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Firenze, Italy

Tamburino C.,University of Catania | Barbanti M.,University of Catania | D'Errigo P.,National Center for Epidemiology | Ranucci M.,IRCCS Policlinico San Donato | And 8 more authors.
Journal of the American College of Cardiology | Year: 2015

Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials. © 2015 American College of Cardiology Foundation.

Parodi G.,Careggi Hospital | Antoniucci D.,Careggi Hospital
American Heart Journal | Year: 2010

Left ventricular (LV) remodeling has been shown to occur in a relevant proportion of patients with acute myocardial infarction successfully treated with primary percutaneous coronary intervention. The development of LV remodeling after primary percutaneous coronary intervention is associated with increased mortality and with shorter event-free survival. Therapy to prevent or limit LV remodeling is of paramount importance, and it should be started in the early phase of reperfusion. Early identification of patients at risk for LV remodeling may have important prognostic and therapeutic implications. The pathophysiology, time course, and predictors of LV remodeling, as well as the relevant diagnostic techniques and therapeutic interventions evaluated to date, will be discussed. © 2010 Mosby, Inc.

Tamburino C.,Ferrarotto Hospital | Capodanno D.,Ferrarotto Hospital | Ramondo A.,University of Padua | Petronio A.S.,AOU Pisana | And 12 more authors.
Circulation | Year: 2011

Background- There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis. Methods and Results- A total of 663 consecutive patients (mean age 81.0±7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year. Conclusions- Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation2+ mainly impact late outcomes between 30 days and 1 year. © 2011 American Heart Association. All rights reserved.

Migliorini A.,Careggi Hospital | Stabile A.,Ospedale Civico | Rodriguez A.E.,Otamendi Hospital | Gandolfo C.,Ospedale Civico | And 6 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter <2.5 mm. Coprimary end points were early ST-segment resolution and 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990) © 2010 American College of Cardiology Foundation.

Parodi G.,Careggi Hospital | Valenti R.,Careggi Hospital | Migliorini A.,Careggi Hospital | Maehara A.,Columbia University | And 4 more authors.
Circulation: Cardiovascular Interventions | Year: 2013

Background-Manual thrombus aspiration (MTA) is completely ineffective in 30% of cases, and the high profiles of the catheters prevent their use in tortuous and calcified vessels. The rheolytic thrombectomy (RT) device has the potential for improved thrombus removal in acute myocardial infarction as compared with MTA. No data exist on the comparison between the 2 techniques. Methods and Results-Randomized study, including 80 acute myocardial infarction patients allocated to RT or MTA before infarct artery stenting. Primary end point of this study is residual thrombus burden by optical coherence tomography. Secondary end points are (1) residual thrombolysis in myocardial infarction thrombus grade; (2) postintervention thrombolysis in myocardial infarction flow and myocardial blush; (3) early ST-segment resolution; (4) percentage of malapposed stent struts at 6 months; (5) 6-month restenosis; and (6) 6-month major adverse cardiovascular events. All but 1 patient had residual thrombus after manual aspiration thrombectomy or RT. The number of optical coherence tomography quadrants containing thrombus in MTA arm was higher than in the RT arm, but this difference did not reach significance (median value 65 and 53, respectively; P=0.083). Large residual thrombus was more frequently revealed in the manual aspiration thrombectomy arm (patients with number of quadrants above the median value 60% in the manual aspiration thrombectomy arm and 37% in the RT arm, P=0.039). All markers of reperfusion were better in the RT arm. At 6 months, the percentage of malapposed stent struts in the MTA arm was higher than in the RT arm (2.7±4.5% and 0.8±1.6%, respectively; P=0.019). Conclusions-MTA or RT allows only incomplete removal of thrombus in patients with acute myocardial infarction. The primary end point of the study was not met. However, RT as compared with MTA seems to be more effective in thrombus removal and myocardial reperfusion. © 2013 American Heart Association, Inc.

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