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Objectives The purpose of this study was to assess the concordance between transcatheter aortic valve implantation angles generated by the “double S-curve” and “cusp-overlap” techniques. Background The “double S-curve” and “cusp-overlap” methods aim to define optimal fluoroscopic projections for transcatheter aortic valve replacement (TAVR) with a self-expandable device. Methods The study included 100 consecutive patients undergoing TAVR with self-expanding device planned by multidetector computed tomography. TAVR was performed using the double S-curve model, as a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy. Optimal projection according to the cusp-overlap technique was retrospectively generated by overlapping the right and left cups on the multidetector computed tomography annular plane. The angular difference between methods was assessed in spherical 3 dimensions and on the left and right anterior oblique (RAO) and cranial and caudal (CAU) axes. Results The double S-curve and cusp-overlap methods provided views located in the same quadrant, mostly the RAO and CAU, in 92% of patients with a median 3-dimensional angular difference of 10.0° (interquartile range: 5.5° to 17.9°). The 3-dimensional deviation between the average angulation obtained by each method was not statistically significant (1.49°; p = 0.349). No significant differences in average coordinates were noted between the double S-curve and cusp-overlap methods (RAO: 14.7 ± 15.2 vs. 12.9 ± 12.5; p = 0.36; and CAU: 27.0 ± 9.4 vs. 26.9 ± 10.4; p = 0.90). TAVR using the double S-curve was associated with 98% device success, low complication rate, and absence of moderate-to-severe paravalvular leak. Conclusions The double S-curve and cusp-overlap methods provide comparable TAVR projections, mostly RAO and CAU. TAVR using the double S-curve model is associated with a high rate of device success and low rate of procedural complications.

Objectives The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit. Background The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging. Methods This was an international registry of 23 TAVR centers. Results In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05). Conclusions For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274 )

International audience; Objectives: This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS).Background: The prognostic value of the SYNTAX score in this high-risk setting remains unclear.Methods: The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (2232). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression.Results: Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p < 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes.Conclusions: In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality.

International audience; BackgroundThe impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear.MethodsThis is a pre-specified analysis from the culprit-lesion-only PCI vs multivessel PCI in CS (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and 1 year were assessed using multivariate logistics models.ResultsA noninfarct related CTO was present in 157 of 667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at 1 year was also increased but did not reach statistical significance (adjusted Odds ratio 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (Odds ratio 0.79 95%CI 0.42-1.49 and Odds ratio 0.67 95%CI 0.48-0.96, respectively), without significant interaction (P = .68).ConclusionsIn patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO.

The purpose of this study was to assess the concordance between transcatheter aortic valve implantation angles generated by the "double S-curve" and "cusp-overlap" techniques.The "double S-curve" and "cusp-overlap" methods aim to define optimal fluoroscopic projections for transcatheter aortic valve replacement (TAVR) with a self-expandable device.The study included 100 consecutive patients undergoing TAVR with self-expanding device planned by multidetector computed tomography. TAVR was performed using the double S-curve model, as a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy. Optimal projection according to the cusp-overlap technique was retrospectively generated by overlapping the right and left cups on the multidetector computed tomography annular plane. The angular difference between methods was assessed in spherical 3 dimensions and on the left and right anterior oblique (RAO) and cranial and caudal (CAU) axes.The double S-curve and cusp-overlap methods provided views located in the same quadrant, mostly the RAO and CAU, in 92% of patients with a median 3-dimensional angular difference of 10.0° (interquartile range: 5.5° to 17.9°). The 3-dimensional deviation between the average angulation obtained by each method was not statistically significant (1.49°; p = 0.349). No significant differences in average coordinates were noted between the double S-curve and cusp-overlap methods (RAO: 14.7 ± 15.2 vs. 12.9 ± 12.5; p = 0.36; and CAU: 27.0 ± 9.4 vs. 26.9 ± 10.4; p = 0.90). TAVR using the double S-curve was associated with 98% device success, low complication rate, and absence of moderate-to-severe paravalvular leak.The double S-curve and cusp-overlap methods provide comparable TAVR projections, mostly RAO and CAU. TAVR using the double S-curve model is associated with a high rate of device success and low rate of procedural complications.

