Transcatheter Tricuspid Valve Replacement Research Articles

Safety, efficacy, and clinical outcomes of transcatheter tricuspid valve replacement: One-year follow-up.

The aim was to evaluate the safety and efficacy of TTVR in patients with severe TR at the 1-year follow-up. This project was a single-center, observational study. From September 2020 to May 2021, 15 patients with severe or extremely severe TR at high risk of traditional surgery were enrolled. All patients had preoperative imaging assessments to evaluate the tricuspid valve and the anatomy of the right heart. All patients were planned to treated with the LuX-Valve (Ningbo Jenscare Biotechnology, Ningbo, China). The LuX-Valve was implanted under the intraoperative guidance of TEE and X-ray fluoroscopy. Data were collected at baseline, before discharge, and at 30 days, 6 months, and 1 year postoperatively. The LuX-Valves were successfully implanted in all 15 patients. TR was significantly reduced to ≤ 2 +. One patient died on postoperative day 12 of a pulmonary infection that was considered unrelated to the procedures or the devices. The remaining 14 patients (100.0%) reached the primary end point. One patient (7.1%) was rehospitalized during 1-year follow-up because of device thrombosis. The number of patients who survived at 1 year with New York Heart Association (NYHA) functional class II was higher than that before TTVR (11/14 vs. 0/15, P = 9.11 × 10-4). Patients with peripheral edema and ascites decreased from 100.0 to 46.7% at baseline to 28.6% and 14.3% at 1 year (P = 1.57 × 10-3 and 2.53 × 10-2). TTVR is associated with RV remodeling, increased cardiac output, and improvement in NYHA functional class. Using the LuX-Valve for TTVR to treat patients with severe TR is a feasible and relatively safe method with reliable clinical results. Further studies are needed to determine long-term outcomes.

Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure

BackgroundPatients with long-term tricuspid regurgitation (TR) are mostly accompanied by hepatic, cardiac, and venous remodeling. Transcatheter tricuspid valve replacement (TTVR) device has emerged as a promising alternative to open-heart surgery for TR patients. No study has assessed the impact of TTVR on hepatic, cardiac, and venous remodeling. MethodsTwenty-two patients with TR enrolled in this study underwent TTVR between October 2020 and January 2021. Liver, heart, and veins were reconstructed by three-dimensional computed tomography reconstruction software at baseline and 6 months follow-up. ResultsTwenty-two patients were enrolled in this study. The mean age was 64.8 ± 8.2 years, and all patients had severe or greater TR with multiple comorbidities. The left hepatic lobe volume decreased from 518.8 ± 171.9 ml to 470.4 ± 179.6 ml at 6 months during follow-up (p = 0.049). Evidence of a decrease in three hepatic veins parameters and splenic vein parameters was noted from baseline to 6 months. And a significant decrease in right atrial volume (317.5 ml [interquartile range: 216.1 to 497.3 ml] vs. 266.7 ml [interquartile range: 178.7 to 480.7 ml]; p = 0.003) were observed in the study. ConclusionsSix-month outcomes show that TR elimination by LuX-Valve is associated with the reverse remodeling of liver, heart, and veins. Accordingly, LuX-Valve is a promising alternative for patients presenting with severe TR.

Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies.

