Search

Objective To evaluate outcomes of monitored anesthesia care (MAC) compared with general anesthesia (GA) in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). Design Secondary analysis from the observational and prospective OBSERVANT (OBservational Study of Effectiveness of avR–taVi procedures for severe Aortic steNosis Treatment) study. Setting Multicenter study, including Italian hospitals performing TAVR interventions. Participants One thousand four hundred ninety-four patients with severe and symptomatic aortic stenosis. Interventions Transfemoral TAVR under general or local anesthesia. Measurements and Main Results A propensity score procedure was applied, and 310 pairs were matched with similar baseline characteristics (EuroSCORE II: local anesthesia 6.6±5.9% v general anesthesia 7.0±7.7%, p = 0.430). MAC was associated with similar 30-day mortality compared with GA (3.9% v 4.8%, p = 0.564). TAVR was performed under MAC without any increased risk of other adverse events. The risk of paravalvular regurgitation≥mild was similar between the study groups (MAC 49.5% v general anesthesia 57.0%, p = 0.858). Two patients receiving on MAC had severe paravalvular regurgitation, whereas this complication was not observed after GA. Permanent pacemaker implantation was 19.1% in the MAC group v 14.8% in the GA group (p = 0.168). Mean intensive care unit stay was 3.5 days for the GA group v 2.9 days for the MAC group (p = 0.086). A similar 3-year survival rate was observed (MAC 69.4% v GA 69.9%, p = 0.966). Conclusions Transfemoral TAVR can be performed under MAC with similar immediate and late outcomes as compared with GA. A possible risk of severe paravalvular regurgitation and pacemaker implantation with TAVR under MAC requires further investigation.

Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both 'sutured' and 'sutureless' valves) will provide a 'real-world' picture of available results of current surgical options and will help to clarify the 'grey zones' of current guidelines. Introduction Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both 'sutured' and 'sutureless' valves) will provide a 'real-world' picture of available results of current surgical options and will help to clarify the 'grey zones' of current guidelines.Methods and analysis European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing 'early' 30-day all-cause and cardiovascular mortality, as well as major morbidity, and 'late' cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.Ethics and dissemination The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship.

Aims: No data exists on inter-institutional differences in terms of adherence to international guidelines regarding the discontinuation of antithrombotics and rates of severe bleeding in coronary artery bypass grafting (CABG). Methods and results: This is an analysis of 7118 patients from the prospective multicentre European CABG (E-CABG) registry who underwent isolated CABG in 15 European centres. Preoperative pause of P2Y12 receptor antagonists shorter than that suggested by the 2017 ESC guidelines (overall 11.6%) ranged from 0.7% to 24.8% between centres (adjusted P

Background: Patients with increased glycated hemoglobin (HbA1c) seem to be at increased risk of sternal wound infection (SWI) after coronary artery bypass grafting (CABG). However, it is unclear whether increased baseline HbA1c levels may affect other postoperative outcomes. Material and methods: Data on preoperative levels of HbA1c were collected from 2606 patients undergoing elective isolated CABG from 2015 to 2016 and included in the prospective, multicenter E-CABG registry. Results: The prevalence of HbA1c ≥ 53 mmol/mol (7.0%) among non-diabetics was 5.3%, among non-insulin dependent diabetics was 53.5% and among insulin dependent diabetics was 67.1% (p 75 mmol/mol (9.0%) among non-diabetics was 0.5%, among non-insulin dependent diabetics was 5.8% and among insulin dependent diabetics was 10.6% (p

