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Objectives: To address the safety (rate of thromboembolic events and circuit complications) and efficacy (rate of bleeding control) of recombinant activated coagulation factor VII (rFVIIa) to treat severe bleeding refractory to all surgical and medical treatments in patients under veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support., Methods: In a tertiary referral University Cardiothoracic Surgery Centre including three intensive care units, 30 patients received the rFVIIa during ongoing VA or VV ECMO support (8.6% of ECMO activity from 2005 to 2014; N = 347). Early and late clinical results were analysed (retrospective analysis of prospectively collected data). In a substudy, a case-matching procedure was performed among ECMO patients who received (Group A) or did not receive (Group B) rFVIIa treatment., Results: The mediastinum was the most common site of refractory bleeding (after heart transplantation or other cardiac surgery; 90%); 90% (n = 27) of patients were on VA ECMO and the remainder on VV ECMO. The survival rate at ECMO explantation and at the 30th post-implantation day was 67 and 50%, respectively. The final efficacy rate of rFVIIa in stopping bleeding was 93.3%. The rate of thromboembolic events was 3.3% (1 case) and the rate of circuit change was 16.7% (without instances of overt circuit clotting). After case-matching, Group A comprised 23 patients and Group B included 43 patients. No statistically significant differences were observed among groups in terms of thromboembolic events (P = 0.99), circuit change, ventilation time (P = 0.71), infectious complications (P = 06) and survival at both ECMO explantation and the 30th post-implantation day. Late survival was comparable (Kaplan-Meier analysis; P = 0.42)., Conclusions: In case of life-threatening bleeding refractory to all conventional therapies, rFVIIa presents an acceptable safety profile in patients under ECMO support. No circuit dysfunctions and limited rates of thromboembolism are observed., (© The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aims: Global longitudinal strain (GLS) seems accurate for detecting subclinical myocardial dysfunction, and may therefore be used to improve risk stratification for cardiac surgery., Methods and Results: Longitudinal strain (by two-dimensional speckle tracking) was computed in 425 patients [mean age 67 ± 13 years, 69% male, left ventricular ejection fraction (LVEF) 51 ± 13%] referred for cardiac surgery [isolated coronary artery bypass graft (CABG) (n = 155), aortic valve surgery (n = 174), mitral surgery (n = 96)]. GLS (global-ε) was assessed for predicting early postoperative death. Despite a fair correlation between LVEF and global strain (r = -0.73, P < 0.0001), 40% of patients with preserved LVEF (defined as LVEF ≥50%) had abnormal global-ε (defined as global-ε >-16%): -12.8 ± 1.7%, range -15% to -8%. In patients with preserved LVEF, NT-proBNP level (983 vs. 541 pg/mL, P = 0.03), heart failure symptoms (NYHA class, 2.2 ± 0.9 vs. 1.9 ± 0.9, P = 0.02), and the need for prolonged (>48 h) inotropic support after surgery (33.3 vs. 21.2%, P = 0.03) were greater when global-ε was impaired. Importantly, despite similar EuroSCORE (9.7 ± 12 vs. 7.7 ± 9%, P = 0.2 for EuroSCORE I and 4.2 ± 6.2 vs. 3.4 ± 4.9%, P = 0.4 for EuroSCORE II), the rate of postoperative death was 2.4-fold (11.8 vs. 4.9%, P = 0.04) in patients with preserved LVEF when global-ε was impaired. Multivariate analysis showed that global-ε is an independent predictor for early postoperative mortality [odds ratio = 1.10 (1.01-1.21)] after adjustment to EuroSCORE., Conclusion: GLS has an incremental value over LVEF for risk stratification in patients referred for cardiac surgery.

