Data requirements for TAVI registration updated in France

On January 31st, 2019, the French High Authority for Health (HAS) has published a new assessment of transcatheter aortic valve implantation (TAVI).

TAVI are registered under the brand name in the LPPR list, as well as in the Liste-en-sus.  This method of registration involves the filing of a medical-technical file with the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in order to evaluate their expected or rendered service in order to be reimbursed by health insurance. The CNEDiMTS has an obligation to "specify the terms and principles according to which it implements the criteria for the evaluation of health products with a view to their coverage by health insurance." The objective of this assessment was to clarify the level of requirement of the commission in terms of minimal clinical data to provide for:

• The registration of a new TAVI on the LPPR list
• The acceptance of a new indication for a TAVI already registered on the LPPR list
• The renewal of registration of a TAVI registered on the LPPR

Minimum data requirements

The introduction of a transcatheter valve in the management of aortic stenosis or aortic insufficiency should be accompanied by a demonstration of efficacy and safety compared to the reference strategy (surgery, TAVI reference...) according to the indication, the symptomatology and the risk of the surgical procedure for the patient (operating risk scores). The implantation of a TAVI within the native aortic valve or within a previously implanted bioprosthesis are two distinct clinical situations that will have to be studied separately, or the identification of two subgroups of one study defined a priori.

CNEDiMTS calls for the systematic provision of a prospective, comparative, randomized, superiority or non-inferiority study aimed at comparing the device with the reference strategy in the indications claimed. The primary endpoint should be a relevant clinical endpoint for assessing mortality (possible relevant composite endpoint) with a follow-up duration of at least 1 year. If the selected design is a non-inferiority study, the non-inferiority of the new device with respect to the comparator must be shown with a loss of efficacy agreed on the acceptable and well-argued primary endpoint (non-inferiority bound to represent the most significant loss of effectiveness clinically negligible given the other advantages that the device studied).

The studies should report complications related to the 30-day procedure according to the VARC recommendations in force (mortality, disabling stroke, major bleeding, disabling or life-threatening, i.e. BARC ≥3, major vascular complication, central and paravalvular aortic insufficiency grade ≥ 2, pacemaker implantation) and adverse events at 1-year follow-up. In patients benefiting from the implantation of a transcatheter bioprosthesis for degenerated valvular bioprosthesis, the risk of patient-prosthesis mismatch should be indicated.

For the renewal of registration, the applicant must provide:

• Observational data in current practice. These monitoring data should cover a significant number of patients and representative of the target population concerned. They should describe the symptomatology and the quality of life of the patients (according to validated scales), durability (thrombosis of the valve, endocarditis, nonstructural dysfunction of the valve, moderate to severe valve structural dysfunction, failure of the prosthetic valve). according to the standardized definitions of EAPCI-ESC-EACTS consensus in force) in the long term (5 years and then 10 and 15 years), the late evaluation of the valvular surface and the accessibility to percutaneous coronary revascularization after transcatheter implantation. an aortic valve bioprosthesis
• The long-term results of the randomized controlled trial that enrolled TAVI

Furthermore, HAS reminds that according to the order of 3 July 2012 and the instruction n° DGOS / PF4 / 2013/91 of 7 March 2013,  pre- and post-procedural data is collected by health institutions of  all French patients benefiting from the placement of aortic valve bioprosthesis transcatheter. Thus, CNEDiMTS will take note of the clinical data from the FRANCE-TAVI register, which also includes the patient's post-intervention follow-up data.

See the full details in French here.

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