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.
A 71-year-old male presented with esophageal cancer and severe aortic valve regurgitation. Treatment strategies for such patients are controversial. Considering the risks of cardiopulmonary bypass and potential esophageal cancer metastasis, we successfully performed transcatheter aortic valve implantation and minimally invasive three-incision thoracolaparoscopy combined with radical resection of esophageal cancer (McKeown) simultaneously in the elderly patient who did not require neoadjuvant treatment. This dual minimally invasive procedure took 6 hours and the patient recovered smoothly without any surgical complications.
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.
ObjectiveTo summarize the results and clinical experience of transcatheter valve-in-valve implantation using domestic self-expanding valve in patients with aortic degenerated bio-prosthesis. MethodsFrom January 2019 to April 2023, the patients who underwent transcatheter valve-in-valve surgery in the Department of Cardiac Surgery of Tianjin Chest Hospital due to surgical bio-prosthesis failure were included. Characteristics of valves, perioperative complications, and hemodynamic manifestations during the early postoperative and follow-up period were analyzed. ResultsA total of 24 patients were enrolled, including 14 males and 10 females with an average age of 68.17±7.72 years, and the average interval between the two operations was 10.48±4.09 years. All patients were successfully discharged without complications such as coronary artery obstruction and pacemaker implantation, and the average transvalvular pressure gradient was 16.39±6.52 mm Hg before discharge. During the median follow-up time of 16 months, the left ventricular diastolic inner diameter and ejection fraction were continuously improved. ConclusionTranscatheter valve-in-valve using domestic self-expanding valves is safe and feasible to treat aortic bioprosthetic valve failure. Sound patient selection and surgical strategies are critical to achieve good hemodynamics.
Transcatheter aortic valve replacement (TAVR) has seen a surge in clinical research, basic research, and innovative device development both domestically and internationally in the previous 2023. This article aims to review the progress of TAVR in the past year from the perspectives of international, and domestic research development of application. It highlights new clinical and basic research findings both domestically and internationally, the emergence of new devices and technologies, and the development and use of TAVR in China. Finally, it provides an outlook on the trajectory of TAVR development in 2024.
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.
ObjectiveTo compare the efficacy and safety of Venus A-Valve and other overseas devices in transcatheter aortic valve replacement (TAVR) for patients with severe aortic stenosis (AS).MethodsWe retrospectively analyzed the baseline characteristics, procedural details, and postprocedural outcomes of severe AS patients who underwent TAVR with Venus A-Valve or overseas devices between April 2012 and January 2019 in West China Hospital of Sichuan University.ResultsA total of 342 AS patients undergoing TAVR were finally included, 238 with Venus A-Valve and the other 104 with overseas devices (43 with CoreValve, 33 with Lotus, 21 with SAPIEN XT, and 7 with SAPIEN 3). Baseline characteristics were comparable between the two groups, and the proportion of patients with bicuspid aortic valve was around 50% in both groups. After successful valve implantation, all patients’ hemodynamics were significantly improved, with the median of maximum velocity decreased to 2.30 m/s (inter-quartile range: 0.60 m/s) and 2.50 m/s (inter-quartile range: 0.62 m/s), respectively (P=0.003). Postprocedural 30-day and 1-year all cause mortalities were similar (30-day: 5.9% vs. 1.9%, P=0.086; 1-year: 8.4% vs. 5.8%, P=0.307), while low incidence of procedure-related complications and improved life quality were achieved in both groups.ConclusionTAVR with the domestic Venus A-Valve is feasible, safe, and can produce favorable outcomes for AS patients, and especially for Chinese TAVR population with a high prevalence of bicuspid aortic valve.
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.
Objective To investigate the feasibility and early efficacy of transapical transcatheter aortic valve replacement (TAVR) combined with transcatheter mitral valve edge-to-edge repair (TEER) in patients with high-risk aortic valve lesions combined with severe mitral regurgitation. Methods The clinical data of patients who underwent "one-stop" transapical TAVR+TEER in our hospital from August 2022 to October 2023 were retrospectively analyzed. Results Five patients were collected, including 3 males and 2 females with a mean age of 66.6±1.8 years. Four patients had aortic valve insufficiency combined with mitral regurgitation and one had aortic valve stenosis and insufficiency combined with mitral regurgitation. All patients successfully completed transapical TAVR+TEER, and the immediate postoperative echocardiographic results revealed that none of them had more than mild perivalvular leakage and mitral regurgitation, and the prosthetic valves were in good position and function. At 1 week postoperatively, echocardiographic results showed 5 patients with no displacement of the prosthetic valve, detachment of the mitral clip, or damage to the leaflets. At 1 month postoperatively, cardiac function was improved to varying degrees in 4 patients, and 1 patient died of multiorgan failure. At 2 months postoperatively, 1 patient died of cerebrovascular accident, and at 3 months postoperatively the echocardiographic results of the remaining 3 patients revealed that there was no more than mild perivalvular leakage or mitral regurgitation, and the patients' postoperative cardiac function and daily life ability were significantly improved. Conclusion In high-risk aortic valve lesions combined with severe mitral regurgitation, "one-stop" transapical TAVR+TEER is feasible with favorable early efficacy and safety.
