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: To report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system in a contemporary, real-world setting. METHODS: The bRIGHT post-approval study is a prospective, single-arm, open-label, multicenter, post-market registry conducted at 26 sites in Europe with central event adjudication and echocardiographic core-lab assessment. RESULTS: Enrolled subjects were elderly (79±7 years) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR and 80% percent of subjects were in NYHA class III/ IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA class (21% to 75% I/II, P<0.0001) and KCCQ score (19±26-point improvement, P<0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects that achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline RV TAPSE were independently associated with mortality at 1 year (OR: 2.169, 95% CI: [1.494, 3.147], P<0.0001; OR: 0.636, 95% CI: [0.415, 0.974], P=0.0375). Mortality was not associated with baseline TR grade, nor with center volume. CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse, real-world population.

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. Echocardiographic assessment was performed at a core laboratory. Outcomes included safety and clinical effectiveness and echocardiographic assessment of TR. RESULTS: At 2 years, TR was reduced to moderate or less in 60% of subjects, and reduction of at least 1 grade was achieved in 85.4% of subjects. TR reduction was sustained in 75% of the patients. While most metrics suggest the majority of favorable remodeling occurred within the first 30 days post-procedure, both right ventricular end diastolic diameter and tricuspid annular plane systolic excursion show signals of continued favorable remodeling through 2 years. Substantial improvements in 6-minute walking distance, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire score were sustained from 30 days to 2 years. Even with low rates of cardiovascular mortality (15.3%) and all-cause mortality (18.7%) noted at 2 years, all-cause hospitalization rate decreased from 1.30 events per patient-year 1 year before device implantation to 0.66 events per patient-year 2 years after the TriClip procedure, representing a reduction of 49% (P<0.0001). CONCLUSIONS: Tricuspid transcatheter edge-to-edge repair using the TriClip implant was found to be safe and effective, with sustained benefits at 2 years in subjects with symptomatic moderate or greater TR. Repair efficacy was durable at 2 years in 75% of the patients. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03227757.

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. Echocardiographic assessment was performed at a core laboratory. RESULTS: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. CONCLUSIONS: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089).

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. Our models predict that early neotissue accumulation is driven primarily by inflammatory processes in response to the implanted polymeric scaffold, but that turnover becomes progressively mechano-mediated as the scaffold degrades. Using a lamb model, we confirm that early neotissue formation results primarily from the foreign body reaction induced by the scaffold, resulting in an early period of dynamic remodeling characterized by transient TEVG narrowing. As the scaffold degrades, mechano-mediated neotissue remodeling becomes dominant around 26 weeks. After the scaffold degrades completely, the resulting neovessel undergoes growth and remodeling that mimicks native vessel behavior, including biological growth capacity, further supported by fluid-structure interaction simulations providing detailed hemodynamic and wall stress information. Conclusions: These findings provide insights into TEVG remodeling, and have important implications for clinical use and future development of TEVGs for children with congenital heart disease.

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. The distance from the cusp to the coronary ostium, DLC2D, was measured from the geometric model and indexed with the coronary artery diameter, d, to yield a fractional obstruction measure, DLC2D/d. RESULTS: Twenty-three of 28 high-risk patients successfully underwent TAVR without coronary obstruction, of whom 1 had coronary obstruction and 4 were deemed non-TAVR candidates. DLC2D/d differed significantly between the 2 groups (P < .0018), but neither h nor SOVd did (P > .32). The optimal sensitivity and specificity for DLC2D/d were 85% and occurred at a cutoff of 0.45. The optimal sensitivity and specificity of h and SOVd in this high-risk group were only 60% and 40%, respectively, for cutoffs of h = 10 mm and SOVd = 30.5 mm. CONCLUSIONS: The 2D geometric model derived in this study shows promise for identifying patients with low-lying coronary ostium and/or small SOVd that may be safely treated with TAVR. DLC2D/d is more predictive of obstruction or poor TAVR candidacy compared with h and SOVd.

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. Replacing a stenotic fetal valve with a functional TEHV has the potential to interrupt the development of single-ventricle heart disease by restoring proper flow through the heart.

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. Particle image velocimetry was performed. Pressure gradient (ΔP), effective orifice area (EOA), regurgitant fractions (RF), pinwheeling indices (PI) and turbulent stresses were evaluated. ΔP was 8.56 ± 0.139 and 7.76 ± 0.083 mmHg with fetal valve and SAPIEN respectively (p < 0.0001); EOA was 0.10 ± 0.0007 and 2.1 ± 0.025 cm2 with fetal valve and SAPIEN respectively (p < 0.0001); RF with the fetal valve was 2.35 ± 1.99% and with SAPIEN 10.92 ± 0.11% (p < 0.0001); PI with fetal valve was 0.404 ± 0.01 and with SAPIEN 0.37 ± 0.07; The flow regime with the fetal valve was turbulent and Reynolds numbers reached about 7000 while those with the SAPIEN reached about 20,000 at peak velocity. Turbulent stresses were significantly higher with fetal valve compared with SAPIEN. Instantaneous viscous shear stresses with fetal valve were 5.8 times higher than those obtained with SAPIEN and Reynolds shear stresses were 2.5 times higher during peak systole. The fetal valve implantation leads to a turbulent flow (specific to this particular type and design of valve) regime unlike what is expected of a small valve with different flow properties compared to adult valves.

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. The distance from cusp to coronary ostium (DLC) was derived from the 3-dimensional models and indexed with the coronary artery diameter to yield a fractional obstruction measure (DLC/d). RESULTS: Twenty-two out of 28 high-risk patients successfully underwent transcatheter aortic valve replacement without coronary obstruction and 6 did not. DLC/d between the 2 groups was significantly different (P < .00078), whereas neither coronary ostium height nor SOVd were significantly different (P > .32). A cutoff of DLC/d < 0.7 was predictive with 100% sensitivity and 95.7% specificity. The optimal sensitivity and specificity of coronary ostium height and SOVd in this high-risk group was only 60% and 40%, respectively, for cutoff coronary ostium height of 10 mm and SOVd of 30.5 mm. CONCLUSIONS: Three-dimensional modeling has the potential to enable more patients to be safely treated with transcatheter aortic valve replacement who have a low-lying coronary ostium or small SOVd. DLC/d is more predictive of obstruction than coronary ostium height and SOVd.

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., 2015; Kheradvar et al., 2015a). The aim of this study is to optimize the potential of a hyaluronan (HA) enhanced polymeric transcatheter aortic valve (HA-TAV) that has promised to reduce blood damage causing-turbulent flow while maintaining durability. HA-enhanced linear low-density polyethylene (LLDPE) leaflets were sutured to novel cobalt chromium stents, size 26 mm balloon expandable stents. Hemodynamic performance was assessed in a left heart simulator under physiological pressure and flow conditions and compared to a 26 mm Medtronic Evolut and 26 mm Edwards SAPIEN 3. High-speed imaging and particle image velocimetry (PIV) were performed. The HA-TAV demonstrated an effective orifice area (EOA) within one standard deviation of the leading valve, SAPIEN 3.The regurgitant fraction (RF) of the HA-TAV (11.23 ±â€¯0.55%) is decreased in comparison the Evolut (15.74 ±â€¯0.73%) and slightly higher than the SAPIEN 3 (10.92 ±â€¯0.11%), which is considered trace regurgitation according to valve standards. A decreased number of higher principal Reynolds shear stresses were shown for the HA-TAV at each cardiac phase. The HA-TAV is directly comparable and in some cases superior to the leading commercially available prosthetic heart valves in in-vitro hemodynamic testing.