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2,740 result(s) for "tricuspid valve"
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Transcatheter Valve Replacement in Severe Tricuspid Regurgitation
Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed. In this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy. A total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001). For patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).
Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation
In a randomized trial involving patients undergoing mitral-valve surgery for degenerative mitral regurgitation, the addition of tricuspid repair resulted in a lower risk of the primary outcome, a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation, or death. Tricuspid repair resulted in more frequent permanent pacemaker implantation.
Effect of inferior caval valve implantation on circulating immune cells and inflammatory mediators in severe tricuspid regurgitation
Background Interventional valve implantation into the inferior vena cava (CAVI) lowers venous congestion in patients with tricuspid regurgitation (TR). We evaluated the impact of a reduction of abdominal venous congestion following CAVI on circulating immune cells and inflammatory mediators. Methods Patients with severe TR were randomized to optimal medical therapy (OMT) + CAVI ( n  = 8) or OMT ( n  = 10). In the OMT + CAVI group, an Edwards Sapien XT valve was implanted into the inferior vena cava. Immune cells and inflammatory mediators were measured in the peripheral blood at baseline and three-month follow-up. Results Leukocytes, monocytes, basophils, eosinophils, neutrophils, lymphocytes, B, T and natural killer cells and inflammatory markers (C-reactive protein, interferon-gamma, interleukin-2, -4, -5, -10, and tumor necrosis factor-alpha) did not change substantially between baseline and three-month follow-up within the OMT + CAVI and OMT group. Conclusion The present data suggest that reduction of venous congestion following OMT + CAVI may not lead to substantial changes in systemic inflammation within a short-term follow-up. Clinical trial registration NCT02387697 Graphical Abstract
TRISCEND II: Novel Randomized Trial Design for Transcatheter Tricuspid Valve Replacement
Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation—a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials.
Role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair
Background Severe tricuspid regurgitation (TR) is associated with chronic volume overload and right ventricular remodeling (RVR). Transcatheter tricuspid valve repair (TTVr) reduces TR and can improve quality of life (QoL), but the role of preprocedural RVR on TTVr outcomes remains unclear. Aims To investigate the role of RVR on outcomes after TTVr for severe TR. Methods Consecutive patients undergoing TTVr (61% edge-to-edge vs. 39% direct annuloplasty) for severe TR were retrospectively compared by preexisting RVR which was defined as dilation of RV mid-level diameter (> 35 mm) according to guidelines. QoL was evaluated using NYHA class, Minnesota Living with Heart Failure Questionnaire (MLHFQ), 36-Item Short Form Health Survey (SF-36), and 6-min walking distance (6MWD) 1-month after TTVr. Mid-term mortality and heart failure (HF) hospitalization were assessed through 1 year. Results RVR was present in 137 of 223 patients (61%). Symptoms and QoL improved equally in both groups: ≥ 1 NYHA class (57% vs. 65% of patients with vs. without RVR, respectively), 6MWD (36% vs. 34%), MLHFQ (81% vs. 69%), and SF-36 (68% vs. 65%) improvement. One-year mortality and HF hospitalization were significantly higher in patients with RVR (24% and 30%, respectively) than in patients without (8% and 13%, both p  < 0.05). In multivariable analysis, RVR was independently associated with mortality (HR 2.3, 95%CI (1.0–5.0), p  = 0.04) and the combined endpoint of mortality or rehospitalization (HR 2.0, 95%CI (1.1–3.8), p  = 0.03). Conclusions TTVr was associated with significant QoL improvement after 1 month, irrespective of RVR. Despite increased mortality and rehospitalization for heart failure, TTVr in the presence of RVR still provides substantial symptomatic benefit for patients with severe TR. Graphical abstract Role of preexisting right ventricular remodeling (RVR) in symptoms and prognosis after transcatheter tricuspid valve repair (TTVr).
Effects on tricuspid regurgitation by different techniques for passing permanent pacemaker leads through the tricuspid valve: a randomized, open-label, superiority clinical trial study protocol
Background In recent years, lead-induced tricuspid regurgitation (LITR) has attracted increasing attention. At present, there are two commonly used transvalvular methods for pacing lead wires to enter the right ventricle. The first transvalvular approach involves placing the tip of the pacing lead directly through the tricuspid valve into the right ventricle, including “direct-crossing” and “drop-down.” The second transvalvular approach is to bend the pacing lead so that the reflexed lead body crosses the tricuspid valve and then enters the right ventricle, which is “prolapsing.” However, there are no clinical trials to evaluate or compare the effects of the above two different pacing lead transvalvular approaches on tricuspid regurgitation. In this study, we will perform a randomized clinical trial to understand the effect of different transvalvular lead wire transversal techniques on the incidence of tricuspid regurgitation. Methods Three hundred seventy-six subjects with right ventricular single-chamber pacemaker implantation or dual-chamber pacemaker implantation were recruited in the First Affiliated Hospital of Shantou University Medical College. Participants will be randomized into the direct group (“direct-crossing” and “drop-down”) or the bending group (“prolapsing”). The primary objective will be new tricuspid regurgitation or exacerbation of existing tricuspid regurgitation within 1 year of follow-up. Discussion This study aims to verify whether different transvalvular approaches influence the incidence of LITR, and is expected to provide an optimized method for routine pacemaker surgery and improve the long-term prognosis and quality of life of patients. Trial registration Chinese Clinical Trials Registry ChiCTR2100045558. Registered on April 19, 2021.
