Exercise testing in patients with tricuspid regurgitation undergoing transcatheter tricuspid valve intervention.

BACKGROUND: Transcatheter tricuspid valve intervention (TTVI) has shown promising results with persistent reduction of tricuspid regurgitation (TR) and improvements in functional class and quality of life (QOL). OBJECTIVES: To analyze the impact of TTVI on maximal and submaximal exercise capacity (SEC). METHODS: Constant work-rate exercise-time (CWRET) testing reflects SEC, which is more likely to be relevant for daily life activities and provides more differentiated physiological insight into the nature of exercise intolerance. Thus, 30 patients undergoing TTVI (21 direct annuloplasty and 9 edge-to-edge repair) received cardiopulmonary exercise testing (CPET) and CWRET (at 75% of maximum work rate in the initial CPET) before and 3 months after TTVI. RESULTS: Patients' age was 80.5 [74.8-82.3] years and 53.3% were female. TR reduction ≥ 2 grades was achieved in 93.3% (TR grade ≤ moderate in 83.3%). Echocardiography revealed improved right ventricular (RV) characteristics with decreased RV basal diameter (47.0 mm [43.0-54.3] vs. 41.5 mm [36.8-48.0]; p < 0.001) and decreased inferior caval vein diameter. CWRET testing showed a significantly improved SEC (246.5 s [153.8-416.8] vs. 338.5 s [238.8-611.8] p = 0.001). Maximum oxygen uptake showed a positive trend without statistically significant differences (9.9 ml/min/kg [8.6-12.4] vs. 11.7 ml/min/kg [9.7-13.3]; p = 0.31). In contrast to the six-minute-walking distance (6MWD), SEC correlated moderately with effective regurgitation orifice area reduction (r = 0.385; p = 0.036), increased cardiac output (r = 0.378; p = 0.039), and improved QOL (r = 387; p = 0.035). CONCLUSION: Improvements in exercise capacity after TTVI mainly occur in the submaximal rather than in the maximal exercise range and correlate with hemodynamic effects and QOL. This may have a methodological impact on assessment of exercise capacity in these patients.

Robustness of tricuspid regurgitation reduction at 1 year following edge-to-edge repair for primary tricuspid regurgitation.

BACKGROUND AND OBJECTIVE: Within recent years, transcatheter tricuspid edge-to-edge repair (T-TEER) has emerged as a safe and effective treatment option in patients with secondary tricuspid regurgitation (TR). However, for primary TR, data on the robustness and durability of TR reduction 1 year following T-TEER is limited. METHODS: All consecutive patients treated with T-TEER for TR at two high-volume centers between September 2018 and December 2022 were enrolled in a registry. Primary TR was defined as tricuspid valve (TV) prolapse or flail TV leaflets as assessed by pre- and peri-interventional transesophageal echocardiography (TEE). RESULTS: 201 patients were included in this analysis, of whom 27 (13.4%) were classified as primary TR and 174 (86.6%) as TR of secondary origin. All-cause mortality during 1-year follow-up was reached by 50 patients (24.9%) [primary: 7 (25.9%), secondary: 43 (24.7%)], and 151 (75.1%) completed follow-up with transthoracic echocardiography (TTE). Patients' median age was 80 (76-83) years, 112 (55.7%) were female and 181 (90.1%) reported a New-York heart association functional class (NYHA-FC) of III or IV. The remaining baseline clinical and echocardiographic parameters were comparable between the groups, but secondary TR patients had a significantly higher TRI-SCORE (5 (4-8) vs. 7 (5-14), P = 0.010). In both groups, an immediate reduction of TR-Grade post-intervention was observed. This reduction was sustained at follow-up with 80.0% of the primary TR patients classified as moderate or less and 61.8% of the secondary TR patients. This translated to a significant improvement of NHYA-FC in both groups. Kaplan-Meier analysis revealed no differences regarding rates for all-cause mortality between the groups (P < 0.99). CONCLUSION: T-TEER achieves a robust TR reduction in primary TR patients 1 year after intervention with noninferior clinical results to treatment for secondary TR with regards to mortality, re-hospitalization, and NYHA-FC.

Time to assess more than prognosis: advancements and challenges in transcatheter tricuspid valve interventions.

