Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data.

Background: The PASCAL Precision transcatheter valve repair system provides a new option for treating prohibitive surgical risk patients with significant, symptomatic degenerative mitral regurgitation (DMR).

Objectives: The authors report early U.S.

A Real-World Comparison of Left Atrial Appendage Occlusion Using Two Commercially Available Devices.

Amplatzer and Watchman devices are the most used left atrial appendage occlusion (LAAO) systems. Real-world studies comparing their newer generation systems, the Amulet and Watchman FLX, are scarce. The goal of this study is to compare procedural and clinical outcomes of Amulet and Watchman FLX recipients.

Prevention of Bilateral Coronary Obstruction During Valve-In-Valve TAVR With a Self-Expanding Valve: The BABICORN Procedure.

Objective: We present a case of valve-in-valve transcatheter aortic valve replacement in an 85-year-old woman with severe bioprosthetic aortic valve stenosis at a high risk of left and right coronary artery obstruction. This risk was mitigated by a procedure combining both BASILICA and UNICORN (BABICORN [Bileaflet Alteration with BASILICA and Iatrogenic Cusp Obliteration Using Radiofrequency Needle]) for double leaflet modification.

Key Steps: Electrosurgical traversal of the right leaflet and creating the electrosurgical loop using 2 guide catheters and an Astato wire within.

30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study.

Background: Primary results from the Optimize PRO study demonstrated that transcatheter aortic valve replacement (TAVR) with the cusp overlap technique (COT) resulted in low 30-day permanent pacemaker implantation (PPI) rates and no moderate or greater aortic regurgitation (AR).

Objectives: The aim of this study was to evaluate outcomes after Evolut FX implantation using the COT and postprocedural computed tomography (CT).

Methods: The Optimize PRO FX Addendum study is a postmarket, prospective, multicenter, nonrandomized study.

Global Results From the Optimize PRO Study: Standardized TAVR Technique and Care Pathway.

Background: The safety and efficacy of utilizing standardized implant protocols and care pathways are limited in large global prospective studies of transcatheter aortic valve replacement (TAVR), and institutional variability remains. This analysis aims to report 30-day outcomes from the global Optimize PRO study evaluating valve performance and procedural outcomes using an "optimized" TAVR care pathway and the cusp overlap technique (COT) in patients receiving Evolut PRO/PRO+ valves.

Methods: The Optimize PRO study is a multicenter, postmarket, prospective study conducted in 50 centers in the United States, Canada, Europe, the Middle East, and Australia.

Readmission Mortality After TAVR: The Combined Effect of Teaching Hospital Status and Cause of Readmission.

Background: Variability in transcatheter aortic valve replacement (TAVR) readmission rates highlights the importance of assessing post-discharge outcomes. Understanding how teaching hospital status and causes of readmission influence mortality could optimise post-TAVR care.

Methods: Using the National Readmissions Database, we identified 155,298 TAVR admissions from 2012 to 2020.

Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at ≥ Intermediate Risk.

Background: The incidence and clinical importance of bioprosthetic valve dysfunction (BVD) in patients undergoing supra-annular, self-expanding transcatheter aortic valve replacement (TAVR) or surgery is not well understood.

Objectives: The purpose of this study was to evaluate the 5-year incidence and clinical outcomes of BVD in patients undergoing CoreValve/Evolut TAVR or surgery.

Methods: This post hoc analysis pooled data from the U.

5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

Background: The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Outcomes at 5 years have not been reported.

Objectives: This study sought to evaluate 5-year clinical and hemodynamic outcomes with TAVR vs surgery in patients from the Evolut Low Risk trial.

Combined left atrial appendage occlusion and catheter ablation procedure for left atrial arrhythmias: A real-world, propensity-matched analysis.

Introduction: Real-world studies comparing safety and efficacy of combined percutaneous left atrial appendage occlusion (LAAO) and catheter ablation (CA) to LAAO alone are limited.

Methods: Patients from a large US hospital system undergoing combined LAAO and left-atrial CA from 8/2020 to 2/2024 were retrospectively analyzed and compared to a control group undergoing LAAO alone. Controls were identified using a 1:2 propensity score match based on LAAO device type (Watchman FLX vs.

3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.

Background: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited.

Objectives: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study.

Methods: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.

Predictors of Disease Progression and Adverse Clinical Outcomes in Patients With Moderate Aortic Stenosis Using an Artificial Intelligence-Based Software Platform.

Patients with moderate aortic stenosis (AS) have a greater risk of adverse clinical outcomes than that of the general population. How this risk compares with those with severe AS, along with factors associated with outcomes and disease progression, is less clear. We analyzed serial echoes (from 2017 to 2019) from a single healthcare system using Tempus Next (Chicago, Illinois) software.

Quality of Life 5 Years Following Transfemoral TAVR or SAVR in Intermediate Risk Patients.

Background: Symptomatic patients with severe aortic stenosis (AS) at high risk for surgical aortic valve replacement (SAVR) sustain comparable improvements in health status over 5 years after transcatheter aortic valve replacement (TAVR) or SAVR. Whether a similar long-term benefit is observed among intermediate-risk AS patients is unknown.

Objectives: The purpose of this study was to assess health status outcomes through 5 years in intermediate risk patients treated with a self-expanding TAVR prosthesis or SAVR using data from the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial.

Improved Hemodynamics With Self-Expanding Compared to Balloon-Expandable Transcatheter Aortic Valve Implantation in Small Annulus Patients: A Propensity-Matched Analysis.

Patients with small aortic annuli (SAA) pose a challenge in patients undergoing aortic valve replacement because of the potential for prosthesis-patient mismatch (PPM). This study aimed to compare the clinical and hemodynamic outcomes of self-expandable valve (SEV) versus balloon-expandable valve (BEV) transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and SAA. All patients who underwent TAVI for severe native aortic stenosis with a SAA between January 2018 and December 2022 were retrospectively included in the study from a single center.

Use and performance of the evolut FX transcatheter aortic valve system.

Background: The next generation supra-annular, self-expanding Evolut FX transcatheter aortic valve (TAV) system was designed to improve catheter deliverability, provide stable and symmetric valve deployment, and assess commissural alignment during the procedure. The impact of these modifications has not been clinically evaluated.

Methods: Procedural information was collected by survey in 2 Stages: Stage I comprised 23 centers with extensive experience with Evolut TAV systems, and Stage II comprised an additional 46 centers with a broad range of balloon- and self-expanding system experience.

Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus.

Background: Patients with severe aortic stenosis and a small aortic annulus are at risk for impaired valvular hemodynamic performance and associated adverse cardiovascular clinical outcomes after transcatheter aortic-valve replacement (TAVR).

Methods: We randomly assigned patients with symptomatic severe aortic stenosis and an aortic-valve annulus area of 430 mm or less in a 1:1 ratio to undergo TAVR with either a self-expanding supraannular valve or a balloon-expandable valve. The coprimary end points, each assessed through 12 months, were a composite of death, disabling stroke, or rehospitalization for heart failure (tested for noninferiority) and a composite end point measuring bioprosthetic-valve dysfunction (tested for superiority).