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The mortality rate of patients with post-myocardial infarction (MI) ventricular septal defects (VSDs) is high, and the benefit of surgery is unclear. We aimed to investigate the management and outcomes of post-MI VSD over a 10-year period in a large cohort.Data of patients with post-MI VSD admitted in three French university hospitals from 2008 to 2019 were examined. The characteristics of those who underwent surgery were compared with those who received medical treatment. Mortality risk factors, survival curves, and outcomes at 30 days and 1 year after treatment were determined.Of the 92 patients whose data were examined, 50 underwent surgery and 42 received exclusive medical treatment. All patients were critically ill. Overall, 76.1% of patients received inotropic support, and 63% received mechanical ventilation. Circulatory assistance, mainly via intra-aortic balloon pump and extra-corporeal membrane oxygenation, was provided to 46.7% patients, with 14.1% requiring a second assistance. The median time to surgery was 4 days. At 1 year, mortality was 46% in those who underwent surgery and 83.3% in those treated medically (p .001). Survival curves at 1 and 3 months showed major differences, and the survival rate showed little change 30 days after treatment. Cardiogenic shock and cardiac arrest emerged as risk factors for mortality.In our retrospective, multicenter study, the mortality resulting from post-MI VSD did not seem to improve over the last decade. Although surgery carried considerable risks, it improved survival.

Objectives This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the Mitraclip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial. Background It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials. Methods In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months. Results We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm2, RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. Conclusions In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the Mitraclip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).

COVID-19 has put each and every one at test. Cardiological clinics are facing constrained resources, limiting timely treatment of patients as usual. Patients with valvular heart disease are one of the most time sensitive patient populations, with delayed therapy possible leading to increased morbidity and mortality. Identifying and allocating the available resources to the most vulnerable patients is crucial in providing optimal patient care with prioritization of essential surgical or percutaneous procedures for valvular heart disease. Implementing telemedicine approaches might help to minimize non-essential physician-to-patient contact to ensure safety, for both patients and lastly but not least the treating physicians.

Interventional cardiology devices and especially stents are constantly evolving. A good radiopacity is essential to properly position the stent and to reduce the risk of complications during percutaneous coronary intervention (PCI). We wanted to assess the radiopacity of coronary stents. 9 stents were evaluated. Stents were deployed in a silicon bifurcation model and several pulsed fluoroscopy acquisitions (7.5 and 15 pulses/s) of each device were performed in a catheterization laboratory. Quantitative radiopacity assessment was performed using a radiopacity visual scale and qualitative radiopacity assessment was performed by showing the images to three experienced operators, single-blind. Our study showed statistically significant differences between stents regarding radiopacity assessed in a quantitative analysis (p < 0.000001) or a qualitative analysis (p < 0.000001), whether the acquisitions were made in 7.5 or 15 pulses/s. Resolute Onyx and Synergy were the most radio-opaque in both qualitative and qualitative analysis. Moreover, there was a statistically significant correlation between the radiopacity of stents, their strut thickness (p < 0.0001) and the presence of platinum in their metallic alloy (p < 0.0001). This study highlighted significant differences in the radiopacity of coronary stents deployed in a bench test model. The strut thickness and the presence of platinum increased the radiopacity.

Background In adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is acute coronary artery occlusion. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST segment elevation. Hypothesis Performing an immediate CAG after an OHCA without ST segment elevation on the post-resuscitation ECG and no obvious non-cardiac cause of arrest could lead to a better 180-day survival rate with no or minimal neurological sequel as compared with a delayed CAG performed 48 to 96 hours after the arrest. Design The EMERGE trial is a prospective national, randomized, open and parallel group trial, in which 970 survivors of OHCA will be randomized (1:1) to either immediate (as soon as possible after return of spontaneous circulation) or delayed (48 to 96 h) CAG. Participants will be OHCA patients with no ST segment elevation on the post resuscitation ECG and no obvious non-cardiac cause of arrest. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel corresponding to Cerebral Performance Category (CPC) 1 or 2. The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC score at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay. Summary The EMERGE trial is a prospective, multicenter, randomized, controlled trial that will assess the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST segment elevation and who will be managed with either immediate or delayed CAG.

Aims Tricuspid regurgitation (TR) is associated with significant morbidity and mortality. Its independent prognostic role has been repeatedly demonstrated. However, this valvular heart condition is largely undertreated because of the increased risk of surgical repair. Recently, transcatheter techniques for the treatment of TR have emerged, but their implications for the clinical endpoints are still unknown. Methods and results The Tri.fr trial will be a multicentre, controlled, randomized (1:1 ratio), superior, open-label, and parallel-group study conducted in 300 patients with severe secondary TR that is considered non-surgical by heart teams. Inclusion will be possible only after core laboratory review of transthoracic and transoesophageal echocardiography and after validation by the clinical eligibility committee. A description of the mechanisms of the TR will be conducted by the core laboratory. Atrial or ventricular impacts on the severity of the secondary TR will be taken into account for the randomization. The patients will be followed for 12-month, and the primary outcome will be the Packer composite clinical endpoint [combining New York Heart Association class, patient global assessment (PGA), and major cardiovascular events]. It will test the hypothesis that a tricuspid valve percutaneous repair strategy using a clip dedicated to the tricuspid valve is superior to best guideline-directed medical therapy in symptomatic patients with severe secondary TR. Conclusion Tri.fr will be the first randomized, academic, multicentre study testing the value of percutaneous correction in patients with severe secondary TR.