Transcatheter tricuspid valve replacement (TTVR) is rapidly emerging as a therapeutic option amongst patients with secondary tricuspid regurgitation. Historical data from surgical tricuspid valve replacement (TVR) studies may serve as a benchmark for the development of TTVR trials. The aim of the study was to investigate the early and late outcomes following isolated surgical TVR. Multiple electronic databases were searched to identify studies on isolated surgical TVR. The prespecified primary endpoint was operative mortality; secondary endpoints were early and late outcomes. Overall estimates of proportions and incidence rates with 95% confidence intervals (CI) were calculated using random-effects models. Multiple sensitivity analyses accounting for baseline characteristics, country and the operative period were applied. Results: A total of 35 studies (5,316 patients) were included in this meta-analysis. The operative period ranged from 1974 to 2019. The overall rate of operative mortality was 12% (95% CI: 9-15), with higher mortality for patients who were operated on before 1995, who had prior cardiac surgeries, or who had liver disease. The most frequent clinical events were pacemaker implantation (10% [95% CI: 6-16]), bleeding (12% [95% CI: 8-17]), acute kidney injury (15% [95% CI: 9-24]) and respiratory complications (15% [95% CI: 12-20]). At follow-up analysis of the bioprosthetic TVR, there was an incidence rate per 100 person-years of 6 (95% CI: 2-13) for death and 8 (95% CI: 5-13) for recurrence of significant tricuspid regurgitation. This meta-analysis provides an overview of the historical clinical outcomes following isolated surgical TVR. These findings can support the development of future clinical trials in the tricuspid space by providing thresholds for clinical outcomes.

First-in-human implantation of the Topaz transcatheter tricuspid valve replacement system.

First-in-human implantation of the Topaz transcatheter tricuspid valve replacement system.

Tough Crossing: A Challenging Case of Valve-in-Valve Transcatheter Tricuspid Valve Replacement

Transcatheter tricuspid valve replacement is a feasible treatment alternative in high-risk patients with degenerated tricuspid prosthesis. Either transjugular or transfemoral approaches are feasible, with the latter being used more commonly. We describe a challenging case of valve-in-valve transcatheter tricuspid valve replacement where we used a long sheath positioned in the right ventricular outflow tract to deliver the transcatheter heart valve.

Hemodynamics of transcatheter tricuspid valve replacement with Lux-Valve.

ObjectiveTranscatheter tricuspid valve intervention (TTVI) has emerged as an alternative treatment option for high-risk and inoperable patients with symptomatic tricuspid regurgitation (TR). However, scarce data in hemodynamic profiles were available on TTVI. In this paper, we attempt to report the hemodynamic profiles of LuX-Valve.Methods30 patients from July 2020 to July 2021 were enrolled in this study. The patient was diagnosed with severe symptomatic TR. The clinical, invasive hemodynamic, and echocardiographic data were collected.ResultsThe surgical success rate was 100%. The cardiac index and stroke volume increased sharply from 2.42(2.27, 2.85) and 47.8(43.6, 62.0) to 3.04 ± 0.63 and 57.2 ± 14.7, respectively. With the elimination of TR and the increase of forward blood flow of the tricuspid valve, the extravascular lung water [798.0 (673.0, 1147.0) vs. 850.3 ± 376.1, P < 0.01] increased subsequently. The peak right atrium pressure decreased after Lux-Valve implantation (21.0 ± 6.4 vs. 19.4 ± 6.5, P < 0.05). On the contrary, the nadir right atrium pressure increased [10.0(8.0, 15.0) vs. 12.0(10.0, 17.0), P < 0.01]. Notably, the right atrium pressure difference dropped sharply from 9.0(5.0, 13.0) to 5.0(4.0, 8.0) after Lux-Valve implantation. There was no significant change in the pulmonary artery pressure. The right atrium volume decreased from 128(83, 188) to 91(67, 167) mL at 1 month and 107(66,157) mL at 6 months. With the remolding of the right heart chamber, the tricuspid annulus diameter shrank significantly from 42.5 ± 5.6 to 36.6 ± 6.3 mm at 1 month and 36.0 (33.0, 38.0) at 6 months.ConclusionInvasive right atrium pressure may act as a potential candidate for TR evaluation and procedural guidance. Elimination of TR by LuX-Valve implantation improves the cardiac output and right atrium pressure and has no significant effect on the pulmonary artery pressure even with the increment of forward blood flow, suggesting the hemodynamic superiority of transcatheter tricuspid valve replacement but needs further study.

