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Goal The aim of the study is to assess the incidence, risk factors and prognosis of definite stent thrombosis (ST) at 1 year in the France PCI multicenter prospective registry. Patients and methods Only patients who underwent coronary angioplasty with at least one stent implantation between 1st January 2014 and 31 December 2019 were included. The population was separated into 2 groups: the "ST" group with stent thrombosis and the "control" group without stent thrombosis. Results 35,435 patients were included. 256 patients (0.72%) presented a ST at 1 year. The rate of ST decreased significantly in acute coronary syndrome (1.5% in 2014 vs. 0.73% in 2019; p = 0.05) but not in chronic coronary syndrome (0.46% in 2014 vs 0.40%; p = 0.98). The risk factors are young age (65.8 years vs 68.2; p = 0.002), clinical context (35.27% vs 16.68%; p = 0.0001), diabetes (35.2 % vs 26.4%; p = 0.002), renal failure (11.7% vs 8%; p = 0.009) and history of coronary angioplasty (28.63% vs 21.86%; p = 0.009) and peripheral arterial disease (14.5% vs 10.1%; p = 0.021), LV dysfunction (37% vs 27.5%; p = 0.003), mean length (39.6 mm vs 31, 7mm; p Conclusion Since 2014, the incidence of ST at 1 year has been decreasing but remains stuck at a floor level of 0.54% in 2019. The battle for ST seems to have been partly won and its risk factors well identified, but its mortality is still high.

Background There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. Objectives The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. Methods The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. Results The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months’ extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). Conclusions In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555 )

Objectives Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). Background The choice of optimal drug for anticoagulation after TAVR remains debated. Methods Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two primary endpoints were death from any cause (efficacy) and major bleeding (safety). Results A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P Conclusions In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR.

International audience; Background & aims: Sarcopenia is a multifactorial syndrome resulting in a decrease in both muscle mass and function. Little is known about the prevalence and prognostic impact of sarcopenia in patients with acutely decompensated chronic heart failure (ADHF). We aimed to evaluate the prevalence (main endpoint) and impact of sarcopenia on ADHF patients.Methods: 140 ADHF patients were enrolled between November 2014 and September 2018 in a multi-center prospective longitudinal study. A similar, independent multi-departmental cross-sectional study in 165 ADHF patients was used for external validation of prevalence data. All subjects were assessed on the European Working Group on Sarcopenia criteria.Results: Ninety-one patients (65%) had sarcopenia (vs. 53.6% in the external replication regional cohort). Patients with sarcopenia were older and more likely to have eGFR

Background Kawasaki disease (KD) is a medium vessel vasculitis occurring in children, as yet of undetermined aetiology. KD can lead to severe complications such as coronary artery aneurysms, thrombosis, and sudden death. Monitoring of coronary anomalies is an important issue in the early phase of the disease, and their follow-up is based on different imaging methods. The interventional treatment of these coronary anomalies, which is often complex, is a therapeutic challenge. Case summary We are reporting the case of a four-year-old child who presented KD which was complicated by coronary aneurysm of the proximal left anterior descending artery and ectasia of the right coronary artery (RCA). These lesions progressively calcified and resulted at the age of 13 in chronic occlusion of the RCA. After confirmation of myocardial viability and myocardial ischaemia, a complex angioplasty guided by intracoronary imaging was performed using rotational atherectomy, a cutting balloon, and a high pressure balloon. The control coronary angiography performed 1 year later revealed two false aneurysm on the RCA at the angioplasty site, which were successfully treated with a covered stent. Discussion This case report describes the challenges of treating coronary artery abnormalities such as calcified coronary lesions in children with KD. The coronary intervention of these lesions remains complex and may lead to coronary rupture. We highlight the advantage of using intracoronary imaging in the management of these calcified lesions for successful revascularization, and to assess the complications of percutaneous coronary intervention.

Background Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as an alternative for the treatment of degenerated bioprosthetic valves (BPVs) for high surgical risk patients. However, this procedure often results in patient-prosthesis mismatch. BPV fracture is a novel technique to address this problem. From now, complications following BPV fracture are few. Case summary We present the case of a 84-year-old female with history of first surgical aortic BPV replacement with a Mitroflow Sorin 23 mm due to severe aotic stenosis in 2009. In 2017, a second intervention due to bioprosthetic aortic valve stenosis valve was performed with valve-in-valve TAVI with CoreValve Evolut R 23 mm. In 2021, she was admitted with severe heart failure due to TAVI degeneration with severe stenosis in the bioprothesis. After heart team discussions, the patient was deemed inoperable for new heart surgery and considered as a candidate for BPV fracture as last possible alternative. After BPV fracture was performed, the patient suffered acute hypotension. Urgent transoesophageal echocardiography and angiogram demonstrated severe acute intra-TAVI aortic insufficiency because of probable disruption of the CoreValve leaflets. The patient was successfully treated with a ViV 23 mm SAPIEN three Edwards valve with a resolution of the aortic insufficiency and improvement of her haemodynamics. The patient remains asymptomatic after 6 months, with improvement in clinical status. Discussion This case demonstrates a disruption of the transcatheter heart valve leaflets causing severe aortic regurgitation as one of the complication of BPV fracture. To our knowledge, this is the first report of a TAVI in a patient who was already operated with ViV-TAVI. Although case series described few complications with improvement in clinical status, the procedure should be established with appropriate planning and careful technique.