AIMS: The aim of this study was to determine the prognostic impact of pre- and post-PCI TIMI flow grade and TIMI myocardial perfusion grade (TMPG) in a well-defined group of patients with cardiogenic shock due to acute myocardial infarction. METHODS AND RESULTS: Patients with infarct-related cardiogenic shock randomised into the CULPRIT-SHOCK trial were included in the angiographic predictor analysis whenever their TIMI flow grade or TMPG was available in the core lab database (96.9% of cases). A multivariable logistic regression analysis, adjusted on non-angiographic covariates, was performed to investigate whether TIMI flow grade or TMPG was independently associated with all-cause mortality or renal replacement therapy up to one year. Pre-PCI TIMI flow grade and TMPG did not impact on mortality. When analysed in separate multivariable models, post-PCI TIMI 3 flow and TMPG grade 3 were both significantly associated with reduced risk of 30-day mortality: aOR 0.61 (95% CI: 0.38-0.97, p=0.037) and 0.46 (95% CI: 0.29-0.72, p

OBJECTIVES The aim of this study was to define the optimal fluoroscopic viewing angles of both coronary ostia and important coronary bifurcations by using 3-dimensional multislice computed tomographic data. BACKGROUND Optimal fluoroscopic projections are crucial for coronary imaging and interventions. Historically, coronary fluoroscopic viewing angles were derived empirically from experienced operators. METHODS In this analysis, 100 consecutive patients who underwent computed tomographic coronary angiography (CTCA) for suspected coronary artery disease were studied. A CTCA-based method is described to define optimal viewing angles of both coronary ostia and important coronary bifurcations to guide percutaneous coronary interventions. RESULTS The average optimal viewing angle for ostial left main stenting was left anterior oblique (LAO) 37°, cranial (CRA) 22° (95% confidence interval [CI]: LAO 33° to 40°, CRA 19° to 25°) and for ostial right coronary stenting was LAO 79°, CRA 41° (95% CI: LAO 74° to 84°, CRA 37° to 45°). Estimated mean optimal viewing angles for bifurcation stenting were as follows: left main: LAO 0°, caudal (CAU) 49° (95% CI: right anterior oblique [RAO] 8° to LAO 8°, CAU 43° to 54°); left anterior descending with first diagonal branch: LAO 11°, CRA 71° (95% CI: RAO 6° to LAO 27°, CRA 66° to 77°); left circumflex bifurcation with first marginal branch: LAO 24°, CAU 33° (95% CI: LAO 15° to 33°, CAU 25° to 41°); and posterior descending artery and posterolateral branch: LAO 44°, CRA 34° (95% CI: LAO 35° to 52°, CRA 27° to 41°). CONCLUSIONS CTCA can suggest optimal fluoroscopic viewing angles of coronary artery ostia and bifurcations. As the frequency of use of diagnostic CTCA increases in the future, it has the potential to provide additional information for planning and guiding percutaneous coronary intervention procedures.

This study sought to evaluate the prognostic value of the SYNTAX (SYNergy between PCI with TAXUS and Cardiac Surgery) scores in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary disease with infarct-related cardiogenic shock (CS).The prognostic value of the SYNTAX score in this high-risk setting remains unclear.The CULPRIT-SHOCK (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock) trial was an international, open-label trial, where patients presenting with infarct-related CS and multivessel disease were randomized to a culprit-lesion-only or an immediate multivessel PCI strategy. Baseline SYNTAX score was assessed by a central core laboratory and categorized as low SYNTAX score (SS ≤22), intermediate SYNTAX score (22SS≤32) and high SYNTAX score (SS32). Adjudicated endpoints of interest were the 30-day risk of death or renal replacement therapy (RRT) and 1-year death. Associations between baseline SYNTAX score and outcomes were assessed using multivariate logistic regression.Pre-PCI SYNTAX score was available in 624 patients, of whom 263 (42.1%), 207 (33.2%) and 154 (24.7%) presented with low, intermediate and high SYNTAX score, respectively. A stepwise increase in the incidence of adverse events was observed from low to intermediate and high SYNTAX score for the 30-day risk of death or RRT and the 1-year risk of death (p 0.001, for all). After multiple adjustments, intermediate and high SYNTAX score remained strongly associated with 30-day risk of death or renal replacement therapy and 1-year risk of all-cause death. There was no significant interaction between SYNTAX score and the coronary revascularization strategy for any outcomes.In patients presenting with multivessel disease and infarct-related CS, the SYNTAX score was strongly associated with 30-day death or RRT and 1-year mortality.

