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.
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.
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 explore the safety and feasibility of general anesthesia with tracheal intubation in transcatheter aortic valve implantation (TAVI), and the key points in anesthetic management. Methods Twenty-five patients with aortic stenosis treated by TAVI in West China Hospital of Sichuan University between September 2012 and June 2013 were included in this study. General anesthesia with tracheal intubation was chosen. We recorded and analyzed the hemodynamics, blood gas, oxygen saturation data before and after anesthesia induction, before surgery, during rapid ventricular pacing, before and after aortic valve implantation. Besides, the incidence of perioperative complications and 30-day mortality were also recorded. Results All the 25 patients underwent the implantation surgery successfully. Two patients had the second implantation surgery due to moderate reflux. All the subjects in this study tolerated general anesthesia well without any anesthesia-related complications. There were 19 cases of newly developed or aggravated heart blocks, 7 of permanent pace maker, 2 of perioperative hemorrhage, 2 of cerebral vascular events, and 1 death case. Conclusioins General anesthesia with tracheal intubation can be utilized safely in patients undergoing TAVI. TAVI is a challenging technique in need of precise collaborations of multi-disciplines, in which anesthetists should play more as a leader in evaluation and decision-making during the surgery.
An 89 years old male patient was admitted to the First Medical Center of Chinese PLA General Hospital due to chest tightness and shortness of breath for half a month. Severe aortic valve stenosis was found in post admission assessment. We proposed to perform transcatheter aortic valve replacement surgery. Preoperative evaluation showed severe distortion of the descending aorta. We used the double guide wire technique and a 14F long sheath to assist the stepwise balloon expansion, and successfully completed the valve implantation. For patients with severe tortuous aorta, how to successfully complete transcatheter aortic valve replacement, this case may provide some reference.
With the development of transcatheter aortic valve replacement, it has become the first-line treatment for elderly patients with aortic valve stenosis. A case of transcatheter aortic valve replacement in a patient at high risk of coronary artery occlusion was reported. The use of intravascular ultrasound to observe the spatial relationship between the coronary ostia and the valve was the characteristic of this case. This patient was an elderly male who was assessed as a high risk of acute coronary artery occlusion before transcatheter aortic valve replacement. After fully evaluation of the patient’s surgical risks\benefits, the strategy was formulated. Percutaneous coronary intervention was the first step. At the same time, intravascular ultrasound was used to observe the spatial relationship between the coronary ostia and the valve, and balloon was embedded for coronary protection. The procedure went smoothly.
ObjectiveTo investigate the feasibility and safety of transcatheter aortic valve replacement (TAVR) through apical approach for aortic regurgitation of large annulus.MethodsFrom November 2019 to May 2020, 10 male patients aged 64.50±4.20 years with aortic valve insufficiency (AI) underwent TAVR in the Department of Cardiovascular Surgery, Xijing Hospital. The surgical instruments were 29# J-valveTM modified and the patients underwent TAVR under angiography. The preoperative and postoperative cardiac function, valve regurgitation, complications and left ventricular remodeling were summarized by ultrasound and CT before and after TAVR.ResultsA total of 10 valves were implanted in 10 patients. Among them, 1 patient was transferred to the aortic arch during the operation and was transferred to surgical aortic valve replacement; the other 9 patients were successfully implanted with J-valve, with 6 patients of cardiac function (NYHA) class Ⅱ, 4 patients of grade Ⅲ. And there was a significant difference between preoperation and postoperation in left ventricular ejection fraction (44.70%±8.78% vs. 39.80%±8.48%, P<0.05) or aortic regurgitation (1.75±0.72 mL vs. 16.51±8.71 mL, P<0.05). After 3 months, the patients' cardiac function was good.ConclusionTAVR is safe and effective in the treatment of severe valvular disease with AI using J-valve.
ObjectiveTo systematically review the efficiency and safety of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis at intermediate-low risk compared with surgical aortic valve replacement (SAVR).MethodsTwo researchers searched literatures independently in databases including PubMed, Embase, Scopus, Cochrane Library, China Biology Medicine disc, China National Knowledge Internet, VIP database for studies published from January 2012 to October 2017, then screened for propriate studies, collected information from different follow-up period all on the principle of Cocharan handbook. At last statistal analysis was performed in RevMan 5.3 to calculate relative risk (RR) and its 95% confidence interval (CI).ResultsThirteen studies were enrolled in this Meta-analysis with 10 753 patients, including 5 263 cases in TAVR group and 5 490 cases in SAVR group. Meta-analysis showed that there were no statistically significant differences in all-cause mortality between TAVR group and SAVR group in 30 days, 1 year or 2 years after operation [RR=0.96, 95%CI (0.75, 1.24), P=0.78; RR=0.84, 95%CI (0.68, 1.03), P=0.09; RR=0.97, 95%CI (0.84, 1.14), P=0.75]; while stroke more preferred SAVR no matter 30 days or 1 year [RR=0.64, 95%CI (0.51, 0.80), P<0.000 1;RR=0.76, 95%CI (0.63, 0.92), P=0.004].ConclusionThere is no significant difference in all-cause mortality of intermediate-low risk patients undergoing TAVR and SAVR, but TAVR perfoms better in terms of srtoke.