Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice

Lurz, Philipp; Besler, Christian; Schmitz, Thomas; Bekeredjian, Raffi; Nickenig, Georg; Möllmann, Helge; Bardeleben, Ralph Stephan von; Schmeißer, Alexander; Atmowihardjo, Iskandar; Estévez‐Loureiro, Rodrigo; Lubos, Edith; Heitkemper, Megan; Huang, Dina; Lapp, Harald; Donal, Erwan

doi:10.1016/j.jacc.2023.05.008

Cited by 63 publications

(16 citation statements)

References 13 publications

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“…This kept the TEE usage time to a minimum, more exactly to only a few minutes, and is in our opinion the main factor behind the better safety outcome. The rate of gastrointestinal bleeding during T-TEER in the TEE group (3/23, 13%) is also in line with registry data [20].…”

Section: Efficacy and Safety Of The Multimodality Imaging Methodssupporting

confidence: 86%

Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging

Patrascu,

Binder,

Alashkar

et al. 2024

JCM

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Background: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by transesophageal echocardiography (TEE). As each patient has unique anatomy and acoustic window, adding transthoracic echocardiography (TTE) and cardiac CT could improve procedural planning and guidance. Objectives: We aimed to assess T-TEER success and outcomes of a personalized guidance approach, based on multimodality imaging (MMI) of patient-tailored four right-sided chamber views (four-right-ch), as depicted by CT, TTE, TEE and fluoroscopy. Methods: Patients were assigned to MMI or classical TEE guidance, depending on TTE acoustic window. In MMI patients, planning included cardiac CT, which determined the fluoroscopic angulations of the specific four-right-ch, while guidance relied heavily on TTE, with minimal intermittent TEE for leaflet grasping and result confirmation. Both TTE and TEE were matched to respective CT and fluoroscopy four-right-ch. TR severity and quality of life (QoL) parameters were assessed from baseline to 12 months. Results: A total of 40 T-TEER patients were included, with 17 procedures guided by MMI and 23 solely by TEE. Baseline characteristics were similar between groups, e.g., age (83.1 ± 4.1 vs. 81 ± 5.3, p = 0.182) or STS-Score (11.1 ± 7.4% vs. 10.6 ± 5.9%, p = 0.813). The primary efficacy endpoint of ≥one-grade TR reduction at 30 days was 94% (16/17) in MMI vs. 91% (21/23) in TEE patients, with two or more TR grade reduction in 65% vs. 52% (p = 0.793). Device success was overall 100%, with no device-related complications, but three TEE-associated cases of gastrointestinal bleeding in the TEE-only group. By 12 months, all 15 MMI and 19 TEE survivors improved NYHA functional class and QoL, e.g., Kansas City Cardiomyopathy Questionnaire Score Δ29.6 ± 6.7 vs. 21.9 ± 5.8 (p = 0.441) pts., 6-min walk distance Δ101.5 ± 36.4 vs. 85.7 ± 32.1 (p = 0.541) meters. Conclusions: In a subset of patients with good TTE acoustic window, MMI guidance of T-TEER is effective and seems to avoid gastroesophageal injuries caused by TEE probe manipulation. TR reduction, irrespective of guidance method, impacts long-term QoL.

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Section: Efficacy and Safety Of The Multimodality Imaging Methodssupporting

confidence: 86%

Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging

Patrascu,

Binder,

Alashkar

et al. 2024

JCM

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“…24 The postmarket study bRIGHT (An Observational Realworld Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device; https:// www.clinicaltrials.gov; NCT04483089) will evaluate the real-world experience using the TriClip G4 system, and the published early 30-day results reinforce the results described herein. 25 We demonstrate, with the first report of a 2-year follow-up and outcomes analysis in subjects treated in the prospective single-arm international TRILUMINATE trial in a European and US heart valve center setting, that the TriClip repair system delivers a high safety profile and sustained clinical effectiveness in treating a patient population with moderate or greater TR and high surgical risk. The reduction in heart failure hospitalization and general hospitalization was more pronounced at 2 years than reported previously, with 84% and 49%, respectively.…”

Section: Discussionmentioning

confidence: 78%

“…24 The postmarket study bRIGHT (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device; https://www.clinicaltrials.gov; NCT04483089) will evaluate the real-world experience using the TriClip G4 system, and the published early 30-day results reinforce the results described herein. 25…”

