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

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

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 evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) with the novel Prizvalve^® system in treating severe aortic stenosis. Methods: This is a single-center, prospective, single-arm, observational study. A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement (SAVR) were included, and TAVI was achieved with the Prizvalve^® system between March 2021 and May 2021 in West China Hospital. Transthoracic echocardiography (TTE) was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity. The device success rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient<20 mmHg (1 mmHg=0.133 kPa) or a maximal transaortic velocity<3 m/s post TAVI, and without severe aortic regurgitation or paravalvular leak post TAVI. TTE was performed at 30 days after the surgery, and all-cause mortality as well as the major cardiovascular adverse events (including acute myocardial infarction, disabling hemorrhagic or ischemic stroke) up to 30 days post TAVI were analyzed. Results: The age of 11 included patients were (78.1±6.3) years, with 8 males. A total of 10 patients were with NYHA functional class Ⅲ or Ⅳ. Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients. Post-implant mean transaortic gradient was (7.55±4.08) mmHg and maximal transaortic velocity was (1.78±0.44) m/s, and both decreased significantly as compared to baseline levels (both P<0.05). No severe aortic regurgitation or paravalvular leak was observed post TAVI. Device success was achieved in all the 11 patients. No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI. Mean transaortic gradient was (9.45±5.07) mmHg and maximal transaortic velocity was (2.05±0.42) m/s at 30 days post TAVI, which were similar as the values measured immediately post TAVI (both P>0.05). Conclusions: TAVI with the Prizvalve^® system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR. Further clinical studies could be launched to obtain more clinical experience with Prizvalve^® system.
Aged ; Aged, 80 and over ; Aortic Valve ; Aortic Valve Stenosis/surgery* ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation ; Humans ; Male ; Prospective Studies ; Transcatheter Aortic Valve Replacement/methods* ; Treatment Outcome

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

Objective: To systematically review the prognosis of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis. Methods: A systematic search of PubMed, EMBASE, Scopus, Cochrane Library, China biomedical literature database, China journal full text database (CNKI), Wanfang database and VIP database from January 2012 to February 2022 was conducted for randomized controlled trial (RCT) that comparing TAVR and SAVR in the treatment of severe aortic stenosis. The primary outcomes were the incidence of all-cause mortality, stroke incidence, reoperation rate and complications (pacemaker implantation, atrial fibrillation) at 1 month and 1, 2, 5 years after operation. Jadad scale was used to evaluate the literature quality of RCTs. All statistical analyses were performed using the standard statistical procedures provided in RevMan 5.4.1. Results: A total of 17 studies including 11 712 patients were identified, including 6 007 patients treated with TAVR and 5 705 patients treated with SAVR. There were 4 high-quality studies and 13 medium-quality studies. The results of meta-analysis showed that the rate of new onset atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.28, 95%CI 0.21-0.38, P<0.001), and there was no significant difference in all-cause death, stroke, pacemaker implantation and reoperation rate (all P>0.05) at 30 days follow-up. At one year after TAVR and SAVR treatment, all-cause mortality (RR=0.85, 95%CI 0.74-0.97, P=0.01) and new onset atrial fibrillation (RR=0.28, 95%CI 0.20-0.39, P<0.001) were lower in TAVR group than SAVR group. However, the pacemaker implantation rate was higher in TAVR group than that of SAVR group (RR=1.79, 95%CI 1.11-2.89, P=0.02), while there was no significant difference in the incidence of stroke and reoperation between the two groups (P>0.05). At two years after TAVR and SAVR treatment, the pacemaker implantation rate was higher in TAVR group than that in SAVR group (RR=2.23, 95%CI 1.28-3.86, P=0.004), and the rate of new atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.46, 95%CI 0.38-0.56, P<0.001). There was no significant difference in all-cause death, stroke and reoperation rates between the two groups (P>0.05). At five years after TAVR and SAVR treatment, the pacemaker implantation rate (RR=1.89, 95%CI 1.13-3.17, P=0.02) and reoperation rate (RR=3.64, 95%CI 1.75-7.58, P=0.000 5) were higher in TAVR group than those in SAVR group, while the rate of new onset atrial fibrillation was lower in TAVR group than that in SAVR group (RR=0.45, 95%CI 0.37-0.55, P<0.001). There was no significant difference in all-cause death and stroke incidence between the two groups (all P>0.05). Conclusions: The all-cause mortality and the incidence of new onset atrial fibrillation after TAVR are lower than SAVR, and TAVR is a preferred therapy for patients with aortic stenosis.
Aortic Valve ; Aortic Valve Stenosis/surgery* ; Atrial Fibrillation/etiology* ; Heart Valve Prosthesis Implantation ; Humans ; Prognosis ; Randomized Controlled Trials as Topic ; Stroke ; Transcatheter Aortic Valve Replacement/methods*