Aims In low-gradient aortic stenosis (LGAS), the high valvulo-arterial impedance observed despite low valvular gradient suggests a high vascular load. Thoracic aortic calcifications (TACs) and valvular aortic calcifications (VACs) are, respectively, surrogates of aortic load and aortic valvular gradient. The aim of this study was to compare the respective contributions of TAC and VAC on 3-year cardiovascular (CV) mortality following TAVI in LGAS vs. high-gradient aortic stenosis (HGAS) patients. Methods and results A total of 1396 consecutive patients were included. TAC and VAC were measured on the pre-TAVI CT-scan. About 435 (31.2%) patients had LGAS and 961 (68.8%) HGAS. LGAS patients were more prone to have diabetes, coronary artery disease (CAD), atrial fibrillation (AF), and lower left ventricular ejection fraction (LVEF), P Conclusion TAC plays a major prognostic role in LGAS while VAC remains the key in HGAS patients. This confirms that LGAS is a complex vascular and valvular disease.

Aims After transcatheter aortic valve replacement (TAVR), cardiovascular and non-cardiovascular comorbidities may offset the survival benefit from the procedure. We aimed to describe the relationships between that benefit and patient comorbidities. Methods and results The study pooled two European cohorts of patients with severe aortic stenosis (AS-pooled): one with patients who underwent (cohort of AS patients treated by TAVR, N = 233) and another with patients who did not undergo TAVR (cohort of AS patients treated medically; N = 291). The investigators collected the following: calcification prognostic impact (CAPRI) and Charlson scores for cardiovascular and non-cardiovascular comorbidities, activities of daily living (ADL)/instrumental activities of daily living (IADL) scores for frailty as well as routine Society of Thoracic Surgeons (STS) score and Logistic Euroscore. Unlike ADL/IADL scores, CAPRI and Charlson scores were found to be independent predictors of 1-year all-cause death in the AS-pooled cohort, with and without adjustment for STS score or Logistic Euroscore; they were thus retained to define a three-level prognostic scale (good, intermediate, and poor). The survival benefit from TAVR—vs. no TAVR—was stratified according to these three prognosis categories. The beneficial effect of TAVR on 1-year all-cause death was significant in patients with good and intermediate prognosis, hazard ratio (95% confidence interval): 0.36 (0.18; 0.72) and 0.32 (0.15; 0.67). That effect was reduced and not statistically significant in patient with poor prognosis [0.65 (0.22; 1.88)]. Conclusion The study showed that, beyond a given comorbidity burden (as assessed by CAPRI and Charlson scores), the probability of death within a year was high and poorly reduced by TAVR. This indicates the futility of TAVR in patients in the poor prognosis category.

Aim We evaluated a decision algorithm for percutaneous coronary interventions (PCI) based on a no-stent strategy, corresponding to a combination of scoring balloon angioplasty (SCBA) and drug-coated balloon (DCB), as a first line approach. Stents were used only in unstable patients, or in case of mandatory bailout stenting (BO-stent). Methods From April 2019 to March 2020, 984 consecutive patients, including 1922 lesions, underwent PCI. The 12-month primary end-point was a composite of major adverse cardiac events (MACE) defined as all-cause death, nonfatal myocardial infarction, nonfatal stroke, and target lesion revascularization. Patients were classified into conventional or no-stent strategy groups according to the PCI strategy. In the no-stent strategy group, they were further classified into BO-stent or DCB-only groups. Their metal index was calculated by stent length divided by the total lesion length. Results The no-stent strategy was applied in 85% of the patients, and it was successful for 65% of them. MACE occurred in 7.1% of the study population, including 4.2% of all-cause death. Target lesion revascularization was required in 1.4%, 3.6%, and 1.5% of patients in the conventional DES, BO-stent, and DCB-only groups, respectively. MACE occurred more often in the elderly and in those treated with at least one stent (metal index greater than 0). Conclusions The no-stent strategy, i.e., revascularization of coronary lesions by SCBA followed by DCB and with DES bailout stenting, was effective and safe at 1 year. This PCI approach was applicable on a daily practice in our cath lab. Trial registration This study was registered with clinicaltrials.gov (NCT03893396, first posted on March 28, 2019). Graphical abstract Feasibility, safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease. DES: drug eluting stent; SCBA: scoring balloon angioplasty; BO-stent: at least one stent; DCB: drug coated balloon; BMS: bare metal stent; Bailout (dash lines); MACE: major adverse cardiac event

Resume La restenose intrastent (RIS) demeure un probleme frequent en cardiologie interventionnelle. Les donnees de l'angiographie sont limitees pour evaluer les RIS. La tomographie par coherence optique (OCT) est une technique d'imagerie endocoronaire de haute resolution. Elle permet d'individualiser les mailles du stent et ainsi de reveler une sous expansion de stent ou une fracture qui sont parfois difficiles a mettre en evidence en angiographie. On identifie egalement le tissu de restenose qui peut etre classe en en neointima homogene, neointima heterogene ou neoatherosclerose. L'OCT permet donc de guider le traitement de la RIS qui varie en fonction de l‘etiologie. Cette technique d'imagerie permet egalement de verifier l'obtention des criteres de succes de l'angioplastie et d'ainsi de corriger un potentiel facteur de risque de recidive de RIS. Ces propos sont illustres par deux cas cliniques. L'OCT est desormais validee dans cette indication, il reste a valider l'interet de la technique sur le suivi des patients et d'integrer les nouveaux outils a notre disposition.

International audience; Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.Funding: ACTION Study Group and AstraZeneca.

