interval (CI) 0.70; 1.23]. CABG was associated with lower long-term major adverse cardiovascular events (MACE) (IRR 0.64, 95% CI 0.54; 0.76) and lower long-term re-revascularization (IRR 0.37, 95% CI 0.30; 0.47). There was no significant difference in long-term myocardial infarction (CABG vs. PCI, IRR 0.96, 95% CI 0.50; 1.84) and peri-operative mortality (CABG vs. PCI, odds ratio 1.36, 95% CI 0.94; 1.95). For the treatment of NSTE-ACS, CABG and PCI are associated with similar rates of long-term mortality and myocardial infarction. CABG is associated with lower rates of long-term MACE and re-revascularization. Randomized comparisons in this setting are necessary.
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http://dx.doi.org/10.1038/s41598-022-09158-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8948200PMC
March 2022

Impact of weather and pollution on the rate of cerebrovascular events in a large metropolitan area.

Panminerva Med 2022 Mar;64(1):17-23

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University, Latina, Italy -

Background: Despite mounting evidence, there is uncertainty on the impact of the interplay between weather and pollution features on the risk of acute cerebrovascular events (CVE). We aimed at appraising role of weather and pollution on the daily risk of CVE.

Methods: Anonymized data from a hub CVE center in a large metropolitan area were collected and analyzed according to weather (temperature, pressure, humidity, and rainfall) and pollution (carbon monoxide [CO], nitrogen dioxide [NO2], nitrogen oxides [NOX], ozone [O3], and particulate matter [PM]) on the same and the preceding days. Poisson regression and time series analyses were used to appraise the association between environmental features and daily CVE, distinguishing also several subtypes of events.

Results: We included a total of 2534 days, with 1363 days having ≥1 CVE, from 2012 to 2017. Average daily rate was 1.56 (95% confidence interval: 1.49; 1.63) for CVE, with other event rates ranging between 1.42 for stroke and 0.01 for ruptured intracranial aneurysm. Significant associations were found between CVE and temperature, pressure, CO, NO2, NOX, O3, and PM <10 µm (all P<0.05), whereas less stringent associations were found for humidity, rainfall, and PM <2.5 µm. Time series analysis exploring lag suggested that associations were stronger at same-day analysis (lag 0), but even environmental features predating several days or weeks were significantly associated with events. Multivariable analysis suggested that CO (point estimate 1.362 [1.011; 1.836], P=0.042) and NO2 (1.011 [1.005; 1.016], P<0.001) were the strongest independent predictors of CVE.

Conclusions: Environmental features are significantly associated with CVE, even several days before the actual event. Levels of CO and NO2 can be potentially leveraged for population-level interventions to reduce the burden of CVE.
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http://dx.doi.org/10.23736/S0031-0808.21.04525-0DOI Listing
March 2022

Postinfarction Ventricular Septal Rupture: Identification of the Failure Mechanism of a Percutaneous Closure Procedure.

JACC Case Rep 2022 Mar 2;4(5):255-261. Epub 2022 Mar 2.

Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy.

Ventricular septal rupture (VSR) is a rare but highly lethal (∼60%) mechanical complication of myocardial infarction (MI). Although surgical repair has been the gold standard to correct the structural anomaly, percutaneous closure of the defect may represent a valuable therapeutic alternative, with the advantage of immediate shunt reduction to prevent further hemodynamic deterioration in patients with prohibitive surgical risk. Nonetheless, catheter-based VSR closure has faced certain drawbacks that have hampered its application. We describe a clinical case of postinfarction VSR treated with a percutaneous closure device and discuss the procedure's failure mechanism. ().
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http://dx.doi.org/10.1016/j.jaccas.2021.09.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8897053PMC
March 2022
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