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.
ObjectiveTo explore the short-term efficacy and safety of Ozaki surgery in treating adult patients with aortic valve disease and to summarize clinical experience. MethodsClinical data of adult patients with aortic valve disease who underwent Ozaki surgery in the Department of Cardiovascular Surgery, Beijing Anzhen Hospital of Capital Medical University Nanchong Branch in 2025 were collected, and the effectiveness and safety of Ozaki surgery were analyzed. ResultsA total of 5 patients were included, including 3 males and 2 females, with an average age of (47.80±12.99) years. One patient was aortic stenosis, 2 patients were aortic regurgitation, and 2 patients were aortic stenosis combined with regurgitation. Two patients underwent isolated Ozaki surgery, 1 patient underwent Ozaki+coronary artery bypass surgery, and 2 cases underwent Ozaki+mitral valve plasty+tricuspid valve plasty. The average operation time was (6.70±1.25) hours. The average extracorporeal circulation time was (217.20±59.47) minutes, the average aortic cross-clamping time was (153.60±45.71) minutes, the average postoperative ventilator support time was (25.00±11.79) hours, the average intensive care unit stay was (2.43±1.30) days, and the average postoperative hospital stay was (11.20±1.92) days. The postoperative average aortic valve flow rate was (1.70±0.26) m/s, and the average transvalve pressure gradient was (11.00±1.87) mm Hg. Postoperatively, 3 patients had no aortic regurgitation, and 2 patients had trace regurgitation. Postoperative complications included pulmonary infection in 3 patients, severe pneumonia in 1 patient, liver function damage in 4 patients, and renal function damage in 3 patients. No patients experienced arrhythmias or other complications. All 5 patients recovered and were discharged, and their cardiac function significantly improved postoperatively compared to preoperatively (P<0.001), with both left ventricle (P=0.047) and left atrium (P=0.016) reduced in size. ConclusionThe short-term results of Ozaki surgery for adult patients with aortic valve disease are satisfied, but long-term outcomes still need further exploration.
This study reports the first successful clinical application of a robotic-assisted system in transcatheter balloon-expandable aortic valve implantation using the Edwards SAPIEN 3 valve. Two male patients, aged 60 and 63 years, respectively, presented with severe aortic stenosis confirmed by echocardiography and computed tomography, showing significant valvular calcification and elevated transvalvular pressure gradients, meeting the indications for transcatheter aortic valve implantation (TAVI). Both procedures were performed via the right femoral artery using a robotic-assisted delivery and positioning system developed by Shanghai Surgerii Medical Technology Co., Ltd. The operator controlled the delivery system and valve positioning precisely through the console, while the assistant performed balloon expansion and valve deployment. Both procedures were completed successfully without intraoperative complications. The operative times were 75 minutes and 67 minutes, with fluoroscopy times of 16 minutes and 23 minutes, and radiation doses of 714 mGy and 971 mGy, respectively. Postoperative echocardiography demonstrated well-functioning prosthetic valves, with mean transvalvular pressure gradients of 3.9 mm Hg and 8.0 mm Hg, and none or trivial paravalvular leakage. No coronary obstruction, conduction disturbance, or vascular complications were observed. This report represents the world’s first clinical use of a robotic-assisted system for balloon-expandable TAVI. It confirms the feasibility and safety of robotic assistance in transcatheter valve delivery and positioning, offering a new approach to enhance procedural precision and stability, and providing valuable insights for the future development of intelligent, minimally invasive therapies for structural heart disease.
Transcatheter aortic valve replacement (TAVR) has become a common theraputic option for aortic stenosis, but the evidence for precise anatomy for TAVR is accumulating. This paper presents the case of an 71-year-old female patient who had an extremely high risk of coronary obstruction due to both coronary ostia lying too low. The patient underwent TAVR with the help of coronary protection successfully. During the procedure, the patient was protected with wires only for both coronaries. After deployment, angiofluoroscopy suggested that chimney stenting should be applied for left coronary. The whole procedure was unenventful and both coronaries were seen.
Due to the lack of calcification of the aortic valve, it is difficult to provide effective support for the fixation of artificial valve in aortic stenosis characterized by leaflet thickening. There is a risk of postoperative perivalvular leakage and secondary valve implantation, which is widely regarded as a relative contraindication for transcatheter aortic valve replacement (TAVR). But aortic valvuloplasty and self-expanding transcatheter aortic valve has showed its safety and efficacy. This paper reports a patient with bicuspid aortic valve characterized by leaflet thickening treated with TAVR. After the operation, the patient’s symptom of exertional dyspnea was significantly improved, New York Heart Association class increased to Ⅱ, no perivalvular leakage was found, and the mean transaortic pressure gradient and the maximum aortic valve velocity decreased significantly.
In recent years, the number of interventions for valvular heart disease has been increasing day by day, and it has become a hot topic in the field of cardiovascular surgery. Given the aging global population and trends in the prevalence of valvular disease and the broadening of indications for transcatheter aortic valve replacement (TAVR), a breakthrough of 130000 TAVR procedures is expected by 2026. In the new technology development period, the development potential and technical advantages of heart valve interventional therapy should be faced squarely. This paper focuses on key issues such as comparison of outcomes after TAVR versus surgical aortic valve replacement (SAVR), prosthetic valve endocarditis after TAVR, and broadening of indications for TAVR, as well as recommendations on how surgeons face the era of TAVR. We hope that this article will help and attract the attention of cardiac surgeons.
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.