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 analyze predictive factors, clinical implications and prognosis effects of new-onset conduction block after transcatheter aortic valve implantation (TAVI). Methods The clinical data of 86 patients who underwent TAVI through transfemoral approach from 2019 to 2021 in Fujian Provincial Hospital were retrospectively analyzed, including 59 males and 27 females with an average age of 72.9±8.0 years. The patients were divided into a normal group and a new-onset conduction block group according to whether there was new-onset conduction block after operation, and then the new-onset conduction block group was subdivided into a left bundle branch block (LBBB) group (28 patients) and a complete atrioventricular block (CAVB) group (11 patients). We compared the hemodynamics and TAVI-related complications between the postoperative and early follow-up periods, and used the multivariate logistic regression models to identify risk factors for the new-onset conduction block. Results The median EuroSCORE of all patients were 8 (2) points before the operation. In the postoperative and early follow-up periods, the hemodynamics and TAVI-related complications had no statistical difference between the new-onset conduction block group and the normal group (P>0.05). The incidence of permanent pacemaker implantation (81.8%, 9/11) and mortality due to cardiac causes (18.1%, 2/11) in the CAVB group were significantly higher than those in the normal group and theLBBB group (P<0.05). Female, severe calcification of the aortic valve, too large valve size and deep valve implants were the risk factors for new-onset conduction block after TAVI. ConclusionThe incidence of LBBB and CAVB is high after TAVI, however, both of them do not significantly effect the hemodynamics of the patients. Higher incidence of permanent pacemaker implantation is found in the CAVB group which affects the rate of rehospitalization and mortality. Female patients, severe calcification of the aortic valve, too large valve size and deep valve implants are the risk factors for the new-onset conduction block after TAVI.
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 effect of partial aortic root remodeling for root reconstruction on Stanford type A aortic dissection. Methods From January 2010 to December 2015, 30 patients (25 males, 5 females) underwent partial aortic root remodeling for root reconstruction on Stanford type A aortic dissection with involvement of aortic root. The range of age was from 27 to 72 years, and the mean age was 51.2±8.0 years. The proximal aortic dissection received partial aortic root remodeling, and the operation procedures included partial aortic root remodeling+ascending aortic replacement in 9 patients, partial aortic root remodeling+ascending aortic replacement+hemi-arch replacement in 6 patients, partial aortic root remodeling+ascending aortic replacement+Sun's procedure in 15 patients. The patients were followed up for 10 to 60 months with a mean of 37.9±3.2 months. Preoperative and postoperative degrees of aortic regurgitation were compared. Results All patients survived from the operation, and one patient died from severe pulmonary infection 15 days after operation. The overall survival rate was 96.7% (29/30). One patient died during the follow-up. Two patients underwent aortic valve replacement in the 12th and 15th postoperative month respectively because of severe aortic regurgitation (AI). Up to the last follow-up, trivial or no aortic regurgitation was demonstrated in 24 patients, but mild aortic regurgitation occurred in 2 patients. Conclusion The surgical treatment for aortic root pathology due to Stanford type A aortic dissection is challenging, and partial aortic root remodeling operations could restore valve durability and function, and obtains the early- and mid-term results.
Transcatheter aortic valve replacement (TAVR) has been confirmed to be safety and efficacy for high-risk elderly aortic stenosis, and the clinical effect of TAVR for medium and low-risk aortic stenosis is not worse than that of surgery. The development of surgical techniques and instruments has made cardiologists attempt to broaden the surgical indications. Many elderly and high-risk patients with pure native aortic regurgitation have been treated “off label” with similar techniques, completing artificial valve replacement, restoring valve function and improving the prognosis. However, due to the high requirements of surgical techniques and surgical complications, there is a lack of randomized controlled studies to confirm its safety and effectiveness. Unlike aortic stenosis, native aortic regurgitation presents unique challenges for transcatheter valves. In this article, the authors review current advances in the treatment of aortic valve regurgitation with TAVR.
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.
Patients with bicuspid aortic valve (BAV) are characterized by asymmetric anatomy, severe calcification and combined aortic dilatation. Compared with tricuspid aortic valve stenosis patients, patients with BAV stenosis confront with greater surgical risks in transcatheter aortic valve replacement (TAVR), including paravalvular leak, aortic valve rupture, coronary artery obstruction, atrioventricular block and so on. However, with the advent of new generation of prosthetic valves and optimization of surgical strategies, several studies have shown that TAVR is safe and effective in the treatment of BAV stenosis. Therefore, we aim to provide an overview of the use of TAVR in patients with BAV stenosis.
