J-Valve System Research Articles

Transapical Transcatheter Aortic Valve Implantation with the J-Valve System in Aortic Regurgitation

BackgroundAortic regurgitation (AR) is a condition associated with significant morbidity and mortality, particularly in severe cases. The J-valve system, next-generation transcatheter heart valve (THV), may overcome the procedural challenges associated with treating pure AR. This study reported the outcome of J-valve for treatment of AR. MethodsThis study observed 47 patients undergoing transcatheter aortic valve implantation (TAVI) with the J-Valve system. Diagnostic evaluation included transthoracic echocardiography and multislice computed tomography to assess AR severity and anatomical characteristics essential for TAVI. Follow-ups were conducted at various intervals post-operation to evaluate outcomes. ResultsThe patients had a mean age of 73.0±9.0 years and a median ejection fraction (EF) of 58.0% (IQR, 45.0%-64.0%). The median EuroSCORE II was 3.0% (IQR, 2.0%-6.7%).The procedural success rate was 100%, with no need for a second valve implantation or conversion to sternotomy. Short-term outcomes showed significant improvements in the New York Heart Association (NYHA) functional classification (P<0.001), left ventricular ejection fraction (LVEF) (P=0.009) and left ventricular end-diastolic diameter (LVEDD) (P<0.001). A singular case of valve migration and severe perivalvular leakage (PVL) due to Behçet's disease prompted a revised approach incorporating immunomodulation therapy. ConclusionsTAVI with the J-Valve system presents a viable alternative for managing severe AR, demonstrating high procedural success and substantial clinical improvement. However, the case of valve migration due to Behçet's disease highlights the need for careful preoperative screening and consideration of autoimmune disorders in differential diagnoses.

Transcatheter aortic valve implantation for severe aortic regurgitation using the J-Valve system: A midterm follow-up study.

Transcatheter aortic valve implantation (TAVI) is a well-established intervention for severe aortic valve stenosis. However, its application for severe aortic regurgitation (AR) is still under evaluation. This study aims to present the 3-year follow-up outcomes of the J-Valve system in managing severe AR. The aim of this study was to evaluate the mid-term efficacy and durability of the J-Valve system in the treatment of severe AR and to provide new information on this intervention. In this retrospective, single-center study, we evaluated the prognostic outcomes of patients with AR, who underwent treatment with the J-Valve system at Nanjing Drum Tower Hospital. Consecutive patients who were treated with the J-Valve were included in the analysis. The study focused on the echocardiographic follow-up to assess the effectiveness and durability of the J-Valve system in managing AR. From January 2018 to December 2022, 36 high-risk AR patients treated with the J-Valve system had a procedural success rate of 97.2%, with one case requiring open-heart surgery due to valve displacement. Significant improvements were observed in left ventricular diameter (from 63.50 [58.75-69.50] mm to 56.50 [53.00-60.50] mm, p < 0.001) and left atrial diameter (from 44.00 [40.00-45.25] mm to 39.00 [36.75-41.00] mm, p = 0.003) postsurgery. All patients completed the 1-year follow-up, with an overall mortality rate of 2 out of 36 (5.6%). Among the surviving patients, there was one case of III° atrioventricular block and one case of stroke, both occurring within 90 days postsurgery. After a 3-year follow-up, 15.0% of patients had mild or moderate valvular regurgitation, with no cases of moderate or severe paravalvular leak. Additionally, 89.5% of patients were classified as New York Heart Association class I or II, showing significantly enhanced cardiac function. The J-Valve system has shown positive therapeutic outcomes in treating AR, with notable effectiveness in managing the condition and significant improvements in heart failure symptoms and cardiac remodeling. However, due to the limited sample size and partial follow-up data, it is important to emphasize the need for further research with comprehensive long-term follow-up, to fully validate these results.

Transcatheter aortic valve replacement in patients with quadricuspid aortic valve in a single center.

