Short-Term Outcomes of ACURATE neo2.

Inferior outcomes with ACURATE neo, a self-expanding transcatheter heart valve (THV) for the treatment of severe aortic stenosis, were mainly driven by higher rates of moderate/severe paravalvular leak (PVL). To overcome this limitation, the next-generation ACURATE neo2 features a 60% larger external sealing skirt. Data on long-term performance are limited; however, clinical evidence suggests improved short-term performance which is comparable to contemporary THVs.

Mind the Gap in TAVR: Recognizing and Managing Misloaded Self-Expanding TAVR Devices.

Misloading during transcatheter aortic valve replacement (TAVR) is rare but can cause unpredictable valve release if unrecognized. We describe how to identify a misloaded ACURATE neo2 device, and 3 methods to solve this by using a modified technique of valve deployment, ipsilateral extraction, and contralateral valve externalization with extracorporeal valve release.

ACURATE neo2 Transcatheter aortic valve implantation without balloon aortic valvuloplasty - direct ACURATE neo2.

Background: ACURATE neo2 (Neo2) implantation is performed after systematic Balloon Aortic Valvuloplasty (BAV) in most patients. No reports exist about the feasibility and safety of direct Neo2 transcatheter aortic valve implantation (TAVI) in comparison to the standard practice.

Aim: We aimed to identify the patients' baseline anatomical characteristics, procedural, and early post-procedural outcomes in patients treated using Neo2 with and without BAV.

The Early neo2 Registry: Transcatheter Aortic Valve Implantation With ACURATE in a European Population.

Background ACURATE is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. Methods and Results The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE . Data were collected from 554 consecutive patients treated with ACURATE at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.

Feasibility of a No-Implant Approach to Interatrial Shunts: Preclinical and Early Clinical Studies.

Background: Heart failure with preserved ejection fraction represents a major unmet clinical need with limited treatment options. Recent device therapies under investigation have focused on decompression of the left atrium through an implantable interatrial shunt. Although these devices have shown favorable safety and efficacy signals, an implant is required to maintain shunt patency, which may increase the patient risk profile and complicate subsequent interventions requiring transseptal access.

No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes From Multicenter Pilot Feasibility Studies.

Background: Most approaches to the creation of an interatrial shunt require placement of a permanent implant to maintain patency.

Objectives: The goal of this study was to investigate the safety and efficacy of a no-implant interatrial shunt for patients with heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF).

Methods: This was a multicenter, uncontrolled study of patients with HFpEF/HFmrEF and NYHA functional class ≥II, ejection fraction >40%, and pulmonary capillary wedge pressure (PCWP) during supine exercise ≥25 mm Hg with PCWP-to-right atrial gradient ≥5 mm Hg.

BASILICA Procedure Prior to Valve-in-Valve TAVR in a Supra-Annular TAV Prosthesis.

An 80-year-old man with a supra-annular transcatheter aortic valve (TAV) prosthesis presented with severe transvalvular aortic regurgitation 18 months after the TAV replacement procedure. The authors report the first ever valve-in-valve procedure using BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) in such a supra-annular TAV prosthesis. Minimal paravalvular leakage, normal coronary artery flow, and easy coronary access were seen postimplantation.

Commissural Alignment With ACURATE neo2 Valve in an Unselected Population.

Background: Commissural alignment has become an important topic in transcatheter aortic valve replacement (TAVR) because it may improve coronary access, facilitate future valve procedures, and possibly improve valve durability. The efficacy of commissural alignment with ACURATE neo2 has not yet been shown in a large population.

Objectives: The authors sought to determine the feasibility and success of attempting commissural alignment in an unselected TAVR population treated with the ACURATE neo2 prosthetic heart valve.

Reducing cardiac tamponade caused by temporary pacemaker perforation in transcatheter aortic valve replacement.

Background: Cardiac tamponade caused by temporary right ventricular (RV) pacemaker perforation is a rare but serious complication in transcatheter aortic valve replacement (TAVR).

Aims: To study the incidence of temporary pacemaker related cardiac tamponade in TAVR, and the relation to the type of pacemaker lead used in periprocedural temporary transvenous pacing.

Methods: A single center registry of transfemoral TAVRs in 2014-2020.

Core Lab Adjudication of the ACURATE Hemodynamic Performance Using Computed-Tomography-Corrected Left Ventricular Outflow Tract Area.

(1) Background: Hemodynamic assessment of prosthetic heart valves using conventional 2D transthoracic Echocardiography-Doppler (2D-TTE) has limitations. Of those, left ventricular outflow tract (LVOT) area measurement is one of the major limitations of the continuity equation, which assumes a circular LVOT. (2) Methods: This study comprised 258 patients with severe aortic stenosis (AS), who were treated with the ACURATE .

