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La Mediterranea è in prima linea nel campo della ricerca medica. Molti gli studi scientifici pubblicati sulle maggiori riviste internazionali.

Recenti pubblicazioni scientifiche

Intravenous hydration for the prevention of CIAKI - Nature reviews nephrology

Autori: C. Briguori, G. Signoriello

Intravenous hydration for the
prevention of CIAKI

Iodinated contrast media are essential for diagnostic and interventional
radiological and cardiological procedures, but may cause kidney damage.
Intravenous hydration is the current cornerstone for prevention of
contrast-induced acute kidney injury; however, new data from the AMACING
trial suggest that this approach might not be beneficial in low-risk patients.

Trattato di chirurgia cardiaca, SEU 2016 - Roma

Autori: L. Chiariello

Trattato di chirurgia cardiaca

Bivalirudin or Unfractionated Heparin in Patients with Acute Coronary Syndromes, BMJ Publishing Group Limited

Autori: Leonardi S1, Frigoli E2, Rothenbühler M3, Navarese E4, Calabró P5, Bellotti P6, Briguori C7, Ferlini M1, Cortese B8, Lupi A9, Lerna S10, Zavallonito-Parenti D11, Esposito G12, Tresoldi S13, Zingarelli A14, Rigattieri S15, Palmieri C16, Liso A17, Abate F18, Zimarino M19, Comeglio M20, Gabrielli G21, Chieffo A22, Brugaletta S23, Mauro C24, Van Mieghem NM25, Heg D3, Jüni P26, Windecker S27, Valgimigli M28; MATRIX Investigators.

Bivalirudin or unfractionated heparin in patients with acute coronary syndromes managed invasively with and without ST elevation (MATRIX): randomised controlled trial.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  • 1Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
  • 2EUSTRATEGY Association, Forli’, Italy.
  • 3CTU Bern, University of Bern, Switzerland Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland.
  • 4Policlinico Multimedica IRCSS, University of Milan, Milan, Italy.
  • 5Division of Cardiology, Department of Cardiothoracic Sciences, Second University of Naples, Naples, Italy.
  • 6Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa, Italy.
  • 7Clinica Mediterranea, Napoli, Italy.
  • 8Ospedale Fatebene Fratelli, Milano, Italy.
  • 9University Hospital Maggiore della Carità, Novara, Italy.
  • 10Ospedale Sirai-Carbonia, Carbonia, Italy.
  • 11Humanitas Research Hospital, IRCCS, Rozzano, Italy.
  • 12Division of Cardiology-Department of Advanced Biomedical Sciences, Federico II University of Naples.
  • 13A O Ospedale di Desio, Lombardia, Italy.
  • 14IRCCS San Martino-IST, Genoa, Italy.
  • 15Interventional Cardiology Sandro Pertini Hospital Rome, Italy.
  • 16Ospedale Pasquinucci, Massa, Italy.
  • 17Citta’ di Lecce Hospital, Lecce, Italy.
  • 18Ospedale Giovanni Paolo II, Sciacca, Italy.
  • 19Università degli Studi G d’Annunzio Chieti e Pescara, Chieti, Italy.
  • 20Ospedale San Jacopo, Pistoia, Italy.
  • 21Azienda Ospedali Riuniti-Presidio GM Lancisi, Ancona, Italy.
  • 22Ospedale San Raffaele IRCCS, Milano, Italy.
  • 23Hospital Clinic, Cardiovascular Institute, IDIBAPS, Barcelona, Spain.
  • 24AORN Cardarelli, Napoli, Italy.
  • 25Erasmus MC, Rotterdam, Netherlands.
  • 26Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael’s Hospital, and Department of Medicine, University of Toronto, Canada.
  • 27Swiss Cardiovascular Centre Bern, Bern University Hospital, CH-3010 Bern, Switzerland.
  • 28Swiss Cardiovascular Centre Bern, Bern University Hospital, CH-3010 Bern, Switzerland marco.valgimigli@insel.ch.

Abstract

OBJECTIVE:

To test the optimal antithrombotic regimen in patients with acute coronary syndrome.

DESIGN:

Randomised controlled trial.