BackgroundQuadricuspid aortic valve (QAV) is a rare congenital malformation that can present with aortic regurgitation or aortic stenosis (AS)), requiring surgical treatment. Transcatheter aortic valve replacement (TAVR) is an alternative treatment for older patients and its prognosis for QAV therapy remains challenging. We sought to examine our early experience with TAVR in patients with QAV.Materials and methodsProspectively collected data were retrospectively reviewed in patients with QAV undergoing TAVR in our institution.ResultsFive patients with QAV and AR or AS were treated with TAVR between January 2016 and January 2022. The mean age was 73.8 years (range 69–82 years), and the median Society of Thoracic Surgeons score was 7.51% (range 2.668–18.138%). Two patients had type B and three had either type A, D, or F according to the Hurwitz and Roberts classification for QAV. Four patients with pure aortic regurgitation underwent transapical TAVR using the J-Valve system, and the patient with severe AS underwent transfemoral TAVR using the Venus-A system. Procedural success was achieved in all five patients. Trivial paravalvular leak was only detected in one case after the procedure, and one patient received a permanent pacemaker due to high-degree atrioventricular block three days later. The median follow-up period was 18 (12–56) months. After discharge, no deaths occurred during the 1 year follow-up. All patients improved by ≥1 New York Heart Association functional class at 30 days; four patients were in functional class ≤II later in the follow-up period. All patients’ heart failure symptoms improved considerably.ConclusionOur early experience with TAVR in QAV demonstrates these procedures to be feasible with acceptable early results. Further follow-up is necessary to determine the long-term outcomes of this modality.Clinical trial registration[ClinicalTrials.gov], identifier [NCT02917980].

Transcatheter Mitral Valve-in-Valve Implantation With a New Transcatheter Heart Valve for Bioprosthetic Degeneration.

BackgroundTranscatheter mitral valve-in-valve (TMVIV) procedure with aortic transcatheter heart valves has recently become a less invasive alternative for patients with mitral bioprosthetic dysfunction. This study reports the initial experience of TMVIV implantation using the J-Valve System (JieCheng Medical Technology Corporation Ltd., Suzhou, China).MethodsA retrospective observational multicenter study was conducted to evaluate the short-term outcomes of TMVIV. In total, 26 consecutive patients with symptomatic bioprosthetic failure at eight hospitals underwent TMVIV using the J-Valve System between May 2019 and June 2021. Procedural results and clinical outcomes were analyzed using the Mitral Valve Academic Research Consortium criteria.ResultsThe mean age was 75.3 ± 7.1 years and 69.2% of patients were female. The mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 12.3 ± 8.3%. The technical success rate was 96.2%. Nine of the 26 patients (34.6%) were implanted with a J-Valve of a size equal to the internal diameters of the deteriorated prostheses. At the 30-day and 1-year follow-ups, all-cause mortality was 3.8 and 16.0% and the stroke rates were 0 and 12.0%, respectively. Device-related mortality was 0% and the mean mitral valve gradient was 6.4 ± 2.7 mm Hg. No patient experienced device embolization, left ventricular outflow tract obstruction, or mitral valve reintervention. Postprocedural mitral regurgitation was none or trace in all the patients. All the patients were in the New York Heart Association (NYHA) class ≤ II at the last follow-up.Conclusion:Transcatheter implantation of the J-Valve System in high-risk patients with mitral bioprosthetic dysfunction was found to be a reasonable alternative and associated with good short-term outcomes.

Transapical mitral valve-in-valve implantation for failed bioprosthetic valve using the J-valve system with locator device: early and mid-term outcomes.

BackgroundPrior to the approval of the Sapien valve in 2020, there were no commercially available short-frame valves for transapical mitral valve-in-valve (MVIV) implantation. In January 2019, we first attempted the reverse mounted J-valve for transapical MVIV implantation with good clinical results. The present study aimed to explore the safety and effectiveness of transapical MVIV implantation with the J-valve reversely mounted on the delivery system.MethodsPatients who underwent transapical MVIV implantation using the J-valve were analyzed from January 2019 to December 2020 with a 1-year follow-up. Before the procedure, computed tomography (CT) angiography data were analyzed to determine the inner diameter, left ventricular outflow tract (LVOT), and coaxial angel. An oversize rate of 5–10% was used to select the J-valve depending on the scanned inner diameter of the original mitral bioprosthesis. During the procedure, the three U-shape graspers were one-to-one buckled with the three tissue valve struts with the assist of echo and fluoroscopy. The implant depth into the left atrium was a 0–20% part of the J-valve, and the valve was then released under rapid pacing. Post-balloon dilatation was used when needed.ResultsNineteen patients (mean age 70.05±11.19 years), with a mean Society of Thoracic Surgeons score of 8.01%±4.20%, were included. By transesophageal echocardiography, we found that the mean transvalvular gradient was 6.21±2.63 mmHg. The mean follow-up time was 20.31±7.23 months, and the survival rate was 94.74% at the last follow-up. The transvalvular gradient decreased from 15.06±3.00 mmHg at basal to 7.13±2.28 mmHg at the 1-year follow-up (P<0.001). The left ventricular ejection fractions (LVEF) increased from 60.31%±7.30% to 59.94%±7.72% at the 1-year follow-up (P=0.863). Thirteen (81.25%) patients had no or trace paravalvular leak (PVL), two (12.50%) patients had minor PVL, one (6.25%) patient had moderate PVL, and there were no cases of major regurgitation at the 1-year transthoracic echocardiography (TTE) examination results.ConclusionsThe J-valve reversely mounted on the delivery system can be used for transapical MVIV implantation with less operative morbidity and favourable outcomes.

