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 analyze the efficacy of delineating the clinical target volume (CTV) following the trajectory of trigeminal nerve branches and elective neck irradiation (ENI) in postoperative intensity-modulated radiotherapy (IMRT) for adenoid cystic carcinoma of head and neck (ACCHN).Methods:In this study, the data of ACCHN patients without distal metastasis who received postoperative radiotherapy after radical surgery at the Ninth People's Hospital of Shanghai Jiaotong University School of Medicine from January 2016 to December 2022 were retrospectively analyzed. Postoperative radiotherapy target zone and intensity-modulated radiotherapy plan for ACCHN were formulated according to the site of primary focus, whether nerve invasion and pathological staging. Kaplan-Meier method was applied to perform survival analysis, while assessing the tumor local control rate and locoregional recurrence pattern under this target zone outlining principle.Results:A total of 309 ACCHN patients were included. With a median follow-up of 49 months, the 5-year local control rate was 93.2%, the 5-year overall survival rate, locoregional recurrence-free survival rate, and distant metastasis-free survival rate were 90.8%, 90.6%, 66.3%, respectively. Twenty-three patients developed locoregional recurrence, including 14 with primary tumor recurrence alone, 5 with regional lymph node recurrence alone, and 4 with both primary and regional lymph node recurrence. Among the patients with primary tumor recurrence, 11 had recurrence related to the trigeminal nerve branches,and 7 had recurrence in the tumor bed or surgical bed region, with no out-of-field recurrence. Among the 9 patients with lymph node recurrence, none had undergone neck dissection.Conclusions:Delineating the CTV following the trigeminal nerve branches in postoperative radiotherapy for ACCHN achieves excellent local control. Elective neck irradiation avoids irradiation of the entire neck lymphatic drainage area with a low regional recurrence rate.

Objective:To evaluate the impact of surgical margin status and pathological subtypes on the prognosis of patients with adenoid cystic carcinoma of the head and neck (ACCHN) who underwent postoperative radiotherapy.Methods:A retrospective analysis was conducted on 309 patients with initially treated, non-metastatic ACCHN who completed postoperative radiotherapy at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine from January 2016 to December 2022. All patients underwent curative (non-palliative) surgery followed by postoperative radiotherapy, with a median dose of 66 Gy (range: 54-70 Gy). The Kaplan-Meier method was used to compare 5-year local recurrence-free survival (LRFS) between R0 (negative margin) and non-R0 resections in patients with initially resectable (T 1-T 4a stage) and initially unresectable (T 4b stage) disease. Univariate and multivariate Cox proportional hazards models were employed to analyze risk factors for local recurrence, with a focus on surgical margin status and pathological subtypes. Results:The median follow-up was 48 months. Of the 309 patients included in the study, 133 were males and 176 were females, with a median age of 51 years (range: 18-77 years). Primary tumors were located in the major salivary glands in 135 cases (including 42 in the parotid gland, 65 in the submandibular gland, and 28 in the sublingual gland) and in the minor salivary glands in 174 cases. The 5-year overall survival, locoregional recurrence-free survival, distant metastasis-free survival, and progression-free survival rates were 91.5%, 90.8%, 66.1%, and 63.9%, respectively. Non-R0 resection was achieved in 177 patients (57.3%). Among initially resectable patients ( n=253), the non-R0 resection rate was 49.0% ( n=124), with only 6 cases (2.4%) experiencing local recurrence (all non-R0 resections). In initially unresectable patients ( n=56), the non-R0 resection rate was as high as 95% ( n=53), with 13 cases (23%) experiencing local recurrence (2 cases in non-R0 resection and 1 case in R0 resection). For initially resectable patients, non-R0 resection significantly reduced the 5-year LRFS rate to 95.2%, compared to 100% in R0 resection patients ( P=0.014). However, multivariate analysis revealed that the solid pathological subtype was an independent risk factor for 5-year LRFS ( HR=7.40, 95% CI: 2.81-19.52, P<0.001), while the surgical margin status was not an independent factor. Conclusions:The combined strategy of surgery and postoperative radiotherapy provides high local control rates for ACCHN patients. Achieving R0 resection is crucial for initially resectable patients, while a comprehensive treatment strategy involving surgery and postoperative radiotherapy remains essential for initially unresectable patients. The solid pathological subtype is the most significant risk factor for local recurrence.

Objective:To analyze the efficacy of delineating the clinical target volume (CTV) following the trajectory of trigeminal nerve branches and elective neck irradiation (ENI) in postoperative intensity-modulated radiotherapy (IMRT) for adenoid cystic carcinoma of head and neck (ACCHN).Methods:In this study, the data of ACCHN patients without distal metastasis who received postoperative radiotherapy after radical surgery at the Ninth People's Hospital of Shanghai Jiaotong University School of Medicine from January 2016 to December 2022 were retrospectively analyzed. Postoperative radiotherapy target zone and intensity-modulated radiotherapy plan for ACCHN were formulated according to the site of primary focus, whether nerve invasion and pathological staging. Kaplan-Meier method was applied to perform survival analysis, while assessing the tumor local control rate and locoregional recurrence pattern under this target zone outlining principle.Results:A total of 309 ACCHN patients were included. With a median follow-up of 49 months, the 5-year local control rate was 93.2%, the 5-year overall survival rate, locoregional recurrence-free survival rate, and distant metastasis-free survival rate were 90.8%, 90.6%, 66.3%, respectively. Twenty-three patients developed locoregional recurrence, including 14 with primary tumor recurrence alone, 5 with regional lymph node recurrence alone, and 4 with both primary and regional lymph node recurrence. Among the patients with primary tumor recurrence, 11 had recurrence related to the trigeminal nerve branches,and 7 had recurrence in the tumor bed or surgical bed region, with no out-of-field recurrence. Among the 9 patients with lymph node recurrence, none had undergone neck dissection.Conclusions:Delineating the CTV following the trigeminal nerve branches in postoperative radiotherapy for ACCHN achieves excellent local control. Elective neck irradiation avoids irradiation of the entire neck lymphatic drainage area with a low regional recurrence rate.

Objective:To evaluate the impact of surgical margin status and pathological subtypes on the prognosis of patients with adenoid cystic carcinoma of the head and neck (ACCHN) who underwent postoperative radiotherapy.Methods:A retrospective analysis was conducted on 309 patients with initially treated, non-metastatic ACCHN who completed postoperative radiotherapy at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine from January 2016 to December 2022. All patients underwent curative (non-palliative) surgery followed by postoperative radiotherapy, with a median dose of 66 Gy (range: 54-70 Gy). The Kaplan-Meier method was used to compare 5-year local recurrence-free survival (LRFS) between R0 (negative margin) and non-R0 resections in patients with initially resectable (T 1-T 4a stage) and initially unresectable (T 4b stage) disease. Univariate and multivariate Cox proportional hazards models were employed to analyze risk factors for local recurrence, with a focus on surgical margin status and pathological subtypes. Results:The median follow-up was 48 months. Of the 309 patients included in the study, 133 were males and 176 were females, with a median age of 51 years (range: 18-77 years). Primary tumors were located in the major salivary glands in 135 cases (including 42 in the parotid gland, 65 in the submandibular gland, and 28 in the sublingual gland) and in the minor salivary glands in 174 cases. The 5-year overall survival, locoregional recurrence-free survival, distant metastasis-free survival, and progression-free survival rates were 91.5%, 90.8%, 66.1%, and 63.9%, respectively. Non-R0 resection was achieved in 177 patients (57.3%). Among initially resectable patients ( n=253), the non-R0 resection rate was 49.0% ( n=124), with only 6 cases (2.4%) experiencing local recurrence (all non-R0 resections). In initially unresectable patients ( n=56), the non-R0 resection rate was as high as 95% ( n=53), with 13 cases (23%) experiencing local recurrence (2 cases in non-R0 resection and 1 case in R0 resection). For initially resectable patients, non-R0 resection significantly reduced the 5-year LRFS rate to 95.2%, compared to 100% in R0 resection patients ( P=0.014). However, multivariate analysis revealed that the solid pathological subtype was an independent risk factor for 5-year LRFS ( HR=7.40, 95% CI: 2.81-19.52, P<0.001), while the surgical margin status was not an independent factor. Conclusions:The combined strategy of surgery and postoperative radiotherapy provides high local control rates for ACCHN patients. Achieving R0 resection is crucial for initially resectable patients, while a comprehensive treatment strategy involving surgery and postoperative radiotherapy remains essential for initially unresectable patients. The solid pathological subtype is the most significant risk factor for local recurrence.

