Humans ; Pulmonary Valve Stenosis/therapy* ; Infant, Newborn ; Perioperative Care/standards* ; Consensus ; Balloon Valvuloplasty/methods* ; Pulmonary Valve/surgery*

OBJECTIVES: To evaluate the short-term outcomes of transcatheter pulmonary valve replacement (TPVR) using the Venus-P valve in patients with moderate-to-severe pulmonary regurgitation and right ventricular systolic dysfunction (RVSD) following surgical repair of complex congenital heart disease. METHODS: A retrospective analysis was conducted on patients undergoing Venus-P valve implantation (TPVR group, n=28) or surgical pulmonary valve replacement (SPVR group, n=19) at Fuwai Hospital between February 2014 and February 2024. All patients had moderate-to-severe pulmonary regurgitation with right ventricular ejection fraction less than 45% preoperatively. Postoperative pulmonary valve function and ventricular parameters were assessed at discharge and during a 6-month follow-up. RESULTS: All procedures were successfully completed with no early mortality. At 6 months, the TPVR group demonstrated significantly lower pulmonary valve transvalvular pressure gradients compared to the SPVR group (P<0.05). Both groups exhibited significant improvements from baseline in New York Heart Association (NYHA) functional class, biventricular ejection fractions, and right ventricular end-diastolic volume index (all P<0.05). The reduction in right ventricular end-diastolic diameter differed between the two groups (P<0.01). However, multivariable analysis revealed no association between this difference and surgical approach (β=4.4, P>0.05). In the TPVR group, QRS duration was significantly shortened postoperatively (P<0.01), with improvements in left ventricular end-diastolic volume index and cardiac index (both P<0.01), but these improvements did not differ significantly from the SPVR group (all P>0.05). During the follow-up, one patient in each group developed infective endocarditis within 1-month post-procedure; both were successfully treated with antibiotics. No other major complications were observed. CONCLUSIONS For patients with moderate-to-severe pulmonary regurgitation and RVSD, TPVR using the Venus-P valve effectively improves short-term pulmonary valve function and ventricular performance with a favorable safety profile, demonstrating potential as a minimally invasive alternative to SPVR .
Humans ; Pulmonary Valve Insufficiency/surgery* ; Retrospective Studies ; Pulmonary Valve/surgery* ; Heart Valve Prosthesis Implantation/methods* ; Ventricular Dysfunction, Right/physiopathology* ; Treatment Outcome ; Female ; Male ; Child ; Adult ; Heart Valve Prosthesis ; Adolescent ; Cardiac Catheterization/methods* ; Child, Preschool

COMPERA 2.0 risk stratification has been demonstrated to be useful in patients with precapillary pulmonary hypertension (PH). However, its suitability for patients at risk for post-capillary PH or PH associated with left heart disease (PH-LHD) is unclear. To investigate the use of COMPERA 2.0 in patients with severe aortic stenosis (SAS) undergoing transcatheter aortic valve replacement (TAVR), who are at risk for post-capillary PH, a total of 327 eligible SAS patients undergoing TAVR at our institution between September 2015 and November 2020 were included in the study. Patients were classified into four strata before and after TAVR using the COMPERA 2.0 risk score. The primary endpoint was all-cause mortality. Survival analysis was performed using Kaplan-Meier curves, log-rank test, and Cox proportional hazards regression model. The study cohort had a median (interquartile range) age of 76 (70‒80) years and a pulmonary arterial systolic pressure of 33 (27‒43) mmHg (1 mmHg=0.133 kPa) before TAVR. The overall mortality was 11.9% during 26 (15‒47) months of follow-up. Before TAVR, cumulative mortality was higher with an increase in the risk stratum level (log-rank, both P<0.001); each increase in the risk stratum level resulted in an increased risk of death (hazard ratio (HR) 2.53, 95% confidential interval (CI) 1.54‒4.18, P<0.001), which was independent of age, sex, estimated glomerular filtration rate (eGFR), hemoglobin, albumin, and valve type (HR 1.76, 95% CI 1.01‒3.07, P=0.047). Similar results were observed at 30 d after TAVR. COMPERA 2.0 can serve as a useful tool for risk stratification in patients with SAS undergoing TAVR, indicating its potential application in the management of PH-LHD. Further validation is needed in patients with confirmed post-capillary PH by right heart catheterization.
Humans ; Aortic Valve Stenosis/complications* ; Aged ; Hypertension, Pulmonary/mortality* ; Male ; Female ; Transcatheter Aortic Valve Replacement ; Aged, 80 and over ; Risk Assessment/methods* ; Proportional Hazards Models ; Kaplan-Meier Estimate ; Retrospective Studies

Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitationpulmonary pressure gradient<40 mmHg (1 mmHg=0.133 kPa). Results: A total of 5 patients were included, with 4 males, aged 14 to 37 years. The initial diagnosis included Tetralogy of Fallot (2 cases), truncus arteriosus (1 case), pulmonary atresia (1 case) and subaortic stenosis (1 case, prior Ross procedure). Four patients underwent RVOT reconstruction with homograft or artificial conduit, and one patient was treated with trans-annular patch technique. The indications of TPVR included RVOT obstruction and regurgitation (3 cases), isolated obstruction (1 case), and isolated regurgitation (1 case). Of the 4 patients with varying severity of ROVT obstruction, the average preprocedural peak jet velocity of RVOT was 3.5 m/s, and the average peak pressure gradient was 50.0 mmHg. Except for one patient, who had previously been implanted with a covered Cheatham-Platinum (CP) stent due to severe stenosis of the main pulmonary artery, other patients underwent pre-stenting with a covered CP stent before TPVR. Clinical implant success was achieved in all of the 5 patients, and there was no serious periprocedural complications. The average trans-pulmonary peak jet velocity and peak pressure gradient derived from postprocedural echocardiography was 2.3 m/s and 21.2 mmHg, respectively. All patients experienced significant symptom relief after the procedure. All patients completed 3-month follow-up, and 4 completed 6-month follow-up. There was no case of infectious endocarditis during follow-up. All patients were graded as NYHA functional class one at the latest follow-up. Conclusions: TPVR using the domestically-produced balloon-expandable Prizvalve system is safe and feasible for the treatment of patients with post-surgical RVOT dysfunction and suitable landing-zone anatomy. The safety, effectiveness, and long-term valve durability of the Prizvalve system deserve further research.
Male ; Humans ; Pulmonary Valve/surgery* ; Heart Valve Prosthesis/adverse effects* ; Heart Valve Prosthesis Implantation ; Constriction, Pathologic/surgery* ; Prospective Studies ; Ventricular Outflow Obstruction/surgery* ; Treatment Outcome ; Cardiac Catheterization/methods* ; Transcatheter Aortic Valve Replacement

Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitationpulmonary pressure gradient<40 mmHg (1 mmHg=0.133 kPa). Results: A total of 5 patients were included, with 4 males, aged 14 to 37 years. The initial diagnosis included Tetralogy of Fallot (2 cases), truncus arteriosus (1 case), pulmonary atresia (1 case) and subaortic stenosis (1 case, prior Ross procedure). Four patients underwent RVOT reconstruction with homograft or artificial conduit, and one patient was treated with trans-annular patch technique. The indications of TPVR included RVOT obstruction and regurgitation (3 cases), isolated obstruction (1 case), and isolated regurgitation (1 case). Of the 4 patients with varying severity of ROVT obstruction, the average preprocedural peak jet velocity of RVOT was 3.5 m/s, and the average peak pressure gradient was 50.0 mmHg. Except for one patient, who had previously been implanted with a covered Cheatham-Platinum (CP) stent due to severe stenosis of the main pulmonary artery, other patients underwent pre-stenting with a covered CP stent before TPVR. Clinical implant success was achieved in all of the 5 patients, and there was no serious periprocedural complications. The average trans-pulmonary peak jet velocity and peak pressure gradient derived from postprocedural echocardiography was 2.3 m/s and 21.2 mmHg, respectively. All patients experienced significant symptom relief after the procedure. All patients completed 3-month follow-up, and 4 completed 6-month follow-up. There was no case of infectious endocarditis during follow-up. All patients were graded as NYHA functional class one at the latest follow-up. Conclusions: TPVR using the domestically-produced balloon-expandable Prizvalve system is safe and feasible for the treatment of patients with post-surgical RVOT dysfunction and suitable landing-zone anatomy. The safety, effectiveness, and long-term valve durability of the Prizvalve system deserve further research.
Male ; Humans ; Pulmonary Valve/surgery* ; Heart Valve Prosthesis/adverse effects* ; Heart Valve Prosthesis Implantation ; Constriction, Pathologic/surgery* ; Prospective Studies ; Ventricular Outflow Obstruction/surgery* ; Treatment Outcome ; Cardiac Catheterization/methods* ; Transcatheter Aortic Valve Replacement

