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 investigate the safety and feasibility of the CHESS endoscpic ruler (CHESS ruler), and the consistency between the measured values and the interpretation values by endoscopic physician experience.Methods:From January 2021 to January 2022, a total of 105 liver cirrhosis patients with portal hypertension were prospectively enrolled from General Hospital, Xixia Branch Hospital, Ningnan Hospital of People′s Hospital of Ningxia Hui Autonomous Region (29 cases), and the First People′s Hospital of Yinchuan (25 cases), General Hospital of Ningxia Medical University (18 cases), Wuzhong People′s Hospital (10 cases), the Fifth People′s Hospital of Ningxia Hui Autonomous Region (10 cases), Shizuishan Second People′s Hospital (6 cases), Yinchuan Second People′s Hospital (5 cases), and Zhongwei People′s Hospital (2 cases) 8 hospitals. The clinical characteristics of all the patients, including gender, age, nationality, etiolog of liver cirrhosis, and Child-Pugh classification of liver function were recorded. A big gastroesophageal varices was defined as diameter of varices ≥5 mm. Endoscopist (associated chief physician) performed gastroscopy according to the routine gastroscopy procedures, and the diameter of the biggest esophageal varices was measured by experience and images were collected, and then objective measurement was with the CHESS ruler and images were collected. The diameter of esophageal varices of 10 randomly selected patients (random number table method) was determined by 6 endoscopists (attending physician or associated chief physician) with experience or measured by CHESS ruler. Kappa test was used to test the consistency in the diameter of esophageal varices between measured values by CHESS ruler and the interpretation values by endoscopic physician experience.Results:Among 105 liver cirrhosis patients with portal hypertension, male 65 cases and female 40 cases, aged (54.8±12.2) years old, Han nationality 82 cases, Hui nationality 21 cases and Mongolian nationality 2 cases. The etiology of liver cirrhosis included chronic hepatitis B (79 cases), alcoholic liver disease (7 cases), autoimmune hepatitis (7 cases), chronic hepatitis C (2 cases), and other etiology (10 cases). Liver function of 32 cases was Child-Pugh A, Child-Pugh B 57 cases, and Child-Pugh C 16 cases. All 105 liver cirrhosis patients with cirrhotic portal hypertension were successfully measured the diameter of gastroesophageal varices by CHESS ruler, and the success rate of application of CHESS ruler was 100.0% (105/105). The procedure time from the CHESS ruler into the body to the exit of the body after measurement was (3.50±2.55) min. No complications happened in all the patients during measurement. Among 105 liver cirrhosis patients with cirrhotic portal hypertension, 96 cases (91.4%) were recognized as big gastroesophageal varices by the endoscopists. Totally 93 cases (88.6%) were considered as big gastroesophageal varices by CHESS ruler. Eight cases were recognized as big gastroesophageal varices by the endoscopist, however not by the CHESS ruler; 5 cases were recognized as big gastroesophageal varices by the CHESS ruler, but not by the endoscopists; 4 cases were not recognized as big gastroesophageal varices both by the endoscopists and CHESS ruler; 88 cases were recognized as big gastroesophageal varices both by the endoscopists and CHESS ruler. The missed diagnostic rate of big gastroesophageal varices by the endoscopists experience was 5.4% (5/93), and the Kappa value of consistency coefficient between the measurement by the CHESS ruler and the interpretation by endoscopists experience was 0.31 (95% confidence interval 0.03 to 0.60). The overall Kappa value of consistency coefficient by 6 endoscopists measured by CHESS ruler in big gastroesophageal varices diagnosis was 0.77 (95% confidence interval 0.61 to 0.93).Conclusion:As an objective measurement tool, CHESS ruler can make up for the deficiency of subjective judgment by endoscopists, accurately measure the diameter of gastroesophageal varices, and is highly feasible and safe.