Introduction: In adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is coronary artery disease. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation (ST +) on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST +. Hypothesis: Performing an immediate CAG after an OHCA without ST + on the post-resuscitation ECG and no obvious non-cardiac cause of arrest leads to a better outcome. Methods: The EMERGE trial is a multicenter, randomized, controlled trial that assessed the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST + randomized (1:1) to either immediate or delayed (48 to 96h) CAG. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel (Cerebral Performance Category (CPC) 1 or 2). The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC scale at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay. Results: 279 patients were enrolled, 141 in the immediate and 138 in the delayed CAG group. Mean age was 65 and 195 were males. The mean delays between randomization and CAG were 0.6 ± 3.7 hours and 55.1 ± 37.2 hours in the immediate and delayed CAG group respectively. The 180-day survival rates among patients with CPC 1 or 2 were 34.1% and 30.7% in the immediate and delayed CAG group, respectively (hazard ratio: 0.87 [95% CI, 0.65; 1.15], P=0.324). The 180-day survival rates in the whole population were 36.2% and 33.3% in the immediate and delayed CAG group, respectively (HR: 0.86 [95% CI, 0.64-1.15], P=0.308). Conclusions: In patients successfully resuscitated after an OHCA without ST +, a strategy of immediate CAG was not found to be better than a strategy of delayed CAG with respect to 180-day survival rate with no or minimal neurological sequel.

Resume Les pathologies de la voie droite sont historiquement les consequences de la chirurgie correctrice d’une malformation cardiaque congenitale en periode neonatale ou pediatrique (Tetralogie de Fallot, intervention de Ross). Ces chirurgies realisees dans l’enfance conduisent a l’apparition de dysfonctionnements de la voie droite (stenose, fuite) chez le grand enfant ou l’adulte jeune pour lesquels une nouvelle chirurgie serait a risque operatoire eleve. L’avenement des premieres valves percutanees en 2000 a permis d’ouvrir la voie de la revalvulation pulmonaire. La procedure de revalvulation pulmonaire percutanee offre une alternative credible a la chirurgie dans la population des patients porteurs d’une cardiopathie congenitale souvent multi operes donc a risque operatoire eleve. Les deux valves actuellement sur le marche francais (Melody®, SapienXT®) permettent de couvrir l’ensemble des indications exceptees les voies tres larges qui restent eminemment chirurgicales. Les equipes qui pratiquent ces actes sur des sujets jeunes doivent beneficier d’une experience suffisante pour limiter le risque procedural. Sur cette base, plusieurs equipes positionnent desormais la revalvulation pulmonaire percutanee en priorite sur la revalvulation chirurgicale qui n’est retenue qu’en cas d’impossibilite du traitement percutane.

Aims The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. Methods and results At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30). Conclusions In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.

A 48-year-old who underwent a Mustard operation in 1972 followed by a second cardiac intervention in 1996 for pulmonary venous baffle enlargement and residual baffle leak closure, complicated by recurrent atrial flutter, was admitted to our institution for severe systemic atrio-ventricular valve regurgitation (SAVVR) associated with severely impaired systemic right ventricular (RV) function. After careful preoperative anatomic assessment including three-dimensional transesophageal echocardiography (3DTEE) to define the clipping strategy and computed tomography to optimize the transvenous baffle puncture site, the intervention was performed under general anesthesia, fluoroscopic, and 3DTEE guidance. One XTR MitraClip was successfully implanted, achieving a significant reduction in regurgitation and immediate clinical improvement. The transbaffle puncture was closed using an 8 mm atrial septal defect (ASD) device without residual shunt or obstruction of the venous baffle. Post-operative clinical evaluation showed immediate improvement in the NYHA functional class (from III to II), but the patient presented with recurrent flutter at 1 week after the procedure, which was successfully treated by catheter ablation with another transbaffle approach next to the ASD device. Clinical improvement was maintained at 1- and 6-month follow-up with significant reduction in SAVVR, reduced systemic RV volumes and improved RV ejection fraction. This case demonstrates the feasibility of percutaneous treatment of systemic SAVV in patients with systemic RV after atrial redirection.

Background Even though several devices have been developed to facilitate occlusion of cardio vascular structures in adults, only a few types of plugs have been approved in selected pediatric indications. However, apart from patent ductus arteriosus (PDA) closure, little data has been published in children, particularly with regard to the heterogeneity of the procedures and outcomes. Aim To describe the efficacy, safety, and characteristics of the utilization of the Amplatzer Vascular Plug (AVP) II and IV for cardiovascular percutaneous occlusions in children under 10 years. Methods Retrospective multicenter (2006–2020, 6 academic centers) observational review of pediatric transcatheter occlusions using AVP II or IV. Results A total of 125 consecutive children (60 Conclusions AVP II and IV are safe and effective for the percutaneous treatment of numerous cardiovascular lesions in children under ten. In our multicenter experience, such devices represent a real “off-label” pediatric alternative in well-selected patients.