We provide an overview about the current landscape of transcatheter tricuspid valve interventions (TTVI) and summarize recent findings from trials including TRILUMINATE, TRILUMINATE Pivotal, bRIGHT, TRICLASP, TRISCEND, TRISCEND II, TRICUS, and Cardioband TR EFS. These studies have demonstrated the safety and efficacy of TTVI. Yet, they have failed to show a prognostic benefit over conservative treatment. On the other hand, significant improvements in health status assessments have been observed. Assessment of right ventricular (RV) function prior to tricuspid interventions is crucial, as changes in preload and afterload may lead to RV failure which is associated with a high mortality. Therefore, this review emphasizes the impact of TTVIs on quality of life and explores the influence of RV dysfunction on therapeutic success and prognosis.

GLIDE Score: Scoring System for Prediction of Procedural Success in Tricuspid Valve Transcatheter Edge-to-Edge Repair.

BACKGROUND: Tricuspid valve transcatheter edge-to-edge repair (T-TEER) is the most widely used transcatheter therapy to treat patients with tricuspid regurgitation (TR). OBJECTIVES: The aim of this study was to develop a simple anatomical score to predict procedural outcomes of T-TEER. METHODS: All patients (n = 168) who underwent T-TEER between January 2017 and November 2022 at 2 centers were included in the derivation cohort. Additionally, 126 patients from 2 separate institutions served as a validation cohort. T-TEER was performed using 2 commercially available technologies. Core laboratory assessment of procedural transesophageal echocardiograms was used to determine septolateral and anteroposterior coaptation gap, leaflet morphology, septal leaflet length and retraction, chordal structure density, tethering height, en face TR jet morphology and TR jet location, image quality, and the presence of intracardiac leads. A scoring system was derived using univariable and multivariable logistic regression. Endpoints assessed were immediate postprocedural TR reduction ≥2 grades and TR grade moderate or less. RESULTS: The median age was 82 years (Q1-Q3: 78-84 years); 48% of patients were women; and patients presented with severe (55%), massive (36%), and torrential (8%) TR. Five variables (septolateral coaptation gap, chordal structure density, en face TR jet morphology, TR jet location, and image quality) were identified as best predicting procedural outcome and were incorporated in the GLIDE (Gap, Location, Image quality, density, en-face TR morphology) score (range 0-5). TR reduction ≥2 grades and TR grade moderate or less were observed in >90% of patients with GLIDE scores of 0 and 1 and in only 5.6% and 16.7% of those with GLIDE scores ≥4. The GLIDE score was then externally validated in a separate cohort (area under the curve: 0.77; 95% CI: 0.69-0.86). TR reduction significantly correlated with functional improvement assessed by NYHA functional class and 6-minute walk distance at 3 months. CONCLUSIONS: The GLIDE score is a simple, 5-component score that is readily obtained during patient imaging and can predict successful T-TEER.

Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study).

BACKGROUND: Transcatheter tricuspid valve repair (TTVr) has significantly expanded treatment options for tricuspid regurgitation (TR). However, a sizeable proportion of patients are still declined for TTVr and little is known about their clinical characteristics and cardiac morphology. OBJECTIVES: This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology. METHODS: A total of 547 patients were evaluated for TTVr between January 2016 to December 2021 from 3 centers in the United States and Germany. Clinical records and echocardiographic studies were used to assess medical history and right ventricular (RV) and tricuspid valve (TV) characteristics. RESULTS: Median age was 80 (IQR: 74-83) years and 60.0% were female. Over half (58.1%) were accepted for TTVr. Of those who were deemed unsuitable for TTVr (41.9%), the most common exclusion reasons were anatomical criteria (56.8%). In the regression analysis, RV and right atrial size, TV coaptation gap, and tethering area were identified as independent screen failure predictors. Other rejection reasons included clinical futility (17.9%), low symptom burden (12.7%), and technical limitations (12.7%). Most of the excluded patients (71.6%) were managed conservatively with medical therapy, while a small number either proceeded to TV surgery (22.3%) or subsequently became eligible for transcatheter tricuspid valve replacement in later available clinical trials in the United States (6.1%). CONCLUSIONS: The majority of TTVr screen failure patients are excluded due to TV, right atrial, and RV enlargement. However, a significant proportion is excluded due to clinical futility. These identifiable anatomical and clinical characteristics emphasize the importance of earlier referral and intervention of TR and the need for continued innovation of Transcatheter tricuspid valve interventions.

Right coronary artery deformation and injury following tricuspid valve surgery.

