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International audience; Aim: To assess the relationship between sleep quality, fear of hypoglycemia, glycemic variability and psychological well-being in type 1 diabetes mellitus.Methods: Our data were provided by the VARDIA Study, a multicentric cross-sectional study conducted between June and December 2015. Sleep characteristics were assessed by the Pittsburgh Sleep Quality Index (PSQI). Fear of hypoglycemia and psychological well-being were measured with the Hypoglycemia Fear Survey version II (HFS-II) and the Hospital Anxiety and Depression Scale (HADS), respectively. Glycemic variability (GV) was determined using the CV of three 7-point self-monitoring blood glucose profiles and the mean amplitude of glycemic excursion (MAGE).Results: 315 patients were eligible for PSQI questionnaire analysis: 54% women, mean age 47 ± 15, mean diabetes duration of 24 ± 13 years, HbA1c of 7.6 ± 0.9% (60 ± 7,5mmol/mol). Average PSQI score was 6.0 ± 3.3 and 59.8% of the patients had a PSQI score > 5. HFS-II score and HADS were significantly higher among "poor" sleepers (p < 0.0001) and PSQI score was positively associated with HADS (β = 0.22; 95% CI = 0.08;0.35). GV evaluated by CV or MAGE did not differ between "poor" and "good" sleepers (p = 0.28 and 0.54, respectively).Conclusions: Adult patients with type 1 diabetes have sleep disturbances which correlate with psychological well-being. This study suggests that psychological management can be a target to improve sleep quality in adults with type 1 diabetes mellitus.

BACKGROUND: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short‐ and long‐term prognosis remains unclear. HYPOTHESIS: We hypothesized that the long‐term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE‐2) registry. METHODS: FRANCE‐2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three‐year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%. RESULTS: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78‐1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3‐year mortality (HR: 1.42; 95% CI: 1.10‐1.87). CONCLUSIONS: CAD is not associated with decreased short‐ and long‐term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long‐term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial.

Aims In type 1 diabetes (T1D), treatment efficacy is limited by the unpredictability of blood glucose results and glycemic variability (GV). Fear of Hypoglycemia (FOH) remains a major brake for insulin treatment optimization. We aimed to assess the association of GV with FOH in participants with T1D in an observational cross-sectional study performed in 9 French Diabetes Centres ( NCT02790060 ). Methods Participants were T1D for ≥5 years, aged 18–75 years, on stable insulin therapy for ≥3 months. The coefficient of variation (CV) of blood glucose and mean amplitude of glycemic excursions (MAGE) were used to assess GV from 7-point self-monitoring of blood glucose (SMBG). FOH was assessed using the validated French version of the Hypoglycemia Fear Survey-II (HFS-II) questionnaire. Results Among a total of 570 recruited participants, 298 were suitable for analysis: 46% women, 58% on continuous subcutaneous insulin infusion [CSII], mean age 49 ± 16 years, HbA1c 7.5 ± 0.9%, HFS-II score 67 ± 18 and 12% with recent history of severe hypoglycemia during the previous 6 months, mean CV 39.8 ± 9.7% and MAGE 119 ± 42 mg/dL. CV and MAGE did not significantly correlate with HFS-II score (R = −0.05;P = 0.457 and R = 0.08;P = 0.170). Participants with severe hypoglycemia in the previous 6 months had higher HFS scores. Participants with higher HFS scores presented more hypoglycemias during follow-up. Conclusions FOH as determined using the HFS-II questionnaire was not associated with 7-point SMBG variability in participants with T1D, but was associated with a positive history of severe hypoglycemia. Higher FOH was associated with higher frequency of hypoglycemia during follow-up.

Corticospinal output pathways have typically been considered to be the primary driver for voluntary movements of the hand/forearm; however, more recently, reticulospinal drive has also been implicated in the production of these movements. Although both pathways may play a role, the reticulospinal tract is thought to have stronger connections to flexor muscles than to extensors. Similarly, movements involuntarily triggered via a startling acoustic stimulus (SAS) are believed to receive greater reticular input than voluntary movements. To investigate a differential role of reticulospinal drive depending on movement type or acoustic stimulus, corticospinal drive was transiently interrupted using high-intensity transcranial magnetic stimulation (TMS) applied during the reaction time (RT) interval. This TMS-induced suppression of cortical drive leads to RT delays that can be used to assess cortical contributions to movement. Participants completed targeted flexion and extension movements of the wrist in a simple RT paradigm in response to a control auditory go signal or SAS. Occasionally, suprathreshold TMS was applied over the motor cortical representation for the prime mover. Results revealed that TMS significantly increased RT in all conditions. There was a significantly longer TMS-induced RT delay seen in extension movements than in flexion movements and a greater RT delay in movements initiated in response to control stimuli compared with SAS. These results suggest that the contribution of reticulospinal drive is larger for wrist flexion than for extension. Similarly, movements triggered involuntarily by an SAS appear to involve greater reticulospinal drive, and relatively less corticospinal drive, than those that are voluntarily initiated.NEW & NOTEWORTHY Through the use of the transcranial magnetic stimulation-induced silent period, we provide novel evidence for a greater contribution of reticulospinal drive, and a relative decrease in corticospinal drive, to movements involuntarily triggered by a startle compared with voluntary movements. These results also provide support for the notion that both cortical and reticular structures are involved in the neural pathway underlying startle-triggered movements. Furthermore, our results indicate greater reticulospinal contribution to wrist flexion than extension movements.

Background Aspecific scoring systems are used to predict the risk of death postsurgery in patients with infective endocarditis ( IE ). The purpose of the present study was both to analyze the risk factors for in‐hospital death, which complicates surgery for IE , and to create a mortality risk score based on the results of this analysis. Methods and Results Outcomes of 361 consecutive patients (mean age, 59.1±15.4 years) who had undergone surgery for IE in 8 European centers of cardiac surgery were recorded prospectively, and a risk factor analysis (multivariable logistic regression) for in‐hospital death was performed. The discriminatory power of a new predictive scoring system was assessed with the receiver operating characteristic curve analysis. Score validation procedures were carried out. Fifty‐six (15.5%) patients died postsurgery. BMI >27 kg/m 2 (odds ratio [ OR ], 1.79; P =0.049), estimated glomerular filtration rate OR , 3.52; P IV ( OR , 2.11; P =0.024), systolic pulmonary artery pressure >55 mm Hg ( OR , 1.78; P =0.032), and critical state ( OR , 2.37; P =0.017) were independent predictors of in‐hospital death. A scoring system was devised to predict in‐hospital death postsurgery for IE (area under the receiver operating characteristic curve, 0.780; 95% CI, 0.734–0.822). The score performed better than 5 of 6 scoring systems for in‐hospital death after cardiac surgery that were considered. Conclusions A simple scoring system based on risk factors for in‐hospital death was specifically created to predict mortality risk postsurgery in patients with IE .

Caring for patients with incurable cancer presents unique challenges. Managing symptoms that evolve with changing clinical status and, at the same time, ensuring alignment with patient goals demands specific attention from clinicians. With care needs that often transcend traditional service provision boundaries, patients who seek palliation commonly interface with a team of providers that represents multiple disciplines across multiple settings. In this case study, we explore some of the dynamics of a cross-disciplinary approach to symptom management in an integrated outpatient radiotherapy service model. Providers who care for patients with incurable cancer must rely on one another to secure delivery of the right services at the right time by the right person. In a model of shared responsibilities, flexibility in who does what and when can enhance overall team performance. Adapting requires within-team and between-team monitoring of task and function execution for any given patient. This can be facilitated by a common understanding of the purpose of the clinical team and an awareness of the particular circumstances surrounding care provision. Backup behavior, in which one team member steps in to help another meet an expectation that would otherwise not be fulfilled, is a supportive team practice that may follow naturally in high-functioning teams. Such team processes as these have a place in the care of patients with incurable cancer and help to ensure that individual provider efforts more effectively translate into improved palliation for patients with unmet needs.