SETTING:

Patients with acute coronary syndrome with and without ST segment elevation in 78 centres in Italy, the Netherlands, Spain, and Sweden.

PARTICIPANTS:

7213 patients with acute coronary syndrome and planned percutaneous coronary intervention: 4010 with ST segment elevation and 3203 without ST segment elevation. The primary study results in the overall population have been reported previously.

INTERVENTIONS:

Patients were randomly assigned, in an open label fashion, to one of two regimens: bivalirudin with glycoprotein IIb/IIIa inhibitors restricted to procedural complications or heparin with or without glycoprotein IIb/IIIa inhibitors.

MAIN OUTCOME MEASURES:

Primary endpoints were the occurrence of major adverse cardiovascular events, defined as death, myocardial infarction or stroke; and net adverse clinical events, defined as major bleeding or major adverse cardiovascular events, both assessed at 30 days. Analyses were performed by the principle of intention to treat.

RESULTS:

Use of a glycoprotein IIb/IIIa inhibitor in patients assigned to heparin was planned at baseline in 30.7% of patients with ST segment elevation, in 10.9% without ST segment elevation, and in no patients assigned to bivalirudin. In patients with ST segment elevation, major adverse cardiovascular events occurred in 118 (5.9%) assigned to bivalirudin and 129 (6.5%) assigned to heparin (rate ratio 0.90, 95% confidence interval 0.70 to 1.16; P=0.43), whereas net adverse clinical events occurred in 139 (7.0%) patients assigned to bivalirudin and 163 (8.2%) assigned to heparin (0.84, 0.67 to 1.05; P=0.13). In patients without ST segment elevation, major adverse cardiovascular events occurred in 253 (15.9%) assigned to bivalirudin and 262 (16.4%) assigned to heparin (0.97, 0.80 to 1.17; P=0.74), whereas net adverse clinical events occurred in 262 (16.5%) patients assigned to bivalirudin and 281 (17.6%) assigned to heparin (0.93, 0.77 to 1.12; P=0.43).

CONCLUSIONS:

A bivalirudin monotherapy strategy compared with heparin with or without glycoprotein IIb/IIIa inhibitors, did not result in reduced major adverse cardiovascular events or net adverse clinical events in patients with or without ST segment elevation.Trial Registration ClinicalTrials.gov NCT01433627.

Livanova Perceval Prosthesis to Treat Elderly Frail Patients: Immediate and Short-Term Results - Annals of Cardiovascular Diseases

Autori: Marco Russo1*, Benedetto Del Forno2, Guglielmo Saitto1,Valentina Gislao1, Carlo Bassano1, Antonio Scafuri1, and Luigi Chiariello3

Livanova Perceval Prosthesis to Treat Elderly Frail Patients: Immediate and Short-Term Results

Pubblicato su: Annals of Cardiovascular Diseases
1Cardiac Surgery Division, Tor Vergata University of Rome, Italy
2Department of Cardiac Surgery, IRCCS San Raffaele ScientificInstitute, Italy
3Heart Center, Mediterranean Clinic, Italy
Abstract
Background:
High risk older patients needing surgery for aortic valve stenosis may benefit from low-impact procedures. Suture less prostheses allow a more expedite procedure and might induce better clinical results. Aim of this study was to compare early and short-term clinical performance of Livanova Perceval in a frail patient’s population.
Methods:
From May 2012 to January 2014 twenty one patients (mean age 80.6
± 4.3 years), received a Sorin Perceval S™ (Group 1). Forty three patients treated with conventional AVR were selected as a control group (mean age 79.1 ± 3.3 years) (Group 2). The mean Logistic Euro score was 15.5% ± 7.3 in Group 1 and 14.7% ± 6.1 in Group 2; 14 patients (66%) of Group 1 and 26 patients (60%) of Group 2 were in NYHA functional class III/IV.
Results:
The observed 30 days mortality rate was zero in Group 1 and 9%
in Group 2 (pns). The mean cross-clamp and cardiopulmonary bypass time were significantly lower in Group 1 for isolated AVR (31.3 ± 4.6 vs. 45.6 ± 10.3 minutes p<0.0001 and 45.2 ± 6.6 vs. 59.1 ± 10.6 p<0.0001). In Group 1 there was no evidence of paraprosthesis leak, myocardial infarction or acute kidney injury and the postoperative hospital stay was 7.2 ± 2.4 days. The need of pacemaker implantation was significantly higher in Group 1. At 24 months follow up, the overall survival was
89.1 ± 11% in Group 1 vs. 83.6 ± 16.4% in Group 2 (pns) and freedom from adverse events was 84 ± 16% in Group 1 vs. 65.2 ± 34.8% in Group 2 (pns).
Conclusions:
The Livanova Perceval bioprosthesis seems to be an excellent option
for elderly patients needing aortic valve replacement at increased risk for surgery.
The incidence of early AV block represents the only relevant drawback of this device.