Transcatheter Double Valve Replacement to Treat Aortic Stenosis and Severe Tricuspid Regurgitation with 3D Printing Guidance after Mechanical Mitral Valve Replacement

Background: Transcatheter treatments of tricuspid regurgitation (TR) have been emerging as alternatives for high-risk patients. In contrast to the immobilization of the common transcatheter tricuspid device, using a radial force-independent stent valve device at the native tricuspid annular site has several distinct advantages. Case summary: A 76-year-old patient with renal insufficiency who underwent mechanical mitral valve replacement in 2001 and transcatheter aortic valve replacement in 2021 due to severe aortic stenosis presented with chest pain and shortness of breath. Echocardiography suggested that the flow velocities of the mitral mechanical valve and aortic prosthetic valve were both within the normal range, with no significant paravalvular regurgitation; the tricuspid valve exhibited massive regurgitation (VMAX 258 cm/s, PGMAX 27 mmHg). Due to the high surgical risk, we simulated the procedure with a three-dimensional (3D)-printed model and performed transcatheter tricuspid valve replacement using a LuX-Valve (Ningbo Jenscare Biotechnology Co., Ningbo, China). Discussion: We describe transcatheter tricuspid valve replacement using the LuX-Valve and preprocedural guidance with 3D printing. Postprocedural TR was significantly reduced, indicating that 3D printing plays an important role in preprocedural guidance and that the LuX-Valve was safe and practicable for tricuspid valve replacement.

TCT-533 Long-Term Multimodality Imaging and Histological Assessments of a Novel Transcatheter Tricuspid Valve Replacement in Large Animal Model

TCT-533 Long-Term Multimodality Imaging and Histological Assessments of a Novel Transcatheter Tricuspid Valve Replacement in Large Animal Model

Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation: A Systematic Review and Meta-analysis.

Background:The present data aim to evaluate the feasibility of the orthotopic transcatheter tricuspid valve replacement devices, echocardiographic, functional improvements, and mortality rates following replacement in patients with significant tricuspid valve regurgitation.Methods:We systematically searched for the studies evaluating the efficacy and safety of transcatheter tricuspid valve replacement for significant tricuspid valve regurgitation. The efficacy and safety outcomes were the improvements in New York Heart Association functional class, 6-minute walking distance, all-cause death, and periprocedural and long-term complications. In addition, a random-effect meta-analysis was performed comparing outcomes before and after transcatheter tricuspid valve replacement.Results:Nine studies with 321 patients were included. The mean age was 75.8 years, and the mean European System for Cardiac Operative Risk Evaluation II score was 8.2% (95% CI: 6.1 to 10.3). Severe, massive, and torrential tricuspid valve regurgitation was diagnosed in 95% of patients (95% CI: 89% to 98%), and 83% (95% CI: 73% to 90%) of patients were in New York Heart Association functional class III or IV. At a weighted mean follow-up of 122 days, New York Heart Association functional class (risk ratio = 0.20; 95% CI: 0.11 to 0.35; P < .001) and 6-minute walking distance (mean difference = 91.1 m; 95% CI: 37.3 to 144.9 m; P < .001) significantly improved, and similarly, the prevalence of severe or greater tricuspid valve regurgitation was significantly reduced after transcatheter tricuspid valve replacement (baseline risk ratio = 0.19; 95% CI: 0.10 to 0.36; P < .001). In total, 28 patients (10%; 95% CI: 6% to 17%) had died. Pooled analyses demonstrated non-significant differences in hospital and 30-day mortality and >30-day mortality than predicted operative mortality (risk ratio = 1.03; 95% CI: 0.41 to 2.59; P = .95, risk ratio = 1.39; 95% CI: 0.69 to 2.81; P = .35, respectively).Conclusion:Transcatheter tricuspid valve replacement could be an emerging treatment option for patients with severe tricuspid regurgitation who are not eligible for transcatheter repair or surgical replacement because of high surgical risk and poor prognosis.