Background: The evidence of the benefits of using venoarterial extracorporeal membrane oxygenation (VA-ECMO) after coronary artery bypass grafting (CABG) is scarce. Methods: We analyzed the outcomes of patients who received VA-ECMO therapy due to cardiac or respiratory failure after isolated CABG in 12 centers between 2005 and 2016. Patients treated preoperatively with ECMO were excluded from this study. Results: VA-ECMO was employed in 148 patients after CABG for median of 5.0 days (mean, 6.4, SD 5.6 days). In-hospital mortality was 64.2%. Pooled in-hospital mortality was 65.9% without significant heterogeneity between the centers (I2 8.6%). The proportion of VA-ECMO in each center did not affect in-hospital mortality (p = 0.861). No patients underwent heart transplantation and six patients received a left ventricular assist device. Logistic regression showed that creatinine clearance (p = 0.004, OR 0.98, 95% CI 0.97–0.99), pulmonary disease (p = 0.018, OR 4.42, 95% CI 1.29–15.15) and pre-VA-ECMO blood lactate (p = 0.015, OR 1.10, 95% CI 1.02–1.18) were independent baseline predictors of in-hospital mortality. One-, 2-, and 3-year survival was 31.0%, 27.9%, and 26.1%, respectively. Conclusions: One third of patients with need for VA-ECMO after CABG survive to discharge. In view of the burden of resources associated with VA-ECMO treatment and the limited number of patients surviving to discharge, further studies are needed to identify patients who may benefit the most from this treatment.

Background— The proven efficacy of transcatheter aortic valve implantation (TAVI) in high-risk patients is leading to the expansion of its indications toward lower-risk patients. However, this shift is not supported by meaningful evidence of its benefit over surgical aortic valve replacement (SAVR). This analysis aims to describe outcomes of TAVI versus SAVR in low-risk patients. Methods and Results— We compared the outcome after TAVI and SAVR of low-risk patients (European System for Cardiac Operative Risk Evaluation II [EuroSCORE II] P =0.82). Cardiac tamponade, permanent pacemaker implantation, major vascular damage, and moderate-to-severe paravalvular regurgitation were significantly more frequent after TAVI compared with SAVR. Stroke rates were equal in the study groups. SAVR was associated with higher risk of cardiogenic shock, severe bleeding, and acute kidney injury. At 3 years, survival was 83.4% after SAVR and 72.0% after TAVI ( P =0.0015), whereas freedom from major adverse cardiac and cerebrovascular events was 80.9% after SAVR and 67.3% after TAVI ( P Conclusions— In patients with low operative risk, significantly better 3-year survival and freedom from major adverse cardiac and cerebrovascular events were observed after SAVR compared with TAVI. Further studies on new-generation valve prostheses are necessary before expanding indications of TAVI toward lower-risk patients.

Background There are scarce data on outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with renal failure. Methods We evaluated the impact of renal failure on outcomes after TAVI and SAVR and compared the results of these procedures in patients with chronic kidney disease stages 3b to 5 from the Observational Study of Effectiveness of AVR-TAVI Procedures for Severe Aortic Stenosis Treatment (OBSERVANT) study. Results Chronic kidney disease (CKD) stages 3b to 5 was associated with an increased risk of mortality after either TAVI or SAVR compared with CKD stages 1 to 3a. Among 170 propensity score–matched pairs with CKD stages 3b to 5, patients who underwent TAVI had a significantly higher rate of permanent pacemaker implantation, vascular damage, and mild to moderate paravalvular regurgitation, and tended to have a higher 30-day mortality (7.1% versus 2.9%; p = 0.09). Thirty-day mortality after transapical TAVI was 7.1%. SAVR had a significantly higher rate of blood transfusions, stroke, and acute kidney injury. At 2 years, patients undergoing TAVI had somewhat higher all-cause mortality (31.2% versus 23.4%; p = 0.118), major cardiac and cerebrovascular events (37.2% versus 31.0%; p = 0.270), and a lower risk of dialysis (12.4% versus 21.2%; p = 0.052) compared with SAVR. Conclusions CKD stages 3b to 5 increases the risk of mortality after TAVI and SAVR. In this subset of patients, SAVR was associated with somewhat better early and late survival. The risk of acute kidney injury was higher after SAVR. These findings suggest that CKD stages 3b to 5 does not contraindicate SAVR. Strategies to prevent severe acute kidney injury should be implemented with either SAVR or TAVI.

The aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p0.0001), and paravalvular leak (8.9% vs 2.4%; p0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality.