Background Complete revascularization (CR) – assessed by the residual SYNTAX score (rSS) – following PCI is associated with a better prognosis – in stable coronary disease, acute coronary syndrome and myocardial infarction (MI). Whether, the completeness of revascularization impacts the prognosis of patients in cardiogenic shock (CS) remains unclear. Aim Assess the prognosis value of rSS following primary PCI in multivessel patients undergoing MI-related CS. Methods The CULPRIT SHOCK trial – the largest randomized trial (n=706) to date in CS – compared an immediate multivessel PCI (MVPCI) strategy to a culprit lesion only PCI (with possible staged revascularization) strategy in multivessel patients with MI-related CS. The rSS were retrospectively assessed following last PCI (either index or staged) by a central core laboratory and patients were allocated in 4 different groups according to rSS: CR (rSS=0), 0< rSS ≤5, 5< rSS ≤14, rSS >14. The prognostic impact of rSS on the 30-day composite endpoint (mortality and/or severe renal failure) and 30-day and 1-year mortality were assessed using multivariate logistic regression. Results Among the 604 patients with last rSS available, aged 68.2±11.4, the median rSS was 9.0 [4.0–17.0]. CR was achieved in 75 (25%) patients in the MVPCI strategy and in 31 (10.2%) in the culprit lesion only PCI strategy. One hundred and six (17.5%), 102 (16.9%), 198 (32.8%) and 198 (32.8%) patients had a rSS=0, 0< rss ≤5, 5< rSS ≤14 and rSS >14, respectively. Patients with a higher rSS were older, less active smoker, had more triple vessel disease, chronic total occlusion, post-PCI culprit coronary TIMI flow 14 had higher rates of 30-day primary endpoint (OR [95% CI]: 2.02 [1.24; 329] and 2.75 [1.69; 4.49]), 30-day mortality (OR [95% CI]: 2.13 [1.29; 3.51] and 3.14 [1.90; 5.18]) and 1-year mortality (OR [95% CI]: 2.39 [1.46; 3.90] and 3.47 [2.11; 5.71]) compared to patients with CR. After multiple adjustment, rSS – tested as continuous variable – was independently associated with 30-day primary endpoint, 30-day and one-year mortality (Figure) Conclusion Among multivessel patients with MI-related cardiogenic shock, 1) complete revascularization is achieved only in one fourth of the patients using a MVPCI strategy and, 2) the residual SYNTAX score is independently associated with early and late mortality. Acknowledgement/Funding Funded by the European Union 7th Framework Program and others

Background Thrombolysis In Myocardial Infarction (TIMI) flow is a prognostic factor which assessment is complex in life-threatening situations. Because TIMI flow evaluation by site investigator (SI) is subject to bias, independent Core-Laboratory (CL) adjudication is the reference standard in clinical trials. Purpose To evaluate the concordance between CL and SI in the evaluation of the culprit artery TIMI flow, and the associated prognosis in the CULPRIT-SHOCK trial. Methods All patients of the CULPRIT-SHOCK trial with CL adjudications were included in this analysis. CL adjudicators were blinded to patient's characteristics and outcomes: pre and post-PCI TIMI flows were solely evaluated on the basis of coronary angiograms. SI determined the TIMI flow before and immediately after PCI of the culprit lesion. The concordance was determined by Cohen's κ coefficient. A multivariate analysis was used to evaluate 1) factors of discordance 2) the association between each method of evaluation and the mortality at 30 days and 1 year. Results Among CULPRIT-SHOCK patients, 663 patients were eligible for this analysis. Of the 214 patients adjudicated TIMI flow 3 by CL before PCI, SI over-estimated the obstruction to TIMI flow 0–1-2 in 121 (56.5%). Of the 139 patients scored TIMI flow 0–1-2 by CL after PCI, SI over-graded their results to TIMI flow 3 in 79 (56.8%). Overall, the K coefficient of agreement was 0.44, 95% CI [0.36; 0.51] before PCI and 0.44, 95% CI [0.35; 0.53] after PCI. Mechanical circulatory support and culprit left main were the main factors of discordance of TIMI flow after PCI. The association between TIMI flow 0–1-2 after PCI and 30-days mortality was significant, whether adjudicated by SI or CL (figure). Post-PCI TIMI-flow 0–1-2 was associated to 1-year mortality only when evaluated by SI (figure). Association between TIMI and mortality Conclusions In comparison to the independant CL evaluation, SI overestimated the severity of coronary slow flow before PCI, and the success of PCI in improving coronary flow. The level of agreement between CL and SI was moderate. While both evaluations predicted 30-days mortality, only SI scoring was associated to 1-year mortality. Acknowledgement/Funding European Union Seventh Framework Program, the German Heart Research Foundation, German Cardiac Society.

