Humans ; Aortic Valve/surgery* ; Heart Valve Prosthesis/adverse effects* ; Heart Valve Prosthesis Implantation ; Treatment Outcome ; Transcatheter Aortic Valve Replacement/adverse effects* ; Aortic Valve Stenosis/surgery* ; Aortic Valve Insufficiency/surgery*

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 regurgitationResults: 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

Humans ; Transcatheter Aortic Valve Replacement/adverse effects* ; Heart Septal Defects, Ventricular/surgery* ; Heart Valve Prosthesis Implantation ; Iatrogenic Disease ; Ventricular Outflow Obstruction/surgery* ; Treatment Outcome ; Aortic Valve/surgery*

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 regurgitationResults: 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

Humans ; Transcatheter Aortic Valve Replacement/adverse effects* ; Heart Septal Defects, Ventricular/surgery* ; Heart Valve Prosthesis Implantation ; Iatrogenic Disease ; Ventricular Outflow Obstruction/surgery* ; Treatment Outcome ; Aortic Valve/surgery*

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*

Objective: To investigate the feasibility, efficacy and safety of transbrachial access for interventional therapy on prosthetic paravalvular leak (PVL) post surgical valve replacement. Methods: This is a retrospective study. Patients with PVL after surgical valve replacement who underwent interventional therapy via the brachial artery approach in Structural heart disease center of Fuwai hospital between August 2017 and October 2019, were included. All patients underwent puncture of the brachial artery under local anesthesia, angiography and transcatheter closure procedure were performed. The procedure was performed under transthoracic echocardiography (TTE) guidance. Baseline data, operation data and pre-and post-operative TTE examination results were collected and analyzed. Postoperative complications were recorded and operational adverse events were obtained during follow up in the outpatient department after discharge. The operation success rate was calculated, which was defined as the degree of perivalvular regurgitation decrease by 1 grade and above according to TTE without interfering the valve movement and coronary artery blood flow within 30 days after occluder placement. Results: A total of 10 patients were enrolled in this study, the mean age was (57.5±14.6) years, and 6 patients were males. There were 7 cases with aortic PVL, and 3 cases with mitral PVL. Except for one patient who was converted to the femoral vein-transseptal approach, the other 9 patients were successfully implanted with the devices via the brachial artery approach. The operation time was (103.3±34.0) minutes, and there was no need for rigorous bed rest after the operation. The median hospital stay was 7.5 (3.0, 9.8) days. The operation success rate was 9/10 via the brachial artery approach. The differences in the degree of perivalvular regurgitation, New York Heart Association (NYHA) classification, left ventricular end diastolic diameter and left atrial diameter before and after operation were statistically significant (all P<0.05). One case developed new hemolysis with renal insufficiency on the second day after procedure and discharged after successful dialysis. Another case experienced complication of brachial artery pseudoaneurysm after procedure and discharged after successful treatment with thrombin injection. The mean follow-up time was (14.3±7.9) months. During the follow-up, NYHA classification remained as Ⅰ/Ⅱ in 9 patients, no operational adverse events were observed. Conclusions: Transbrachial access for interventional therapy on PVL post surgical valve replacement is a feasible, effective, and safe procedure. It has the advantages of simplifying the operation process and reducing postoperative bed rest time.
Adult ; Aged ; Aortic Valve/surgery* ; Cardiac Catheterization ; Feasibility Studies ; Female ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation/adverse effects* ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Surgical Instruments ; Treatment Outcome

Aneurysm, False/surgery* ; Heart Aneurysm/etiology* ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation/adverse effects* ; Heart Ventricles/surgery* ; Humans ; Mitral Valve/surgery* ; Postoperative Complications

Aortic Valve/surgery* ; Aortic Valve Stenosis/surgery* ; Cardiac Catheterization ; Heart Rupture ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation ; Humans ; Transcatheter Aortic Valve Replacement/adverse effects* ; Treatment Outcome

Aortic Valve ; surgery ; Female ; Heart Valve Diseases ; surgery ; Heart Valve Prosthesis Implantation ; adverse effects ; mortality ; Humans ; Logistic Models ; Male ; Multivariate Analysis ; Risk Factors