During a simple reaction time (RT) task, movements can be initiated early and involuntarily through presentation of a loud startling acoustic stimulus (SAS), a phenomenon termed the StartReact effect. In order to infer that activity in startle-related structures led to the early response triggering, it is important to observe a concurrent startle reflex in sternocleidomastoid. It is generally accepted that to consistently elicit a startle reflex, the SAS must be both intense and unpredictable. However, it remains unclear what effect explicit foreknowledge of an impending SAS has on the effectiveness of a SAS to elicit a startle reflex when preparing a motor response. To test this, participants completed two separate blocks of a simple RT task (counterbalanced order), where the control auditory go-signal was replaced with a SAS on 20 % of trials. In an unwarned block, knowledge of the trial type (SAS vs. control) was not provided in advance, while in a warned block, the trial type was forewarned. Results revealed that while foreknowledge of an impending SAS reduced the magnitude of the startle reflex, it did not affect the proportion of startle reflexes elicited or the magnitude of the StartReact effect. An increase in control trial RT was observed during the unwarned block, but only when it was performed first. These results indicate that preparation of a motor response leads to sufficiently increased activation in startle-related neural structures such that even with explicit knowledge of an upcoming SAS, participants are unable to proactively gate the upcoming sensory input.

The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.

Background Aortic valve replacement (AVR) in small aortic roots remains a surgical dilemma with a higher risk of patient-prosthesis mismatch (PPM). The Perimount Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We examined the early hemodynamic performance, the mid-term outcomes of the PMEAV, and the impact of PPM on outcome and functional class. Methods We performed a retrospective analysis of prospectively collected in-hospital data, and a prospective single-center follow-up of 849 patients who received a 19 to 23 mm PMEAV (2008–2014). Concomitant mitral or tricuspid replacement was the exclusion criterion. Early hemodynamic features were prospectively collected; mid-term follow-up was conducted according to current guidelines. Results Size of implanted prosthesis was 19 mm in 11.5% of patients, 21 mm in 36.9%, and 23 mm in 51.5%. Operative mortality was 4.5% (3.1% for isolated AVR). The rate of severe and moderate PPMs was significantly higher in the 19 mm group. Follow-up was 99.9% complete (3.7 ± 2 years). Actuarial freedom from structural valve deterioration (SVD) at 5 years was 99.1%. At stratified Kaplan–Meier's analysis, PPM and age Conclusion This series shows satisfactory clinical outcomes of the PMEAV implanted in small aortic annuli at mid-term follow-up. Although PPM may occur in smaller sizes, it has limited clinical impact, and it is not associated with mid-term mortality or worse functional class. Few SVD events are evidenced; nonetheless, limited follow-up duration and its methodology need to be considered.

Working party approved by the French Society of Anaesthesia and Intensive Care Medicine (SFAR) and the French Society for the study of Diabetes (SFD); International audience; Ambulatory surgery can be carried out in diabetic patients. By using a strict organisational and technical approach, the risk of glycaemic imbalance is minimised, allowing the patients to return to their previous way of life more quickly. Taking into account the context of ambulatory surgery, with a same day discharge, the aims are to minimise the changes to antidiabetic treatment, to maintain adequate blood sugar control and to resume oral feeding as quickly as possible. The preoperative evaluation is the same as for a hospitalised patient and recent glycaemic control (HbA1c) is necessary. Perioperative management and the administration of treatment depend on the number of meals missed. The patient can return home after taking up usual feeding and treatment again. Hospitalisation is necessary if significant glycaemic imbalance occurs. In pregnancy, it is necessary to distinguish between known pre-existing diabetes (T1D or T2D) and gestational diabetes, defined as glucose intolerance discovered during pregnancy. During labour, blood sugar levels should be maintained between 0.8 and 1.4 g/L (4.4–8.25 mmol/L). Control of blood sugar levels is obtained by using a continuous administration of insulin using an electronic syringe (IVES) together with a glucose infusion. Post-partum, management depends on the type of diabetes: in T1D and T2D patients a basal-bolus scheme is restarted with decreased doses while in gestational diabetes insulin therapy is stopped after delivery. Antidiabetic treatment is again necessary if blood sugar levels remain > 1.26 g/L (7 mmol/L).

Analysis of the causes, outcomes, and mortality of patients with severe symptomatic aortic stenosis requiring the implantation of 2 valves during transcatheter aortic valve implantation was conducted from the French Aortic National CoreValve and Edwards 2 (FRANCE2) registry. Pre- and postprocedural data from 3,919 patients from January 2010 to December 2011 (CoreValve or Edwards) were collated and analyzed. Characteristics of patients requiring immediate second valve procedures were compared with those of the other patients. The 72 patients (1.8%) who underwent implantation of a second valve were studied. Indications were device malpositioning (72%) and embolization (28%). Clinical and echocardiographic characteristics of patients receiving 2 valves were comparable with those of the other patients. The 2-year survival rate was 51.7% for patients with 2 valves as opposed to 62.3% for those with 1 valve (p0.001). The need for a second valve was an independent predictor of all-cause (hazard ratio 2.32, 95% confidence interval 1.50 to 3.60, p0.001) and cardiovascular (hazard ratio 2.64, 95% confidence interval 1.35 to 5.15, p0.001) mortality at 2 years. During follow-up, clinical and echocardiographic data remained similar between the 2 groups. In conclusion, in the FRANCE2 study, the main causes for second valve implantation during the same procedure were malpositioning and embolization. Although the procedure was feasible, it was accompanied by excess mortality. Valve hemodynamic status was preserved during the course of follow-up.

Summary Background Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI). Aim The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry. Methods From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders. Results Patients in the previous BAV group ( n = 664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade ≥ 2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups ( P = 0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90–2.34; P = 0.14) or 1-month to 1-year mortality. Conclusions Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment.

Increased reaction times (RT) during choice-RT tasks stem from a requirement for additional processing as well as reduced motor-specific preparatory activation. Transcranial direct current stimulation (tDCS) can modulate primary motor cortex excitability, increasing (anodal stimulation) or decreasing (cathodal stimulation) excitability in underlying cortical tissue. The present study investigated whether lateralized differences in choice-RT would result from the concurrent modulation of left and right motor cortices using bi-hemispheric tDCS. Participants completed a choice-RT task requiring either a left or right wrist extension. In forced-choice trials an illuminated target indicated the required response, whereas in free-choice trials participants freely selected either response upon illumination of a central fixation. Following a pre-test trial block, offline bi-hemispheric tDCS (1 mA) was applied over the left and right motor cortices for 10 minutes, which was followed by a post-tDCS block of RT trials. Twelve participants completed three experimental sessions, two with real tDCS (anode right, anode left), as well as a sham tDCS session. Post-tDCS results showed faster RTs for both right and left responses irrespective of tDCS polarity during forced-choice trials, while sham tDCS had no effect. In contrast, no stimulation-related RT or response selection differences were observed in free-choice trials. The present study shows evidence of an effector-independent speeding of response initiation in a forced-choice RT task following bi-hemispheric tDCS and yields novel information regarding the functional effect of bi-hemispheric tDCS.