International audience

BackgroundWhile rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology.Main bodyWe reviewed the existing literature on mitral and tricuspid transcatheter therapies. Mitraclip is becoming an established therapy for secondary mitral regurgitation in selected patients with disproportionately severe regurgitation associated with moderate left ventricle dysfunction. Evidence is less convincing for primary mitral regurgitation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for secondary as well as primary mitral regurgitation. But further development is needed to improve delivery. Transcatheter tricuspid intervention arrives late after similar technologies have been developed for aortic and mitral valves and is currently at its infancy. This is likely due in part to previously under-recognized impact of tricuspid regurgitation on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on tricuspid annuloplasty and replacement is limited, and more research is warranted.ConclusionThe future appears bright for transcatheter mitral therapies, albeit their place in clinical practice is yet to be clearly defined. Tricuspid transcatheter therapies might address the unmet need of tricuspid regurgitation treatment.

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

OBJECTIVES: To develop and compare an array of Machine Learning (ML) methods to predict in-hospital mortality after TAVR in the United States (US). BACKGROUND: Existing risk prediction tools for in-hospital complications in patients undergoing transcatheter aortic valve replacement (TAVR) have been designed using statistical modeling approaches and have certain limitations. METHODS: Patient data was obtained from the National Inpatient Sample (NIS) database from 2012–2015. The data was randomly divided into a development cohort (n=7,615) and a validation cohort (n=3,268). Logistic Regression (LR), Artificial Neural Network (ANN), Naïve Bayes (NB) and Random Forest (RF) ML algorithms were applied to obtain in-hospital mortality prediction models. RESULTS: A total of 10,883 TAVRs were analyzed in our study. The overall in-hospital mortality was 3.6%. Overall, prediction models’ performance measured by Area Under the Curve (AUC) were good (> 0.80). The best model was obtained by LR, AUC=0.92 (95% CI, 0.89–0.95). Most obtained models plateaued after introducing 10 variables. Acute kidney injury was the main predictor of in-hospital mortality ranked with the highest mean importance in all the models. The NIS TAVR score showed the best discrimination among available TAVR prediction scores. CONCLUSIONS: Machine learning methods can generate robust models to predict in-hospital mortality for TAVR. The NIS TAVR score should be considered for prognosis and shared decision making in TAVR patients.

International audience; Objectives: This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.Background: The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device.Methods: The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2).Results: A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%.Conclusions: TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.

TAVI is currently recommended for severe symptomatic aortic stenosis in patients at prohibitive, high or intermediate surgical risk as estimated by surgical risk scores (STS score and EuroSCORE II). Comorbidity, technical feasibility of TAVI and concurrent pathology with need for complementary surgical correction are conditions to be considered to choose between open surgery and TAVI. The decision is often made by the "Heart Team". The transfemoral access must be favored. Conduction disturbance, stroke, bioprosthesis thrombosis and durability are the main setbacks of TAVI. Double antiplatelet therapy with aspirin and clopidogrel during 3 to 6 months is currently recommended after TAVI, followed by long-term aspirin single therapy.

Within the past decade, transcatheter aortic valve implantation (TAVI) has become established as the optimal treatment option for elderly, inoperable and high-risk patients with severe aortic stenosis, and is now recommended by international guidelines. Randomized controlled trials have demonstrated the non-inferiority of TAVI to open surgery in intermediate-risk patients and, most recently, in low-risk patients. Further randomized controlled trials are underway, but existing studies have already provided reassuring data in this cohort, and TAVI is offered routinely to younger and lower-risk patients in numerous centers. Improvements in the design of devices and delivery systems, accompanied by increased operator experience, have dramatically improved the safety of the procedure, and further expansion into low-risk groups seems inevitable once concerns about valve durability and device cost have been addressed. In this article, we provide a review of the existing literature, and estimate the clinical impact of TAVI in low-risk patients. Abbreviated title: Why should we extend TAVI to low-risk patients?

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.