In recent years, transcatheter aortic valve implantation (TAVI) without predilation (direct TAVI) has become the preferred method for implanting TAVI prostheses. Appropriate patient selection is important to avoid suboptimal outcomes and associated complications.To evaluate whether aortic valve calcification measured with computed tomography predicts suboptimal results from direct TAVI with a self-expanding prosthesis.Single-centre retrospective analysis of patients who received a CoreValve™ prosthesis (Medtronic, Minneapolis, MN, USA) in a direct TAVI procedure between January 2018 and March 2019. Aortic valve calcification assessment (aortic valve calcium score, calcium volume and calcium mass) was calculated from the computed tomography scan before TAVI. Procedural characteristics, need for postdilation and complications were analysed.Of 168 included patients, 18 were postdilated. Aortic valve calcium score (4259 vs. 2578; P0.001), calcium volume (1184 vs. 647mmA high aortic valvular calcium score, assessed by computed tomography scan, is an independent predictor of suboptimal prosthesis implantation outcomes in direct TAVI.

International audience; Background: Intravascular ultrasound (IVUS)-guided PCI improves the prognosis of left main stem (LMS) PCI and is currently recommended by international guidelines. Although OCT resolution is greater than that of IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data.Aims: This pilot study aimed to analyse the feasibility, safety and impact of OCT-guided LMS PCI.Methods: This prospective, multicentre trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis

Objectives The aim of this study was to develop a new scoring system based on thoracic aortic calcification (TAC) to predict 1-year cardiovascular and all-cause mortality. Background A calcified aorta is often associated with poor prognosis after transcatheter aortic valve replacement (TAVR). A risk score encompassing aortic calcification may be valuable in identifying poor TAVR responders. Methods The C4CAPRI (4 Cities for Assessing CAlcification PRognostic Impact) multicenter study included a training cohort (1,425 patients treated using TAVR between 2010 and 2014) and a contemporary test cohort (311 patients treated in 2015). TAC was measured by computed tomography pre-TAVR. CAPRI risk scores were based on the linear predictors of Cox models including TAC in addition to comorbidities and demographic, atherosclerotic disease and cardiac function factors. CAPRI scores were constructed and tested in 2 independent cohorts. Results Cardiovascular and all-cause mortality at 1 year was 13.0% and 17.9%, respectively, in the training cohort and 8.2% and 11.8% in the test cohort. The inclusion of TAC in the model improved prediction: 1-cm3 increase in TAC was associated with a 6% increase in cardiovascular mortality and a 4% increase in all-cause mortality. The predicted and observed survival probabilities were highly correlated (slopes >0.9 for both cardiovascular and all-cause mortality). The model’s predictive power was fair (AUC 68% [95% confidence interval [CI]: 64% to 72%]) for both cardiovascular and all-cause mortality. The model performed similarly in the training and test cohorts. Conclusions The CAPRI score, which combines the TAC variable with classical prognostic factors, is predictive of 1-year cardiovascular and all-cause mortality. Its predictive performance was confirmed in an independent contemporary cohort. CAPRI scores are highly relevant to current practice and strengthen the evidence base for decision making in valvular interventions. Its routine use may help prevent futile procedures.

BACKGROUND/PURPOSE Guidelines recommend intracoronary optical coherence tomography (OCT) to assess stent failure and guide percutaneous coronary intervention (PCI) but OCT may be useful for other indications in routine clinical practice. METHODS/MATERIALS We conducted an international registry of OCT cases at two large tertiary care centers to assess clinical indications and the potential impact on decision making of OCT in clinical routine. Clinical indications, OCT findings, and their impact on interventional or medical treatment strategy were retrospectively assessed. RESULTS OCT was performed in 810 coronary angiography cases (1928 OCT-pullbacks). OCT was used for diagnostic purposes in 67% (N = 542) and OCT-guided percutaneous coronary intervention in 50% (N = 404, 136 cases with prior diagnostic indication). Most frequent indications for diagnostic OCT were culprit lesion identification in suspected ACS (29%) and stent failure assessment (28%). OCT findings in the diagnostic setting influenced patient management in 74%. OCT-guided PCIs concerned ACS patients in 45%. Among the 55% with chronic coronary syndrome, long lesions >28 mm (19%), left main PCI (16%), and bifurcation PCI with side-branch-stenting (5%) were the leading indications for PCI-guidance. Post-procedural OCT findings led to corrective measures in 52% (26% malapposition, 14% underexpansion, 6% edge dissection, 3% intrastent mass, 3% geographic plaque miss). CONCLUSIONS OCT was most frequently performed to identify culprit lesions in suspected ACS, for stent failure assessment, and PCI-guidance. OCT may impact subsequent treatment strategies in two out of three patients.

Background Mean gradient (MG) elevation can be detected immediately post-procedure or secondarily during follow-up. Comparison between these two parameters and impact on outcomes has not previously been investigated. Objectives The study aimed to identify incidence, influence on prognosis and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (DMGI), in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. Methods The registry includes all consecutive symptomatic patients with severe aortic stenosis. Three groups were analyzed: 1) PPMG 10 mmHg (control); 2) PPMG 10 mmHg (group 1); 3) PPMG ≥20 mmHg (group 2). Results From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. The control group comprised 2078 patients; the group 1, 131 patients; and the group 2, 144 patients. DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-year mortality than in control group (32.6% vs. 40.1%, p=0.27, respectively). PPMG was at least 20 mmHg in 6.1%, and was associated with higher 4-year mortality than in control group (48.7% versus 40.1%, p=0.005, respectively) (Figure 1). Two-thirds of patients with initial PPMG ≥20 mmHg had finally a MG Conclusions Patients with PPMG >20 mmHg 1 year post-TAVI had higher 4-year mortality than the general population of the registry, unlike patients with MG normalization at 1 year. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): French National Society of Cardiology

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. Results: In propensity–matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46–1.91]; P P P =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06–1.29]; P =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. Clinical Trial Registration: https://www.clinicaltrials.gov . Unique identifier: NCT01777828.

