Real-World Patient Eligibility and Feasibility of Transcatheter Edge-to-Edge Repair or Replacement Interventions for Tricuspid Regurgitation.

Novel transcatheter therapies for tricuspid regurgitation (TR) appear promising, yet their applicability to an all-comer TR population remains unclear. We aimed to assess the feasibility of emerging transcatheter tricuspid therapies in a real-world population with greater than or equal to moderate symptomatic TR. A total of 178 patients were referred to our center between January 2019 and December 2021 for greater than or equal to moderate symptomatic TR and were classified into 4 groups: Investigative (patients eligible for enrollment in the Triluminate, Clasp TR, and TRISCEND trials), off-label clipping, surgery, and medical treatment. A total of 10.7% of the population were deemed eligible for investigative therapies, 20.2% and 19.7% of patients were offered off-label clipping and surgery, respectively, and 49.4% received medical treatment. Common reasons for investigative therapy-related ineligibility were unsuitable anatomy (large tricuspid annulus or wide leaflet coaptation gap) and the presence of significant comorbidities. Compared with the other groups, the investigative group was less likely to harbor concomitant ≥moderate mitral regurgitation, greater than or equal to moderate right ventricular dysfunction or severe pulmonary hypertension (P < .05). At 1 year, there remained a significant reduction in TR severity in the investigative group (P < .001) in comparison with the medical treatment group. However, the results were comparable to off-label clipping (P = .60) and inferior to surgery (P =.04). Exploratory analyses failed to show evidence of differences in the rates of all-cause mortality (P =.40) and heart failure hospitalizations (P = .94) between all groups. Current real-world eligibility of TR patients for emerging transcatheter therapies remains limited, underscoring the need for continued innovative efforts to offer device therapies to a broader TR cohort.

Comparative analysis of MitraClip/TriClip and PASCAL in transcatheter tricuspid valve repair for tricuspid regurgitation: a systematic review and meta-analysis.

BACKGROUND: The edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices-MitraClip, PASCAL, and TriClip-remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR. METHODS: Five databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials. RESULTS: The database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P < 0.01) [TriClip: (MD = -7.4; 95% CI: -9.24, -5.56), MitraClip: (MD = -4.04; 95% CI: -5.03, -3.05), and PASCAL: (MD = -6.56; 95% CI: -7.76, -5.35)]. The procedural success rates and incidence of single leaflet device attachment (SLDA) were similar across all devices. Furthermore, there were no significant differences in mortality, stroke rates, or major bleeding events among the three devices. CONCLUSION: The TriClip outperforms the MitraClip and PASCAL in reducing vena contracta width, indicating greater effectiveness for severe tricuspid regurgitation. All devices show similar safety profiles and procedural success rates. Further research is needed to confirm these results.

His-bundle pacing from the right atrium: Solving pacemaker implantation challenges post-TriClip.

INTRODUCTION: This case report highlights the novel role of His-bundle pacing (HBP) from right atrium, not just for preserving cardiac function, but also for avoiding interference with TriClip devices. METHODS AND RESULTS: A 78-year-old female with severe tricuspid regurgitation received two TriClip devices. Postprocedure, frequent significant sinus pauses required a pacemaker. HBP was chosen to avoid lead complications. Under local anesthesia, a His pacing lead was inserted via the axillary vein using specialized catheter. Follow-ups over 2.5 years showed stable parameters with no complications. CONCLUSION: HBP is effective for patients with TriClip devices, ensuring optimal cardiac function and lead stability.

Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study.

BACKGROUND: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life. OBJECTIVES: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR. METHODS: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory. RESULTS: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001). CONCLUSIONS: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757).

TriClip G4: A game-changer for tricuspid valve regurgitation treatment.

