Right Ventricular Outflow Tract Anatomy Research Articles

In Vitro Assessment of Right Ventricular Outflow Tract Anatomy and Valve Orientation Effects on Bioprosthetic Pulmonary Valve Hemodynamics.

The congenital heart defect Tetralogy of Fallot (ToF) affects 1 in 2500 newborns annually in the US and typically requires surgical repair of the right ventricular outflow tract (RVOT) early in life, with variations in surgical technique leading to large disparities in RVOT anatomy among patients. Subsequently, often in adolescence or early adulthood, patients usually require surgical placement of a xenograft or allograft pulmonary valve prosthesis. Valve longevity is highly variable for reasons that remain poorly understood. This work aims to assess the performance of bioprosthetic pulmonary valves in vitro using two 3D printed geometries: an idealized case based on healthy subjects aged 11 to 13 years and a diseased case with a 150% dilation in vessel diameter downstream of the valve. Each geometry was studied with two valve orientations: one with a valve leaflet opening posterior, which is the native pulmonary valve position, and one with a valve leaflet opening anterior. Full three-dimensional, three-component, phase-averaged velocity fields were obtained in the physiological models using 4D flow MRI. Flow features, particularly vortex formation and reversed flow regions, differed significantly between the RVOT geometries and valve orientations. Pronounced asymmetry in streamwise velocity was present in all cases, while the diseased geometry produced additional asymmetry in radial flows. Quantitative integral metrics demonstrated increased secondary flow strength and recirculation in the rotated orientation for the diseased geometry. The compound effects of geometry and orientation on bioprosthetic valve hemodynamics illustrated in this study could have a crucial impact on long-term valve performance.

Transcatheter Pulmonary Valve Replacement With the Sapien Prosthesis

BackgroundThere are limited published data focused on outcomes of transcatheter pulmonary valve replacement (TPVR) with either a Sapien XT or Sapien 3 (S3) valve. ObjectivesThis study sought to report short-term outcomes in a large cohort of patients who underwent TPVR with either a Sapien XT or S3 valve. MethodsData were entered retrospectively into a multicenter registry for patients who underwent attempted TPVR with a Sapien XT or S3 valve. Patient-related, procedural, and short-term outcomes data were characterized overall and according to type of right ventricular outflow tract (RVOT) anatomy. ResultsTwenty-three centers enrolled a total of 774 patients: 397 (51%) with a native/patched RVOT; 183 (24%) with a conduit; and 194 (25%) with a bioprosthetic valve. The S3 was used in 78% of patients, and the XT was used in 22%, with most patients receiving a 29-mm (39%) or 26-mm (34%) valve. The implant was technically successful in 754 (97.4%) patients. Serious adverse events were reported in 67 patients (10%), with no difference between RVOT anatomy groups. Fourteen patients underwent urgent surgery. Nine patients had a second valve implanted. Among patients with available data, tricuspid valve injury was documented in 11 (1.7%), and 9 others (1.3%) had new moderate or severe regurgitation 2 grades higher than pre-implantation, for 20 (3.0%) total patients with tricuspid valve complications. Valve function at discharge was excellent in most patients, but 58 (8.5%) had moderate or greater pulmonary regurgitation or maximum Doppler gradients >40 mm Hg. During limited follow-up (n = 349; median: 12 months), 9 patients were diagnosed with endocarditis, and 17 additional patients underwent surgical valve replacement or valve-in-valve TPVR. ConclusionsAcute outcomes after TPVR with balloon-expandable valves were generally excellent in all types of RVOT. Additional data and longer follow-up will be necessary to gain insight into these issues.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system

Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the right ventricular outflow tract (RVOT) or pulmonary valve. To prolong the need for additional open-heart interventions, percutaneous pulmonary valve implantation (PPVI) may be performed as a less invasive alternative. No multi-patient studies currently report the feasibility and safety of this procedure using the new generation SAPIEN 3 (S3) transcatheter heart valve. Pulmonic S3 is a multicentre observational registry of patients undergoing PPVI with the S3 valve across Europe, and Canada started in March 2016. Until end of January 2018, data for 81 patients with a mean age of 26.5 years was obtained. The most common underlying diagnosis was tetralogy of Fallot (ToF) (58.0%), with only 16.3% of patients having native RVOT anatomy. Ninety percent received pre-stenting. Procedural success was 100%. Prosthesis dislodgement (without need for open surgery) occurred in one patient, with another experiencing conduit perforation. Both were successfully resolved and no other procedural complications, endocarditis, stent fracture or mortality were reported up to two years. The peak systolic gradient over the RVOT fell from 45.6 mmHg pre-procedurally to 16.2 mmHg post-procedurally, the proportion of patients with moderate/severe pulmonary regurgitation from 89.2% to 0.0% and those with an NYHA class ≥ II from 86.8% to 15.9%. PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes. Longer-term outcomes remain to be described. NCT02777892 .

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN 3 transcatheter heart valve system

Multiple surgical revisions are often necessary in individuals with congenital heart defects affecting the right ventricular outflow tract (RVOT) or pulmonary valve. To prolong the need for additional open heart interventions, percutaneous pulmonary valve implantation (PPVI) may be performed as a less invasive alternative. No multi-patient studies currently report the feasibility and safety of this procedure using the new generation SAPIEN 3 (S3) transcatheter heart valve. Pulmonic S3 is a multicentre observational registry of patients undergoing PPVI with the S3 valve across Europe, and Canada started in March 2016. Until end of January 2018, data for 81 patients with a mean age of 26.5 years was obtained. The most common underlying diagnosis was Tetralogy of Fallot (ToF) (58.0%), with only 16.3% of patients having native RVOT anatomy. 90% received pre-stenting. Procedural success was 100%. Prosthesis dislodgement (without need for open surgery) occurred in one patient, with another experiencing conduit perforation. Both were successfully resolved and no other procedural complications, endocarditis, stent fracture or mortality were reported up to two years. The peak systolic gradient over the RVOT fell from 45.6 mmHg pre-procedurally to 16.2 mmHg post-procedurally, the proportion of patients with moderate/severe pulmonary regurgitation from 89.2% to 0.0% and those with an NYHA class ≥ II from 86.8% to 15.9%. PPVI with the S3 valve appears feasible and safe in a wide range of patients with congenital heart defects, with good short-term haemodynamic and functional outcomes. Longer-term outcomes remain to be described. Clinicaltrials.gov identifier NCT02777892.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system.

Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years. The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS. NCT02302131.