BACKGROUND Spontaneous coronary artery dissection (SCAD) is an increasingly reported but poorly understood condition. Few European data are available. AIMS The aims of this study were to obtain European data on SCAD, determine the prevalence of fibromuscular dysplasia (FMD) and enable genetic analyses in this population. METHODS Data from a national French registry of SCAD cases were analysed prospectively and retrospectively. Clinical and angiographic data and management strategy were collected. Major adverse cardiovascular events (MACE) were analysed after one year of follow-up. Subjects were screened for FMD and blood was collected for DNA extraction. RESULTS From June 2016 to August 2018, 373 SCAD cases were confirmed by the core lab. Mean age was 51.5 years. Patients were mostly women (90.6%) and 54.7% of cases had less than two cardiovascular risk factors. At one year, 295 patients (79.1%) were treated conservatively, the MACE rate was 12.3%, and there were no cases of mortality. The recurrence rate of SCAD was 3.3%. FMD was found at ≥1 arterial site in 45.0% of cases. We also confirmed the genetic association between the PHACTR1 locus and SCAD (odds ratio=1.66, p=7.08×10-8). CONCLUSIONS Here we describe the DISCO registry, the largest European SCAD cohort where FMD was found in 45% of cases and the genetic association with PHACTR1 was confirmed. This nationwide cohort is a valuable resource for future clinical and genetic investigation to understand SCAD aetiology.

International audience

Background Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain. Methods The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy. Results A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment–Elevation Myocardial Infarction (INNOVATION, South Korea) trials. Conclusions We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.

Background Mitral Annular Calcifications (MAC) and Thoracic Aortic Calcifications (TAC) represent 2 well-established predictors of mortality after TAVI; they could be combined to enhance the prediction of outcome after TAVI and improve patient selection. Purpose To evaluate the cumulative prognostic value of MAC and TAC in patients with aortic stenosis, treated with TAVI on 1-year all-cause and cardiovascular (CV) mortalities. Methods Between 2010 and 2014, 1382 TAVI patients were included, in 4 high volume french centers. High MAC was defined as ≥ 2 cm3 and high TAC was defined as > 3.6 cm3(boundary of third tertile). Three groups were considered; 1: low MAC and low TAC, 2: high MAC or high TAC, and 3: high MAC and high TAC. Outcomes were all-cause and CV deaths. Kaplan Meier graphs, PLogRank test and multivariable Cox analysis were used to assess the prognostic value of MAC and TAC: Model 1 adjusted for EUROSCORE, Model 2 for age, gender, atrial fibrillation, coronary artery disease, left ventricle ejection fraction, mean aortic gradient, renal function, peripheral vascular disease, history of stroke, chronic obstructive pulmonary disease, and vascular access. Results Groups 1, 2 and 3 comprised 839 (60.7%), 492(35.6%), and 51(3.7%) patients respectively. At 1-year post TAVI, 25 patients were lost to follow-up and 230(16.6%) died, of whom 164(11.9%) from CV causes. Fig. 1 displays all-cause and CV deaths according to the 3 groups (PLogRank = 0.005 for both). In model 1, group 3 had an excess risk compared to group 1: HR 2.21 CI(1.27–3.85), p = 0.005, and HR 2.29 CI(1.19–4.42), p = 0.013 for all-cause and CV mortality, respectively. Similar results were found in model 2: HR 2.06 CI(1.18–3.60), p = 0.01, and HR 2.14 CI(1.10–4.16), p = 0.025 for all-cause and CV mortality, respectively. Conclusion A cumulative impact of MAC and TAC on post-TAVI mortality is demonstrated. A special attention for potential futility should be payed to patients with a high MAC/TAC burden.

Background Very late scaffold thrombosis (VLScT) occurs more frequently after bioresorbable scaffold (Absorb BVS 1.1, Abbott Vascular, Santa Clara, California) implantation than with metallic everolimus-eluting stents. Objectives The purpose of this study was to elucidate mechanisms underlying VLScT as assessed by optical coherence tomography (OCT). Methods The INVEST (Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis) registry is an international consortium of investigators who used OCT to examine patients with VLScT. Results Between June 2013 and May 2017, 36 patients with 38 lesions who had VLScT underwent OCT at 19 centers. VLScT occurred at a median of 20 months (interquartile range: 16 to 27 months) after implantation. At the time of VLScT, 83% of patients received aspirin monotherapy and 17% received dual-antiplatelet therapy. The mechanisms underlying VLScT were (in descending order) scaffold discontinuity (42.1%), malapposition (18.4%), neoatherosclerosis (18.4%), underexpansion or scaffold recoil (10.5%), uncovered struts (5.3%), and edge-related disease progression (2.6%). Discontinuity (odds ratio [OR]: 110; 95% confidence interval [CI]: 73.5 to 173; p Conclusions The leading mechanism underlying VLScT was scaffold discontinuity, which suggests an unfavorable resorption-related process, followed by malapposition and neoatherosclerosis. It remains to be determined whether modifications in scaffold design and optimized implantation can mitigate the risk of VLScT. (Independent OCT Registry on Very Late Bioresorbable Scaffold Thrombosis [INVEST]; NCT03180931)

