1.One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
Yuehuan LI ; Jiawei ZHOU ; Lai WEI ; Yingqiang GUO ; Liang MA ; Huiming GUO ; Xiangbin PAN ; Dongjin WANG ; Fanyan LUO ; Jue WANG ; Minxin WEI ; Deguang FENG ; Yingbin XIAO ; Liming LIU ; Jian′an WANG ; Jiangang WANG ; Haibo ZHANG
Chinese Journal of Surgery 2025;63(11):1052-1058
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
2.One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
Yuehuan LI ; Jiawei ZHOU ; Lai WEI ; Yingqiang GUO ; Liang MA ; Huiming GUO ; Xiangbin PAN ; Dongjin WANG ; Fanyan LUO ; Jue WANG ; Minxin WEI ; Deguang FENG ; Yingbin XIAO ; Liming LIU ; Jian′an WANG ; Jiangang WANG ; Haibo ZHANG
Chinese Journal of Surgery 2025;63(11):1052-1058
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
3.Comparison of mid-to-long term outcomes between mitral valve repair and biological valve replacement in patients over 60 with rheumatic mitral valve disease based on a propensity score matching study
Wenbo ZHANG ; Jie HAN ; Tiange LUO ; Baiyu TIAN ; Fei MENG ; Wenjian JIANG ; Yuqing JIAO ; Xiaoming LI ; Jintao FU ; Yichen ZHAO ; Fei LI ; Xu MENG ; Jiangang WANG
Chinese Journal of Surgery 2024;62(11):1016-1023
Objective:To compare and discuss the mid-to-long-term outcomes of mitral valve repair (MVP) versus biological mitral valve replacement (bMVR) in patients aged 60 years and above with rheumatic mitral valve disease.Methods:This is a retrospective cohort study. A total of 765 patients aged 60 years and older, diagnosed with rheumatic mitral valve disease and who underwent MVP or bMVR at Beijing Anzhen Hospital from January 2010 to January 2023, were retrospectively included. Among them, 186 were male and 579 were female, with an age of (66.1±4.5) years (range: 60 to 82 years). Patients were divided into two groups based on the surgical method: the mitral valve repair group (MVP group, n=256) and the bioprosthetic mitral valve replacement group (bMVR group, n=509). A 1∶1 propensity score matching was performed using a caliper value of 0.2 based on preoperative data. Paired sample t-tests, χ2 tests, or Fisher′s exact tests were used for intergroup comparisons. Kaplan-Meier method was employed to plot survival curves and valve-related reoperation rate curves for both groups before and after matching, and Log-rank tests were used to compare the mid-to long-term survival rates and valve-related reoperation rates between the two groups. Results:A total of 765 patients who completed follow-up were ultimately included, with a follow-up period ( M(IQR)) of 5.1(5.0) years (range: 1.0 to 12.9 years). After matching, each group consisted of 256 patients. The incidence of early postoperative atrial fibrillation (39.1% vs. 49.2%, χ2=4.95, P=0.026) and early mortality rates (2.0% vs. 6.2%, χ2=4.97, P=0.026) were lower in the MVP group. Unadjusted Kaplan-Meier analysis showed significantly higher 5-year and 10-year survival rates for the MVP group (92.54% vs. 83.02%, 86.22% vs. 70.19%, Log-rank: P=0.001). After adjustment with propensity scores, the Kaplan-Meier analysis still indicated higher 5-year and 10-year survival rates in the MVP group compared to the bMVR group (92.54% vs. 85.89%, 86.22% vs. 74.83%, Log-rank: P=0.024). There were no significant differences in the rates of valve-related reoperation between the two groups before and after matching (5-year and 10-year reoperation rates pre-matching: 1.75% vs. 0.57%, 5.39% vs. 7.54%, Log-rank: P=0.207; post-matching: 1.75% vs. 0, 5.39% vs. 9.27%, Log-rank: P=0.157). Conclusion:For patients aged 60 years and above with rheumatic mitral valve disease, mitral valve repair offers better mid-to-long-term survival compared to biological valve replacement.