International audience; Objective To clarify the mid-term durability of the Trifecta bioprosthesis for aortic valve replacement (AVR). Methods We retrospectively analyzed the prospectively collected data of 824 consecutive implants of the Trifecta valve at a single institution. A 100% complete follow-up was available (average duration, 2.2 ± 1.3 years; range, 0.03-6.9 years; 1747.6 patient-years). Echocardiography data at discharge were recorded prospectively. Results Operative mortality was 3.8%; 2.7% in patients receiving isolated AVR. There were 5 valve-related early reoperations, including 1 for infective prosthetic endocarditis and 4 for nonstructural valve dysfunction. The global rate of severe patient–prosthesis mismatch was 1.26%. Overall 5-year survival was 74.9%, and freedom from valve-related death was 97.8%. The majority of deaths attributed to the valve were due to unknown causes. We observed 6 SVD events at 3.4 ± 1.6 years after surgery. At 5 years, the actuarial freedom from SVD was 98% ± 0.9% (n = 6), freedom from reintervention for SVD was 98% ± 0.9% (n = 5, including 2 transcatheter valve-in-valve), and freedom from open reoperation for SVD was 98.9% ± 0.6%. The 5-year freedom from prosthetic endocarditis was 97.7% ± 0.7% (n = 12, 6 requiring reoperation). There was 1 case of late NSVD (5-year freedom, 99.8% ± 0.2%). Freedom from hemorrhagic events was 98.6% ± 0.5% (86% occurring in patients on anticoagulants); there were no thromboembolic events at follow-up. Conclusions The Trifecta bioprosthesis is a reliable device for AVR. We confirm excellent immediate hemodynamic properties and a very low rate of patient–prosthesis mismatch. The absolute number of SVD cases observed remains limited; nevertheless, their timing, pathological characteristics, and clinical presentation mandate continued follow-up.

International audience; BACKGROUND: In aortic stenosis (AS), the left ventricle (LV) should face an increased afterload that is due to both the stenotic aortic valve and the peripheral vascular resistance (PVR). Valvulo-arterial impedance (ZVa ) is a recently introduced parameter, which permits the evaluation of global LV afterload in AS. Aim of this study was to assess the influence of increasing ZVa on the longitudinal, circumferential, and radial components of LV mechanics. METHODS: A total of 126 patients (mean age: 80.1±12.0 years, males: 47%) with severe AS (aortic surface 5.1 mm Hg/mL/m(2) ). ZVa increase from Q1 to Q4 was associated with a progressive reduction in GLS and GCS (ANOVA, both P

Cardiac allograft vasculopathy (CAV) is a major factor limiting long-term survival after heart transplantation (HTx). Specific determinants of CAV and long-term outcome after CAV occurrence have been poorly investigated after heart-lung transplantation (HLTx).Between January 1996 and December 2006, 79 patients underwent HLTx (36.3 ± 12.2 years old; 47% men) and 141 patients underwent HTx (49.2 ± 12.3 years old; 77% men) at two different institutions. CAV grading was reviewed in both groups according to the 2010 standardized nomenclature of the International Society for Heart and Lung Transplantation. The mean post-transplant follow-up was 94 (1 to 181) months.Overall 10-year survival rate was 58% after HTx and 43% after HLTx (p = 0.11). The Grade 1 (or higher) CAV-free survival rate was 95% at 4 years and 69% at 10 years after HLTx, and 77% and 39%, respectively, after HTx (p0.01). Mean cyclosporine blood levels were similar between the groups at 3, 6, 12, 24 and 36 months. The main causes of mortality beyond 5 years after HTx and HLTx were malignancies and bronchiolitis obliterans, respectively. By multivariate analysis, recipients who developed3 acute myocardial rejections during the first year post-transplant were exposed to a higher risk of CAV (95% CI 1.065 to 2.33, p = 0.02). Episodes of acute pulmonary rejection and bronchiolitis obliterans were not associated with an increased risk of CAV (p = 0.52 and p = 0.30).HLTx recipients appeared protected from CAV compared with HTx patients in this retrospective study. Repeated acute cardiac rejections were independent predictors of CAV. Unlike bronchiolitis obliterans, CAV had a very low impact on long-term survival after HLTx.

The purposes of the present study were to determine the impact of chronic obstructive pulmonary disease (COPD) on Valve Academic Research Consortium-defined outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). A total of 3,933 consecutive patients underwent TAVI from January 2010 to December 2011 in 34 centers and were included in the French national TAVI registry "FRANCE 2"; 895 (22.7%) had concomitant COPD, 3,038 (77.3%) did not. There were no significant differences in procedural characteristics or 30-day Valve Academic Research Consortium-defined outcomes between those with and without COPD. Multivariate regression analysis showed COPD to be an independent predictor of 1-year mortality and combined efficacy end point after adjustment for concomitant co-morbidities (hazard ratio 1.19, 95% confidence interval 1.005 to 1.41, p = 0.03 and hazard ratio 1.52, 95% confidence interval 1.29 to 1.79, p 0.001, respectively). The higher mortality rate at 1 year in patients with COPD was related to cardiovascular deaths (COPD 10.0% vs non-COPD 6.2%, p = 0.008). Subgroup analysis found that the effect of COPD on 1-year mortality rate was constant across different subgroups, especially the type of approach and the type of anesthesia subgroups. In conclusion, concomitant COPD in patients referred for TAVI characterizes a high-risk population. The excess in mortality is largely determined by a higher rate of cardiovascular deaths and exists regardless of the type of procedure performed and its results.

Background— Significant postprocedural aortic regurgitation (AR) is observed in 10% to 20% of cases after transcatheter aortic valve replacement (TAVR). The prognostic value and the predictors of such a complication in balloon-expandable (BE) and self-expandable (SE) TAVR remain unclear. Methods and Results— TAVR was performed in 3195 consecutive patients at 34 hospitals. Postprocedural transthoracic echocardiography was performed in 2769 (92%) patients of the eligible population, and these patients constituted the study group. Median follow-up was 306 days (Q1–Q3=178–490). BE and SE devices were implanted in 67.6% (n=1872) and 32.4% (n=897). Delivery was femoral (75.3%) or nonfemoral (24.7%). A postprocedural AR≥grade 2 was observed in 15.8% and was more frequent in SE (21.5%) than in BE-TAVR (13.0%, P =0.0001). Extensive multivariable analysis confirmed that the use of a SE device was one of the most powerful independent predictors of postprocedural AR≥grade 2. For BE-TAVR, 8 independent predictors of postprocedural AR≥grade 2 were identified including femoral delivery ( P =0.04), larger aortic annulus ( P =0.0004), and smaller prosthesis diameter ( P =0.0001). For SE-TAVR, 2 independent predictors were identified including femoral delivery( P =0.0001). Aortic annulus and prosthesis diameter were not predictors of postprocedural AR for SE-TAVR. A postprocedural AR≥grade 2, but not a postprocedural AR=grade 1, was a strong independent predictor of 1-year mortality for BE (hazard ratio=2.50; P =0.0001) and SE-TAVR (hazard ratio=2.11; P =0.0001). Although postprocedural AR≥grade 2 was well tolerated in patients with AR≥grade 2 at baseline (1-year mortality=7%), it was associated with a very high mortality in other subgroups: renal failure (43%), AR Conclusions— Postprocedural AR≥grade 2 was observed in 15.8% of successful TAVR and was the strongest independent predictor of 1-year mortality. The use of the SE device was a powerful independent predictor of postprocedural AR≥grade 2.

Background— Pulmonary hypertension (PH) is associated with poor prognosis in patients with severe aortic stenosis. The aim of this multicenter study was to describe clinical outcome after transcatheter aortic valve implantation. Methods and Results— The FRANCE 2 Registry included all patients undergoing transcatheter aortic valve implantation in France in 2010 and 2011. Patients were divided into 3 groups depending on systolic pulmonary artery pressure (sPAP) estimated in transthoracic echocardiography: group I, sPAP P =0.032). Mild-to-moderate and severe PH were identified as an independent factor of all-cause mortality. The major adverse cardiovascular event rates did not differ according to sPAP. New York Health Association functional class improved significantly in all groups. Conclusions— PH (sPAP ≥40 mm Hg) in patients with aortic stenosis undergoing transcatheter aortic valve implantation was associated with increased 1-year mortality especially when severe (sPAP ≥60 mm Hg) but not with increased 30-day mortality, and functional status was significantly improved regardless of PAP level.