International audience; Background The COCCINELLE study is a nationwide retrospective French cohort set up to evaluate the risk of radiation associated cancer in patients who undergone cardiac catheterization (CC) procedures for diagnosis or treatment of congenital heart disease during childhood [1].Material and methods Children who undergone CC procedures from 01/01/2000 to 31/12/2013 before the age of 16 in one of the 15 pediatric cardiology departments which perform pediatric CC in mainland France were included. The follow-up started at the date of the first recorded CC procedure until the exit date, i.e. the date of death, the date of first cancer diagnosis, the date of the 18th birthday, or the 31/12/2015, whichever occurred first. The cohort was linked to the National Childhood Cancer Registry to identify patients diagnosed with cancer and with the French National Directory for the Identification of Natural Persons to retrieve the patients’ vital status. An external comparison was conducted using standardized incidence ratios (SIR). Breslow and Day’s approximation was used to estimate 95% confidence intervals (CI) for the SIRs [2]. Results A total of 17,104 children were included in the cohort and followed for 110,335 person-years, with 22,227 CC procedures collected. Among the patients, 81.6 % received only one procedure. Fifty-nine cancer cases were observed in the cohort. SIRs were increased for all-cancer (SIR = 3.8, 95% CI 2.9, 4.9), leukemia (SIR = 3.3, 95% CI 2.0, 5.4), lymphoma (SIR = 14.9, 95% CI 9.9, 22.5) and solid cancers excluding central nervous system tumors (SIR = 3.3, 95% CI 2.0, 5.5) compared with the general population. Conclusion Increased risks of cancer were observed. Potential explanations include shared genetic or environmental factors, immunosuppression drugs, and exposure to medical ionizing radiation procedures. The dose-response analysis between ionizing radiation doses received during CCs and cancer occurrence will allow to address this question.Keywords: Ionizing radiation, cardiac catheterization, congenital heart disease, cancerCompeting interestsThe authors declare that they have no competing of interest.References1.Baysson H, Nkoumazok B, Barnaoui S, Réhel J, Girodon B, Milani G, Boudjemline Y, Bonnet D, Laurier D, Bernier M (2015) Follow-up of children exposed to ionising radiation from cardiac catheterisation: the Coccinelle study. Radiation protection dosimetry 165:13–162.Breslow NE, Day NE (1987) Statistical Methods in Cancer Research Volume II: The Design and Analysis of Cohort Studies, IARC Scientific Publication. IARC Scientific Publication No. 82, Lyon, France: International Agency for Research on Cancer.NotesCOCCINELLE: French acronym for COhorte sur le risque de Cancer après Cardiologie INterventionnELLECC: Cardiac CatheterizationSIR: Standardized Incidence Ratios CI: Confidence IntervalsCNS: Central Nervous System

Aims Important controversies remain concerning the determinants of life-threatening arrhythmias during ST-segment elevation myocardial infarction (STEMI) and their impact on late adverse events. This study sought to investigate which factors might facilitate ventricular tachycardia (VT) and ventricular fibrillation (VF), in a homogeneous population of anterior STEMI patients defined by abrupt left anterior descending coronary artery (LAD) occlusion and no collateral flow. Methods and results The 967 patients, who entered into the CIRCUS (Does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients) study, were assessed for further analysis. Acute VT/VF was defined as VT (run of tachycardia >30 s either self-terminated or requiring electrical/pharmacological cardioversion) or VF documented by electrocardiogram or cardiac monitoring, during transportation to the cathlab or initial hospitalization. VT/VF was documented in 136 patients (14.1%). Patients with VT/VF were younger and had shorter time from symptom onset to hospital arrival. Site of LAD occlusion, thrombus burden, area at risk, pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction flow, and ST-segment resolution were similar to that of patients without VT/VF. There was no impact of VT/VF on left ventricular remodelling or clinical outcomes. By multivariate analysis, the use of morphine (odds ratio 1.71; 95% confidence interval (1.13–2.60); P = 0.012) was the sole independent predictor of VT/VF occurrence. Conclusions In STEMI patients with LAD occlusion, our findings support the view that morphine could favour severe ventricular arrhythmias.

Background : To evaluate the long-term results of implantation of homogeneous large size of pulmonary homograft (PH) for reconstruction of the right ventricular outflow tract (RVOT). Methods : Between January 2000 and December 2017, 107 patients were implanted with PH for reconstruction of the RVOT. Data were collected retrospectively in this single-center study. PH failure was defined as a peak of gradient > 40 mmHg and/or as a pulmonary regurgitation > grade 2. Primary endpoint was the re-operation of the RVOT during follow-up. Secondary endpoints were overall survival, occurrence of PH failure and the rate of re-operation for all cause. Results : Mean age of the recipients was 26.13  13.59 years. Mean size of PH was 23.02  6.87 mm. Re-operation of the RVOT occurred in 8 patients (7.8%). Time before re-operation was 2.74 years (Interquartile Range: 6.41). Freedom from re-operation for RVOT at 5 and 10 years was respectively 95.7% and 90.0%. Overall survival at 10 years was 95.2%. PH failure occurred in 13 patients (12.0%). Mean time before PH failure was 5.00  4.35 years. Freedom from PH failure at 10 years was 81.6%. Re-operation for PH failure occurred in 4 patients (3.9%). Concomitant tricuspid valve surgery (p=0.037), initial pulmonary stenosis (p=0.04), recipient of PH < 16 years old (p=0.043) were risk factors of late reoperation in univariate analysis. Multivariate analysis showed no independent risk factor of late reoperation. Conclusions : Implantation of large PH for RVOT reconstruction provides excellent mid-term results in terms of re-operation.

This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial.It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials.In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months.We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mmIn the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).