PURPOSE: Significant late-onset tricuspid regurgitation (TR) is unfortunately common after double valve replacement (DVR); however, its underlying factors remain undefined. We evaluated the effect of aortic patient-prosthesis mismatch (PPM) on late-onset TR and clinical outcomes after DVR. MATERIALS AND METHODS: Of the 2392 consecutive patients who underwent aortic valve replacement between January 1990 and May 2014 at our institution, we retrospectively studied 462 patients who underwent DVR (excluding concomitant tricuspid valvular annuloplasty or replacement). Survival and freedom from grade >3 TR were compared between PPM (n=152) and non-PPM (n=310) groups using the Kaplan-Meier method. RESULTS: Although the overall survival rates were similar between the two groups at 5 and 10 years (95%, 91% vs. 96%, 93%, p=0.412), grade >3 TR-free survival was significantly lower in the PPM group (98%, 91% vs. 99%, 95%, p=0.014). Small body-surface area, atrial fibrillation, PPM, and subaortic pannus were risk factors for TR progression. However, aortic prosthesis size and trans-valvular pressure gradient were not significant factors for either TR progression or overall survival. CONCLUSION: Aortic PPM in DVR, regardless of mitral prosthesis size, was associated with late TR progression, but was not significantly correlated with overall survival. Therefore, we recommend careful echocardiographic follow-up for the early detection of TR progression in patients with aortic PPM in DVR.
Aortic Valve ; Atrial Fibrillation ; Cardiac Valve Annuloplasty ; Echocardiography ; Follow-Up Studies ; Freedom ; Heart Valve Prosthesis Implantation ; Humans ; Methods ; Prostheses and Implants ; Retrospective Studies ; Risk Factors ; Survival Rate ; Tricuspid Valve Insufficiency*

PURPOSE: The incidence of prosthesis-patient mismatch (PPM) after mitral valve replacement (MVR) has been reported to vary. The purpose of the current study was to investigate incidence of PPM according to the different methods of calculating effective orifice area (EOA), including the continuity equation (CE), pressure half time (PHT) method and use of reference EOA, and to compare these with various echocardiographic variables. MATERIALS AND METHODS: We retrospectively reviewed 166 individuals who received isolated MVR due to rheumatic mitral stenosis and had postoperative echocardiography performed between 12 and 60 months after MVR. EOA was determined by CE (EOA(CE)) and PHT using Doppler echocardiography. Reference EOA was determined from the literature or values offered by the manufacturer. Indexed EOA was used to define PPM as present if < or =1.2 cm2/m2. RESULTS: Prevalence of PPM was different depending on the methods used to calculate EOA, ranging from 7% in PHT method to 49% in referred EOA method to 62% in CE methods. The intraclass correlation coefficient was low between the methods. PPM was associated with raised trans-prosthetic pressure, only when calculated by CE (p=0.021). Indexed EOA(CE) was the only predictor of postoperative systolic pulmonary artery (PA) pressure, even after adjusting for age, preoperative systolic PA pressure and postoperative left atrial volume index (p<0.001). CONCLUSION: Prevalence of mitral PPM varied according to the methods used to calculate EOA in patients with mitral stenosis after MVR. Among the various methods used to define PPM, EOA(CE) was the only predictor of postoperative hemodynamic parameters.
Adult ; Aged ; Echocardiography ; Echocardiography, Doppler ; Female ; Heart Valve Diseases/*surgery ; *Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation/*adverse effects/methods ; Hemodynamics ; Humans ; Incidence ; Male ; Middle Aged ; Mitral Valve/physiopathology/*surgery ; Prevalence ; Retrospective Studies ; Treatment Outcome

INTRODUCTIONPercutaneous transcatheter aortic valve implantation (TAVI) has become an established therapy for inoperable and high-surgical-risk patients with severe aortic stenosis. Although TAVI in patients with degenerated surgical aortic bioprostheses (i.e. valve-in-valve TAVI) is increasingly reported in Western studies, such data is lacking in Asian patients. We describe the initial experience of valve-in-valve TAVI in Asia.

METHODSEight patients who underwent valve-in-valve TAVI due to degenerated aortic bioprostheses were enrolled. The mechanism of bioprosthetic valve failure was stenotic, regurgitation or mixed. All procedures were performed via transfemoral arterial access, using the self-expanding CoreValve prosthesis or balloon-expandable SAPIEN XT prosthesis.

RESULTSThe mean age of the patients was 71.6 ± 13.2 years and five were male. Mean duration to surgical bioprosthesis degeneration was 10.2 ± 4.1 years. Valve-in-valve TAVI was successfully performed in all patients. CoreValve and SAPIEN XT prostheses were used in six and two patients, respectively. There were no deaths, strokes or permanent pacemaker requirement at 30 days, with one noncardiac mortality at one year. All patients experienced New York Heart Association functional class improvement. Post-procedure mean pressure gradients were 20 ± 11 mmHg and 22 ± 8 mmHg at 30 days and one year, respectively. Residual aortic regurgitation (AR) of more than mild severity occurred in one patient at 30 days. At one year, only one patient had mild residual AR.

CONCLUSIONIn our experience of valve-in-valve TAVI, procedural success was achieved in all patients without adverse events at 30 days. Good clinical and haemodynamic outcomes were sustained at one year.

Aged ; Aged, 80 and over ; Aortic Valve ; surgery ; Aortic Valve Insufficiency ; surgery ; Aortic Valve Stenosis ; surgery ; Arteries ; Bioprosthesis ; Cardiac Catheterization ; methods ; Female ; Fluoroscopy ; Follow-Up Studies ; Heart Valve Prosthesis ; Heart Valve Prosthesis Implantation ; Hemodynamics ; Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; Prosthesis Failure ; Severity of Illness Index ; Transcatheter Aortic Valve Replacement

BACKGROUNDLack of fluoroscopic landmarks can make valve deployment more difficult in patients with absent aortic valve (AV) calcification. The goal of this article was to evaluate the feasibility and effectiveness of transcatheter implantation of a valved stent into the AV position of a goat, assisted with a microcatheter which provides accurate positioning of coronary artery ostia to help valved stent deployment.

METHODSThe subjects were 10 healthy goats in this study. A microcatheter was introduced into the distal site of right coronary artery (RCA) through femoral artery sheath. A minimal thoracic surgery approach was used to access the apex of the heart. The apex of the left ventricle was punctured; a delivery catheter equipped with the valved stent was introduced over a stiff guidewire into the aorta arch. We could accurately locate the RCA ostia through the microcatheter placed in the RCA under fluoroscopy. After correct valve position was confirmed, the valved stent was implanted after rapid inflation of the balloon. The immediate outcome of the function of the valved stents was evaluated after implantation.

RESULTSAll ten devices were successfully implanted into the AV position of the goats. Immediate observation after the procedure showed that the valved stents were in the desired position after implantation by angiography, echocardiogram. No obstruction of coronary artery ostia occurred, and no moderate to severe aortic regurgitation was observed.

CONCLUSIONSWhen the procedure of transcatheter implantation of a balloon-expandable valved stent into the AV position of goats is assisted with microcatheter positioning coronary artery ostia, the success rate of operation can be increased in those with noncalcified AV.

Animals ; Aortic Valve ; surgery ; Female ; Goats ; Heart Valve Prosthesis Implantation ; methods ; Male ; Transcatheter Aortic Valve Replacement ; methods