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Temporal Trends in TAVR in France
Study Questions:
What are the nationwide performance trends and clinical outcomes of transcatheter aortic valve replacement (TAVR) in France during a 6-year period?
Methods:
The investigators prospectively included TAVRs performed in 48 centers across France between January 2013 and December 2015 in the FRANCE TAVI registry. Findings were further compared with those reported from the FRANCE 2 registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers. The primary endpoint of the study was in-hospital all-cause mortality reported among the full cohort. Secondary endpoints were in-hospital complications among the full cohort and 30-day all-cause mortality reported among centers in which vital status after 30 days was known for at least 90% of patients to ensure the comparability of follow-up completeness between registries.
Results:
A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. 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 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 room (15.8% vs. 35.7%). 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 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, while rates of tamponade and pacemaker implantation significantly increased.
Conclusions:
The authors concluded that this registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale.
Perspective:
This national registry from France reports significant changes in baseline characteristics of patients undergoing TAVR, with an important decrease in estimated surgical risk over time, reflecting lower rates of comorbidities despite the inclusion of older patients. Furthermore, in-hospital and 30-day mortality were significantly lower in the more recent cohort potentially related to improved multidisciplinary procedural planning and execution, newer versions of transcatheter devices, and enhanced post-procedural care. However, infrequent but life-threatening complications did not decline over time with a significant increase in tamponade rates and pacemaker rates suggesting a need to focus on strategies to reduce these complications.
Keywords: Cardiac Surgical Procedures, Echocardiography, Transesophageal, France, Geriatrics, Heart Valve Diseases, Hospital Mortality, Pacemaker, Artificial, Registries, Stroke, Transcatheter Aortic Valve Replacement
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