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International audience; Aims: While major vascular complications (MVC) remains an issue after Transfemoral (TF) transcatheter aortic valve replacement (TAVR), we compared outcomes in TF versus transcarotid (TC) approaches in patients with complex vascular anatomy.Methods and results: Among patients undergoing TAVR in our center between 2015 and 2018, we evaluated patients with complex vascular anatomy defined on CT scan as: (a) iliofemoral diameter between 5.5 and 6 mm or

International audience; Increasing operators’ experience and improvement of the technique have resulted in a drastic reduction in complications following transcatheter aortic valve replacement (TAVR) in patients with lower surgical risk. In parallel, the procedure was considerably simplified, with a routine default approach including local anesthesia in the catheterization laboratory, percutaneous femoral approach, radial artery as the secondary access, prosthesis implantation without predilatation, left ventricle wire pacing and early discharge. Thus, the “simplified” TAVR adopted in most centers nowadays is a real revolution of the technique. However, simplified TAVR must be accompanied upstream by a rigorous selection of patients who can benefit from a minimalist procedure in order to guarantee its safety. The minimalist strategy must not become dogmatic and careful pre-, per- and post-procedural evaluation of patients with well-defined protocols guarantee optimal care following TAVR. This review aims to evaluate the benefits and limits of the simplified TAVR procedure in a current and future vision.

Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during transcatheter aortic valve implantation (TAVI).The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA.From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (International Normalized Ratio [INR] between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI was performed according to current guidelines and a 50 U/kg bolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 3 (VARC3) and the Bleeding Academic Research Consortium (BARC) definitions at a 30-day follow-up.A total of 88 patients were included with a median age of 84 years (81.8-87.0), 42% being female. The median society of thoracic surgeons score was 5.1 (4.1-7.5), the median CHADS2-VASc was 5.5 (5-6) and 60.2% had a chronic kidney failure. Median INR at the time of implantation was 2.1 (1.8-2.6). The main VKA indication was atrial fibrillation. Transfemoral access was used in 88.6% of the patients. Major bleeding (BARC ≥ 3b) occurred in five patients (5.7%) and major vascular complications occurred in seven patients (8.0%). At 1 month follow-up, major bleeding (BARC ≥ 3) or vascular complications occurred in 10 patients (11.4%). In patients with major bleeding peripheral arterial disease (RR = 10.95; 95% confidence interval (CI) 1.63-73.75; p = 0.014) and carotid access (RR = 8.56; 95% CI 1.19-1.51; p = 0.033) were more common. INR 2.5 was significantly associated with vascular complications (RR = 7.14; 95% CI 1.29-39.63; p = 0.025). At 30 days, mortality and stroke rates were 2.3% and 4.5%, respectively.TAVI with uninterrupted VKA treatment seems feasible and safe with a low risk of major bleeding and vascular complications in this first single-center experience. Particular caution is advocated in high body mass index patients and to keep INR 2.5.

International audience; Background: Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding complications may be reduced with BAV performed without heparin.Methods: This randomized, double-blind, placebo-controlled study was conducted from January 2013 to September 2016. Patients were randomly assigned to placebo or intravenous unfractionated heparin (UH) 50 IU/kg bolus during the procedure. The primary endpoint included major vascular, bleeding and ischemic complications (stroke, transient ischemic attack, myocardial infarction) according to VARC-2 criteria.Results: Among 89 randomized patients, 82 completed the study (n = 39 in the UH group and n = 43 in the placebo group). At baseline, diabetes, sex male and renal failure were more frequent in the UH group and peripheral artery disease was more frequent in the placebo group. The primary endpoint was achieved in 7 patients (8.5%), 1 in the placebo group (2.3%) versus 6 in the UH group (15.4%). After adjustment on diabetes, sex, renal failure, peripheral artery disease, percutaneous closure device and chronic obstructive pulmonary disease, UH utilization was associated with a significant risk of major vascular, bleeding and ischemic complications (primary endpoint) (adjOR: 11.9; 95%CI: 1.2-117.2; p = 0.03). Hospitalization length was lower in the placebo group compared to the UH group (p = 0.03).Conclusions: BAV without per procedural UH was associated with a reduction of major VC and bleeding events without increasing the ischemic risk and with a shorter hospitalization length.

