OBJECTIVES: To analyze the early clinical outcomes of the Xcor^TM transcatheter aortic valve replacement (TAVR) system in treating severe aortic stenosis. This study has been registered at Chinese Clinical Trial Registry (ChiCTR2200065593). METHODS: This single-arm, prospective clinical trial enrolled patients with severe aortic stenosis treated with the Xcor^TM TAVR system at the Section of Heart Valve & Coronary Artery Surgery, Guangdong Provincial People's Hospital. Perioperative and follow-up parameters were compared to evaluate differences in hemodynamic outcomes. All-cause mortality, aortic regurgitation, paravalvular leakage, cerebrovascular events, and reoperation were analyzed. RESULTS: Thirty-two patients with severe aortic stenosis were included (20 males, 12 females), with (70.9±4.3) years old and a Society of Thoracic Surgeons (STS) score of 6.45% (6.07%, 7.28%). Notably, 87.5% of patients had New York Heart Association (NYHA) class≥Ⅲ. All patients underwent successful Xcor^TM bioprosthesis implantation, achieving an immediate technical success rate of 100.0% and device success rate of 96.9%. Mean aortic valve gradient decreased from (55.21±23.17) mmHg (1 mmHg=0.133 kPa) to (8.45±5.30) mmHg, peak aortic jet velocity decreased from (4.66±0.85) m/s to (1.99±0.48) m/s, aortic valve area increased from (0.66±0.21) cm² to (2.09±0.67) cm² (all P<0.01). Intraoperative ventricular fibrillation occurred in one patient, while one case exhibited moderate prosthetic valve regurgitation and paravalvular leakage post-procedure. At 12-month follow-up, sustained improvements were observed in cardiac function, left ventricular ejection fraction, hemodynamic parameters, and SF-12 quality-of-life scores (all P<0.01). All-cause mortality was 12.5% (4/32), with 13.8% (4/29) developing moderate paravalvular leakage. CONCLUSIONS The Xcor^TM TAVR system demonstrated favorable early outcomes in severe aortic stenosis patients, significantly improving symptoms and hemodynamics while exhibiting excellent performance in preventing malignant arrhythmias and coronary obstruction.
Humans ; Male ; Female ; Aortic Valve Stenosis/surgery* ; Transcatheter Aortic Valve Replacement/methods* ; Aged ; Follow-Up Studies ; Prospective Studies ; Treatment Outcome ; Aged, 80 and over ; Heart Valve Prosthesis ; Middle Aged

Objective To compare the benefits and drawbacks of primary patch expansion versus pericardial tube right ventricular-pulmonary artery connection in patients diagnosed with pulmonary atresia with ventricular septal defect (PA/VSD). Methods A retrospective study was conducted on patients diagnosed with PA/VSD who underwent primary right ventricular-pulmonary artery connection surgery at our center between 2010 and 2020. Patients were categorized into two groups based on the type of right ventricular-pulmonary artery connection: a pericardial tube group and a patch expansion group. Clinical data and imaging findings were compared between the two groups. Results A total of 51 patients were included in the study, comprising 31 males and 20 females, with a median age of 12.57 (4.57, 49.67) months. The pericardial tube group included 19 patients with a median age of 17.17 (7.33, 49.67) months, while the patch expansion group consisted of 32 patients with a median age of 8.58 (3.57, 52.72) months. In both groups, the diameter of pulmonary artery, McGoon index, and Nakata index significantly increased after treatment (P<0.001). However, the pericardial tube group exhibited a longer extracorporeal circulation time (P<0.001). The reoperation rate was notably high, with 74.51% of patients requiring further surgical intervention, including 26 (81.25%) patients in the patch expansion group and 12 (63.16%) patients in the pericardial tube group. No statistical differences were observed in long-term cure rates or mortality between the two groups (P＞0.005). Conclusion In patients with PA/VSD, both patch expansion and pericardial tube right ventricular-pulmonary artery connection serve as effective initial palliative treatment strategies that promote pulmonary vessel development and provide a favorable foundation for subsequent radical operations. However, compared to the pericardial tube approach, the patch expansion technique is simpler to perform and preserves some intrinsic potential for pulmonary artery development, making it the preferred procedure.

