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) is effective in the treatment of severe symptomatic aortic stenosis and its applicable population is also gradually expanding, but it carries risk of ischemic and bleeding events, which underscores the importance of optimizing adjuvant antithrombotic regimens. The release of the 2022 version of Chinese expert consensus on antithrombotic therapy after transcatheter aortic valve implantation has promoted the standardized and safe development of antithrombotic therapy after TAVR in China. Combined with the latest progress of antithrombotic therapy after TAVR, from emphasizing ischemia and bleeding risk assessment, single-agent antiplatelet therapy for patients without anticoagulation indications, the selection of antithrombotic strategies for patients with other antithrombotic indications, antithrombotic strategy changes in postoperative valve thrombosis and bleeding events, this article interprets this consensus.
ObjectiveTo compare and analyze the clinical effects of two kinds of frame design valves after transcatheter aortic valve replacement (TAVR).MethodsWe retrospectively reviewed 124 patients who underwent TAVR and were followed up for 1 year. There were 71 males and 53 females aged 75.57±6.21 years. These patients were treated with Venus-A or Edwards Sapien aortic valves. The hemodynamics and cardiac function of these two kinds of transcatheter aortic valves (THV) were evaluated by echocardiography. The 30-day mortality and 1-year clinical effect of the patients were calculated.ResultsEight-one patients used Venus-A valve and 43 patients used Edwards Sapien valve. The aortic valve transaortic pressure gradient was reduced and the rate of perivalvular leakage was low (both 2.6%) in both groups, and there was no statistical difference between the two groups. The implantation rate of permanent pacemaker was 17.3% and 11.6%, respectively. The 1-month survival (94.0% and 93.0%) and 1-year survival (94.0% and 91.0%) rates were not statistically different.ConclusionThe two groups of THV with different stent structures have good short-term clinical effect and low implantation rate of permanent pacemaker.
We reported a case of a 61-year-old female patient, six years status post her last cardiac surgery, who was admitted with a chief complaint of bilateral lower extremity edema for over a year, which had acutely worsened with associated chest pain for two days. The patient had a complex cardiac surgical history: 12 years prior, she underwent double valve replacement (aortic and mitral) plus tricuspid valvuloplasty for mitral valve prolapse with severe regurgitation and moderate-to-severe aortic regurgitation. Nine years ago, she underwent bioprosthetic mitral valve replacement and vegetation removal for prosthetic valve vegetation with severe regurgitation. Six years ago, she underwent a transapical transcatheter mitral valve replacement and mitral balloon valvuloplasty due to prosthetic mitral valve prolapse with severe regurgitation. Following evaluation during this admission, she successfully underwent a valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). The patient had an uneventful postoperative recovery. This case report aims to explore the clinical strategy and application of the ViV-TAVR technique for managing bioprosthetic valve failure in patients with a history of complex valvular surgeries.
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.
It has been 20 years since the first transcatheter aortic valve replacement (TAVR) was performed internationally in 2002, and the development of TAVR technology in China has also been more than 10 years. The reliability of TAVR has been clinically proven, and it has also brought good benefits to patients with aortic stenosis. With the gradual progress of technology, TAVR has a trend to surpass surgical aortic valve replacement and become the mainstream surgery for patients with aortic stenosis. This article will review the relevant issues in the development of TAVR technology in recent years, based on existing research, and provide certain clinical references for the future development of TAVR technology.
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.
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.
Objective To summarize the clinical experience and mid-term outcomes of transcatheter aortic valve implantation valve-in-valve (TAVI-ViV) for failed surgical bioprostheses in the aortic position. Methods Patients who underwent TAVI-ViV procedures at Tianjin University Chest Hospital between January 2019 and January 2025 were consecutively enrolled. Baseline characteristics, procedural details, and postoperative hemodynamic performance were collected and analyzed. Early postoperative and follow-up valve hemodynamics were evaluated, and surgical experiences were summarized. The primary endpoint was all-cause mortality, and the secondary endpoint was severe prosthetic valve stenosis. Results A total of 45 patients were included, with a mean age of (68.38±7.72) years and an average interval between surgeries of (11.00±3.67) years. The Society of Thoracic Surgeons (STS) score was 6.80% (4.29%, 8.21%). The procedural success rate was 97.78% (44/45), with one case aborted due to coronary obstruction. The mean implantation depth was (6.87±3.45) mm, the annular expansion rate ranged from 10% to 40%, and the stent crown compression rate varied from 0% to 42%. The median follow-up duration was 21 months, with 27 patients completing the 2-year follow-up. At 2 years postoperatively, the overall follow-up rate was 92.59% (25/27), and the echocardiographic follow-up rate was 66.67% (18/27). The all-cause mortality rate was 7.41% (2/27). The mean peak aortic valve velocity was 2.96±0.69 m/s, the mean transvalvular gradient was (21.83±10.98) mm Hg, and 3 patients exhibited velocities ≥4 m/s (indicating severe stenosis). The regression analysis showed that the implant depth deviation [β=0.41, SE=0.18, OR=1.51, 95%CI (1.06, 2.30), P=0.024］, the compression rate of the corona [β=2.48, OR=11.93, 95%CI (1.21, 122.40), P=0.034], and the enlargement rate of the annulus [β=1.96, OR=7.13, 95%CI (1.28, 35.50), P=0.026] were the independent predictors of high flow velocity after surgery. Conclusion The optimal implantation depth for TAVI-ViV using a self-expanding valve system is 4 to 5 mm. When the annular expansion rate approaches 10%, hemodynamic performance can be significantly improved. The degree of crown compression in the valve stent is strongly correlated with elevated postoperative transvalvular gradients.
ObjectiveTo evaluate the anticoagulation efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) in patients with high-risk atrial fibrillation (AF) undergoing transcatheter aortic valve implantation (TAVI). MethodsA computer-based search was conducted on PubMed, EMbase, The Cochrane Library, CNKI, SinoMed, and VIP databases to identify studies on the application of NOACs and VKAs in high-risk AF patients after TAVI. The search period was from database inception to January 2023. The quality of the included studies was assessed using the Cochrane risk assessment tool and the Newcastle-Ottawa Scale (NOS). Meta-analysis was performed using RevMan 5.4 software. ResultsA total of 7 studies involving 24 592 patients were included. The meta-analysis results showed that compared to patients using VKAs, those treated with NOACs had a significantly lower risk of all-cause mortality [RR=0.74, 95%CI (0.58, 0.94), P=0.01]. Subgroup analysis indicated that when the follow-up period was less than 1 year, there was no significant difference in all-cause mortality between the NOAC and VKA groups [RR=0.57, 95%CI (0.17, 1.88), P=0.35]; however, when the follow-up period was ≥1 year, the VKA group had a higher all-cause mortality rate than the NOAC group, with a statistically significant difference [RR=0.73, 95%CI (0.57, 0.95), P=0.02]. No significant differences were found between the two groups regarding early stroke [RR=0.50, 95%CI (0.19, 1.28), P=0.15], stroke during follow-up [RR=1.04, 95%CI (0.88, 1.22), P=0.64], bleeding [RR=0.94, 95%CI (0.73, 1.21), P=0.61], major or life-threatening bleeding [RR=0.80, 95%CI (0.49, 1.31), P=0.38], or acute kidney injury [RR=0.51, 95%CI (0.16, 1.59), P=0.24]. Conclusion Compared to VKAs, the use of NOACs in patients with high-risk AF undergoing TAVI may reduce the risk of all-cause mortality, especially during long-term anticoagulation therapy, potentially offering greater benefits. However, further evidence from randomized controlled trials is needed to confirm these findings.