Tricuspid valve regurgitation, or TR, is a difficult-to-manage condition. In addition to EVOQUE, percutaneous annuloplasty, and surgical repair, the TriClip G4 system has been added to the interventional therapeutic choices for TR. Recently, the Food and Drug Administration (FDA) approved the use of the TriClip G4 device to treat patients with symptomatic, severe TR who have received optimal medication therapy but are at intermediate or higher risk of surgery. This review attempts to offer a thorough examination of the procedural features, learning curves, results of the device and compares the TriClip G4 system to other interventional therapies for TR. TriClip G4 has shown to have promising results in pivotal clinical trials, be cost-effective, and improve the quality of life of patients. Furthermore, it has its unique advantages against other conventional techniques and devices.

Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. OBJECTIVES: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment. RESULTS: Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume. CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089).

Pharmacological Considerations during Percutaneous Treatment of Heart Failure.

Heart Failure (HF) remains a global health challenge, marked by its widespread prevalence and substantial resource utilization. Although the prognosis has improved in recent decades due to the treatments implemented, it continues to generate high morbidity and mortality in the medium to long term. Interventional cardiology has emerged as a crucial player in HF management, offering a diverse array of percutaneous treatments for both acute and chronic HF. This article aimed to provide a comprehensive review of the role of percutaneous interventions in HF patients, with a primary focus on key features, clinical effectiveness, and safety outcomes. Despite the growing utilization of these interventions, there remain critical gaps in the existing body of evidence. Consequently, the need for high-quality randomized clinical trials and extensive international registries is emphasized to shed light on the specific patient populations and clinical scenarios that stand to benefit most from these innovative devices.

Transcatheter Edge-to-Edge Repair for Acute Papillary Muscle Rupture After Transvenous Lead Extraction in a d-TGA.

We present a case of a patient known for dextrotransposition of the great arteries corrected with a Mustard procedure, in whom severe mitral valve regurgitation secondary to transvenous lead extraction was successfully repaired with transcatheter edge-to-edge repair using the TriClip device (Abbott Vascular).

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. METHODS: The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. RESULTS: The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7 ± 0.7 cm with a range of 2.5 to 6.2 cm. From the TG SAX view, the coaptation gap measured 8.1 ± 3.1 and 5.2 ± 2.3 mm in the central and mid regions of the anterior-septal coaptation line and 6.6 ± 3.2 and 3.8 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7 ± 2.4, 5.2 ± 2.4, and 4.6 ± 3.0 mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7 mm, 7 to 10 mm, and >10 mm. CONCLUSION: A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.

Trans-oesophageal echocardiography-guided implantation of a cardiac resynchronization therapy pacemaker and successful ablation of the atrioventricular node after TriClip: case report.

Background: Edge-to-edge intervention is the most common trans-catheter procedure performed for isolated severe tricuspid regurgitation in high-surgical-risk patients. However, it creates an obstacle for future right ventricular (RV) procedures such as implantation of cardiac implantable electronic devices (CIEDs). Reports of the management of CIED implantation after tricuspid edge-to-edge therapy are scarce. Case summary: A 76-year-old woman suffered from severe tricuspid regurgitation with New York Heart Association three symptoms despite optimal medical therapy. After a thorough evaluation, the heart team recommended the TriClip procedure as the treatment of choice. However, 12 months after a successful TriClip procedure, rapid atrial fibrillation needed to be addressed with CIED implantation and atrioventricular (AV) node ablation. Pre-procedural planning included the intended posterior location of the CIED to avoid interference with the implanted clip and future AV node ablation. With an additional left ventricular lead positioned anteriorly to the RV lead, the posterior position of the RV lead was secured. Under peri-procedural trans-oesophageal echocardiography (TEE), the planned procedures were performed successfully. Discussion: A blind manoeuvring of the RV lead may damage the edge-to-edge tricuspid device. In addition, friction due to an overly close contract between the RV lead and the edge-to-edge device may damage the RV lead. A successful and safe CIED implantation and atrioventricular node ablation can be performed after tricuspid edge-to-edge therapy with careful planning and its precise execution under TEE surveillance.

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

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality. OBJECTIVES: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory. RESULTS: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. CONCLUSIONS: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089).