Objective    To investigate the predictive value of right atrial myocardial fibrosis in the prognosis of isolated tricuspid regurgitation surgery after left heart valve surgery. Methods    The patients who underwent tricuspid valvuloplasty by the same operator in Guangdong Provincial People's Hospital from April 2016 to August 2021 due to long-term isolated severe tricuspid regurgitation after left heart valve surgery were included in the study. According to the degree of right atrial myocardial fibrosis, the patients were divided into three groups: a mild group, a moderate group, and a severe group. The clinical data of these patients were compared and analyzed. Results    A total of 75 patients were enrolled, including 16 males and 59 females with an average age of 57.0±8.4 years. There were 30 patients in the mild group, 29 patients in the moderate group and 16 patients in the severe group. In terms of the preoperative data, there were statistical differences in cardiac function grade, right atrial diameter, tricuspid incompetence area among the three groups (P<0.05). In terms of the postoperative data, there were statistical differences among the three groups in the cardiopulmonary bypass time, mechanical ventilation time, ICU monitoring time, complication rate and mortality (P<0.05). Further pairwise comparison showed that, compared with the mild group, the severe group had longer mechanical ventilation time (P=0.024), longer ICU monitoring time (P=0.003) and higher incidence of postoperative complications (P=0.024), while the moderate group had no statistical difference in all aspects (P>0.05); compared with the moderate group, the severe group had longer ICU monitoring time (P=0.021) and higher incidence of complications (P=0.006). Conclusion    The early outcome of tricuspid valvuloplasty in patients with isolated tricuspid regurgitation after left heart valve surgery with severe right atrial myocardial fibrosis is worse than that in the patients with mild and moderate fibrosis, suggesting that the degree of myocardial fibrosis in the right atrium can be a predictor of the effect of tricuspid regurgitation surgery and a judgement indicator of the surgery timing.

Objective     To evaluate the early clinical outcomes of the Renatus® balloon-expandable valve in the treatment of severe aortic stenosis. Methods    From November 2021 to April 2022, a total of 38 patients who received Renatus® balloon-expandable valve for severe aortic stenosis in Guangdong Provincial People's Hospital were included. There were 22 males and 16 females, with an average age of 73.7±5.3 years. Mean aortic gradient and peak aortic jet velocity at baseline, post-procedure, and follow-up were compared. Clinical outcomes including all-cause mortality, perivalvular leakage, serious adverse cardiovascular events and the occurrence of permanent pacemaker implantation were assessed. Results    All patients completed the procedure successfully without conversion to thoracotomy or perioperative death. The post-implant mean aortic pressure gradient was decreased from 41.5 (27.8, 58.8) mm Hg to 6.0 (3.0, 8.0) mm Hg, and the peak aortic jet velocity was also decreased from 4.1±0.9 m/s to 1.7±0.4 m/s (P<0.001). Pacemakers were required in 2 (5.3%) patients. The median follow-up time was 27.5 (23.0, 87.5) d, with a follow-up rate of 100.0%. The mean aortic gradient was 8.0 (7.0, 10.8) mm Hg and peak aortic jet velocity was 2.0±0.3 m/s, showing significant improvement compared with those in the preoperative period (P<0.001). No severe aortic regurgitation or paravalvular leak was observed. There was no serious cardiovascular adverse event or reoperative event during the study period. Conclusion    Transcatheter aortic valve replacement with the domestic Renatus® balloon-expandable valve system is a safe and effective procedure for selected patients with severe aortic stenosis who are at high risk or not candidates for surgical aortic valve replacement.