Pectoralis Muscle Flap Repair Reduces Paradoxical Motion of the Chest Wall in Complex Sternal Wound Dehiscence - The Korean Society for Thoracic and Cardiovascular Surger

Autori: Jacob Zeitani, M.D.,1 Marco Russo, M.D.,2 Eugenio Pompeo, M.D.,3 Gian Luigi Sergiacomi, M.D.,4 and Luigi Chiariello, M.D.5

Pectoralis Muscle Flap Repair Reduces Paradoxical Motion of the Chest Wall in Complex Sternal Wound Dehiscence

 Pubblicato su: The Korean Society for Thoracic and Cardiovascular Surger
1Cardiac Surgery Unit, Clinica Mediterranea, Policlinic of Tor Vergata University
2Department of Cardiac Surgery, Policlinic of Tor Vergata University
3Department of Thoracic Surgery, Policlinic of Tor Vergata University
4Department of Diagnostic Images, Policlinic of Tor Vergata University
Corresponding author: Marco Russo, Cardiac Surgery Division, Tor Vergata University of Rome, Policlinico Tor Vergata, Viale Oxford 81, 00133 Rome, Italy, (Tel) 39-3282528248 (Fax) 39-0620903868
5Cardiac Surgery Unit, Clinica Mediterranea, Policlinic of Tor Vergata University – Heart Center Mediterranean Clinica – Italy – Napoli
Abstract

Background

The aim of the study was to test the hypothesis that in patients with chronic complex sternum dehiscence, the use of muscle flap repair minimizes the occurrence of paradoxical motion of the chest wall (CWPM) when compared to sternal rewiring, eventually leading to better respiratory function and clinical outcomes during follow-up.

Methods

In a propensity score matching analysis, out of 94 patients who underwent sternal reconstruction, 20 patients were selected: 10 patients underwent sternal reconstruction with bilateral pectoralis muscle flaps (group 1) and 10 underwent sternal rewiring (group 2). Eligibility criteria included the presence of hemisternum diastases associated with multiple (≥3) bone fractures and radiologic evidence of synchronous chest wall motion (CWSM). We compared radiologically assessed (volumetric computed tomography) ventilatory mechanic indices such as single lung and global vital capacity (VC), diaphragm excursion, synchronous and paradoxical chest wall motion.

Results

Follow-up was 100% complete (mean 85±24 months). CWPM was inversely correlated with single lung VC (Spearman R=−0.72, p=0.0003), global VC (R=−0.51, p=0.02) and diaphragm excursion (R=−0.80, p=0.0003), whereas it proved directly correlated with dyspnea grade (Spearman R=0.51, p=0.02) and pain (R=0.59, p=0.005). Mean CWPM and single lung VC were both better in group 1, whereas there was no difference in CWSM, diaphragm excursion and global VC.

Conclusion

Our study suggests that in patients with complex chronic sternal dehiscence, pectoralis muscle flap reconstruction guarantees lower CWPM and greater single-lung VC when compared with sternal rewiring and it is associated with better clinical outcomes with less pain and dyspnea.