4.Clinical efficacy of ultrasound-guided spinal nerve block and paraverteral nerve block in treating postherpetic neuralgia
Kai ZHANG ; Jiangang LUO ; Xiaoye ZHU ; Mengqi LI ; Zhigang CHENG ; Fei REN ; Nianyue BAI ; Yunjiao WANG ; Qulian GUO
Journal of Chinese Physician 2024;26(9):1308-1312
Objective:To compare the clinical efficacy of ultrasound-guided spinal nerve block (SNB) and paraverteral nerve block (PVB) in treating postherpetic neuralgia.Methods:A total of 52 patients with postherpetic neuralgia who visited the Pain Clinic of the Xiangya Hospital, Central South University from February 2020 to December 2022 were selected and randomly divided into an ultrasound-guided SNB group and a PVB group using a random number table method, with 26 patients in each group. Patients in the SNB group received ultrasound-guided spinal nerve block therapy; The PVB group received ultrasound-guided paraverteral nerve block treatment. Visual Analog Scale (VAS) scores, 36-Item Short Form Survey (SF-36) scores, and total effective rate were observed in two groups of patients before treatment, 2 weeks after treatment, 1 month after treatment, 3 months after treatment, and 6 months after treatment. Complications during treatment were also observed.Results:The total effective rates of SNB group patients at 1, 3, and 6 months after treatment were significantly higher than those of PVB group (all P<0.05). After treatment, the VAS scores of both groups of patients at each time point were significantly reduced compared to before treatment (all P<0.05); The VAS scores of patients in the SNB group were lower than those in the PVB group at 1, 3, and 6 months after treatment, but the difference was not statistically significant (all P>0.05). There was no statistically significant difference in Physical Component Summary (PCS) and Mental Component Summary (MCS) scores between SNB and PVB groups before nerve block treatment (all P>0.05). The MCS and PCS scores of the two groups of patients were significantly higher than before treatment at 2 weeks, 1 month, 3 months, and 6 months after treatment (all P<0.05). The MCS scores of the SNB group were significantly higher than those of the PVB group at 2 weeks, 1 month, 3 months, and 6 months after treatment (all P<0.05), but there was no statistically significant difference in PCS scores between the two groups (all P>0.05). Both groups of patients did not experience any serious complications related to the treatment in this study during the follow-up period. Conclusions:Both ultrasound-guided spinal nerve block and paraverteral nerve block can safely and effectively treat postherpetic neuralgia. The clinical effect of ultrasound-guided spinal nerve block in treating postherpetic neuralgia is better than that of paraverteral nerve block.
