A country-wide examination of data in France showed a marked increase in transcatheter aortic valve replacement (TAVR) procedures, in addition to reduction in in-hospital mortality for all AVR subsets.
The study, led by Virginia Nguyen, MD, PhD, with the department of cardiology at Bichat Hospital in Paris, was published online April 17 in the Journal of the American College of Cardiology.
Large, national examinations of trends—comparing TAVR and surgical aortic valve replacement (SAVR)—are scarce. The researchers examined data from the French Programme de Médicalisation des Systèmes d’Information (PMSI), the country’s mandatory administrative database, to examine how aortic stenosis treatment has changed between 2007 and 2015.
“The number of AVRs markedly increased in France between 2007 and 2015 due to the wide adoption of TAVR, which represented one-third of all AVRs in 2015,” Nguyen et al. wrote. “Patients’ profile improved, suggesting that patients are referred earlier, and in-hospital mortality declined in all AVR subsets.”
Significant finding included:
- Of the total 131,251 interventions in the time period, 83 percent were SAVR (109,317) and 17 percent were TAVR (21,934).
- Between 2007 and 2015, SAVR rates remained steady, around 10,800 per year, while TAVR procedures jumped from zero in 2007 to 6,722 in 2015.
- In total, SAVR was associated with lower in-hospital mortality (3.9 percent versus 5.3 percent) and rate of pacemaker implantation (4.4 percent and 14 percent).
- In-hospital mortality declined from 12.7 percent in 2009 to 3 percent in 2015.
- By 2015, the in-hospital mortality rates of TAVR (3 percent) and SAVR (2.9 percent) were nearly identical.
“[W]e clearly demonstrated the dramatic increase of AVR performed in France in the last decade,” the authors wrote. “Similar trends at the German nationwide level have also been reported, although for a shorter period of evaluation. Aortic valve stenosis is a degenerative disease whose prevalence increases with age. However, it is unlikely that the observed AVR increase was only related to the aging of the population in such a limited period. In addition, age-adjusted trends showed similar results (data not presented). These results raise two important questions: First, whether these changes can be attributed to a substitutive or complementary use of TAVR (availability and increased awareness of this novel technology), and second, whether this linear trend will continue and for how long.”
A follow-up editorial published in JACC examined the approach of studying national data, including inherent limits to the conclusions the industry can take from such analysis.
“The primary strength of the study is the size and comprehensive nature of this inclusive administrative database, which allows for an analysis of procedure trends and real-world outcomes of all AVRs performed in France during the study period,” wrote Martin B. Leon, MD, with New York-Presbyterian Hospital/Columbia University Irving Medical Center, and colleagues. “However, the use of an unaudited, in-hospital, administrative database also presents significant limitations that must be considered in the interpretation of results, especially relating to comparative clinical strategy recommendations. The assessment of baseline patient characteristics is incomplete, and no formal surgical risk stratification is included.”
But the authors encouraged an approach of caveat emptor—or “buyer beware”—from medical consumers, including both patients and physicians. Changes in clinical practice require definitive results from trials and studies.
“The TAVR ‘tsunami,’ which is driving expansion of clinical indications to include low-risk surgical populations based on age alone, is threatening to out-distance the current level of evidence,” they wrote. “A modicum of restraint is in order as we await the results of the ongoing randomized clinical trials of TAVR versus SAVR in low-risk patients. Once these data are properly analyzed, perhaps administrative database studies such as the current one may help to confirm the appropriate application of clinical trial results to real-world practice.”