Keywords: Sternum, Wound dehiscence, Cardiac surgical procedures, adverse event
Go to:

Introduction

Sternal wound dehiscence occurs in approximately 0.4% to 5.1% of patients undergoing cardiac surgery [1]. The typical profile of patients undergoing cardiac surgery procedures nowadays explains the persistence of wound healing problems. Patients are older, and they usually present more risk factors, such as diabetes and obesity, that involve a high risk for wound complications. Several surgical techniques have been proposed to treat sternal dehiscence, including rewiring, titanium plates, and sternum reconstruction by mean of muscles or omental flaps [2–6]. When multiple bone fractures occur, a simple rewiring often is not sufficient and sternal reinforcement as proposed by Robicsek et al. [7], or other reinforcement techniques, are required to stabilize the surgical site. The muscle flap procedure is an alternative method for treating wound complications. In a recent series, we have reported that muscle flap reconstruction guarantees better early and long-term results in terms of reduced mortality, procedure failure, and respiratory function with higher lung volumes and lower New York Heart Association (NYHA) class at follow-up (FU) [8].

In complex sternal wound dehiscence, the presence of multiple rib fractures might induce paradoxical chest motion, which might negatively affect both healing of the sternum and ventilatory mechanics [7–9]. A flail segment of the chest wall will have several effects on the respiratory system: inefficient ventilation/negative pressure during inspiration creates a paradoxical movement, but generally, total ventilation is maintained. However, asymmetric motion of the hemisternum can slow wound healing [10]. The role of different surgical approaches in complex sternal dehiscences and in particular the relationship of paradoxical motion of the chest wall and respiratory outcome are poorly investigated in the literature.

In this study we tested the hypothesis that in patients with chronic complex sternum dehiscence, the use of muscle flap repair minimizes the occurrence of paradoxical motion of the chest wall (CWPM) when compared to sternal rewiring, eventually leading to better respiratory function and clinical outcomes.

Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial - Jacc Cardiovascular Interventions

Autori: Ariotti S1, Adamo M2, Costa F2, Patialiakas A3, Briguori C4, Thury A5, Colangelo S6, Campo G7, Tebaldi M7, Ungi I5, Tondi S8, Roffi M9, Menozzi A10, de Cesare N11, Garbo R6, Meliga E12, Testa L13, Gabriel HM14, Ferlini M15, Vranckx P16, Valgimigli M17; ZEUS Investigators.

Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial.

Pubblicato su: Jacc Cardiovascular Interventions

1Swiss Cardiovascular Center Bern, Inselspital, Bern University Hospital, Switzerland; Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.

2Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.

3Cardiology Department, Crete Naval Hospital, Crete, Greece.

4Clinica Mediterranea, Napoli, Italy.

5Cardiology Center, Szeged, Hungary.

6Interventional Cardiology, San Giovanni Bosco Hospital, Torino, Italy.

7Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona, Ferrara, Italy.

8Azienda Unità Sanitaria Locale di Modena-Ospedale Baggiovara, Italy.

9Division of Cardiology, University Hospital, Geneva, Switzerland.

10Interventional Cardiology Unit, Azienda Ospedaliero-Universitaria di Parma, Italy.

11Policlinico S. Marco, Zingonia (Bergamo), Italy.

12Azienda Ospedaliera Ordine Mauriziano, Torino, Italy.

13Interventional Cardiology, Ist. Clinico S. Ambrogio, IRCCS San Donato, Milan, Italy.

14Hospital de Santa Cruz, Carnaxide, Lisbon, Portugal.

15Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

16Virga Jesse Ziekenhuis, Hasselt, Belgium.

17Swiss Cardiovascular Center Bern, Inselspital, Bern University Hospital, Switzerland; Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands. Electronic address: marco.valgimigli@insel.ch.

Abstract

OBJECTIVES:

This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease.

BACKGROUND:

DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns.

METHODS:

The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization.

RESULTS:

Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups.