Objectives The aim of this study was to describe and analyze data from patients treated in France with the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences LLC, Irvine, California) in the pulmonary position. Background The Edwards SAPIEN valve has recently been introduced for percutaneous pulmonary valve implantation (PPVI). Methods From April 2011 to May 2017, 71 patients undergoing PPVI were consecutively included. Results The median age at PPVI was 26.8 years (range 12.8 to 70.1 years). Primary underlying diagnoses were conotruncal malformations (common arterial trunk, tetralogy of Fallot and variants; n = 45), Ross procedure (n = 18), and other diagnoses (n = 8). PPVI indication was pure stenosis in 33.8% of patients, pure regurgitation in 28.1%, and mixed lesions in 38.1%. PPVI was successfully implemented in 68 patients (95.8%). Pre-stenting of the right ventricular outflow tract was performed in 70 patients (98.6%). Early major complications occurred in 4 subjects (5.6%), including 1 death, 1 coronary compression, and 2 pulmonary valve embolizations. Three of the 4 major complications occurred in the first 15 operated patients. No significant regurgitation was recorded after the procedure. Transpulmonary gradient was significantly reduced from 34.5 to 10.5 mm Hg (p Conclusions Early results with the Edwards SAPIEN valve in the pulmonary position demonstrate an ongoing high rate of procedural success.

Objectives This study sought to report the specific considerations and implications of percutaneous edge-to-edge repair in one case of severe systemic tricuspid regurgitation (STR). Background In congenitally-corrected transposition of great arteries (ccTGA) tricuspid valve results spontaneously in systemic position. In this situation, progressive STR and systemic right ventricular (SRV) dysfunction are frequently observed, leading ultimately to altered functional capacities and pulmonary edema. In this setting surgical valve repair or replacement is challenging given the underlying SRV failure, therefore heart transplant is usually preferred. However, recent studies have underlined the reliability of edge-to-edge repair for secondary severe tricuspid and mitral regurgitation. Few data are currently available concerning the percutaneous management of STR. Case management We report about the case of a 59 year-old man presenting with dyspnea and mild peripheral edema. He was known for non-operated ccTGA with SRV ejection fraction (EF) of 25%, and severe STR, defined as an effective regurgitant orifice area of 40 mm2. The patient was in theory eligible for heart transplant but a percutaneous approach was first attempted. The procedure was performed under general anesthesia, transesophageal echocardiography guidance and through a femoral vein route. A MitraClip XTR device (Abbott Vascular, Santa Clara, CA) was successfully implanted between the septal and the anterior leaflets, without any complication ( Fig. 1 ). After the procedure the STR improved dramatically from grade IV to I. After 2 years follow-up the patient is still asymptomatic and free from severe STR, concomitantly SRV EF improved up to 32% under optimal medical treatment. Conclusions Percutaneous edge-to-edge therapy of STR in ccTGA seems to be feasible, safe and effective to reduce regurgitation grade, to limit SRV dilatation and to improve patient symptoms.

Cardiac catheterization has greatly contributed to the progress made in the management of congenital heart diseases (CHD). Initially used in diagnosis, it allowed the understanding of heart diseases, their anatomy and hemodynamics. Gradually, the development of interventional cardiology has played a major role in the management of these malformations (Patent ductus arteriosus [PDA] and atrial septal defect [ASD] closure, pulmonary dilatation, percutaneous pulmonary valve implantation…). The development of such technology was made possible through the concomitant development of imaging techniques: fluoroscopy, ultrasound, MRI and CT. Imaging should provide an accurate view of the lesions, the surrounding cardiac structures, as well as medical devices and catheters used. Here we address the field of fusion images. The principle of image fusion is based on the association by superposition of several imaging techniques: real-time fluoroscopy and slice imaging performed offline, or ultrasound imaging performed simultaneously. The goal is to improve the overall view of the organ, its surrounding structures and as the consequence to help the interventional cardiologist.

International audience; BACKGROUND: Bifurcation lesions in coronary arteries are complex to treat with coronary stents, which are not designed for that purpose and can be unproperly deployed. Moreover, devices are constantly evolving, and so are angioplasty techniques. OBJECTIVES: The aim of this study was to determine the performances of different stents in the treatment of bifurcation lesions using the re-proximal optimization technique (rePOT). METHODS: Eleven stent platforms were evaluated: Xience Sierra (Abbott), Xience Alpine (Abbott), Synergy (Boston), Coroflex Isar (Bbraun), Cobra PzF (Celonova), Ultimaster (Terumo), Resolute Integrity (Medtronic), Resolute Onyx (Medtronic), Optimax (Hexacath), Orsiro (Biotronik), and Absorb (Abbott). Stents were deployed in a silicone fractal bifurcation model using the rePOT. Micro-computed tomography was performed to assess side branch ostium coverage and strut malapposition, as well as the effect of rePOT on stent cell area. RESULTS: Our study showed significant differences between stent platforms regarding side branch ostium coverage (p = .002). The Synergy and Cobra PzF stents were the most performant devices to avoid ostium coverage. Strut malapposition varied significantly between devices (p = .008) but the percentage of malapposed struts was relatively low. Significant differences were observed between stents regarding the cell area before (p = .002) and also after rePOT (p = .003), and the increase in cell area caused by rePOT varied considerably between devices (p = .08). CONCLUSION: This study highlighted significant differences in the performances of stent platforms deployed in a fractal bifurcation model using rePOT, with a variable impact of the procedure on stent cell area.