Objective To introduce a modified technique of right ventricular outflow tract (RVOT) reconstruction using a handmade bicuspid pulmonary valve crafted from expanded polytetrafluoroethylene (ePTFE) and to summarize the early single-center experience. Methods Patients with complex congenital heart diseases (CHD) who underwent RVOT reconstruction with a handmade ePTFE bicuspid pulmonary valve due to pulmonary regurgitation at Guangdong Provincial People’s Hospital from April 2021 to February 2022 were selected. Postoperative artificial valve function and right heart function indicators were evaluated. Results A total of 17 patients were included, comprising 10 males and 7 females, with a mean age of (18.18±12.14) years and a mean body weight of (40.94±19.45) kg. Sixteen patients underwent reconstruction with a handmade valved conduit, with conduit sizes ranging from 18 to 24 mm. No patients required mechanical circulatory support, and no in-hospital deaths occurred. During a mean follow-up period of 12.89 months, only one patient developed valve dysfunction, and no related complications or adverse events were observed. The degree of pulmonary regurgitation was significantly improved post-RVOT reconstruction and during follow-up compared to preoperative levels (P<0.001). Postoperative right atrial diameter, right ventricular diameter, and tricuspid regurgitation area were all significantly reduced compared to preoperative values (P<0.05). Conclusion The use of a 0.1 mm ePTFE handmade bicuspid pulmonary valve for RVOT reconstruction in complex CHD is a feasible, effective, and safe technique.

Objective:To evaluate the safety, efficacy, advantages and disadvantages of the modified double-orifice valve plasty via total thoracoscopy for partial atrioventricular septal defect(PAVSD) through a retrospective analysis of early postoperative results.Methods:Patients diagnosed with PAVSD who underwent the standardized modified double-orifice valve plasty via total thoracoscopy between September 2023 and August 2024 were retrospectively enrolled. Baseline characteristics, surgical parameters, and follow-up outcomes were systematically analyzed.Results:A total of 14 patients(6 males, 8 females) were included, with a mean age of(32.9±15.5) years old and body weight of(55.1±11.6) kg. All procedures were successfully completed. The mean operative time, cardiopulmonary bypass time, and aortic cross-clamp time were(266.6±67.2) min, (160.7±34.2) min, and(97.0±31.1) min, respectively. Postoperative ICU stay, hospital stay, and total hospitalization duration were(1.7±1.1) days, (6.4±4.2) days, and(12.6±4.5) days, respectively. The mean follow-up duration was(7.9±3.6) months. Preoperatively, left atrioventricular valve regurgitation(LAVVR) was graded as mild, moderate, or severe in 5, 4, and 5 patients. Postoperatively, 13 patients exhibited mild or less LAVVR, with 1 case of moderate regurgitation. By 3 months, all patients demonstrated LAVVR of mild or lower severity, which remained stable through follow-up. Peak LAVV gradients were(4.6±2.7) mmHg(1 mmHg=0.133 kPa)(range: 1.8-10.2 mmHg) postoperatively, improving to(3.6±0.6) mmHg(3.2-4.0) mmHg at 1 year. Right atrioventricular valve regurgitation improved from preoperative moderate-severe(50.0%) to LAVVR of mild or lower severity in all patients by 3 months. No mortality, residual shunts, or high-grade atrioventricular block occurred through follow-up. By 1 month, NYHA functional class improved to Ⅰ in all patients, which remained stable through follow-up.Conclusion:Standardized modified double-orifice valve plasty via total thoracoscopy for PAVSD demonstrates safety, minimal invasiveness, and rapid recovery, with favorable early outcomes.

Objective:To establish a standardized code database of adverse drug reactions (ADRs) terms related to linezolid and analyze the common ADRs of linezolid.Methods:Linezolid drug labels, websites (including Side Effect Resource, and the official websites of US Food and Drug Administration, European Medicines Agency and National Medical Products Administration) and scientific literature database (including CNKI, Wanfang, VIP, PubMed, Embase and Web of Science databases) were systematically searched, and ADR terms about linezolid were collected. ADR terms were mapped to the international classification of diseases-10 (ICD-10) code to establish a linezolid adverse reaction database.Results:A total of 117 ADR terms about linezolid were collected and 91 ICD-10 codes were obtained after being mapped to ICD-10. A standardized database was constructed and successfully embedded into the ADR spontaneous reporting system as a specific drug submodule. The gastrointestinal system, skin and subcutaneous tissue system, various nervous systems, blood and lymphatic systems were the most common system organs involved in linezolid-related ADRs under the 91 ICD-10 codes. Among them, ADRs under the gastrointestinal system codes K14.302 (black hairy tongue) and K52.104 (drug-induced gastroenteritis and colitis), the skin and subcutaneous tissue system code L27.005 (drug-induced dermatitis), various nervous system codes G90.800 (other disorders of autonomic nervous system), G62.001 (drug-induced polyneuropathy) and G44.400 (drug-induced headache, not elsewhere classified), the blood and lymphatic system codes D69.502 (drug- induced thrombocytopenia) and D70.x02 (drug-induced granulocytopenia), the metabolic and nutritional codes E87.204 (lactic acidosis), as well as the endocrine system code E16.000 (drug-induced hypoglycaemia without coma) had been reported frequently in the scientific literature. In addition, there were 14 ADR terms related to linezolid under 13 ICD-10 codes not recorded in the drug instructions.Conclusions:It is feasible to use ICD-10 code to standardize ADR terms related to linezolid and establish a database. Common ADRs of linezolid include thrombocytopenia, lactic acidosis, neutropenia, black hairy tongue, gastroenteritis/colitis, hypoglycemia, rash, serotonin syndrome, peripheral neuropathy and headache, which should be paid attention to and researched furtherly.