5.Comparison of mid-to-long term outcomes between mitral valve repair and biological valve replacement in patients over 60 with rheumatic mitral valve disease based on a propensity score matching study
Wenbo ZHANG ; Jie HAN ; Tiange LUO ; Baiyu TIAN ; Fei MENG ; Wenjian JIANG ; Yuqing JIAO ; Xiaoming LI ; Jintao FU ; Yichen ZHAO ; Fei LI ; Xu MENG ; Jiangang WANG
Chinese Journal of Surgery 2024;62(11):1016-1023
Objective:To compare and discuss the mid-to-long-term outcomes of mitral valve repair (MVP) versus biological mitral valve replacement (bMVR) in patients aged 60 years and above with rheumatic mitral valve disease.Methods:This is a retrospective cohort study. A total of 765 patients aged 60 years and older, diagnosed with rheumatic mitral valve disease and who underwent MVP or bMVR at Beijing Anzhen Hospital from January 2010 to January 2023, were retrospectively included. Among them, 186 were male and 579 were female, with an age of (66.1±4.5) years (range: 60 to 82 years). Patients were divided into two groups based on the surgical method: the mitral valve repair group (MVP group, n=256) and the bioprosthetic mitral valve replacement group (bMVR group, n=509). A 1∶1 propensity score matching was performed using a caliper value of 0.2 based on preoperative data. Paired sample t-tests, χ2 tests, or Fisher′s exact tests were used for intergroup comparisons. Kaplan-Meier method was employed to plot survival curves and valve-related reoperation rate curves for both groups before and after matching, and Log-rank tests were used to compare the mid-to long-term survival rates and valve-related reoperation rates between the two groups. Results:A total of 765 patients who completed follow-up were ultimately included, with a follow-up period ( M(IQR)) of 5.1(5.0) years (range: 1.0 to 12.9 years). After matching, each group consisted of 256 patients. The incidence of early postoperative atrial fibrillation (39.1% vs. 49.2%, χ2=4.95, P=0.026) and early mortality rates (2.0% vs. 6.2%, χ2=4.97, P=0.026) were lower in the MVP group. Unadjusted Kaplan-Meier analysis showed significantly higher 5-year and 10-year survival rates for the MVP group (92.54% vs. 83.02%, 86.22% vs. 70.19%, Log-rank: P=0.001). After adjustment with propensity scores, the Kaplan-Meier analysis still indicated higher 5-year and 10-year survival rates in the MVP group compared to the bMVR group (92.54% vs. 85.89%, 86.22% vs. 74.83%, Log-rank: P=0.024). There were no significant differences in the rates of valve-related reoperation between the two groups before and after matching (5-year and 10-year reoperation rates pre-matching: 1.75% vs. 0.57%, 5.39% vs. 7.54%, Log-rank: P=0.207; post-matching: 1.75% vs. 0, 5.39% vs. 9.27%, Log-rank: P=0.157). Conclusion:For patients aged 60 years and above with rheumatic mitral valve disease, mitral valve repair offers better mid-to-long-term survival compared to biological valve replacement.
6.Value of application of combined ultrasound and spinal CT/MRI-assisted lumbar puncture in spinal muscular atrophy patients with spinal deformities
Jiangang LUO ; Fei REN ; Nianyue BAI ; Shenghui YANG ; E WANG
Chinese Journal of Anesthesiology 2022;42(10):1228-1232
Objective:To investigate the value of application of combined ultrasound and spinal CT/MRI-assisted lumbar puncture in spinal muscular atrophy (SMA) patients with spinal deformities.Methods:Twelve SMA patients with spinal deformities were evaluated for combined ultrasound and spinal CT/MRI imaging-assisted lumbar intrathecal administration of nusinersen between November 2021 and September 2022.The degree of difficulty of lumbar puncture in SMA patients was graded according to the spinal imaging, and then different puncture methods were designed according to different puncture difficulty grades.The success rate, preparation time, operation time, the number of attempts, and complications of lumbar puncture were counted.Results:In this study, 48 lumbar punctures were performed in 12 patients with SMA, with a success rate of 100%.The average preparation time for puncture was 13.60 min, the average puncture time was 4.96 min, and the average number of attempts was 1.33. No complications such as injury to the spinal cord, nerve and viscera were found in all patients.Conclusions:Combined ultrasound and spinal CT/MRI-assisted lumbar puncture has high value when applied for SMA patients with spinal deformities.