Summary Background Unlike previous randomized clinical trials (RCTs), recent trials and meta-analyses have shown that transcatheter closure of patent foramen ovale (PFO) reduces stroke recurrence risk in young and middle-aged adults with an otherwise unexplained PFO-associated ischaemic stroke. Aim To produce an expert consensus on the role of transcatheter PFO closure and antithrombotic drugs for secondary stroke prevention in patients with PFO-associated ischaemic stroke. Methods Five neurologists and five cardiologists with extensive experience in the relevant field were nominated by the French Neurovascular Society and the French Society of Cardiology to make recommendations based on evidence from RCTs and meta-analyses. Results The experts recommend that any decision concerning treatment of patients with PFO-associated ischaemic stroke should be taken after neurological and cardiological evaluation, bringing together the necessary neurovascular, echocardiography and interventional cardiology expertise. Transcatheter PFO closure is recommended in patients fulfilling all the following criteria: age 16–60 years; recent (≤ 6 months) ischaemic stroke; PFO associated with atrial septal aneurysm (> 10 mm) or with a right-to-left shunt > 20 microbubbles or with a diameter ≥ 2 mm; PFO felt to be the most likely cause of stroke after thorough aetiological evaluation by a stroke specialist. Long-term oral anticoagulation may be considered in the event of contraindication to or patient refusal of PFO closure, in the absence of a high bleeding risk. After PFO closure, dual anti-platelet therapy with aspirin (75 mg/day) and clopidogrel (75 mg/day) is recommended for 3 months, followed by monotherapy with aspirin or clopidogrel for ≥ 5 years. Conclusions Although a big step forward that will benefit many patients has been taken with recent trials, many questions remain unanswered. Pending results from further studies, decision-making regarding management of patients with PFO-associated ischaemic stroke should be based on a close coordination between neurologists/stroke specialists and cardiologists.

Background Incidence and correlates of readmission for heart failure in all-comers, after successful transcatheter aortic valve replacement (TAVR) remain unclear. Objective We sought to evaluate the incidence, risk factors and clinical impact of readmission for HF after successful TAVR in an unselected patient population. Methods All patients who underwent successful TAVR in two high-volume French tertiary centers from February 2010 to December 2016 were prospectively included and followed-up for one year. Cox multivariate model was used to assess risk factors of readmission for heart failure, evaluated a time-updated covariate and mortality. Results A total of 1139 patients (mean age 82.4±7.7 years, 52.2% male) were included. Readmission for heart failure occurred in 99 (8.7%) patients. Risk factors of readmission for HF were chronic pulmonary disease (adjHR 1.8; 95% CI [1.2–2.8], p=0.008), chronic kidney disease (adjHR 1.7; 95% CI [1.1–2.6], p=0.01), diabetes mellitus (adjHR 1.7; 95% CI [1.1–2.5], p=0.01), prior atrial fibrillation (adjHR 1.6; 95% CI [1.1–2.4], p=0.02) and post-TAVR left ventricular ejection fraction (LVEF) ≤35% (adjHR 2.1 95% CI 1.2–3.7, p=0.009). Readmission for HF was strongly associated with mortality (Figure) along with increased STS score (adjHR 1.07 95% CI 1.03–1.12, p=0.002), prior atrial fibrillation (adjHR 2.13 95% CI 1.53–2.96, p Figure 1 Conclusion Readmission for heart failure occurs in one out of ten patients after successful TAVR and is strong risk factor of mortality. Comorbidities and post-TAVR LVEF≤35% are the main correlates of readmission for heart failure. Acknowledgement/Funding ACTION study group

International audience; BackgroundThe effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear.AimsTo evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation.MethodsAll patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1 year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥ 20 mmHg or an increase of ≥ 10 mmHg during echocardiographic follow-up.ResultsOf the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42–2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤ 30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58 patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤ 23 mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63–7.07).ConclusionsBaseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.; ContexteL’impact du traitement anticoagulant oral (TAO) sur les paramètres cliniques et hémodynamiques après TAVI demeure incertain.ObjectifsÉvaluer l’impact du TAO dans l’année suivant un TAVI.MéthodesTous les patients traités par TAVI dans deux centres français entre 2010 et 2016 furent prospectivement inclus. Le critère de jugement principal (CJP) était composé de la mortalité, accident vasculaire cérébrale, hospitalisation pour insuffisance cardiaque ou hémorragie sévères, défini selon les critères VARC-2. Une détérioration hémodynamique valvulaire prothétique (DHV) était définie par un gradient moyen transprothétique ≥ 20 mmHg ou par une majoration ≥ 10 mmHg durant le suivi échocardiographique.RésultatsUn TAO fut prescrit à 400 patients soit 35,1 % des 1139 patients inclus dans le registre. Le CJP est survenu plus fréquemment en cas de TAO post-TAVI qu’en son absence (29,4 % vs 17,3 % %; HR 1,83, IC à 95 % 1,42–2,35). Les facteurs de risque (FdR) du CJP étaient une pneumopathie chronique, une insuffisance rénale chronique, une fibrillation atriale, une FEVG ≤ 30 % après TAVI et un abord vasculaire extrafémoral. La prescription de TAO après un TAVI n’était pas un FdR indépendant du CJP. Une DHV fut relevée chez 58 patients, dont 11 (19 %) traités par TAO et 47 (81 %) non traités par TAO. Les FdR de DHV étaient l’absence de TAO après TAVI, un IMC augmenté, l’utilisation de bioprothèse expansible au ballon et un diamètre de bioprothèse ≤ 23 mm. Un crossover de TAO (défini comme un arrêt ou une initiation de TAO au cours du suivi) survenu chez 9,6 % des patients et était associé à la mortalité (HR ajusté 3,39, IC à 95 % 1,63–7,07).ConclusionsLes antécédents médicaux et non la prescription de TAO sont associés au devenir clinique après un TAVI. A l’inverse, la prescription de TAO est associée à une moindre survenue de DHV. Previous article in issue

