Publications by authors named "Steven J Yakubov"

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.

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We document the first reported use of the Amplatzer Vascular Plug 4 for anterior mitral leaflet perforation repair in a 56-year-old male who had undergone valve-in-valve transcatheter aortic valve replacement. Previously reported cases involving the use of other occluder devices for mitral leaflet perforation repair either required guide catheter or delivery sheath exchanges, arteriovenous wire loop for deployment, or use of mitral transcatheter edge-to-edge repair for leaflet stability. Our case highlights the efficacy of the bilobar-designed Amplatzer Vascular Plug 4 for precise occlusion in anterior mitral leaflet perforation through antegrade-only delivery and safety through the simplification of procedural steps.

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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.

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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.

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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.

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This updated Heart Valve Collaboratory framework addresses the growing concern for transcatheter valve failure (TVF) following transcatheter aortic valve replacement (TAVR). With the increasing volume of redo-TAV and surgical TAV explantation, there is a critical need for standardized pathways and protocols for evaluating TVF using echocardiography and cardiac computed tomography (CT) angiography. This document clarifies prior definitions of bioprosthetic valve deterioration and bioprosthetic valve failure in a practical, imaging directed context for TAVR.

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Article Synopsis
  • A study compared transcatheter aortic valve replacement (TAVR) with traditional surgery in low-risk patients under 75 years old with severe aortic stenosis to evaluate safety and effectiveness over three years.* -
  • Results showed that TAVR patients had similar overall mortality rates but significantly fewer disabling strokes (0.6%) compared to surgery patients (2.9%), while TAVR also resulted in better valve performance.* -
  • Both treatment options had comparable low rates of valve reinterventions, but TAVR patients experienced higher rates of pacemaker implantation (21.0% vs. 7.1%).*
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Article Synopsis
  • * Optimize PRO, a prospective study, implements two strategies: using a cusp overlap technique during TAVR and a CD algorithm that assesses patients based on their post-procedure ECG for early discharge decisions.
  • * Results indicate that patients with conduction disturbances had a significantly higher PPI rate at 30 days compared to those without (28.1% vs 1.5%), but the standardized management of CDs led to similar safety outcomes, suggesting effective early recognition and monitoring of arrhythm
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Transcatheter tricuspid valve replacement (TTVR) offers the potential for improved outcomes for the significant number of patients with severe tricuspid valve regurgitation relative to current treatment options. Imaging is a critical component of the success of this procedure. Here we describe strategies and techniques for the use of 3-dimensional intracardiac echocardiography as an adjunct to standard transesophageal echocardiography during TTVR procedure.

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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.

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Article Synopsis
  • A study evaluated permanent pacemaker implantation (PPI) rates in patients who underwent transcatheter aortic valve replacement (TAVR) using Evolut valves from July 2018 to June 2021, reporting significant trends in PPI rates over time.
  • Out of 54,014 procedures, the 30-day PPI rate dropped from 16.6% in 2018 to 10.8% in 2021, and in-hospital rates decreased by 40.1% during the same period, indicating improved outcomes.
  • Key factors associated with a higher likelihood of needing a new PPI included existing conduction defects, atrial fibrillation, use of home
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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.

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There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials.

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Article Synopsis
  • A study evaluated the safety and performance of the Intrepid transapical transcatheter mitral valve replacement (TMVR) system over two years in patients with symptomatic, moderate to severe mitral regurgitation (MR) who are at high surgical risk.
  • 252 patients were analyzed, showing 13.1% all-cause mortality at 30 days, increasing to 36.2% by two years, along with significant heart failure rehospitalization rates.
  • Despite early challenges, more than half of the patients showed improvement in functional status and mild MR at two years, indicating potential benefits from the TMVR system.
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  • The study compares the 5-year rates of valve reintervention after transcatheter aortic valve replacement (TAVR) using CoreValve/Evolut versus surgical aortic valve replacement (SAVR).
  • It found that TAVR had a higher overall reintervention rate (2.2%) compared to SAVR (1.5%), particularly within the first year.
  • Evolut TAVR showed significantly fewer reinterventions than CoreValve TAVR, but its rates were comparable to SAVR, indicating varying risks associated with different valve types.
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  • The study investigates whether adding left atrial appendage ligation to catheter pulmonary vein isolation enhances the treatment of nonparoxysmal atrial fibrillation (AF).
  • It was conducted as a multicenter, randomized clinical trial involving 404 patients, comparing a group that received both treatments to another that only received pulmonary vein isolation.
  • The main objectives were to evaluate the effectiveness of preventing atrial arrhythmias and the safety of the procedures, with follow-up monitoring extending up to 12 months after treatment.
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Background: There are limited data regarding treatment for failed balloon-expandable transcatheter heart valves (THVs) in redo-transcatheter aortic valve implantation (TAVI).

Aims: We aimed to assess THV performance, neoskirt height and expansion when performing redo-TAVI with the ACURATE platform inside a SAPIEN 3 (S3) compared to redo-TAVI with an S3 in an S3.

Methods: Redo-TAVI was performed on the bench using each available size of the S3, the ACURATE neo2 (ACn2) and the next-generation ACURATE Prime XL (AC XL) implanted at 2 different depths within 20 mm/23 mm/26 mm/29 mm S3s serving as the "failed" index THV.

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Background: Bicuspid aortic valve (BAV) is present in approximately 0.5%-2% of the general population, causing significant aortic stenosis (AS) in 12%-37% of affected individuals. Transcatheter aortic valve replacement (TAVR) is being considered the treatment of choice in patients with symptomatic AS across all risk spectra.

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