Long-term outcomes with medical therapy, transcatheter repair, or surgery for isolated tricuspid regurgitation: a systematic review and network meta-analysis
Background Several transcatheter tricuspid valve (TV) repair devices for tricuspid regurgitation (TR) have emerged. However, few studies have compared transcatheter TV repair with medical therapy (MT) alone or isolated TV surgery. Methods PubMed and EMBASE were searched in February 2024. Studies comparing at least any of the following 2 were included: MT, surgical TV repair, surgical TV replacement, or transcatheter TV repair. The primary outcome was long-term mortality (≧ 1 year). The secondary outcomes were short-term mortality (30-day or in-hospital mortality) and periprocedural complications. We performed a network meta-analysis using a random effects model. Results A total of 25,831 patients from 22 studies (one randomized trial and 21 observational studies) were included. MT alone was associated with higher long-term mortality compared to surgical TV repair (HR [95% CI] 1.72 [1.34–2.23]), surgical TV replacement (HR [95% CI] 1.49 [1.14–1.96]), and transcatheter TV repair (HR [95% CI] 1.52 [1.30–1.78]). Long-term mortality was comparable between transcatheter and surgical interventions. Transcatheter TV repair had a lower risk of short-term mortality (versus surgical TV repair; RR [95% CI] 0.40 [0.22–0.72], versus surgical TV replacement; RR [95% CI] 0.35 [0.19–0.66]) and lower rates of periprocedural complications, including new pacemaker implantation, renal complications, cardiogenic shock than surgical interventions. Conclusions MT alone for TR was associated with higher long-term mortality compared to surgical or transcatheter TV interventions. Transcatheter TV repair had better periprocedural outcomes compared to surgical interventions with similar long-term mortality. Despite the possibility of selection bias, transcatheter TV repair appears to be an attractive option for TR treatment.
Congenital Right Atrial Aneurysm Associated With Tricuspid Valve Dysplasia
Congenital right atrial aneurysm (RAA) is a rare anomaly that may cause arrhythmias, thromboembolism, or heart failure. We report a prenatally diagnosed RAA with coexisting tricuspid valve (TV) dysplasia. Postnatally, the patient showed progressive atrial enlargement, and TV regurgitation. At 9 months, surgery was performed due to high thromboembolic and arrhythmic risk, including aneurysmal wall resection and TV repair. Postoperative recovery was uneventful. In conclusion, this case underscores the need for comprehensive imaging and individualized management in RAA, especially when coexisting valvular abnormalities are present.
Robustness of tricuspid regurgitation reduction at 1 year following edge-to-edge repair for primary tricuspid regurgitation
Background and objective Within recent years, transcatheter tricuspid edge-to-edge repair (T-TEER) has emerged as a safe and effective treatment option in patients with secondary tricuspid regurgitation (TR). However, for primary TR, data on the robustness and durability of TR reduction 1 year following T-TEER is limited. Methods All consecutive patients treated with T-TEER for TR at two high-volume centers between September 2018 and December 2022 were enrolled in a registry. Primary TR was defined as tricuspid valve (TV) prolapse or flail TV leaflets as assessed by pre- and peri-interventional transesophageal echocardiography (TEE). Results 201 patients were included in this analysis, of whom 27 (13.4%) were classified as primary TR and 174 (86.6%) as TR of secondary origin. All-cause mortality during 1-year follow-up was reached by 50 patients (24.9%) [primary: 7 (25.9%), secondary: 43 (24.7%)], and 151 (75.1%) completed follow-up with transthoracic echocardiography (TTE). Patients’ median age was 80 (76–83) years, 112 (55.7%) were female and 181 (90.1%) reported a New-York heart association functional class (NYHA-FC) of III or IV. The remaining baseline clinical and echocardiographic parameters were comparable between the groups, but secondary TR patients had a significantly higher TRI-SCORE (5 (4–8) vs. 7 (5–14), P  = 0.010). In both groups, an immediate reduction of TR-Grade post-intervention was observed. This reduction was sustained at follow-up with 80.0% of the primary TR patients classified as moderate or less and 61.8% of the secondary TR patients. This translated to a significant improvement of NHYA-FC in both groups. Kaplan–Meier analysis revealed no differences regarding rates for all-cause mortality between the groups ( P  < 0.99). Conclusion T-TEER achieves a robust TR reduction in primary TR patients 1 year after intervention with noninferior clinical results to treatment for secondary TR with regards to mortality, re-hospitalization, and NYHA-FC.
Reconstruction of an Unguarded Tricuspid Orifice Using a Simplified Sliding Plasty Technique
Abstract Unguarded tricuspid orifice is a rare anomaly of the tricuspid valve characterized by complete absence of tricuspid valve tissue and chordae on a proportion of the annulus. Management strategies vary widely. We report a case of successful repair of an unguarded tricuspid orifice with a simplified technique. A 35-year-old male presented with severe tricuspid regurgitation and right ventricular volume overload. Intraoperative inspection of the valve revealed an unguarded tricuspid orifice. For repair, sliding plasty of the anterior and posterior leaflets was performed, followed by ring annuloplasty and commissuroplasty. Postoperative, echocardiogram showed minimal residual tricuspid regurgitation and significantly improved right ventricular dimensions. This case highlights the possibility of successful repair of an unguarded tricuspid orifice. If feasible, repair can be a good choice. Unguarded tricuspid orifice is a congenital malformation where a normal orifice between the right atrium and ventricle exists, with complete absence of tricuspid valve tissue and chordae on a proportion of the annulus.