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.
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.
Pure native aortic valve regurgitation (NAVR) is one of the common heart valve diseases, and the prognosis of symptomatic chronic NAVR is poor. Although transcatheter aortic valve replacement (TAVR) is currently an "off-label" procedure, it remains the option for patients with high risk for surgery. In this case, an 81-year-old man with multiple comorbidity and high Society of Thoracic Surgeons score, the risk for surgery is rather high. Through the preoperative evaluation by the multidisciplinary heart team, considering that the patient had calcification at the junction of annulus, as well as mild aortic stenosis, after careful consideration, 29# Venus A-Valve was chosen. After the procedure, the symptoms were obviously improved and the follow-up effect was good. Due to various causes of NAVR, great anatomical variation of annulus, little calcification of aortic valve, and lack of anchor point and other problems, the procedure to treat NAVR with TAVR is still difficult. At the same time, there are few valve systems developed for the anatomical characteristics of aortic regurgitation valve. TAVR in the treatment of patients with high risk for surgery still requires long-term practice and technical development.
Transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. The use of new heart valves prosthesis has improved surgical safety and efficacy. This report described a 72-year-old male patient with severe aortic stenosis combined with severe aortic regurgitation, who was evaluated at moderate-high risk of surgery and received a transapical TAVR using the Ken-Valve heart valve. The transcatheter operation time was 8 min, and the blood loss was 50 mL. The tracheal intubation was removed immediately after the surgery. Transesophageal echocardiography on the 4th postoperative day showed that the aortic valve leaflets worked well, and there was no valve orifice and paravalvular leakage. The patient was discharged on the 5th day after the surgery without complications. Transapical TAVR using Ken-Valve was an easy surgical procedure for aortic valve disease, and had short operation time.
Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for severe aortic stenosis. The localization and anchor of many transcatheter heart valves available in the clinic today are dependent on the calcific aortic valve leaflet of patients. We reported here a successful case of transapical aortic valve implantation with Ken-Valve heart valve in an 82-year-old male patient with pure severe aortic regurgitation without native valve calcium. Postoperative follow-up (3 months after the surgery) showed that the cardiac function significantly improved. The echocardiography indicated that the Ken-Valve prosthesis worked well without perivalvular regurgitation. The short-term clinical effect was satisfactory. The Ken-Valve with three position anchors is proved to be suitable for the treatment of pure aortic regurgitation.
We reported a 54-year-old female patient with severe tricuspid regurgitation, who received mechanic valve in the mitral position 15 years ago. The patient’s Society of Thoracic Surgeons score was 8.27%, and was intolerant to open heart surgery, so she was recommended for transcatheter tricuspid valve replacement via right vena jugularis interna. The procedures were guided by echocardiography and X ray fluoroscopy on November 13, 2021, the prosthesis was implanted successfully, and the patient was recoved without any adverse events. After 1 month follow-up, her general condition was apparently improved.
Objective To summarize the early results and clinical experience of using the J-Valve for transcatheter valve-in-valve implantation in patients with degenerated bioprosthesis at different anatomic positions. Methods A retrospective analysis was conducted to evaluate the short-term outcomes of 39 consecutive patients who underwent transcatheter valve-in-valve implantation using the J-Valve System in the Department of Cardiac Surgery of Guangdong Provincial People’s Hospital from April 2020 to August 2021 due to bioprosthetic degeneration at different anatomic positions. Among them, 35 patients underwent transcatheter mitral valve-in-valve (TMViV) implantation, 1 transcatheter aortic valve-in-valve (TAViV) implantation, 1 transcatheter tricuspid valve-in-valve (TTViV) implantation, 1 TMViV implantation with simultaneous TAViV implantation, and another one TMViV implantation with simultaneous transcatheter aortic valve replacement (TAVR) and perivalvular leakage (PVL) closure. Results Among the 35 patients who underwent isolated TMViV implantation, 17 were male and 18 were female with a mean age of 72.6±10.8 years. Mean duration between two operations was 10.5±2.7 years. The mean Society of Thoracic Surgeons and EuroSCORE Ⅱ scores were 12.95%±9.61% and 13.91%±8.94%, respectively. The device success rate was 97.1% and no death occured during the operation. One patient was transferred to thoracotomy due to device displacement, 1 was re-opened for uncontrolled bleeding, and 1 presented left ventricular outflow tract obstruction. One patient underwent craniotomy due to intracranial hemorrhage within 30 days after surgery, and no other complications occurred including death, stroke, permanent pacemaker implantation, cardiac tamponade, or re-hospitalization. The mean follow-up time was 6.0±4.4 months, the mean mitral valve gradient was significantly improved (10.4±2.0 mm Hg vs. 5.5±1.2 mm Hg, P<0.05), and the New York Heart Association class≤Ⅱ in all the patients at the last follow-up. Among the other 4 patients who did not undergo isolated TMViV implantation, the transapical TAViV implantation and the trans-right atrium TTViV implantation were successful without intra- or post-operative complications. The patient who underwent TMViV and TAViV implantation simultaneously via transapical approach died of severe pulmonary hemorrhage and multiple organ failure 16 days after surgery. The other patient who underwent transapical TMViV combined with TAVR and PVL closure died of septic shock 10 days after the surgery. Conclusion Transcatheter valve-in-valve implantation using the J-Valve system is shown to be a safe and effective procedure to treat mitral, aortic and tricuspid bioprosthetic valve dysfunction in high-risk patients, providing a new alternative to surgical surgery for degenerated bioprosthesis at different anatomic positions. However, simultaneous different valves intervention should be very cautious.