Effective 3 Leaflet Grasping During TriClip Procedure: The "3-Point" Buzzer Beater.

To the best of our knowledge, this is the first report of simultaneous grasping of the 3 leaflets during TriClip (Abbott Cardiovascular) implantation. The final valve configuration with a triple orifice resembled the result of the clover surgical technique. This technique should be considered in selected cases of challenging grasping.

Case report: Transcatheter edge-to-edge repair after prior surgical tricuspid annuloplasty.

Residual and recurrent tricuspid regurgitation may occur frequently after surgical tricuspid valve repair. However, reoperation for tricuspid regurgitation is rare, although many patients are again highly symptomatic. Tricuspid transcatheter edge-to-edge repair (TEER) is a promising therapy for severe tricuspid regurgitation. Herein, we report a 77-year-old woman with recurrent symptomatic massive tricuspid regurgitation 2 years after sutured annuloplasty of the tricuspid valve. TEER was successfully performed using the TriClip® device and tricuspid regurgitation was reduced to a mild degree. In conclusion, tricuspid TEER is feasible following surgical suture annuloplasty. TEER is an alternative option for patients with a failed previous annuloplasty repair for tricuspid regurgitation to undergo a less invasive treatment rather than a potentially higher-risk reoperation.

[Tricuspid regurgitation: transcatheter treatment by TriClip®]. / Insuffisance tricuspide. Traitement transcathéter par TriClip®.

Tricuspid regurgitation (TR) is not rare and has been associated with poor clinical outcomes when severe. The etiology of TR is functional in most cases and is usually associated with left-sided valvular heart disease. Severe TR is responsible for right heart failure and may evolve to global heart failure. Current echocardiographic classification includes several grades (trivial, moderate, severe, massive, torrential TR) which influence patients' prognosis in an incremental manner. Management of patients with severe TR is discussed in Heart Team after evaluation of surgical risk. The TRI-SCORE may be used to evaluate the intra-hospital mortality risk in case of isolated tricuspid surgery. Isolated TR surgery is rarely performed as surgical risk outweighs expected clinical benefits. Transcatheter treatment of severe TR may be considered in highly selected cases. Transcatheter edge-to-edge repair (TEER) restores leaflets coaptation. First tricuspid TEER procedures were performed with the MitraClip® (Abbott, Santa Clara, CA, USA) device, but a specific device has been developed: the TriClip® (Abbott). The prospective multicenter TRILUMINATE trial evaluated the TriClip® procedure in patients with symptomatic moderate to severe TR and high surgical risk. The results show a good efficacy with reduction of post-procedural TR grade and increase in NYHA functional class, 6-minute walking test distance, right ventricular function, and quality of life at 1 year. Other devices are currently being evaluated or in development (i.e., transcatheter tricuspid implantation). Non-surgical TR management is likely to evolve and improve significantly soon.

L'insuffisance tricuspide (IT) est une valvulopathie assez fréquente dans la population et qui est associée à un mauvais pronostic lorsqu'elle est modérée à sévère. Elle est le plus souvent fonctionnelle et liée à une valvulopathie du cœur gauche. Cliniquement, elle se marque par le développement de signes d'insuffisance cardiaque droite avec évolution vers une décompensation cardiaque globale. La classification échocardiographique actuelle distingue plusieurs stades (IT minime, modérée, sévère, massive et torrentielle) qui influencent le pronostic de façon incrémentielle. La prise en charge est discutée de manière collégiale après stratification du risque opératoire, dont l'évaluation est facilitée par le TRI-SCORE (risque de mortalité intra-hospitalière post-opératoire de chirurgie isolée de la valve tricuspide). La prise en charge chirurgicale d'une IT isolée est rarement pratiquée en raison d'un risque opératoire souvent élevé. Une prise en charge percutanée peut être envisagée dans certains cas, selon les limitations anatomiques. La technique de réparation bord à bord au niveau tricuspidien permet de restaurer une coaptation valvulaire par accolement des feuillets. Initialement réalisée à l'aide du système MitraClip® (Abbott, Santa Clara, CA, USA), il existe maintenant un système dédié spécifiquement à la tricuspide : le TriClip® (Abbott), dont la dernière génération existe en quatre tailles. Le TriClip® a été évalué dans l'étude prospective multicentrique TRILUMINATE chez des patients avec IT modérée à sévère symptomatique à haut risque chirurgical. La procédure a montré une efficacité avec réduction rapide du grade d'IT et amélioration de la classe fonctionnelle NYHA, de la distance de marche à 6 minutes, de la fonction ventriculaire droite et de la qualité de vie à un an. D'autres dispositifs sont en cours d'étude ou en développement (implantation tricuspide percutanée). La prise en charge non chirurgicale de l'IT devrait se développer de manière significative dans le futur.