Summary Background Unlike previous randomized clinical trials (RCTs), recent trials and meta-analyses have shown that transcatheter closure of patent foramen ovale (PFO) reduces stroke recurrence risk in young and middle-aged adults with an otherwise unexplained PFO-associated ischaemic stroke. Aim To produce an expert consensus on the role of transcatheter PFO closure and antithrombotic drugs for secondary stroke prevention in patients with PFO-associated ischaemic stroke. Methods Five neurologists and five cardiologists with extensive experience in the relevant field were nominated by the French Neurovascular Society and the French Society of Cardiology to make recommendations based on evidence from RCTs and meta-analyses. Results The experts recommend that any decision concerning treatment of patients with PFO-associated ischaemic stroke should be taken after neurological and cardiological evaluation, bringing together the necessary neurovascular, echocardiography and interventional cardiology expertise. Transcatheter PFO closure is recommended in patients fulfilling all the following criteria: age 16–60 years; recent (≤ 6 months) ischaemic stroke; PFO associated with atrial septal aneurysm (> 10 mm) or with a right-to-left shunt > 20 microbubbles or with a diameter ≥ 2 mm; PFO felt to be the most likely cause of stroke after thorough aetiological evaluation by a stroke specialist. Long-term oral anticoagulation may be considered in the event of contraindication to or patient refusal of PFO closure, in the absence of a high bleeding risk. After PFO closure, dual anti-platelet therapy with aspirin (75 mg/day) and clopidogrel (75 mg/day) is recommended for 3 months, followed by monotherapy with aspirin or clopidogrel for ≥ 5 years. Conclusions Although a big step forward that will benefit many patients has been taken with recent trials, many questions remain unanswered. Pending results from further studies, decision-making regarding management of patients with PFO-associated ischaemic stroke should be based on a close coordination between neurologists/stroke specialists and cardiologists.

International audience; AIMS: Percutaneous mitral valve repair has become an alternative to conventional surgery in patients suffering primary mitral regurgitation (MR) with a contraindication to surgery and could benefit patients at high surgical risk. The aim of the MITRA-HR study is to raise the level of evidence supporting the use of the MitraClip(R) device in primary MR patients with a pre-defined high risk for surgery. METHODS AND RESULTS: MITRA-HR is a prospective, multicentre, randomised study designed to compare mitral valve repair using MitraClip(R) with conventional surgery in patients with severe primary mitral regurgitation at high risk for surgery. The surgical risk is defined by age, Society of Thoracic Surgeons (STS) risk estimate score, frailty, major organ system dysfunction, and procedure-specific impediments. The study will enrol 330 patients randomised between conventional surgery and MitraClip(R) with a 1:1 ratio. The composite primary endpoint includes all-cause mortality, unplanned rehospitalisation for cardiovascular reasons, and mitral valve reintervention at 12 months. The main secondary safety endpoint is a major adverse event composite assessment evaluated 30 days after the procedure. CONCLUSIONS: The randomised MITRA-HR study is designed to provide additional supportive evidence of non-inferiority in efficacy and superiority in safety for percutaneous mitral valve repair using MitraClip(R) compared to conventional surgery in high surgical risk patients.

Coronary bifurcation revascularization needs to take account of the diameter differential between vessels and to limit side-branch obstruction (SBO). The self-apposing properties of the Xposition S™ stent (STENTYS, France) seem interesting in this regard. The present experimental fractal bench study determined the best provisional stenting technique using Xposition S™. Three sequential strategies were compared (n = 5/group): implantation alone, side-branch inflation (SBI), and re-POT (initial proximal optimization technique (POT) + SBI + final POT). 2D- and 3D-OCT analyses and micro-CT scan were performed to quantify the main mechanical results at each step. Of the three groups, SBI and re-POT provided better final results than implantation alone in terms of residual SBO (respectively, 24.6 ± 5.6% and 24.8 ± 5.0% vs. 46.5 ± 10.3%, p

Summary Background The incidence of and risk factors for readmission for heart failure after successful transcatheter aortic valve implantation (TAVI) are unclear. Aims We sought to evaluate the incidence of, risk factors for and clinical impact of readmission for heart failure after successful TAVI in an unselected patient population. Methods All patients who underwent successful TAVI in two high-volume French tertiary centres from February 2010 to December 2016 were included prospectively and followed up for 1 year. A Cox multivariable model was used to assess risk factors for readmission for heart failure and mortality. Results A total of 1139 patients (mean age 82.4 ± 7.7 years; 52.2% male sex) were included. Readmission for heart failure occurred in 99 (9.2%) patients. Risk factors for readmission for heart failure were previous atrial fibrillation (adjusted hazard ratio [adjHR] 1.62, 95% confidence interval [CI] 1.09–2.40), diabetes mellitus (adjHR 1.67, 95% CI 1.11–2.50), chronic kidney disease (adjHR 1.72, 95% CI 1.13–2.62), chronic pulmonary disease (adjHR 1.81, 95% CI 1.17–2.81) and left ventricular ejection fraction after TAVI ≤ 35% (adjHR 2.12, 95% CI 1.20–3.75). Readmission for heart failure was strongly associated with mortality (adjHR 3.11, 95% CI 1.95–4.94), along with increased Society of Thoracic Surgeons’ score (adjHR 1.07, 95% CI 1.03–1.12), chronic pulmonary disease (adjHR 1.45, 95% CI 1.00–2.09), previous atrial fibrillation (adjHR 2.11, 95% CI 1.52–2.93) and shock during the index hospitalization (adjHR 2.56, 95% CI 1.41–4.65). Conclusions Readmission for heart failure occurs in one in 10 patients after successful TAVI, and is a strong risk factor for mortality. Co-morbidities and left ventricular ejection fraction after TAVI ≤ 35% are the main risk factors for readmission for heart failure.