Summary Background Left bundle branch block (LBBB) induces mechanical dyssynchrony that may lead to left ventricular systolic dysfunction. Aims To evaluate the incidence, predictors and clinical impact of new LBBB in patients undergoing surgical aortic valve replacement (SAVR). Methods After exclusion of patients with pre-existing LBBB, a previous pacemaker or a paced rhythm at hospital discharge, 547 consecutive patients undergoing SAVR were included. All-cause death, cardiovascular death and the combined outcome of all-cause death or a first heart failure event were assessed at 3 months and 1 year. Patients with and without new LBBB were compared. Results New LBBB occurred in 4.6% of patients after SAVR (compared with 16.4% of patients treated by transcatheter aortic valve implantation during the study period). Previous valve surgery and an immediate postoperative paced rhythm were independent predictors of new LBBB. At 1-year follow-up, there were no significant differences in all-cause death, cardiovascular death, or the combined outcome of all-cause death or a first heart failure event between patients with and without new LBBB. However, new LBBB was associated with a trend towards functional deterioration and more heart failure events at 1 year. Conclusion At 1-year follow-up, new LBBB did not have a significant impact on clinical outcome, but was associated with worse functional status and more heart failure events.

To address the long-term durability of bioprostheses used for aortic valve replacement (AVR) in adult patients aged ≤60 years at the time of surgery.Through a retrospective review of a prospectively collected database, we identified 416 bioprosthetic AVRs performed between 1977 and 2013. A prospective follow-up of valve-related and non-valve-related events was performed.Follow-up was 98.5% complete (2423.1 patient-years; average, 6 ± 5.5 years). At 15 years, overall survival was 62.1 ± 4.4%; freedom from valve-related death was 97.1 ± 1.6%. There were 68 SVD events (11.9 ± 28.8 years after surgery). Freedom from SVD at 15 years was 48.7 ± 5.5% for Kaplan-Meier analysis and 61.4 ± 4.3% for competing-risks analysis. After stratification into age subgroups (40 years, ≥40 and 50 years, and ≥50 and ≤60 years), we observed no significant difference in freedom from SVD (P = .50). The average delay to SVD was not statistically different among subgroups (P = .30). There were 57 reoperations for SVD (11.8 ± 5.2 years after implantation). The 15 year freedom from reoperation for SVD was 55.4 ± 5.6% by Kaplan-Meier analysis and 67.1 ± 4.2% by competing-risks analysis. After stratification by age, freedom from reoperation for SVD was comparable (P = .13). Freedom from any valve-related complication or death was 42 ± 5% by Kaplan-Meier analysis and 54.4 ± 4.1% by competing-risks analysis.The lifetime risk of SVD is considerable in patients aged ≤60 years at the time of bioprosthesis implantation. Nonetheless, durability remains consistent during the first decade; additional data are required for the second decade. Patients' information is pivotal for valve choice (competing-risks method).

Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up.This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry.The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used.A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p 0.001), low body mass index, (p 0.001), atrial fibrillation (p 0.001), dialysis (p 0.001), New York Heart Association functional class III or IV (p 0.001), higher logistic EuroSCORE (p 0.001), transapical or subclavian approach (p 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in 2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up.The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

International audience; Aims The aim of this article is to assess the left atrial (LA) reservoir function in patients with severe aortic stenosis (AS) and to evaluate its impact on the recurrence of major adverse cardiac events (MACEs).Methods and results About 128 patients (mean age 79 ± 9 years) with severe AS were included in the study. Global peak LA strain (PLAS) measured by two-dimensional speckle-tracking echocardiography (STE) during left ventricular (LV) systole represented the LA reservoir function. Overall death, hospitalization for cardiac cause, and worsening heart failure were defined as MACEs. With respect to the values observed in a control group of 20 healthy patients, PLAS resulted significantly reduced in AS. According to the multivariate linear regression analysis, LV global longitudinal strain, mitral E/e′ ratio, and systolic pulmonary arterial pressure (sPAP) were the best correlates to PLAS. During follow-up, the predefined MACEs occurred in 39 patients. According to the multivariate Cox regression analysis, a PLAS \textless21% was a significant predictor of MACEs [hazard ratio (HR) 2.88, P = 0.04], as was coronary artery disease (HR 2.68, P = 0.004) and the New York Heart Association functional class (HR 2.08, P = 0.03).Conclusion In patients with severe AS, a global PLAS \textless21% is an independent predictor of prognosis. Given the combined influence of LV diastolic and systolic function and of LA performance on sPAP, the decline of PLAS might be considered a marker of global myocardial impairment in AS. Further studies are needed to confirm the critical role of LA relaxation in prognosis and to validate its relevance in routine clinical practice

Objective This study aimed to assess the long-term outcome of combined coronary revascularization. Methods Between January 2000 and September 2010, 106 consecutive patients underwent combined coronary revascularization, either the same day or staged within 90 days. Percutaneous coronary intervention was always performed before coronary artery bypass grafting. We identified three groups as follows: one-stop combined coronary revascularization (n = 20), percutaneous coronary intervention for acute coronary syndrome before subsequent surgery (n = 39), and percutaneous coronary intervention for stable coronary artery disease before subsequent surgery (n = 47). Off-pump technique was used in all cases. Results A total of 107 angioplasties were realized (drug-eluting stents, 21; bare metal stents, 114; balloon angioplasty, 4). Percutaneous coronary intervention was mostly performed in the right coronary artery or branches (85%). The mean (SD) number of grafts was 1.9 (0.6), among them 1.8 (0.7) with arterial grafts. A total of 87.7% of the patients underwent exclusive arterial revascularization. There was one reexploration for bleeding and no in-hospital death. Eleven patients died in the follow-up. Repeat percutaneous coronary intervention was necessary for six patients and repeat surgery for one patient. The mean (SD) follow-up was 6.1 (2.7) years. Complete follow-up was obtained in 96.2% of the patients. Freedom from ischemic events (all-cause deaths, angina, acute coronary syndrome, myocardial infarction) was 86.3% (3.7%) at 5 years and 79.7% (5.2%) at 8 years (no difference between groups). Freedom from major adverse cardiac or cerebrovascular events was 88.8% (3.4%) at 5 years and 75.7% (5.2%) at 8 years (no difference between groups). Conclusions Combined coronary revascularization increases the use of arterial grafts, with good long-term outcome.

International audience; OBJECTIVES To examine the haemodynamic performance of the St Jude Trifecta valve for aortic valve replacement (AVR) at 3 years after implantation. METHODS In a single-centre, prospective, observational, independent study, we enrolled 122 patients who had AVR using a Trifecta bioprosthesis in the July 2010–June 2011 period. A clinical and echocardiographic in-house follow-up was scheduled. RESULTS In our series, 14.7% of patients received a 19-mm, 28.7% had a 21-mm, 35.2% had a 23-mm and 21.3% had a greater-size prosthesis. There were no cases of operative mortality or of valve-related complications both early and at follow-up (except one sudden unexplained death). Completeness of the 3-year echocardiographic follow-up was 80% among survivors. The average mean transvalvular gradient (mTVG) at 3 years was 14.2, 10.8, 8.6, 7.1 and 6.8 mmHg (sizes 19 to 27/29, respectively). There was no statistically significant difference between average mTVGs measured immediately after implantation versus at the 3-year follow-up in the overall population. The average peak transvalvular gradient (pTVG) at 3 years was 25, 20, 16.8, 13.9 and 14.4 mmHg (sizes 19 to 27/29, respectively). The average indexed effective orifice area (iEOA) at 3 years was 0.8, 0.9, 1, 1.3 and 1.3 cm2/m2 (sizes 19–27, respectively). The rate of moderate patient–prosthesis mismatch (PPM) at 3 years was 15.7%; there were two instances of severe PPM (2.2%). All cases of PPM occurred in the 19, 21 and 23 mm size subgroups. CONCLUSIONS The Trifecta valve retains its excellent haemodynamic properties at the 3-year follow-up. The rate of PPM is considerably low