Objective To explore the related risk factors of hypokalemia in elderly patients with acute cerebral hemorrhage(ACH),and construct a risk prediction model based on logistic regres-sion.Methods A total of 190 elderly ACH patients treated in Foshan Hospital of Traditional Chi-nese Medicine from June 2022 to May 2024 were enrolled as study objects,and were divided into hypokalemic group(potassium＜3.5 mmol/L,n=51)and normal group(potassium 3.5-5.5 mmol/L,n=139)according to whether hypokalemia occurred.Logistic regression model was used to analyze the risk factors of hypokalemia in the elderly ACH patients.Based on the identified risk factors,a comprehensive index model was constructed.ROC curve was drawn to analyze the diag-nostic value of the index for occurrence of hypokalemia in the patients.Results Larger female ra-tio,higher NIHSS score at admission,elevated urea nitrogen and blood creatinine at admission,and higher glomerular filtration rate(GFR)≤60 ml/min,and ratio of using hydrochlorothiazide＞20 mg/d were observed in the hypokalemic group than the normal group(P＜0.01).Univariate logistic regression analysis showed that female,NIHSS score at admission,urea nitrogen at ad-mission,serum creatinine at admission,GFR ≤60 ml/min,and hydrochlorothiazide dose＞20 mg/d were risk factors for hypokalemia in the ACH patients(P＜0.05,P＜0.01).Multivariate lo-gistic regression analysis indicated that female,NIHSS score at admission,GFR ≤60 ml/min,and hydrochlorothiazide dose＞20 mg/d were independent risk factors for hypokalemia in the elderly ACH patients(OR=6.393,95％CI:2.138-19.112,P=0.001;OR=3.123,95％CI:2.161-4.513,P=0.000;OR=3.327,95％CI:1.137-9.736,P=0.028;OR=3.111,95％CI:1.083-8.933,P=0.035).ROC curve analysis revealed that the AUC values of female,NIHSS score at admission,GFR,hydrochlorothiazide dose and comprehensive index in predicting hypokalemia in elderly ACH patients were 0.621,0.897,0.601,0.613 and 0.857,with a sensitivity of 52.90％,76.50％,49.00％,54.90％and 72.50％,and a specificity of 71.20％,88.50％,71.20％,67.60％and 87.80％,respectively.Conclusion Female,NIHSS score at admission,GFR ≤60 ml/min,and hydrochlorothiazide dose＞20 mg/d may affect the occurrence of hypokalemia in elderly ACH pa-tients,and our comprehensive index model based on these risk factors has high performance in predicting the occurrence of hypokalemia in elderly ACH patients.

Objective To investigate vascular remodeling and low-density lipoprotein(LDL)deposition,the growth and development trends of lateral branch plaques in bifurcated vessels,and the potential locations of subsequent plaque growth due to the presence of plaques.Methods An idealized model of bifurcated vessels was established and the distribution of wall shear stress before and after the growth of edge-branch plaques was obtained using computational fluid dynamics.Seven sections were intercepted in the areas of low shear stress:planes 1-3 were the low shear stress areas on the lateral branch before plaque formation,planes 4-5 were the proximal and distal edges of the plaque,and planes 6-7 were the lower shear stress areas of the plaque.Vascular remodeling and LDL deposition in the cross section were simulated.The growth and development trends of plaques are also discussed.Results Among planes 1-3,plane 2 produced obvious negative remodeling and the highest concentration of LDL deposition(102.266 mmol/L),thereby indicating that this was the initial location of the atherosclerotic plaque.Compared to plane 4,plane 5 produced more pronounced vascular remodeling,lumen narrowing,and the highest deposition concentration(110.17 mmol/L)after plaque formation,which indicated that the patch had a tendency for eccentric growth downstream.Compared to plane 6,plane 7(blood flow separation reattachment site)produced more negative remodeling and the highest deposition concentration(93.851 mmol/L),thereby indicating the possibility of new plaque formation near the reattachment point of blood flow separation.Conclusions Obvious vascular remodeling at low shear stress in the lateral branches leads to lumen stenosis and high LDL deposition,thus,forming atherosclerotic plaques.The lateral wall of the bifurcated blood vessels is the initial location of atherosclerotic plaque growth.After growth,the plaque tends to develop downstream,and subsequent plaques may form at the flow separation and reattachment points.