Current Status and Challenges of Valvular Heart Disease Interventional Therapy

Abstract Valvular heart disease (VHD) is common in the global population, occupying an heavy disease burden among aging population. Currently, it is the booming era of transcatheter VHD treatment, even with superiority than traditional open heart surgery in some clinical outcomes. We collected data sources mainly derived from published articles and conference presentations, including randomized controlled trials, first-in-man studies, clinical registries, and other single- or multi-center and prospective or retrospective clinical studies. This review summarized the relevant devices and researches of transcatheter aortic valve replacement, transcatheter mitral valve repair and replacement, transcatheter tricuspid valve repair and replacement, and transcatheter pulmonary valve replacement. Moreover, possible challenges of interventional therapy for various VHD in the future were discussed as well.

Transcatheter Tricuspid Valve Replacement: A Feasible Solution to a Real-world Problem.

As one of the most prevalent valvular pathologies affecting millions globally, moderate-to-severe tricuspid regurgitation (TR) predisposes to increased mortality. Despite the well-established risk of adverse outcomes, an overwhelming majority of TR patients are managed conservatively due to challenges associated with timely diagnosis, clinical course of the disease, competing comorbities that carry prohibitive surgical risk, and poor surgical outcomes. These challenges highlight the importance of transcatheter tricuspid valve replacement (TTVR) which has restructured TR management in promising and innovative ways. We start with an overview of the pathophysiology of TR considering its implications in management. We then elaborate on the current state of TR management, including its limitations, thereby highlighting the unique role of TTVR. This is followed by a review of perioperative considerations such as careful patient selection, role of multimodality imaging, the various imaging techniques that are available and their contribution towards successful TTVR. We then review the valves that are currently available and under investigation, including the latest data available on device efficacy and safety, and highlight the ongoing clinical trials. TTVR is evolving at an exponential pace and has made its mark in the treatment of severe symptomatic tricuspid regurgitation. The promising results sustained by currently available devices and ongoing investigation of valves under development continue to pave the path for further innovation in transcatheter interventions. However, it is important to acknowledge and appreciate the novelty of this approach, the lack of long-term data on safety, efficacy, morbidity, and mortality, and use the lessons learned from real-world experiences to provide a definitive and reproducible solution for patients with symptomatic TR.

Valve geometry assessment during transcatheter tricuspid valve replacement offered by large field-of-view intravascular ultrasound

Valve geometry assessment during transcatheter tricuspid valve replacement offered by large field-of-view intravascular ultrasound

Transfemoral Tricuspid Valve Replacement in Patients With TricuspidRegurgitation: TRISCEND Study 30-Day Results.

The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk. Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life. In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30days. Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P< 0.001), 6-minute walk distance improved 49.8m (P< 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P< 0.001). Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30days. The TRISCEND II randomized trial (NCT04482062) is underway.

Echocardiographic guidance in transcatheter structural cardiac interventions.

Catheter-based treatment of structural heart diseases (SHD) has seen tremendous advances in the past decades, thanks to the development of new devices and advances in imaging techniques. Today, we have an extensive armamentarium of imaging tools for preprocedural planning, intraprocedural guidance and follow-up of SHD. Intraprocedural guidance is based mainly on transoesophageal echocardiography; however, other imaging modalities are used as complementary or alternative techniques, each of them with its strengths and weaknesses. Thus, a multimodality imaging approach provides added values in this setting. As the field of imaging parallels the continuous technical improvements, this review will describe the state of the art imaging techniques, focusing on echocardiography during procedural guidance of the most common catheter-based interventions, providing tips and tricks for interventional cardiologists: in particular, how to guide transseptal crossing; left atrial appendage closure; transcatheter mitral or tricuspid valve repair or replacement; percutaneous closure of patent foramen ovale and atrial defects; and percutaneous closure of paravalvular leaks. Open challenges for the near future are the need for physicians with specific technical skills and competencies in SHD imaging, more attention to high levels of radiation exposure, and optimisation of intraprocedural and post-procedural evaluation.

