Transcatheter Tricuspid Valve Repair Research Articles

Transcatheter tricuspid valve intervention in the presence of a cardiac implantable electronic device; state of the art review.

A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs.

Tricuspid regurgitation and heart failure: the fate of treated vs. untreated cohort in the percutaneous era.

Tricuspid regurgitation (TR) is associated with heart failure (HF) and reduced survival. Within a short-time period, transcatheter tricuspid valve repair or replacement (TTVR/TTVr) for TR has evolved from innovation to clinical reality. The present study's aim is to provide 1-year results between TR patients treated with TTVR and TTVr compared with untreated patients, in terms of cardiac survival, rehospitalization, right-side HF symptom development, and New York Heart Association (NYHA) improvement. Seventy-seven patients (pts) have been prospectively inserted into a dedicated database from January 2020 till January 2023. Twenty-six patients (33.8%) have been treated with TTVR/r [treated group (TG)], and 51 pts (66.2%) have been left untreated with medical therapy optimization [untreated group (UNTG)]. Analysing the cardiac death between the two groups, there was a significant statistical difference since TG has less incidence of exitus in the general population (P = 0.05). Concerning HF hospitalization, TG has a lower incidence with a P = 0.005. In TG, there was a significant improvement in NYHA class at follow-up (FUP) (P = 0.001) as well as an improvement in right-side HF symptoms (P = 0.001). This study shows that treatment in the case of TR with right-side HF has a positive impact on cardiac death and HF hospitalization at 1 year. And there is a significant improvement in clinical and echocardiographic status at FUP in the TG.

Worsening of mitral regurgitation after successful transcatheter tricuspid valve repair.

Worsening of mitral regurgitation after successful transcatheter tricuspid valve repair.

A decade's summary of transcatheter tricuspid valve repair.

Tricuspid regurgitation (TR) is the most common pathology for the tricuspid valve. Moderate to severe TR is associated with morbidity and adverse outcomes. The concept that TR resolves on its own if the underlying disease is successfully treated has proven to be false. Only a few patients with significant TR are deemed suitable for surgery. Given the late presentation of patients with high perioperative risks and substantial perioperative mortality, the development of transcatheter therapies and the experience gained with transcatheter aortic valve implantation operations have turned attention towards treating this challenging group of patients. In this article, we review the treatment options and highlight the role of transcatheter valve therapies in patients with severe TR.

Artificial intelligence-analyzed computed tomography in patients undergoing transcatheter tricuspid valve repair

BackgroundBaseline right ventricular (RV) function derived from 3-dimensional analyses has been demonstrated to be predictive in patients undergoing transcatheter tricuspid valve repair (TTVR). The complex nature of these cumbersome analyses makes patient selection based on established imaging methods challenging. Artificial intelligence (AI)-driven computed tomography (CT) segmentation of the RV might serve as a fast and predictive tool for evaluating patients prior to TTVR. MethodsPatients suffering from severe tricuspid regurgitation underwent full cycle cardiac CT. AI-driven analyses were compared to conventional CT analyses. Outcome measures were correlated with survival free of rehospitalization for heart-failure or death after TTVR as the primary endpoint. ResultsAutomated AI-based image CT-analysis from 100 patients (mean age 77 ± 8 years, 63% female) showed excellent correlation for chamber quantification compared to conventional, core-lab evaluated CT analysis (R 0.963–0.966; p < 0.001). At 1 year (mean follow-up 229 ± 134 days) the primary endpoint occurred significantly more frequently in patients with reduced RV ejection fraction (EF) <50% (36.6% vs. 13.7%; HR 2.864, CI 1.212–6.763; p = 0.016). Furthermore, patients with dysfunctional RVs defined as end-diastolic RV volume > 210 ml and RV EF <50% demonstrated worse outcome than patients with functional RVs (43.7% vs. 12.2%; HR 3.753, CI 1.621–8.693; p = 0.002). ConclusionsDerived RVEF and dysfunctional RV were predictors for death and hospitalization after TTVR. AI-facilitated CT analysis serves as an inter- and intra-observer independent and time-effective tool which may thus aid in optimizing patient selection prior to TTVR in clinical routine and in trials.