Highlights • Incidence of atrial fibrillation (AF) following patent foramen ovale (PFO) closure is low (, Background Increased risk of new-onset atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials without however systematic AF screening. We aimed to evaluate the incidence of AF within 6-month following PFO closure with serial 24-hour ambulatory electrocardiogram (AECG) monitoring. Methods All patients undergoing PFO closure were prospectively included in 2 centers. AF was defined as irregular rhythm without discernible P waves > 30 s on AECG at day 0, 1-month and 6-month follow-up. Primary endpoint was the incidence of AF within the study period. Secondary endpoints evaluated clinical outcomes within 6-month follow-up. Results Between February 2018 and March 2019, 62 patients underwent PFO closure including 40 male (64.5%) with a mean age of 48 ± 9.5. Atrial septal aneurysm was observed in 37 patients (64.9%), 57 patients (91.9%) received an Amplatzer Occluder device (Abbott Vascular) and 5 (8.1%) an Occlutech device (Occlutech). After a mean follow-up of 7.7 ± 2.8 months, new-onset AF occurred in 3 patients (4.8%), all within the first month following PFO closure, including one per-procedural, all were asymptomatic and paroxysmal. Two patients with AF (3.2%) required chronic oral anticoagulant therapy. No adverse outcomes occurred at follow-up. No predictive factors of AF were highlighted. A total of 16 patients (25.8%) reported palpitations without AF on the AECGs. Conclusion In highly selected patients, incidence of AF, evaluated with 3 systematic 24-hour AECG within 6-month following PFO closure, was low (

International audience; Background: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) may impact prognosis of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). We aimed to evaluate the evolution of previous RV dysfunction and/or significant TR after TAVI procedure.Methods: All patients undergoing TAVI between January 2018 and January 2019 were enrolled in this prospective cohort. Patients with at least one right heart (RH) abnormality at baseline including RV dysfunction (TAPSE < 17 mm, S-wave < 9.5 cm/s, Fractional area change < 35%, Strain > −20%, Tei > 0.54) and/or significant TR (Effective Regurgitant Orifice Area ≥ 40 mm2 and/or Regurgitant Volume ≥ 45 mL) underwent transthoracic echocardiography at day 1 and 6-month after TAVI. The primary endpoint was the regression of pre-TAVI RV dysfunction and/or significant TR at 6-month follow-up.Results: The study enrolled 144 patients including 76 women (52.8%) with a mean age of 81.1 ± 6.8 yo, a mean EuroSCORE 2 of 5.2 ± 3.9%. At least one RH abnormality was observed in 53 patients (36.8%). At 6-month, at least one RV dysfunction parameter significantly improved in 26 patients (63.4%), TAPSE increasing from 13.0 ± 2.6 to 16.0 ± 9.8 mm, p < 0.0001 and S-wave from 7.7 ± 1.2 to 10.0 ± 2.6 cm/s, p = 0.004. Among 31 patients with baseline significant TR, TR decreased in 14 (45.2%); p = 0.003. Among patients with baseline RH abnormalities, 13 (24.5%) fully recovered. Baseline significant TR was predictive of 6-month clinical outcomes (OR = 3.1, 95%CI = [1.01–9.0], p = 0.03).Conclusion: In our recent intermediate surgical risk TAVI population, RV dysfunction and/or significant TR are frequent at baseline and fully or partially recover in most patients at 6-month follow-up

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitationgrade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

Telemetry monitoring (TM) with or without intensive care unit (ICU) admission is the standard of care after Transcatheter aortic valve replacement (TAVR). Regarding to improvements of the technique and procedural results, TM may be considered only in selected patients. We aimed to confirm feasibility and safety of selective TM in patients undergoing TAVR.We prospectively evaluated 449 consecutive patients undergoing TAVR. Patients were transferred to general cardiology ward (GCW) without TM after the procedure when stable clinical state, transfemoral access, no baseline right bundle branch block (RBBB), left ventricular ejection fraction (LVEF) 40%, and no complication including any electrocardiogram (ECG) change within 1 h after the procedure ("low-risk" group). Others patients were considered for TM in ICU ("high-risk" group). The primary endpoint evaluated in-hospital major adverse events after unit admission according to VARC-2 criteria.The mean age was 81.8 ± 7.5 years and mean EuroSCORE II was 7.5 ± 4.8%. In total, 116 patients (25.8%) were considered as "low-risk" patients and 163 patients (36.3%) were referred to GCW, including those with immediate pacemaker implantation. A total of 96 patients (21.3%) reached the primary endpoint including mainly conductive disorders (12.8%). No major adverse events, particularly no late severe conductive disorder, occurred in the "low-risk" group (negative predictive value of 100%). Baseline RBBB (p 0.01), LVEF40% (p = 0.02) and "high-risk" group (p 0.01) were predictive of outcomes.Using rigorous periprocedural selection criteria, patients' admission in GCW without TM can be routinely and safely performed in 1/3 of patients after TAVR.