Objective To evaluate the coronary artery ostium obstruction caused by the commissure of transcatheter heart valve (THV) with the markers on THV under X-ray, which was identified by observing the position relationship between the commissure of THV and the coronary artery ostium from analyzing aortic root computed tomographic angiography (CTA) images after transcatheter aortic valve replacement (TAVR). Methods A retrospective analysis was performed on 25 patients undergoing TAVR who were checked with electrocardiographically gated CTA for the aortic root after the TAVR procedure between January 2020 and December 2021 in General Hospital of Northern Theater Command. The images of THV with the lowest position of non-coronary sinus and the right anterior oblique and caudal in most cases were observed when the THVs were deployed. The position relationships of the three markers on the THV after valve release were recorded, which were divided into three conditions, namely the three markers being averagely distributed, the middle marker being close to left, and the middle marker being close to right. Postoperative CTA images of the patients were analyzed. The angle between the commissure of THV and the coronary artery ostium was measured, and the angles in each group were presented as medium (lower quartile, upper quartile). Results A total of 17 patients were finally included. The angles between the commissure of THV and the left coronary artery ostium were 19.0 (16.0, 31.0)°, 36.0 (15.0, 44.0)°, and 3.0 (3.0, 5.0)° in the markers averagely distributed group (n=7), the middle marker close to left group (n=6), and the middle marker close to right group (n=4), respectively, which were significantly different (P=0.033). The angles between the commissure of THV and the right coronary artery ostium were 43.0 (25.0, 51.0)°, 47.0 (41.0, 57.0)°, and 13.0 (7.5, 21.0)° in the markers averagely distributed group, the middle marker close to left group, and the middle marker close to right group, respectively, which were significantly different (P=0.017). There was significant difference in the obstruction degrees of left coronary artery ostium by the commissure of THV (P=0.008), and no significant difference in the obstruction degrees of right coronary artery ostium (P=0.062). When the middle marker was close to right, there was no more than moderately obstruction on the right coronary artery ostium and no any obstruction on the left coronary artery ostium. When the middle marker was close to left, the obstruction rate of the left coronary artery ostium with more than moderate degree was 4/6 (66.7%) and it was 6/6 (100.0%) for the right coronary artery ostium. Conclusions The degree of coronary artery ostium obstruction by the commissure of THV can be accurately evaluated by using markers on THV. Among them, when the middle marker is close to right, the commissures of THV are least likely to block the coronary artery ostium.
With the expanding indications for transcatheter aortic valve replacement (TAVR) guidelines, combined valvular disease is often encountered in the clinic, and existing relevant studies have shown that preoperative moderate to severe mitral regurgitation is associated with higher mortality. In these patients, the optimal treatment strategy for TAVR with evidence-based heart failure, TAVR with transcatheter mitral intervention, or staging transcatheter therapy are unclear. Therefore, a comprehensive assessment of the anatomy and function of the aortic and mitral valves, as well as an in-depth assessment of the patient’s baseline risk profile, are the basis for an individualized approach to treatment. This article will review the results of the relevant research to better help clinicians diagnose and treat relevant patients.
ObjectiveTo systematically review the clinical outcome of patients with new-onset left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR).MethodsElectronic search was performed in PubMed, EMbase, Cochrane Library, Web of Science, CNKI, Wanfang and CBM databases to identify studies about the new-onset LBBB after TAVR from inception to March 19, 2022. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using Stata 15.0 software.ResultsA total of 17 cohort studies were included, covering 9 205 patients, including 2 202 patients with new-onset LBBB and 7 003 without new-onset LBBB after TAVR. The results of meta-analysis showed that patients with new-onset LBBB after TAVR at 30-day (RR=1.65, 95%CI 1.30 to 2.10, P<0.001) and 1-year (RR=1.30, 95%CI 1.16 to 1.45, P<0.001) all-cause mortality was higher than no new-onset LBBB group. One-year cardiovascular mortality was higher in the new-onset LBBB group (RR=1.47, 95%CI 1.21 to 1.79, P<0.001). In the occurrence of 30-day (RR=1.51, 95%CI 1.10 to 2.08, P=0.011) and 1-year (RR=1.34, 95%CI 1.14 to 1.58, P=0.001) rehospitalization rate, 30-day (RR=3.05, 95% CI 1.49 to 6.22, P=0.002) and 1-year (RR=2.15, 95%CI 1.52 to 3.03, P<0.001) pacemaker implantation, the incidence of patients with new-onset LBBB was higher than that of the no new-onset LBBB group.ConclusionCompared with the patients without LBBB after TAVR, the clinical prognosis of patients with new-onset LBBB after TAVR is poor. In the future, the management and follow-up of the patients with LBBB after TAVR should be further strengthened to improve the prognosis of patients.