Overview of 2024 FDA Advisory Panel Meeting on the TriClip transcatheter tricuspid valve repair system

Tricuspid regurgitation (TR) is common and associated with significant mortality and morbidity. Because the effectiveness and safety of medical and surgical treatments are limited, there is a significant unmet need for the treatment of this disease. Therefore, there is a growing market for percutaneous devices that offer safer, less invasive, and more effective treatment options in this patient population. On February 13, 2024, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Devices Panel to discuss the safety and effectiveness of the TriClip Transcatheter Valve Repair System (Abbott, Santa Clara, CA, USA). Several important points were discussed, including newly published data from the TRILUMINATE Pivotal study, the use of patient-oriented outcomes for device approval, and a discussion about training requirements and rollout plans when approving a breakthrough device. In this manuscript, we summarize the data presented by the sponsor and FDA and describe the deliberations and discussions during the meeting.

Transfemoral leadless pacemaker implantation after tricuspid valve surgery and intervention

Abstract Background and Purpose Pacemaker (PM) implantation after surgical or transcatheter tricuspid valve (TV) repair or replacement may be challenging. Transcatheter leadless pacemaker (LPM) implantation has become a routine procedure and is frequently adopted in patients without the need for an atrial lead, in cases with cardiac implantable device infection or in patients with marked comorbidities. The use of LPM in patients with previous TV repair or replacement has only been described in singular cases in literature. We present our single center experience of LPM implantation after TV repair. Methods Patients with a history of TV repair or replacement who underwent LPM in our institution between 01/2020 and 11/2023 were retrospectively analyzed. All patients underwent routine clinical follow-up investigations including LPM interrogation and transthoracic echocardiography to assess for TV status. For LPM implantation right anterior oblique (RAO) and left anterior oblique (LAO) caudal fluoroscopy projections were utilized to enable LPM device passage across the TV. Results The study population consisted of 10 patients (9 females, mean age 74.0±10.0 years). Two patients had a history of surgical TV annuloplasty repair and two patients a history of surgical valve replacement, four patients of transcatheter TV repair (one through the mitral clip), one patient of transcatheter valve-in-ring bio prosthesis implantation prosthesis after previous surgical ring deployment and one patient transcatheter TV replacement (Figure1). All patients suffered from permanent atrial fibrillation previous to implantation procedures. Three patients were on chronic hemodialysis therapy before LPM implantation. LPM systems were successfully implanted in all cases with a mean procedure time of 43.5±26.5 minutes and a mean fluoroscopy time of 5.9±5.5 minutes and a radiation dose of 1148,7±1424,9 cGy·cm2. For fluoroscopically guided TV crossing a mean LAO angle of 43.6±14.1° (range 22 to 53°) and caudal angle of 8.5±6.9° (range 0 to 20°) was utilized (Figure 2). The LPM device was positioned in the first positioning attempt in a right ventricular high septal localization in 8 cases. Mean pacing threshold was 0.36±0.07 V at 0.25 ms, with a mean sensing amplitude of 10.5±2.9 mV and a mean of 853±324 Ohms pacing impedance. No periprocedural complications occurred. Mean duration of follow-up was 8.1±9.2 months. There were no newly developed TV regurgitations noted. Pacing thresholds (0.37±0.1 V/0.25 ms), sensing amplitude (11.8±4.5 mV) as well as pacing impedances (865±365 Ohms) remained stable until the last follow-up investigation. Conclusion LPM implantation was feasible in patients with a history of TV repair or replacement. LPM implantation was safe and effective in various modalities of TV repair. LPM may be an alternative to conventional pacemaker implantations as well as surgical lead placement in selected patients.Figure 1.Figure 2.

Atrial fibrillation after transcatheter tricuspid valve repair: rhythm control strategies and outcomes