International audience; Inflammatory processes are deeply involved in ischemia-reperfusion injuries (IRI) and ventricular remodelling (VR) after a ST-segment elevation myocardial infarction (STEMI). They are associated with clinical adverse events (heart failure and cardiovascular death) adding damage to the myocardium after reperfusion. Moreover, acute myocardial infarction (AMI) induces a local sympathetic denervation leading to electrical instability and arrythmia. Colchicine, a well-known alkaloid with direct anti-inflammatory effects, was shown to reduce the myocardial necrosis size and limit the VR. In a recent proof of concept study, colchicine appears to prevent sympathetic denervation in a mice model of ischemia/reperfusion, but not in the necrosis or in the border zone areas. The Colchicine to Prevent Sympathetic Denervation after an AMI study (COLD-MI) is an ongoing, confirmative, prospective, monocentre, randomized, open-label trial. The COLD-MI trial aims to evaluate the intensity of sympathetic denervation after AMI and its potential modulation due to low dose colchicine. Sympathetic denervation will be noninvasively evaluated using single-photon emission computed tomography (SPECT). After a first episode of STEMI (Initial TIMI flow ≤ 1) and primary percutaneous coronary intervention (PPCI), patients will be randomized (n = 56) in a 1:1 ratio to either receive colchicine or not for 30 days. The primary end point will be the percentage of myocardial denervation measured by 123I-metaiodobenzylguanidine (123I-MIBG) SPECT at a 6-month follow-up. The main secondary end points will be basic ECG parameters (QRS duration, corrected QT) and HRV parameters from a 24 hour-recording Holter at 1- and 6-months follow-up. Results from this study will contribute to a better understanding of the cardioprotective effect of colchicine after AMI. The present study describes the rationale, design, and methods of the trial.

Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon‐expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open‐label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High‐sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high‐sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1‐month adverse events (all‐cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high‐sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78–87 years), with 129 men (61.1%). Mean postprocedure high‐sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group ( P =0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group ( P =0.004). BAV increased by 2.8‐fold (95% CI, 1.4–5.8) myocardial injury probability. Myocardial injury was associated with 1‐month adverse events ( P =0.03). Conclusions BAV increased the incidence and magnitude of myocardial injury after TAVR with new‐generation balloon‐expandable valves. Myocardial injury was associated with 1‐month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation. Registration URL: https://www.Clinicaltrials.gov ; Unique identifier: NCT02729519.

Aims Intra-aortic balloon pump (IABP) utilization was expected to be quickly abandoned following the IABP-shock trial and its class III, level B of recommendation in the 2016 ESC guidelines. The aim of this study was to evaluate the use of IABP compared to other mechanical support devices in a nationwide approach. Methods We conducted a retrospective study based on the French national hospital discharge database. All patients implanted by an assist device either by IABP, extracorporeal membrane oxygenation (ECMO) or IMPELLA® from 2014 to 2018 (2 years before/2 years after the 2016 guidelines) were included. The primary endpoint was the incidence of IABP implantation over the years. Secondary endpoints were incidence of total assist devices implantations, ECMO and IMPELLA® implantation. Results From 2014 to 2018, a total of 18,872 patients benefited from mechanical support by IABP (n=6,637, 35.2%), ECMO (n=11,833, 62.7%) or IMPELLA® (n=402, 2.1%) in France. The incidence of total mechanical support implantations (ECMO and IABP) was constant over the years. IABP implantation decreased progressively from 1,725 implantations in 2014 to 976 in 2018 (−44%). By contrast, ECMO implantation increased progressively from 1,919 implantations in 2014 to 2,715 implantations in 2018 (+42%). IMPELLA® implantations remained stable over the years from 63 (1.7%) implantations in 2014 to 83 (2.1%) in 2018. Conclusion In this nationwide real-life study, despite a significant decline in IABP implantations over the years since the ESC guidelines, this device remained used in clinical practice with around 1,000 implantations in 2018. The size of the centers is not strictly correlated with this use, suggesting differential uses depending of the local background. Funding Acknowledgement Type of funding source: None