Objectives: In a multicentre series of patients with low-ejection fraction/low-gradient aortic stenosis (LEF/LGAS), we evaluated the prognostic impact of valvuloarterial impedance (Zva)., Background: Zva in AS, a measure of global afterload taking into account systemic arterial compliance, has been proposed for risk stratification in paradoxical LGAS. We hypothesized that Zva could help risk stratification in LEF/LGAS., Methods and Results: We retrospectively calculated Zva (5.6 ± 1.7 mmHg/mL/m(2)) of 184 consecutive patients (mean age: 71 ± 10 years) with severe symptomatic LEF/LGAS (valve area ≤1 cm2;, EF ≤40%, mean transaortic pressure gradient ≤40 mmHg) included between 1995 and 2005 in a multicentre registry. Zva was higher in patients with LVEF at rest ≤20% (6.6 ± 2.3 vs. 5.5 ± 1.6; P = 0.05) and correlated negatively with LVEF at rest (R = -0.25; P = 0.001). Zva was lower in patients without contractile reserve (CR) on dobutamine stress echocardiography (DSE) compared with patients with true severe AS (5.3 ± 1.3 vs. 5.8 ± 1.8 mmHg/mL/m(2); P = 0.048). Zva and the variation in stroke volume during DSE were positively correlated (P = 0.0001) but Zva did not allow distinction between true and pseudo-severe AS (5.8 ± 1.8 vs. 5.3 ± 1.8 mm Hg/mL/m(2); P = 0.30). In the total population, Zva was not predictive of long-term mortality. In the 128 patients who underwent aortic valve replacement, Zva was not predictive of operative death and of long-term mortality., Conclusions: Increased Zva is related to low LVEF and more frequent CR on DSE in LEF/LGAS. However, Zva did not allow an accurate distinction between true and pseudo-severe AS and failed to predict operative and long-term mortality after aortic valve replacement, in LEF/LGAS.

Aims: To evaluate the impact of acoustic window on the feasibility and accuracy of longitudinal global strain (global-ε) by speckle tracking for assessing left ventricular (LV) systolic function., Methods and Results: The study included 70 patients (57 ± 17 years, 64% men), 28 selected patients with a suboptimal image quality (IQ) defined by three or more segments (4 ± 3 segments/patient) with wall motion score not analysable visually and 42 patients with an optimal two-dimensional (2D) echocardiography IQ. Left ventricular ejection fraction (LVEF) by Simpson's biplane method (2D-EF), global-ε by speckle tracking, and peak systolic mitral annulus velocity [systolic tissue Doppler imaging (S-TDI)] were compared with LVEF by cardiac magnetic resonance (EF-CMR; 45 ± 18%, range 9-76%). Speckle-tracking analysis was feasible in all segments with an optimal acoustic window and in 85% (103/121) of segments poorly visualized. Global-ε similarly correlated with LVEF by CMR in patients with and without optimal IQ (r = 0.81 vs. 0.82 for good vs. poor IQ). In contrast, 2D-EF (r = 0.76) and S-TDI (r = 0.64) less correlated with LVEF by CMR in patients with a suboptimal IQ. Importantly, IQ only impacted on 2D-EF inter-observer reproducibility (9 ± 5 vs. 24 ± 22% for good vs. poor IQ) but not on global-ε reproducibility (9 ± 1 vs. 8 ± 7% for good vs. poor IQ)., Conclusion: In patients with a limited acoustic window, longitudinal strain by speckle tracking remains accurate and reproducible for assessing global and regional LV systolic function.

Aims: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis., Methods and Results: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less., Conclusion: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.

Background: The impact of antidiabetic medications on clinical outcomes in patients developing acute myocardial infarction (MI) is controversial. We sought to determine whether in-hospital outcomes in patients who were on sulfonylureas (SUs) when they developed their MIs differed from that of diabetic patients not receiving SUs and whether clinical outcomes were related to the pancreatic cells specificity of SUs., Methods and Results: We analyzed the outcomes of the 1310 diabetic patients included in the nationwide French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction in 2005. Medications used before the acute episode were recorded. In-hospital complications were analyzed according to prior antidiabetic treatment. Mortality was lower in patients previously treated with SUs (3.9%) vs. those on other oral medications (6.4%), insulin (9.4%), or no medication (8.4%) (P = 0.014). Among SU-treated patients, in-hospital mortality was lower in patients receiving pancreatic cells-specific SUs (gliclazide or glimepiride) (2.7%), compared with glibenclamide (7.5%) (P = 0.019). Arrhythmias and ischemic complications were also less frequent in patients receiving gliclazide/glimepiride. The lower risk in patients receiving gliclazide/glimepiride vs. glibenclamide persisted after multivariate adjustment (odds ratio 0.15; 95% confidence interval 0.04-0.56) and in propensity score-matched cohorts., Conclusion: In this nationwide registry of patients hospitalized for acute MI, no hazard was associated with the use of SUs before the acute episode. In addition, patients previously receiving gliclazide/glimepiride had improved in-hospital outcomes, compared with those on glibenclamide.