Summary Background Mitral regurgitation is the second most frequent valvulopathy managed by surgery in Europe. For patients who have a contraindication to surgery or a high surgical risk, the percutaneous MitraClip® implantation procedure has emerged as a favourable alternative approach, but elevated procedural costs are a medicoeconomic concern. Aim The objective of this study was to evaluate whether the MitraClip® procedure is profitable in a high-volume French hospital. Methods Patients eligible for mitral valve repair with a MitraClip® device, and covered by the French National Health Service, were included retrospectively in this single-centre study between September 2016 and June 2018. Subgroups were considered based on medicoeconomic severity level. The study primary endpoint was the difference between hospital costs and revenues, calculated for each patient. Secondary endpoints included profit based on severity level, breakdown of costs and adverse events during hospitalization. Results Twenty-two patients were included in the study. The mean hospital cost and revenue were €30,039 ± 2476 and €30,331 ± 2720 per patient, respectively, resulting in a profit of €292 ± 2039 per patient. The total estimated profit was €6429 for the whole study period. The largest benefits were observed for patients assigned to the higher medicoeconomic severity levels (levels 2 and 3). Profit increased following a reduction in the device cost (€1136 ± 2415 per patient). The price of the device represented 78% of the total costs. Conclusions Percutaneous MitraClip implantation is a financially neutral procedure for a French university hospital, but this depends on patient severity level.

Objectives The aim of this fractal bifurcation bench study was to compare provisional bifurcation stenting with a “re-POT” sequence, comprising a proximal optimizing technique (POT), side branch inflation, and final POT, between a bioresorbable vascular scaffold (BVS) and a metallic stent. Background Re-POT proved significantly better than kissing balloon inflation in maintaining circular geometry without overstretch in metal stents, while significantly reducing side branch ostium strut obstruction and global strut malapposition. This should be useful for BVSs, which are more easily breakable. Methods Twenty left main–like and 20 left anterior descending–like fractal coronary bifurcation bench models used 10 each 2.5 × 24 mm and 3.5 × 24 mm Absorb (Ab) BVSs and 10 each 2.5 × 24 mm and 3.5 × 24 mm XIENCE Xpedition (XX) metal stents, implanted by re-POT, with optical coherence tomographic analysis at each step and micro–computed tomographic analysis of Ab devices to detect strut fracture. Results With Ab devices, re-POT reduced percentage strut malapposition close to XX rates (0.8 ± 0.7% vs. 0.0 ± 0.0%, p Conclusions Re-POT optimized most Ab provisional bifurcation treatments, without fracture, respecting fractal geometry, and without exceeding 1.0-mm proximal differential diameter.

International audience; Background: Transcatheter aortic-valve implantation (TAVI) has been shown to improve survival and quality of life in patients with severe aortic stenosis. However, one-third of patients have poor outcome as death, functional decline or quality of life (QoL) decline. The aim of this study was to determine cardiac and geriatric predictors of physical and mental QoL decline 6 months after a TAVI procedure in patients aged 75 and older.Methods: Between January 2013 and June 2014, we did a prospective and multicenter study including patients ≥ 75 years old referred for TAVI. The primary outcome was the measure of QoL, assessed by the Short Form 36 survey (SF-36), before and 6 months after the intervention. Association between QoL decline and baseline characteristics including cardiac and geriatric factors was analysed by logistic regression models.Results: Mean age of the 150 patients studied was 83.7 years old and 56% were men. The primary end point, mean SF-36 physical summary score, significantly improved between baseline and 6-month (33.6 vs. 36.4, p=0.003) whereas mental component score significantly decreased (48.2 vs. 36.4, p-value

Introduction Mitral regurgitation is a heart condition resulting from blood flowing from the left ventricle towards the left atrium, increasing the risk of heart failure and mortality. While surgery can greatly reduce these risks, some patients are not eligible, resulting in medication being their only therapeutic alternative. The MitraClip (Abbot Vascular) is a medical device that is percutaneously implanted and designed to eliminate leaking of the mitral valve. Methods The efficacy of the MitraClip strategy vs medical management was assessed using a 4-state Markov model based on the mitral regurgitation grade (mitral regurgitation grade 0, I/II, and III/IV, and death). At each 1-month cycle, patients were or were not hospitalized. The model analyzed a fictional population of 1000 patients over a 5-year period from a national Health Insurance perspective. The primary end-point was the number of deaths avoided. Data from the EVEREST II High Risk Study patients were used along with a literature review. Results At 5 years, among the 1000 patients, 276 deaths were found to be avoidable with the MitraClip strategy. The incremental cost-effectiveness ratio (ICER) was €93,363 per death avoided. The annual ICER was calculated to take into consideration excess costs resulting from the MitraClip over the first year (€29,984 vs €8557 for the reference strategy) and the reduction of costs in following years (€3122 for MitraClip vs €8557 for reference strategy). Thus, the mean ICER was calculated to be €20,720 per death avoided. Conclusion The MitraClip is a novel alternative therapy for mitral insufficiency in patients ineligible for surgery that may offer a medico-economic advantage.

Background In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. Methods We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. Results At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention grou...