This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.The TC approach for TAVR holds the potential to become the optimal alternative to the transfemoral gold standard. Limited data exist regarding safety and efficacy of TC-TAVR using the Edwards Sapien 3 device.The French Transcarotid TAVR prospective multicenter registry included patients between 2014 and 2018. Consecutive patients treated in 1 of the 13 participating centers ineligible for transfemoral TAVR were screened for TC-TAVR. Clinical and echocardiographic data were prospectively collected. Perioperative and 30-day outcomes were reported according to the updated Valve Academic Research Consortium (VARC-2).A total of 314 patients were included with a median (interquartile range) age of 83 (78 to 88) years, 63% were males, Society of Thoracic Surgeons mortality risk score 5.8% (4% to 8.3%). Most patients presented with peripheral artery disease (64%). TC-TAVR was performed under general anesthesia in 91% of cases, mostly using the left carotid artery (73.6%) with a procedural success of 97%. Three annulus ruptures were reported, all resulting in patient death. At 30 days, rates of major bleeding, new permanent pacemaker, and stroke or transient ischemic attack were 4.1%, 16%, and 1.6%, respectively. The 30-day mortality was 3.2%.TC-TAVR using the Edwards Sapien 3 device was safe and effective in this prospective multicenter registry. The TC approach might be considered, in selected patients, as the first-line alternative approach for TAVR whenever the transfemoral access is prohibited. Sapien 3 device was safe and effective in our multicenter cohort.

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.

OBJECTIVES Radiation exposure is a concern for both patients and operators during transcatheter aortic valve implantation (TAVI). Efforts to reduce radiation dose are warranted. We aimed at investigating if per-operative advanced image processing can reduce patient and operator irradiation use during TAVI. METHODS We performed a prospective single-centre observational study comparing patient and operator radiation exposure using standard fluoroscopy (control group) or a novel technology of live advanced fluoroscopic image processing (test group) among consecutive patients undergoing TAVI between August 2015 and April 2016. Patient irradiation (dose-area product, effective dose and air kerma), contrast media volume and clinical outcomes were assessed. RESULTS Among 152 elderly [median age (interquartile range): 83 (78-87)] patients (n = 76 per group) undergoing TAVI, baseline clinical characteristics were similar between the control and test groups, except for a higher median EuroSCORE II (2.8% vs 2.3%, P = 0.02) and higher rate of TAVI for failing surgical bioprosthesis (11.8% vs 2.6%, P = 0.03) in the control group. The dose-area product was reduced in the test group: mean reduction of -27.5 Gy × cm2 [95% confidence intervals (CIs): 15.9-39.1, P

Aims To assess the incidence, risk factors and prognosis of periprocedural myocardial infarction (MI) and myocardial injury in patients undergoing elective percutaneous coronary intervention (PCI). Methods and results We included all consecutive patients who underwent elective PCI with a negative troponin level at admission from 1 January 2014 to 31 December 2015. The primary endpoint was defined as the composite of periprocedural MI (Type 4a MI), stent thrombosis (Type 4b MI), and myocardial injury according to the Third universal definition of MI. Multivariable analysis was performed to identify independent predictors of periprocedural MI and myocardial injury and its relation to 30-day and 1-year clinical outcome. Of the 1390 elective PCI patients, the primary endpoint occurred in 28.7% of patients, including 7.0% of Type 4a MI, 0.14% of Type 4b MI, and 21.6% of myocardial injury. Independent risk factors for the occurrence of the primary endpoint were left main PCI, total stent length >30 mm, multiple stenting, chronic kidney disease (estimated glomerular filtration rate 75 years. At 30 days, patients with periprocedural MI and myocardial injury had a higher rate of cardiovascular events [5.5% vs. 1.2%, adjusted hazard ratio (adjHR) = 3.8, 95% confidence interval (CI) 1.9-6.9; P

The transcarotid (TC) approach for trancatheter aortic valve replacement (TAVR) hold the potential to become the optimal alternative to the transfemoral gold standard. Limited data exists regarding safety and efficacy of TC-TAVR using the Edwads Sapien 3 device. The French Transcarotid TAVR

Transcatheter aortic valve implantation (TAVI) is currently performed through an alternative access in 15 % of patients. The transapical access is progressively being abandoned as a result of its invasiveness and poor outcomes. Existing data does not allow TAVI operators to favour one access over another — between transcarotid, trans-subclavian and transaortic — because all have specific strengths and weaknesses. The percutaneous trans-subclavian access might become the main surgery-free alternative access, although further research is needed regarding its safety. Moreover, the difficult learning curve might compromise its adoption. The transcaval access is at an experimental stage and requires the development of dedicated cavo-aortic crossing techniques and closure devices.

Sodium azide is a highly toxic chemical agent, which effects are similar to cyanide, and its ingestion is almost constantly fatal when the dose is above 1g. We report the case of a 69-year-old woman who survived a massive sodium azide poisoning with an unsual clinical course and outcome. It caused severe toxic cardiomyopathy presenting like a silent myocardial infaction with systolic and diastolic impairment that lasted one month. There is no antidote. We present a review of the literature about this rare poisoning, its mechanisms and discuss treatment options.