Section: Discussionmentioning

confidence: 99%

Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial

von Bardeleben,

Lurz,

Sorajja

et al. 2023

Circ: Cardiovascular Interventions

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BACKGROUND: Tricuspid regurgitation (TR) is a common and progressive valve disease with significant mortality and hospitalization burden. Tricuspid transcatheter edge-to-edge repair provides a treatment option for high-risk patients with primary and secondary TR. METHODS: The TRILUMINATE trial ([Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation]; n=85) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of tricuspid transcatheter edge-to-edge repair with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessment was performed at a core laboratory. Outcomes included safety and clinical effectiveness and echocardiographic assessment of TR. RESULTS: At 2 years, TR was reduced to moderate or less in 60% of subjects, and reduction of at least 1 grade was achieved in 85.4% of subjects. TR reduction was sustained in 75% of the patients. While most metrics suggest the majority of favorable remodeling occurred within the first 30 days post-procedure, both right ventricular end diastolic diameter and tricuspid annular plane systolic excursion show signals of continued favorable remodeling through 2 years. Substantial improvements in 6-minute walking distance, New York Heart Association functional class, and Kansas City Cardiomyopathy Questionnaire score were sustained from 30 days to 2 years. Even with low rates of cardiovascular mortality (15.3%) and all-cause mortality (18.7%) noted at 2 years, all-cause hospitalization rate decreased from 1.30 events per patient-year 1 year before device implantation to 0.66 events per patient-year 2 years after the TriClip procedure, representing a reduction of 49% ( P <0.0001). CONCLUSIONS: Tricuspid transcatheter edge-to-edge repair using the TriClip implant was found to be safe and effective, with sustained benefits at 2 years in subjects with symptomatic moderate or greater TR. Repair efficacy was durable at 2 years in 75% of the patients. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03227757.

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“…In the single-arm TRILUMINATE trial, 57% of patients had residual TR ≤ 2 at 30 days, 31 and in the recently published bRIGHT study, 77% of the patients had TR ≤ 2 at 30 days. 32 This better reflects real-world data. To view it from a different perspective, in our study and the previously mentioned studies, which include real-world data, about a quarter of the patients were left with at least severe TR after the procedure.…”

Section: Discussionmentioning

confidence: 83%

Tricuspid edge-to-edge repair for tricuspid valve prolapse and flail leaflet: feasibility in comparison to patients with secondary tricuspid regurgitation

Dannenberg,

Bartko,

Andreas

et al. 2023

European Heart Journal - Cardiovascular Imaging

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Aims Transcatheter tricuspid edge-to-edge repair (T-TEER) has gained widespread use for the treatment of tricuspid regurgitation in symptomatic patients with high operative risk. Although secondary TR is the most common pathology, some patients exhibit primary or predominantly primary TR. Characterization of patients with these pathologies in the T-TEER context has not been systematically performed. Methods and Results Patients assigned to T-TEER by the interdisciplinary Heart Team were consecutively recruited in two European centers over 4 years. Echocardiographic images were evaluated to distinguish between primary and secondary causes of TR. Both groups were compared concerning procedural results. 339 patients were recruited, 13% with primary TR and 87% with secondary TR. Patients with primary TR had a smaller right ventricle (basal diameter 45 vs. 49 mm, p = 0.004), a better right ventricular function (fractional area change 45 vs. 41%, p = 0.001), a smaller right (28 vs. 34cm², p = 0.021) and left (52 vs. 67 ml/m², p = 0.038) atrium, and a better left ventricular ejection fraction (60 vs. 52%, p = 0.005). The severity of TR was similar in primary and secondary TR at baseline (TR vena contracta width pre-interventional 13 ± 4 vs. 14 ± 5 mm, p = 0.19), and T-TEER significantly reduced TR in both groups (TR vena contracta width post-interventional 4 ± 3 vs. 5 ± 5 mm, p = 0.10). These findings remained stable after propensity score matching. Complications were similar between both groups. Conclusion T-TEER confers equally safe and effective reduction of TR in patients with primary and secondary TR.

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Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice

Cited by 63 publications

References 13 publications

Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging

Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging

Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial

Tricuspid edge-to-edge repair for tricuspid valve prolapse and flail leaflet: feasibility in comparison to patients with secondary tricuspid regurgitation

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