Transcatheter Tricuspid Valve Research Articles

Transcatheter Tricuspid Valve Intervention for the Treatment of Tricuspid Regurgitation with TriClip: All You Need to Know.

Severe tricuspid regurgitation (TR) is a common pathology in the daily practice of a cardiologist. This disease entity is associated with significant morbidity and mortality if left untreated. Classically, surgical repair or replacement were the only therapeutic options present and were often not performed due to high postprocedural mortality. Transcatheter tricuspid valve intervention has emerged as a novel and effective therapeutic option for the treatment of significant TR. Several devices have been developed with different mechanisms of action. In this review, we will provide an overview of transcatheter edge-to-edge repair of TR using the TriClip device (Abbott, Santa Clara, CA, USA).

Transcatheter Tricuspid Valve Intervention: Our Experience and the Current Status in the US

Transcatheter Tricuspid Valve Intervention: Our Experience and the Current Status in the US

Unveiling Sex Differences in Tricuspid Valve Disease: A Systematic Review and Meta-Analysis of Surgical Management.

Tricuspid regurgitation (TR) is a heart condition where blood flows backward through the tricuspid valve. Tricuspid valve disease constitutes a major valvular heart condition that is receiving heightened attention due to tailored treatment options and sex-specific differences in treatment outcomes. The study aims to investigate whether biological sex has a significant influence on the development, progression, and treatment outcomes of tricuspid valve disease in adults. We conducted a comprehensive search to identify studies examining the impact of sex on the pathophysiology of TR as well as treatment outcomes in patients with TR. We searched PUBMED/MEDLINE, SCOPUS, and Excerpta Medica dataBASE (EMBASE) from inception to September 2023 to identify relevant studies. Twelve studies totaling 22,574 patients met our eligibility criteria. These studies were categorized into three subgroups: patients with TR without intervention (3,848 patients, with 48.1% males and 51.9% females), those who underwent open heart surgery (17,498 patients: 46.2% males and 53.8% females), and those who underwent transcatheter tricuspid valve repair/replacement (TTVR; 1,687 patients: 41.6% males and 58.4% females). Analysis revealed no major differences in terms of TR etiology. Males tended to have a slightly lower mean age difference (mean difference (MD): -0.60 years; 95% confidence interval (CI) (-1.49, -0.04); p = 0.10) but had more frequent chronic lung disease (risk ratio (RR): 1.12, 95% CI (1.01, 1.25), p = 0.03). Males showed higher baseline TR volume (MD: 4.11, 95% CI (0.53, 7.68), p = 0.02) and lower left ventricular ejection fraction (MD: -5.85, 95% CI (-6.97, -4.73), p < 0.00001). Following open heart surgery for TR treatment, males required more frequent permanent pacemaker implantation (PPM; RR: 1.57, 95% CI (1.21, 2.03), p = 0.0006). Similarly, TTVR showed a higher need for PPM in males (RR: 1.45, 95% CI (1.10, 1.93), p = 0.010). In-hospital mortality exhibited no sex differences, but males had a slightly elevated late mortality risk. Sex differences in TR patients were notable in baseline characteristics, with males having a higher risk of certain conditions. The more frequent requirement for PPM was a major sex-based difference in terms of prognosis.

Computed Tomography Planning for Transcatheter Tricuspid Valve Interventions

Computed Tomography Planning for Transcatheter Tricuspid Valve Interventions

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.

Early deterioration of right ventricular strain in patients undergoing transcatheter tricuspid valve intervention