CONCLUSIONS:

Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

Neutrophil gelatinase-associated lipocalin: a promising biomarker for human acute kidney injury - JACC

Autori: Alan S. Maisel, MDa,b; Nicholas Wettersten, MDb; Dirk J. van Veldhuisen, MDc; Christian Mueller, MDd; Gerasimos Filippatos, MDe; Richard Nowak, MDf; Christopher Hogan, MDg; Michael C. Kontos, MDh; Chad M. Cannon, MDi; Gerhard A. Müller, MD, PhDj; Robert Birkhahn, MDk; Paul Clopton, MSa; Pam Taub, MDb; Gary M. Vilke, MDl; Kenneth McDonald, MDm,n; Niall Mahon, MDn,o; Julio Nuñez, MDp; Carlo Briguori, MD, PhDq; Claudio Passino, MDr; Patrick T. Murray, MDn

Neutrophil Gelatinase-Associated Lipocalin for Acute Kidney Injury During Acute Heart Failure Hospitalizations

 Pubblicato su: JACC
a Division of Cardiovascular Medicine, Veterans Affairs Medical Center, San Diego, La Jolla, California
b Division of Cardiovascular Medicine, University of California, San Diego, La Jolla, California
c Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
d Department of Cardiology, University Hospital Basel, Basel, Switzerland
e Department of Cardiology, Athens University Hospital Attikon, University of Athens, Athens, Greece
f Department of Emergency Medicine, Henry Ford Hospital System, Detroit, Michigan
g Division of Emergency Medicine and Acute Care Surgical Services, VCU Medical Center, Virginia Commonwealth University, Richmond, Virginia
h Division of Cardiology, VCU Medical Center, Virginia Commonwealth University, Richmond, Virginia
i Department of Emergency Medicine, University of Kansas Hospital, Kansas City, Kansas
j Department of Nephrology and Rheumatology, University Medical Center Göttingen, University of Göttingen, Göttingen, Germany
k Department of Emergency Medicine, New York Methodist, Brooklyn, New York
l Departement of Emergency Medicine, University of California, San Diego, La Jolla, California
m Department of Cardiology, St. Vincent’s University Hospital, Dublin, Ireland
n Department of Nephrology, Mater Misericordaie University Hospital, University College Dublin, Dublin, Ireland
o Department of Cardiology, Mater Misericordaie University Hospital, Dublin, Ireland
p Department of Cardiology, Hospital Clínico Universitario Valencia, University of Valencia, Valencia, Spain
q Department of Cardiology, Clinica Mediterranea, Naples, Italy
r Department of Cardiology and Cardiovascular Medicine, Fondazione Gabriele Monasterio, Pisa, Italy
Abstract

Background  Worsening renal function (WRF) often occurs during acute heart failure (AHF) and can portend adverse outcomes; therefore, early identification may help mitigate risk. Neutrophil gelatinase-associated lipocalin (NGAL) is a novel renal biomarker that may predict WRF in certain disorders, but its value in AHF is unknown.

Objectives  This study sought to determine whether NGAL is superior to creatinine for prediction and/or prognosis of WRF in hospitalized patients with AHF treated with intravenous diuretic agents.

Methods  This was a multicenter, prospective cohort study enrolling patients presenting with AHF requiring intravenous diuretic agents. The primary outcome was whether plasma NGAL could predict the development of WRF, defined as a sustained increase in plasma creatinine of 0.5 mg/dl or ≥50% above first value or initiation of acute renal-replacement therapy, within the first 5 days of hospitalization. The main secondary outcome was in-hospital adverse events.

Results  We enrolled 927 subjects (mean age, 68.5 years; 62% men). The primary outcome occurred in 72 subjects (7.8%). Peak NGAL was more predictive than the first NGAL, but neither added significant diagnostic utility over the first creatinine (areas under the curve: 0.656, 0.647, and 0.652, respectively). There were 235 adverse events in 144 subjects. The first NGAL was a better predictor than peak NGAL, but similar to the first creatinine (areas under the curve: 0.691, 0.653, and 0.686, respectively). In a post hoc analysis of subjects with an estimated glomerular filtration rate <60 ml/min/1.73 m2, a first NGAL <150 ng/ml indicated a low likelihood of adverse events.