Right Ventricular-Pulmonary Arterial Coupling and Afterload Reserve in Patients Undergoing Transcatheter Tricuspid Valve Repair

BackgroundThe right ventricular (RV)–pulmonary arterial (PA) coupling ratio relates the efficiency with which RV stroke work is transferred into the PA. Lower ratios indicate an inadequate RV contractile response to increased afterload. ObjectivesThis study sought to evaluate the prognostic significance of RV-PA coupling in patients with tricuspid regurgitation (TR) who were undergoing transcatheter tricuspid valve repair or replacement (TTVR). MethodsThe study investigators calculated RV-PA coupling ratios for patients enrolled in the global TriValve registry by dividing the tricuspid annular plane systolic excursion (TAPSE) by the PA systolic pressure (PASP) from transthoracic echocardiograms performed before the procedure and 30 days after the procedure. The primary endpoint was all-cause mortality at 1-year follow-up. ResultsAmong 444 patients analyzed, their mean age was 76.9 ± 9.1 years, and 53.8% of the patients were female. The median TAPSE/PASP ratio was 0.406 mm/mm Hg (interquartile range: 0.308-0.567 mm/mm Hg). Sixty-three patients died within 1 year of TTVR, 21 with a TAPSE/PASP ratio >0.406 and 42 with a TAPSE/PASP ratio ≤0.406. In multivariable Cox regression analysis, a TAPSE/PASP ratio >0.406 vs ≤0.406 was associated with a decreased risk of all-cause mortality (HR: 0.57; 95% CI: 0.35-0.93; P = 0.023). In 234 (52.7%) patients with echocardiograms 30 days after TTVR, a decline in RV-PA coupling was independently associated with reduced odds of all-cause mortality (odds ratio [OR]: 0.42; 95% CI: 0.19-0.93; P = 0.032). The magnitude of TR reduction after TTVR (≥1+ vs <1+; OR: 2.53; 95% CI: 1.06-6.03; P = 0.037) was independently associated with a reduction in post-TTVR RV-PA coupling. ConclusionsRV-PA coupling is a powerful, independent predictor of all-cause mortality in patients with TR undergoing TTVR. These data suggest that the TAPSE/PASP ratio can inform patient selection and prognostication following TTVR.

Challenges and future perspectives of transcatheter tricuspid valve interventions: adopt old strategies or adapt to new opportunities?

Tricuspid regurgitation (TR) is a highly prevalent valvular heart disease and is associated with an increased risk of cardiovascular events and death at long-term follow-up. Functional TR accounts for over 90% of TR and is mainly due to annular or right ventricular dilatation. Most often, TR is observed in patients with left-sided valvular heart disease (with or without previous surgical correction) and pulmonary hypertension. Isolated TR is less frequent, though burdened by high surgical mortality. This, together with an incomplete understanding of the disease, has brought to a significant undertreatment in spite of the growing evidence of the impact of severe TR on mortality. Moreover, uncertainties about the appropriate timing for intervention and the predictors of procedural success have contributed to limit TR treatment. Transcatheter tricuspid valve replacement or repair interventions represent novel and less invasive alternatives to surgery and have shown early promising results. The purpose of this review is to provide a complete and updated overview of TR pathology with a special focus on current percutaneous treatment options, future challenges and directions.

Transfemoral transcatheter tricuspid valve replacement after failed leaflet repair.

Transfemoral transcatheter tricuspid valve replacement after failed leaflet repair.

Twelve-month outcomes of the LuX-Valve for transcatheter treatment of severe tricuspid regurgitation.