International audience; Background We address the differential long-term results of tricuspid valve replacement and late valve-related events among bioprostheses versus mechanical prostheses. Methods In a single-institution investigation, we reviewed the patients’ prospectively collected data and performed a clinical follow-up. Both the Kaplan-Meier (actuarial) and the competing risks (actual) methodologies were used. Results Overall, 188 tricuspid valve replacements were performed during 1971 to 2012. In this complex population (reoperations, 48.1%; associated procedures in 71.3%), operative mortality was 27.6% (significantly declining in recent years). A bioprosthesis was used in 82.4%. Follow-up was 10.2 ± 9.1 years (as long as 37.3 years, or 1,270 patient-years; 91.2% complete). At 15 years, freedom from structural valve deterioration was 93.3% ± 6.4% (competing risks 94.7 ± 5.1%) in the mechanical group and 85.2% ± 5.4% (competing risks 92% ± 2.9%) in the bioprostheses group (p = 0.19). Freedom from any valve-related adverse events was lower among mechanical valves versus bioprostheses (although not statistically significant). Mechanical valves showed significantly lower freedom from thromboembolic events (actuarial 62.3% ± 14.3% versus 97.7% ± 1.6%; competing risks 74.1% ± 10% versus 98% ± 1.4%; p < 0.001) and earlier adverse events (4.9 ± 4.5 versus 11.1 ± 9.4 years) than bioprostheses. There were 11 reoperations for bioprosthetic structural valve deterioration (89.8% and 94.3% actuarial and actual freedom, respectively). Conclusions Bioprostheses for tricuspid valve replacement have a very good long-term durability. Mechanical valves display earlier and more severe morbidity at follow-up

International audience; OBJECTIVES: The St Jude Medical Trifecta bioprosthesis incorporates a single pericardial sheet externally mounted on a titanium stent that provides excellent haemodynamic results. The purpose of this multicentre study was to report on the haemodynamic performance and the expected lower risk of prosthesis-patient mismatch in patient with small aortic annulus diameters. METHODS: The 19- and 21-mm Trifecta valves were implanted in 88 and 266 eligible patients, respectively between 2011 and 2013 at three centres in France (Angers, Rennes and Amiens). The mean age of the population was 78 +/- 7 and 76 +/- 6 years for 19- and 21-mm valve sizes of which 96.6 and 68% were female, respectively. The aortic valve replacement was associated with another surgery in 18.2 and 21.8% in each group, respectively. RESULTS: The mean follow-up was 20.3 +/- 11.9 and 24 +/- 11.4 months for 19- and 21-mm valves, respectively. Early all-cause mortality was 2.5% and late mortality occurred in 5.8% of patients. The mean pressure gradient and the effective orifice area at discharge and at 1 year were respectively 12.4 +/- 4.6 and 14.7 +/- 5.8 mmHg (P = 0.003), 1.5 +/- 0.3 and 1.4 +/- 0.9 cm(2) (P = 0.06) in the 19-mm valve group; 10.4 +/- 3.8 and 11.7 +/- 4.5 mmHg (P = 0.001), 1.8 +/- 0.3 and 1.5 +/- 0.4 cm(2) (P = 0.1) in the 21-mm valve group. At 1 year, only 38 (11%) and 28 (8.1%) patients presented a moderate or severe prosthesis-patient mismatch for the two groups. After univariate analysis, no risk factor of mismatch was found. CONCLUSIONS: The 19- and 21-mm St Jude Medical Trifecta provide excellent haemodynamic performance and the rate of moderate and severe prosthesis-patient mismatch is low.

Objective: Preoperative measurements of collateral blood flow in patients with triple vessel disease and chronic occlusions of the right coronary artery do not, currently, ascertain the need to revascularise an occluded right coronary artery. We performed direct measurements of flow across left coronary bypass grafts to determine their contributions to collateral blood flow. Methods: Collateral blood flow was scored preoperatively according to Rentrop in 13 patients with triple vessel disease and chronic occlusions of the right coronary artery who underwent complete, off-pump, surgical revascularisation. The transit-time flow through the left coronary grafts was measured before and after unclamping of the right coronary artery bypass graft. Results: Unclamping of the right coronary artery bypass graft was associated with a 5.9 ± 6.9 ml/min (mean ± SD) decrease in flow across the left circumflex territory (P = 0.009), which was proportional to the preoperative Rentrop score (P = 0.007). No significant change was observed in flow across the graft to the left anterior descending artery. Conclusions: Grafts to the left circumflex system are the only grafts that supply a significant, albeit modest amount of collateral blood flow to chronically occluded right coronary artery. These observations confirm that (1) most collateral flow after revascularisation is supplied by the native network, and (2) revascularisation of an occluded right coronary artery is fully justified.

Referred to by : Joseph M. Bednarczyk, Rohit K. SingalFunctional outcomes after resuscitative extracorporeal membrane oxygenation for cardiac arrest: The patients speak for themselvesThe Journal of Thoracic and Cardiovascular Surgery, Volume 150, Issue 4, October 2015, Pages 955-956; International audience; OBJECTIVES: Extracorporeal life support (ECLS) is an emerging option to treat selected patients with cardiac arrest refractory to cardiopulmonary resuscitation (CPR). Our primary objective was to determine the mortality at 30 days and at hospital discharge among adult patients receiving veno-arterial ECLS for refractory cardiac arrest. Our secondary objectives were to determine the 1-year survival and the health-related quality of life, and to examine factors associated with 30-day mortality. METHODS: In a retrospective, single-center investigation within a tertiary referral center, we analyzed the prospectively collected data of 49 patients rescued from refractory cardiac arrest through emergent implantation of ECLS (E-CPR) (18.1% of our overall ECLS activity, 2005-2013), implanted in-hospital and during ongoing external cardiac massage in all cases. A prospective follow-up with administration of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire was performed. RESULTS: The mean age was 47.6 ± 1.6 years; out-of-hospital cardiac arrest occurred in 12% of cases; average low-flow time was 47.2 ± 33 minutes; causes of cardiac arrest were heart disease (61.2%), trauma (14.3%), respiratory disease (4.1%), sepsis (2%), and miscellaneous (18.4%). PRIMARY OBJECTIVE: Rates of survival at E-CPR explantation and at 30 days were 42.9% and 36.7%, respectively; brain death occurred in 24.5% of cases. SECONDARY OBJECTIVES: Increased simplified acute physiology score; higher serum lactate levels and lower body temperature at the time of implantation were associated with 30-day mortality. Bridge to heart transplantation or implantation of a long-term ventricular assist device was performed in 8.2%. No deaths occurred during the follow-up after discharge (36.7% survival; average follow-up was 15.6 ± 19.2 months). The average Physical Component Summary and Mental Component Summary scores (SF-36 questionnaire) were, respectively, 45.2 ± 6.8 and 48.3 ± 7.7 among survivors. CONCLUSIONS: Extracorporeal cardiopulmonary resuscitation is a viable treatment for selected patients with cardiac arrest refractory to CPR. In our series, approximately one third of rescued patients were alive at 6 months and presented quality-of-life scores comparable to those previously observed in patients treated with ECLS

International audience; Previous coronary artery bypass grafting (CABG) increases operative risk in conventional valve replacement. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high-risk patient subgroups. The present study compared outcome and overall survival in patients who underwent TAVI with and without history of CABG. From January 2010 to December 2011, 683 of the 3,761 patients selected for TAVI in 34 French centers (18%) had a history of CABG. Outcomes (mortality and complications) were collected prospectively according to the Valve Academic Research Consortium (VARC) criteria. Patients with previous CABG were younger, with higher rates of diabetes and vascular disease and higher logistic European System for Cardiac Operative Risk Evaluation (29.8 ± 16.4 vs 20.1 ± 13.0, p

