Objective To evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 system. MethodsThis was a prospective, multicenter, single arm study in 4 centers in China. The clinical data of 50 patients with high-risk symptomatic severe aortic stenosis who underwent TAVR using the SAPIEN 3 system from June 2017 to June 2019 were analyzed, including 27 males and 23 females aged 76.8±6.1 years. ResultsThe Society of Thoracic Surgeon score was 6.0%±2.8%. Totally, 20.0% of patients had severe bicuspid aortic stenosis. The operation time was 41.8±16.5 min and the hospital stay time was 8.5±5.0 d. At the postoperative 30-day follow-up, no all-cause mortality occurred and the device success rate was 89.5%. Major vascular complications occurred in one (2.0%) patient, stroke in one (2.0%) patient, new pacemaker implantation in one (2.0%) patient, as well as coronary artery obstruction in one (2.0%) patient. There was no moderate or moderate/severe paravalvular leak. The aortic pressure gradient was decreased from 49.2±16.2 mm Hg before the operation to 12.4±4.6 mm Hg at the postoperative 30-day follow-up, and the valvular area was increased from 0.6±0.3 cm2 to 1.3±0.3 cm2 (P<0.01). Moreover, the New York Heart Association classification in 83.7% of the patients was improved during the follow-up. ConclusionThis pre-marketing multicenter study has demonstrated the safety and effectiveness of transfemoral TAVR with the SAPIEN 3 transcatheter valve system in Chinese aortic stenosis patients at high risk for surgery.
This paper discusses a female patient with severe aortic stenosis, who was preoperatively assessed to be at high risk of left coronary artery occlusion, but developed complete occlusion of the right coronary artery during the procedure of transcatheter aortic valve replacement, leading to hemodynamic disorder. Surgical treatment under emergency cardiopulmonary bypass played a critical role in rescuing the patient.
In 2020, due to the impact of the novel coronavirus epidemic, the development of transcatheter heart valve therapy has been shown to slow down, but there are still many aspects worth noting. The indication of monoclonal antibody after transcatheter aortic valve replacement (TAVR) should be further clarified. Low surgical risk patients were included in TAVR relative indications. Mitraclip G4 was approved by CE. The indication of atrial septal occlusion after mitraclip should be further clarified. The technique of coaptation augmentation is expected to become a new method of mitral valve interventional repair. Tendyne transcatheter mitral valve was approved by European Union. Transcatheter tricuspid valve treatment equipments, TriClip and PASCAL obtained CE mark. TAVR technology is being popularized rapidly in China, and what’s more, balloon dilated valve Sapien 3 and new recyclable repositioning valve system-Venus plus have entered the domestic market. A number of mitral valve therapeutic instruments have appeared one after another, and China's first tricuspid valve lux has completed its FIM research. Finally, with the improvement of devices and technology in the future, interventional therapy of heart valve is expected to benefit more patients.
目的观察微创体外循环(minimal extracorporeal circulation,MECC)对主动脉瓣置换术临床效果的影响。 方法回顾性分析我院2010年3月至2012年10月共25例应用MECC方法行单纯主动脉瓣置换术(AVR)的临床资料,其中男15例、女10例,年龄40(19~58)岁。 结果总体外循环时间67(51~89)min、主动脉阻断时间42(33~63)min、转流中最低血红蛋白(Hb)9.6(8.3~12.6)g/dl、流转后Hb 9.5(7.7~12.6)g/dl,体外循环中无1例患者因Hb低而输入红细胞。所有患者均顺利拔除胸腔引流管,顺利出院,无院内死亡。 结论MECC系统应用于主动脉瓣置换安全可行,比传统心肺旁路系统具有更好的生物相容性和良好的临床结果,值得推广。
ObjectiveTo systematically review the predictive factors of new-onset conduction abnormalities(NOCAs) after transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) patients. MethodsThe CNKI, VIP, WanFang Data, PubMed, Cochrane Library and EMbase databases were electronically searched to collect the relevant studies on NOCAs after TAVR in patients with BAV from inception to December 5, 2022. Two researchers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.4 software. ResultsSix studies involving 758 patients with BAV were included. The results of the meta-analysis showed that age (MD=−1.48, 95%CI −2.73 to −0.23, P=0.02), chronic kidney disease (OR=0.14, 95%CI 0.06 to 0.34, P<0.01), preoperative left bundle branch block (LBBB) (OR=2.84, 95%CI 1.11 to 7.23, P=0.03), membranous septum length (MSL) (MD=0.93, 95%CI 0.05 to 1.80, P=0.04), implantation depth (ID) (MD=−2.06, 95%CI −2.96 to −1.16, P<0.01), the difference between MSL and ID (MD=3.05, 95%CI 1.92 to 4.18, P<0.01), and ID>MSL (OR=0.27, 95%CI 0.15 to 0.49, P<0.01) could be used as predictors of NOCAs. ConclusionCurrent evidence shows that age, chronic kidney disease, LBBB, MS, ID, the difference between MSL and ID, and ID>MSL could be used as predictors of NOCAs. Due to the limited quantity and quality of included studies, more high-quality studies are required to verify the above conclusion.