International audience; Aortic stenosis is a frequent disease in the elderly. Its prevalence is 0.4% with a sharp increase after the age of 65, and its outcome is very poor when the patient becomes symptomatic. The interventional procedure known as TAVI (trans-catheter aortic valve implantation), which was developed in France and carried out for the first time in Rouen by Prof. Alain Cribier and his team in 2002, has proven to be a valid alternative to surgical aortic valve replacement. At first, this technique was shown to be efficient in patients with contra-indications to surgical treatment or deemed to be at high surgical risk. Given the very promising outcomes achieved as a result of close heart team collaboration, appropriate patient selection, simplified procedures and reduced complication rates, transfemoral (TF) TAVI is now preferred in symptomatic intermediate risk patients>75 years old according to the latest ESC guidelines. In 2017, in France, TAVI is currently performed in 50 centers with on-site cardiac surgery. The 2016 TAVI outcomes recorded in the French national TAVI registry (France TAVI) are very encouraging and show that for 7133 patients treated (age 83.4±7 years, logistic Euroscore 14%), 87% of whom via the TF approach, cross-over to surgery was very low (0.5%) with a 3.0% in-hospital mortality rate. The substantial increase in TAVI indications and the improvement of its outcomes may in the near future call for a reconsideration of the number of high volume centers authorized to carry out this technique.

International audience; Objectives The purpose of the study was to develop a standardized and global bench test protocol to evaluate the biomechanical characteristics of the most currently used drug-eluting coronary stents. Background The use of coronary stents has contributed to the reduction of cardiovascular mortality but can be associated with specific complications. Improving the biomechanical matching between the stents and the coronary anatomy may reduce these complications. Methods We assessed five commercially available drug-eluting stents: the Absorb, Orsiro, Resolute Onyx, Synergy, and Xience Alpine stents. Following stent deployment at nominal pressure in ambient air, radial elastic recoil and foreshortening were measured. Flexibility (crimped and deployed stents) and longitudinal and radial resistances were evaluated using a mechanical tester. Results Biomechanical characteristics were significantly different for all tested devices (ANOVA, P < 0.01). The Synergy, Orsiro, and Xience Alpine stents presented the lowest elastic recoil. The Synergy and Resolute Onyx stents were the most flexible devices. The Xience Alpine and Absorb stents had the highest longitudinal and radial resistances. Conclusions Drug-eluting coronary stents used in current clinical practice have very different biomechanical characteristics, which should be taken into consideration to select the most appropriate device for each clinical situation.

Background— Percutaneous left atrial appendage (LAA) closure is an emerging option for patients with atrial fibrillation at high risk for cerebrovascular events. The multicenter FLAAC registry (French Nationwide Observational LAA Closure Registry) was established to assess LAA closure outcomes in everyday practice. Methods and Results— Four hundred thirty-six patients referred from April 2013 to September 2015 to 33 French interventional cardiology centers for percutaneous LAA closure were included prospectively in the FLAAC registry. Mean age was 75.4±0.4 years. The stroke risk was high (mean CHA 2 DS 2 –VASc score, 4.5±0.1) and most patients had experienced clinically significant bleeding (HAS-BLED score, 3.1±0.05). The device used was Amplatzer LAA occluder in 58% and the Watchman device in 42% of the patients. The procedural success rate was 98.4%. Median postprocedure follow-up was 12.0 (11.8–12.0) months and a single patient was lost to follow-up. During the periprocedural and subsequent follow-up period, procedure-related severe adverse events occurred in 21 (4.9%) and 10 (2.3%) patients, respectively. One-year cumulative incidences of ischemic stroke and cerebral hemorrhage were 2.9% (1.6–5.0) and 1.5% (0.7–3.2), respectively. Overall, 1-year mortality was 9.3% (6.9–12.5) with 7 of the 39 deaths related or possibly related to the device or procedure. Conclusions— This nationwide prospective registry shows that, in the French population, LAA closure is mainly used in patients with high comorbidity rates and a poor prognosis. LAA closure in such patients seems reasonable to decrease the stroke rate. The overall health status of these patients should be taken into account during the preprocedural evaluation process. Clinical Trial Registration— URL: https://www.clinicaltrials.gov . Unique identifier: NCT02252861.

Aims We aimed to evaluate the role of drug-eluting balloon SB inflation, using the novel DANUBIO balloon, after placement of a drug-eluting stent in the main branch in patients with bifurcation lesions. Methods and results Fifty-two patients with bifurcation lesions suitable for stenting were enrolled in the DEBSIDE trial at eight French centres between May 2012 and July 2013. Two patients were excluded from the trial because of significant protocol deviations. Systematic Nile PAX stent placement was followed by final drug-eluting balloon inflation, using the DANUBIO balloon, according to the size of the side branch. Clinical follow-up was scheduled at one, six, and twelve months and an angiographic control at six months. The primary endpoint was six-month late lumen loss (LLL) at the ostium of the side branch. Secondary endpoints were main branch (MB) LLL, binary restenosis of the SB and MB, and clinically driven revascularisation rates for both branches. The procedural success rate was 100%. Angiographic control at six months post-procedure was performed in 48 patients (96%). Two patients with no reported clinical events refused the angiographic control. At six-month follow-up the primary endpoint of side branch LLL was -0.04±0.34 mm and the secondary endpoint of MB LLL was 0.54±0.60 mm. There was only one myocardial infarction (2%) and no reported cardiac deaths. Only one patient (2%) had a non-clinically driven target lesion revascularisation (TLR) at the level of the side branch combined with a main branch revascularisation. Conclusions Systematic final inflation of a DANUBIO balloon in the side branch after placement of a Nile PAX stent in the main branch for the treatment of a bifurcation lesion is safe and effective and results in very low LLL and a low restenosis rate at the side branch ostium. The DEBSIDE clinical trial was registered at the United States National Institute of Health website (NCT01485081).