Conclusions  Plasma NGAL was not superior to creatinine for the prediction of WRF or adverse in-hospital outcomes. The use of plasma NGAL to diagnose acute kidney injury in AHF cannot be recommended at this time. (Acute Kidney Injury Neutrophil Gelatinase-Associated Lipocalin [N-GAL] Evaluation of Symptomatic Heart Failure Study [AKINESIS]; NCT01291836)

The Renal Guard System for the Prevention of Contrast-Induced Acute Kidney Injury - Journal of kidney

Autori: Cristina Quintavalle1, Chiara Sordelli2, Giovanni Napolitano3, Gerolama Condorelli1 and Carlo Briguori2*

The Renal Guard System for the Prevention of Contrast-Induced Acute Kidney Injury

Pubblicato su: Journal of kidney

 

 

1Department of Molecular Medicine and Medical Biotechnologies, “Federico II” University of Naples, and IEOS, CNR Naples, Italy

2Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy

3University of Cardiology, Hospital San Giuliano, Naples, Italy

*Corresponding Author:
Carlo Briguori MD, PhD
Interventional Cardiology
Clinica Mediterranea
Via Orazio 2, Naples
I-80121, Italy
Tel: 39081/7259764
Fax: 39081/7259777
E-mail: carlobriguori@clinicamediterranea.it
Abstract

Contrast-induced acute kidney injury (CI-AKI) accounts for approximately 10% of all causes of hospital-acquired renal failure, causes a prolonged in-hospital stay and represents a strong predictor of poor early and late outcome. A general consensus exists on the beneficial prophylactic effect of hydration The Renal Guard system (PLC Medical System, Inc. Franklin, MA, USA) has been developed to facilitate optimal hydration therapy. This device allows to achieve high urine flow rate (≥ 300 ml/h) while simultaneously balancing urine output and venous fluid infusion to prevent hypovolemia. Some studies have shown that the Renal Guard system is more effective than the conventional hydration regimen in preventing CI-AKI. A recent study suggests that the best threshold for CI-AKI prevention is a mean intraprocedural urine flow rate ≥ 450 ml/h.

Keywords

Iodinated contrast media; Nephrotoxicity; Prevention; Antioxidant

Introduction

In the last decades percutaneous coronary, peripheral and valvular procedures have substantially increased. The administration of iodinated contrast media (CM) is essential for all these procedures. Although usually well tolerated; CM may induce acute kidney injury (AKI). CM-induced AKI (CI-AKI) has become the third cause for hospital-acquired renal failure with a prolongation of the hospital stay and consequently an increase of health costs1. Beyond that, patients developing CI-AKI are at higher risk of both a further deterioration of kidney function and an unfavorable clinical outcome. The most common clinical definitions of CI-AKI are based on the increase in serum creatininelevels ≥ 25% and ≥ 0.5 mg/dl from the baseline value at 48 hours after CM administration or the need for dialysis. Different strategies have been proposed to prevent this complication. In this review we discuss on the potential advantages of the Renal Guard system to prevent CI-AKI.

ConclusionAKI may complicate CM exposure. The Renal Guard system seems to be helpful in preventing CIAKI by allowing a high UFR and maintaining an optimal fluid balance.

RenalGuard System for the prevention of acute kidney injury in patients undergoing transcatheter aortic valve implantation - Journal of Kidney

Autori: Visconti G1, Focaccio A, Donahue M, Golia B, Marzano A, Donnarumma E, Ricciardelli B, Selvetella L, Marino L, Briguori C.

The Renal Guard System for the Prevention of Contrast-Induced Acute Kidney Injury

Pubblicato su: Journal of Kidney

 

 

1Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.

Abstract

AIMS:

We aimed to assess whether the RenalGuard™ System is effective in preventing acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI).

METHODS AND RESULTS:

Forty-eight consecutive patients with chronic kidney disease (CKD) scheduled for TAVI were assigned to: 1) hydration with sodium bicarbonate solution (Control group), or 2) hydration with RenalGuard Therapy (RenalGuard group). Hypotension was defined as periprocedural mean blood pressure <55 mmHg. The primary endpoint was the occurrence of AKI (i.e., an increase of ≥0.3 mg/dL in the serum creatinine concentration at seven days). AKI occurred in 10/26 (38.5%) patients in the Control group and in 1/22 (4.5%) patients in the RenalGuard group (p=0.005, odds ratio [OR] 0.076, 95% confidence interval [CI]: 0.009-0.66). RenalGuard Therapy protected against AKI (OR 0.71, 95% CI: 0.07-0.775, p=0.026), whereas post-procedural hypotension (OR 3.88, 95% CI: 1.06-14.24, p=0.040), and contrast media volume (OR 3.65, 95% CI: 1.15-5.75, p=0.043) increased the risk of AKI.