Objective:To establish a standardized code database of adverse drug reactions (ADRs) terms related to linezolid and analyze the common ADRs of linezolid.Methods:Linezolid drug labels, websites (including Side Effect Resource, and the official websites of US Food and Drug Administration, European Medicines Agency and National Medical Products Administration) and scientific literature database (including CNKI, Wanfang, VIP, PubMed, Embase and Web of Science databases) were systematically searched, and ADR terms about linezolid were collected. ADR terms were mapped to the international classification of diseases-10 (ICD-10) code to establish a linezolid adverse reaction database.Results:A total of 117 ADR terms about linezolid were collected and 91 ICD-10 codes were obtained after being mapped to ICD-10. A standardized database was constructed and successfully embedded into the ADR spontaneous reporting system as a specific drug submodule. The gastrointestinal system, skin and subcutaneous tissue system, various nervous systems, blood and lymphatic systems were the most common system organs involved in linezolid-related ADRs under the 91 ICD-10 codes. Among them, ADRs under the gastrointestinal system codes K14.302 (black hairy tongue) and K52.104 (drug-induced gastroenteritis and colitis), the skin and subcutaneous tissue system code L27.005 (drug-induced dermatitis), various nervous system codes G90.800 (other disorders of autonomic nervous system), G62.001 (drug-induced polyneuropathy) and G44.400 (drug-induced headache, not elsewhere classified), the blood and lymphatic system codes D69.502 (drug- induced thrombocytopenia) and D70.x02 (drug-induced granulocytopenia), the metabolic and nutritional codes E87.204 (lactic acidosis), as well as the endocrine system code E16.000 (drug-induced hypoglycaemia without coma) had been reported frequently in the scientific literature. In addition, there were 14 ADR terms related to linezolid under 13 ICD-10 codes not recorded in the drug instructions.Conclusions:It is feasible to use ICD-10 code to standardize ADR terms related to linezolid and establish a database. Common ADRs of linezolid include thrombocytopenia, lactic acidosis, neutropenia, black hairy tongue, gastroenteritis/colitis, hypoglycemia, rash, serotonin syndrome, peripheral neuropathy and headache, which should be paid attention to and researched furtherly.

Objective:To evaluate the safety, efficacy, advantages and disadvantages of the modified double-orifice valve plasty via total thoracoscopy for partial atrioventricular septal defect(PAVSD) through a retrospective analysis of early postoperative results.Methods:Patients diagnosed with PAVSD who underwent the standardized modified double-orifice valve plasty via total thoracoscopy between September 2023 and August 2024 were retrospectively enrolled. Baseline characteristics, surgical parameters, and follow-up outcomes were systematically analyzed.Results:A total of 14 patients(6 males, 8 females) were included, with a mean age of(32.9±15.5) years old and body weight of(55.1±11.6) kg. All procedures were successfully completed. The mean operative time, cardiopulmonary bypass time, and aortic cross-clamp time were(266.6±67.2) min, (160.7±34.2) min, and(97.0±31.1) min, respectively. Postoperative ICU stay, hospital stay, and total hospitalization duration were(1.7±1.1) days, (6.4±4.2) days, and(12.6±4.5) days, respectively. The mean follow-up duration was(7.9±3.6) months. Preoperatively, left atrioventricular valve regurgitation(LAVVR) was graded as mild, moderate, or severe in 5, 4, and 5 patients. Postoperatively, 13 patients exhibited mild or less LAVVR, with 1 case of moderate regurgitation. By 3 months, all patients demonstrated LAVVR of mild or lower severity, which remained stable through follow-up. Peak LAVV gradients were(4.6±2.7) mmHg(1 mmHg=0.133 kPa)(range: 1.8-10.2 mmHg) postoperatively, improving to(3.6±0.6) mmHg(3.2-4.0) mmHg at 1 year. Right atrioventricular valve regurgitation improved from preoperative moderate-severe(50.0%) to LAVVR of mild or lower severity in all patients by 3 months. No mortality, residual shunts, or high-grade atrioventricular block occurred through follow-up. By 1 month, NYHA functional class improved to Ⅰ in all patients, which remained stable through follow-up.Conclusion:Standardized modified double-orifice valve plasty via total thoracoscopy for PAVSD demonstrates safety, minimal invasiveness, and rapid recovery, with favorable early outcomes.

