Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access.
Objectives
This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR.
Methods
Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score−based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed.
Results
Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers.
Conclusions
n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.
Edwards Lifesciences and Medtronic partly funded the FRANCE TAVI registry. Dr. Karam has received consultant fees from Abbott. Dr. Modine has been a consultant for Abbott, Edwards Lifesciences, Medtronic, and Microport. Dr Commeau has received consultant fees from Edwards, Abbott, and Boston Scientific. Dr. Koning has clinical research relationships with Boehringer Ingelheim, Boston Scientific, Abbott, Biosensor, and Biotronik. Dr. Seitz is a shareholder in Volta Medical; and has received consulting fees from Biosense Webster and Abbott. Dr. Spaulding has been a consultant for Medtronic. Dr. Spaulding has received consulting fees from Abiomed, Zoll, Medtronic, and Medpass. Dr. Lefevre has served as a proctor for Edwards Lifesciences and Abbott. Dr. Eltchaninoff has served as a proctor for and received lecture fees from Edwards Lifesciences. Dr. Iung has been a consultant for Edwards Lifesciences; and has received speaker fees from Boehringer Ingelheim and Novartis. Dr. Leprince has served as a proctor for Medtronic and Edwards. Dr. Le Breton has received speaker fees from Edwards Lifesciences and Medtronic. Dr. Lafont has served as a proctor for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