Trans-apical aortic valve implantation for quadricuspid aortic valve with aortic regurgitation using J-valve system: a case reports

BackgroundQuadricuspid aortic valve (QAV) is a rare congenital heart defect usually accompanied with different hemodynamic abnormalities. Due to the rarity of QAV, treatment and prognosis of QAV patients with aortic regurgitation still remain challenging. We here present the first case of a patient with severe QAV regurgitation who underwent successful treatment and performed favorable prognosis with transapical aortic valve implantation (TAVI) using J-Valve system.Case presentationA 62-year-old man experienced intermittent palpitation, shortness of breath and chest pain. Echocardiography revealed congenital QAV with massive aortic regurgitation and mild aortic stenosis, left ventricular enlargement. Aortic valve replacement was successfully performed with TAVI using J-Valve system. The postoperation and follow-up was uneventful.ConclusionTAVI using J-Valve system has emerged as a new high success rate method for treatment of patients with simple non-calcified aortic valve insufficiency.

A novel alternative: transapical transcatheter mitral valve-in-valve implantation using J-Valve for failed bioprosthesis.

BackgroundFailed mitral bioprosthesis has conventionally been treated with redo surgical mitral valve replacement (SMVR). Transcatheter mitral valve-in-valve implantation (TM-VIVI) is emerging as an alternative to SMVR in high-risk patients. We report our experience with transapical TM-VIVI using the J-Valve system.MethodsFrom May 2020 to January 2021, 21 patients with a failed mitral bioprosthesis underwent transapical TM-VIVI without concomitant procedures at Guangdong Provincial People’s hospital. The mean age was 74.62 years. All patients were heavily symptomatic with severe mitral regurgitation and increased trans-prosthetic gradient. The Society of Thoracic Surgeons predicted risk of mortality (STS PROM) and European System for Cardiac Operative Risk Evaluation II (EuroScore II) scores were used and predicted high mortality (STS PROM, 12.91%±9.94%; EuroScore II, 12.04%±10.5%). All the procedures were performed in a hybrid room.ResultsThe success rate was 100% with no conversion to median sternotomy and no intraprocedural death. The mean ventilation time and intensive care unit (ICU) stay were 25±21.44 minutes and 4.14±7.08 days, respectively. No major postoperative complications were observed, except 1 patient suffered pneumonia and required tracheostomy. All patients recovered well. Postoperative echocardiography revealed excellent hemodynamics with no residual mitral regurgitation in 19 patients and mild regurgitation in 2 patients. In a subgroup analysis, no significant differences among procedural and postoperative outcomes were detected in patients with previous aortic-mitral double valve replacement (DVR) compared to other patients.ConclusionsOur results demonstrate the safety and feasibility of transapical TM-VIVI using the J-Valve system, even in patients following DVR.