Background Some patients still exhibit a premature poor outcome after transcatheter aortic-valve implantation (TAVI). Factors leading to this poor outcome should be identified. Objective To assess the evolution overtime of the prognostic impact of 3 categories of predictors: 1) age and comorbidities, 2) vascular and 3) cardiac factors. Patients and methods Ancillary study from the C4CAPRI study including consecutive patients referred for TAVI to four high-volume French centers. The primary and secondary outcomes were cardiovascular and all-cause mortality, respectively. Cox models included for each category respectively: 1) age, sex, renal function, and pulmonary disease; 2) NYHA, ejection fraction, pulmonary pressures, preoperative aortic gradient and mitral regurgitation; 3) coronary artery disease, peripheral vascular disease, previous stroke and thoracic aorta calcification (TAC) assessed by CT-scan. Evolution of the effect of predictive factors overtime was determined by the distribution of scaled Schoenfeld residuals against time. Results A total of 1425 patients were included between 2010 and 2014. After 1000 days of follow-up, 364 (26%) deaths occurred of whom 241 (17%) of cardiovascular cause. Significant predictors of mortality were 1) age, renal function, pulmonary disease (for all-cause death only); 2) NYHA, pulmonary pressure, aortic gradient; 3) TAC, peripheral vascular disease (for all-cause death only). The factors which effect overtime was stable or increased were mainly vascular factors at variance with cardiac factors which effect vanished during the follow-up. The effect of comorbidities was in-between. Conclusion TAVI solves most of the cardiac problem as indicated by the decreased deleterious effect of cardiac factors overtime. On the contrary, the pejorative value of vascular factors persists or increases advocating for their involvement in the course of the disease. Future therapy should target the vascular tree to improve outcome after TAVI.

Background Transcatheter aortic valve implantation (TAVI) has revolutionized the management of severe aortic stenosis. The development of new-onset complete left bundle branch block (LBBB) is, however, a frequent complication. The objective of the present study was to assess the impact of new-onset LBBB after TAVI on the evolution of left ventricular ejection fraction (LVEF). Methods Forty consecutive patients were included following the development of new-onset LBBB after TAVI implantation and were matched for age and LVEF with 40 patients implanted during the same period who did not develop LBBB. The primary endpoint was evolution of the LVEF measured by echocardiography prior to implantation and between 6-12 months after TAVI. Results The development of a LBBB was associated with a 5-point decrease in LVEF [− 12.5–2.5], contrary to the non-LBBB group (1.5 [− 6.5–9.5], P = 0.007) at 8 months, with the persistence of the LBBB (n = 23) exacerbating this decrease (− 7 [− 13; 2], P = 0.009). When left ventricular dysfunction (LVEF Conclusions The appearance of new-onset LBBB after TAVI has a pejorative impact on left ventricular systolic function, particularly in patients with an initial LVEF

Background Sarcopenia is a multifactorial syndrome resulting in a decrease in both muscle mass and function. It occurs with advancing age or chronic conditions such as chronic heart failure (CHF), with a negative impact on both morbidity and mortality and on the prognosis of chronic diseases. The objective of this study was to evaluate the prevalence of sarcopenia and its impact in patients with chronic heart failure. Methods In a multicenter prospective study, sarcopenia screening and its impact were systematically conducted in 140 patients with CHF, immediately after an episode of acute HF according to the EWGSOP criteria and algorithm. Results The prevalence of sarcopenia was 65% (95% CI [56.5–72.9]) and was associated with impaired functional status and autonomy. Sarcopenic patients were older (78.2 ± 9.0 vs. 71.4 ± 10.9 years, P Conclusions Our study demonstrates an excess prevalence of sarcopenia in CHF patients in the immediate aftermath of decompensation with an observed increase of other causes hospitalizations. This highlights the importance of identifying and managing this pathology in a multidisciplinary approach to improve the prognosis of these fragile patients.

Introduction Visual qualitative assessment of mitral annular calcification (MAC) suggests a prognostic impact after transcatheter aortic-valve implantation (TAVI). Purpose We aimed to show the impact of a quantitative assessment of MAC volume on one year all-cause mortality in patients treated with TAVI. Methods Patients from a national registry that encompassed all consecutive patients treated with TAVI between 2010 and 2014 in four centers were included. MAC volume was quantitatively assessed on pre-TAVI computed tomography (CT) with a semi-automatic dedicated software. Patients with unavailable CT or with mechanical mitral valve were excluded. MAC volume was considered either as a categorical variable for Kaplan–Meier analysis (log rank test) or as a continuous variable for the Cox model. A multivariate Cox model adjusted for age, sex, atrial fibrillation, peripheral artery disease, estimated glomerular filtration rate (eGFR), left ventricular ejection fraction (LVEF), vascular approach and aortic regurgitation post implantation > 2/4 was performed. Results A total of 1468 patients aged 83.5 ± 7 years were included. Mean eGFR and LVEF were 50 ± 22.8 mL/mn and 56 ± 14%, respectively. Transfemoral approach was used in 1018/1464 patients (69%). The most calcified decile concerned 149 patients, who had ≥ 2 cm3 MAC volume. After one year follow-up, 245/1442 patients (17%) died, 211/1293 (16,3%) in patients with Fig. 1 . In univariate survival analysis, MAC volume was associated with a higher all-cause mortality; HR 1,11; 95% confidence interval (CI) [1.035–1.191]; P = 0.004. In multivariate survival analysis, MAC volume was still associated with higher all-cause mortality, for every cm3 increase in MAC volume; HR 1.106; 95% CI [1.027–1.191]; P = 0.008. Conclusion MAC volume assessed quantitatively is a predictor of one-year all-cause mortality after TAVI.