International audience; Objectives: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).Background: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.Methods: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.Results: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.Conclusions: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)

Background Valve-in-valve (ViV) transcatheter aortic-valve implantation (TAVI) emerged has a less invasive treatment than repeated surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV vs. native valve TAVI. Purpose We aimed to compare hemodynamic performances and 1-year outcomes between patients undergoing ViV procedure and patients undergoing non-ViV TAVI. Methods This bicentric study included all patients undergoing aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients undergoing TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (± 5 years), sex and STS score. Primary endpoint was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. Results A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2 ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mmHg vs. 11.4 ± 5.4 mmHg; P 20 mmHg vs. 6 (7.8%) in the non-ViV group (P = 0.0001). Aortic regurgitations > grade 2 were similar in both groups (P = 0.71). In the ViV group new pacemaker implantation were less frequent (P = 0.01) and coronary occlusions occurred only in ViV group (n = 2 (4.1%)) ( Fig. 1 ). Conclusion ViV is a promising alternative to repeated cardiac surgery in patients with failed bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.

The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).

Background With the growing indications of transcatheter aortic valve implantation (TAVI) worldwide and among lower risk patients, valve durability has become a crucial issue. Purpose To assess mid and long-term evolution of different generations of percutaneous balloon-expandable prostheses, predictive factors of valve deterioration and its correlation with long-term mortality. Methods All consecutive patients undergoing TAVI for severe aortic stenosis with balloon-expandable prosthesis between 2009 and 2014 and with a minimum follow-up of one-year were included in this monocentric prospective study. All echocardiograms were reviewed by two independent experts. Clinical events were defined according to the Valve Academic Research Consortium criteria. Valve deterioration was defined according to the 2017 EAPCI-ESC-EACTS international consensus statement at the longest follow-up. Results A total of 160 patients were included with a median follow-up of 3.4 years [1.5–4.9] and a maximum of 8 years. Patients were mostly implanted with the first generation Sapien XT valve (n=138, 86.2%). Median age was 85 [79–86] years, with 42.5% of women and a median logistic Euro-SCORE of 14.2% [10.6–23.2]. Immediately after TAVI, mean aortic gradient decreased dramatically from 51±12mmHg to 9±2.6mmHg (p Evolution of mean aortic gradient Conclusions After a maximal 8-year follow-up, valve deterioration after balloon-expandable TAVI is very low. In this high-risk population, TAVI seems to be a safe and durable alternative to surgery in severe aortic stenosis regardless of prosthesis generation. Acknowledgement/Funding Edwards Lifesciences

Background With the growing indications of trans-catheter aortic-valve implantation (TAVI) and beneficial results among lower risk patients, valve durability is become a crucial issue. Purpose To assess long-term evolution of different generations of percutaneous balloon-expandable prostheses, incidence and predictive factors of structural valve deterioration (SVD). Methods All consecutive patients undergoing TAVI for severe aortic stenosis with balloon-expandable prosthesis between 2009 and 2014 were included in this monocentric prospective study. All echocardiograms were reviewed by two independent experts. Clinical events were defined according to the Valve Academic Research Consortium. SVD was defined according to the 2017 EAPCI-ESC-EACTS international consensus at the longest follow-up. Results A total of 160 patients were included with a median follow-up of 3.4 [1.5–4.9] years and a maximum of 8 years. Patients were mostly implanted with the first generation Sapien XT valve (n = 138, 86.2%). Median age was 85 [79–86] years with a median logistic Euro-SCORE of 14.2% [10.6–23.2]. Immediately after TAVI, mean aortic gradient decreased dramatically from 51 ± 12 mmHg to 9 ± 2.6 mmHg (P Fig. 1 ). Conclusions Up to 8-year follow-up, SVD following balloon-expandable TAVI is very low. TAVI seems to be a safe alternative to surgery in severe aortic stenosis regardless of prosthesis generation.

Key points ASCVD reduction is based on LDL reduction, especially by statins. Highly elevated TG could be harmful, especially because of the risk of pancreatitis. Elevation of TG is mainly due to metabolic disorders and diabetes, alcohol intake and overweight. Genetic factors have been clearly identified in the most severe cases. TG have been generally considered as bystanders for cardiovascular diseases (CVD). Both biological and basic research provide strong data suggesting that TG-rich lipoproteins could be involved in the pathophysiology of CVD. Recent epidemiological and genetics studies strongly corroborate the causal role of TG in CVD. This paves the way for new approaches in the management of patients both for primary and secondary prevention.