Abstract Background Transcatheter tricuspid valve (TV) repair emerged as a viable treatment option in patients with severe tricuspid regurgitation and high operative risk. Although atrial fibrillation (AF) is common in these patients, the prognostic value of maintenance of sinus rhythm (SR) after transcatheter TV repair is unknown. Purpose We sought to assess the prevalence and efficacy of rhythm control strategies and impacts of maintenance of sinus rhythm on outcomes after transcatheter TV repair. Methods All patients undergoing transcatheter TV repair in our center between April 2017 and December 2022 were included in this single-center retrospective analysis. Patients who maintained SR throughout the follow-up (FU) were compared to patients who did not. The composite study endpoint included death from any cause, heart failure (HF) hospitalization and repeat TV repair. Furthermore, prevalence and efficacy of rhythm control strategies were evaluated. Results A total of 203 patients (mean age 78 ± 7 years, 145 (68 %) female) after transcatheter TV repair was analyzed. After a median follow-up of 12 months (IQR 4-20), 21 patients (10 %) did maintain SR. AF was present in 183 patients (90 %), of whom 134 had permanent AF. In the AF group, direct-current cardioversion (DCCV) was performed in 6 patients (3 %). Following DCCV, SR was restored in 4 patients (75 %), of whom 3 patients (75 %) presented in SR 30 days after DCCV. 2 patients (1 %) underwent AF ablation. After a case-control matching including 38 patients (SR vs. AF), during a median follow-up of 8 months (IQR 1-20) the study endpoint occurred in 7 of 19 patients (37 %) in the SR group and 12 of 19 patients (63 %) in the AF group (HR 0.70, p = 0.43). Conclusions The incidence of AF among patients undergoing transcatheter TV repair is high. In the present patient cohort, there was a trend towards a higher likelihood of death from any cause, HF hospitalization and repeat transcatheter TV repair in patients with AF. Further randomized studies are needed to evaluate the impact of rhythm control in patient undergoing TV repair.

Prognostic Implications of Residual Tricuspid Regurgitation Grading After Transcatheter Tricuspid Valve Repair

BackgroundThe safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern. ObjectivesThe authors sought to assess the impact of residual TR severity post–TTV repair on survival. MethodsWe evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe). ResultsResidual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96). ConclusionsThe moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention.

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

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.

Role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair.

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. To investigate the role of RVR on outcomes after TTVr for severe TR. 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 (> 35mm) 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 1year. 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). TTVr was associated with significant QoL improvement after 1month, 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.

Etiologies and Impact of Exclusion Rates for Transcatheter Mitral and Tricuspid Valve Structural Heart Clinical Trials at a High-Volume Quaternary Care Hospital

There are various devices under clinical investigation for transcatheter mitral valve intervention (TMVI) and tricuspid valve intervention (TTVI), but exclusion rates remain high. We aim to investigate exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr) and transcatheter tricuspid valve replacement (TTVR). There were a total of 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. Causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria and medical futility. Among 129 patients, the exclusion rates for TMVr, TMVR, TTVr and TTVR were 81%, 85%, 91% and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomical unsuitability. TMVr had the highest rate of patient withdrawal (64%), the lowest anatomic unsuitability (5%) due to short posterior leaflet length. Replacement interventions have higher anatomic unsuitability (33%) compared to repair interventions (17%) (p=0.04). Most exclusions of anatomic unsuitability was due to mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. Fifty percent of exclusions from TTVr were due to presence of pacemaker/defibrillator leads. Among patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p<0.01 and p=0.01, respectively). In conclusion, exclusion rates for TMVI and TTVI trials remain high due to various reasons, limiting patients’ enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy.

Frailty, periinterventional complications and outcome in patients undergoing percutaneous mitral and tricuspid valve repair.

Frailty is common in elderly and multimorbid patients and associated with increased vulnerability to stressors. In a single centre study frailty according to Fried criteria was assessed in consecutive patients before transcatheter mitral and tricuspid valve repair. Postprocedural infections, blood transfusion and bleeding and renal failure were retrospectively assessed from records. Median follow-up time for survival was 560 days (IQR: 363 to 730 days). 90% of 626 patients underwent mitral valve repair, 5% tricuspid valve repair, and 5% simultaneous mitral and tricuspid valve repair. 47% were classified as frail. Frailty was associated with a significantly increased frequency of bleeding (16 vs 10%; p = 0.016), blood transfusions (9 vs 3%; p = < 0.001) and infections (18 vs 10%; p = 0.006), but not with acute kidney injury (20 vs 20%; p = 1.00). Bleeding and infections were associated with longer hospital stays, with a more pronounced effect in frail patients (interaction test p < 0.05, additional 3.2 and 4.1 days in frail patients, respectively). Adjustment for the occurrence of complications did not attenuate the increased risk of mortality associated with frailty (HR 2.24 [95% CI 1.62-3.10]; p < 0.001). Bleeding complications and infections were more frequent in frail patients undergoing transcatheter mitral and tricuspid valve repair and partly explained the longer hospital stay. Albeit some of the complications were associated with higher long-term mortality, this did not explain the strong association between frailty and mortality. Further research is warranted to explore interventions targeting periprocedural complications to improve outcomes in this vulnerable population.