7.The correlation between carotid blood flow and the parameters derived by pulse oximetry plethysmographic waveform during cardiopulmonary resuscitation in a porcine model
Lu YIN ; Jiangang WANG ; Wei LUO ; Yangyang FU ; Huadong ZHU ; Jun XU ; Xuezhong YU
Chinese Journal of Emergency Medicine 2022;31(1):24-30
Objective:To explore the correlation between carotid blood flow and the parameters derived by pulse oximetry Plethysmographic waveform in cardiopulmonary resuscitation, so as to provide a new index for carotid blood flow monitoring in cardiopulmonary resuscitation.Methods:Seven male domestic pigs were utilized for cardiac arrest model through ventricular fibrillation induced by electrical stimulation. Eight minutes after cardiac arrest, artificial chest compression was given for 4 min, and epinephrine 20 μg/kg was injected intravenously at 2 min after chest compression. The compression frequency, compression depth, right carotid blood flow, pulse oximetry plethysmographic waveform, aortic pressure, right atrium pressure and end tidal carbon dioxide partial pressure were continuously monitored and recorded. From 30 s to 4 min after chest compression, the values of the mean right carotid blood flow, the area under curve (AUC) of pulse oximetry plethysmographic waveform, the mean perfusion index, the mean coronary perfusion pressure and the average end-tidal carbon dioxide partial pressure during 6 s before time point were calculated every 30 s. The correlations between right carotid blood flow and the AUC of pulse oximetry plethysmographic waveform and perfusion index were analyzed respectively.Results:Ventricular fibrillation was induced successfully in seven animals. There were no significant differences in the mean chest compression frequency and depth per min during 4 min of chest compression. Right carotid blood flow at 30 s after chest compression was (92.7±32.7) mL/min, and decreased to (48.5±23.5) mL/min at 1 min after chest compression ( P<0.05). There was no significant difference in blood flow before and after epinephrine injection ( P>0.05). The AUC of the blood oxygen plethysmographic waveform and perfusion index showed synchronous change trends with right carotid blood flow. Both coronary perfusion pressure and end-tidal carbon dioxide partial pressure showed different change trends with right carotid blood flow. There was a positive correlation between the right carotid blood flow and the AUC of blood oxygen plethysmographic waveform ( r=0.66, P<0.01), and also a positive correlation between right carotid blood flow and perfusion index ( r=0.57, P<0.01). Conclusions:Carotid blood flow is positively correlated with the AUC of blood oxygen plethysmographic waveform and perfusion index in a porcine model of cardiopulmonary resuscitation. Real-time monitoring of the two parameters derived by pulse oximetry plethysmographic waveform can reflect the changes of carotid blood flow to a certain extent.
8.The effect of spinal interleutkin-33 on radicular pain after non-compressive lumbar disc herniation
Jiali ZHU ; Jiangang LUO ; Yao LIU ; Jianqin YAN
Chinese Journal of Physical Medicine and Rehabilitation 2021;43(1):1-6
Objective:To explore the effect of spinal interleutkin-33 (IL-33) on radicular pain in rats modeling non-compressive lumbar disc herniation.Methods:A total of 80 male Sprague-Dawley rats were randomly divided into a sham operation group, a model group, a lentivirus negative control group, a low-dose IL-33 recombinant lentivirus group and a high-dose IL-33 group, each of 16. Non-compressive lumbar disc herniation was successfully induced in all except the rats in the sham operation group. Two days later, the model group was injected intrathecally with 10μl of enhanced infection solution. The lentivirus control group received 10μl of negative lentivirus, the low-dose IL-33 recombinant lentivirus group received 5μl of IL-33 recombinant lentivirus and the high-dose IL-33 recombinant lentivirus group received 10μl of IL-33 recombinant lentivirus. The 50% paw withdrawal threshold (50% PWT) was measured one day before the modeling and on the 1 st, 3 rd, 5 th, 7 th, 9 th, 11 th, 13 th, 15 th, 17 th, 19 th, and 21 st day afterward. On the 12 th day the expressions of IL-33 protein and mRNA were evaluated. Results:The average expression of IL-33 protein and mRNA in the model and the lentivirus negative control group increased significantly after the modelling compared with the sham group, while expression in the low- and high-dose IL-33 recombinant lentivirus groups was significantly lower than in the lentivirus negative control group. Compared with one day before the modelling, average 50% PWTs on the affected side decreased significantly in all of the modelling groups. From the 9 th to the 21 st day significantly increased 50% PWTs were observed on the affected side in the low-dose and high-dose IL-33 recombinant lentivirus groups compared with the other two modelling groups. Immunostaining showed significant increase in the expression of IL-33 in the dorsal horn of the spinal cord in the model group, compared with the sham operation group. Significant decrease in the average expression of IL-33 in the spinal dorsal horns was observed in the low-dose and high-dose IL-33 recombinant lentivirus groups. Conclusions:Intervertebral disk herniation may increase the expression of IL-33 in the spinal cord, and may cause radicular pain.
