Femoral access-site complications in patients undergoing transcatheter aortic valve replacement with new generation devices
InstitutionsUKU. Klinik für Innere Medizin II
UKU. Klinik für Innere Medizin III
This is a large, retrospective, non-randomized single-center experience showing high rates of device success and rare Valve Academic Research Consortium-2 (VARC) defined complications for the new generation Transcatheter Heart Valve (THV) devices Edwards Sapien 3 (ES3; Edwards Lifescience Inc., Irvine, California), Medtronic Evolut R (Medtronic Inc., Minneapolis, Minnesota) and Boston Scientific Lotus (Boston Scientific Corporation, Marlborough, Massachusetts). Aortic stenosis (AS), a typical disease in the elderly population is caused by multiple factors. Its prevalence is expected to increase as the world’s population is growing and currently is in a demographic change. Transcatheter Aortic Valve Replacement (TAVR) with new generation devices has proven to be superior to older devices as treatment for AS. This work aimed to compare the three most commonly used THV devices at Ulm University with regard to VARC-2 defined outcome and specific access-site artery injuries. 1,155 patients received TAVR between January 2014 and December 2017 off which 897 were analyzed. 542 patients received an ES3, 233 Lotus and 122 an Evolut R. Data was collected using contrast agent x-ray images of the intervention as well as contrast agent computed tomography (CT) prior to the procedure. Post-procedural arterial state of the access-site vessel and VARC-2 defined outcome was assessed. Lotus valve was associated with a higher rate of major bleedings classified as Bleeding Academic Research Consortium (BARC) type 3a than ES3 and Evolut R. The Evolut R showed a tendency for lower rates of minor bleedings BARC type 2/3a as well as for the composite complication of perforation, dissection, endovascular stent grafting and endovascular flap. Sheath-to-femoral-artery-ratio (SFAR) seems to remain an issue for patients treated with new generation heart valves as an equal or larger SFAR than 0.67 was associated with a higher rate of major bleedings BARC type 3a in this study. Furthermore, larger SFAR was associated with higher rates of dissection, endovascular flap, multiple complications as well as with the composite complication of perforation, dissection and endovascular stent grafting and the composite complication added by endovascular flap. Delivery of the Lotus valve via 20 French (F)-sized sheaths was associated with lower device success and higher rate of multiple complications at the access-site. However, no other differences in VARC-2 defined outcome between the use of 20F or 22F-sized sheaths were apparent. Female sex did not seem to have an impact on the rate of major vascular complications.
Subject HeadingsAortenklappenersatz [GND]
Transcatheter aortic valve replacement [MeSH]
Aortic valve stenosis; Surgery [MeSH]
Treatment outcome [MeSH]