Step-by-step transesophageal echocardiographic guidance for transjugular transcatheter tricuspid valve replacement with a radial force-independent bioprosthesis.

The prohibitive risk of isolated tricuspid valve (TV) surgery encouraged rapid development of a transcatheter solution for tricuspid regurgitation (TR). The favorable results of these devices informed recent guidelines to recommend considering transcatheter treatment of symptomatic secondary severe TR in inoperable patients. Transcatheter TV repair systems usually reduce TR through leaflet approximation and direct annuloplasty. Orthotopic transcatheter TV replacement (TTVR) devices generally rely on radial force and tricuspid leaflet engagement for implantation and stability. The LuX-Valve is a novel radial force-independent orthotopic TTVR device that is operated through the trans-atrial approach. Its radial force-independency is achieved through an interventricular septal anchor tab (septal insertion) and two leaflet graspers (leaflet engagement). Such a unique design makes the intraprocedural imaging different from that of other currently available TTVR systems. The latest generation of this device, the LuX-Valve Plus, comes with a newly designed delivery system through the transjugular approach, which makes the intraprocedural monitoring and adjustment of the device even more complex for successful implantation. However, its unique imaging needs for intra-procedural guidance and post-operative evaluation have not been described before. Therefore, we aimed to elaborate the key steps of transesophageal echocardiography (TEE) to guide this novel procedure. Herein, the primary 2-dimensional (2D) and 3-dimensional (3D) echocardiographic work planes are proposed and the critical steps are emphasized for better communication between imagers and interventionists. The suitability of 2D and 3D echocardiography to guide this procedure is also discussed to increase the flexibility of choice during the implantation.

Refining accuracy of RV–PA coupling in patients undergoing transcatheter tricuspid valve treatment

BackgroundAssessing right ventricular (RV) function is paramount for risk stratification, which remains challenging in patients with tricuspid regurgitation (TR). We assessed RV–pulmonary artery (PA) coupling and its predictability of outcomes after transcatheter tricuspid valve repair (TTVR).MethodsStudy participants comprised patients undergoing transcatheter tricuspid valve repair to treat symptomatic TR from June 2015 to July 2021. We calculated an RV–PA coupling ratio using a formula, which is dividing tricuspid annular plane systolic excursion (TAPSE) by echocardiographically estimated (ePASP) or invasively measured PASP (iPASP) at baseline. The primary outcome was all-cause mortality or heart failure rehospitalization within one year.ResultsThe study participants (n = 206) were at high surgical risk (EuroSCORE II: 7.4 ± 4.8%). The primary outcome occurred in 57 patients within one year. The c-statistics for the outcome were 0.565 (95% CI 0.488–0.643) for TAPSE/ePASP and 0.695 (95% CI 0.631–0.759) for TAPSE/iPASP. The correlation between the ePASP and iPASP was attenuated in patients with massive/torrential TR compared to those with severe TR (interaction p = 0.01). In the multivariable Cox proportional model, TAPSE/iPASP was inversely associated with the risk of the primary outcome (per 0.1-point increase: adjusted-HR 0.67, 95% CI 0.56–0.82, p < 0.001), independent of baseline demographics. According to the TAPSE/iPASP quartiles (i.e., ≤ 0.316; 0.317–0.407; 0.408–0.526; ≥ 0.527), the event-free survival was 43.4%, 48.3%, 77.9%, and 85.4% at one year after TTVR.ConclusionRV–PA coupling predicts one-year mortality and heart failure rehospitalization after TTVR in patients with TR. The predictability is improved if invasively-measured PA pressure is included.Graphical abstractAssessing right ventricular (RV) function is paramount for risk stratification. The present analysis confirms that RV–PA coupling, measured as TAPSE/PASP, predicts one-year mortality and heart failure rehospitalization in patients undergoing TTVR. There is a significant interaction between TR severity and the correlation of ePASP with iPASP, and therefore the correlation is attenuated in patients with massive to torrential TR. The predictability of RV–PA coupling is improved if PA pressure is measured invasively and included in the formula.

