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Background: The study evaluates a novel technique using oxygen measurements to indirectly evaluate the behavior of carbon dioxide (CO2) in the residual gas released by thoracic stent-grafts and to better understand the mechanism of the CO2 flushing technique. Methods: Ten Zenith TX2 ProForm thoracic stent-grafts (ZDEG-PT-34-199-PF, Cook Medical, Bjæverskov, Denmark) were equally divided into 2 groups (Group A and B). Group A was flushed with 60 ml of 0.9% saline. Group B was flushed with 100% carbon dioxide gas followed by 60 ml of 0.9% saline. The stent-grafts were deployed into a plastic tube that was placed and fixated to the bottom of a translucent container filled with water to collect the residual air released by the stent-grafts. Oxygen (O2) concentration and gas volume were measured in the released gas. Results: The oxygen concentration was significant (p

International audience; Objective: We evaluated the early- and medium-term outcomes of single- and double-fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular degenerative aortic arch aneurysm repair.Methods: We performed a single-center, retrospective analysis of prospectively collected data from 52 patients from August 2013 through January 2021 who had undergone homemade fenestrated thoracic endovascular aortic repair for degenerative aortic aneurysms. In all cases, a distal smaller fenestration for the left subclavian artery (LSA) was fashioned and was the only one stented. For a double-fenestrated endograft, a proximal larger fenestration that incorporated both the brachiocephalic trunk and the left common carotid artery was added.Results: A total of 52 patients with degenerative aortic arch aneurysms were treated. Of the 52 patients, 36 were men, the mean age was 75 ± 8 years, 31% had received a single LSA fenestration, and 69% had undergone double-fenestrated thoracic endovascular aortic repair. Of the 52 procedures, 5 (10%) were emergent procedures. The technical success was 100%. The median time required for stent graft modification was 22 ± 6 minutes. The 30-day mortality was 2% (n = 1). Five patients (10%) had experienced a cerebrovascular event, including two transient ischemic attacks, one minor stroke with full neurologic recovery, and two with sequelae. Two patients (4%) had experienced perioperative retrograde dissection during follow-up. No patient had developed a type I, II, or III endoleak from the LSA. No patient had required reintervention. All supra-aortic trunks were patent. During a mean follow-up of 18 ± 11 months, no patient had required conversion to open surgical repair, aortic rupture, or paraplegia.Conclusions: Single or double PMEG is a safe and suitable tool for the treatment of high morbidity pathology such as aortic arch degenerative aneurysm repair. In addition, this device can be used in patients requiring elective or emergency repair.

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.

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.

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

OBJECTIVES The critical step in total endovascular aortic arch repair is to ensure alignment of fenestrations with, and thus maintenance of flow to, supra-aortic trunks. This experimental study evaluates the feasibility and accuracy of a double-fenestrated physician-modified endovascular graft [single common large fenestration for the brachiocephalic trunk and left common carotid artery and a distal small fenestration for left subclavian artery (LSA) with a preloaded guidewire for the LSA] for total endovascular aortic arch repair. METHODS Eight fresh human cadaveric thoracic aortas were harvested. Thoracic endografts with a physician-modified double fenestration were deployed for total endovascular aortic arch repair in a bench test model. A guidewire was preloaded through the distal fenestration for the LSA. All experiments were undertaken in a hybrid room under fluoroscopic guidance with subsequent angioscopy and open evaluation for assessment. RESULTS Mean aortic diameter in zone 0 was 31.3 ± 3.33 mm. Mean duration for stent graft modification was 20.1 ± 5.8 min. Mean duration of the procedure was 24 ± 8.6 min. The Medtronic Valiant Captivia stent graft was used in 6 and the Cook Alpha Zenith thoracic stent graft in 2 cases. LSA catheterization was technically successful with supra-aortic trunk patency in 100% of cases. CONCLUSIONS The use of a double-fenestrated stent graft with a preloaded guidewire appears to be a useful technical addition to facilitate easy and correct alignment of stent graft fenestrations with supra-aortic trunk origins.