A Novel Model to Predict 1-Year Mortality in Elective Transfemoral Aortic Valve Replacement: The TAVR-Risk Score.

Objectives: We aimed to develop and validate an effective prediction model for 1-year mortality risk in elective transfemoral transcatheter aortic valve replacement (TAVR), ie, the TAVR-Risk (TARI) model.

Background: TAVR is the primary treatment for patients with symptomatic severe aortic valve stenosis; however, risk assessment tools for longer-term outcomes after TAVR remain scarce.

Methods: This retrospective cohort study used logistic regression to test univariate and multivariate associations.

Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations.

Background: Arterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost.

Aims: To evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI).

Methods: A single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc.

Tricuspid valve disease prevalence and the impact of tricuspid valve surgery on cardiovascular events and hospital resource use in medicare beneficiaries.

Background: Tricuspid valve disease (TVD) is presumed common, however, little is known about its prevalence or the impact of tricuspid valve surgery (TVS) on healthcare resource use.

Methods: To describe the prevalence of TVD and assess the impact of TVS on resource utilization, Medicare Fee-For-Service beneficiaries from 2011 -2019 were assessed for the prevalence of non-rheumatic TVD. Hospital costs and rates of all-cause, cardiovascular (CV), and heart failure (HF) hospitalizations were compared in the 3 months pre TVS to acute (0-3 months) and chronic (3 -12 months) post TVS periods.

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE 2 versus ACURATE Transcatheter Aortic Valve Implantation.

The new-generation ACURATE 2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE 2 versus the ACURATE transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE 2 and ACURATE systems.

Prospective Evaluation of Transseptal TMVR for Failed Surgical Bioprostheses: MITRAL Trial Valve-in-Valve Arm 1-Year Outcomes.

Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.

Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses.

Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled.

Prospective Evaluation of TMVR for Failed Surgical Annuloplasty Rings: MITRAL Trial Valve-in-Ring Arm 1-Year Outcomes.

Objectives: The authors report 1-year outcomes of high-risk patients with failed surgical annuloplasty rings undergoing transseptal mitral valve-in-ring (MViR) with the SAPIEN 3 aortic transcatheter heart valve (THV).

Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study evaluating transseptal MViR with the SAPIEN 3 aortic THV in high-risk patients with failed surgical annuloplasty rings.

Methods: Prospective enrollment of high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis and failed annuloplasty rings at 13 U.

Prospective Study of TMVR Using Balloon-Expandable Aortic Transcatheter Valves in MAC: MITRAL Trial 1-Year Outcomes.

Objectives: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial.

Background: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves.

Methods: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.

The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on Transcatheter and Surgical Aortic Valve Replacement in Low- and Intermediate-Risk Patients: A Meta-Analysis of Randomized and Propensity-Matched Studies.

Objective: There is an increasing amount of evidence supporting use of transcatheter aortic valve replacement (TAVR) for treatment of aortic stenosis in patients at low or intermediate risk for surgical aortic valve replacement (SAVR). TAVR is now approved for use in all patient cohorts. Despite this, there remains debate about the relative efficacy of TAVR compared with SAVR in lower-risk cohorts and various subgroups of patients.

Imaging for Tricuspid Valve Repair and Replacement.

Primary or secondary tricuspid regurgitation (TR) represents an important health care burden and challenge which has often been neglected or undertreated in the past. The expansion and reinforcement of the indications for tricuspid valve (TV) intervention in the 2017 editions of the guidelines as well as the introduction of transcatheter tricuspid valve intervention (TTVI) has considerably increased the attention of the community on the TV and the volume of TV interventions in the past years. Depending on the anatomic target, TTVI can be categorized as the following: 1) direct or indirect tricuspid restrictive annuloplasty; 2) direct (edge-to-edge repair) or indirect (coaptation device) restoration of leaflet coaptation; 3) heterotopic tricuspid valve implantation; and 4) transcatheter tricuspid valve replacement.

Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Aortic Valves From the STS/ACC TVT Registry.

Objectives: This study sought to compare outcomes in patients with bicuspid versus tricuspid anatomy undergoing transcatheter aortic valve replacement (TAVR).

Background: TAVR has shown excellent safety and efficacy in patients with tricuspid aortic valve stenosis, but limited data are available on the use of self-expanding valves in patients with bicuspid valves.

Methods: The Society of Thoracic Surgeons/American College of Cardiology TVT Registry was used to analyze patients who underwent TAVR with the Evolut R or Evolut PRO valves.