Objective     To summarize the early results and clinical experience of using the J-Valve for transcatheter valve-in-valve implantation in patients with degenerated bioprosthesis at different anatomic positions. Methods     A retrospective analysis was conducted to evaluate the short-term outcomes of 39 consecutive patients who underwent transcatheter valve-in-valve implantation using the J-Valve System in the Department of Cardiac Surgery of Guangdong Provincial People’s Hospital from April 2020 to August 2021 due to bioprosthetic degeneration at different  anatomic positions. Among them, 35 patients underwent transcatheter mitral valve-in-valve (TMViV) implantation, 1 transcatheter aortic valve-in-valve (TAViV) implantation, 1 transcatheter tricuspid valve-in-valve (TTViV) implantation, 1 TMViV implantation with simultaneous TAViV implantation, and another one TMViV implantation with simultaneous transcatheter aortic valve replacement (TAVR) and perivalvular leakage (PVL) closure. Results     Among the 35 patients who underwent isolated TMViV implantation, 17 were male and 18 were female with a mean age of 72.6±10.8 years. Mean duration between two operations was 10.5±2.7 years. The mean Society of Thoracic Surgeons and EuroSCORE Ⅱ scores were 12.95%±9.61% and 13.91%±8.94%, respectively. The device success rate was 97.1% and no death occured during the operation. One patient was transferred to thoracotomy due to device displacement, 1 was re-opened for uncontrolled bleeding, and 1 presented left ventricular outflow tract obstruction. One patient underwent craniotomy due to intracranial hemorrhage within 30 days after surgery, and no other complications occurred including death, stroke, permanent pacemaker implantation, cardiac tamponade, or re-hospitalization. The mean follow-up time was 6.0±4.4 months, the mean mitral valve gradient was significantly improved (10.4±2.0 mm Hg vs. 5.5±1.2 mm Hg, P<0.05), and the New York Heart Association class≤Ⅱ in all the patients at the last follow-up. Among the other 4 patients who did not undergo isolated TMViV implantation, the transapical TAViV implantation and the trans-right atrium TTViV implantation were successful without intra- or post-operative complications. The patient who underwent TMViV and TAViV implantation simultaneously via transapical approach died of severe pulmonary hemorrhage and multiple organ failure 16 days after surgery. The other patient who underwent transapical TMViV combined with TAVR and PVL closure died of septic shock 10 days after the surgery. Conclusion     Transcatheter valve-in-valve implantation using the J-Valve system is shown to be a safe and effective procedure to treat mitral, aortic and tricuspid bioprosthetic valve dysfunction in high-risk patients, providing a new alternative to surgical surgery for degenerated bioprosthesis at different anatomic positions. However, simultaneous different valves intervention should be very cautious.

Objective    To evaluate whether long frozen elephant trunk (FET) increases the risk of spinal cord injury in patients with acute type A aortic dissection. Methods    From 2018 to 2019, 172 patients with acute type A aortic dissection were treated in Guangdong Provincial People’s Hospital. They were divided into two groups according to the length of FET: patients treated with stents of 100 mm in length were enrolled into a short FET group, and those with stents of 150 mm in length into a long FET group. There were 124 patients in the short FET group, including 108 (87.1%) males and 16 (12.9%) females with a mean age of 51.8±7.9 years. There were 48 patients in the long FET group, including 44 (91.7%) males and 4 (8.3%) females with a mean age of 50.6±9.7 years. The clinical data and prognosis of the patients were analyzed. Results    The mean distal stent graft was at the level of T 8.5±0.7 in the long FET group, and at the level of T 6.8±0.6 in the short FET group (P=0.001). Sixteen patients died after operation in the two groups, including 13 (10.5%) in the short FET group and 3 (6.2%) in the long FET group (P=0.561). There were 7 patients of spinal cord injury in the two groups, including 6 (4.8%) in the short FET group and 1 (2.2%) in the long FET group (P=0.675). There was no statistical difference in other complications between the two groups. The follow-up time was 16.7 (1-30) months. During the follow-up, 2 patients died in the long FET group and 5 died in the short FET group. No new spinal cord injury or distal reintervention occurred during the follow-up. Conclusion    Long FET does not increase the incidence of spinal cord injury in patients with acute type A aortic dissection.

