Corevalve

AIMS: This study was performed to compare haemodynamic properties of a novel transcatheter heart valve (THV) with two established valve technologies for treatment of failing surgical aortic bioprosthetic valves (SAV). The ALLEGRA THV has been recently described with a proven safety and performance profile. METHODS AND RESULTS: The study was designed as a retrospective, single-centre study investigating 112 patients (77.7 ± 7.1 years, 53.8% female, STS score 6...

BACKGROUND: With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. AIMS: We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. METHODS: Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry...

BACKGROUND: Self-expanding transcatheter heart valves (THVs) are associated with better echocardiographic hemodynamic performance than balloon-expandable THVs and are considered preferable in patients with small annuli. OBJECTIVES: This study sought to compare 5-year outcomes between self-expanding vs balloon-expandable THVs in severe aortic stenosis (AS) patients with small annuli. METHODS: Consecutive severe AS patients with an aortic valve annulus area <430 mm2 who underwent transcatheter aortic valve replacement (TAVR) with either the CoreValve Evolut (Medtronic) or SAPIEN (Edwards Lifesciences) THV between 2012 and 2021 were enrolled from the Bern TAVI registry...

The impact that post-dilatation has on the risk of experiencing conduction disorders after post-transcatheter aortic valve replacement with self-expanding valves (SE-TAVR) is unclear. We compared the rate of developing an atrioventricular (AV) high-grade conduction disorder and permanent pacemaker implantation (PPI) in post-TAVR patients undergoing post-dilatation. We enrolled patients with severe symptomatic calcified aortic stenosis (CAS) who were undergoing SE-TAVR between 1 January 2016, and 19 April 2019 at a single French center...

Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for severe aortic stenosis. Previous studies compare clinical outcomes of leading TAVR valves, but there is no evidence of cost-utility comparison, leaving a clinical information gap when selecting valves. Here we share a cost-utility analysis comparing the Sapien 3 (S3) (Edwards Lifesciences, Irvine, CA) and CoreValve Evolut R (ER) (Medtronic, Dublin, IR) across five clinical endpoints. Utility scores from patient surveys and clinical outcomes from the literature were used to estimate quality-adjusted life years (QALYs) associated with successful procedure and postoperative complications for S3 and ER...

BACKGROUND: Coronary artery access after repeat transcatheter aortic valve replacement (TAV-in-TAV) is reportedly more difficult because leaflet displacement of the first transcatheter heart valve (THV) impairs coronary cannulation; however, its effects in small patients are unknown. This study aimed to simulate coronary accessibility after TAV-in-TAV in patients of small body size. METHODS: We retrospectively analyzed computed tomography scans after initial THV implantation and classified patients by THV and coronary artery location, valve-to-aorta distance, and valve-to-coronary distance...

IMPORTANCE: The frequency and clinical importance of structural valve deterioration (SVD) in patients undergoing self-expanding transcatheter aortic valve implantation (TAVI) or surgery is poorly understood. OBJECTIVE: To evaluate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in patients undergoing self-expanding TAVI or surgery. DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) randomized clinical trials (RCTs); it was supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178)...

Transcatheter aortic valve replacement (TAVR) has become the standard treatment for aortic stenosis in older patients. It increasingly relies on accurate pre-procedural planning using multidetector computed tomography (MDCT). Since little is known about the required competence levels for MDCT analyses, we comprehensively assessed MDCT TAVR planning reproducibility and accuracy with regard to valve selection in various healthcare workers. 20 randomly selected MDCT of TAVR patients were analyzed using dedicated software by healthcare professionals with varying backgrounds and experience (two structural interventionalists, one imaging specialist, one cardiac surgeon, one general physician, and one medical student)...

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is currently the treatment of choice for the majority of patients at moderate or high surgical risk. However, some complications occur frequently with this procedure. In this study, we aimed to assess whether the cusp-overlap view (COP) technique may be associated with a reduced incidence of some of these complications compared with the classical three-cusp view (TCV) technique. METHODS: In this single-center, retrospective study we investigated; technical success, postprocedural permanent pacemaker implantation (PPMI), new-onset stroke, pericardial tamponade, arrhythmia development, acute renal failure, major bleeding, major vascular complications, procedure-related coronary obstruction, new-onset left bundle branch block (LBBB), paravalvular leak, peri-procedural myocardial infarction (MI), day of hospitalization, death, and major adverse cardiac and cerebrovascular events (MACCE) were determined as the clinical endpoints...

BACKGROUND: Days at home (DAH) quantifies time spent at home after a medical event but has not been fully evaluated for TAVR. We sought to compare 1- and 5-year DAH (DAH365 , DAH1825 ) among high-risk patients participating in a randomized trial of transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis versus surgical aortic valve replacement (SAVR). METHODS: We linked data from the U.S. CoreValve High Risk Trial to Medicare Fee-for-Service claims in 456 patients with 450 (234 TAVR/216 SAVR) and 427 (222 TAVR/205 SAVR) analyzed at 1 and 5 years...