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.

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.

Our aim was to evaluate the early- and medium-term outcomes of using double fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular aortic arch repair.The present single-center retrospective analysis of prospectively collected data included 50 patients from January 2017 through October 2019, who had undergone thoracic endovascular aortic repair (TEVAR). The fenestrations were a proximal larger fenestration that incorporated the brachiocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented.The median duration for stent graft modification was 26 ± 6 minutes. Of the 50 patients, 41 were men. The mean patient age was 68 ± 11.5 years. The indications for treatment included degenerative aortic arch aneurysm (n = 17), dissecting aortic arch aneurysm after type A dissection (n = 13), type B dissection (n = 13), aortic ulcer (n = 3), and other pathologies (n = 4). The technical success rate was 94% (47 of 50) overall, and 100% (28 of 28) after a technical modification incorporating a preloaded guide wire for the LSA fenestration (P .05). The 30-day mortality was 2% (n = 1). Two patients (4%) had a minor stroke with full recovery. One patient (2%) had a type IB and two patients (4%) had a type II endoleak from the LSA. Four patients (8%) required reintervention: one because of a type IB endoleak and three because of access-related complications. All supra-aortic trunks were patent. During a mean follow-up of 16 ± 8.3 months, no conversions to open surgical repair were required and no aortic rupture, paraplegia, or retrograde dissection occurred.Using double fenestrated PMEGs for TEVAR is both feasible and effective for total endovascular aortic arch repair, avoiding the need for anatomic and extra-anatomic surgical revascularization. The absence of brachiocephalic trunk stenting was not associated with endoleaks or treatment failure and resulted in a lower stroke risk than alternative strategies. The midterm results suggest that stenting of the brachiocephalic trunk and right common carotid artery might not be necessary for a large proportion of patients undergoing total endovascular aortic arch repair. The persistence of the seal and ongoing durability require assessment in studies with long-term follow-up data available.

Background The prognostic impact of systematic revascularization of asymptomatic coronary artery stenosis before transcatheter aortic valve replacement (TAVR) is still debated Purpose The main objectives of this study were to evaluate the feasibility and the safety of a functional evaluation of coronary artery disease (CAD) followed by a selective ischemia-guided percutaneous coronary intervention (PCI) after TAVR. Methods This prospective, bi-centric, one-arm, open-label trial included patients with severe aortic stenosis (AS) eligible for TAVR and with significant CAD defined as one or more coronary stenosis ≥70%. Patients with left main stenosis ≥50%, proximal left anterior descending artery (LAD) stenosis ≥90% or > class 2 Canadian cardiovascular society angina pectoris were excluded. Coronary revascularization was not performed before TAVR and myocardial ischemia was evaluated by stress cardiac imaging one month after the procedure using Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging or Stress Echocardiography using dobutamine infusion. The primary endpoint was the composite of all cause of death, stroke, major bleeding (Bleeding Academic Research Consortium (BARC) ≥3), major vascular complication (Valve Academic Research Consortium 2 criteria), myocardial infarction (MI) and hospitalization for cardiac causes at 6 months following TAVR. Results Between June 2016 and March 2019, 71 patients were included with a complete follow-up in 66 patients. The mean age was 84±5.2 years and the mean Euroscore was 13±8.6. Stress cardiac imaging could be achieved in 70% (n=46) of the patients and the main causes to not perform it were patient refusal or secondary impaired medical condition. Significant myocardial ischemia was observed in only 3 patients (4.5%), of whom 2 patients had successful PCI. The primary endpoint occurred at 6 months in 15 patients (23%) including death in 6 patients (9%), stroke in 3 patients (5%) and major bleedings in 3 patients (5%). Acute MI was observed in only 2 patients (3%) that had not-LAD proximal and severe coronary stenosis (≥90%). Hospital readmission (n=27, 41%) was mostly related to non-cardiac causes (n=18, 27%). Conclusions In patients scheduled to TAVR and with significant coronary disease, a strategy of selective ischemia-guided coronary revascularization after TAVR appears safe with a low rate of myocardial infarction and myocardial ischemia requiring revascularization during follow-up. However, the poor adherence of elderly patients to stress test could suggest to perform PCI of proximal and severe coronary lesions. Large-scale and randomized trials are warranted to validate this strategy. Funding Acknowledgement Type of funding source: None

