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.

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.

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.

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 analyze the clinical efficacy of transthoracic occlusion via a right subaxillary incision and conventional surgery in the treatment of ventricular septal defect (VSD). Methods    The clinical data of patients with congenital VSD undergoing right subaxillary incision surgery in our hospital from January 2017 to January 2020 were retrospectively analyzed. According to the surgical methods, the patients were divided into two groups: a conventional surgery group (conventional group) and a transthoracic occlusion group (occlusion group). There were 221 patients in the conventional group, including 97 males and 124 females, with an average age of 2.6±2.2 years and an average weight of 13.4±6.2 kg; there were 185 patients in the occlusion group, including 90 males and 95 females, with an average age of 3.2±2.6 years and an average weight of 14.7±6.6 kg. The clinical effectiveness was compared. Results    The success rate of surgery was 100% in both groups. The intraoperative blood loss was less in the occlusion group (P<0.05). The incision length, operation time, postoperative mechanical ventilation time, retention time in the intensive care unit, the time to resume normal diet and normal activities after operation were all shorter than those in the conventional group (P all <0.05). The total cost during hospitalization of the conventional group was less than that of the occlusion group (P<0.001). There was no statistical difference in the incidence rate of perioperative complications between the two groups (P>0.05). During the follow-up (15.8±8.8 months), the incidence of complications in the conventional group was higher than that in  the occlusion group with a statistical difference (P<0.001). Conclusion    Compared with conventional surgery, transthoracic occlusion for VSD via right subaxillary incision has the advantages of smaller incision, shorter operation time, less blood loss, shorter postoperative recovery time and less long-term complications. However, the total hospitalization cost is relatively high, mainly because of the high consumables cost, and the long-term effects still need further comparative observation.

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 examine the surgical treatment of Stanford type A aortic dissection (type A dissection) after thoracic endovascular aortic repair (TEVAR).Methods:The data of 58 patients with reoccurrence of type A dissection after TEVAR admitted into the Department of Cardiovascular Surgery, Henan Chest Hospital from February 2012 to January 2020 were analyzed retrospectively. There were 40 males and 18 females, aged (57.0±6.7) years (range: 31 to 71 years). The time between recurrence of type A dissection and TEVAR ( M( Q R)) was 37 days (72.8 months) (range: 1 h to 14 years). Forty-eight cases underwent emergency operation, 9 cases underwent sub-emergency operation, and 1 case died of dissection rupture on the way to the operating room. All 57 patients underwent radical treatment. Fifty-four cases underwent the frozen elephant trunk technique under deep hypothermia circulatory arrest and selective cerebral perfusion, and 3 cases (>65 years old) underwent arch debranch anastomosis+ascending aorta replacement+descending arch covered stent implantation under mild hypothermia. Results:The operation time was (445±32) minutes (range: 382 to 485 minutes), the aortic crossclamp time was (103±19) minutes (range: 89 to 133 minutes), the cardiopulmonary bypass time was (189±27) minutes (range: 162 to 221 minutes), and the intraoperative blood loss was (665±343) ml (range: 450 to 1 750 ml). Postoperative ICU stay time was 5 (6) days (range: 2 to 27 days), and postoperative hospital stay was 14.0 (4.5) days (range: 2 to 36 days). Three cases died, including 2 cases with severe brain complications and 1 case with systemic multiple organ failure caused by severe liver insufficiency and gastrointestinal hemorrhage. Postoperative follow-up was 0.5 to 7.0 years, which showed that 1 case had left coronary artery anastomotic stoma fistula 3 months after operation and underwent reoperation, 2 cases underwent thoracoabdominal aortic replacement again, and the rest of patients had no anastomotic stoma fistula and incomplete stent distortion and expansion on CT angiography. Four cases died during follow-up, and 1 case died of sudden cerebral infarction 2 years after operation.Conclusion:The recurrent type A dissection after TEVAR is mostly related to stent graft, and the patients can undergo operation actively with good prognosis.