Abstract Background Severe tricuspid regurgitation (TR) leads to volume overload and increased wall stress causing detrimental right ventricular (RV) remodelling and dysfunction and is associated with excess mortality. Transcatheter tricuspid valve interventions (TTVI) emerged to treat patients with severe TR and high surgical risk, but predictors of outcome remain largely unknown. RV free wall longitudinal strain (RVFWLS) is a sensitive parameter for RV dysfunction and has shown prognostic value in patients with functional TR treated conservatively. Periinterventional changes in RVFWLS and right atrial (RA) strain have not been evaluated in patients undergoing TTVI. Purpose To analyse the effect of transcatheter tricuspid valve annuloplasty (TTVA) and transcatheter edge-to-edge repair (TEER) on RVFWLS and RA strain, assessed by speckle tracking echocardiography, and their association with outcome. Methods We retrospectively analysed consecutive patients with severe TR that underwent TTVI at our centre between 2020 and 2022. 126 patients were included (n=48 underwent TTVA with the Cardioband system, n=78 underwent TEER with the PASCAL system). Established parameters for RV function (TAPSE, FAC) as well as RVFWLS and RA reservoir strain (RASR) were analysed at baseline and one month after TTVI. Results All patients (median age 80 years, 69% female, 79% in NYHA III/IV functional class) were at prohibitive surgical risk. RV function at baseline was slightly reduced according to FAC (34% [29-39]) and preserved according to TAPSE (18mm [15-20]), whereas RVFWLS (-18.6±5.7%) and RASR (10.0% [7.0-14.0]) were severely reduced in markedly dilated right heart chambers (RV basal 45mm [41-49], RA area 34 cm2 [28-41]). TR reduction following TTVI to TR grade ≤ 2 was achieved in 77%. Right heart chamber size significantly decreased after one month (RV basal 41mm [38-45], RA area 29cm2 [25-38], P&amp;lt;0.001), with no improvement of FAC (37% [30-40], P=0.668) or RASR (10% [7-13], P=0.143) but deterioration of RV longitudinal function (TAPSE 17mm [13-20], P=0.002; RFWLS -16.1±5.7%, P=0.001) compared to baseline. RVFWLS reduction occurred irrespective of the procedure performed (TEER [-9.2±41.4] vs. TTVA [-7.0±31.3], P=0.783). RVFWLS deterioration occurred in 63%, whereas it improved in 37% of patients. Symptomatic and clinical outcome did not differ in patients with deteriorated vs. improved RVFWLS (improvement of at least one NYHA class 61.9% vs. 58.3%, P=0.569, one-year mortality 13.7% vs. 12.3%, P=0.940, one-year heart failure rehospitalization 10.8% vs. 17.1%, P=0.701). Conclusion Deterioration of RVFWLS after TTVI possibly reflects the decreased wall stress due to TR and consecutive preload reduction. However, symptomatic and clinical outcomes did not differ in patients with deteriorated RVFWLS vs. patients with improved RVFWLS. Reduction of RA size after TTVI did not translate into improvement of RASR, indicating an already advanced pre-existing RA dysfunction.

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

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

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

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

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.

Characteristics and outcomes of patients with atrial versus ventricular secondary tricuspid regurgitation undergoing tricuspid transcatheter edge-to-edge repair-Results from the TriValve registry.

Functional or secondary tricuspid regurgitation (STR) is the most common phenotype of tricuspid regurgitation (TR) with atrial STR (ASTR) and ventricular STR (VSTR) being recently identified as two distinct entities. Data on tricuspid transcatheter edge-to-edge repair (T-TEER) in patients with STR according to phenotype (i.e. ASTR vs. VSTR) are lacking. The aim of this study was to assess characteristics and outcomes of patients with ASTR versus VSTR undergoing T-TEER. Patients with STR undergoing T-TEER were selected from the Transcatheter Tricuspid Valve Therapies (TriValve) registry. ASTR was defined by (i) left ventricular ejection fraction ≥50%, (ii) atrial fibrillation, and (iii) systolic pulmonary artery pressure <50 mmHg. Patients not matching these criteria were classified as VSTR. Patients with primary TR and cardiac implantable electronic device were excluded. Key endpoints included procedural success and survival at follow-up. A total of 298 patients were enrolled in the study: 65 (22%) with ASTR and 233 (78%) with VSTR. Procedural success was similar in the two groups (80% vs. 83% for ASTR vs. VSTR, p = 0.56) and TEER was effective in reducing TR in both groups (from 97% of patients with baseline TR ≥3+ to 23% in ASTR and to 15% in VSTR, all p = 0.001). At 12-month follow-up, survival was significantly higher in the ASTR versus VSTR cohort (91% vs. 72%, log-rank p = 0.02), with VSTR being an independent predictor of mortality at multivariable analysis (hazard ratio 4.75). In a real-world, multicentre registry, T-TEER was effective in reducing TR grade in both ASTR and VSTR. At 12-month follow-up, ASTR showed better survival than VSTR.

Abstract 18974: Transcatheter Tricuspid Valve Replacement in a Symptomatic Bioprosthetic Tricuspid Stenosis Patient With Carcinoid Heart Disease: A Case Report