Deep sedation vs. general anesthesia for transcatheter tricuspid valve repair.

Background: Transcatheter tricuspid valve repair (TTVr) is routinely performed under general anesthesia (GA). This study aimed to investigate whether TTVr procedures can be performed effectively and safely without GA but using deep sedation (DS). Methods: We performed a retrospective analysis of 104 patients from three centers who underwent TTVr between 2020 and 2021. The primary performance endpoints were technical success and severity of TR assessed at the time of discharge. The safety outcome was a composite of in-hospital complications, including occurrence of death, conversion to surgery, major adverse cardiac and cerebrovascular events, major vascular complications, or occurrence of pneumonia. Results: Sixty-four procedures were performed in GA and 40 procedures were performed in DS. The groups did not differ in age, EuroScore II, TR severity, ventricular function, or hemodynamic parameters. Technical success was achieved in 92.5% of the patients in the DS group and in 93.6% of the patients in the GA group (p = 0.805). In none of the patients intraprocedural conversion from DS to GA was required. There was no difference in total duration of the procedure, and number of devices implanted. The degree of TR was ≤2+ in 77.5% of the patients in the DS group and in 74.2% of the patients in the GA group (p = 0.705). The composite safety endpoint did not differ between the groups (2.5 vs. 6.3%, p = 0.384). The total duration of hospital stay was shorter in patients who underwent TTVr in DS compared to those who underwent TTVr in GA (6 [5, 9] days vs. 8 [6, 11] days; p = 0.011). Conclusion: Performing TTVr in DS was effective with similar procedural results, and was safe with similar low complication rates compared to GA.

Innovative medical technologies in the percutaneous treatment of tricuspid regurgitation in Poland.

Tricuspid regurgitation (TR) usually develops secondarily to left-sided heart diseases, whereas primary lesions to the valve apparatus is less common. Untreated severe TR has a poor prognosis and surgical treatment, i.e., valve repair or replacement, is the only treatment option with class I recommendation. However, cardiac surgical procedures may be associated with a high risk of complications. Recent advances in percutaneous approaches to managing structural heart diseases, especially mitral valve diseases, have enabled the implementation of this therapeutic strategy in the population of patients with TR. This paper presents data on the clinical efficacy, cost-effectiveness and expected population size for one of these procedures, namely the TriClip TTVr System procedure. Its efficacy was assessed in the TRILUMINATE study involving 85 patients with co-morbidities and at high surgical risk. After 1 year of follow-up, the reduction in the TR grade was reported in 71% of patients. Clinical improvement in New York Heart Association functional class, a 6-minute walk test, and the quality of life were also observed. A published analysis comparing percutaneous treatment modalities with a drug therapy based on data from medical registers was utilized, and propensity score matching was also employed. Percutaneous treatment reduced 1-year mortality and rehospitalization risk. The economic analysis showed the use of TriClip TTVr System is cost-effective: the cost of an additional quality-adjusted life year ranged from approximately PLN 85,000 to PLN 100,000, which is below the official threshold in Poland. The potential annual number of candidates for this treatment modality in Poland is estimated at 265.