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

Background Veno-arterial extracorporeal life support (VA-ECLS) results in cardiopulmonary shunting with reduced native cardiac output (NCO). Low NCO occurrence is common and associated with risk of thromboembolic and pulmonary complications. Practical tools for monitoring NCO during VA-ECLS would therefore be valuable. Pulse pressure (PP) and end-tidal carbon dioxide (EtCO2) are known to be related to cardiac output. We have designed a study to test whether PP and EtCO2 were efficient for the monitoring of NCO during VA-ECLS. Methods In this prospective single-center observational study, patients who underwent a VA-ECLS for cardiogenic shock from January 2016 to October 2017 were included, provided low NCO was suspected by a PP 2. The ability of PP and EtCO2 to predict NCO Results Among the 106 patients treated with VA-ECLS for cardiogenic shock during the study period, 26 were studied, allowing the collection of 196 study points. PP and EtCO2 relationships with NCO were nonlinear and showed strong correlations for NCO r = 0.69 and r = 0.78 respectively). A PP 2 p = 0.058). Conclusions PP and EtCO2 may offer an accurate real-time monitoring of low NCO events during VA-ECLS support. Further studies are needed to show if their utilization may help to implement therapeutic strategies in order to prevent thromboembolic and respiratory complications associated with VA-ECLS, and to improve patients’ prognosis. Trial registration NCT03323268, July 12, 2016

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: 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.

International audience; Purpose: To analyze the structural variation of the aortic arch and the supra-aortic arteries and establish an average spatial configuration that would be a pattern for a “universal double fenestration” design for physician-modified endovascular grafts (PMEGs) used in total thoracic endovascular aortic repair (TEVAR). Materials and Methods: Aortic arch morphology was retrospectively analyzed by reviewing the preoperative thoracic computed tomography angiography scans in 33 consecutive patients (mean age 68 years; 27 men) treated between January 2017 and March 2019 using double-fenestrated PMEGs for zone 0 TEVAR. Image analysis was completed according to a standardized technique on a vascular workstation with center lumen line reconstruction for all measurements. Variations in branching pattern of the aortic arch were classified into 8 types.Results: The arch trunk configuration was type I in 26 patients (79%), type II in 5 (15%), type III in 1, and type IV in 1. Mean aortic diameters at the level of mid ascending aorta, innominate artery (IA), left common carotid artery (LCCA), and left subclavian artery (LSA) were 35.7±3.7, 34.2±4.5, 33.3±6.7, and 33.7±4.7 mm, respectively. Mean diameters of the trunk were 12.2±1.7, 7.5±1.4, and 8.0±0.8 mm, respectively. Mean longitudinal center to center lengths were 15.9±2.5 mm between the LSA and LCCA and 12.1±3.0 mm between the LCCA and IA. Mean clock positions using the LSA as reference were 12:50 for the IA and 12:05 for the LCCA. In 32 patients (97%) all the supra-aortic branch vessels fit perfectly inside two delimited areas defined by a proximal common square area of 30×30 mm for the IA and LCCA and a second distal 8-mm-diameter circle for the LSA.Conclusion: Variations of the aortic arch anatomy are numerous and common. A general morphological pattern is described that delimits the aortic area where these variations occur. This information can be utilized for the design of an off-the-shelf double-fenestrated stent-graft for zone 0 TEVAR

International audience; Rupture of Valsalva sinus remains a very rare and deadly complication of Valsalva sinus aneurysm with a high mortality rate. We report here the case of a 47-year-old man who presented to the emergency department with acute exercise-induced dyspnea, chest pain, and fever. Transthoracic (TTE) and transesophageal echocardiography (TEE) highlighted a rupture of the right Valsalva sinus in the right atrium due to infective endocarditis. After stabilization of the patient, a successful surgical repair with double pericardial patches was performed.