A few studies recently reported controversial results with transfemoral transcatheter aortic valve replacement (TF-TAVR) versus transapical transcatheter aortic valve replacement (TA-TAVR), often without adequate adjusted analysis for baseline differences. Data on patients who underwent TF-TAVR and TA-TAVR from the Observational Study of Effectiveness of avR-tavI procedures for severe Aortic stenosis Treatment study were analyzed with propensity score 1-to-1 matching. From a cohort of 1,654 patients (1,419 patients underwent TF-TAVR and 235 patients underwent TA-TAVR), propensity score matching resulted in 199 pairs of patients with similar operative risk (EuroSCORE II: TF-TAVR 8.1 ± 7.1% vs TA-TAVR, 8.4 ± 7.3%, p = 0.713). Thirty-day mortality was 8.0% after TA-TAVR and 4.0% after TF-TAVR (p = 0.102). Postoperative rates of stroke (TA-TAVR, 2.0% vs TF-TAVR 1.0%, p = 0.414), cardiac tamponade (TA-TAVR, 4.1% vs TF-TAVR 1.5%, p = 0.131), permanent pacemaker implantation (TA-TAVR, 8.7% vs TF-TAVR 13.3%, p = 0.414), and infection (TA-TAVR, 6.7% vs TF-TAVR 3.6%, p = 0.180) were similar in the study groups but with an overall trend in favor of TF-TAVR. Higher rates of major vascular damage (7.2% vs 1.0%, p = 0.003) and moderate-to-severe paravalvular regurgitation (7.8% vs 5.2%, p = 0.008) were observed after TF-TAVR. On the contrary, TA-TAVR was associated with higher rates of red blood cell transfusion (50.0% vs 30.4%, p = 0.0002) and acute kidney injury (stages 1 to 3: 44.4% vs 21.9%, p

AGILE is an Italian Space Agency mission dedicated to the observation of the gamma-ray Universe. The AGILE very innovative instrumentation combines for the first time a gamma-ray imager (sensitive in the energy range 30 MeV - 50 GeV), a hard X-ray imager (sensitive in the range 18-60 keV) together with a Calorimeter (sensitive in the range 300 keV - 100 MeV) and an anticoincidence system. AGILE was successfully launched on April 23, 2007 from the Indian base of Sriharikota and was inserted in an equatorial orbit with a very low particle background. AGILE provides crucial data for the study of Active Galactic Nuclei, Gamma-Ray Bursts, pulsars, unidentified gamma-ray sources, Galactic compact objects, supernova remnants, TeV sources, and fundamental physics by microsecond timing. An optimal angular resolution (reaching 0.1-0.2 degrees in gamma-rays, 1-2 arcminutes in hard X-rays) and very large fields of view (2.5 sr and 1 sr, respectively) are obtained by the use of Silicon detectors integrated in a very compact instrument. The paper describes the AGILE Mission and its space and ground segments., 20 pages, 26 figures. submitted to Astron. & Astrophys

Risk stratification tools used in patients with severe aortic stenosis have been mostly derived from surgical series. Although specific predictors of early mortality with transcatheter aortic valve replacement (TAVR) have been identified, the prognostic impact of their combination is unexplored. We sought to develop a simple score, using preprocedural variables, for prediction of 30-day mortality after TAVR. A total of 1,878 patients from a national multicenter registry who underwent TAVR were randomly assigned in a 2:1 manner to development and validation data sets. Baseline characteristics of the 1,256 patients in the development data set were considered as candidate univariate predictors of 30-day mortality. A bootstrap multivariate logistic regression process was used to select correlates of 30-day mortality that were subsequently weighted and integrated into a scoring system. Seven variables were weighted proportionally to their respective odds ratios for 30-day mortality (glomerular filtration rate45 ml/min [6 points], critical preoperative state [5 points], New York Heart Association class IV [4 points], pulmonary hypertension [4 points], diabetes mellitus [4 points], previous balloon aortic valvuloplasty [3 points], and left ventricular ejection fraction40% [3 points]). The model showed good discrimination in both the development and validation data sets (C statistics 0.73 and 0.71, respectively). Compared with the logistic European System for Cardiac Operative Risk Evaluation in the validation data set, the model showed better discrimination (C statistic 0.71 vs 0.66), goodness of fit (Hosmer-Lemeshow p value 0.81 vs 0.00), and global accuracy (Brier score 0.054 vs 0.073). In conclusion, the risk of 30-day mortality after TAVR may be estimated by combining 7 baseline clinical variables into a simple risk scoring system.