Aims: To evaluate the use of intracardiac echocardiography probe through oesophageal route (ICE-TEE) for the monitoring of percutaneous foramen ovale (PFO) closure procedure., Methods and Results: The study was conducted in 50 patients divided into two groups: in group I (n = 24), accuracy of ICE-TEE in assessing the inter-atrial septum (IAS) was compared with standard TEE, and in group II, we used ICE-TEE to monitor 26 consecutive patients referred for PFO closure. In group I, IAS was constantly visualized with a close correlation between ICE-TEE and standard TEE for IAS excursion (r = 0.9, P < 0.0001). In group II, ICE-TEE allowed to rule out four patients (three without PFO and one with septal atrial defect associated) and identified three complications during PFO closure procedure (pericardial effusion, inadequate device deployment, and cardiac thrombus). Finally, device implantation was successfully performed in the 22 patients with no residual shunt and thrombus observed after 3 months., Conclusion: ICE-TEE could be used to monitor PFO closure procedure.

Aims: To assess the prognostic impact of prosthesis-patient mismatch (PPM) in a large consecutive series of patients operated for low-gradient aortic stenosis (AS)., Methods and Results: Outcomes after surgery for low-gradient AS were prospectively assessed in 152 consecutive patients from seven institutions. There were 113 men (74%); mean age was 72 years (64-76); valve area, 0.7 cm(2) (0.6-0.8); left ventricular (LV) ejection fraction 0.31 (0.25-0.37) and baseline mean transaortic pressure gradient (MPG), 30 mmHg (25-35) Among 139 patients with available prosthetic valve effective orifice area (EOA), PPM (defined by an indexed EOA < or = 0.85 cm(2)/m(2)) was present in 79 patients (57%) and had no significant impact on post-operative mortality. Independent predictors of overall mortality were LV contractile reserve [hazard ratio (HR) 0.52; 95% confidence interval (CI) 0.35-0.78; P = 0.002], associated coronary artery bypass grafting (HR 1.87; 95% CI 1.24-2.82; P =0.003), baseline MPG (per 1 mmHg decrease to 10 mmHg; HR 1.03; 95% CI 1.01-1.06; P = 0.021), previous cancer (HR 2.13; 95% CI 1.05-4.29; P = 0.037), and logistic EuroSCORE (per 1% increase; HR 1.02; 95% CI 1.01-1.04; P = 0.040). CONCLUSION In this large multicentre series of patients with low-gradient AS, we found that PPM (moderate in most cases) had no influence on post-operative mortality. Therefore, the performance of more complex interventions in order to avoid moderate PPM may not be justified in the setting of low-gradient AS, because their higher risk probably outweighs the expected benefit.

Aims: B-type Natriuretic Peptide (BNP) is activated in patients with severe, symptomatic aortic stenosis (AS), but the prognostic value of BNP in this setting has not been extensively studied. This study aimed to assess the prognostic value of the BNP level in symptomatic and asymptomatic patients with severe AS., Methods: Seventy consecutive patients referred to our echocardiography laboratory for severe AS with preserved left ventricular function were prospectively enrolled (40 men, median age 74 years [62-82]; aortic valve area 0.7 cm2 [0.6-0.8]; transaortic gradient 48 mmHg [38-60], and left ventricular fractional shortening 38% [32-43]). C-terminal BNP serum level at enrollment was evaluated against baseline functional and echocardiographic parameters as well as clinical outcome., Results: BNP level was elevated in the presence of symptoms and increased with NYHA functional class. BNP serum level >66 pg/ml detected symptomatic patients with a sensitivity, specificity and accuracy of 84%, 82% and 84%, respectively. In symptomatic and asymptomatic patients, BNP level was a strong independent predictor for cardiovascular death by multivariable analysis adjusted to age and NYHA functional class., Conclusions: BNP serum level allows to differentiate symptomatic from asymptomatic patients with severe AS. BNP is an independent predictor of outcome in these patients and may be helpful for risk stratification.