Objective To analyze risk factors for pulmonary vein obstruction (PVO) after intracardiac total anomalous pulmonary venous connection (TAPVC) repair. Methods A retrospective analysis of clinical data of the patients with intracardiac TAPVC who underwent surgery at our center from April 2009 to April 2019 was conducted. Kaplan-Meier curves were used to assess the risk of postoperative PVO. Logistic regression analysis was used to identify relevant risk factor for postoperative PVO. Results We finally included 169 patients. The median age at surgery was 89.0 (41.5, 195.0) days, and the median weight at surgery was 4.8 (3.8, 6.0) kg. The preoperative PVO rate was 18.3% (31/169). Post-repair PVO occurred in 8.9% (15/169) of the patients. The atresia of common pulmonary and subtype of coronary sinus/right atrium did not significantly affect the risk of PVO (P=0.053, P=0.330). Relevant risk factors included preoperative PVO (P<0.001) and the ratio of left ventricular end-systolic diameter to right ventricular diameter (P=0.025). Conclusion Surgical repair of intracardiac TAPVC has achieved satisfactory results in our center, but the long-term risk of obstruction should not be underestimated. An increased ratio of left ventricular end-systolic diameter to right ventricular diameter and preoperative PVO are associated with post-repair PVO.

Objective To compare the efficacy of additional tricuspid valve annuloplasty (TVP) and isolated closure for atrial septal defect (ASD) with moderate to severe tricuspid regurgitation (TR). Methods Clinical data of the patients diagnosed with ASD combined with secondary moderate to severe TR and treated in our hospital from January 2009 to June 2020 were retrospectively analyzed. Patients were divided into a TVP group and a non-TVP group based on whether TVP was performed simultaneously. The baseline data of two groups were matched with a ratio of 1∶1 propensity score. Results A total of 32 pairs from 257 patients were successfully matched. In the TVP group, there were 24 females and 8 males with an average age of 44.0±13.1 years. In the non-TVP group, there were 28 females and 4 males with an average age of 44.5±11.6 years. The TR area and estimated pulmonary artery pressure in the two groups were significantly decreased compared with preoperation (all P<0.001). The TR area (P=0.001) and the estimated pulmonary artery pressure (P=0.002) were decreased more significantly in the TVP group than those in the non-TVP group. Linear regression analysis showed that age and preoperative TR area had a positive correlation with TR area at follow-up (β=0.045 and 0.259, respectively, both P<0.05), while additional TVP had a negative correlation (β=–1.542, P=0.001). Conclusion Additional TVP can significantly reduce the TR area and pulmonary artery pressure, and elderly patients with severe TR before surgery should actively receive TVP.

Objective To evaluate the role of preoperative serological indexes in predicting long-term survival and tumor recurrence of hepatocellular carcinoma (HCC) patients after liver transplantation, aiming to explore its significance in expanding the Milan criteria. Methods Clinical data of 669 recipients undergoing liver transplantation for HCC were retrospectively analyzed. The optimal cut-off value was calculated by the receiver operating characteristic (ROC) curve. The risk factors affecting the overall survival and recurrence-free survival rates of HCC patients after liver transplantation were identified by univariate and multivariate regression analyses. The correlation between preoperative serum liver enzymes and pathological characteristics in HCC patients was analyzed. The predictive values of alpha-fetoprotein (AFP) combined with γ -glutamyl transferase (GGT) and different liver transplant criteria for the survival and recurrence of HCC patients after liver transplantation were compared. Results Exceeded Milan criteria, total tumor diameter (TTD) > 8 cm, AFP > 200 ng/mL and GGT > 84 U/L were the independent risk factors for the overall survival and recurrence-free survival rates of HCC patients after liver transplantation (all P < 0.05). Correlation analysis showed that preoperative serum GGT level was correlated with TTD, number of tumor, venous invasion, microsatellite lesions, capsular invasion, tumor, node, metastasis (TNM) stage, Child-Pugh score and exceeded Milan criteria (all P < 0.05). Milan-AFP-GGT-TTD (M-AGT) criteria were proposed by combining Milan criteria, TTD with serum liver enzyme indexes (AFP and GGT). The 5-year overall survival and recurrence-free survival rates of HCC recipients who met the M-AGT criteria (111 cases of exceeded Milan criteria) were significantly higher than those who met Hangzhou criteria (both P < 0.05), whereas had no significant difference from their counterparts who met the University of California at San Francisco (UCSF) criteria (both P > 0.05). Conclusions Preoperative serological indexes of AFP and GGT could effectively predict the long-term survival and tumor recurrence of HCC patients after liver transplantation. Establishing the M-AGT criteria based on serological indexes contributes to expanding the Milan criteria, which is convenient and feasible.