Background and Aims: Although women with severe symptomatic aortic stenosis have more complications than men when undergoing surgical valve replacement, they are under-represented in clinical trials. The Randomized researcH in womEn all comers wIth Aortic stenosis (RHEIA) trial investigates the balance of benefits and risks of transcatheter aortic valve implantation (TAVI) vs. surgery in women. Methods: Women were randomized 1:1 to transfemoral TAVI with a balloon-expandable valve or surgery. The primary composite endpoint was death, stroke, or (valve, procedure or heart failure related) rehospitalization at 1 year. Non-inferiority testing with a pre-specified 6% margin and superiority testing were performed in the as-treated population. Results: At 48 European centres, 443 women underwent randomization, and 420 were treated as randomized. Mean age was 73 years, and the mean estimated surgical risk of death was 2.1% (Society of Thoracic Surgeons risk score). Kaplan–Meier estimates of the primary endpoint event rates at 1 year were 8.9% in the TAVI and 15.6% in the surgery group. This difference of −6.8% with an upper 95% confidence limit of −1.5% demonstrated the non-inferiority of TAVI (P < .001). The two-sided 95% confidence interval of −13.0% to −.5% further resulted in superiority (P = .034). The 1-year incidence of the primary endpoint components was: .9% with TAVI vs. 2.0% with surgery for death from any cause, 3.3% vs. 3.0% for stroke, and 5.8% vs. 11.4% for rehospitalization. Conclusions: Among women with severe aortic stenosis, the incidence of the composite of death, stroke, or rehospitalization at 1 year was lower with TAVI than with surgery. ClinicalTrials.gov number: NCT04160130.

Severe aortic stenosis patients with bicuspid anatomy have been excluded from the major transcatheter aortic valve replacement (TAVI) randomized clinical trials. As a result, there is no official recommendation on bicuspid TAVI. A panel of bicuspid experts was created to fill this gap. In this consensus statement, an algorithm is proposed to guide the choice of surgery or TAVI within this complex patient population, depending on aortic dilatation, age, surgical risk score, and anatomy. A step-by-step guide for sizing and positioning of the SAPIEN 3/Ultra TAVI bioprostheses is presented. Annular sizing remains the primary strategy in most bicuspid patients. However, some anatomies may require sizing at the supra-annular level, for which patients the panel recommends the circle method, a dedicated sizing and positioning approach for SAPIEN 3/Ultra. The consensus provides valuable pre-operative insights on the interactions between SAPIEN 3/Ultra and the bicuspid anatomy; understanding the valve–anatomy relationship is critical to avoid complications and to optimize outcomes for patients.

Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. clinicaltrials.gov: NCT04160130.

Transfemoral (TF) access is default in transcatheter aortic valve implantation (TAVI). Transaxillary (TAx) access has been shown to be a safe alternative in case of prohibitive iliofemoral anatomy, but whether TAx as preferred access has similar safety and efficacy as TF access is unknown. The aim of this study was to compare outcomes between patients treated with self-expanding devices using TF or TAx route as preferred access in TAVI. A single center cohort of 354 patients treated using TAx as preferred access and a multi-center cohort of 5980 patients treated using TF access were compared. Propensity score matching was used to reduce selection bias and potential confounding. After propensity score matching, each group consisted of 322 patients. Clinical outcomes according to VARC-2 were compared using chi-square test. In 6334 patients undergoing TAVI, mean age was 81.4 ± 7.0 years, 57% was female and median logistic EuroSCORE was 14.7% (IQR 9.5-22.6). In the matched population (age 79.3 ± 7.0, 50% female, logistic EuroSCORE 13.4%, IQR 9.0-21.5), primary outcomes 30-day and one-year all-cause mortality were similar between Tax and TF groups (30 days: 5% versus 6%, p = 0.90; 1 year: 20% versus 16%, p = 0.17). Myocardial infarction was more frequent in patients undergoing Tax TAVI compared with TF (4% versus 1%, p = 0.05), but new permanent pacemakers were less frequently implanted (12% versus 21%, p = 0.001). TAx as preferred access is feasible and safe with outcomes that are comparable to TF access.

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)