Importance: Long-term follow-up after transcatheter aortic valve replacement (TAVR) is of interest given that longitudinal data on mortality and durability of transcatheter heart valves are limited. The REPRISE III (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Randomized Clinical Evaluation) randomized clinical trial compared the mechanically expanded Lotus valve with the self-expanding CoreValve/EvolutR TAVR platforms. Objective: To describe the final 5-year outcomes of the REPRISE III trial...

Transcatheter aortic valve replacement (TAVR) first received FDA approval for high-risk surgical patients in 2011 and has been approved for low-risk surgical patients since 2019. It is now the most common type of aortic valve replacement, and its use continues to accelerate. Computer modeling and simulation (CM&S) is a tool to aid in TAVR device design, regulatory approval, and indication in patient-specific care. This study introduces a computational fluid-structure interaction (FSI) model of TAVR with Medtronic's CoreValve Evolut R device using the immersed finite element-difference (IFED) method...

Subclinical leaflet thrombosis has been increasingly observed in patients undergoing transcatheter aortic valve replacement. Intra-annular transcatheter aortic valves (TAVs) have a larger neo-sinus volume than supra-annular devices and are potentially at a higher risk of hypoattenuated leaflet thickening (HALT). However, clinical data from randomized clinical trials have shown that approximately one-third of patients undergoing TAVR with intra- or supra-annular devices develop HALT in 1 year. The findings point to the potential role of leaflet design in developing HALT...

BACKGROUND: No detailed data on left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) exist from randomised clinical trials comparing the ACURATE neo and CoreValve Evolut devices. AIMS: Our aim was to assess the incidence and impact of new LBBB and PPI with self-expanding prostheses from a powered randomised comparison. METHODS: From the SCOPE 2 trial, 648 patients with no previous pacemaker were analysed for PPI at 30 days, and 426 patients without previous LBBB were adopted for analysis of LBBB at 30 days...

Background: Heart block requiring permanent pacemaker (PPM) implantation is a relatively frequent complication of transcatheter aortic valve replacement (TAVR). Objective: The purpose of this study was to perform a contemporary meta-analysis to provide an updated assessment of clinically useful predictors of PPM implantation post-TAVR. Methods: Medline and EMBASE searches were performed to include all studies reporting PPM post-TAVR between 2015 and 2020...

Subclinical leaflet thrombosis has been increasingly recognized following transcatheter aortic valve replacement (TAVR). Determining the risk factors is vital in preventing clinical leaflet thrombosis and ensuring long-term value durability. Clinical data have indicated that regional stent under-expansion of transcatheter aortic valves (TAVs), particularly self-expanding devices, may be associated with an increased risk of subclinical leaflet thrombosis. This study aimed to determine the effects of regional TAV frame under-expansion on leaflet kinematics, leaflet structural characteristics, and explore its impact on the likelihood of leaflet thrombosis...

INTRODUCTION: Since the initial experience with the CoreValve (Medtronic, Minneapolis, Minnesota), there have been continuous iterations of this valve system in order to improve procedural success and reduce periprocedural complications. The Evolut Pro, Pro+, and FX are the latest generations of this transcatheter heart valve (THV). AREAS COVERED: This review paper aims to analyze the main characteristics and clinical evidence about the Evolut Pro THV and summarize the main iterations of the newer generation Evolut FX valve system...

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as an alternative for the treatment of degenerated bioprosthetic valves (BPVs) for high surgical risk patients. However, this procedure often results in patient-prosthesis mismatch. BPV fracture is a novel technique to address this problem. From now, complications following BPV fracture are few. CASE SUMMARY: We present the case of a 84-year-old female with history of first surgical aortic BPV replacement with a Mitroflow Sorin 23 mm due to severe aotic stenosis in 2009...

AIMS: The aim of this study was to minimize the procedure, and reduce the length of hospital stay (LoS) is the future objective for transcatheter aortic valve replacement (TAVI).Aims of the study are to identify procedural and electrocardiographical predictors of fast-track discharge in patients who underwent TAVI. METHODS: Patients treated with TAVI included in the One Hospital ClinicalService project were categorized according to the LoS. 'Fast-Track' population, with a postprocedural LoS less than or equal to 3 days, was compared with the 'Slow-Track' population with a postprocedural LoS greater than 3 days...

OBJECTIVES: Evaluate transcatheter heart valve (THV) geometry according to left ventricular outflow tract (LVOT) calcium degree and its impact on hemodynamics and outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) with a contemporary self-expanding THV. BACKGROUND: LVOT calcium remains challenging for contemporary THVs. LVOT calcium location and degree may affect THV deployment and impact flow patterns and shear stress, accelerating THV degeneration...