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.
Objective To summarize the short-term results of valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) in the treatment of bioprosthetic valve failure after aortic valve replacement. Methods We reviewed the clinical data of patients who underwent ViV-TAVI from 2021 to 2022 in the First Affiliated Hospital of Zhengzhou University. The valve function was evaluated by echocardiography before operation, immediately after operation and 3 months after operation. The all-cause death and main complications during hospitalization were analyzed. Results A total of 13 patients were enrolled, including 8 males and 5 females with a mean age of (65.9±8.5) years, and the interval time between aortic valve replacement and ViV-TAVI was (8.5±3.4) years. The Society of Thoracic Surgeons mortality risk score was 10.3%±3.2%. None of the 13 patients had abnormal valve function after operation. The mean transvalvular pressure gradient of aortic valve was decreased (P<0.001), the peak flow velocity of aortic valve was decreased (P<0.001), and the left ventricular ejection fraction was not changed significantly (P=0.480). There were slight perivalvular leakage in 2 patients and slight valve regurgitation in 3 patients. Three months after operation, the mean transvalvular pressure difference and peak flow velocity of aortic valve in 12 patients were significantly decreased compared with those before operation (P≤0.001). Conclusion This study demonstrates that ViV-TAVI for the treatment of bioprosthetic valve failure after aortic valve replacement is associated with favorable clinical and functional cardiovascular benefits, the short-term results are satisfactory.
Objective To investigate the early safety and efficacy of transapical transcatheter aortic valve implantation (TAVI) for high-risk elderly patients with pure aortic valve insufficiency. Methods A prospective multicenter clinical study of domestic J-valveTM TAVI for high-risk native non-calcified aortic valve insufficiency was conducted from April 2014 to May 2018, and the early postoperative results were analyzed. A total of 82 patients were enrolled, including 62 patients from West China Hospital, Sichuan University, 16 patients from Zhongshan Hospital, Fudan University, and 4 patients from Beijing Fuwai Hospital, National Center for Cardiovascular Diseases. There were 55 males and 27 females. The age was 61-90 (73.8±6.3) years. The logistic EuroSCORE was 10.0%-44.4% (17.5%±8.1%). All patients underwent TAVI using J-ValveTM system. Clinical evaluation and echocardiography were performed preoperatively and 1 month postoperatively. Multislice spiral CT was reviewed before discharge. Results Three patients were transferred to thoracotomy for cardiopulmonary bypass operation, and 1 patient had decreased cardiac function due to leakage of the valve 1 week after surgery. The overall technical and procedural success rate was 95.1% and 93.9%, respectively. During hospitalization, 1 patient died of moderate pericyclosis complicated with multiple organ failure, and 1 patient died of pulmonary infection. Six (7.6%) patients received pacemaker implantation due to new onset Ⅲ° atrioventricular block. Echocardiographic follow-up showed paravalvular leak was observed in the few of patients, mild paravalvular leak was in 13 patients on the 30th day. Two patients showed moderate paravalvular leak. Left ventricular end-diastolic volume decreased from 197.7±66.8 mL (pre-TAVI) to 147.2±53.3 mL (30-day post-TAVI) (P<0.05). Mean pressure gradient was 9.5±4.1 mm Hg (30-day post-TAVI). Conclusion This multicenter study demonstrates that TAVI with the J-Valve system for the treatment of pure aortic regurgitation is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic regurgitation early-term follow-up. Our results further support that TAVI with the specific designed J-Valve system is an acceptable alternative therapy for high-risk patients with pure AR. Our result demonstrates good early-term durability and preserved hemodynamic function. The procedure appears to offer an adequate and lasting resolution for selected patients with pure aortic regurgitation.
Objective To analyze the clinical intervention effect of multi-disciplinary team (MDT) nursing mode on patients after transcatheter aortic valve implantation (TAVI). Methods A total of 89 patients who were admitted to our hospital and underwent TAVI surgery from April to December 2021 were selected, including 64 males and 25 females, with an average age of 64.7±11.8 years. The subjects were divided into a MDT intervention group (n=42) and a control group (n=47) according to different postoperative nursing intervention methods. Clinical effectivenesses were compared between the two groups. Results The left ventricular ejection fraction in the two groups significantly increased on the 7th day after the operation, and the increase in the MDT intervention group was more obvious, with no statistical difference between the two groups (P=0.14). On the 7th day after surgery, forced vital capacity/predicated value and forced expiratory volume in one second/predicated value significantly decreased, and decreased more significantly in the control group than those in the MDT intervention group with statistical differences (P=0.01). The ICU stay time (P=0.01), hospital stay time (P<0.01) and total postoperative pulmonary complications rate (P=0.03) in the MDT intervention group were significantly shorter or lower than those in the control group The evaluation results of the anxiety and depression status of the patients before and after nursing intervention showed that the scores of anxiety and depression in the two groups were significantly lower than before, and the scores of each scale in the MDT intervention group were lower. The score of quality of life of the two groups significantly improved at the end of 6 months after surgery, and in the MDT intervention group it was significantly higher than that in the control group (P=0.02). Conclusion MDT intervention mode can promote the rapid recovery of patients after TAVI, effectively reduce the risk of postoperative pulmonary complications, and improve the postoperative quality of life.