Transapical Transcatheter Valve Replacement Using J-Valve for Aortic Valve Diseases

The J-Valve system (Jie ChengMedical Technologies, Suzhou, China) is designed specifically for transapical transcatheter aortic valve replacement and has three U-shaped graspers. With the unique structure, the J-Valve is suitable for both aortic stenosis and aortic regurgitation. We used the J-Valve system for patients with aortic valve diseases and observed favorable results. From January 2018 to August 2019, 23 patients underwent transapical transcatheter valve replacement using the J-Valve system. High-risk patients with diseased peripheral vessels (small diameter, heavily calcified, and tortuous arteries), pure aortic regurgitation, and complex prosthetic valve-in-valve cases were enrolled. Ten patients mainly had aortic stenosis, 11 patients had pure aortic regurgitation, and 2 patients had valve-in-valve aortic valve position. The Society of Thoracic Surgeons and European System for Cardiac Operative Risk Evaluation average preoperative scores were 8.9% and 8.7%, respectively. The technique success rate was 91.3% (21 of 23; 1 patient was referred for open surgery and 1 patient received intraoperative valve-in-valve), and 1 patient died of cardiogenic shock after the procedure (mortality 4.3%, 1 of 22). One patient had stroke postoperatively and recovered well; no cases needed to undergo permanent pacemaker implantation. During the follow-up period, 1 patient died of acute heart attack. No moderate or severe paravalvular leakage was found. Transcatheter aortic valve replacement surgery with the J-Valve system is effective, even when it is traumatic and requires the transapical route. The applicability of the J-Valve system in pure aortic regurgitation patients is the advantage of this system.

Transcatheter Aortic Valve Implantation With J-Valve: 2-Year Outcomes From a Multicenter Study

We report the 2-year follow-up outcomes of the J-Valve in the treatment of either aortic stenosis (AS) or pure aortic insufficiency (AI) from a multicenter study. From March 2014 to October 2016, 107 patients with either AS (n= 63) or pure AI (n= 44) were enrolled in a trial and were treated by transcatheter aortic valve implantation with the J-Valve system. All patients except 1 completed a 2-year clinical and echocardiographic follow-up (follow-up rate of 99%). The procedural and clinical outcomes were presented according to Valve Academic Research Consortium-2 criteria. The success rate of the device was 91.5%. All-cause mortality was 4.7% and 10.3% at 30 days and 2 years, respectively. Echocardiographic follow-up showed mild prosthetic valve regurgitation in 1.0% and 6.8% of patients at 30 days and 2 years, respectively. No patient showed more than mild aortic prosthetic regurgitation. At the 2-year follow-up, 97.6% of patients had mild or less than mild paravalvular leak and 99.8% of patients experienced notable improvement in heart failure symptoms (at least 1 NYHA level reduction). We found no major differences in echocardiographic and clinical follow-up between AS and AI, except for a significantly higher transvalvular gradient in the AS cohort (P= .01). This study demonstrated good midterm outcomes of transcatheter aortic valve implantation with the J-Valve system in the treatment of patients with either AS or AI. It suggests that the J-Valve system is a promising alternative therapy in high-risk patients.

A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system

BackgroundThe novel J-Valve (JC Medical Inc, Burlingame, CA, USA) was developed to cope with aortic valvular disease by facilitating accurate positioning. We present the first one-year results regarding the safety and efficacy of the J-Valve system implantation in patients with severe aortic stenosis (AS) or aortic regurgitation (AR) undergoing transapical-transcatheter aortic valve implantation. MethodsThis prospective multicenter study enrolled 107 high-risk patients (mean age 74.4 ± 5.2 years; mean EuroSCORE-I 11.2 ± 1.2%) with severe AS (n = 64) or AR (n = 43), at the three largest cardiac centers in China. The study was fully monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium criteria. ResultsThe success rate of the procedure was 91.6% (98/107). At 1 year, the all-cause mortality was 5.0%, stroke 2%, and rate of new pacemakers 5.0%. Only mild paravalvular leak was reported. Among the patients with AS, the 1-year follow-up demonstrated a sustainable reduction of mean transaortic gradient from 57.7 ± 15.4 mmHg to 15.5 ± 8.3 mmHg. All patients who completed the follow-up reported improvements in New York Heart Association functional class (n = 93) and health-related quality of life as assessed by the EuroQol five dimensions questionnaire index (n = 94). In intergroup comparisons, the 1-year major adverse cardiovascular events-free survival was similar between the groups based on valve disease (AS vs. AR, log-rank p = 0.17) or morphology (tricuspid vs. bicuspid aortic valve, log-rank p = 0.25). ConclusionsOur study provides further evidence on the safety and efficacy of the J-Valve in high-risk patients with AS or AR for surgery.