WOS:000369045700015; International audience; The valve-in-valve (ViV) procedure is an option for patients with symptomatic structural degeneration of a bioprosthesis and excessive reoperative risk. The risk of coronary obstruction appears to be increased if ViV is performed for certain pericardial prostheses in which the leaflets are mounted outside the stent posts. Herein is described a successful ViV for a degenerated Trifecta aortic bioprosthesis, and the technical considerations for performing a ViV procedure within such types of prosthesis are considered. Emphasis is placed on the importance of preoperative investigations (computed tomography scan-based measurements of coronary ostial height and of sinus of Valsalva diameters), and on the precise deployment of the valve (transapical approach with transesophageal echocardiography control) to minimize the risk of major complications. The presence of a failing Trifecta bioprosthesis should not be considered an absolute contraindication to ViV on the basis of the risk of coronary obstruction

International audience; OBJECTIVES: The relationship between anemia, renal insufficiency, and the outcomes of TAVI patients has not been thoroughly studied. We aimed to evaluate the influence of pre- and post-procedural anemia on the incidence of renal insufficiency, especially AKI, and on the outcomes of TAVI. METHODS: Data from the French national TAVI registry were collected in 3,472 patients who underwent TAVI between January 2010 and December 2012. Of these 2,137 were in the no/mild anemia group, 748 were in the moderate anemia group, and 587 were in the severe anemia group before TAVI. Furthermore, we divided the 3,472 patients into three groups according to post-procedural anemia, measured as post-procedural hemoglobin (Hb) drop: \textless2 g/dl (n=1,633, group 1), 2 to \textless4 g/dl (n=1,458, group 2), and \textgreater4 g/dl (n = 381, group 3). Procedure and outcome variables were compared. RESULTS: Increased severity of anemia before TAVI was associated with significantly different rates of 1-year mortality (15%, 19%, and 24%, P\textless0.01), with similar differences in the incidence of AKI (5%, 8%, and 10%, P\textless0.01). Increased severity of Hb drop was associated with significantly different rates of 1-year mortality (16%, 18%, and 23%, P\textless0.01), and with similar differences in the incidence of AKI (6%, 7%, and 10%, P=0.04). Both pre- and post-procedural anemia were predictors of the incidence of AKI (OR 1.82, P\textless0.01; OR 1.82, P\textless0.01, respectively) and 1-year mortality (HR 1.44, P\textless0.01; HR 1.50, P\textless0.01, respectively). CONCLUSIONS: Both pre- and post-procedural anemia were significantly associated AKI and 1-year mortality

International audience; OBJECTIVE: The study objective was to compare the 30-day outcomes of a standardized aortic valve repair technique (REPAIR group) associating root remodeling with an expansible aortic ring annuloplasty versus mechanical composite valve and graft (CVG group) replacement in treating aortic root aneurysms. METHODS: A total of 261 consecutive patients with aortic root aneurysm were enrolled in this multicentric prospective cohort (131 in the CVG group, 130 in the REPAIR group) in 20 centers. The main end point is a composite criterion including mortality; reoperation; thromboembolic, hemorrhagic, or infectious events; and heart failure. Secondary end points were major adverse valve-related events. Crude and propensity score adjusted estimates are provided. RESULTS: The mean age was 56.1 years, and the valve was bicuspid in 115 patients (44.7%). The median (interquartile range) preoperative aortic insufficiency grade was 2.0 (1.0-3.0) in the REPAIR group and 3.0 (2.0-3.0) in the CVG group (P = .0002). Thirty-day mortality was 3.8% (n = 5) in both groups (P = 1.00). Despite a learning curve and longer crossclamp times for valve repair (147.7 vs 99.8 minutes, P \textless .0001), the 2 groups did not differ significantly for the main criterion (odds ratio, 1.31; 95% confidence interval, 0.72-2.40; P = .38) or 30-day mortality (odds ratio, 0.99; 95% confidence interval, 0.28-3053; P = .99), with a trend toward more frequent major adverse valve-related events in the CVG group (odds ratio, 2.52; 95% confidence interval, 0.86-7.40; P = .09). At discharge, 121 patients (96.8%) in the REPAIR group had grade 0 or 1 aortic insufficiency. CONCLUSIONS: A new standardized approach to valve repair, combining an expansible aortic annuloplasty ring with the remodeling technique, presented similar 30-day results to mechanical CVG with a trend toward reducing major adverse valve-related events. Analysis of late outcomes is in process for 3- and 10-year follow-ups.

The aim of this study was to determine baseline characteristics and clinical outcomes of patients with pre-existing atrial fibrillation (AF) and of patients who presented with new-onset AF after transcatheter aortic valve implantation (TAVI).Little is known regarding the impact of AF after TAVI.The FRANCE-2 registry included all patients undergoing TAVI (N = 3,933) in France in 2010 and 2011. New-onset AF was defined as the occurrence of AF post-procedure in a patient with no documented history of AF.AF was documented before TAVI in 25.8% of patients. New-onset AF was observed in 174 patients after TAVI among patients without a history of pre-existing AF (6.0%). At 1 year, the rates of all-cause death (26.5 vs. 16.6%, respectively; p0.001) and cardiovascular death (11.5 vs. 7.8%, respectively; p0.001) were significantly higher in patients with pre-existing AF compared with those without AF. Rehospitalization for worsening heart failure and New York Heart Association functional class was also higher in patients with pre-existing AF versus those without, resulting in a higher rate of combined efficacy endpoint in this group (p0.001). A history of stroke, surgical (nontransfemoral) approach, cardiological, and hemorrhagic procedure-related events were all independently related to the occurrence of new-onset post-procedural AF. New-onset AF in patients without pre-existing AF was associated with a higher rate of combined safety endpoint at 30 days (p0.001) and a higher rate of both all-cause death and combined efficacy endpoint at 1 year (p = 0.003 and p = 0.02, respectively).Pre-existing and new-onset AF are both associated with higher mortality and morbidity after TAVI.

We thank Drs Iqbal and Serruys for their interesting comments on our study.1 Transcatheter aortic valve replacement is a very good alternative to conventional surgical replacement in patients with aortic stenosis at increased risk for surgery.2,3 As efficient as it is, transcatheter aortic valve replacement has important limitations, including postprocedural aortic regurgitation (AR). Our study was designed to (1) describe the rate of postprocedural AR evaluated at discharge in a large series of consecutive patients treated with balloon-expandable (BE) and self-expandable devices, (2) analyze the predictors of postprocedural ARs in the overall population for each device, and (3) analyze the impact of postprocedural ARs on clinical outcome. The results of our study1 and others2 demonstrate clearly that postprocedural AR≥moderate as evaluated by echocardiography at discharge is frequent (15%) and is an independent predictor of long-term mortality. Our study demonstrates also that the clinical significance of a postprocedural AR≥moderate is …

International audience; Aims Systolic pulmonary artery pressure (sPAP) is a well-known outcome predictor in patients with valvular heart disease. Limited data are available regarding the evaluation of right ventricular (RV) performance, particularly in patients with aortic stenosis (AS). The aim of this study was to evaluate the prevalence, determinants, and prognostic significance of RV dysfunction in severe AS independently from the strategy of treatment chosen. Methods and results Two hundred patients (mean age: 79.9 ± 8.8 years) with severe AS underwent two-dimensional and speckle tracking echocardiography for the evaluation of left ventricular (LV) and RV functions, aortic valve gradients, and sPAP. A tricuspid annular plane systolic excursion (TAPSE) ≤17 mm defined RV dysfunction. RV dysfunction was detected in 48 patients (24%). At multivariable regression analysis, LV global longitudinal strain (r = −0.29, P = 0.001), mean aortic gradient (r = 0.25, P = 0.002), and LV ejection fraction (r = 0.18, P = 0.02) were well correlated with TAPSE. After a median 16-month follow-up, cardiovascular death occurred in 17 patients. At multivariate Cox regression analysis, biventricular dysfunction (TAPSE ≤17 mm and LVEF ≤50%) emerged as the strongest predictor of prognosis (hazard ratio 4.08, 95% confidence interval 1.36–12.22; P = 0.012). Conclusions RV dysfunction is common in AS patients, and this finding can likely be accounted for by the RV–LV interdependence. Given that biventricular function impairment was a strong predictor of mortality in our population, we suggest that RV dysfunction should be systematically looked for in AS patients