International audience

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 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 TAVI. Purpose The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. Methods From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (INR between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI were performed according to current guidelines and a 50UI/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 2 (VARC2) and the Bleeding Academic Research Consortium (BARC) definitions at 30 day follow-up. Results A total of 88 patients were included with a median age of 84 years [81.8–87], 42% being female, the median STS 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 time of implantation was at 2.1 [1.8–2.6]. VKA were used for atrial fibrillation (89.8%), mechanic mitral prosthesis (5.7%) or venous thromboembolic disease (4.5%). Trans femoral access was used in 88.6% of the patients. Major bleeding (BARC ≥3b) occurred in 5 patients (5,7%) and major vascular complications occurred in 7 patients (8%). Peripheral arterial disease (RR = 10.95; 95% CI: 1.63 to 73.75; p=0.014) and carotid access (RR=8.56; 95% CI: 1.19 to 61.51; p=0.033) were significantly associated with major bleeding. INR >2.5 was significantly associated with vascular complications (RR=7.14; 95% CI: 1.29 to 39.63; p=0.025). In multivariate analysis, Body mass index (OR=1.26; 95% CI: 1.02 to 1.57; p=0.032) and INR >2.5 (OR=18.91; 95% CI: 1.62 to 221.26; p=0.010) were independent factor significantly associated with vascular complications or major bleeding. Mortality rate at 30 days follow-up was 2.3%, there was no myocardial infarction and stroke rate was 4.5%. Figure 1. Study flowchart Conclusion TAVI with uninterrupted VKA treatment seems to be feasible and safe with low risk of bleeding and vascular complications in this first single centre experience. Particular caution is advocated in low BMI patients and to keep INR

Background Systematic admission to the intensive care unit (ICU) was considered as a standard of care after transcatheter aortic valve implantation (TAVI). However, regarding to improvements in procedural results, our team pointed out feasibility and safety of TAVI without ICU admission in selected patients referred in our center in 2015 Purpose The aim of this study was to evaluate the evolution of our practice after the first study to confirm the feasibility and safety of TAVI without ICU in a large population of patients. Methods We evaluate prospectively 451 consecutive patients undergoing TAVI between January 2017 and december 2017. The same “low-risk” criteria were applied to this cohort of patients to allow admission to conventional cardiology unit: stable clinical state, transfemoral access, no right bundle branch block at baseline, left ventricular ejection fraction >40% and no complications occurring during the procedure. Any new conduction disturbance was considered as indication for ICU. Results The mean age was 81.8±7.5 years and the mean logistic Euroscore was 9.1±3.3%. The balloon-expandable Sapien 3 was used in 181 patients (40.1%) and the transfemoral route was the main vascular approach (n=412, 91.3%). According to the predefined criteria, 289 patients (64.1%) were considered at “high-risk”. In-hospital major complications occurred in 52 patients (11.5%) including 3 deaths (0.7%), 6 major vascular complications (1.3%), 1 stroke (0.2%), 7 heart failures (1.5%), 2 tamponades (0.4%), 2 ventricular perforations (0.4%) and 31 high-degree conduction disorders (6.9%) including 26 patients undergoing immediate pacemaker implantation allowing a non-ICU decision. All complications occurred in the “high-risk” group (figure) and the negative predictive value of the “low-risk” criteria to predict complications was 100%. In multivariate analysis, right bundle branch block (p ICU and non-ICU admission after TAVI Conclusion Our results confirm that with a rigorous selection of patients and using simple criteria, TAVI can be routinely performed without ICU admission in nearly 40% of patients with a stable proportion of patients not referred to ICU between 2015 and 2017.