ObjectiveTo observe the short-term therapeutic outcomes of atrial septal defects (ASD) repair using on-pump beating-heart technique assisted by robotic surgery system (Da Vinci Si) or thoracoscopy.MethodsClinical data of 50 patients undergoing ASD repair at the First Affiliated Hospital of Anhui Medical University from January 2015 to December 2018 were retrospectively analyzed. According to the different surgical methods, patients were divided into a robot group and a total thoracoscopy group. In the robot group, there were 35 patients including 11 males and 24 females, at an average age of 42.1±16.8 years, and in the total thoracoscopy group there were 15 patients including 8 males and 7 females at an average age of 38.4±10.9 years. During follow-up, the left ventricular ejection fraction, left and right atrial diameter, and right ventricular end-diastolic diameter in the cardiac Doppler echocardiography were recorded. The operation time, extracorporeal circulation time, ventilation time, postoperative ICU stay, postoperative hospital stay, perioperative pleural drainage and early complications were compared between the two groups.ResultsIn the perioperative period, the robot group had less operation time (3.8±0.3 h vs. 6.1±1.4 h), extracorporeal circulation time (72.3 ± 10.4 min vs. 139.1 ± 32.8 min), ventilation time (5.5±1.2 h vs. 9.5 ± 2.1 h), postoperative hospital stay (6.7±0.5 d vs. 9.8 ± 0.6 d) and thoracic drainage (253.4±26.8 mL vs. 289.3 ± 29.5 mL) than the total thoracoscopy group (P<0.05), while the postoperative complications were not statistically significant between the two groups (P>0.05). All patients were reviewed by color Doppler ultrasound at 1 month after operation. The postoperative dilated right atrium, right ventricle and left atrium were smaller than those before surgery.ConclusionFor patients undergoing ASD repair, robot-assisted and total thoracoscopy can achieve good results, but the robot group has more advantages in terms of operation time, extracorporeal circulation time, ventilation time, postoperative hospital stay and thoracic drainage.
Commissural misalignment of biological valve and autologous valve during transcatheter aortic valve replacement may affect the filling of coronary artery, reduce the feasibility of redo-aortic valve intervention and damage the valve function, which will adversely affect long-term prognosis of patients. Some studies have obtained achievement by changing the axial direction of valve and using individualized computer simulation technology to improve the alignment technology. However, there are still many unknown problems about the impact of commissural misalignment on patients, and accurate commissural alignment techniques still need to be further explored. This article systematically expounds the possible impact of commissural misalignment between biological valve and autologous valve in transcatheter aortic valve replacement, possibly effective accurate commissural alignment techniques and related research progress.
Objective To evaluate the short-term efficacy of transcatheter aortic valve replacement (TAVR) using Venus A-Plus valve delivery system in patients with severe aortic stenosis. Methods The clinical data of patients undergoing TAVR in our hospital from August 2018 to March 2022 were collected and divided into a Venus A-PLUS and a Venus A group according to the type of valve delivery system used. The perioperative data of the two groups were compared. ResultsA total of 121 patients were included, including 70 patients in the Venus A-Plus group (45 males and 25 females with a mean age of 67.81±6.62 years), and 51 patients in the Venus A group (33 males and 18 females with a mean age of 68.25±7.01 years). All patients underwent TAVR, and the postoperative hemodynamic features (left ventricular ejection fraction, mean cross-valve pressure difference, peak flow rate) were significantly improved (P<0.05). There was no statistical difference in surgical success rate, all-cause mortality, conversion to thorax opening, midvalve placement, moderate or above perivalvular regurgitation, new left bundle branch block or new right bundle branch block between the two groups (P>0.05). Conclusion TAVR with Venus A-Plus valve delivery system in patients with severe aortic stenosis is satisfactory, safe and reliable.