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Aortic valve replacement procedures increased in France after TAVR adoption
The wide adoption of transcatheter aortic valve replacement led to an increase of AVR procedures in France from 2007 to 2015, according to a study published in the Journal of the American College of Cardiology.
“Our results could ... be helpful for updating evaluation of the cost-effectiveness of TAVR technology compared with [surgical] AVR (assuming a similar mid- and long-term outcome after hospital discharge),” Virginia Nguyen, MD, PhD, of the department of cardiology at Bichat Hospital at Assistance Publique-Hôpitaux de Paris, and colleagues wrote. “Another major policy implication is to raise awareness on the major [aortic stenosis] social and economic burden and strongly incentivize government bodies and policymakers to support research programs aimed at tackling the occurrence and progression of [aortic stenosis].”
Hospital discharge data
The researchers analyzed data from 131,251 patients (mean age, 74 years; 60% men) who underwent AVR between 2007 and 2015. Those with aortic regurgitation were excluded from the analysis.
Among the cohort, 17% underwent TAVR. Among those who underwent surgical AVR, 26% also had CABG and 3.5% also had mitral valve surgery.
Comorbidities were assessed by the Charlson comorbidity index.
Outcomes of interest included in-hospital mortality, defined as death occurring between intervention and hospital discharge, complications and length of stay.
From 2007 to 2015, the total numbers of AVRs increased by 72% (P for trend < .0001), primarily due to the 2,557% increase in TAVR (P for trend= .0004). The rate of surgical AVRs was stable during this time period (10% increase; P for trend = .18).
As the Charlson index decreased in patients who underwent surgical AVR, the in-hospital mortality rate also declined from 2007 to 2011 and then stabilized until 2015 (5% to 2.9%; P for trend < .0001). Patients who underwent TAVR had similar mortality rates to those that underwent surgical AVR in 2015 (3% vs. 2.9%; P = .72).
When patients were categorized by age (< 75 years, 75-79 years, 80-84 years and 85 years), all groups had a significant increase in the number of TAVR procedures (P for trend = .003). This number exceeded the number of surgical AVR procedures in patients from the two oldest groups.
Decreased mortality rates
Mortality rates declined for both isolated groups, but in 2015, the mortality rates for patients who underwent TAVR was similar or slightly lower compared with isolated surgical AVR in patients aged 75 to 79 years (P = .66), 80 to 84 years (P = .47) and at least 85 years (P = .06).
“The overall increase [in the number of AVRs] was associated with an improvement in patient profile, suggesting that patients are now referred earlier in the course of disease,” Nguyen and colleagues wrote. “Our results may have major implications for clinical practice and policymakers.”
In a related editorial, Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at Columbia University Medical Center at NewYork-Presbyterian Hospital, professor of medicine at Columbia University College of Physicians and Surgeons and founder of the Cardiovascular Research Foundation, and colleagues wrote: “The TAVR ‘tsunami,’ which is driving expansion of clinical indications to include low-risk surgical populations based on age alone, is threatening to outdistance the current level of evidence. A modicum of restraint is in order as we await the results of the ongoing randomized clinical trials of TAVR vs. [surgical] AVR 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.” – by Darlene Dobkowski
Disclosures: Nguyen reports no relevant financial disclosures. Leon reports he received institutional research and educational grants from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic and served as an unpaid member of the executive committee for Edwards Lifesciences. Please see the study for all other authors’ relevant financial disclosures.
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Leon MB, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.02.025.
Nguyen V, et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.01.079.