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.
“Valve-in-valve” technique is an effective method to treat the bioprosthesis structural valve degeneration. In this paper, an 82-year-old male patient with severe aortic valve regurgitation had underwent surgical aortic valve replacement. He had a bioprosthesis structural valve degeneration which caused severe aortic stenosis more than 3 years after surgery. His symptoms of chest distress and short breath were aggravated progressively, and not relieved by conventional treatment. As the deterioration in his unstabled circulation system, an emergency transcatheter aortic valve replacement was conducted for him. The operation was finally successful, the symptoms were relived significantly after operation, and then the follow-up indicated that he had a good recovery.
Patients with severe aortic stenosis will gradually develop symptoms of heart failure. Aortic valve replacement is an effective treatment at present, while transcatheter aortic valve replacement is suitable for high-risk elderly patients. This article reports a patient with severe aortic valve stenosis and severe scoliosis who underwent transcatheter aortic valve replacement. Detailed preoperative evaluation and avoidance of peripheral vascular injury were the characteristics of this case. The patient was an elderly male with severe scoliosis. After fully evaluating the risks and benefits of surgery, a surgical strategy was formulated. The patient was in the supine position to complete the preoperative CT, and then the long sheath was used to pass through the thoracoabdominal aortic angle during the operation. After angiography-assisted adjustment and determination of the optimal release angle, the valve was accurately released, and the operation went smoothly without serious peripheral vascular damage.
The implantation of bioprosthetic heart valves have increased dramatically due to the aging population and the widespread application of transcatheter aortic valve replacement (TAVR). TAVR is increasingly being used in younger, lower-risk patients with a longer life expectancy, so it is important to overcome structural valve degeneration and ensure long-term TAVR durability. Although the mid-term durability results of the TAVR valve are encouraging, its long-term durability needs to be further explored. This article will mainly introduce the influencing factors of TAVR valve durability, evaluation criteria for structural valve degeneration, clinical research results related to TAVR valve durability, and problems to be solved.
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.
Transcatheter aortic valve replacement is an effective treatment for aortic stenosis currently, especially in elderly, surgical high-risk, and surgical procedures-intolerant patients with severe aortic stenosis. After several generations of updates in design and function, the self-expandable valves have shown significant efficacy in treating aortic stenosis patients with bicuspid aortic valve, bioprosthetic valve failure or small annulus, and superiority in terms of valve durability, and the favorable hemodynamic outcomes could translate into clinical endpoint benefit. This literature review summarizes the advantages and recent advances of the self-expandable valves in transcatheter aortic valve replacement.
This paper reported a 75-year-old female patient. She was admitted to our hospital for “repeated chest pain, shortness of breath for more than 5 years, and syncope 3 times”. The CT scan of the patient showed severe aortic valve stenosis, bicuspid valve, and severe calcification; then she underwent transcatheter aortic valve replacement in our hospital. After the prosthesis was implanted, there was a significant paravalvular leak. Considering the triangular area formed between the calcified clumps, the valve was not fully dilated. Paravalvular leak closure was performed during the operation, attempted through the valve stent mesh to closuring. A rare incarceration of the transmitter occurred. An attempt was made to pull out the incarcerated transmitter through a pull-up technique, which resulted in the prosthesis prolapse. The patient was eventually transferred to surgery aortic valve replacement.
Objective To investigate the left ventricular reverse remodeling (LVRR) in patients with aortic valve insufficiency with reduced ejection fraction (AIrEF) and aortic valve insufficiency with preserved ejection fraction (AIpEF) after transcatheter aortic valve replacement (TAVR). MethodsThe clinical and follow-up data of patients who underwent TAVR in the Department of Cardiothoracic Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from 2018 to 2021 were retrospectively analyzed. According to the guideline, the patients with left ventricular ejection fraction<55% were allocated to an AIrEF group, and the patients with left ventricular ejection fraction≥55% were allocated to an AIpEF group. ResultsA total of 50 patients were enrolled. There were 19 patients in the AIrEF group, including 15 males and 4 females with a mean age of 74.5±7.1 years. There were 31 patients in the AIpEF group, including 19 males and 12 females with a mean age of 72.0±4.8 years. All patients underwent TAVR successfully. Echocardiographic results showed that TAVR significantly promoted LVRR in the patients. Significant LVRR occurred in the early postoperative period (the first day after the surgery) in both groups. It remained relatively stable after the LVRR in the early postoperative period (the first day after surgery) in the AIpEF patients, while it continued to occur in the early postoperative period (the first day after surgery) to three months after the surgery in the AIrEF patients, and then remained relatively stable. Compared to preoperative values, AIrEF patients had a reduction in the average left ventricular end-diastolic volume index and left ventricular end-systolic volume index by 16.8 mL/m2 (P=0.003) and 8.6 mL/m2 (P=0.005), respectively, and the average left ventricular end-diastolic diameter index and end-systolic diameter index decreased by 2.5 mm/m2 (P=0.003) and 1.9 mm/m2 (P=0.003), respectively on the first day after the surgery. In comparison to the first day after the surgery, AIrEF patients experienced an average increase of 12.1% in the left ventricular ejection fraction three months after the surgery (P＜0.001). ConclusionTAVR has achieved good therapeutic effects in patients with aortic valve insufficiency, significantly promoting the LVRR in patients, and has better curative effects in AIrEF patients.