Editorial Transcatheter Aortic Valve Replacement for All-comers With Severe Aortic Stenosis: Could It Become a Reality? El TAVI como primera opcio ´n en la estenosis ao ´ rtica grave: ? quimera o realidad? Tilak K.R. Pasala ^ and Carlos E. Ruiz ^, * Structural and Congenital Heart Center, Hackensack University Medical Center, Hackensack, New Jersey, United States Article history: Available online 27 October 2017 Transcatheter aortic valve replacement (TAVR) has progressed at a rapid pace driven by the Heart Valve Team approach and a rigorous commitment to evidence-based medicine. Rapid advances in technology have propelled TAVR to the forefront of treatment options. TAVR has progressed from a procedure performed in hybrid operating rooms under general anesthesia to a cathlab procedure performed under monitored anesthesia, thus reducing hospital stay and in some cases allowing ‘‘same-day’’ discharge. The indications for TAVR have been broadened, supported by hard evidence. Currently, TAVR is indicated for prohibitive, high and intermediate surgical risk patients. However, can TAVR become the therapy of choice for all patients in the near future? To answer this question, we need to explore some of the resolved issues and future challenges (Figure 1) that could make this technology a formidable force in the treatment of aortic stenosis (AS). RESOLVED/NEARLY RESOLVED ISSUES High- and Intermediate-risk In the initial study published in 2010, TAVR was shown to be superior to medical therapy for patients with severe AS who could not undergo surgery due to prohibitive risk. 1 Since then, multiple, rigorously-conducted, randomized, controlled trials have shown that TAVR was noninferior to surgical aortic valve replacement (SAVR) in patients at high and intermediate risk for surgery. 2–5 In addition, a propensity-matched registry study comparing the third-generation TAVR valve (SAPIEN 3, Edwards Lifesciences, Irvine, CA) with the surgical arm of the PARTNER 2A trial in intermediate-risk patients showed that TAVR was superior to SAVR in reducing a composite endpoint of mortality, stroke, and moderate-to-severe paravalvular leak (PVL). 6 This cemented the role of TAVR for patients with severe AS at prohibitive, high and intermediate risk. Since then, TAVR has been supported by guidelines as the therapy of choice in prohibitive-risk patients, and as an alternative to surgery for high- and intermediate-risk patients. Paravalvular Leak Paravalvular leak after TAVR has been shown to be associated with worse long-term cardiovascular events. 2 Annular calcification and inadequate deployment were frequently quoted reasons for the occurrence of PVL. The rate of PVL is lower with SAVR as the surgeon has direct visualization with better control to prevent PVL. However, PVL after surgery remains greatly underrecognized. 2,4 The rate of moderate-to-severe PVL with first- and second- generation TAVR valves (both SAPIEN and CoreValves) was high at 9% to 12%. The third-generation SAPIEN-3 valve, which has a ‘‘skirt’’ built around the inlet segment of the valve, reduced PVL to as low as 1.5%. 1,2,4–6 The third-generation CoreValve (Evolut PRO, Medtronic plc, Dublin, Ireland), also with a skirt around the inlet segment, is showing promise in reducing PVL. The newer mechanical-expanding Lotus valve (Boston Scientific, Malborough, MA, USA) has been shown to have a very low incidence of moderate-to-severe PVL rate at 1 year (REPRISE III trial, presented at EuroPCR 2017, Paris, France). The occurrence of moderate-to- severe PVL with the newer-generation valves is significantly lower and will continue to improve. Vascular and Major Bleeding Complications The earlier generation TAVR devices had much larger delivery systems with sheath sizes as large as 26 Fr. Current delivery systems are down to 14 Fr, and upcoming newer devices are downsizing the delivery systems to 10 Fr. Unquestionably, this technological improvement accounts for the significant decrease in vascular complications (1.2% in the Society of Thoracic Surgeons/ American College of Cardiology Transcatheter Valve Therapy 2016 registry database) and the need to use alternative access (< 10%). 7 Additionally, the systematic use of careful computed tomography angiography analysis, ultrasound-guided access, the micro-puncture needle technique, combined with the use of vascular closure devices and elimination of surgical cut-down has made large bore access and closure for TAVR extremely safe. Life- threatening bleeding complications are much lower compared with surgery and are as low as 2.4%. 7 As delivery systems become Rev Esp Cardiol. 2018;71(3):141–145 * Corresponding author: Structural and Congenital Heart Center, Hackensack University Medical Center and The Joseph M. Sanzari Children’s Hospital, 30 Prospect Ave. 5 Main, RM. 5640, Hackensack, New Jersey 07601, United States. E-mail address: carlos.ruiz@hackensackmeridian.org (C.E. Ruiz). ^ Both authors were involved in all steps of manuscript preparation. http://dx.doi.org/10.1016/j.rec.2017.09.014 1885-5857/  C 2017 Sociedad Espan ˜ola de Cardiologı ´a. Published by Elsevier Espan ˜a, S.L.U. All rights reserved. Document downloaded from https://www.revespcardiol.org/, day 07/12/2021. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited. Document downloaded from https://www.revespcardiol.org/, day 07/12/2021. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited.