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: Abdominal aortic aneurysm is a pathological condition in which the abdominal aorta is dilated beyond 3.0 cm. The surgical options include open surgical repair (OSR) and endovascular aneurysm repair (EVAR). Prediction of acute kidney injury (AKI) after OSR is helpful for decision-making during the postoperative phase. To find a more efficient method for making a prediction, this study aims to perform tests on the efficacy of different machine learning models. METHODS: Perioperative data of 80 OSR patients were retrospectively collected from January 2009 to December 2021 at Xiangya Hospital, Central South University. The vascular surgeon performed the surgical operation. Four commonly used machine learning classification models (logistic regression, linear kernel support vector machine, Gaussian kernel support vector machine, and random forest) were chosen to predict AKI. The efficacy of the models was validated by five-fold cross-validation. RESULTS: AKI was identified in 33 patients. Five-fold cross-validation showed that among the 4 classification models, random forest was the most precise model for predicting AKI, with an area under the curve of 0.90±0.12. CONCLUSIONS Machine learning models can precisely predict AKI during early stages after surgery, which allows vascular surgeons to address complications earlier and may help improve the clinical outcomes of OSR.
Humans ; Aortic Aneurysm, Abdominal/complications* ; Endovascular Procedures/methods* ; Retrospective Studies ; Blood Vessel Prosthesis Implantation/adverse effects* ; Acute Kidney Injury/etiology* ; Machine Learning ; Treatment Outcome ; Postoperative Complications/etiology* ; Risk Factors

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*

The use of implantable cardioverter defibrillators (ICDs) in young women has been increasing in recent years owing to greater awareness about inherited cardiac conditions that increase the risk of sudden death. Traditional placement of ICDs in the infraclavicular region among young women often leads to visible scars, a constant prominence that causes irritation from purse or bra straps and can result in body image concerns and device-related emotional distress. In this case series, two women with long QT syndrome required placement of ICDs for prevention of sudden cardiac death. Submammary placement of ICDs was performed in collaboration with electrophysiologists. We describe our local experience and technique in submammary placement of ICDs as well as the challenges faced.
Death, Sudden, Cardiac/prevention & control* ; Defibrillators, Implantable ; Female ; Heart Diseases ; Humans ; Prosthesis Implantation/methods* ; Singapore

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

This study aims to investigate whether displacement force on stents can accurately represents the displacement of the stent after endovascular aneurysm repair (EVAR) by comparing the measured stent displacement with the displacement forces calculated by computational fluid dynamics (CFD). And the effect of cross-limb and parallel-limb EVAR on stent displacements is further studied. Based on our objective, in this study, ten cross-limb EVAR patients and ten parallel-limb EVAR patients in West China Hospital of Sichuan University were enrolled. Patient-specific models were first reconstructed based on the computed tomography angiography images, then the stent displacements were measured, and the displacement forces acting on the stents were calculated by CFD. Finally, the cosα value of the angle between the displacement force and the displacement vector was used to analyze the matching degree between the displacement and the displacement force. The results showed that the displacement forces on cross-limb stents and parallel-limb stents were (2.67 ± 2.14) N and (1.36 ± 0.48) N, respectively. Displacements of stent gravity center, stent displacements relative to vessel, and vessel displacements of cross-limb and parallel-limb stents were (4.43 ± 2.81) mm and (6.39 ± 2.62) mm, (0.88 ± 0.67) mm and (1.11 ± 0.71) mm, (3.55 ± 2.88) mm and (5.28 ± 2.52) mm, respectively. The mean cosα for cross-limb and parallel-limb stents were 0.02 ± 0.66 and - 0.10 ± 0.73, respectively. This study indicates that the displacement force on the stent can't accurately represent the displacement of the stent after EVAR. In addition, the cross-limb EVAR is probably safer and more stable than the parallel-limb EVAR.
Aortic Aneurysm, Abdominal/surgery* ; Blood Vessel Prosthesis ; Blood Vessel Prosthesis Implantation ; Endovascular Procedures/methods* ; Humans ; Prosthesis Design ; Retrospective Studies ; Stents ; Treatment Outcome

Objectives: To compare the short-term outcomes of branched stentgrafts for left subclavian artery (LSA) revascularization or partial LSA coverage without reconstruction in the treatment of type B aortic dissection with proximal tear close to LSA. Methods: A total of 125 type B aortic dissection patients were treated with thoracic endovascular aortic repair (TEVAR) in Xinqiao Hospital of the Army Medical University from January 2019 to March 2021. Their medical records were reviewed and the outcomes were followed up. According to the different treatment methodologies, the patients were divided into complete LSA coverage with reconstruction group (n=25) and partial LSA coverage without reconstruction group (n=100). The data of baseline characteristics, clinical outcomes, and incidence of postoperative in-hospital adverse events were collected and compared between the two groups. The adverse events during one-year follow-up were also compared between the two groups. Kaplan-Meier analysis and log-rank test were used to compare the cumulative survival rates between groups. Results: Compared with partial LSA coverage group, distance of proximal tear to LSA((8.69±2.32)mm vs. (13.77±1.71) mm) was shorter, in-hospital expenses[175 400(166 000-189 900) yuan vs. 143 700 (138 100-151 800) yuan] was higher, average length of stent [200.00 mm vs. 150.00 (150.00-150.00) mm] and operation time [155.00 (140.00-170.00) min vs. 95.00 (80.00-100.00) min] were longer, and volumes of contrast agent [300.00 (200.00-300.00) ml vs. 200.00 (200.00-300.00) ml] (P<0.05) were higher for patients in the complete LSA coverage with reconstruction group. The incidence of post-operative fever was significantly higher in complete LSA coverage with revascularization group than that in partial LSA partial coverage with reconstruction group (56% vs. 25%, P=0.003). There was no significant difference in the incidences of all-cause death, stroke, endoleak, paraplegia, and LSA branch vessel occlusion between the two groups during follow-up. Kaplan-Meier analysis showed that there was no significant difference in the cumulative survival rates between the two groups (log-rank test: P=0.572 5). Conclusion: The TEVAR with complete LSA revascularization or partial LSA coverage without reconstruction for type B aortic dissection close to LSA are safe and effective with high success rates. There is no significant difference between these two techniques in short-term outcomes.
Aortic Dissection/surgery* ; Aortic Aneurysm, Thoracic/surgery* ; Blood Vessel Prosthesis Implantation/methods* ; Endovascular Procedures/methods* ; Humans ; Retrospective Studies ; Stents ; Subclavian Artery/surgery* ; Time Factors ; Treatment Outcome

Objective: To investigate the clinical characteristics and diagnosis and treatment strategies of patients with severe traumatic aortic injury (TAI). Methods: A total of 25 patients with TAI, who hospitalized in our hospital between August 2005 to March 2021 and underwent thoracic aortic endovascular repair (TEVAR), were included in this retrospective study. According to the time from admission to TEVAR, the patients were divided into emergency TEVAR group (14 cases, TEVAR within 24 h of admission) and elective TEVAR group (11 cases, patients underwent surgery or fracture reduction and fixation first for serious injuries and then underwent TEVAR more than 24 h after admission). The general clinical data of patients, injury severity score (ISS), time from admission to intervention, total hospital stay, the proportion of closed chest drainage and the proportion of abdominal organ repair were obtained and compared. Clinical follow-up and 1-year postoperative aortic computed tomography angiography (CTA) were performed on the patients. Death, the occurrence of aortic adverse events and injury recovery were followed up and recorded. Results: The mean age of these 25 TAI patients was (41.4±14.4) years, 20 patients were males (80.0%). 21 patients (84.0%) had persistent chest and back pain, 17 (68.0%) had pleural effusion and 5 (20.0%) had mediastinal hematoma. The injury severity score (ISS) was significantly higher in the elective TEVAR group than in the emergency TEVAR group (24.9±14.4 vs. 35.5±9.3, P=0.044). The time from admission to intervention ((1.0±0.0) d vs. (3.4±0.9) d, P<0.001], the time from admission to TEVAR ((1.0±0.0) d vs. (11.5±13.8) d, P=0.030) and total hospital stay ((6.1±2.3) d vs. (26.8±7.7) d, P<0.001) were significantly longer in elective TEVAR group than in emergency TEVAR group. The proportion of thoracic closed drainage was significantly lower in the elective TEVAR group than in the emergency TEVAR group (9 (64.3%) vs. 2 (18.2%), P=0.042). The proportion of abdominal organ repair was significantly higher than in the emergency TEVAR group (0 vs. 4 (36.4%), P=0.026). All of 25 patients were discharged alive and followed up for (84.0±30.5) months. All patients survived and completed 1-year postoperation CTA. There were no aortic adverse events occurred, and no complications after surgery, and the fractures and organ injuries healed well. Conclusions: The clinical characteristics of severe TAI are acute multi-injuries combined with persistent chest and/or back pain, pleural effusion, and mediastinal hematoma. Timely diagnosis and treatment are important factors for the outcome. The treatment strategy for multi-injuries should give priority to dealing with life-threatening injuries. TEVAR is the primary treatment strategy for severe TAI and is related to satisfactory outcomes.
Adult ; Aorta, Thoracic/surgery* ; Aortic Diseases ; Blood Vessel Prosthesis Implantation/adverse effects* ; Endovascular Procedures/methods* ; Female ; Hematoma/surgery* ; Humans ; Male ; Middle Aged ; Pleural Effusion/surgery* ; Retrospective Studies ; Risk Factors ; Treatment Outcome