International audience; Background: The link between hs-Tn and infarct size has already been proved in several articles. However few is known about the kinetic of the troponin and its link to the infarct characteristics, likewise MVO. Our primary objective was to study which hs-Tn characterizes the best infarction.Methods and results: We identified 29 consecutive STEMI patients to study. The kinetics of hs-TnT (Roche) and two different TnIs (hs-TnI from Abbott, s-TnI from Siemens) were evaluated for all patients. Area under curves (AUC), first peak (FP) and second peak (SP), for hs-TnT, were compared to IS and MVO size using contrast-enhanced cardiac magnetic resonance. For IS, statistically SP of hs-TnT presented the best correlation compared to other peak values [r = 0.9 vs. 0.73 for FP hs-TnT; vs. 0.69 for hs-TnI; vs. 0.57 for s-TnI; respectively P < 0.01, P < 0.01, P < 0.01]. For MVO size, statistically SP of hs-TnT presented the best correlation compared to other peak values [r = 0.84 vs. 0.75 for FP hs-TnT; vs. 0.72 for hs-TnI; vs. 0.62 for s-TnI; respectively P = 0.01, P < 0.01, P < 0.01]. The best AUC were archived by the hs-TnT (AUC = 0.95) but there were no statistical differences when compared to other hs-Tn AUC.Conclusion: The SP of hs-TnT had the greatest level of correlation and therefore seems to be the best biological parameter to evaluate and characterize infarct size.; Introduction: La relation en troponine hypersensible et taille d’infarctus a été prouvée dans de nombreux articles. Cependant, peu de relations ont été établies entre cinétique de troponine et les caractéristiques de l’infarctus, notamment l’obstruction microvasculaire. Notre objectif principal était d’étudier quelle troponine de haute sensibilité caractérisait le mieux l’infarctus du myocarde.Méthodes et résultats: 29 patients ayant subi un infarctus du myocarde aigu ont été inclus consécutivement dans cette étude. Les cinétiques de la troponine T-hs (Roche) et deux troponines I (hs-TnI de chez Abbott, s-TnI de chez Siemens) ont été évaluées pour tous les patients. Les aires sous la courbe, la valeur du premier pic (PP) et du second pic (SP), pour la troponine T-hs, étaient comparées aux valeurs de taille d’infarctus et d’obstruction microvasculaire mesurées par IRM cardiaque. Concernant la taille de la nécrose, le second pic (SP) de troponine T-hs (hs-TnT) avait la meilleure corrélation en comparaison des autres valeurs de pic (r = 0,9 vs 0,73 pour le PP de hs-TnT ; vs 0,69 pour le pic de hs-TnI ; vs 0,57 pour le pic de s-TnI ; respectivement p < 0,01, p < 0,01, p < 0,01). Concernant la taille de l’obstruction microvasculaire, le SP de hs-TnT présentait la meilleure corrélation également en comparaison des autres valeurs de pics (r = 0,84 vs 0,75 pour PP de hs-TnT ; vs 0,72 pour le pic de hs-TnI ; vs 0,62 pour le pic de s-TnI ; respectivement p = 0,01, p < 0,01, p < 0,01). La meilleure aire sous la courbe de troponine était retrouvée avec la hs-TnT (AUC = 0,95), sans différence significative cependant comparativement aux autres troponines.Conclusion: Le second pic de troponine T-hs semblait être le meilleur paramètre biologique d’évaluation des caractéristiques de l’infarctus du myocarde.

Introduction Regarding the extent of TAVI's indication to patients with intermediary risks, it seems essential to lower its complication. Conduction disturbances after TAVI remains a major complication without any standardized guidelines to help with its treatment. Purpose The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study. Method In TAVI patients, indications for pacing were persistent high-degree atrioventricular block or bundle branch block appearance associated to HV interval longer than 70 ms, 24 hours after the procedure. After a two-month follow-up, clinical and ECG evaluation and 24-hour ECG Holter monitoring were realized in patients without pacemaker and compared to data obtained from the devices in pacemaker implanted patients (% of ventricular pacing > 1%; presence of more than 1 AVB episode). Results A total of 165 consecutive patients who underwent TAVI were prospectively included. Out of the 165 patients included, 157 were sampled: 20 in the high grade persistent AV block, 5 in the persistent bundle branch heart block with HV interval > 70 ms, 13 with HV interval Conclusion From this experimental protocol it appears that an HV based algorithm has a good specificity but a poor sensibility. Conduction disorders are stable at day 3 and allow to decide if pacing is needed. Besides QRS duration, PR interval might be of interest in predicting risk of AV block after TAVI.