Objective To compare the surgical effects between minimally invasive anterior ondontoid screw fixation assisted by our self-designed odontoid guider and open anterior ondontoid screw fixation in the treatment of odontoid fractures of Anderson-D'Alonzo type Ⅱ.Methods From July 2011 to July 2016,28 adults with odontoid fracture of Anderson-D'Alonzo type Ⅱ were treated at Department Ⅱ of Spinal Surgery,Hospital of 89 Army Group of Chinese PLA.Of them,15 were treated by minimally invasive anterior ondontoid screw fixation assisted by our self-designed odontoid guider (guider group) while the other 13 by open anterior ondontoid screw fixation (open group).All the patients were male,aged from 31 to 59 years (average,42.7 years).The 2 groups were compared in terms of incision length,operation time,intraoperative bleeding,intraoperative fluoroscopic frequency and hospital stay.Results There were no significant differences between the 2 groups of patients in their preoperative general data,indicating they were compatible (P ＞ 0.05).All the patients were followed up for 12 to 45 months (average,22.1 months).The internal fixation was in good place and clinical union achieved in all the 28 patients.The incision length (2.2 ± 0.1 cm),operation time (45.0 ± 3.1 min),intraoperative bleeding (29.0 ± 2.3 mL) and intraoperative fluoroscopic frequency (15.5 ± 1.9 times) for the guider group were all significantly less than those (2.9 ±0.7 cm,61.6±3.8 min,51.6±3.9 mL and 21.7±3.2 times,respectively) for the open group (P ＜0.05),but there was no significant difference between the 2 groups in hospital stay (6.5 ± 0.5 d versus 6.5 ± 0.6 d) (P ＞ 0.05).Conclusion In the treatment of odontoid fractures of Anderson-D'Alonzo type Ⅱ,compared with open anterior ondontoid screw fixation,the minimally invasive anterior ondontoid screw fixation assisted by our self-designed odontoid guider may lead to a smaller incision,shorter operation time,less blood loss and a lower fluoroscopic frequency.

Objective    To analyze the clinical efficacy and mid-term outcomes of reimplantation of anomalous origin of left coronary artery from the pulmonary artery (ALCAPA), and to evaluate whether concomitant management of mitral regurgitation (MR) during ALCAPA repair is needed. Methods    Between March 2005 and March 2015, 52 consecutive patients (20 males and 32 females with a median age of 10 months ranging 2-193 months) underwent reimplantation of ALCAPA at Department of Cardiac Surgery, Guangdong Cardiovascular Institute. There were 14 males and 21 females with a mean age of 35.4±42.8 months not receiving mitral valvuloplasty (a Non-MVP group), and 6 males and 11 females with a mean age of 13.5±11.0 months receiving mitral valvuloplasty (a MVP group). In order to facilitate the analysis, degree of MR was graded by number: 0.0=none, 1.0=trivial, 2.0=mild, 2.5=mild-moderate, 3.0=moderate, 3.5=moderate-severe and 4.0=severe. Results    The left ventricular fractional shortening (LVFS) and left ventricular end diastolic diameter (LVEDD) demonstrated significant improvement between preoperation and discharge (28.6%±9.6% vs.   32.1%±10.1%, P=0.023; 38.4±5.6 mm vs. 30.5±5.7 mm, P<0.001), and there was also significant improvement in the mean MR grade between preoperation and discharge (2.9±1.2, vs. 2.4±1.2, P=0.001). There were 4 in-hospital deaths (7.7%). The median follow-up was 21.0 months (ranging 1.5-111.0 months). Three patients (5.8%) were lost to follow-up, 1 patient required reoperation for mitral valve replacement and there was no death during follow-up. Significant improvement was seen in LVFS between discharge and final follow-up (32.1%±10.1% vs. 38.0%±6.0%, P=0.001); however, there was no significant difference in the degree of MR between discharge and final follow-up (2.4±1.2 vs. 2.3±1.2, P=0.541). There was no significant difference in cardiopulmonary bypass time, aortic cross-clamping time, mechanical ventilation time or hospital stay between the two groups. Conclusion    Creation of a dual coronary system with reimplantation of the left coronary artery results in complete recovery of left ventricular function. However, concomitant management of MR during ALCAPA repair remains controversial. Concomitant mitral valve repair for ALCAPA patients with moderate-severe and severe MR is helpful to early function recovery of mitral valve.

