Transcatheter Aortic Valve Implantation With the New Balloon-Expandable Sapien 3 Versus Sapien XT Valve System

Abstract

T ranscatheter aortic valve implantation (TAVI) has become a firmly established treatment option for symptomatic severe aortic stenosis (AS) in inoperable patients 1 and patients at high operative risk. 2,3 Although proven noninferior to surgical aortic valve replacement in terms of all-cause mortality, TAVI is associated with a higher incidence of postoperative aortic regurgitation (AR) and vascular complications. 2,3 Other non-negligible TAVI-related complications are cerebral embolic events and advanced conduction disturbances. 4 The extension of TAVI to lower risk populations requires minimization of these adverse events, partly depending on technological developments in transcatheter heart valves (THVs) and delivery systems.Recently, the new balloon-expandable Sapien 3 THV (S3-THV; Edwards Lifesciences, Irvine, CA) has become commercially available. 5 The S3-THV embodies the next generation balloon-expandable valve of the Sapien valve family, building on the clinical experiences gained with the previous Sapien XT-THV (SXT-THV; Edwards Lifesciences). With its new features, including an outer annular sealing cuff, improved delivery system, and low crimped profile, the S3-THV is thought to achieve better results than the preceding SXT-THV. 5 Initial data from a multicenter registry prospectively evaluating the S3-THV looked promising, reporting low rates of AR, vascular complications, and stroke. 6 Comparative studies on the clinical outcomes of TAVI with the S3-THV and SXT-THV are currently scarce.Aim of this study was to retrospectively compare the hemodynamic and clinical outcomes of TAVI with the S3-THV versus the SXT-THV in patients with symptomatic severe native AS.Background-The new balloon-expandable Sapien 3 transcatheter heart valve (S3-THV) incorporates new features to reduce aortic regurgitation (AR) and vascular complications in transcatheter aortic valve implantation. Aim of this study is to compare the outcomes of the S3-THV with the preceding Sapien XT THV (SXT-THV) in patients who underwent transcatheter aortic valve implantation for symptomatic severe native aortic stenosis. Methods and Results-Eligible patients were retrospectively identified in our institutional database and periprocedural clinical and imaging data were collected. Non-parsimonious one-to-many propensity score matching was performed to account for differences in baseline characteristics. Between November 2011 and December 2014, 167 patients underwent balloon-expandable transcatheter aortic valve implantation with either the S3-THV (n=49) or SXT-THV (n=118 MethodsThis is a retrospective single-center study. All patients who underwent TAVI for severe native AS at the University Medical Center Utrecht by means of S3-THV or SXT-THV implantation were identified in our institutional database and included in the study. Implantation of the SXT-THV had to be state-of-the-art, meaning performed with the Novaflex+ delivery system through an expandable sheath. Patients with bicuspid aortic valve anatomy or a degenerated surgical aortic...

Comparison between the SAPIEN S3 and the SAPIEN XT transcatheter heart valves: A single-center experience

“…Reported 30-d mortality rates with the S3-THV ranges from 0.5% to 4.5%[16,17,25]. We report also a low 30-d mortality of 3.5% in the S3-THV cohort that was not statistically lower than the 8.7% rate of the XT-THV group after covariates adjustment.…”

“…Patients underwent TAVI by the transfemoral, transaortic or transapical approach according to previously described techniques[17]. …”

“…Despite positive procedural and short-term outcomes in small single center series and registries, large reports comparing the S3-THV to its predecessor, the Sapien XT (XT-THV), are lacking[16,17]. Recent reports suggest an increased rate of new PPM implantation following TAVI with the S3-THV, compared to the XT-THV[16,17].…”

“…Recent reports suggest an increased rate of new PPM implantation following TAVI with the S3-THV, compared to the XT-THV[16,17]. Whether procedural characteristics such as depth of implant are related to PPM implantation with this new device remains unclear[18].…”

International Expert Consensus on Sutureless and Rapid Deployment Valves in Aortic Valve Replacement Using Minimally Invasive Approaches

“…Since postoperative complications contribute to prolongation of both ICU and hospital stay, the experts identified reduced ventilation times,19,25 reduced blood transfusion rates, and lower incidence of atrial fibrillation and pleura effusions,25 as possible reasons for improved overall outcome. Transcatheter aortic valve implantation patients showed paravalvular leakages more frequently than sutureless and rapid deployment valves8; recent studies, however, suggest a decrease of transvalvular regurgitation58 and paravalvular leakages59 with modified design. Multivariate analysis showed sutureless aortic valve replacement to have a not statistically significant protective effect against aortic regurgitation, pacemaker implantation, and renal replacement therapy as compared with transapical TAVI 60.…”