CONCLUSIONS:

This non-randomised pilot study suggests that RenalGuard Therapy may be effective in preventing AKI in CKD patients undergoing TAVI.

RenalGuard system in high-risk patients for contrast-induced acute kidney injury - American Heart Journal

Autori: Briguori C1, Visconti G2, Donahue M2, De Micco F2, Focaccio A2, Golia B2, Signoriello G3, Ciardiello C4, Donnarumma E5, Condorelli G6.

RenalGuard system in high-risk patients for contrast-induced acute kidney injury.

Pubblicato su: American Heart Journal

 

 

1Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy. Electronic address: carlobriguori@clinicamediterranea.it.

2Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.

3Department of Mental Health and Preventive Medicine, Second University of Naples, Naples, Italy.

4HT MED, Pozzuoli, Naples, Italy.

5IRCCS SDN, Naples, Italy.

6Department of Cellular and Molecular Biology and Pathology, “Federico II” University of Naples, Naples, Italy.

Abstract

BACKGROUND:

High urine flow rate (UFR) has been suggested as a target for effective prevention of contrast-induced acute kidney injury (CI-AKI). The RenalGuard therapy (saline infusion plus furosemide controlled by the RenalGuard system) facilitates the achievement of this target.

METHODS:

Four hundred consecutive patients with an estimated glomerular filtration rate ≤30 mL/min per 1.73 m(2) and/or a high predicted risk (according to the Mehran score ≥11 and/or the Gurm score >7%) treated by the RenalGuard therapy were analyzed. The primary end points were (1) the relationship between CI-AKI and UFR during preprocedural, intraprocedural, and postprocedural phases of the RenalGuard therapy and (2) the rate of acute pulmonary edema and impairment in electrolytes balance.

RESULTS:

Urine flow rate was significantly lower in the patients with CI-AKI in the preprocedural phase (208 ± 117 vs 283 ± 160 mL/h, P < .001) and in the intraprocedural phase (389 ± 198 vs 483 ± 225 mL/h, P = .009). The best threshold for CI-AKI prevention was a mean intraprocedural phase UFR ≥450 mL/h (area under curve 0.62, P = .009, sensitivity 80%, specificity 46%). Performance of percutaneous coronary intervention (hazard ratio [HR] 4.13, 95% CI 1.81-9.10, P < .001), the intraprocedural phase UFR <450 mL/h (HR 2.27, 95% CI 1.05-2.01, P = .012), and total furosemide dose >0.32 mg/kg (HR 5.03, 95% CI 2.33-10.87, P < .001) were independent predictors of CI-AKI. Pulmonary edema occurred in 4 patients (1%). Potassium replacement was required in 16 patients (4%). No patients developed severe hypomagnesemia, hyponatremia, or hypernatremia.

CONCLUSIONS:

RenalGuard therapy is safe and effective in reaching high UFR. Mean intraprocedural UFR ≥450 mL/h should be the target for optimal CI-AKI prevention.

Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial - Cardiovascular Drugs and Therapy

Autori: Briguori C1, Madonna R2, Zimarino M2, Calabrò P3, Quintavalle C4, Salomone M5,6, Condorelli G4, De Caterina R7.

Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty – the Remedy Trial.

 Pubblicato su: Cardiovascular Drugs and Therapy

 

 

1Clinica Mediterranea, Naples, Italy.

2Institute of Cardiology and Center of Excellence on Aging, “G. d’Annunzio” University – Chieti, C/o Ospedale SS. Annunziata, Via dei Vestini, 66013, Chieti, Italy.

3Department of Cardiothoracic Sciences, Monaldi Hospital, Second University of Naples, Naples, Italy.

4Department of Molecular Medicine and Medical Biotechnologies, “Federico II” University of Naples, Naples, Italy.

5Dimensione Ricerca, Milan, Italy.

6ES Health Science Foundation, Lugo, Italy.

