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).

The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

No abstract

No abstract

No abstract

Background-The first generation of pericardial valves had a high rate of premature deterioration. The aim of this study was to compare the outcome after aortic valve replacement with second generation pericardial prostheses (Pericarbon and Carpentier-Edwards). Methods and Results-Between 1987 and 1994, 162 patients underwent aortic valve replacement with either a Pericarbon (nϭ81, 69Ϯ11 years) or a Carpentier-Edwards (nϭ81, 70Ϯ11 years) pericardial prosthesis. Mean follow-up was 4.4Ϯ2.7 years for Pericarbon and 4.8Ϯ2.4 years for Carpentier-Edwards valves (Pϭ0.27), giving a total follow-up of 745 patient-years. Thirty-day mortality and 5-year actuarial survival were, respectively, 6.2% and 63.2Ϯ5.7% in the Pericarbon group and 6.2% and 63.5Ϯ5.6% in the Carpentier-Edwards group. At 8 years, freedom from (and linearized rates per patient-year) thromboembolism, structural failure, and all valve-related events were, respectively, 91.8Ϯ3.6% (1.4%), 76.9Ϯ8.7% (2.5%), and 58.4Ϯ9.3% (5.6%) in the Pericarbon group and 94.4Ϯ2.7% (1%), 100% (0%, PϽ0.01), and 88.8Ϯ3.7% (2%, PϽ0.05) in the Carpentier-Edwards group. There were 9 (11.1%) Pericarbon structural failures related predominantly to severe calcification and stenosis. The actual reoperation rate was 7.4% (1.6% per patient-year) in the Pericarbon group for fibrocalcific degeneration (nϭ3), periprosthetic leak (nϭ1), endocarditis (nϭ1), and aortic dissection (nϭ1). There was neither structural valve failure nor valve reoperation in the Carpentier-Edwards group. Echocardiographic review of 70 patients from 85 survivors (82.3%) found 4 additional Pericarbon valves with signs of early structural failure but no Carpentier-Edwards valve with such changes. Conclusions-Eight years after aortic valve replacement, Pericarbon pericardial prostheses compared unfavorably with Carpentier-Edwards pericardial prostheses, with a high incidence of structural valve failure and reoperation. (Circulation. 1999;100[suppl II]:II-11-II-16.) Key Words: valves Ⅲ surgery Ⅲ prosthesis Ⅲ complications F irst generation pericardial valves have been abandoned because of poor clinical results and a high rate of deterioration characterized by leaflet tears and valve incompetence. 1-6 Second generation pericardial valves (Carpentier-Edwards, Pericarbon) have now been available for over 10 years but little is known about their mid-term comparative results. The main advantages of pericardial valves are their low thrombogenicity, permitting the avoidance of oral anticoagulation, and their alleged improved hemodynamic performance compared with porcine bioprostheses. 7-11 The aim of this retrospective study was to compare mid-term outcome in patients with 2 different types of pericardial valves (Carpentier-Edwards, Pericarbon) implanted in the aortic position between 1987 and 1994 in our institution. Methods Patients We retrospectively reviewed the medical records of all patients who underwent isolated aortic valve replacement with second generation pericardial valves in our institution between July 1987 (fir...

No abstract

WHAT THIS PAPER ADDSThis analysis of the ENDURANT France registry provides five year outcomes from a French population treated under real life conditions. Patients experienced a 69.9% AE 3.5% KaplaneMeier overall survival, 97.6% AE 1.2% freedom from aneurysm related mortality, low rates of type IA endoleaks, few secondary procedures, and showed positive signs of remodelling. These outcomes are similar to other recent global registries and better than the outcomes with earlier generation devices. With the current focus on managing costs and reimbursements, these five year outcomes of a French specific cohort provide further evidence of the long term durability and success with the Endurant stent graft system.Objective: Endovascular repair is the preferred method of treatment for infrarenal abdominal aortic aneurysms with numerous publications from multiple geographic regions showing excellent patient outcomes. Since the original ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) randomised control trial, studies of French specific population have also contributed significantly to the body of evidence in support of endovascular abdominal aortic repair. Methods: In the ENDURANT France registry, 180 patients were consecutively enrolled from 20 French centres starting in 2012. Investigational sites included public and private practice and differing centre volumes to be as representative of real world French experience as possible. The aim of this study was to present the five year outcomes from this registry. Results: Instructions for use (IFU) were respected in 97.8% (176/180) of patients. At five years, the KaplaneMeier overall survival was 69.9% AE 3.5% and the freedom from aneurysm related death was 97.6% AE 1.2%. The freedom from Type IA endoleaks was 94.5% AE 1.7%, freedom from endoleaks of any type was 70.1 AE 3.4%, and freedom from secondary endovascular procedure 90.4% AE 2.6%. In addition, 61.6% (45/73) of patients exhibited sac shrinkage at five years. Conclusion: In this five year report of the Endurant France registry, survival, re-intervention, and freedom from endoleak rates were comparable to recent EVAR registries and there was a high sac shrinkage rate. Secondary procedure and aneurysm rupture were lower than those of ACE, the French RCT which included older generation devices. This prospective registry demonstrates favourable five year outcomes of the Endurant stent graft used within IFU.