# Abbreviations

AS
                        
                           Aortic stenosis
                        
                        CepiDC
                        
                           Centre d’Épidémiologie des Causes Médicales de Décès
                        
                        HAS
                        
                           Haute Autorité de Santé
                        
                        PMSI
                        
                           Programme de Médicalisation des Systèmes d’Information
                        
                        SNDS
                        
                           Système National des Données de Santé
                        
                        SNIIRAM
                        
                           Système National d’Information Inter-régime de l’Assurance Maladie
                        
                        TAVI
                        
                           Transcatheter aortic valve implantation

# Background

The France TAVI registry is the national French registry of patients undergoing transcatheter aortic valve implantation (TAVI). It was launched in January 2013 to provide continuity with the FRANCE-2 registry, which prospectively included all TAVI performed between January 2010 and January 2012. The FRANCE-2 registry includes data from 4201 patients with follow-up information at 6 months, and annually from 1 to 5 years.

# Overview of the France TAVI registry

France TAVI is an all-comers registry, prospectively including data on all patients who underwent TAVI for severe aortic stenosis (AS) at 54 active TAVI centres in France. This registry is an initiative of the French Society of Cardiology at the request of the Ministry of Health. Its database is growing by more than 15,000 procedures per year, and it currently includes more than 130,000 patients. No funding is received for this registry from regulatory authorities despite their legal obligation, however manufacturers involved in percutaneous valves (Medtronic, Edwards and Abbott) fund the registry annually.

All data were initially collected using a dedicated web interface, managed by the French Society of Cardiology, which implements regular checks on data quality, including assessments of internal consistency. Since 2021, basic data are now mainly extracted directly from procedural records kept by interventional cardiologists, as approximately 80% of centres use software that enables automatic data collection. The remaining centres continue to enter data via the web interface.

The strengths of this registry are the structured training of all personnel, monitoring of centres by supervisors, adjudication of outcomes and adverse events, as well as strict oversight including strong efforts to complete or correct data wherever possible. Loss to follow-up at 10 years was only 1.2%.

# Why France TAVI?

Today, TAVI is recognized worldwide as the first-line treatment for patients with symptomatic AS, provided the patient had suitable anatomy and is aged≥65 years in America [1] or≥70 years in Europe [2]. This level of TAVI recommendation was achieved by rigorous step-by-step scientific evaluation since its introduction. Pilot and randomized controlled trials (RCTs) gradually validated the use of TAVI in patients with AS with high, intermediate and then low surgical risk, whereas real-life studies, such as France TAVI, have confirmed these results independently of the use of selection criteria in daily practice. Registries enable monitoring of changes – over time – in AS assessment, treatment indications, procedures and valve types. Patient registries are the cornerstone of contemporary medical research.

The France TAVI registry allows us to study the safety and efficacy of TAVI procedures in France beyond RCTs and to examine potential variations in complication rates over time. Moreover, the large number of patients included in this large-scale national registry could help to confirm the long-term results of TAVI procedures.

Finally, we should not forget that the France TAVI registry is used by the National Authority for Health (Haute Autorité de Santé [HAS]) to follow the use of percutaneous aortic valves in France. Also, participation in the France TAVI registry remains mandatory in order to meet the eligibility criteria for implant centres, as stated in the official journal governing TAVI treatment in France.

# National reimbursement data linkage of France TAVI

Registries are necessary to characterize the provision of care and are widely used to evaluate efficiency, safety, outcomes, quality improvement and performance. However, registries tend to suffer from important limitations, typically related to their design and conduct. Several limitations are difficult to avoid, such as the lack of control groups and the fact of registries are, by definition, not randomized. However, in order to obtain information on outcomes in a real-world setting, such concerns may not be critical. The main residual issue of registries is data completeness, as loss to follow-up is typically higher than in tightly monitored RCTs. Also, incomplete medical record documentation of key elements (e.g., medical history and laboratory data) is common [3]. This leads to gaps in data and weakens the power of analyses.

To address the concern regarding patient follow-up in the France TAVI registry, a linking algorithm was developed in 2019 to match patients included in the France TAVI registry with the French single-payer National Health Data System (Système National des Données de Santé [SNDS]) [4]. The SNDS was created in 2015 by a merger of the national anonymous claim database (Système National d’Information Inter-régime de l’Assurance Maladie [SNIIRAM]), the national diagnosis-related group (DRG) database (Programme de Médicalisation des Systèmes d’Information [PMSI]) and the national registry of causes of death (Centre d’Épidémiologie des Causes Médicales de Décès [CepiDC]) (Fig. 1
                     ). The matching process used a probabilistic approach, based on as close a match as possible between the SNDS data and the profiles in the registry databases. SNDS entries for which probabilistic matching failed and erroneous patient data (incorrect date of birth, incorrect date of admission, multiple dates of death or duplicate data) are excluded from the analyses. All data are analysed anonymously. Each individual record in the SNDS is randomly assigned a numerical identifier that does not include any information about the identity of the patient or the centre.

A 10-year lost to follow-up in the linked France TAVI registry population at around 1% was made possible by this linkage, which is a rate not often achieved even in well-run RCTs. Although the registry is now linked with the SNDS, the evaluation of long-term transcatheter bioprosthetic valve durability remains limited since it does not include echocardiographic follow-up.

# France TAVI and publications

The scientific quality of the French TAVI registries (FRANCE-2 then France TAVI) was rapidly identified by the scientific community, as highlighted by the first publication in the New England Journal of Medicine of the FRANCE-2 registry [5]. Since then, the France TAVI registry has continued to serve as a reference for analysing and improving TAVI practices in France and internationally.

To date, 38 publications has been published from the French TAVI registries, including 13 articles in peer-reviewed journals with impact factors>10, emphasizing the direct involvement of these registries in the continuous improvement of practices. A wide range of topics have been published, including the long-term follow-up of percutaneous aortic valves [6,7] and specific clinical situations including anticoagulation management [7,8], aortic regurgitation after TAVI [9], kidney injury [10,11] and pacemakers [12,13].

# Conclusions

France TAVI represents one of the largest international TAVI registries, particularly due to the percentage of patients included compared to patients implanted in France and, above all, the 99% clinical follow-up at 10 years enabled by matching with the SNDS. It allows national follow-up of TAVI treatment, which has been the primary treatment modality for our patients with symptomatic AS since 2020. It also gives implanting centres the opportunity to conduct ancillary studies.