ObjectiveTo compare the in-hospital outcomes of transapical transcatheter aortic valve replacement (TA-TAVR) for bicuspid aortic valve (BAV) patients and tricuspid aortic valve (TAV) patients. MethodsPatients (including BAV and TAV patients) who underwent TA-TAVR with the J-ValveTM in West China Hospital from July 2014 to July 2020 were included consecutively. The clinical outcomes of the patients were analyzed. ResultsA total of 354 patients were included in the study, 75 in the BAV group and 279 in the TAV group. There were 229 males and 125 females with a mean age of 72.2±6.0 years. No death occurred during the procedure, and the overall technical success rate was 97.7%. The all-cause in-hospital mortality rate was 1.4%. Twenty (26.7%) patients with BAV and 46 (16.5%) patients with TAV had mild or higher perivalvular leaks immediately after the procedure. No patients with BAV required permanent pacemaker implantation postoperatively, while 13 (4.7%) TAV patients required permanent pacemaker implantation, with an overall pacemaker implantation rate of 3.7%. One (1.3%) BAV patient and 7 (2.5%) TAV patients developed acute kidney injury postoperatively. One (1.3%) BAV patient and 1 (0.4%) TAV patient developed perioperative myocardial infarction. The average postoperative hospital stay was 7.6±3.6 d for BAV patients and 8.6±6.1 d for TAV patients. There was no statistical difference in primary or secondary in-hospital outcomes between BAV and TAV patients (P>0.05). ConclusionCompared to TAV patients, BAV patients have similar in-hospital outcomes, with a low incidence of adverse clinical outcomes, which provides preliminary evidence for its implementation in Chinese patients with a high proportion of BAV.
Abstract： Replacement of the aortic valve and aortic root has been the standard surgical strategy for patients with aortic root aneurysm for many years. Along with the increasing knowledge about the aortic root anatomy and physiology, and complications after aortic valve replacement, the technique of valve-sparing aortic root replacement has developed greatly. We focus on the etiology and classification aortic valve insufficiency, the valve-sparing techniques and clinical outcomes of valve-sparing aortic root replacement in this review.
Objective To investigate the hemocompatibility of the acellular valved bovine jugular vein conduit (BJVC) treated with polyepoxy compound (PC), and discuss its application in cardiovascular surgery and tissue engineering in the future. Methods BJVC treated with PC was regarded as the experiment group and BJVC treated with glutaraldehyde (GA) was considered to be the control group. Rat blood was used for in vitro hemolytic test to calculate hemolytic rates of BJVC, and curve of absorbanceclotting time was drawn. Human blood was used to determine the level of D-dimeride and complement activation C3a des Arg, and test its hemocompatibility in vitro. We divided 20 canines into the experiment group (PC group, n=10) and the control group (GA group, n=10) by random digital table. The BJVC treated with PC or GA were implanted between the pulmonary artery and right ventricle. Ten months after the implantation, thrombus and histological observation were performed to evaluate the blood compatibility in vivo. Results The hemolytic rate in the PC group (0.23%) was lower than that in the GA group (0.35%), which was in accordance with the national standard of hemolytic test (lt;5%). The curve of absorbanceclotting time in the experiment group declined more slowly than that of the control group. The D-dimeride level in the experiment group was significantly lower than that of the control group (0.10±0.01 μg/ml vs. 0.12±0.02 μg/ml , t=3.277, P=0.004), but both of them were within the normal level. The level of complement C3a des Arg in the experiment group was significantly lower than that of the control group (0.74±0.09 μg/ml vs. 1.02±0.19 μg/ml, t=4.183, P=0.001). Eight canines survived 10 months after the implantation in both the two groups, and two other canines in each group died due to ventricular fibrillation. Three canines were discovered to have thrombus in the control group while no thrombus was observed in the experiment group. Conclusion Compared with GA, acellular BJVC treated with PC has superiority in hemocompatibility in vitro and vivo, and has potential application in clinical research and practice.