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

Objective The aim of this retrospective analysis was to evaluate the outcomes of physician-modified double fenestrated stent grafts for total endovascular aortic arch repair: one proximal large fenestration for the brachiocephalic trunk and the left common carotid artery and one distal fenestration for the left subclavian artery (LSA). Methods From January 2017 through February 2018, 17 patients (88.2% elective) underwent thoracic endovascular aortic repair (TEVAR) with double homemade fenestrated stent graft for total endovascular aortic arch repair to maintain supra-aortic trunk patency. Indications were degenerative aortic arch aneurysm (n = 7), dissecting aortic arch aneurysms subsequent to surgical treatment of acute type A dissections (n = 6), chronic complicated type B aortic dissection (n = 3), and acute complicated type B aortic dissection (n = 1). Routine postoperative follow-up imaging with computed tomography angiography was performed to assess TEVAR and supra-aortic trunks patency and endoleak. Results The median time for stent graft modification was 19 minutes (range, 16-20 minutes). Endovascular exclusion of the aortic arch was achieved in all the cases. One LSA catheterization failed and LSA revascularization was performed by carotid axillary bypass and coverage of the LSA fenestration by additional stent graft placement. Additional planned endovascular procedures were required in three patients: closure of supra-aortic trunks re-entry tears in two cases of dissecting aortic arch aneurysms and one transcatheter aortic valve replacement for severe native aortic valve regurgitation. One stroke, with no long-term deficit, was observed. No patients died. All left supra-aortic trunks are patent. No type I endoleak was observed. We only observed one patient with a type II endoleak. During a mean follow up of 7 ± 2 months, there were no conversions to open surgical repair, aortic rupture, paraplegia, or retrograde dissection. Conclusions Double homemade fenestrated TEVAR is both feasible and effective for maintaining the patency of the supra-aortic trunks and allows total endovascular aortic arch repair. Durability concerns will need to be assessed in additional studies with long-term follow-up.

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.

Objective A review of the literature was conducted for incidence, outcomes, and risk factors for distal stent graft-induced new entry (SINE) after thoracic endovascular aortic repair (TEVAR) of aortic dissection. Methods The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results Seven articles reporting on 1415 patients with thoracic aortic dissection undergoing TEVAR without supplemental distal bare stenting were included. In this cohort, 86 patients were treated for a residual type A aortic dissection and 1329 for a complicated type B aortic dissection. Distal SINE occurred in 112 patients (7.9%). The mean time to identification of distal SINE was 19 ± 7 months. The incidence of distal SINE after TEVAR for type B aortic dissection differed on the basis of whether it was a chronic or acute dissection repair and was, respectively, 12.9% (43/331) and 4.3% (12/273). Successful secondary interventions were performed in 54% of the patients. All the studies analyzing the relationship between distal stent graft oversizing and incidence of distal SINE reported a significantly higher rate of SINE with oversizing. Conclusions The successful management of complicated descending thoracic aortic dissections by TEVAR is well established. Whereas distal SINE is relatively frequent, if it does occur, the complication can generally be treated with additional TEVAR without a poor outcome. The main determinant of SINE seems to be excessive distal oversizing.

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.

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.

Background This study evaluated the outcome of physician-modified thoracic stent grafts for the treatment of dissecting aortic arch aneurysms after surgical treatment of acute type A dissection. Methods From August 2016 through February 2018, 13 patients (8 men and 5 women) underwent thoracic endovascular aortic repair in which physician-modified thoracic stent grafts were used to treat dissecting aortic arch aneurysms after surgical treatment of acute type A dissection. Patients were a mean age of 70.7 ± 10 years (range, 43 to 82 years). Four patients were treated in an emergent setting for a symptomatic aortic arch aneurysm. The aneurysmal disease involved zone 0 in 10 patients and zone 2 in 3. Seven patients (48%) were treated using an aortic arch stent graft with a single fenestration, combined with cervical debranching in 4 patients. Six patients underwent total endovascular aortic arch repair using a double-fenestrated stent graft. Additional planned endovascular procedures were performed in 3 patients. Results Median time for stent graft modifications was 18 minutes (range, 14 to 21 minutes). All the proximal entry tears in the arch were successfully excluded. The 30-day mortality rate was 0%. One patient (7.6%) had a stroke without permanent sequelae. The median length of stay was 5 days (range, 1 to 17 days). During follow up of 8 ± 6 months, there were no conversions to open repair, aortic rupture, paraplegia, or retrograde dissection. Conclusions The use of physician-modified thoracic stent grafts for the treatment of dissecting aortic arch aneurysm after surgical treatment of acute type A dissection is feasible and effective. Durability concerns will need to be assessed in future studies.