Introduction Sarcopenia is defined by both decrease in muscle mass and function leading to fragility and death. Early identification of sarcopenic patients may help to improve morbidity and mortality of such patients. No data are available in patients with severe aortic stenosis (AS) waiting for trans-cutaneaous aortic-valve implantation (TAVI). The objective of the present study was to evaluate the prevalence of sarcopenia and its impact in patients with severe AS. Methods In a single center prospective study, sarcopenia screening and its impact were systematically conducted in 127 patients with AS waiting for TAVI, according to the EWGSOP criteria and algorithm. Results The prevalence of sarcopenia was 53.5%. Sarcopenic patients were older (83 ± 4.9 vs. 81.3 ± 5.8 years old, P = 0.02), with a lower body mass index (26.4 ± 3.9 vs. 31.0 ± 5.8 kg/m2, P Conclusion Over 50% of patients with aortic stenosis waiting for TAVI are sarcopenic. More data and studies are needed to evaluate the benefit of TAVI in sarcopenic patients and the management of such patients.

Background Low gradient aortic stenosis (LGAS) is still poorly understood. The valular aspect may be less prominent than in the other forms of aortic stenosis (AS) and intertwined with other aspects such as vascular ones. The severity of the valvular disease was assessed from aortic valvular calcifications (VAC) and that of aorta from thoracic aortic calcifications (TAC). Objectives To assess the prognostic significance of VAC and TAC in patients with and without LGAS treated by TAVI. Methods Ancillary study of the C4CAPRI trial including 1282 consecutive patients from 4 French hospitals. The primary outcome was 3 years CV mortality after TAVI. Results 397 (31%) had a LGAS. They were more frequently men, younger, with atrial fibrillation (AF), and lower left ventricular ejection fraction (LVEF), P Conclusions The present study confirms that valvular disease seems less prevailing in LGAS patients than in other forms of AS. On the other hand, vascular after load, estimated by TAC, conveys a major prognostic information in this subgroups. This has clinical impact: VAC may be a marker of early and periprocedural mortality and aortic regurgitation in non-LGAS patients, while TAC may continue to increase left ventricular after load in patients with LGAS whom LVEF is often impaired.

Spontaneous coronary artery dissection (SCAD) is an underdiagnosed clinical entity with a severe prognosis. Whereas conservative management is followed in asymptomatic patients with reassuring hemodynamic status and TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 on angiography, high-risk

Background Both the valvular aortic calcifications (VAC) and the thoracic aorta calcifications (TAC) have a prognostic impact in patients with aortic stenosis. Their respective prognostic values in patients with and without low gradient aortic stenosis (LGAS) remain unknown after TAVI. Objectives To assess the prognostic significance of VAC and TAC in patients with and without LGAS regarding cardiovascular mortality after 3 years follow-up. Methods The CAPRI-LGAS is an ancillary study of the C4CAPRI trial (NCT02935491) including 1282 consecutive TAVI patients. Calcifications were measured on pre-TAVI CT. The primary outcome was defined as cardiovascular mortality 3 years after TAVI. Results Among the 1282 patients, 397 (31%) had a LGAS. Compared to the other patients, LGAS patients were more prone to be men, younger, with atrial fibrillation, and lower left ventricular ejection fraction (LVEF), p Conclusions The present study shows that VAC and TAC involve different prognostic information in patients with and without LGAS after TAVI. While VAC may be a marker of early and periprocedural mortality and aortic regurgitation in non-LGAS patients, TAC may continue to be harmful and increase afterload in patients with LGAS whom LVEF is often impaired.

Background Spontaneous coronary artery dissection (SCAD) is an underdiagnosed and poorly understood cause of acute coronary syndrome (ACS). Clinical, angiographic features and management remain to be better defined in large cohorts. Purpose The aim of this study was to evaluate clinical, angiographic characteristics, treatment modalities and prognosis of patients with SCAD from a multicenter national registry. Methods From 2016 to 2018, SCAD patients were enrolled retrospectively and prospectively in the French multicenter regristry DISCO study in 61 cardiology interventional centers. All coronary angiograms were reviewed by 2 experienced cardiologists for diagnosis confirmation and classified according to current angiographic SCAD classification. Results A total of 373 confirmed SCAD patients were included, 45.6% prospectively, 54.4% retrospectively. Mean age was 51.5±10.3 years, with 90.6% women of whom 51.2% were postmenauposal. Ninety percent of patients had ≤2 cardiovascular risk factors, 96.2% presented with ACS, with a positive troponin in 95.4%, and ST-segment elevation in 45.0%. Precipitating emotional stress factors were reported in 46.0% and a physical trigger in 12.4%. Systemic inflammatory disease was present in 5 patients (1.4%). Peripartum SCAD accounted for only 4.4% of cases. The majority of patients (75.1%) had type 2 angiographic SCAD (diffuse long smooth tubular lesions due to intramural hematoma), with only 13.8% and 8.9% having type 1 (longitudinal filling defect) and type 3 (multiple focal tubular lesions due to intramural hematoma) respectively. Multivessel SCAD occurred in 6.2%. While 84.2% of SCAD patients were initially treated conservatively, 15.5% underwent percutaneous coronary intervention as the initial strategy and 1 patient (0.3%) required surgical implantation of a left ventricular assist device. Repeat angiogram was conducted in 288 patients (median 38 [8–70] days) showing improvement of the culprit lesion in 81.9%. At 1 year follow-up, recurrent SCAD occurred in 2.5%, major adverse cardiac events (stroke, myocardial infarction, and revascularization) in 7.7%, and all patients survived. Conclusion Our study confirms that SCAD predominantly affects early middle-aged women with few cardiovascular risk factors, with peripartum SCAD accounting for a minority of cases. Type 2 angiographic SCAD which is difficult to recognize was the most frequent angiographic appearance. This may contribute to the underestimation of SCAD in clinical practice. The majority of patients were treated conservatively with favorable outcomes. Longer-term follow-up of this large cohort and further investigations on physiopathology are warranted to improve management and risk stratification of patients. Acknowledgement/Funding Fondation Coeur et Recherche, French Coronary Atheroma and Interventional Cardiology Group, French Society of Cardiology

