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.
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.
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.
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 report our experience with enhanced recovery after surgery (ERAS) protocol in patients undergoing transapical transcatheter aortic valve implantation (TAVI) and to determine perioperative predictors for ERAS failure. Methods Between May 2018 and January 2019, 80 patients undergoing TAVI in our hospital were recruited. Among them, 40 patients (24 males, 16 females, aged 73.0±5.0 years) successfully received ERAS, defined as successful extubation in operating room (an ERAS group) and the other 40 patients (28 males, 12 females, aged 73.0±7.0 years, a non-ERAS group) failed to perform ERAS. Results Compared with the non-ERAS group, patients in the ERAS group were associated with a significantly lower incidence of postoperative complications (30.0% vs. 52.5%, P=0.04), shorter postoperative ICU stay (2.2±0.4 d vs. 4.0±4.8 d, P=0.00) and hospital stay (7.0±2.3 d vs. 9.5±4.8 d, P=0.00), and less medical cost (311±20 thousand yuan vs. 347±80 thousand yuan, P=0.00). Independent predictors of ERAS failure were poor preoperative heart function and elevated B-type natriuretic peptides. Conclusion ERAS protocol is feasible and effective in patients undergoing TAVI. Poor preoperative heart function is an independent predictor of failure in early extubation which, in turn, is associated with prolonged ICU and hospital stay and dramatic worsening of patient outcomes.
ObjectiveTo compare the early clinical efficacy and safety of transapical transcatheter aortic valve implantation (TA-TAVI) with surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS). MethodsA retrospective study was conducted on patients with severe AS admitted to the Department of Cardiovascular Surgery, The First Affiliated Hospital of University of Science and Technology of China from January 2020 to March 2024. According to the surgical method, patients were divided into a SAVR group and a TA-TAVI group, and the clinical data of the two groups were compared. ResultsA total of 71 patients were included, with 45 in the SAVR group, including 33 males and 12 females, aged 16-75 (60.89±10.88) years; 26 in the TA-TAVI group, including 15 males and 11 females, aged 61-83 (72.85±5.53) years. The results showed that postoperative aortic valve transvalvular flow velocity [(2.31±0.38) m/s vs. (2.60±0.50) m/s, P=0.019] and transvalvular pressure gradient [(21.09±6.03) mm Hg vs. (28.20±10.79) mm Hg, P=0.001] in the TA-TAVI group were lower than those in the SAVR group. In terms of left ventricular end-diastolic diameter, both preoperative [(56.73±7.74) mm vs. (52.36±7.00) mm, P=0.017] and postoperative [(52.61±7.18) mm vs. (48.04±4.78) mm, P=0.010] values in the TA-TAVI group were larger than those in the SAVR group. In terms of left ventricular ejection fraction, the preoperative value in the TA-TAVI group was lower than that in the SAVR group (58.00%±13.84% vs. 64.87%±7.63%, P=0.026), but there was no statistical difference between the two groups after surgery (P=0.670). The operation time and drainage volume on the first day after surgery in the TA-TAVI group were shorter or lower than those in the SAVR group (P<0.05). There was no statistical difference between the two groups in the postoperative hospital stay, ICU stay, or postoperative mechanical ventilation time (P>0.05). In addition, no serious complications occurred in patients after SAVR, while perivalvular leakage (2 patients), third-degree atrioventricular block (1 patient), and death (3 patients) occurred in the TA-TAVI group. ConclusionFor elderly patients with severe AS and poor cardiac function, TA-TAVI technology has minimal surgical trauma, high safety and effectiveness, and is a safe and effective treatment option besides traditional surgical operations.
ObjectiveTo compare the clinical outcomes of transcatheter aortic valve implantation (TAVI) in oncology and non-oncology patients with severe aortic stenosis (AS).MethodsA computer-based search in PubMed, The Cochrane Library, EMbase, CBM, CNKI and Wanfang databases from their date of inception to December 2021 was performed, together with reference screening, to identify eligible clinical trials. Two investigators screened the articles, extracted data, and evaluated quality independently. RevMan 5.3 and Stata 12.0 softwares were used for meta-analysis.ResultsThe selected 8 cohort studies contained 57 988 patients, including 12 335 cancer patients and 45 653 non-cancer patients. The results of meta-analysis showed that in patients with cancer, the 30-day mortality [OR=0.74, 95%CI (0.65, 0.84), I2=0%, P<0.000 01], stroke [OR=0.87, 95%CI (0.76, 0.99), I2=0%, P=0.04] and acute kidney injury [OR=0.81, 95%CI (0.76, 0.85), I2=49%, P<0.000 01] were lower than those in patients without cancer. The 1-year mortality [OR=1.46, 95%CI (1.15, 1.86), I2=62%, P=0.002] and late mortality [OR=1.51, 95%CI (1.24, 1.85), I2=61%, P<0.000 1] were higher in patients with cancer.ConclusionIt is effective and safe in cancer patients with severe AS undergoing TAVI. However, compared with patients without cancer, it is still high in long-term mortality, and further study of the role of TAVI in cancer patients with AS is necessary.
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.
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.