Aims: The aim of this study was to evaluate the relationship between coronary flow reserve and the recovery of wall motion contractility in patients with recent myocardial infarction., Methods and Results: Nineteen patients (55 +/- 8 years) undergoing balloon angioplasty for recent myocardial infarction were studied. After angioplasty, coronary flow reserve was lower in the infarct-related artery than in a reference artery, 2.2 +/- 0.6 and 2.8 +/- 0.7, respectively, P < 0.05. There was no immediate correlation between coronary blood flow reserve measured after angioplasty and wall motion index. There was a negative correlation between coronary flow reserve and the number of necrotic segments (r = -0.43; P0.006). At the 4 month control angiogram, there was a significant increase in both left ventricular ejection fraction (59 +/- 14% vs 51 +/- 13%; P < 0.05) and wall motion index (-0.63 +/- 1.2 vs -1.94 +/- 0.9 units SD, P = 0.005). In patients in whom wall motion improved (> 1 unit SD), the immediate coronary flow reserve was higher (P < 0.05) than in patients without improved wall motion. In this group, the increase in wall motion index was correlated to the coronary blood flow reserve (r = 0.55; P < 0.02)., Conclusion: These data show that after myocardial infarction, coronary flow reserve is associated with myocardial viability.

Anaerobic threshold (AT), proposed as a non-invasive index of exercise tolerance, independent of patient motivation, is considered more reliable than exercise duration in assessing the effect of drug therapy in chronic heart failure (CHF). However, inter-observer variation in patients may be more difficult than in normal subjects. In a multicentre study, 85 patients from 10 centres performed a total of 331 bicycle maximal tests (ramp protocols, 10 watts.min-1) with respiratory gas analysis by different systems. A central committee reviewed all the tests. Percentages of AT determination ranged from 34% to 71% depending on the method used. Apart from the respiratory exchange ratio (RER) method, which yielded the lowest rate of determination: 34%, and the crossing point (when RER = 1), which yielded the highest rate, 71%, other methods of determination, such as carbon dioxide (42%), minute ventilation (52%) or ventilatory equivalents plotted vs time (57%), did not differ in the rate of AT determination. Thus, even among trained physicians, AT determination was not reliable. The crossing point may nevertheless be a valuable index from a pragmatic standpoint, although it occurs after the actual AT. Peak oxygen uptake should remain the main end-point in assessment of exercise capacity.

Assessment of the ventilatory threshold (VT) has been proposed to assess exercise tolerance more objectively, particularly in clinical trials, but reproducibility, interobserver variability and feasibility of the graphical methods for determination of VT have not been properly studied in patients with chronic heart failure (CHF). Fifty-one patients with mild to moderate CHF (mean peak oxygen uptake (VO2): 20.5 ml.min-1.kg-1) were assessed during two consecutive bicycle exercise tests within 8 days. Two graded exercise protocols were compared with stages of 30 W every 3 min (22 patients) or 10 W/min (29 patients). VT was determined separately by five trained physicians using five different graphical methods. The 'crossing method' (first crossing of the VCO2 and VO2 curves) yielded the highest rate of determination (88%) but tended to overestimate the mean VT. The VE method (disproportionate increase of ventilation relative to VO2) produced the best interobserver agreement (coefficient of variation = 78%). Peak VO2 was very highly reproducible in both exercise protocols (relative difference 2-test 1/test 1 = -0.32% for the 30 W 3 min protocol; +2.18% for the 10 W.min-1 protocol). The reproducibility of VT was slightly lower regardless of the graphical method used to determine it (relative differences varied from -3.3% to +7.3%). Therefore, peak VO2 appears more suitable than VT for assessment of exercise tolerance in CHF.