Objective: To explore the efficacy and safety of transcatheter pulmonary valve perforation in the treatment of neonatal pulmonary atresia with intact ventricular septum (PA-IVS). Methods: The clinical data on surgical treatment and follow-up in 16 patients with PA-IVS who underwent transcatheter pulmonary valve perforation in Women and Children's Hospital, Qingdao University from October 2018 to October 2021 were analyzed retrospectively. The right ventricular systolic pressure and percutaneous oxygen saturation (SpO₂) were compared before and after operation. In addition, the SpO₂ and echocardiographic data at preoperative and the last follow-up were compared. Comparisons between groups were performed using paired-samples t test. Results: Among the 16 patients (10 males and 6 females) with the age at operation of 19 (14, 26) days, 12 cases underwent transcatheter pulmonary valve perforation successfully, 2 cases were transferred to surgery department for open-heart pulmonary valvulotomy, and the remaining 2 cases were transmitted to surgery department for transthoracic pulmonary valve perforation. The age at operation of the 12 patients who underwent transcatheter pulmonary valve perforation was 18 (14, 27) days, and the weight was (3.6±0.4) kg. The immediate postoperative right ventricular systolic pressure decreased significantly ((57±16) vs. (95±19) mmHg (1 mmHg=0.133 kPa), t=7.49, P<0.001), and the postoperative SpO₂ was improved effectively (0.90±0.48 vs.0.75±0.09, t=-5.61, P<0.001). The follow-up time was 22 (7, 33) months for 12 patients who underwent transcatheter pulmonary valve perforation successfully. At the last follow-up, the ratio of right to left ventricular transverse diameter was significantly higher than that before operative (0.55±0.05 vs. 0.45±0.05, t=-3.27,P=0.007). Furthermore, the Z-scores of pulmonary valvular diameter (-0.78±0.23 vs. -1.73±0.56, t=-8.52, P<0.001) and the tricuspid valvular diameter (-0.52±0.12 vs. -1.46±0.38, t=-10.40, P<0.001) were all significantly higher than preoperative data. At last, all the patients achieved biventricular circulation without death or major complications. Conclusion: Transcatheter pulmonary valve perforation is a safe and effective therapy for neonatal PA-IVS, and its curative effect has been confirmed by the medium follow-up data.
Child ; Male ; Infant, Newborn ; Humans ; Female ; Pulmonary Valve/surgery* ; Retrospective Studies ; Pulmonary Atresia/surgery* ; Heart Defects, Congenital

OBJECTIVES: Due to the lack of large-sized pulmonary valved conduit products in clinical practice, hand-sewn expanded polytetrafluoroethylene (ePTFE) valved conduit has been used for right ventricular outflow tract (RVOT) reconstruction in many heart centers around the world. This study aims to summarize the early results of the ePTFE valved conduit and the sewing technology of the conduit in combination with the latest progress, and to provide a reference for the application of ePTFE valved conduit. METHODS: A total of 21 patients using ePTFE valved conduit for RVOT reconstruction in the Second Xiangya Hospital, Central South University from October 2018 to October 2020 were prospectively enrolled in this study. The age at the implantation of the conduit was 4.3 to 43.8 (median 15.1) years old, with weight of (38.9±4.1) kg. In this cohort, 14 patients underwent re-reconstruction of RVOT, including 12 patients with pulmonary regurgitation at 6.3 to 31.0 (median 13.8) years after tetralogy of Fallot (TOF) repair, and 2 patients with failed bovine jugular vein conduit (BJVC). Seven patients underwent Ross operations. Among them, 3 were for aortic valve stenosis, 2 were for aortic regurgitation, and 2 were for both stenosis and regurgitation. The ePTFE valved conduits were standard hand-sewn during the surgery. The 3 leaflets were equal in size with arc-shaped lower edge of the valve sinus. The free edge of the valve leaflets was straight with the length of about 1 mm longer than the diameter. The height of the valve sinus was 4/5 of the diameter. The junction of the valve leaflet was 3/4 of the height of the sinus. The designed leaflets were then continuous non-penetrating sutured into the inner surface of Gore-Tex vessel to make a valved conduit. Valved conduits with diameter of 18, 20, and 22 mm were used in 2, 9, and 10 cases, respectively. The surgical results, postoperative recovery time, and serious complications were summarized, and the changes of postoperative cardiac function status and hemodynamic status of the conduits were investigated. RESULTS: During the implantation of ePTFE valved conduit for RVOT reconstruction, 2 patients underwent mechanical mitral valve replacement with Ross operation, 2 patients with pulmonary regurgitation with repaired TOF underwent left and right pulmonary artery angioplasty, and 1 patient with failed BJVC underwent tricuspid valvuloplasty. The cardiopulmonary bypassing time for patients underwent re-reconstruction of RVOT was (130.9±16.9) min, with aorta clamping for 1 patient to repair the residual defect of the ventricular septum. The cardiopulmonary bypassing and aorta clamping time for Ross operation were (242.7±20.6) min and (145.6±10.5) min, respectively. The duration of postoperative ventilator assistance, intensive care unit stay, and hospital stay were 3.5 h to 7.7 d (median 17.1 h),11.2 h to 29.5 d (median 1.9 d), and 6.0 to 56.0 (median 13.0) d, respectively. All patients survived after discharge from hospital. The follow-up rate after discharge was 100% with median time at 15.0 (13.0 to 39.0) months. No death happened during the follow-up. One patient underwent stent implantation due to right coronary stenosis 2 months after Ross operation. One patient underwent balloon dilation due to right pulmonary artery ostium stenosis 1 year after re-reconstruction of RVOT. The cardiac function of all patients recovered to NYHA class I 6 months after operation. The peak pressure gradient across the valve measured by transthoracic echocardiography before discharge was (9.4±2.6) mmHg (1 mmHg=0.133 kPa), and (18.3±6.1) mmHg at the last follow-up. There was no significant increase in the gradient during the follow-up (P=0.134). No patient suffered from mild or more pulmonary regurgitation. CONCLUSIONS Hand-sewn ePTFE valved conduit is feasible for RVOT reconstruction. It is a promising material for RVOT reconstruction which can effectively meet clinical need. In our experience, the ePTFE valved conduit is simple to manufacture with satisfactory early outcomes.In the application of ePTFE valved conduit, attention should be paid to implantation indications and postoperative anticoagulation management, especially to the preparation details of the valved conduit, to obtain better function and durability of the conduit after implantation.
Adolescent ; Animals ; Cattle ; Constriction, Pathologic/surgery* ; Heart Valve Prosthesis/adverse effects* ; Heart Valve Prosthesis Implantation/methods* ; Humans ; Infant ; Polytetrafluoroethylene ; Prosthesis Design ; Pulmonary Valve Insufficiency/surgery* ; Retrospective Studies ; Treatment Outcome ; Ventricular Outflow Obstruction/surgery*