Role of right ventricular remodeling in functional status and prognosis after transcatheter tricuspid valve repair

Abstract 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 functional and clinical outcomes after TTVr remains unclear. Purpose Aim of this study was to investigate the role of RVR on functional and clinical outcomes after TTVr for severe TR. Methods RVR was defined as dilation of right ventricular mid-level diameter (&amp;gt;35 mm) according to current guidelines. In 226 patients undergoing TTVr (edge-to-edge repair or annuloplasty) for severe TR with heart failure (HF), outcomes were compared between 139 patients with RVR and 87 patients without RVR. Functionality and QoL were evaluated using NYHA class, Minnesota Living With Heart Failure Questionnaire (MLHFQ), 36-Item Short-Form Health Survey (SF-36), and 6-Minute-Walking-Distance (6MWD) 30 days after TTVr. Clinical outcome was assessed through one-year and long-term mortality, HF rehospitalization and need for repeat TV intervention. Results Symptomatic improvement of at least one NYHA class was achieved regardless of RVR (58% vs. 66% of patients with vs. without RVR). Functionality and QoL improved without statistical difference in both groups, with clinically relevant 6MWD improvement of ≥50m in 34% vs. 36% of patients with vs. without RVR; clinically relevant MLHFQ improvement of ≥5 points was present in 70% vs. 81% of patients with vs. without RVR; and clinically relevant SF-36 improvement of ≥2.5 points in 65% vs. 69% with vs. without RVR. One-year mortality after TTVr was 24% vs. 8% in patients with RVR vs. without RVR (p=0.02). One-year HF rehospitalization after TTVr was 30% vs. 13% in patients with vs. without RVR (p=0.04), whereas need for repeat TTVr was not associated with RVR. Long-term follow-up was available after 457±403 days. In multivariable analysis, RVR remained an independent predictor of long-term mortality (HR 2.3, 95%CI [1.03-5.1], p=0.04) and of the combined endpoint of long-term mortality or HF rehospitalization (HR 2.4, 95%CI [1.06-5.5], p=0.04). Conclusion TTVr resulted in clinically relevant improvement of functionality and QoL in patients with HF already after one month, irrespective of RVR. Patients with preprocedural RVR had higher rates of one-year mortality and HF hospitalization. However, preprocedural RVR should not be considered as marker of TTVr futility.

Predictive value of right ventricular geometry and function evaluated in AI-computed tomography in patients undergoing transcatheter tricuspid valve repair

Abstract Background The role of cardiac geometry and function for outcome after transcatheter tricuspid valve repair is poorly understood. This study sought to investigate whether right ventricular geometry and function are predictors for clinical outcome in patients undergoing transcatheter tricuspid valve repair (TTVR). Methods and results 60 Patients (mean age 79 ± 6 years, 53% female) suffering from severe tricuspid regurgitation underwent full cardiac cycle computed tomography (CT) for TTVR procedure planning. In comparison to conventional CT-measuring of left and right ventricle, AI-based data showed excellent correlation of cardiac volumes in diastole and systole (R-value for Pearson´s correlation ranging from 0.926 – 0.991; each P-value for correlation &amp;lt; 0.001). We tested whether patients with reduced right ventricle function are associated with worse outcome regarding mortality and re-hospitalization after one year. The mean follow-up was 198 ± 143 days. After 1 year the combined endpoint of death and re-hospitalization occurred in significantly fewer patients with &amp;gt;50% RV-EF (12.1% vs. 37%; X²=5.2; P=0.023). Furthermore, enlarged right ventricle with ≥220 ml end diastolic volume (RVEDV) was associated with poor outcome (0% vs. 33.4%; X²=6.842; P=0.009). The right ventricle was classified as "dysfunctional" with RVEDV ≥200 ml and RV-EF &amp;lt;55% or "functional" with RVEDV &amp;lt; 200 ml or RV-EF &amp;gt; 55%. Patients with "dysfunctional" right ventricle showed poorer outcome in comparison to patients with "functional" right ventricle. (11.1% vs. 32.3%; X²=4.916; P=0.027). Conclusions AI-based 3D-reconstruction of right ventricular geometry in full cycle cardiac CT shows excellent correlation with conventional cardiac CT-reconstruction. Patients with enlarged ventricle &amp;gt; 220 ml RVEDV or RV-EF ≤ 50 % and patients who have ≥ 200 ml RVEDV and ≤ 55 % were associated with poor outcome after TTVR.Outcome based on RVEDV after TTVROutcome based on RV-EF after TTVR

Tricuspid regurgitation and heart failure: the faith of treated vs untreated cohort in the percutaneous era

