The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

Background: No randomized study powered to compare balloon-expandable (BE) with self-expanding (SE) transcatheter heart valve (THV) on individual endpoints after transcatheter aortic valve replacement (TAVR) has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry included 12,141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for native aortic stenosis (AS). Long-term mortality status was available in all patients (median 20 months, IQR:14-30). 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 co-primary outcome was the occurrence of paravalvular regurgitation (PVR)≥moderate and/or in-hospital mortality. The 2 nd co-primary outcome was 2-year all-cause mortality. Results: In matched-propensity analyses, the incidence of the 1st co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV(11.9%; RR=1.68; 95%CI:1.46-1.91; p<0.0001). Each component of the outcome was also higher in SE-THV patients: PVR≥moderate (15.5% vs. 8.3%; RR=1.90; 95% CI:1.63-2.22; p<0.0001) and in-hospital mortality (5.6% vs 4.2%, RR=1.34; 95%CI:1.07-1.66; p=0.01). During follow-up, all-cause mortality occurred in 899 patients treated with SE-THV (2-year mortality was 29.8%) and in 801 patients treated with BE-THV (2-year mortality 26.6%; HR=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. Conclusions: The present study suggests that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-THV.

Complications or prevention of complications after TEVAR either due to device failure or adverse events may require conversion to open repair or additional open surgical procedure. Open repair can be performed by a team experienced in management of diseases of the thoracic aorta and a low mortality rate achieved despite the precarious preoperative conditions and complex aortic pathologies of patients.

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 6 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.

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Our experience suggests that physician-modified thoracic stent-grafts are feasible for aortic arch lesions and provide encouraging results in the short term. Durability concerns will need to be assessed.

HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L'archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.

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