This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).

Summary Background Immediate improvement in kidney function has been reported after surgical aortic valve replacement or transcatheter aortic valve implantation. Long-term data, however, are not available. Aim To assess the evolution of kidney function in chronic kidney disease stage 3b–5, 1 year after surgical aortic valve replacement or transcatheter aortic valve implantation. Methods All patients with chronic kidney disease stage 3b–5 undergoing surgical aortic valve replacement or transcatheter aortic valve implantation for aortic stenosis in a single centre were included. Kidney function was assessed 1 year postprocedure. Improvement or deterioration in estimated glomerular filtration rate was defined by an increase or decrease of 5 mL/min/1.73 m2, respectively. Results Overall, 127 procedures were analysed (54 surgical aortic valve replacements and 73 transcatheter aortic valve implantations). Kidney function improved in 51% of patients at 1 year (45% of the surgical aortic valve replacement group versus 57% of the transcatheter aortic valve implantation group; P = 0.21), and deteriorated in only 14% of patients at 1 year (18% of the surgical aortic valve replacement group versus 10% of the transcatheter aortic valve implantation group; P = 0.22). Almost a quarter of patients (23%) had an improvement in estimated glomerular filtration rate of > 15 mL/min/1.73 m2, and this was consistent at later follow-up. Few patients went onto chronic dialysis at 1 year (three after surgical aortic valve replacement and one after transcatheter aortic valve implantation). Acute kidney injury was an independent prognostic factor for long-term deterioration in kidney function (odds ratio 2.1, 95% confidence interval 1.4–3.6; P = 0.006). Conclusion Aortic valve replacement, whether by surgical aortic valve replacement or transcatheter aortic valve implantation, improved estimated glomerular filtration rate at 1 year in more than half of patients with chronic kidney disease stage 3b–5.

International audience; Background Elderly patients are at high-risk of bleeding, particularly in the setting of acute coronary syndrome treated with an invasive strategy. Treatment adjustment by platelet function testing (PFT) failed to improve clinical outcomes in the randomized ANTARCTIC trial. Purpose This prespecified substudy aims at determining the predictive factors of bleeding and their relation to ischemic events and mortality. Methods We analyzed the 877 patients over the age of 75 years from the ANTARCTIC trial and randomized to a strategy of dose or drug antiplatelet therapy adjustment or a conventional strategy without PFT. In the monitoring group, patients received prasugrel 5 mg daily after coronary stenting and treatment was adjusted according to PFT. Correlation between occurrence of bleeding and major cardiovascular adverse events (MACE) defined as the composite of cardiovascular death, myocardial infarction and stroke was analyzed at one year. Results Clinically relevant bleedings (Bleeding Academic Research Consortium types 2, 3 or 5) were frequently observed (20.6%, n = 181 patients) with one third occurring in the first month. MACE occurred more frequently at one year in patients with a bleeding (16.6% vs. 7.6%, adj.HR: 2.04(1.24;3.38); P = 0.005). Rates of myocardial infarction and stroke were higher at one year after bleeding (9.9% vs. 4.5%, adj.HR: 2.40(1.24;4.66); P = 0.0093 and 6.6% vs. 1%, adj.HR: 5.55(2.04;15.06); P = 0.0008 respectively) without significant difference in death (6.6% vs. 4.0%; HR: 1.20(0.57;2.51); P = 0.63). Predictive factors of major bleedings in the multivariate model were age > 85 years [adj.HR: 2.48(1.25;4.91); P = 0.0093] and hemoglobin level (per gram of decrease) [adj.HR: 1.45(1.18;1.79); P = 0.0004]. Conclusions Clinically relevant bleedings were frequently observed in elderly patients and strongly associated with myocardial infarction and stroke. Age itself remained a predictive factor of bleeding in this population over the age of 75 years.