Abstract Background/Introduction Tricuspid regurgitation (TR) is associated with heart failure and reduced survival.Within a short-time period, transcatheter tricuspid valve repair or replacement (TTVR)(TTVr) for TR has evolved from innovation to clinical reality. Still, most patients arrive in an advanced state of heart failure (HF), as well as most cohorts remained untreated for various reasons. The faith of these two therapeutic approaches gives differences in results among survival and clinical status at distance. Purpose The present study’s aim is to provide 1 year results between TR patients treated with TTVR and TTVr compared to untreated patients, in terms of cardiac survival, rehospitalization, right-side heart failure symptoms development, and NYHA improvement. The secondary endpoint is to analyze gender disparities as well as echocardiographic and medical therapy changes between groups. Methods 78 patients (pts) have been prospectively inserted into a dedicated database from January 2020 till January 2023. 26 pts (36%) have been treated with TTVR/r (Treated Group-TG) and 51 pts (65%) have been left untreated with medical therapy (MT) optimization (UN-Treated Group-UNTG). In TG, 9 (34%) underwent TEER (Transcatheter Edge-To-Edge Repair), 13 (50%) annuloplasty and 4(15%) TTVr. Tri-Score was used to define right-side pathology in both groups; the Tri-Score mean of 3.9 (8-1 +/- SD 1.68) was in TG, while 6,17 (10-2+/- SD 1.9) in UNTG. In UNTG 52% were female gender while 76%in TG. Most of the patients in UNTG were in TR stage 5 (47%) while in stage 4 in TG (42%). For 1 year follow-up (FUP), Kaplan-Meier weighted survival curves related to cardiac death and HF rehospitalization have been computed as well as Chi-squared test to evaluate right-side HF symptoms progression, echocardiographic changes in right ventricular function, NYHA progression and medical therapy changes, between the 2 groups. Results Analyzing the cardiac death between the 2 groups, there was a significant statistical difference since TG has a less incidence of exitus in the general population (p-value =0,05), Figure 1. Concerning gender, in female gender, the treated pts have lower cardiac death incidence (p-value =0,03).Concerning HF hospitalization, TG has a lower incidence with p-value =0,005, Figure 2. No difference according to gender. In TG there was a significant improvement in NYHA class at FUP (p-value =0,001) as well as an improvement of right-side HF symptoms (p-value =0,001). In UNTG there was a significant increase in the dosage of HF drugs compared to TG, (p-value =0,001) as well as an increase in right ventricular function and dimension at echocardiogram (p-value =0,001). Conclusion(s) this study shows that treatment in case of TR with right side HF has a positive impact upon cardiac death,HF hospitalisation at 1 year. As well as there is a significant improvement in clinical and ecocardiographic status at FUP in treated group.figure 1figure 2

Hemodynamic implications of transcatheter tricuspid valve repair in HFpEF Patients - HERACLES-HFpEF

Abstract Background Patients with severe tricuspid regurgitation (TR) and heart failure with preserved ejection fraction (HFpEF) have been suggested to respond favourably to transcatheter edge-to-edge tricuspid valve repair (TEER), but the mechanisms remain poorly understood. Purpose The aim of this study was to investigate the pathophysiological implications of TV-TEER in patient with HFpEF and severe TR. Methods This was a prospective interventional single arm trial that included 20 HFpEF patients with invasive evidence of increased filling pressures (i.e. left-ventricular enddiastolic pressure [LVEDP] &amp;gt;15 mmHg and preserved ejection fraction i.e. LVEF ≥50%) at a single centre. All patients received transthoracic echocardiography and cardiac magnetic resonance imaging (MRI) immediately before and 1-month after TV-TEER. During the TV-TEER procedure LV pressure-volume loops were recorded by using a conductance catheter (Figure 1A). The primary outcome was the periprocedural change in the ratio of LVEDP to left-ventricular end-diastolic volume (LVEDV) as surrogate for preload independent diastolic function. The secondary outcomes included single-beat estimated end-diastolic pressure volume-relationships (EDPVRs), and LV distending pressure (calculated as LVEDP-mean right atrial pressure) as well as changes at 1-month in LVEDV and right ventricular EDV (RVEDV) as surrogates for ventricular interdependence. Results Between 02/2021 to 12/2022 20 patients (median age 78, IQR 72 to 83 years, 65% ♀) were included in the prospective HERACLES-HFpEF trial. All patients successfully underwent TV-TEER with a median TR grade reduction of 2 (IQR 2 to 1) on a five-grade scaling. Despite a periprocedural increase in LVEDV (p&amp;lt;0.001), LVEDP remained stable after successful TV-TEER (p=0.12). This led to a significant reduction of the primary endpoint LVEDP/LVEDV (p=0.001, Figure 1B). Load independent diastolic function improved with a rightward shift of the EDPVR (Figure 1C). LV distending pressure increased implying stronger LV distension in the restricted pericardial space. At one-month follow-up MRI (available for 17 patients) LVEDV increased (∆ median +5 ml, p=0.017), while RVEDV decreased (∆ median -17 ml, p=0.031). Interestingly, there was a significant inverse correlation between the change of LVEDV and RVEDV, again implying more favourable LV to RV interaction (Figure 1C). Conclusion TV-TEER in HFpEF patients leads to an immediate periprocedural increase in LV volume at maintained filling pressures. The improved diastolic function is possibly attributable to a more favourable LV to RV interaction where RV volumes are reduced to allow for the LV to better distend in the limited pericardial space. TV-TEER might pose a potential therapy for a subgroup of HFpEF patients with severe TR, meriting validation in prospective endpoint driven clinical trials.Figure 1

