Late Follow-up with the Hybrid Aortic Prosthesis THORAFLEX: An Update of the EPIFLEX French Registry

T. Caus¹, M. Villaret², Y. Chabry³, V. Ruggieri⁴, B. MARCHEIX⁵, P. Achouh⁶, F. Koskas^7
1University Hospital Amiens-Picardie, Amiens, Picardie ²Vascutek Terumo, Paris, Ile-de-France ³CHU Henri Mondor, 14800 TOUQUES, Haute-Normandie ⁴University Hospital REIMS, Reims, Champagne-Ardenne ⁵University Hospital Toulouse, Toulouse, Languedoc-Roussillon ⁶European Hospital Georges Pompidou, AP-HP & Université de Paris, Le Chesnay-Rocquencourt, France ⁷University Hospital La Pitié-Salpétrière, Paris, Ile-de-France

Purpose: To report on late results of the hybrid aortic prosthesis THORAFLEX through a national-wide registry initiated at the device’s early phase of adoption.

Methods: The EPIFLEX registry has been set-up to comply with requirements of the French National Heath Agency concerning the reimbursement of the THORAFLEX Hybrid device by a third party. We included all recipient patients operated on in France from 01-May-2016 to 31-April-2019 for acute aortic dissection (TAAD) and chronic dissecting, atheromatous or degenerative aneurysms. For each participating center, we prospectively collected operative data to implement a nationwide database though an on-line e-CRF. We collected data from follow-up from onsite medical files at the end of follow-up (FU). Conduct of the study, as well as maintenance of the registry and exploitation of results, were done accordingly to clinical practice guidelines (IOM, 2011).

Results: Out of 404 device’s implantations during time study, we included 351 patients who met the inclusion criteria. Among them, 215 (61%) were operated on electively. Non-elective cases were significantly younger (p=0.05), had a significantly higher preoperative risk (Log EuroScore, p< 0.0001) and were more frequently operated on in large volume centers (p=0.0003). Overall in-hospital mortality was 15%. Multivariate factors for in-hospital mortality were EuroScore > 35 (p < 0.0001) and preoperative cerebral malperfusion (p=0.03). Despite a positive aortic remodeling observed in most cases treated for TAAD (Figure 1), we report 228 redo procedures during FU. Patients initially treated for acute or chronic aortic dissection (55%) were mainly concerned by those iterative procedures among which 57% were thoracic endocasvular aortic repair (TEVAR). In-hospital mortality for redo procedures was low and overall survival three years for the entire cohort was 78 +/- 4.5% (Figure 2).

Conclusion: The EPIFLEX registry proved the THORAFLEX Hybrid device to be extremely useful for a positive remodeling of distal aorta in case of TAAD, and to be an adequate platform for the landing zone of aortic endoprostheses for complex endovascular procedures. The device appears safe in terms of structural failure or septic complications. Those results are of interest for National Health Agencies who may postpone definitive authorization of the device’s reimbursement by third parties until acknowledgement of significant long-term results of clinical studies.

Identify the source of the funding for this research project: Vascutek Terumo provided for the funding of the Epiflex Registry.