ObjectiveDespite demonstration of the superior outcomes of transcatheter aortic valve implantation (TAVI) versus optimal medical therapy for severe left ventricular systolic dysfunction, studies comparing TAVI and surgical aortic valve replacement (AVR) in this high-risk group have been lacking.MethodsWe performed propensity matching for age, gender, baseline comorbidities, previous interventions, priority at hospital admission, frailty score, New York Heart Association class, EuroSCORE, and associated cardiac diseases. Next, the 30-day mortality and procedure-related morbidity of 162 patients (81 TAVI vs 81 AVR) with severe left ventricular systolic dysfunction (ejection fraction ≤ 35%) were analyzed at the Italian National Institute of Health.ResultsThe 30-day mortality was comparable (P = .37) between the 2 groups. The incidence of periprocedural acute myocardial infarction (P = .55), low output state (P = .27), stroke (P = .36), and renal dysfunction (peak creatinine level, P = .57) was also similar between the 2 groups. TAVI resulted in significantly greater postprocedural permanent pacemaker implantation (P = .01) and AVR in more periprocedural transfusions (P

Nell’ambito dei settori di applicazione ambientale dei saggi biologici la normativa nazionale prevede l’impiego del test di inibizione della bioluminescenza del batterio marino Vibrio fischeri nelle attività di monitoraggio costiero condotto dalle Agenzie Regionali ai sensi della Legge 979/82 “Difesa del Mare” e facoltativamente dal D.Lgs. 152/06. Esso è inoltre ampiamente utilizzato nell’ambito della caratterizzazione dei fondali marini prospicienti i Siti di bonifica di Interesse Nazionale ai sensi del DM 468/01. Sebbene attualmente siano disponibili numerosi protocolli ufficiali adottati da enti e/o organismi internazionali (DIN, 1992; Environment Canada, 2002, APAT IRSA-CNR, 2003), il percorso di standardizzazione ha visto in realtà una scarsa attenzione nei riguardi della valutazione della riproducibilità/ripetibilità dei metodi previsti per ambienti marini e/o salmastri, come condizione indispensabile e precedente la normazione vera e propria. Gli unici esercizi di interconfronto noti interessano in realtà sostanze tossiche di riferimento e campioni di acqua dolce eseguiti nella soluzione standard a base di NaCl (APAT IRSA-CNR, 2003; Farré, 2004). Nell’ambito del percorso di “normazione” stabilito in seno alla Commissione UNICHIM “Metodi Biologici”, sottogruppo “Acque marine e salmastre” è stato organizzato un esercizio di interconfronto finalizzato alla valutazione della riproducibilità e ripetibilità di un metodo da applicare a matrici ambientali liquide marine.

Diabetes mellitus is a well known risk factor for extensive coronary disease. The optimal route for cardioplegia administration in patients with severe ischaemic heart disease undergone surgery, especially with left main stem disease (LMSD) is still under debate. Aim of the study is to compare 2 different strategies of myocardial protection in diabetics with LMSD.Between January 2000 and June 2003 90 consecutive patients with type II diabetes mellitus and LMSD undergoing isolated myocardial revascularization were divided into 2 groups according to the route of cardioplegia delivery: antegrade in 45 patients (group A), antegrade followed by intermittent retrograde in 45 (group B). ECG, Troponin I, MB-CPK, MB-CPK mass were performed at 12, 24, 48, and 72 hours postoperatively. Echocardiography was performed preoperatively and before hospital discharge.Groups were homogeneous in preoperative and intraoperative variables, apart from higher incidence of unstable angina and longer cardiopulmonary bypass time in Group B and hypertension in Group A. Hospital deaths, in intensive care units (ITU) stay, perioperative acute myocardial infarction, intra-aortic balloon pump support, postoperative recovery of left ventricle ejection fraction and wall motion score index were similar in both groups. In hospital stay proved shorter in group B (p=0.002), whereas postoperative atrial fibrillation was higher in group A (p0.001), as postoperative inotropic support (p=0.006). Troponin I proved significantly higher in group A from the 12 degrees to the 72 degrees postoperative hour (p0.0001).Despite major in hospital end-points did not differ with strategy of cardioplegia administration, combined route of intermittent blood cardioplegia allows better biochemical and perioperative results in diabetics with LMSD.