Summary Background The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial. Aim To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty. Methods We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification ≥ 3) and vascular access complications. Results We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10–3.09; P = 0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs. Conclusions Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.

Background - Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited. Objectives - The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period. Methods - TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. Results - A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p

Admission to the intensive care unit (ICU) is a standard of care after transcatheter aortic valve implantation (TAVI); however, the improvement of the procedure and the need to minimize the unnecessary use of medical resources call into question this strategy. We evaluated prospectively 177 consecutive patients who underwent TAVI. Low-risk patients, admitted to conventional cardiology units, had stable clinical state, transfemoral access, no right bundle branch block, permanent pacing with a self-expandable valve, and no complication occurring during the procedure. High-risk patients included all the others transferred to ICU. In-hospital events were the primary end point (Valve Academic Research Consortium 2 criteria). The mean age of patients was 83.5 ± 6.5 years, and the mean logistic EuroSCORE was 14.6 ± 9.7%. The balloon-expandable SAPIEN 3 valve was mainly used (n = 148; 83.6%), mostly with transfemoral access (n = 167; 94.4%). Among the 61 patients (34.5%) included in the low-risk group, only 1 (1.6%) had a minor complication (negative predictive value 98.4%, 95% confidence interval [CI] 0.91 to 0.99). Conversely, 31 patients (26.7%) from the high-risk group had clinical events (positive predictive value 26.7%, 95% CI 0.19 to 0.35), mainly conductive disorders requiring pacemaker (n = 26; 14.7%). In multivariate analysis, right bundle branch block (odds ratio [OR] 14.1, 95% CI 3.5 to 56.3), use of the self-expandable valve without a pacemaker (OR 5.5, 95% CI 2 to 16.3), vitamin K antagonist treatment (OR 3.8, 95% CI 1.1 to 12.6), and female gender (OR 2.6, 95% CI 1.003 to 6.9) were preprocedural predictive factors of adverse events. In conclusion, our results suggested that TAVI can be performed safely without ICU admission in selected patients. This strategy may optimize efficiency and cost-effectiveness of procedures.

Purpose and medical hypothesis: Rest is usually recommended in acute pericarditis, as it could help to lower heart rate (HR) and contribute to limit ‘‘mechanical inflammation’’. Whether HR on admission could be correlated and perhaps participate to inflammation has not been reported. Methods: Between March 2007 and February 2010, we conducted a retrospective study on all patients admitted to our center for acute pericarditis. Diagnosis criteria included two of the following ones: typical chest pain, friction rub, pericardial effusion on cardiac echography, or typical electrocardiogram (ECG) findings. Primary endpoint was biology: CRP on admission, on days 1, 2, 3, and especially peak. Results: We included 73 patients. Median age was 38 years (interquartiles 28–51) and median hospitalization duration was 2.0 days (1.5–3.0). Median heart rate was 88.0 beats per minute (bpm) on admission (interquartiles 76.0–100.0) and 72.0 on discharge (65.0–80.0). Heart rate on admission was significantly correlated with CRP peak (p < 0.001), independently of temperature on admission, hospitalization duration and age. Recurrences occurred within 1 month in 32% of patients. Heart rate on hospital discharge was correlated with recurrence, independently of age. Conclusion: In acute pericarditis, heart rate on admission is independently correlated with CRP levels and heart rate on discharge seems to be independently correlated to recurrence. This could suggest a link between heart rate and pericardial inflammation.

Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure but recent evidence has suggested that aortic valvuloplasty may induce complications. The purpose of the DIRECTAVI study was to evaluate the efficacy

To determine whether vascular and bleeding complications may be reduced with balloon aortic valvuloplasty (BAV) performed without heparin.Vascular and bleeding complications are currently the main adverse events occurring after BAV.This registry included 162 consecutive patients with severe aortic stenosis who underwent BAV by femoral approach in our center between 2008 and 2012. Eighty-five patients had unfractionated heparin (UH) 50 IU/kg bolus IV during the procedure, whereas 77 patients did not have heparin. Our primary combined endpoint included severe vascular or bleeding complications (BARC score ≥3), severe ischemic events (acute limb ischemia or systemic embolism) or death at 1-month follow-up.The primary composite endpoint was achieved in 25 patients overall (15.4%) and was significantly lower in the heparin-free group (10.3% vs 20.0%; P=.03). Vascular, bleeding, or ischemic events were dramatically lower in the heparin-free group (6.5%) compared with the heparin group (18.8%; P=.01). UH use was associated with an increased risk of vascular and bleeding complications (relative risk, 2.92; 95% confidence interval, 1.35-7.94), but not with a decreased risk of ischemic events (relative risk, 1.81, 95% confidence interval, 0.34-9.61). After adjustment for patient and procedure characteristics, including the sheath size, heparin use was the only significant predictor of the primary endpoint (adjusted odds ratio, 2.94; 95% confidence interval, 1.75-14.74).BAV performed without heparin is associated with a reduction of severe vascular events or death without increased ischemic risk. This marked difference is difficult to explain by confounding factors, but should be confirmed in a randomized controlled trial.

Purpose There is good evidence that adherence to medical treatment is enhanced by knowledge and understanding of the drug, its benefits and its side-effects. Objectives To investigate knowledge and perceptions of antithrombotic therapy among a population of patients receiving chronic anticoagulation therapy with vitamine k antagonists (VKA) or direct oral anticoagulants (DOA). Methods We conducted a prospective study among 122 patients admitted in our cardiology unit and receiving anticoagulant therapy for more than 3 months. Atrial fibrillation was the main indication of therapy (n=63, 51.6%) and VKA concerned 87% of patients. All patients were invited to fill in a questionnaire (11 questions), which was handed out by a nurse in a face-to-face interview. None of the patients refused to fill in the questionnaire, which was completed at once and independently. Results While the vast majority of patients know that they have anticoagulant therapy (96,7%), patients presented a clear lack of knowledge concerning mainly food and drug interaction (table 1), the possible consequences of under- or over-anticoagulation (n=31; 25,4%), the reason why they have this therapy (n=39; 32,7%) and how to control their treatment. Comparing the two therapies, we observed a non significant difference in knowledge concerning VKA and DOA except knowledge of risks of therapy which was superior in the DOA group (p In conclusion Patients’ anticoagulant therapy knowledge, either vitamin K antagonists or DOA, is poor. With the increasing use of DOA, from which we have no more biologic control to assess compliance, improved patient education and physician involvement in therapeutic education, is crucial. Download : Download full-size image Abstract 0507 – Figure: Lack of knowledge concerning anticoagluant therapy

Objectives The aim of the study was to evaluate feasibility and safety of transcatheter aortic valve implantation (TAVI) performed without subsequent intensive care unit (ICU) admission using simple clinical, ECG and echocardiographic criteria. Methods We included prospectively 177 consecutive patients who underwent TAVI in our center. Low-risk patients, admitted to conventional cardiology unit, had stable clinical state, LVEF > 40%, transfemoral access, no right bundle branch block (RBBB), permanent pacing with self-expandable valve and no complication during the procedure. High-risk group included other patients who were transferred to ICU. The primary endpoint concerned in-hospital events (VARC-2 criteria). Results Mean age of patients was 83.5±6.5 years and mean logistic Euroscore was 14.6±9.7%. The balloon expandable SAPIENS 3 valve was mainly used (n=148; 83.6%), mostly with transfemoral access (n=167; 94,4%). Among the 61 patients (34.5%) included in the low-risk group, only 1 (1.6%) had a minor complication (NPV: 98.4%; 95% CI: 0.91-0.99). Conversely, 47 patients (40.5%) from the high-risk group had clinical events (PPV: 40.5%; 95% CI: 0.31-0.50), mainly conductive disorders requiring pacemaker (n=26; 22.4%). In multivariate analysis, RBBB (OR: 14.1; 95% CI: 3.5-56.3), use of self-expandable valve without pacemaker (OR: 5.5; 95% CI: 2-16.3), vitamin K antagonist treatment (OR: 3.8; 95% CI: 1.1-12.6) and female gender (OR: 2.6; 95% CI 1.003-6.9) were pre-procedural predictive factors of in-hospital adverse events. Conclusions Our results suggested that TAVI can be performed safely without ICU admission in selected patients. This strategy may optimize efficiency and cost-effectiveness of the procedure. The author hereby declares no conflict of interest Table . In hospital major adverse events in the two groups of patients. Post TAVI adverse events Low risk group (n=61; 34.5%) High risk group (n=116: 65.5%) Death (n=1; 0.6%) 0 1 (0.9%) Acute pulmonary oedema (n=1; 0.6%) 0 1 (0.9%) New high conductive disorder (n=36; 20.2%) 0 36 (31%) Permanent pacing requiring (n=26; 14.7%) 0 26 (22.4%) Major vascular complication (n=1; 0.6%) 0 1 (0.9%) Pericardial effusion requiring medical intervention (n=2; 1.2%) 0 2 (1.8%) Acute kidney injury (Akin 2 or 3) (n=3; 1.8%) 0 3 (2.7%) Secondary transfer to ICU (n=1) (pericardial effusion) 1 (1.6%) Total of patient with at least one complication (n=48; 27.1%) 1 (1.6%) 47 (40.5%)