Aortic stenosis (AS) is the most frequent heart valve disease. Surgical aortic valve replacement (SAVR) is the reference treatment. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment. New strategies for treating the AS are upcoming. The aim of the study was to assess if the clinical profile of octogenarian patients treated surgically before and after the TAVI program initiation has changed. We retrospectively included consecutive octogenarian patients, who underwent isolated SAVR, from January 2006 to December 2011 in a single high-volume center. We compared preoperative and postoperative characteristics before and after the initiation of TAVI (February 2009). Five hundred seventeen patients were included: 229 in the "pre-TAVI" group (2006 to 2008), 288 in the "post-TAVI" group (2009 to 2011). The mean age was 83.2 ± 2.0 in the "pre-TAVI" group, 83.5 ± 2.1 in the "post-TAVI" group (p = 0.106). There were no significant differences in preoperative characteristics: New York Heart Association class (p = 0.374), history of heart failure (p = 0.680), left ventricular ejection fraction (59.8 ± 12.2% in the "pre-TAVI" group, 59.9 ± 11.3% in the "post-TAVI" group, p = 0.922), coronary artery disease (p = 0.431), chronic pulmonary disease (p = 0.363), and previous cardiac surgery (p = 0.085). The logistic EuroSCORE was 7.78 ± 4.60% in the "pre-TAVI" group and 7.33 ± 3.96% in the "post-TAVI" group (p = 0.236). The operative mortality (30-day) was comparable: 5.2% in the "pre-TAVI" group, 6.9% in the "post-TAVI" group (p = 0.424). Thus, with the emergence of TAVI, the number of octogenarian patients operated on, their preoperative characteristics, and the operative mortality remained comparable.

Objective: To analyse the long term prognosis in patients with isolated stenoses of the left main coronary artery (LMCA) following surgical revascularisation. Patients: 106 patients (71 men and 35 women, mean age 61 years) were operated on between 1982 and 1998. Before surgery, 103 patients presented with angina pectoris and only 10 had a history of myocardial infarction. Their mean left ventricular ejection fraction was 62%. Stenoses were localised on the LMCA ostium in 19 patients, a subgroup characterised by a high proportion of women (68%). Three patients presented with chronic LMCA occlusion. Forty six patients were operated on as an emergency. The mean (SD) number of grafts per patient was 2.0 (0.5), and only one patient had no left anterior descending (LAD) coronary artery bypass. Bypass of the LAD using the internal thoracic artery was performed in 88 cases. Results: Early postoperative mortality was 4.7% and the five year survival was 86.8%. Late mortality occurred in nine cases, and in three of these it was linked to a coronary condition. Of the 92 long term survivors, 81.5% were totally symptom-free and 77% of those of working age were able to resume work. The postoperative outcome of patients with isolated ostial LMCA stenosis did not differ significantly from that of the other patients. Conclusions: The postoperative prognosis of isolated LMCA stenosis appears good in terms of mortality and symptoms.

AIMS To assess the relationship between a low preprocedural (

Background The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. Methods Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. Results At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m 2 at discharge to 122 g/m 2 at 1 year. Conclusions At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience.

International audience; AIM: In the TELEDIAB-1 study, the Diabeo system (a smartphone coupled to a website) improved HbA1c by 0.9% vs controls in patients with chronic, poorly controlled type 1 diabetes. The system provided two main functions: automated advice on the insulin doses required; and remote monitoring by teleconsultation. The question is: how much did each function contribute to the improvement in HbA1c? METHODS: Each patient received a smartphone with an insulin dose advisor (IDA) and with (G3 group) or without (G2 group) the telemonitoring/teleconsultation function. Patients were classified as "high users" if the proportion of "informed" meals using the IDA exceeded 67% (median) and as "low users" if not. Also analyzed was the respective impact of the IDA function and teleconsultations on the final HbA1c levels. RESULTS: Among the high users, the proportion of informed meals remained stable from baseline to the end of the study 6months later (from 78.1+/-21.5% to 73.8+/-25.1%; P=0.107), but decreased in the low users (from 36.6+/-29.4% to 26.7+/-28.4%; P=0.005). As expected, HbA1c improved in high users from 8.7% [range: 8.3-9.2%] to 8.2% [range: 7.8-8.7%] in patients with (n=26) vs without (n=30) the benefit of telemonitoring/teleconsultation (-0.49+/-0.60% vs -0.52+/-0.73%, respectively; P=0.879). However, although HbA1c also improved in low users from 9.0% [8.5-10.1] to 8.5% [7.9-9.6], those receiving support via teleconsultation tended to show greater improvement than the others (-0.93+/-0.97 vs -0.46+/-1.05, respectively; P=0.084). CONCLUSION: The Diabeo system improved glycaemic control in both high and low users who avidly used the IDA function, while the greatest improvement was seen in the low users who had the motivational support of teleconsultations.

International audience; OBJECTIVES: To describe the clinical results (both early and at follow-up) of patients currently receiving extracorporeal membrane oxygenation (ECMO) therapy for cardiac and/or pulmonary failure. To assess the effect of indications, clinical presentations and ECMO modalities on early/late clinical outcomes. To identify baseline factors associated with worse survival at follow-up. METHODS: We reviewed the prospectively collected data of 325 patients receiving ECMO therapy at a tertiary referral centre during the 2005-2013 period. Follow-up was prospectively conducted by dedicated personnel (average: 84 ± 86 days, 100% complete). Survival was analysed by stratified Kaplan-Meier curves. RESULTS: Veno-arterial (VA) ECMO was employed in 80% of cases (due to early graft failure (EGF) in 13% of cases, post-cardiotomy in 29%, primary cardiogenic shock in 42% for miscellaneous aetiologies, other indications in 15.4%) and veno-venous (VV) ECMO in the remainders (adult respiratory distress syndrome). In the VA and VV groups, weaning rates were 59 and 53%, survival at 30th postimplantation day was 44 and 45% and survival at the end of the follow-up was 41 and 45%, respectively. Implantation under advanced life support (ALS) occurred in 15% of cases (26% survival at 30 days). VA patients had a higher rate of thrombotic/haemorrhagic complications and of transfusion of blood products and shorter ventilation time. Worse early and follow-up survival were observed among patients aged ≥65 years, having pH ≤ 7, lactates \textgreater12 mmol/l, creatinine \textgreater200 μmol/l at implantation or receiving ECMO under ALS. No difference in survival was noted among VA vs VV patients. Patients receiving ECMO for EGF displayed better early and late survival (64% at 30 days and 53% at 6 months) than post-cardiotomy (36 and 34%, respectively), post-acute myocardial infarction (48 and 40%) and the remaining patients (46 and 45%). CONCLUSIONS: Despite most critical baseline conditions, ECMO therapy is confirmed useful for the treatment of patients with acute cardiopulmonary failure refractory to conventional treatments. The ECMO modality (VA vs VV), as well as indications to support, identifies different patient profiles and dissimilar outcomes. Preimplantation markers of gravity and end-organ damage are useful in the stratification of expected survival. These may facilitate clinical decision-making and appropriate allocation of hospital resources