Background: Patients with carcinoid heart disease are prone to the development of mild to severe tricuspid regurgitation with or without accompanying tricuspid stenosis. We present an interesting case of a patient with bioprosthetic tricuspid valve stenosis secondary to carcinoid heart disease undergoing transcatheter tricuspid valve replacement (TTVR). Case history: The patient is a 64-year-old female with metastatic carcinoid syndrome and subsequent tricuspid valve replacement with 25 mm Magna ease bovine pericardial valve. The surgery was complicated by carcinoid crisis, pneumothorax, and complete heart block. She presented with worsening shortness of breath with exertion. Echocardiography revealed severe tricuspid stenosis associated with a severely dilated right atrium, moderate pulmonary stenosis. Transesophageal echocardiography confirmed carcinoid degeneration of the bioprosthetic tricuspid valve. CT chest and abdomen with contrast showed consistent findings of severe tricuspid stenosis, metastatic carcinoid tumor with new foci in liver, lungs. Ischemic evaluation with angiography revealed normal coronaries. Decision making: The patient was evaluated by the heart team and was considered to be a prohibitive risk patient for redo surgery. We then evaluated her suitability for transcatheter valve replacement, and the patient was felt suitable for undergoing valve-in-valve transcatheter tricuspid valve replacement via the right internal jugular vein approach because of the coaxial alignment of the valve through this route. The patient successfully underwent this procedure with a 26 mm balloon-expandable valve without any complications and is currently in NYHA class I functional status. Conclusion: Carcinoid syndrome can affect bioprosthetic tricuspid valves and transcatheter valve replacement may be advantageous in replacing the affected bioprosthetic valves by reducing morbidity and mortality.

Abstract 17552: Pre-Existing Right Ventricular Lead Performance After Transcatheter Tricuspid Valve Replacements (TTVR)?

Introduction: Transcatheter tricuspid regurgitation (TTVR) is an investigational method for nonsurgical candidates with severe tricuspid regurgitation (TV). Many of these patients possess transvenous right ventricular (RV) leads, which can be a cause for TTVR. Outcomes regarding RV lead viability and functionality after TTVR have varied widely. We sought to describe the outcomes and management of RV leads after TTVR at our institution. Hypothesis: We expect transcatheter tricuspid valve replacement to negatively impact the performance of pre-existing right ventricular leads. Methods: This was a retrospective observational analysis of patients who received TTVR at our center independent of other clinical trials. Statistical analysis was performed using SPSS BMI Software. Results: A total of 30 patients underwent TTVR between 2021 and 2023. Nine patients had CIEDs, including one with SICD and one with transcatheter pacemaker. This resulted in 7 (23%) with an RV lead crossing the TV at the time of TTVR (3 Evoque valves, 5 S3 valves). The RV leads were connected to a pacemaker (PM) in five (71%) patients, an implantable cardiac defibrillator (ICD) in one and a CRT-D in another. On average, the patients underwent TTVR 5 years after cardiac implantable electronic device (CIED) implantation. All patients received RV lead testing at least once after TTVR and they were followed up for a median of 7 months after TTVR. 3 patients underwent pre-emptive lead extraction, which let to four (57%) patients with “jailed” RV leads. 3 of the four patients with jailed leads had lead dysfunction requiring system revision or reprogramming - including elevated lead threshold, clinical evidence of transient loss of capture, and non-jailed atrial lead undersensing post TTVR. Conclusions: We report a high incidence of lead malfunction due to RV jailing with TTVR and good outcomes of those undergoing preemptive extraction strategies. Approaches such as leadless systems and coronary sinus systems may be useful in this patient population.

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

Right ventricular remodeling and clinical outcomes following transcatheter tricuspid valve intervention.

Characterize the impact of residual tricuspid regurgitation (TR) on right ventricle (RV) remodeling and clinical outcomes after transcatheter tricuspid valve intervention. We performed a single-center retrospective analysis of transcatheter tricuspid valve repair (TTVr) or replacement (TTVR) patients. The primary outcomes were longitudinal tricuspid annular plane systolic excursion (TAPSE), fractional area change (FAC), pulmonary artery systolic pressure (PASP), and RV dimensions (RVd). We used multivariable linear mixed models to evaluate association with replacement versus repair and degree of TR reduction with changes in these echo measures over time. Multivariable Cox regression was used to identify associations between changes in these echo measures and a composite clinical outcome of death, heart failure hospitalization, or re-do tricuspid valve intervention. We included a total of 61 patients; mean age was 77.5 ± 11.7 and 62% were female. TTVR was performed in 25 (41%) and TTVr in 36 (59%). Initially, 72% (n = 44) had ≤ severe TR and 28% (n = 17) had massive or torrential TR. The median number of follow up echos was 2: time to 1st follow-up was 50 days (interquartile range [IQR]: 20, 91) and last follow-up was 147 (IQR: 90, 327). Median TR reduction was 1 (IQR: 0, 2) versus 4 (IQR: 3, 6) grades in TTVr versus TTVR (p < 0.0001). In linear mixed modeling, TTVR was associated with decline in TAPSE and PASP, and TR reduction was associated with decreased RVd. In multivariable Cox regression, greater RVd was associated with the clinical outcome (hazard ratio: 9.27, 95% confidence interval: 1.23-69.88, p = 0.03). Greater TR reduction is achieved by TTVR versus TTVr, which is in turn associated with RV reverse remodeling. RV dimension in follow-up is associated with increased risk of a composite outcome of death, heart failure hospitalization, or re-do tricuspid valve intervention.