Objective To summarize and analyze the preliminary clinical outcomes of the KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation (DMR). Methods This study was a single-arm, prospective, single-group target value clinical trial that enrolled patients who underwent the KokaclipTM transcatheter edge-to-edge repair (TEER) system for DMR in the Department of Heart Surgery of Guangdong Provincial People's Hospital, Guangdong Cardiovascular Institute from June 2022 to January 2023. Differences in the grade of mitral regurgitation (MR) during the perioperative and follow-up periods were compared, and the incidences of adverse events such as all-cause death, thoracotomy conversion, reoperation, and severe recurrence of MR during the study period were investigated. Results The enrolled patient population consisted of 14 (50.0%) females with a mean age of 70.9±5.4 years. Twenty-eight (100.0%) patients were preoperatively diagnosed with typeⅡ DMR, with a prolapse width of 12.5 (11.0, 16.1) mm, a degree of regurgitation 4+ leading to pulmonary venous reflux, and a New York Heart Association cardiac function class≥Ⅲ. All patients completed the TEER procedure successfully, with immediate postoperative improvement of MR to 0, 1+, and 2+ grade in 2 (7.1%), 21 (75.0%), and 5 (17.9%) patients, respectively. Mitral valve gradient was 2.5 (2.0, 3.0) mm Hg. Deaths, thoracotomy conversion, or device complications such as unileaflet clamping, clip dislodgement, or leaflet injury were negative. Twenty-eight (100.0%) patients completed at least 3-month postoperative follow-up with a median follow-up time of 5.9 (3.6, 6.8) months, during which patients had a mean MR grade of 1.0+ (1.0+, 2.0+) grade and a significant improvement from preoperative values (P<0.001). There was no recurrence of ≥3+ regurgitation, pulmonary venous reflux, reoperation, new-onset mitral stenosis, or major adverse cardiovascular events. Twenty-two (78.6%) patients’ cardiac function improved to classⅠorⅡ. Conclusion The domestic KokaclipTM TEER system has shown excellent preliminary clinical results in selected DMR patients with a high safety profile and significant improvement in MR. Additional large sample volume, prospective, multicenter studies, and long-term follow-up are expected to validate the effectiveness of this system in the future.

Objective To analyze the long-term outcome of modified Morrow surgery (interventricular septal cardiomyectomy) in the treatment of hypertrophic obstructive cardiomyopathy (HOCM) in children. Methods The clinical data of the children with HOCM (aged≤14 years) who underwent modified Morrow surgery from January 2010 to August 2022 in Guangdong Provincial People's Hospital were retrospectively analyzed, including changes in hospitalization status, perioperative period, and long-term 15-lead electrocardiogram and echocardiography. Results A total of 29 patients were collected, including 22 males and 7 females, aged 10.00 (5.00, 12.00) years. Five (17.9%) patients had New York Heart Association (NYHA) heart function grade Ⅲ or Ⅳ. Ventricular septal cardiomyectomy was performed in all patients. All 29 patients survived and their cardiac function recovered after operation. Before discharge, right bundle branch block was observed in 2 patients and left bundle branch block in 6 patients. After surgery, in the left ventricular septal cardiomyectomy, the left atrial diameter decreased (P＜0.001), left ventricular end-systolic diameter increased (P=0.009), the peak pressure gradient of left ventricular outflow tract decreased (P＜0.001), and the thickness of ventricular septum decreased (P＜0.001). The systolic anterior motion of mitral valve disappeared and mitral regurgitent jet area decreased (P＜0.001). The flow velocity and peak pressure gradient of right ventricular outflow tract also decreased in the patients who underwent right ventricular septal cardiomyectomy. The average follow-up of the patients was 69.03±10.60 months. All the patients survived with their NYHA cardiac function grading Ⅰ or Ⅱ. No new-onset arrythmia event was found. Echocardiography indicated that the peak pressure gradient of the left ventricular outflow tract remained low (P<0.001). Moderate mitral regurgitation occurred in 2 patients, and left ventricular outflow tract obstruction with moderate mitral regurgitation occurred in 1 patient after simple right ventricular septal cardiomyectomy. Conclusion Right ventricular or biventricular obstruction is frequent in the children with HOCM and they usually have more symptoms before surgery. Modified Morrow surgery can effectively relieve outflow tract obstruction and improve their cardiac function. The long-term outcome is satisfactory. However, the posterior wall of the left ventricle remains hypertrophic. Also, there is an increased risk of a conduction block.

Objective:To explore the application of the the anterolateral thigh flap (ALTF) with vascularized fascia lata in repairing large lower lip defects.Methods:From January 2013 to June 2020, the clinical data of the cases with large complex lower lip defect due to extensive resection of lip tumor treated in the Department of Oral and Maxillofacial-Head and Neck Oncology, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine were analyzed retrospectively. The patients were immediately reconstructed using ALTF with vascularized fascia lata. The flap was used for shape reconstruction, and the fascia lata with residual orbicularis muscle was used for functional reconstruction via simulating the "closed-loop structure" of orbicularis. All these patients were followed up by regular visit. The survival of flap, mouth opening and closing were recorded.Results:All the 4 patients were successfully repaired through the above methods. The ALTF area was 18 cm×7 cm-26 cm×8 cm, with (5-8) cm ×1 cm fascia lata at both sides of the flap. The survival rate of ALTF was 100%. After 6-80 months’ follow-up, the ALTF was in good shape, and the mouth opening degree was 2-3 fingers. When the mouth was closed, the upper and lower lip could be sealed completely, and the drinking water is basically watertight.Conclusions:The shape and dynamic reconstruction could be completed in large complex lower lip defects through ALTF with vascularized fascia lata. The clinical effects were satisfying, and it’s an ideal option for repairing large complex lower lip defects.