Objective To grasp the common problems in the implementation of in vitro diagnostic reagent(IVD)clinical trials,and put forward countermeasures to improve the quality of IVD clinical trials.Methods Quality control reports of all IVD clinical trial projects in Wuxi Children's Hospital medical device clinical trial institutions since 2018 were collected,common problems were summarized,causes were analyzed,and solutions were proposed.Results Clinical trials of IVD have many problems in the following five aspects:ethical review,clinical trial preparation and program implementation,informed consent signing,biological sample and reagents management,and clinical trial records,some of which were related to the particularity of the subjects being children.The relevant regulatory system was not perfect,the sponsor's clinical trial concept was backward,the quality management system was incomplete,and investigators were lack of training and understaffed,the lack of quality control experience in the institutional office and the weak professional review ability of the ethics committee were the root causes of the problems.Conclusion Improve the construction of the regulatory system,strengthen the sponsor's awareness of the main responsibility to carry out clinical trials,improve the management system and standard operating procedures of sponsor and institutions,implement personnel training,improve the practical level of investigators,so as to improve the implementation level of IVD clinical trials,and promote the healthy development of IVD industry.

The incidence of chronic venous disease(CVD)is significantly higher in the elderly population compared to non-elderly individuals,with more severe disease manifestations.Additionally,elderly CVD patients often have comorbid conditions such as cardiovascular diseases,making the evaluation process more complex and increasing treatment difficulty.Currently,there are no established recommendations in China for the diagnosis and treatment of CVD in individuals aged 60 and above.Against this backdrop,the Peripheral Vascular Disease Management Branch of the Chinese Geriatric Society has developed the Chinese Expert Consensus on the Diagnosis and Treatment of Chronic Venous Disease in the Elderly based on domestic and international guidelines,relevant evidence-based medical research,and the physiological and clinical characteristics of the elderly population in China.This consensus aims to provide an important reference for improving the diagnosis and treatment of CVD in elderly patients in China.

The incidence of chronic venous disease(CVD)is significantly higher in the elderly population compared to non-elderly individuals,with more severe disease manifestations.Additionally,elderly CVD patients often have comorbid conditions such as cardiovascular diseases,making the evaluation process more complex and increasing treatment difficulty.Currently,there are no established recommendations in China for the diagnosis and treatment of CVD in individuals aged 60 and above.Against this backdrop,the Peripheral Vascular Disease Management Branch of the Chinese Geriatric Society has developed the Chinese Expert Consensus on the Diagnosis and Treatment of Chronic Venous Disease in the Elderly based on domestic and international guidelines,relevant evidence-based medical research,and the physiological and clinical characteristics of the elderly population in China.This consensus aims to provide an important reference for improving the diagnosis and treatment of CVD in elderly patients in China.

Objective To grasp the common problems in the implementation of in vitro diagnostic reagent(IVD)clinical trials,and put forward countermeasures to improve the quality of IVD clinical trials.Methods Quality control reports of all IVD clinical trial projects in Wuxi Children's Hospital medical device clinical trial institutions since 2018 were collected,common problems were summarized,causes were analyzed,and solutions were proposed.Results Clinical trials of IVD have many problems in the following five aspects:ethical review,clinical trial preparation and program implementation,informed consent signing,biological sample and reagents management,and clinical trial records,some of which were related to the particularity of the subjects being children.The relevant regulatory system was not perfect,the sponsor's clinical trial concept was backward,the quality management system was incomplete,and investigators were lack of training and understaffed,the lack of quality control experience in the institutional office and the weak professional review ability of the ethics committee were the root causes of the problems.Conclusion Improve the construction of the regulatory system,strengthen the sponsor's awareness of the main responsibility to carry out clinical trials,improve the management system and standard operating procedures of sponsor and institutions,implement personnel training,improve the practical level of investigators,so as to improve the implementation level of IVD clinical trials,and promote the healthy development of IVD industry.

Objective To evaluate the short-term results of sleeve wrapping technique using remnant aortic wall in modified Bentall procedure. Methods The patients undergoing modified Bentall procedure with the remnant aortic wall as a sleeve to cover the sewing area of composite valved graft and the aortic annulus for proximal hemostasis between March 2021 and March 2022 in Shenzhen Fuwai Hospital were enrolled. Short-term results were assessed by cardiopulmonary bypass time, aortic clamping time, mechanical ventilation time, ICU stay, postoperative hospital stay, effusion drainage on the first postoperative day, left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), and follow-up results. Results A total of 14 patients were collected, including 12 males and 2 females, with a mean age of 55.33±10.57 years. There was no postoperative or follow-up death. Cardiopulmonary bypass time was 147.90±21.29 min, aortic clamping time was 115.70±15.23 min, mechanical ventilation time was 19.42±8.98 h, ICU stay was 99.08±49.42 h, and postoperative hospital stay was 16.33±2.74 d. Thoracic drainage volume was 333.33±91.98 mL on the first postoperative day. Only 2 patients required blood transfusion (4.5 U and 2 U, respectively). During the follow-up of 6.17±3.69 months, there was no death, no aortic or valve-related complications. There was statistical difference in the LVEDD between preoperation and before discharge after surgery (P＜0.001), and between half a year after surgery and before discharge after surgery (P＜0.001). There was a little decrease of LVEF before discharge after surgery compared with preoperative LVEF, but there was no statistical difference (P=0.219). There was no statistical difference in the LVEF half a year after operation compared with that before operation (P=1.000). Conclusion Sleeve wrapping technique using remnant aortic wall in modified Bentall procedure has good short-term results. This modification may be a simple, effective way in controlling proximal bleeding.

Outpatient humanistic care refered to providing a full process of caring medical services to outpatients. In order to standardize the human caring services for outpatients in medical institutions, promote the comprehensive service level of outpatient services, and improve the patient′s medical experience, Chinese Association for Life Care issued the group standard of Management Norms for Human caring of Outpatients in April 2023. This standard clarified the relevant terms and definitions of human caring for outpatients, specified the basic requirements for human caring, the humanistic quality and care responsibilities of outpatient staff, the outpatient care environment and facilities, the outpatient care process and measures, and quality management. It designed standardized and personalized full process care service norms, providing references for medical institutions at all levels to promote the development of human caring for outpatients.

Currently, cardiovascular disease has become a major threat to the health of Chinese residents, and prevention and control work is urgent. Self-determination theory is a widely applied theory of behavioral change, extensively used in the field of patient' rehabilitation. This article reviews the content, relevant theoretical models, motivation measurement methods, application status and influencing factors of self-determination theory in the rehabilitation of cardiovascular disease patients, so as to provide a basis for promoting the transition of cardiovascular disease patients to healthy lifestyles and maintaining healthy behavior.

Objective:To investigate the safety and early and mid-term efficacy of upper sternal mini-incision with debranching technique in B aortic dissection involving the arch.Methods:18 patients with B aortic dissection involving the arch who were admitted into our center from November 2017 to January 2019 were enrolled, to evaluate the intraoperative and postoperative conditions, including special intraoperative treatment, time of operation、poseoperative drainage、time of use ventilators, time of staying in ICU, complications etc, 12-24 months follow-up were performed after operation.Results:No death occurred, 1 case with acute renal failure, 1 case with type I endoleak, 1 case with paraplegia occurred during hospitalization, 1 patient with sudden vomiting of blood 30 days after discharge from hospital who was found aortoesophageal fistula, underwent emergency surgery to replace thoracic aortic and repair esophageal fistula, all of them were cured and discharged, the rate of complication was 22.2%(4/18). none of the other patients had any phenomena such as agnail、distal rupture、twisted or displaced of the stents、ischemic of coronary artery、cerebrovascular accident, etc.Conclusion:The result of upper sternal mini-incision with debranching technique in B aortic dissection involving the arch is satisfied, the early and mid-term survival rate is significantly improved, the patient's prognosis are improved.

Objective    To reveal the risk factors for delayed recovery and complications in infants with weight≤ 5.0 kg after surgical ventricular septal defect (VSD) closure. Methods    We retrospectively reviewed a consecutive series of 86 patients with weight≤5.0 kg who were admitted to our institution for surgical VSD closure between January 2016 and July 2019, including 31 males and 55 females with an age of 17-266 (80.3±40.4) d and a weight of 2.5-5.0 (4.4±0.6) kg. The VSDs were divided into perimembranous (n=65, 75.6%), subaortic (n=17, 19.8%) and subaortic combined muscular types (n=4, 4.7%). Mechanical ventilation (MV) time≥24 h or ICU stay≥72 h were defined as delayed recovery. Death, sudden circulatory arrest, complete heart block requiring a permanent or temporary pacemaker implantation, neurological complications, reoperation (for residue shunt or valvular regurgitation), reintubation and diaphragmatic paralysis were considered as significant major adverse events. Results    There was no death, reoperation due to residual VSD or neurological complication. Totally 51 (59.3%) patients had MV timec≥24 h and 51 (59.3%) patients stayed in the ICU≥ 72 h. Two (2.3%) patients required temporary pacemaker and six (7.0%) patients required reintubation. During the follow-up of 3-36 (15.8±8.8) months, 1 patient died of pneumonia after discharge, 5 patients suffered mild tricuspid valve regurgitation and 1 patient suffered decreased left ventricular systolic function in the follow-up. No aortic valve injuries occurred. Conclusion    For patients whose weight≤5.0 kg, short-term results of surgical VSD closure are excellent. Low weight and age may prolong MV time; low birth weight and pulmonary hypertension may prolong ICU stay, but are not independent risk factors.

Objective    To investigate the application of ascending aorta cannulation and brachiocephalic trunk cannulation in acute type A aortic dissection. Methods    We screened 183 patients with acute type A aortic dissection from January 2017 to January 2020 in our hospital. They were divided into 2 groups according to the cannulation strategy: ascending aorta cannulation and brachiocephalic trunk cannulation (a DAC group, n=42, 33 males and 9 females with a median age of 50 years) and the single axillary artery cannulation (an AAC group, n=141, 116 males and 25 females with a median age of 51 years). The general clinical data, intraoperative data and early postoperative results of the two groups before and after matching with propensity scores were compared. Results    Before propensity-score matching, the operation time, cardiopulmonary bypass time, aortic occlusion time and ICU stay in the DAC group were all shorter than those in the AAC group (P<0.05). The early postoperative mortality, and rates of brain complications, renal failure and pulmonary complications in the DAC group were significantly lower than those in the AAC group. After propensity-score matching, the operation time in the DAC group was significantly shorter than that in the AAC group (P<0.05). The early postoperative mortality, and rates of brain complications and pulmonary complications in the DAC group were significantly lower than those in the AAC group. Conclusion    Ascending aorta cannulation and brachiocephalic trunk cannulation can provide a safe, fast and effective method of establishing cardiopulmonary bypass for some acute type A aortic dissection patients, and significantly shorten the operation time without increasing surgical complications.