International audience; Background: The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.Objectives: FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥10 mm Hg or new gradient ≥20 mm Hg.Methods: To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.Results: Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. Male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p < 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p < 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p < 0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p < 0.001) yielded higher risk of BVD.Conclusions: Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of severe aortic stenosis. The development of a new-onset complete left bundle branch block (LBBB) is, however, a frequent complication. The objective of the present study was to assess the impact of a new-onset LBBB after TAVI on the evolution of left ventricular ejection fraction (LVEF).Forty consecutive patients were included after the development of a new-onset LBBB after TAVI and were matched for age and LVEF with 40 patients implanted during the same period who did not develop an LBBB. The primary endpoint was evolution of the LVEF measured by echocardiography before implantation and between 6 and 12 months after TAVI.The development of an LBBB was associated with a 5-point decrease in LVEF [-12.5; 2.5], contrary to the non-LBBB group (1.5 [-6.5; 9.5], P = 0.007) at 8 months, with the persistence of the LBBB (n = 23) exacerbating this decrease (-7 [-13; 2], P = 0.009). When left ventricular dysfunction (LVEF50%) was present before TAVI, the appearance of an LBBB was associated with a reduction in LVEF (-2 [-8; 2]) contrary to the non-LBBB group (20 [9; 22], P = 0.02).The appearance of a new-onset LBBB after TAVI has a pejorative impact on left ventricular systolic function, particularly in patients with an initial LVEF50%, due to a lack of recovery of the latter, thereby potentially affecting their prognosis.

BACKGROUND 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. OBJECTIVES This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. METHODS 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. RESULTS 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 = 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. CONCLUSIONS 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. (J Am Coll Cardiol 2016; 68: 1637-47) (C) 2016 by the American College of Cardiology Foundation.

Background: No randomized study has investigated the value of optical coherence tomography (OCT) in optimizing the results of percutaneous coronary intervention (PCI) for non–ST-segment elevation acute coronary syndromes. Methods: We conducted a multicenter, randomized study involving 240 patients with non–ST-segment elevation acute coronary syndromes to compare OCT-guided PCI (use of OCT pre- and post-PCI; OCT-guided group) to fluoroscopy-guided PCI (angiography-guided group). The primary end point was the functional result of PCI assessed by the measure of post PCI fractional flow reserve. Secondary end points included procedural complications and type 4a periprocedural myocardial infarction. Safety was assessed by the rate of acute kidney injury. Results: OCT use led to a change in procedural strategy in 50% of the patients in the OCT-guided group. The primary end point was improved in the OCT-guided group, with a significantly higher fractional flow reserve value (0.94±0.04 versus 0.92±0.05, P =0.005) compared with the angiography-guided group. There was no significant difference in the rate of type 4a myocardial infarction (33% in the OCT-group versus 40% in the angiography-guided group, P =0.28). The rates of procedural complications (5.8%) and acute kidney injury (1.6%) were identical in each group despite longer procedure time and use of more contrast medium in the OCT-guided group. Post-PCI OCT revealed stent underexpansion in 42% of patients, stent malapposition in 32%, incomplete lesion coverage in 20%, and edge dissection in 37.5%. This led to the more frequent use of poststent overdilation in the OCT-guided group versus the angiography-guided group (43% versus 12.5%, P P =0.01). Conclusions: In patients with non–ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher postprocedure fractional flow reserve than PCI guided by angiography alone. OCT did not increase periprocedural complications, type 4a myocardial infarction, or acute kidney injury. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01743274.

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.

The optimal antithrombotic treatment after transcatheter aortic valve replacement (TAVR) remains a matter of debate. Although dual antiplatelet therapy is recommended, single antiplatelet therapy or oral anticoagulation is frequently used according to the patient profile. Whether this approach may affect clinical outcome is unknown.FRANCE TAVI (French Transcatheter Aortic Valve Implantation) is a prospective, multicenter, nationwide French registry. The study objectives were to identify independent correlates of long-term all-cause mortality and early bioprosthetic valve dysfunction (BVD), defined as increased prosthetic gradient ≥10 mm Hg or new gradient ≥20 mm Hg.To account for missing values, multiple imputations were performed. Stepwise multivariable Cox regression and logistic regression were used for all-cause mortality and bioprosthesis valve dysfunction was used, respectively. Sensitivity analysis retaining only patients with complete data were also performed.Of 12,804 patients included in the registry between January 1, 2013, and December 31, 2015, a total of 11,469 (mean ± SE age: 82.8 ± 0.07 years; logistic European System for Cardiac Operative Risk Evaluation: 17.8 ± 0.1%; mean duration of follow-up: 495 ± 3.5 days) were alive at discharge with known antithrombotic treatment and were analyzed for mortality. A total of 2,555 patients had at least 2 echocardiographic evaluations and were eligible for BVD assessment. One-third of patients had a history of atrial fibrillation, and the same proportion had oral anticoagulation at discharge (n = 3,836). Neither aspirin nor clopidogrel was independently associated with mortality. Male sex (adjusted hazard ratio [aHR]: 1.63; 95% confidence interval [CI]: 1.44 to 1.84; p 0.001), history of atrial fibrillation (aHR: 1.41; 95% CI: 1.23 to 1.62; p 0.001), and chronic renal failure (aHR: 1.37; 95% CI: 1.23 to 1.53; p 0.001) were the strongest independent correlates of mortality. Anticoagulation at discharge (adjusted odds ratio [aOR]: 0.54; 95% CI: 0.35 to 0.82; p = 0.005) and a nonfemoral approach (aOR: 0.53; 95% CI: 0.28 to 1.02; p = 0.049) were independently associated with lower rates of BVD, whereas chronic renal failure (aOR: 1.46; 95% CI: 1.03 to 2.08; p = 0.034) and prosthesis size ≤23 mm (aOR: 3.43; 95% CI: 2.41 to 4.89; p 0.001) yielded higher risk of BVD.Sex, renal failure, and atrial fibrillation affected mortality the most at the 3-year follow-up. In contrast, anticoagulation (mostly given for atrial fibrillation) decreased the risk of BVD after TAVR.