Cardiac Catheterization ; Cardiac Surgical Procedures ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation ; Heart Ventricles/surgery* ; Humans ; Pulmonary Valve/surgery* ; Pulmonary Valve Insufficiency/surgery* ; Treatment Outcome ; Ventricular Outflow Obstruction/surgery*

Percutaneous pulmonary valve implantation (PPVI) is recognized as a feasible and low risk alternative to surgery to treat dysfunctional right ventricular outflow tract (RVOT) in usually pluri-operated patients. Evolving technology allowed to develop different kind of prosthesis and to go from an initial treatment exclusively of stenotic conduit to an actual approach extended also to wide native RVOT. The Melody transcatheter pulmonary valve (TPV) and the Edwards Sapien valve are nowadays the most commonly implanted prostheses. However, other devices have been developed to treat large RVOT (i.e., the Venus p-valve, the Medtronic Harmony TPV, the Alterra Adaptive Prestent, and the Pulsta valve). Indications for PPVI are the same as for surgical interventions on pulmonary valve, with limits related to the maximum diameter of the available percutaneous prosthesis. Therefore, an accurate preoperative evaluation is of paramount importance to select patients who could benefit from this procedure. The overall periprocedural mortality incidence is around 1.4%, while freedom from RVOT reintervention ranges from 100% at 4 months to 70% at 70 months, according to the different published studies.
Freedom ; Heart Defects, Congenital ; Humans ; Incidence ; Mortality ; Prostheses and Implants ; Pulmonary Valve ; Venus

OBJECTIVES: Elevated pulmonary pressure and right ventricular (RV) dysfunction are the hallmarks of pulmonary vascular disease in animal models and human patients with pulmonary arterial hypertension (PAH). Monocrotaline models of PAH are widely used to study the pathophysiology of PAH. The purpose of this study was to evaluate the severity of PAH rat model by tissue Doppler imaging (TDI). METHODS: PAH was induced in Sprague-Dawley rats by monocrotaline (M) group. The peak systolic (s'), early diastolic (e'), and late diastolic myocardial velocities (a') were measured using TDI at basal segments. Tricuspid annular plane systolic excursion (TAPSE) was measured in the 4-chamber view. Velocity of a tricuspid regurgitation (TR) jet was measured to estimate the pulmonary artery pressure to assess the severity of PAH. RESULTS: Decrease in the RV shortening fraction and ejection fraction were observed in the M group compared with the control (C) group. RV e' velocity and s' velocity were significantly lower in the M group compared with the C group. The TAPSE was significantly lower in the M group compared with the C group (1.26±0.22 mm vs. 2.83±0.34 mm). The TR velocity was significantly higher in the M group compared with the C group (4.48±0.34 m/sec vs. 1.23±0.02 m/sec). CONCLUSION: TAPSE is an easily obtainable, widely recognized and clinically useful echocardiographic parameter of global RV function in the PAH rat model. We recommend that TDI would be a helpful diagnostic tool to evaluate the RV function in PAH rat model.
Animals ; Echocardiography ; Humans ; Hypertension ; Hypertension, Pulmonary ; Models, Animal ; Monocrotaline ; Pulmonary Artery ; Rats ; Rats, Sprague-Dawley ; Tricuspid Valve Insufficiency ; Vascular Diseases ; Ventricular Dysfunction, Right ; Ventricular Function, Right