7Institute of Cardiology and Center of Excellence on Aging, “G. d’Annunzio” University – Chieti, C/o Ospedale SS. Annunziata, Via dei Vestini, 66013, Chieti, Italy. rdecater@unich.it.

Abstract

BACKGROUND:

Periprocedural myocardial infarction (MI) is a frequent complication of percutaneous coronary intervention (PCI). Statins might reduce its incidence. The aims of the present study are to assess whether such benefit is a class-effect or whether differences exist between various lipid-lowering strategies and whether cardioprotection is exerted by increasing circulating endothelial progenitor cells (EPCs).

METHODS:

The REMEDY study will enroll a total of 1080 patients submitted to elective PCI. Eligible patients will be randomized into 4 groups: 1) placebo; 2) atorvastatin (80 mg + 40 mg before PCI); 3) rosuvastatin (40 mg twice before PCI); and 4) rosuvastatin (5 mg) and ezetimibe (10 mg) twice before PCI. Peri-procedural MI is defined as an elevation of markers of cardiac injury (either CK-MB or troponin I or T) values >5x the upper reference limit estimated at the 99th percentile of the normal distribution, or a rise >20 % in case of baseline values already elevated. EPCs will be assessed before, at 24 h and – in a subset of diabetic patients – at 3 months after PCI (EPC-substudies). The primary endpoint of the main REMEDY study is the rate of peri-procedural MI in each of the 4 treatment arms. Secondary endpoints are the combined occurrence of 1-month major adverse events (MACE, including death, MI, or the need for unplanned revascularization); and any post-procedural increase in serum creatinine. Endpoints of the EPC-substudies are the impact of tested regimens on 1) early (24-h) and 3-month EPC levels and functional activity; 2) stent strut re-endothelialization and neointimal hyperplasia; 3) 1-year MACE. REMEDY will add important information on the cardioprotective effects of statins after PCI.

Coronary artery bifurcation narrowing treated by Axxess stent implantation: The CARINAX registry - Pubmed

Autori: Briguori C1, Donahue M1, Visconti G1, Focaccio A1, Pennacchi M2, Lucisano L2, Stio R2, Mancone M2, Calcagno S2, Di Palma V1, Labalestra N1, Signoriello G3, Sardella G2.

RenalGuard system in high-risk patients for contrast-induced acute kidney injury.

 Pubblicato su: Pubmed

 

 

1Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.

2Department of Cardiovascular, Respiratory, Nephrologic, Anesthesiologic and Geriatric Sciences, Policlinico Umberto I, “Sapienza” University of Rome.

3Department Mental Health and Preventive Medicine, Second University of Naples, Italy.

Abstract

OBJECTIVES:

To compare the safety and efficacy of the Axxess™ biolimus-eluting stent with the second-generation drug-eluting stent (DES) in the treatment of bifurcation lesions.

BACKGROUND:

The Axxess™ is a dedicated bifurcation stent, designed to cover the lesion at the carina level.

METHODS:

Between April 2012 and August 2014, 165 patients with de novo bifurcation lesions were treated with the Axxess™ stent (Axxess group). A propensity-score matched group of 165 patients treated with DES in the same period was selected (Control group). The primary objectives were (1) the procedural complication rate, including side branch (SB) occlusion and trouble in SB access after main vessel stenting; and (2) the device, the angiographic, and the procedural success rate.

RESULTS:

Procedural complications occurred in 1 patient (0.6%) in the Axxess group and in 20 patients (12%) in the Control group (OR = 0.03; 95% confidence interval 0.005-0.27; P < 0.001). Device success was obtained in 164 (99.5%) patients in the Axxess group and in all in the Control group (P = 1.00). Angiographic success was obtained in all patients. Inaccurate Axxess™ stent position occurred in 21 (13%) patients, and was more often associated with moderate-to-severe calcifications and distal lesion site. Procedural success was obtained in 91.5% patients in the Axxess group and in 90% patients in the Control group (P = 0.72).

CONCLUSIONS:

The present registry suggests that the Axxess™ stent (1) may represent a valid alternative approach for the treatment of bifurcation lesions and (2) should be avoided in moderate-to-severe calcifications and/or in distal lesions. © 2016 Wiley Periodicals, Inc.

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