Objective To evaluate the effects of early tracheostomy and late tracheostomy on the prognosis of patients with cervical spinal cord injury,so as to provide evidence based guidance for the timing of tracheostomy.Methods Relevant literatures studying the timing of tracheostomy in patients with cervical spinal cord injury were searched in PubMed,Embase,Medline,Cochrane Library,Chinese Biological Medical Literature database (CBM),China National Knowledge Infrastructure database (CNKI),and VIP journal database with time range from journal establishment to March 2018.The retrieved articles were screened according to the inclusion and exclusion criteria.The article quality was rigorously evaluated according to the Newcastle-Ottawa scale (NOS).Meta analysis was conducted using Review Manager 5.3 software to compare the mechanical ventilation time,ICU stay,incidence of pneumonia,incidence of complications,and mortality between early and late tracheostomy in patients with cervical spinal cord injury.Results A total of eight articles of cohort study including 466 patients were included,with 241 patients in the early tracheostomy group and 225 patients in the late tracheostomy group.The eight articles were all determined as high quality studies according NOS.The results of Meta analysis showed that there were significant differences between the two groups in terms of the total mechanical ventilation time (MD =-12.28,95％ CI-20.09--4.47,P ＜ 0.01),post tracheostomy mechanical ventilation time (MD =-9.92,95％ CI-14.27--5.57,P ＜ 0.01),total ICU stay (MD =-10.30,95％ CI-17.12--3.47,P ＜ 0.01),post tracheostomy ICU stay (MD =-5.79,95％ CI -6.53--5.05,P ＜ 0.01),incidence of complications (RR =0.56,95％ CI 0.38-0.83,P ＜ 0.01),and mortality (RR =0.34,95％ CI 0.15-0.78,P ＜ 0.05).However,no significant differences were detected between the two groups in the incidence of total pneumonia (RR =0.77,95％ CI 0.57-1.05,P ＞0.05) and the incidence of post tracheostomy pneumonia (RR =0.80,95％ CI 0.51-1.26,P ＞0.05).Conclusion Early tracheostomy can shorten the mechanical ventilation time,ICU stay,incidence of complications,and mortality,but it cannot reduce the incidence of pneumonia.

BACKGROUND:At present, the common filing materials used to correct secondary unilateral cleft lip nasal deformity include conchae cartilage, costal cartilage, Medpor implants, expanded polytetrafluoroethylene (ePTFE), alogenic acelular dermal matrix. OBJECTIVE:To analyze the therapeutic effects of comprehensive procedures with alogenic acelular dermal matrix or ePTFE for secondary unilateral cleft lip nasal deformity. METHODS: Thirty-six patients with secondary unilateral cleft lip nasal deformity were enroled, including 19 males and 17 females, aged 15-32 years. Alogenic acelular dermal matrix (n=22) or ePTFE (n=14) was used to correct nasal base colapse deformities. Anthropometry method was employed to make measurements. Fixed-point measurement was performed based on patient's pictures before and after correction. Long-term effects of these two kinds of filing materials were analyzed and assessed objectively and quantitatively. RESULTS AND CONCLUSION: After the folow-up of 6 months, al the patients were satisfied with their results, and no infection and no exposure occurred. The treatment effect of the alogenic acelular dermal matrix group was excelent in 16 cases and good in 6 cases; there were 10 cases of excelent and 4 cases of good in the ePTFE group. The objective indicators in the two groups were al improved at 6 months after correction (P < 0.05), but there was no difference between the two groups (P > 0.05). These findings indicate that alogenic acelular dermal matrix or ePTFE is useful to correct secondary unilateral cleft lip nasal deformity.