As technology advances, current evidence supports the use of devices for valvular heart disease interventions, including transcatheter aortic valve implantation, transcatheter mitral or tricuspid valve repair, and transcatheter mitral valve implantation. These procedures require antithrombotic therapy to prevent thromboembolic events during the perioperative period, and these therapies are associated with an increased risk of bleeding complications. To date, there are challenges and controversies regarding how to balance the risk of thrombosis and bleeding in these patients, and therefore the optimal antithrombotic regimen remains unclear. In this review, we summarize the current evidence for antithrombotic therapy after transcatheter intervention in patients with valvular heart disease and highlight the importance of an individualized approach in targeting these patients.
The purpose of this study was to explore the feasibility of dual-source computed tomography (DSCT) high-pitch scan mode in the preoperative evaluation of severe aortic stenosis (AS) referred to transcatheter aortic valve implantation (TAVI). Thirty patients with severe AS referred for TAVI underwent cervico-femoral artery joint DSCT angiography. Measurement and calculation of contrast, contrast noise ratio (CNR) and noise of aorta and access vessels were performed. The intra-and inter-observer reproducibilities for assessing aortic root and access vessels were evaluated. Evaluation of shape and plagues of aorta and access vessels was performed. The contrast, CNR and noise of aorta and access vessels were 348.2~457.9 HU, 12.2~30.3 HU and 19.1~48.1 HU, respectively. There were good intra-and inter-observer reproducibilities in assessing aortic root and access vessels by DSCT (mean difference:-0.73~0.79 mm, r=0.90~0.98, P < 0.001; mean difference:-0.70~0.73 mm, r=0.90~0.96, P < 0.001). In the 30 patients, the diameters of external iliac artery, femeral artery or subclavian artery were less than 7 mm in 5 cases (16.7%), marked calcification in bilateral common iliac arteries in 1 case (3.3%) and marked soft plaque in left common iliac artery in 1 case (3.3%). DSCT high-pitch scan mode was feasible in the preoperative evaluation of aorta and access vessels in patients with AS referred for TAVI.
Objective
To discuss the key points of anesthesia for patients undergoing transcatheter aortic valve implantation (TAVI) surgery.
Methods
We retrospectively collected and analyzed the data of 70 patients who underwent TAVI in the Department of Cardiovascular Surgery, West China Hospital from March 2014 to October 2015. There were 39 males and 31 females with an average age of 73.7±4.5 years. The perioperative preparation and anesthesia points of TAVI were summarized.
Results
All of the 70 included patients were aged and at high risk severe comorbidities such as ischemic heart disease and stroke. The aortic stenosis and regurgitation occurred in 39 and 31 patients respectively. No patients died during the surgery. The total success rate was 95.7%.
Conclusion
TAVI is a complex procedure for high risk patients and need more attention during anesthesia. The successful conduction of the procedure requires the whole team to prepare carefully and cooperate closely.
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.
For patients with aortic valve disease who require replacement of their native valve, surgical aortic valve replacement (SAVR) has been the standard of care. Due to the hemorrhage and thromboembolic risks of long-term anticoagulation therapy for mechanical prosthesis, bioprosthetic aortic valve replacement (AVR) has a trend to be used in younger patients, which raising the concern for the durability of bioprosthetic valves. The newly published 5-year outcomes of PERIGON trial, with no structural valve deterioration, again demonstrated the favorable durability of the new generation bioprosthetic valves, further providing the evidence of using bioprosthetic AVR in younger patients. At the meantime, the rapid progress of transcatheter aortic valve implantation (TAVI) has brought a new treatment option. For younger patients with low risks, choosing SAVR or TAVI becomes a critical decision. This paper reviews the outcomes of PERIGON trial and its implications to the clinical practice and research of bioprosthetic AVR.
ObjectiveTo summarize the clinical experience in the treatment of high-risk patients with severe aortic valve disease by transcatheter aortic valve implantation (TAVI) via heart apex approach and to evaluate the early efficacy.MethodFive patients who underwent TAVI via heart apex approach from September 2017 to February 2019 in Henan Thoracic Hospital were retrospectively analyzed, including 3 males and 2 females, aged 65-84 (74.6±4.5) years.ResultAll operations were performed through a small left incision into the thoracic cavity (3-5 cm), and then through the J-Valve transport system, the aortic valve was successfully released via heart apex after precise positioning under digital subtraction angiography. One patient developed ventricular fibrillation during the operation, and the operation was completed with the assistance of emergency femoral arteriovenous catheterization cardiopulmonary bypass; one patient underwent percutaneous coronary intervention first because of severe coronary stenosis; one patient had paroxysmal atrial fibrillation during the perioperative period, and had hepatorenal insufficiency and thrombocytopenia after the operation, and was improved after medical treatment; one patient had perivalvular leak during the operation, and was improved after re-implantation of the valve; one patient was in stable condition during operation and recovered smoothly after operation. Surgery was successful in all 5 patients. The follow-up time was 2-19 months, and the early clinical effect was good.ConclusionThe short-term clinical efficacy of TAVI via heart apex approach in the treatment of high-risk severe aortic valve disease is definite and safe, but the long-term and medium-term effects need to be further evaluated.
