Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study.

Background: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life.

Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR.

Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR.

Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study.

Background: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated.

Objectives: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting.

Methods: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment.

Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial.

Background: Tricuspid regurgitation (TR) is a common and progressive valve disease with significant mortality and hospitalization burden. Tricuspid transcatheter edge-to-edge repair provides a treatment option for high-risk patients with primary and secondary TR.

Methods: The TRILUMINATE trial ([Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation]; n=85) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of tricuspid transcatheter edge-to-edge repair with the TriClip implant in patients with symptomatic moderate or greater TR.

Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice.

Background: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality.

Objectives: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting.

Methods: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe.

Tissue engineered vascular grafts transform into autologous neovessels capable of native function and growth.

Background: Tissue-engineered vascular grafts (TEVGs) have the potential to advance the surgical management of infants and children requiring congenital heart surgery by creating functional vascular conduits with growth capacity.

Methods: Herein, we used an integrative computational-experimental approach to elucidate the natural history of neovessel formation in a large animal preclinical model; combining an in vitro accelerated degradation study with mechanical testing, large animal implantation studies with in vivo imaging and histology, and data-informed computational growth and remodeling models.

Results: Our findings demonstrate that the structural integrity of the polymeric scaffold is lost over the first 26 weeks in vivo, while polymeric fragments persist for up to 52 weeks.

Development of Tissue Engineered Heart Valves for Percutaneous Transcatheter Delivery in a Fetal Ovine Model.

This multidisciplinary work shows the feasibility of replacing the fetal pulmonary valve with a percutaneous, transcatheter, fully biodegradable tissue-engineered heart valve (TEHV), which was studied in vitro through accelerated degradation, mechanical, and hemodynamic testing and in vivo by implantation into a fetal lamb. The TEHV exhibited only trivial stenosis and regurgitation in vitro and no stenosis in vivo by echocardiogram. Following implantation, the fetus matured and was delivered at term.

Simple 2-dimensional anatomic model to predict the risk of coronary obstruction during transcatheter aortic valve replacement.

Objective: In this study, a 2-dimensional (2D) index relying on preprocedural computed tomography (CT) data was developed to evaluate the risk of coronary obstruction during transcatheter aortic valve replacement (TAVR) procedures.

Methods: Anatomic measurements from pre-TAVR CT scans were collected in 28 patients among 600 who were flagged as high risk (defined as meeting coronary artery height, h, <14 mm and/or sinus of Valsalva diameter, SOVd, <30 mm) for coronary obstruction. A geometric model derived from these anatomic measurements was used to predict the post-TAVR native cusp apposition relative to the coronary ostium.

Fetal Transcatheter Trileaflet Heart Valve Hemodynamics: Implications of Scaling on Valve Mechanics and Turbulence.

The scarcity of data available on the best approach for pulmonary fetal valve replacement or implantation necessitate an investigation on whether practices using adult transcatheter valves could be translated to fetal applications. The objective of this study is to evaluate the hemodynamic characteristics and the turbulent properties of a fetal sized trileaflet transcatheter pulmonary valve in comparison with an adult balloon-expandable valve in order to assess the possibility of designing valves for fetal applications using dynamic similarity. A 6 mm fetal trileaflet valve and a 26 mm SAPIEN 3 valve were assessed in a pulse duplicator.

In vitro hemodynamic assessment of a novel polymeric transcatheter aortic valve.

Transcatheter aortic valve replacement (TAVR) is a life-saving alternative to surgical intervention. However, the identification of features associated with poor outcomes, including residual paravalvular leakage (PVL), leaflet calcification, and subclinical leaflet thrombosis, are cause to be concerned about valve durablilty (Mylotte and Piazza, 2015a, 2015b; Dasi et al., 2017; Makkar et al.

Modeling risk of coronary obstruction during transcatheter aortic valve replacement.

Objective: In this study we aimed to evaluate risk of coronary obstruction during transcatheter aortic valve replacement and develop improved criteria based on computational modeling.

Methods: Patient specific 3-dimensional models were constructed and validated for 28 patients out of 600 patients who were flagged as high risk for coronary obstruction (defined as meeting coronary ostium height < 14 mm and/or sinus of Valsalva diameter [SOVd] < 30 mm). The models consisted finite element analysis to predict the post- transcatheter aortic valve replacement native cusp apposition relative to the coronary ostium and were validated in vitro.