9.The Clinical characteristics and prognosis of patients with decompensated schistosomiasis cirrhosis or decompensated alcoholic cirrhosis in ICU
Limei YU ; Yuexia WANG ; Kai ZHANG ; Yesong WANG ; Zhao YU ; Jian LUO ; Jiangang LI ; Xiangping LIU ; Wei CUI ; Gensheng ZHANG
Chinese Journal of Emergency Medicine 2020;29(10):1348-1353
Objective:Intensive physicians have relatively insufficient knowledge and experience in treating patients with decompensated schistosomiasis cirrhosis (DSC) admitted in intensive care unit (ICU), but are relatively familiar with patients with decompensated alcoholic cirrhosis (DAC). For this purpose, the clinical characteristics and prognosis of these patients were compared and analyzed.Methods:A retrospective analysis was performed from January 2013 to May 2019 in our hospital and Quzhou People’s hospital. The demographic data, laboratory examination, liver function, Child-Pugh classification, complications of cirrhosis, ultrasonic imaging gastroscopy manifestations were recorded and analyzed. In addition, the treatments and prognosis were also compared.Results:A total of 30 patients (12 males and 18 females) with DSC (aged 57-88) and 31 patients with DAC (aged 41-75) were collected. Compared with patients with DAC, DSC patients were more likely to have coronary heart disease, lower proportion of hyponatremia and lower need of ventilator support. Although the incidences of jaundice and hepatic encephalopathy were significantly reduced ( P<0.05), but parameters of liver function and coagulation were no significant differences in both groups ( P>0.05). B-mode ultrasound of liver in patients with DSC displayed more proportion of patchy and diffuse echo changes and liver volume reduction ( P<0.05), whereas the manifestations of gastroscope in both groups were similar. No significant difference in main treatment measures like uses of somatostatin and three-chamber and two-capsule tube was observed. After treatment, the stop time of gastrointestinal bleeding was similar between groups of DAC and DSC [1.25 (0.5-4.125) days vs. 1.75 (1-2.375) days] ( P>0.05). In addition, the length of ICU stay in DAC group was similar to DSC group [(4.96±3.58) days vs. (3.82±1.99) days], so did the 28-day mortality [14.29% (2/14) vs. 18.18% (2/11)] (both P>0.05). Conclusions:In genenal, patients with decompensated schistosomiasis cirrhosis have the similar clinical characteristics, major biochemical indicators and accessory examination results like ultrasound and gastroscopic examinations to patients with decompensated alcoholic cirrhosis. After timely treatments, both of these patients could achieve a good prognosis.
10.The expressions of IL-33 and ST2 receptor in nervous system and their roles in pain
Bo ZHOU ; Jiangang LUO ; Jianqin YAN
Journal of Chinese Physician 2016;18(4):512-515
Interleukin-33 (IL-33),a novel member of IL-1 family,is a multifunctional cytokine.IL-33 can act as a transcriptional repressor.It can also bind to growth stimulation expressed gene 2 protein (ST2) to induce the activation of some inflammatory cells.IL-33 is extensively expressed in nervous system.Some studies showed that the levels of IL-33 and ST2 were significantly changed in pain.Some reports demonstrated that the IL-33/ST2 signaling pathway played critical roles in them.This present article will review the biological characteristics of IL-33/ST2 and their expressions in nervous system and significance of interventional pain related diseases.

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