Background . After 35 years of cardiac valve replacement, the ideal substitute remains to be found. Homografts are considered best but, due to their scarcity, cannot meet the need of valve replacement. Artificial valves (mechanical or biological) remain the most commonly used but controversy is still present as to the better choice. We tested the Carpentier-Edwards bioprosthesis for its efficacy in valve replacement operations. Methods . From 1983 to 1995, 1,108 consecutive patients had an isolated aortic valve replacement with a porcine Carpentier-Edwards bioprosthesis, model 2650 supra-annular valve. Mean age was 73.8 ± 8.3 years. Aortic stenosis was the most common lesion (1,049 patients, 94.7%). The follow-up of 980 operative survivors was 96% complete and represented a total of 4,735 patient-years (maximum, 13.8 years; mean, 4 years and 10 months). Results . Actuarial survival including operative mortality (128 patients, 11.6%) was 43.6% ± 2.3% at 10 years and 27.3% ± 3.3% at 12 years and, at that time, was not statistically different from those of the normal French population matched for age and sex. Structural deterioration of the valve was observed in 27 patients, an actuarial freedom of 94.2% ± 1.5% at 10 years and 83.8% ± 4.5% at 12 years. Hazard function revealed a stable and low risk of structural deterioration until 10 years and significantly increased risk after that. Young age was found to be an increasing risk factor of deterioration. Reoperation for valve-related complications was necessary in 30 patients, an actuarial freedom of 94.5% ± 1.4% at 10 years. Conclusions . The Carpentier-Edwards porcine supra-annular valve affords a good durability up to 10 years, with a low rate of reoperation. The risk of structural deterioration decreases with older age. It is our valve of choice in elderly patients.

Background . With increased life expectancy, valve operations are more and more common in elderly patients. The choice of valve substitute—mechanical valve or bioprosthesis—remains debated. Methods . Two groups of patients of the same age (69, 70, and 71 years) with isolated aortic valve replacement (mechanical 240, bioprostheses 289) were compared for mortality, morbidity, and valve-related complications. Results . No significant difference was found in survival, valve-related mortality, valve endocarditis, and thromboembolism. Mechanical valve had more bleeding events; bioprostheses had more structural deterioration, reoperation, and valve-related morbidity and mortality. Conclusions . To avoid reoperations in octogenarians, the 10-year durability of current bioprostheses should be matched with the life expectancy of the particular patient. Bioprostheses should be used after 74 years in men and 78 years in women.

The aim was to evaluate the early and long-term results of redo-aortic valve replacement (AVR) for dysfunctioning bioprostheses, according to the type of bioprosthesis failure. The performance of the EuroSCORE in predicting operative mortality was addressed.A retrospective analysis was performed of 164 patients who had undergone redo-AVR at the authors' institution. All data were collected prospectively. The type of bioprosthesis failure was categorized as either structural valve dysfunction (SVD), non-structural vale dysfunction (NSVD), or infective endocarditis (IE). The logistic EuroSCORE I was obtained, and a formal analysis of its predictive performance was conducted.The mean logistic EuroSCORE was 26.3 +/- 20.6%, while the observed operative mortality was 10.6%. The EuroSCORE overestimated mortality in all subgroups of indication; operative mortality was higher among the NSVD (14.7%) and IE (13.9%) groups, and lower among SVD patients (8.5%). The performance of the EuroSCORE in predicting mortality was better in SVD patients, and worse in NSVD patients (areas under the ROC curve of 0.857 and 0.751, respectively). Only patient-related factors independently predicted the operative mortality (logistic regression). The SVD patients displayed a significantly better long-term survival compared to NSVD and IE patients. Patient-related factors were seen to be the determinants of long-term survival.Redo-AVR can be performed with good early and long-term results, despite a high predicted risk. The logistic EuroSCORE I globally overestimates the risk, and its performance varies considerably according to the indication for redo-AVR. Therefore, it should not be used to determine the application of valve-in-valve procedures. The type of indication for redo-AVR (SVD, NSVD, IE) defines three different profiles of patients having distinctive early and long-term behaviors.

Infective endocarditis represents a pathological process associated with a high mortality. The dysfunction of cardiac valves and its consequent hemodynamic deterioration often requires urgent surgery. Tissue preservation and valve repair without a substitute material may be extremely difficult. Herein, the details are reported of a safe technique used to repair a mitral valve presenting with P1 destruction caused by pneumococcal endocarditis vegetation, associated with severe mitral regurgitation. A safe repair was achieved by performing a P2 to P1 transposition, after a subvalvular apparatus analysis, followed by annular plication and ring annuloplasty. The postoperative course was uneventful, and echocardiography at discharge showed excellent mitral valve competence. Sufficient evidence was provided to demonstrate that, in these cases, it is better to repair than to replace. Hence, the present technique should be considered, whenever possible, for mitral valve surgical repair in order to avoid substitute interposition in cases of infective endocarditis.

International audience; BACKGROUND: The operative risk of cardiac surgery is ascertained preoperatively on the basis of scores validated in multinational studies. However, the value they add to a simple bedside clinical evaluation (CE) remains controversial. AIMS: To compare operative mortality (defined as death from all causes before the 31st postoperative day) predicted by CE with that predicted by additive and logistic EuroSCOREs, EuroSCORE II and Society of Thoracic Surgeons (STS), Ambler and age-creatinine-ejection fraction (ACEF) scores in patients undergoing aortic valve replacement (AVR) for severe aortic stenosis. METHODS: Overall, 314 consecutive patients were included who underwent AVR between October 2009 and November 2011 (22% with coronary artery bypass graft); mean age 73.4 ± 9.7 years (29% aged\textgreater80 years). Based on CE, patients were divided into four predefined groups of increasing estimated mortality risk: I ≤ 3.9%; II 4-6.9%; III 7-9.9%; IV ≥ 10%. The positive and negative predictive values of the six scores and CE were compared. RESULTS: The observed overall operative mortality was 5.7%. The distribution of the four predicted mortality groups by each score was highly variable. The positive predictive value, calculated for the 64 patients classified at highest risk by CE (groups III or IV) or each score, was 17.2% for EuroSCORE II, 14.1% for CE and STS scores, 10.9% for additive and logistic EuroSCOREs, 10.6% for ACEF and 10.2% for Ambler. The positive predictive value of each score in the low-risk groups (I and II) ranged from 2.8% to 4.4%. CONCLUSION: A simple bedside CE appears as reliable as the various established scores for predicting operative risk in patients undergoing surgical aortic valve replacement. The development and validation of more comprehensive risk stratification tools, including risk factors thus far neglected, seems warranted.

Summary Background Currently, several anatomical approaches and intervention sites can be used to perform transcatheter aortic valve implantations (TAVIs), often with no clinical indications for choosing one or another. While these choices can have an impact on resource consumption, no costing study is available in the European context to provide information on resource use and assist decision-making. Aims To provide comparative data on the cost of the TAVI procedure, depending on anatomical approach and intervention site used, from a hospital perspective, and to analyze factors associated with cost of hospital stay. Methods Multicentre national registry data were collected in 16 centres between January and October 2009. For 287 patients, a descriptive costing study and a multivariable analysis of hospital stay cost were performed. Results The mean cost of the TAVI procedure was € 22,876 and the mean initial hospital stay cost was € 35,164. The procedure cost, excluding valve cost, did not differ between anatomical approaches and was highest in the hybrid room and lowest in the catheterization laboratory. Factors associated with higher hospital stay cost were transapical approach, Society of Thoracic Surgeons score > 10%, warfarin use at inclusion, complications during procedure and pacemaker implantation following valve implantation. Conclusions If clinical considerations do not interfere, hospital staff may find it economically favorable to opt for the catheterization laboratory and against the hybrid room. The mean hospital stay cost is higher than the tariff paid in 2011, a difference that has grown since the change in tariff in 2012, representing an economic disincentive for the uptake of TAVI in France.