International audience; OBJECTIVE:Critical limb ischemia (CLI), the most advanced form of peripheral arterial disease, is associated with strikingly high morbidity and mortality rates. Autogenous single-segment great saphenous vein (GSV) remains the optimal conduit for infrainguinal revascularization. Unfortunately, GSV is unavailable in up to 20% of patients. There is no consensus about the alternative graft that should be used for infragenicular bypass grafting when the GSV is unavailable. Currently, there are no outcome data for cold-stored venous allograft use in regard to recent safety and efficacy objective performance goals described by the Society for Vascular Surgery.METHODS:This is a retrospective analysis of 118 infragenicular revascularizations performed for CLI with cold-stored venous allografts obtained from varicose vein stripping surgery in a single institution from November 2002 to August 2013.RESULTS:Mean age (± standard deviation) was 75 ± 12 years (male, 76%; diabetes, 73%; dialysis, 16%), and 38% (n = 45) had a history of failed ipsilateral revascularization. None had suitable autogenous conduit for even composite vein bypass. The distal anastomosis was performed to an infrapopliteal artery in 85 cases (72%). At 30 days, perioperative death rate was 6.8%, major adverse cardiovascular event rate was 7.6%, and major adverse limb event rate was 11.9%. Mean follow-up was 34 ± 29 months (range, 1-113 months). At 1 year, freedom from major adverse limb event or perioperative death, limb salvage, survival, amputation-free survival, and secondary patency rates were, respectively, 64.9%, 82.5%, 85.4%, 73.3%, and 58.3%. Ejection fraction

Objective The aim of this retrospective analysis was to evaluate the outcomes of homemade fenestrated stent-grafts for thoracic endovascular aortic repair of zone 2 aortic lesions. Methods From November 2013 to January 2017, 24 patients underwent thoracic endovascular aortic repair with left subclavian artery revascularization using a homemade fenestrated stent-graft to preserve the patency of the left subclavian artery. Elective cases accounted for 54% (n = 13) of the sample. Indications included acute complicated type B aortic dissection (n = 9), degenerative aneurysm (n = 9), penetrating aortic ulcer (n = 5), and intramural hematoma (n = 1). Routine postoperative follow-up imaging with computed tomography angiography was performed to assess thoracic endovascular aortic repair and left subclavian artery fenestration patency and endoleak. Results Median duration for stent-graft modification was 16 minutes (range, 14-17 minutes). The technical success rate was 100%. One patient had a distal type I endoleak requiring additional stent-graft placement. One patient had partial coverage of the left common carotid artery requiring left common carotid artery stenting. One patient had a stroke without permanent sequelae (4.1%). Overall mortality was 0%. All left subclavian arteries were patent. Two type III endoleaks required additional left subclavian artery covered stent placement. One type II endoleak is currently observed. During a mean follow-up of 13.2 ± 2 months, there were no conversions to open surgical repair, aortic rupture, paraplegia, or retrograde dissection. Conclusions The use of a homemade fenestrated stent-graft for thoracic endovascular aortic repair of zone 2 aortic lesions is both feasible and effective for left subclavian artery revascularization during thoracic endovascular aortic repair involving a spectrum of thoracic aortic pathology. Durability concerns will need to be assessed in additional studies with long-term follow-up.

