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.

Transcatheter Closure of Postinfarct VSD With the Amplatzer PIVSD Occluder: Results of a US Study.

Background: A postinfarct ventricular septal defect (PIVSD) is associated with high mortality and morbidity, particularly in patients with hemodynamic instability who are not suitable candidates for surgical repair. The Amplatzer PIVSD Occluder (Abbott) is indicated for transcatheter PIVSD closure in patients who are not satisfactory candidates for surgical repair. The objective of this study was to evaluate associated clinical outcomes.

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.

Multidisciplinary Approach to Patent Foramen Ovale Closure for Cryptogenic Stroke: Brain-Heart Board Experience.

Background And Objectives: Patent foramen ovale (PFO) is present in approximately 25% of adult population. The prevalence of PFO is high in patients with cryptogenic stroke suggesting paradoxical embolism. PFO closure in carefully selected patients is an effective secondary preventive strategy in these patients.

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.

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).

1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.

Background: High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients.

Objectives: This analysis evaluates 30-day and 1-year outcomes of the Intrepid TMVR Early Feasibility Study in patients with ≥moderate-severe MR.

Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk.

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).

Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients: 5-Year Outcomes of the SURTAVI Randomized Clinical Trial.

Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.

Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.

Comparison of Radiation Exposure Among Interventional Echocardiographers, Interventional Cardiologists, and Sonographers During Percutaneous Structural Heart Interventions.

Importance: Transesophageal echocardiography during percutaneous left atrial appendage closure (LAAO) and transcatheter edge-to-edge mitral valve repair (TEER) require an interventional echocardiographer to stand near the radiation source and patient, the primary source of scatter radiation. Despite previous work demonstrating high radiation exposure for interventional cardiologists performing percutaneous coronary and structural heart interventions, similar data for interventional echocardiographers are lacking.

Objective: To assess whether interventional echocardiographers are exposed to greater radiation doses than interventional cardiologists and sonographers during structural heart procedures.

Renal Function-Based Contrast Threshold Predicts Kidney Injury in Transcatheter Aortic Valve Replacement.

Background: Acute kidney injury (AKI) after contrast-guided interventions is associated with adverse outcomes, but the role of contrast in the context of renal function is less well described for patients undergoing transcatheter aortic valve replacement (TAVR).

Methods: Patients from the Michigan TAVR registry between January 2016 and December 2019 were included. AKI was defined using Valve Academic Research Consortium 2 definitions.

Optimizing Care of Patients With Right Bundle Branch Block Undergoing Transcatheter Aortic Valve Replacement.

Objectives: To evaluate the use of temporary-permanent pacemaker (TPP) in patients with right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR). We also sought to identify key predictors of permanent pacemaker (PPM) within 30 days of TAVR in this population.

Background: RBBB is a well-recognized risk factor for PPM post TAVR.

Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients.

Objectives: The aim of this study was to compare 1-year outcomes after transcatheter aortic valve replacement (TAVR) in low surgical risk patients with bicuspid aortic stenosis to patients with tricuspid aortic stenosis.

Background: The pivotal TAVR trials excluded patients with bicuspid aortic valves. The Low Risk Bicuspid Study 30-day primary endpoint of death or disabling stroke was 1.

Outcomes in Patients With Asymptomatic Aortic Stenosis (from the Evolut Low Risk Trial).

Transcatheter aortic valve implantation (TAVI) has comparable outcomes with surgical aortic valve replacement (SAVR) in symptomatic patients with severe aortic stenosis, including those at low risk for surgery. Less is known about TAVI outcomes in asymptomatic patients. This analysis compares clinical, hemodynamic, and quality of life (QOL) outcomes after TAVI or SAVR for low-risk asymptomatic patients.

30-Day Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results.

Objectives: The aim of this study was to evaluate outcomes of transcatheter mitral valve replacement (TMVR) with transfemoral access in patients at prohibitive or high surgical risk.

Background: Prohibitive surgical risk may preclude mitral valve replacement surgery in some patients. The investigational Intrepid TMVR system has previously been evaluated using transapical access for delivery of a self-expanding bioprosthetic valve.

Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial.

Aims: In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial.

Methods And Results: A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR.

Midterm Outcomes for Valve-in-Valve Transcatheter Aortic Valve Replacement in the Failed Freestyle Bioprosthesis.

Background: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) is acceptable in patients at high risk for reoperation. Studies suggest that ViV TAVR in stentless valves may be technically more challenging. This study sought to evaluate midterm outcomes for ViV TAVR in the degenerative Freestyle ((Medtronic, Minneapolis, MN)) stentless bioprosthesis.

First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement.

Objectives: This study sought to evaluate the feasibility of complete cerebral protection during transcatheter aortic valve replacement (TAVR) with a novel embolic protection device.

Background: Evidences and data about new cerebral embolic protection devices are lacking and scarce.

Methods: A prospective, nonrandomized, multicenter, first-in-man pilot study designed to evaluate the efficacy and safety of cerebral embolic protection utilizing the Emblok embolic protection system (Innovative Cardiovascular Solutions, Grand Rapids, Michigan) during TAVR.

Use of EN Snare device for successful repositioning of the newest self-expanding transcatheter heart valve.

Once a self-expanding transcatheter aortic valve replacement is fully deployed, a snare device must be used to retrieve it. Minimal data are available regarding technique, efficacy, and complications associated with the retrieval of such valves. Here, we present two patients in which an EN Snare Device (Merit Medical System, South Jordan, UT, USA) was safely and effectively used to retrieve and reposition the latest generation self-expanding transcatheter aortic valve replacement.

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.

Background: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients.