Objective To investigate the efficacy on clinical condition assessment and the safety of ultrasound-guided osteofascial chamber puncture manometry in evaluating the pressure of the osteofascial chamber in patients with venomous snake bites. Methods Patients with venomous snake bites admitted to the Department of Emergency Medicine of West China Hospital of Sichuan University between April 2021 and January 2023 were prospectively included, and their basic information, physiological indicators (heart rate, blood pressure), laboratory examination indicators, physical signs, treatment methods and prognosis were collected. The patients whose extremal pressure was measured by osteofascial chamber puncture under ultrasound guidance were selected as the manometry group. Patients who were bitten by venomous snakes at the same time without puncture pressure measurement were randomly selected as the control group at a ratio of 1∶1. The bleeding, infection, nerve injury, length of hospital stay and long-term prognosis of the two groups were compared to explore the safety of ultrasound-guided osteofascial chamber puncture manometry. The correlation between the pressure measured in the manometry group and creatine kinase (a representative index of acute poisoning severity score) was analyzed to explore the efficacy of ultrasound-guided osteofascial chamber puncture manometry in evaluating the disease. Results There was no significant difference between the manometry group and the control group in new or aggravated infection, bleeding, nerve injury (such as numbness and anesthesia), hospital treatment time, final detumescence time of the affected limb, or final adverse prognosis (P>0.05). There was a positive correlation between the measured pressure and creatine kinase (rs=0.286, P=0.002). Conclusions The higher pressure measured by ultrasound-guided osteofascial chamber puncture manometry is, the more serious the poisoning condition may be. In addition, ultrasound-guided osteofascial chamber puncture manometry does not prolong the hospital time of patients or the final swelling reduction time of the affected limb, and does not increase the incidence of bleeding, infection, nerve damage or eventual adverse prognosis events. It has clinical practicability and feasibility.
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.