Objective The use of off-the-shelf stent grafts for thoracic endovascular aortic repair of type A dissections is limited by variability in both the length of the ascending aorta and the location of the proximal intimal tear. This experimental study aimed to assess the feasibility of using a physician-modified thoracic aortic stent graft to treat acute type A dissection by a transapical cardiac approach. Methods The experiments were performed on six cadaveric human heart, ascending aorta, aortic arch, and descending aorta specimens. Fenestration was fashioned in each standard tubular Valiant thoracic stent graft (Valiant Captivia; Medtronic Vascular, Santa Rosa, Calif) to match the anatomy of each specimen. Stent grafts of sufficient length were selected to cover the entire ascending aorta and aortic arch. Stent graft diameters in proximal sealing zones were oversized by 5% to 10%. The length of the fenestration was the distance between the left subclavian artery and the proximal edge of the origin of the brachiocephalic trunk with an additional 10 mm. The diameter of the scallop was that of the brachiocephalic trunk with an additional 5 mm on all sides. The length of the covered portion of the stent graft was the distance between coronary arteries and the proximal edge of the origin of the brachiocephalic trunk. Two lateral radiopaque markers were positioned to delineate the distal and lateral edge of the scallop. Another 3-cm radiopaque marker was sutured onto the sheath to ensure accurate radiologic positioning of the scallop on the outer curve of the aorta. The left ventricle and the thoracic aorta were connected to a benchtop aortic pulsatile flow model. A 5-mm 30-degree lens was introduced through the left subclavian artery to monitor the procedure. The customized stent graft was deployed by a transapical approach under fluoroscopic control. Results Median duration of stent graft modification was 21 minutes (range, 17-40 minutes). All attempts to deploy the homemade proximal scalloped stent graft by a transapical approach were successful. Completion angiography demonstrated patency of the supra-aortic trunks and of the coronary arteries in all cases. Macroscopic evaluation did not identify any deterioration of the customized stent graft. Conclusions The use of physician-modified stent grafts is feasible for thoracic endovascular aortic repair of type A dissection by a transapical approach in this model.

A 79-year-old woman was admitted with a large chronic dissecting ascending aortic aneurysm starting 5 mm distal to the ostia of the left coronary artery and ending immediately proximal to the innominate artery. A reverse extra-anatomic aortic arch debranching procedure was performed. During the same operative time, through a transapical approach, a thoracic stent graft was deployed with the proximal landing zone just distal to the coronary ostia and the distal landing zone excluding the origin of the left common carotid artery. The postoperative course was uneventful. Computed tomography at 12 months documented patent extra-anatomic aortic arch debranching and no evidence of endoleak. Keywords: Ascending aorta, Thoracic aorta, Aortic dissection, Stent graft

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

International audience

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.

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.

Background Transfemoral (TF) access is considered as the default approach in patients undergoing TAVI. However, ilio-femoral anatomic considerations as diameter, tortuosities and calcifications have to be taken into account and alternatives routes as transcarotid (TC) may be considered. Purpose This study compare outcomes between “complex” TF (cTF) and TC in patients undergoing TAVI. Methods All consecutive patients undergoing TAVI via cTF and TC in our center between 2015 and 2018 were included in this retrospective study. A cTF approach was defined as a common femoral artery Results The study included 131 patients with 51 of them who underwent cTF TAVI (39,2%) whereas 80 patients underwent TC TAVI (60,8%). The mean age was 81.7 ± 6.9 years. Patients in the TC group had a higher operative risk profile (STS score 5.5 vs 7.7; P = 0.01), a lower left ventricular fraction (44% vs 53%; P ≤ 0.001) and a higher incidence of coronary artery disease (61% vs 38%, P = 0.04) compared with cTF patients. Prevalence of female was higher in the cTF group compared to the TC group (66% vs 31% P ≤ 0.0001). There were no significant differences in term of 30 day mortality (1.9% vs. 2.5%; P = 1) or stroke rate (1.9% vs. 2.5%; P = 1) or bleeding rate (11.7% vs. 7.5%; P = 0.53) between the cTF group and the TC group but major vascular complications occurred with a higher frequency in the cTF group (cTF:11.7%; TC:2.5%; P = 0.05) Conclusion Despite a higher risk profile patients, the TC approach provided similar results in term of mortality, stroke, bleeding but was associated with a lower risk of major vascular complications. Carotid access could be considered in challenging femoral anatomy for TAVI procedures.