Background After synthesis by cardiomyocytes, precursor proBNP1-108 is cleaved into NT-proBNP and BNP. Recently, cross-reactivity between these assays was discussed. The aim of this study was to characterize the cross-reactivities, through a new biochemical innovative approach consisting in the total depletion of the circulating proBNP1-108 in patients with heart failure (HF). Methods This prospective study included 180 patients with chronic HF. BNP and NT-proBNP were dosed with commercial kits. ProBNP1-108 was determined using an ELISA research assay specific to the precursor. ProBNP1-108 depletion was performed by immunocapture with a specific antibody targeting exclusively the ProBNP1-108 hinge region. ProBNP1-108, BNP and NT-proBNP levels were determined before and after depletion using this process in HF patients. Results Mean age was 74.34 +/-12.5 y, and 69% of patients were males. NYHA classes II and III were the most frequent (32% and 45% respectively). Before depletion, ProBNP1-108, NT-proBNP and BNP levels were 316.8+/-265.9 pg/ml; 6,054.0+/-11,539 pg/ml and 684.3+/-82.1 pg/ml respectively, and were closely correlated with NHYA classes. After immuno-depletion, proBNP1-108 was decreased in mean by 96% (p

Bleeding and femoral access complications which occurred after balloon aortic valvuloplasty (BAV) may be enhanced by the systematic use of heparin during the procedure. We assessed the hypothesis that BAV performed without heparin may be associated with lower complications rates. Methods We conducted a retrospective analysis of all consecutive patients who had undergone BAV in our center between 2008 and 2011. We evaluated 3 groups: group 1 included patients whose BAV was performed with large sheaths (10 to 12 F) and use of unfractionated heparin (UH) (50IU/kg bolus IV); patients whose BAV was performed with use of smaller size sheaths (8 or 9 F) who were divided into group 2 (with UH bolus) and group 3 (without UH bolus). We collected all major in-hospital adverse events, bleeding (≥BARC 3), vascular complications (including pseudoanerysm or arterio venous fistula) and acute limb ischemia. Results Overall, 132 patients were included in this study. The 3 groups had similar median age (84 years) or previous lower extremity artery disease (overall n= 36, 27%, p=0.79). Vascular and bleeding complications were observed in 17 patients (12.8%) and were significantly higher when UH was used (table 1) with a relative risk of 2.89 (1.18-6.1). Conversely, absence of heparin did not increase ischemic complications or major in-hospital adverse events (p=0.5). Vascular complications were similar among patients who received heparin whatever the size of the used sheath (table 1). Conclusion Balloon aortic valvuloplasty performed without heparin appears to be safe and is associated with a dramatic reduction of vascular and bleeding events. Although randomization was not used, this marked difference is difficult to explain by confounding factors. Table 1 . Vascular and bleeding complications. group 1 (UH+, LS) n=23 group 2 (UH+, SS) n=46 group 3 (UH-, SS) n=63 p value Femoral access and/or bleeding n=17 (12.8%) 4 (17.3%) 9 (19.5.%) 4 (6.3%)* 0.007 Bleeding n=15 (11.3%) 4 (17.3%) 8 (17.3%) 3 (4.7%)* 0.004 Acute limb ischemia n=4 (2.2%) 0 2 (4.3%) 2 (3.1%) 0.82 UH+: unfractionated heparin bolus 50 ui/kg; UH-: no heparin bolus; LS: large sheath; SS: small sheath