TCT-597 Transcatheter Tricuspid Valve Replacement: From Preclinical to Early First-in-Human Experiences With the MonarQ Device

TCT-597 Transcatheter Tricuspid Valve Replacement: From Preclinical to Early First-in-Human Experiences With the MonarQ Device

Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: a 'heart team' approach.

Clinically significant tricuspid regurgitation (TR) has historically been managed with either medical therapy or surgical interventions. More recently, percutaneous trans-catheter tricuspid valve (TV) replacement and tricuspid trans-catheter edge-to-edge repair have emerged as alternative treatment modalities. Patients with cardiac implantable electronic devices (CIEDs) have an increased incidence of TR. Severe TR in this population can occur for multiple reasons but most often results from the interactions between the CIED lead and the TV apparatus. Management decisions in patients with CIED leads and clinically significant TR, who are undergoing evaluation for a percutaneous TV intervention, need careful consideration as a trans-venous lead extraction (TLE) may both worsen and improve TR severity. Furthermore, given the potential risks of 'jailing' a CIED lead at the time of a percutaneous TV intervention (lead fracture and risk of subsequent infections), consideration should be given to performing a TLE prior to a percutaneous TV intervention. The purpose of this 'state-of-the-art' review is to provide an overview of the causes of TR in patients with CIEDs, discuss the available therapeutic options for patients with TR and CIED leads, and advocate for including a lead management specialist as a member of the 'heart team' when making treatment decisions in patients TR and CIED leads.

Surgical outcomes of patients at prohibitive risk who are reconsidered for surgery

ObjectivesTranscatheter treatment of advanced mitral and tricuspid valve disease is largely limited to patients at prohibitive surgical risk, although many are not candidates for transcatheter treatment. Here, we describe surgical outcomes of patients at prohibitive risk who were ineligible for transcatheter therapies to guide surgeons in management of this unique population. MethodsPatients at prohibitive risk, defined per surgeon or cardiologist discretion, who were initially referred for a transcatheter mitral or tricuspid intervention in a multidisciplinary atrioventricular valve clinic, were identified from 2019 to 2022. Preoperative risk, operative outcomes, and long-term mortality were evaluated. ResultsA total of 337 patients at prohibitive risk were referred for evaluation in a multidisciplinary atrioventricular valve clinic. Of those, 161 underwent transcatheter therapy, 130 patients underwent continued medical management, and 45 were reevaluated and had high-risk surgery. Among surgical patients, 51% were women with a median age of 76 years (quartile 1-quartile 3, 65-81 years). Most patients presented in heart failure (83%; n = 37 out of 45), and 73% were in New York Heart Association functional class III or IV. Most patients (94%; n = 43) had a mitral valve intervention, of whom 56% (24 out of 43) had a mitral valve replacement. The 30-day mortality rate was 4% (2 out of 45) and major morbidity occurred in 33% (15 out of 45). By Kaplan-Meier analysis, 1-year survival was 86% ± 9%. ConclusionsSelect patients at prohibitive risk who were ineligible for transcatheter mitral or tricuspid valve intervention underwent surgery with overall low operative mortality and excellent 1-year survival. Patients a prohibitive risk whose anatomy is not amenable to transcatheter devices should be reconsidered for surgery.

Transcatheter Tricuspid Valve Replacement: Case Selection, Technical Considerations, and Procedural Planning

Tricuspid regurgitation (TR) is a highly prevalent valve disorder in the US, with prevalence increasing with age. Without treatment, severe TR carries a poor prognosis. Tricuspid valve (TV) surgery is recommended for patients with severe TR undergoing left-sided valve surgery. Transcatheter TV repair or transcatheter TV replacement are potential options for patients who are not surgical candidates. A few small studies have demonstrated the feasibility and efficacy of transcatheter TV repair in patients with severe symptomatic TR. Careful patient selection by assessing tricuspid valve anatomy, right ventricular and pulmonary hemodynamics, candidacy for anticoagulation, comorbid conditions, and frailty is key to procedural success. Transcatheter TV repair can be performed via the transjugular or transfemoral access, and requires a large-caliber sheath (up to 45 Fr) and delivery system, particularly with dilated tricuspid annulus due to right ventricular enlargement. Multimodality imaging is essential for diagnosing TR severity, defining valve anatomy, and comprehensive functional assessment of the tricuspid valve, right atrium, and right ventricle. Several prosthetic valves, including the EVOQUE system, NaviGate system, Intrepid valve, and Cardiovalve, are currently being investigated in clinical trials.