Long-term outcomes of transcatheter tricuspid valve repair in prohibitive risk patients: futility or benefit?

Abstract Background Transcatheter tricuspid valve repair (TTVR) for tricuspid regurgitation (TR) is an emerging treatment option in inoperable patients. However, patient selection is challenging, and mostly predetermined by comorbidities and non-specific surgical risk scores. Current guidelines (1) distinguish between high-risk (HR) and prohibitive risk (PR) patients, in order to avoid clinical and procedural futility. Therefore, the aim of this study was to understand if PR patients can benefit from TTVR long-term. Methods Forty-one consecutive patients with severe TR were assessed by the heart team, considered inoperable, and underwent edge-to-edge TTVR at our institution between November 2020 and January 2022. They were divided into a PR (n=23) and an HR group (n=18), in accordance with the latest guidelines (1). Subgroup allocation took into account STS (Society of Thoracic Surgeons) risk score, and several comorbidities (Figure 1A). Mean age was 82.2±5.9 (PR) vs 81.1±3.5 years (HR), with mean STS-Score 14.3±6.7% vs 6.2±1.6% (Figure 1B). Results The primary efficacy endpoint of at least one-grade TR reduction by 30 days was recorded in 92.7% of all patients, with no device related complications. By 12 months, 6 patients died, 5 PR and 1 HR, and MACE rate was 18.1%. Secondary endpoints addressed symptoms, quality of life and multiorgan function, which improved in both groups (Figure 2). More precisely, at inclusion, all patients in the PR group were in NYHA class III and IV, while after 12 months only 27.7%. In comparison, there were no more HR patients in NYHA stage III and IV, after one year. Similarly, self-reported quality of life increased, as assessed by the "Kansas City Cardiomyopathy Questionnaire" (KCCQ) score, which increased by 23±18.2 (p&amp;lt;0.001) in PR and 27.5±16.1 (p&amp;lt;0.001) points in HR patients, respectively. Walk distance in the 6-minute test also improved by 79.2±82 (p&amp;lt;0.001) vs 113.6±72.8 (p&amp;lt;0.001) meters. Renal and liver function were also impacted by TR reduction, with statistical significance in the PR group [GFR- Glomerular Filtration Rate improvement from 46.7±13.9ml/min/1,73m2 to 51.9±18.1 (p=0.045) vs 62.1±17.1 to 62.1±18.5 (p=0.990); AST- Aspartate Aminotransferase from 33.7±15.4U/L to 27.3±12.3 (p=0.001) vs 33.2±26.1 to 26.2±6.8 (p=0.188)]. Furthermore, TR reduction led to long-term reverse cardiac remodeling, as right ventricular systolic function increased [TAPSE from 14.2±3.1mm to 17.7±2.2 (p&amp;lt;0.001) vs 16.4±3.5 to 20.7±5.4 (p&amp;lt;0.001)], and right atrial size decreased [indexed volume from 93.5±39.1 ml/m2 to 66.3±42.6 (p=0.005) vs 86.3±57.8 to 63.3±59.5 (p=0.032)]. Conclusions TTVR is feasible in very sick symptomatic patients and is associated with improved quality of life, functional capacity, multiorgan function and reverse cardiac remodeling. Patient selection based on risk assessment with surgical risk scores may deprive many symptomatic inoperable patients of this specific percutaneous treatment.Figure 1Figure 2