Original Investigation
Temporal Trends in Transcatheter Aortic Valve Replacement in France: FRANCE 2 to FRANCE TAVI

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Abstract

Background

Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics and clinical outcomes over time are limited.

Objectives

The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.

Methods

TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.

Results

A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE]: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium–defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.

Conclusions

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)

Key Words

national registry
outcomes
pacemaker
transfemoral

Abbreviations and Acronyms

ACC
American College of Cardiology
ESV
Edwards SAPIEN valve
EuroSCORE
European System for Cardiac Operative Risk Evaluation
FRANCE 2
French Aortic National CoreValve and Edwards 2 registry
MCV
Medtronic CoreValve
PPI
permanent pacemaker implantation
STS
The Society of Thoracic Surgeons
TAVR
transcatheter aortic valve replacement
TVT
transcatheter valve therapy

Cited by (0)

Edwards Lifesciences and Medtronic partly funded the FRANCE TAVR registry. Edwards Lifesciences and Medtronic had no role in data management, data analysis, or writing of the manuscript. Dr. Auffret has received fellowship support from the French Cardiology Federation (Fédération Française de Cardiologie); and has received research grants from Abbott, Edwards Lifesciences, Medtronic, Biosensors, Terumo, and Boston Scientific. Dr. Le Breton has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Rodés-Cabau has received research grants from Edwards Lifesciences, Medtronic, and St. Jude Medical. Dr. Eltchaninoff has served as a proctor for and received lecture fees from Edwards Lifesciences. Dr. Lefevre has served as a proctor for Edwards Lifesciences and Abbott. Dr. Koning has clinical research relationships with Boehringer Ingelheim, Boston scientific, Abbott, Biosensor, and Biotronik. Dr. Leprince has served as a proctor for Medtronic. Dr. Jean Philippe Collet has received research grants from Bristol-Myers Squibb and Medtronic; and lecture fees from Bristol-Myers Squibb, Bayer, Daichii-Sankyo, AstraZeneca, and Medtronic. Dr. Himbert has served as a proctor and consultant for Edwards Lifesciences; and has served as a proctor for Medtronic. Dr. Souteyrand has served as a consultant to Medtronic, St. Jude Medical, Abbott, and Terumo. Dr. Teiger has served as a proctor for Medtronic. Dr. Iung has received consulting fees from Boehringer Ingelheim; and has received a speaker fee from Edwards Lifesciences. Dr. Spaulding has received research grants from the French Ministry of Health; has received consulting fees from Abiomed, Zoll, Medtronic, and Medpass; has received speaker fees from AstraZeneca, Cordis, Servier, Lead-Up, Bayer, The Medicines Company, Eli Lilly, and WebMD; and is a member of the advisory board of Xeltis. Dr. Beygui has received institutional research grants from AstraZeneca, Medtronic, Biosensor, St. Jude Medical, ACIST, and Daichii-Sankyo; and has received consulting and presentation honoraria from AstraZeneca, Medtronic, and Bristol-Myers Squibb. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Listen to this manuscript's audio summary by JACC Editor-in-Chief Dr. Valentin Fuster.

The key personnel, institutions, and organizations participating in the FRANCE TAVI Registry are listed in the Online Appendix. Deepak L. Bhatt, MD, MPH, served as Guest Editor for this paper.