Transapical Transcatheter Aortic Valve Implantation Using a New TAVI System for High-Risk Patients With Severe Aortic Stenosis

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for high-risk patients with aortic stenosis using the J-Valve system. 30 high-risk patients with severe AS underwent TAVI procedure were enrolled with mean age 74.5±4.5 years and mean logistic Euro-SCORE-I of 28.4±9.6%. All patients were followed up for 6 months. Outcomes were analysed in accordance with the updated standardised endpoints defined by the Valve Academic Research Consortium -2 (VRAC-2) criteria. VARC-2 defined device success was obtained in 93% (28 of 30 patients). No operative mortality was noted. No major complications such as third-degree AV-block, myocardium infraction or cerebrovascular events were noted during procedure and follow-up. Transvalvular PG was decreased at 6 months compared with preoperative state (PG mean: 55.4±14.9 vs 14.6±6.9mmHg p<0.01). No moderate or above degree paravalvular leakage (PVL) was noted. All patients with successful valve implantation were alive with improved exercise tolerance. Our initial result has demonstrated that the J-Valve system has the potential to become a feasible treatment option for high-risk patients with severe AS.

Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study

ObjectiveTranscatheter aortic valve implantation has become a routine procedure to treat screened inoperable or high-risk patients. In this study, we present the first outcome of echocardiographic midterm using a new second-generation transcatheter aortic valve implantation system, the J-Valve system (Jie Cheng Medical Technologies, Suzhou, China), in patients with aortic stenosis or aortic regurgitation. MethodsFrom July 2014 to June 2015, 21 patients with isolated aortic valve disease at high risk for open surgery received transapical transcatheter aortic valve implantation using the J-Valve system. The primary end point was a combined efficacy end point after 1 year, which included all-cause mortality after more than 30 days and failure of current therapy for aortic stenosis or aortic regurgitation requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Secondary end points were cardiovascular mortality, major stroke, and life-threatening, disabling, or major bleeding after 6 and 12 months. ResultsThe mean age of the study cohort was 75.52 ± 5.22 years, the European System for Cardiac Operative Risk Evaluation II score was 11.33% ± 1.28%, and the mean logistic European System for Cardiac Operative Risk Evaluation I score was 31.13% ± 9.68%. Transcatheter aortic valve implantation with the J-Valve system was successfully performed in 19 of the 21 patients (90.5%). For patients with aortic stenosis, 12-month follow-up echocardiography demonstrated an increase in mean effective valve area from 0.62 ± 0.17 cm2 to 1.52 ± 0.35 cm2 and a decrease in transvalvular mean gradient from 61 ± 15 mm Hg to 18 ± 9 mm Hg. All surviving patients (n = 18) reported improvements in at least 1 of the New York Heart Association classes. The combined ratio of successful implantation and absence of adverse events in our cohort (n = 21) was 76.19%. ConclusionsThe J-Valve system exhibits a convincing midterm performance and is a safe and feasible procedure with low perioperative and postoperative complications.

A New Transcatheter Aortic Valve Replacement System for Predominant Aortic Regurgitation Implantation of the J-Valve and Early Outcome.

This study introduces a newly designed transcatheter aortic valve system, the J-Valve system, and evaluates its application in patients with predominant aortic regurgitation without significant valve calcification. We also report the early results of one of the first series of transapical implantations of this device and aim to offer guidance on the technical aspects of the procedure. Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification. Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50 ± 8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co., Ltd., Suzhou, China), a self-expandable porcine valve, in the aortic position at our institution. All patients were considered to be prohibitive or high risk for surgical valve replacement (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.15% to 44.44%; mean, 29.32 ± 7.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed. Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00 ± 77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major post-operative complications or mortality during the follow-up. Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.

Transapical implantation of a new second-generation transcatheter heart valve in patients with pure aortic regurgitation: a preliminary report.

Transcatheter aortic valve implantation (TAVI) has become an effective treatment option for high-risk or inoperable patients with aortic stenosis. However, experience with TAVI for non-calcified aortic regurgitation is still limited. The new J-Valve(™) system is a new second-generation TAVI device that is designed for transapical implantation. It is characterized by three U-shaped, anatomically oriented devices-'graspers' that could facilitate intuitive 'self-positioning' valve implantation and provide extra-radial fixation by embracing the native valve leaflets. Here, we reported the initial experience of TAVI in high-risk patients with pure aortic regurgitation using the J-Valve(™) system.