Severe functional tricuspid regurgitation is associated with adverse clinical outcomes. Conventional surgical risk for patients with advanced tricuspid regurgitation stage is high. Alternative approaches are therefore required. The purpose of this study was to investigate the feasibility, technical details, and midterm outcomes of implantation of a novel radial force-independent orthotopic transcatheter tricuspid valve -the LuX-Valve- in patients with severe functional tricuspid regurgitation. The implantations of the LuX-Valve were performed in six patients with left-sided valvular surgery and secondary massive tricuspid regurgitation. The anatomy of the tricuspid valve and right heart measurements were evaluated by echocardiography and computed tomography in all patients. Conventional right ventricular (RV) function parameters and RV global longitudinal strain were obtained at baseline and 12-month follow-up. LuX-Valve implantation was performed under the guidance of digital subtraction angiography and transoesophageal echocardiography. All patients had successful implantations of LuX-Valves through the right atrium with a substantial reduction in the degree of tricuspid regurgitation. Although one patient with moderate paravalvular leakage died because of right heart failure during three-month follow-up, the five patients who lived had no significant paravalvular leakage, and displayed significant improvements in mean transvalvular gradient, right heart sizes, conventional RV function indices and RV global longitudinal strain, and a reduction in New York Heart Association Functional Class during 12-month follow-up. Transcatheter tricuspid valve replacement with the LuX-Valve was feasible and safe for patients with severe functional tricuspid regurgitation. This strategy seems a promising treatment option for patients at high surgical risk.

Transcatheter valve implantation for degenerated tricuspid bioprosthesis and failed tricuspid ring.

Transcatheter tricuspid valve-in-valve (TViV) and valve in-ring (TViR) implantation have become a viable therapy for a failed tricuspid bioprosthesis. Here we report short (thirty days) and long (one-year) term clinical outcomes of ten patients who underwent TViV at our institution. The electronic databases of New York Presbyterian Columbia Medical Center were retrospectively reviewed for cases of transcatheter tricuspid valve replacement (TViV or TViR). Between 2012 and 2019, data from ten patients who underwent TViV were collected. The primary safety outcome was procedure-related adverse events, including clinically evident cardiac perforation, new pericardial effusion and sustained ventricular arrhythmia. The primary efficacy endpoint was defined as successful valve deployment with total (paravalvular or intravalvular) tricuspid regurgitation (TR) estimated as mild or less. Results are descriptive in nature. A total of ten patients who underwent TViV were included in the study. Of them, 40% presented with isolated tricuspid bioprosthetic stenosis (TS), 20% with isolated TR and 40% with mixed TS and TR. All patients were treated with the SAPIEN valve (first generation, XT, or Sapien 3). The TViV procedure was successful in all patients, and no immediate post-replacement paravalvular leak (PVL) or intra-procedural complications were reported. The primary safety and efficacy endpoints were met in all patients. At thirty-days, all patients were alive and reported significant improvements in symptoms and functional status. Transcatheter tricuspid valve implantation is a safe and effective therapy for degenerative tricuspid bioprosthesis.

Diagnosis and Management of Failed Surgical Tricuspid Valve Annuloplasty

Annular-based strategies for treating tricuspid valve (TV) regurgitation do not always have satisfactory long-term outcomes. Management of failed TV annuloplasty can be challenging and requires a dedicated heart team approach. This review explores the treatment options available for failed TV annuloplasty. Recent developments and novel percutaneous treatment options have emerged as promising alternatives for patients with failed TV annuloplasty. Leaflet-based interventions, valve-in-valve procedures, transcatheter tricuspid valves and new-generation trans-caval valves are all feasible options, which can assure good results whilst minimizing risks for the patient. Failure of tricuspid annuloplasty is not uncommon amongst patients treated with either a tricuspid ring or suture-based device. The complex anatomy, physiology and clinical risk profile should be carefully evaluated on an individual patient-by-patient basis in order to select the most appropriate clinical and percutaneous treatment strategy. Different transcatheter tricuspid valve repair or replacement techniques may provide an attractive alternative treatment option for managing this challenging patient cohort.