Objective The aim of this study was to evaluate the outcomes of homemade proximal scalloped stent grafts for thoracic endovascular aortic repair of zone 2 acute aortic syndrome. Methods Between May 2015 and December 2015, 10 patients with unremitting symptoms or rupture secondary to an acute aortic syndrome involving zone 2 underwent urgent or emergency thoracic endovascular aortic repair. Among them, 8 were treated using homemade proximal scalloped stent grafts to preserve the patency of the left subclavian artery. Indications included traumatic transection (n = 3) and acute (n = 4) and subacute (n = 1) complicated type B aortic dissection. Follow-up computed tomography scans were performed at 1 week and 3 and 6 months. Results The median duration for stent graft modification was 15 minutes (range, 14-17 minutes). The technical success rate was 100%; sealing was achieved in all cases with no type I endoleaks. All left subclavian arteries were patent, although 1 case was associated with a 50% stenosis. No deaths occurred as a consequence of the aortic repair, but 1 patient died of a traumatic renal hematoma on postoperative day 5. During a mean follow-up of 7.2 ± 2 months, there were no conversions to open surgical repair, aortic ruptures, paraplegia, retrograde dissection, or other aortic complications. Conclusions The use of the homemade proximal scalloped stent graft is both feasible and effective for left subclavian artery revascularization during thoracic endovascular aortic repair involving a spectrum of acute thoracic aortic pathology. This approach provides a rapid, reproducible method of scalloping the endograft. Durability concerns will need to be assessed in additional studies with long-term follow-up.

Background Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation. Methods/design The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure. Discussion This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice. Trial registration ClinicalTrials.gov identifier: NCT02729519. Registered on 15 July 2016. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2036-y) contains supplementary material, which is available to authorized users.

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

Objective To assess factors predisposing patients to retrograde type A aortic dissection (RTAD) who have undergone hybrid aortic arch repair. Methods From 2001 to 2013, 32 patients underwent hybrid aortic arch repair in our department: 19 in zone 1 and 13 in zone 0. Among these patients, 6 experienced RTAD (18.7%): 3 in zone 0 (23%), 3 in zone 1 (15.8%). Preoperative computed tomography scans of these 32 patients were evaluated. A morphologic assessment of the aortic arch, ascending aorta, and aortic root was performed. Other potential risk factors were investigated. Binary logistic regression was performed to test for possible associations with RTAD. Results Five patients were successfully converted to open repair. Patients who had RTAD were similar to those who did not, across pertinent variables, including age, type of device, diameter of the ascending aorta, and presence of a bicuspid aortic valve (all P > .1). Incidence of RTAD was observed to be higher among women ( P = .034), patients with stent-graft oversizing ≥10% ( P = .018), and patients treated with a stent-graft of diameter >42 mm ( P = .01). Aortic morphology analysis showed that an indexed aortic diameter of ≥20 mm/m 2 ( P = .003); aortic root morphology, specifically loss of the sinotubular junction ( P = .004); and presence of an aortic arch malformation ( P = .03) were correlated with risk of RTAD. Two patients in the zone-0 group with severe angulation (>120°) between the ascending and the transverse aorta suffered RTAD. Conclusions The occurrence of RTAD after hybrid aortic arch repair is common. To prevent this complication, preoperative screening of the aortic arch, ascending aorta, and aortic root morphology is critical.

We hypothesized that staged repair of extensive thoracic aneurysms might mitigate the incidence and severity of spinal ischemia by facilitating structural remodeling of the spinal cord vasculature. Staged hybrid repair (in two or three stages) was undertaken in 7 patients with extensive thoracic aortic aneurysms. The 30-day mortality and spinal ischemia rates were 0%. The conceptual basis of staging extensive aortic repairs is the maintenance of adequate flow to a sufficient number of spinal arteries and that spinal perfusion is preserved during the early postoperative period when the patient is most vulnerable to hypotension, by deliberately allowing interval distal type I endoleak.