Foam-based Left Atrial Appendage Closure (CLAAS) Device: Evaluation in a Chronic Canine Model.

Background: The Conformal Left Atrial Appendage System (CLAAS) is a transcatheter implant designed to occlude the left atrial appendage to prevent stroke in patients with nonvalvular atrial fibrillation. The implant incorporates a novel polyurethane polycarbonate-urea foam matrix to enhance device performance. The objective of this study was to characterize the thrombogenicity, sealing, implant integrity, local tissue response, and systemic toxicity of the implant in a healthy canine model.

Regulatory strategies for early device development and approval.

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies.

Transmitral Gradient Assessment Using a Radial Coronary Catheter and Pressure Wire: The First Clinical Report.

•Single radial artery access for direct transmitral gradient measurement is feasible•A radial TIG coronary catheter can be advanced retrograde into the left atrium•A coronary pressure wire is delivered to the left atrium and left in place•The catheter is subsequently withdrawn into the left ventricle•This permits simultaneous left atrial and left ventricular hemodynamic assessment.

Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.

Objectives: The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device.

Background: The CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation.

Methods: Patients with atrial fibrillation at high stroke risk (CHADS-VASc score ≥2) were recruited using standard selection criteria.

Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device.

Background: Left atrial appendage (LAA) occlusion has been established as an alternative to systemic anticoagulation for stroke prevention in patients with atrial fibrillation; however, limitations of current devices have slowed adoption. We present preclinical evaluations of a novel device, the Conformal Left Atrial Appendage Seal (CLAAS).

Methods: An in vitro assessment of conformability was conducted to evaluate the two CLAAS devices (regular 27 mm and large 35 mm) and a Watchman 2.

Funding of Studies Supporting IA Guideline Recommendations in Cardiovascular Medicine-A Systematic Review.

Each guideline recommendation from the American Heart Association and the American College of Cardiology includes an indication of the level of supporting evidence and the associated strength of recommendation with "IA" recommendations representing those with the highest quality supporting evidence and the least amount of uncertainty for benefit. In this analysis, study type and funding sources were systematically tabulated across these IA guideline recommendations over the past 5 years. Nearly half of studies supporting IA guideline recommendations were randomized controlled trials (45%).

Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review.

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act.

Redefining the Prognostic Value of High-Sensitivity Troponin in COVID-19 Patients: The Importance of Concomitant Coronary Artery Disease.

Background: Although studies assessing cardiovascular comorbidities and myocardial injury in Coronavirus disease 2019 (COVID-19) patients have been published, no reports focused on clinical outcomes of myocardial injury in patients with and without chronic coronary syndromes (CCS) are currently available.

Methods: In this study, consecutive COVID-19 patients admitted to four different institutions were screened for enrolment. Patients were divided into two groups (CCS vs.

Dofetilide-Associated QT Prolongation: Total Body Weight Versus Adjusted or Ideal Body Weight for Dosing.

Dofetilide is an antiarrhythmic drug with dosing based on the Cockcroft-Gault formula using total body weight (TBW). We investigated the impact of calculating dofetilide dose using adjusted body weight (ABW) or ideal body weight (IBW) on subsequent dose reduction or discontinuation. We conducted a retrospective review of 265 patients admitted to an academic medical center for initiation of dofetilide using TBW.

Spontaneous Closure of a Secundum Atrial Septal Defect.

Spontaneous closure of an atrial septal defect (ASD) is well described in pediatric cardiology but may be less familiar to adult internists and cardiologists. We report a moderately sized 6-mm ASD that closed spontaneously without intervention. A literature review found that a smaller defect size and an early age of diagnosis are the most important predictors of closure.

Atrial Fibrillation and Stent Selection (Bare Metal vs Drug Eluting) (from Medicare Claims).

In treating coronary artery disease, many factors influence the choice of bare metal stent (BMS) or drug-eluting stent (DES), including bleed risk and suitability for prolonged dual antiplatelet therapy. Atrial fibrillation (AF) further complicates this choice, due to common use of anticoagulation. We examined stent selection in the United States by AF status and across academic medical centers (AMCs) to explore how cardiologists are managing this complex choice.

Visual estimation versus different quantitative coronary angiography methods to assess lesion severity in bifurcation lesions.

Objectives: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions.

Background: QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions.

Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study.

Objectives: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs).

Background: The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.

Segmental comparison between a dedicated bifurcation stent and balloon angioplasty using intravascular ultrasound and three-dimensional quantitative coronary angiography: A subgroup analysis of the Tryton IDE randomized trial.

Objective: Randomized comparison between the Tryton Side Branch Stent (Tryton Medical, Durham, NC), used in combination with a main branch drug-eluting stent (DES), and side branch balloon angioplasty (SBBA, in combination with a main branch DES) using intravascular ultrasound (IVUS), and three-dimensional quantitative coronary angiography (3D-QCA).

Background: The Tryton stent has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) of bifurcation lesions.

Methods: We present the pre-specified IVUS (n = 159) and 3D-QCA (n = 190) sub-group analyses of the Tryton coronary bifurcation trial (randomizing Tryton vs.

Outcomes of a dedicated stent in coronary bifurcations with large side branches: A subanalysis of the randomized TRYTON bifurcation study.

Objectives: To examine the benefit of the Tryton dedicated side branch (SB) stent compared with provisional stenting in the treatment of complex bifurcation lesions involving large SBs.

Background: The TRYTON Trial was designed to evaluate the utility of a dedicated SB stent to treat true bifurcation lesions involving large (≥2.5 mm by visual estimation) SBs.

A randomized trial of a dedicated bifurcation stent versus provisional stenting in the treatment of coronary bifurcation lesions.

Background: Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention. Current evidence recommends a conservative (provisional) approach when treating the side branch (SB).

Objectives: The TRYTON (Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty.

Optical coherence tomography versus intravascular ultrasound in the evaluation of observer variability and reliability in the assessment of stent deployment: the OCTIVUS study.

Objectives: To compare the variability in the assessment of coronary stents among interventional cardiologists (readers) using optical coherence tomography (OCT) and intravascular ultrasound (IVUS).

Background: IVUS is established and validated in the evaluation of coronary stent. For cardiologists without core lab expertise, the utility of IVUS is limited by image quality.

Serial intravascular ultrasound observations from the Tryton first-in-man study.

Aims: To report serial intravascular ultrasound (IVUS) findings of bifurcation lesions treated with the dedicated Tryton Side Branch Stent to assess mechanisms of restenosis.

Methods And Results: The Tryton FIM study was a multicentre, prospective, single-arm, "first-in-man" study to treat de novo bifurcation lesions. Minimum lumen area (MLA) sites and overall volumes were analysed within main vessels and side branches.