Background: Due to its close anatomical proximity to the annular plane of the tricuspid valve (TV), the right coronary artery (RCA) is at risk of injury and distortion during surgical and interventional repair. Recently, reversible, non-flow limiting, purse-string like deformations of the RCA following percutaneous TV annuloplasty have been described. In contrast, there are only anecdotal reports on RCA deformation following conventional TV surgery. Materials and methods: A retrospective analysis of all patients undergoing TV surgery in our hospital between 2009 and 2019 was performed including all patients who received a post-operative coronary angiography (POCA). Angiographic footage was reviewed for RCA affections. Results: A total of 1,383 patients underwent TV surgery (replacement and repair) for tricuspid regurgitation in our center. TV repair was performed in 1,248 (90.2%) patients and 135 (9.8%) patients underwent isolated TV surgery. Sixty-five patients (4.7%) underwent POCA within 48 h after surgery due to suspected myocardial ischemia, representing the final study population. Mean age was 70.3 ± 11.3 years, 56.3% were female. Mean EuroSCORE II was 9.8 ± 11.6%. Patients with the need for POCA due to suspected myocardial injury suffered from a higher mortality compared to event-free patients over the long-term follow up period (median 2.9 years) regardless of the observed coronary status. RCA affections were observed in 24 (36.9%) patients. A new RCA deformation without flow-impairment or vascular damage was found in 16 (24.6%) of the cases and was managed conservatively. There was no significantly worse outcome observed as compared to patients without RCA affections. Six (9.2%) patients showed an RCA deformation accompanied by subtotal occlusion. A complete RCA-occlusion was observed in 2 (3.1%) patients. Revascularization by percutaneous coronary intervention could be successfully performed in these patients. RCA deformation occurred exclusively after TV repair while no cases were observed after TV replacement. Conclusion: Right coronary artery deformation without flow-limitation following surgical TV repair is a specific/typical phenomenon which might not impair patients' outcome and could be managed conservatively in most of the cases. RCA injury indicating further interventional therapy is a rare complication of TV surgery. However, the need for immediate POCA in general appears to be associated with a worsened intermediate-term outcome.

Cognitive function in late-stage HFpEF patients with tricuspid regurgitation undergoing transcatheter tricuspid valve intervention.

OBJECTIVES: This study evaluates the impact of transcatheter tricuspid valve interventions (TTVI) on cognitive function (CF), quality of life (QOL), and exercise capacity in late-stage heart failure with preserved ejection fraction (HFpEF) and relevant tricuspid regurgitation (TR). BACKGROUND: Reduced cardiac output (CO) critically affects CF. Severe TR aggravates CO reduction in HFpEF, while TTVI has been demonstrated to re-establish CO to a significant extent. The effect of TTVI on CF of HFpEF patients has so far not been investigated. METHODS: Assessment of CF was performed using the standardized Montreal Cognitive Assessment test in 34 symptomatic HFpEF patients with at least severe TR before and 3 months after TTVI alongside echocardiographic examinations and assessment of exercise capacity and QOL. RESULTS: Median age of the patients was 81.0 [78.8; 83.0] years and 50.0% were female. CF was impaired in 67.6% of the patients. TR ≤ moderate was achieved in 94.1% of the cases. Overall CF improved significantly (from 20.6 ± 3.9 to 23.0 ± 4.4; p = 0.001). Particularly, significant improvements were identified in the executive function (p < 0.001) and memory (p = 0.008). In addition, linear regression analysis demonstrated a significant collinearity of improvement between executive function as well as memory and increased CO (ρ = 0.695; p < 0.001 and ρ = 0.628; p < 0.001, respectively). The walked distance and QOL also improved significantly 3 months after TTVI. CONCLUSION: Cognitive impairment is highly prevalent in HFpEF patients with severe TR. TTVI results in an improved CF, especially with regard to executive function and memory. These improvements also correlate with more efficient hemodynamics reflected by increased CO.

Dynamics of Cognitive Function in Patients with Heart Failure Following Transcatheter Mitral Valve Repair.

Aims: Interventional transcatheter edge-to-edge mitral valve repair (TMVR) is an established treatment option for patients with severe mitral regurgitation (MR) and high operative risk. Cognitive impairment is one of the most common conditions among often extensive comorbidities in these patients. The specific patterns of cognitive decline and particularly the effect of TMVR are not well described. Thus, this study aimed to investigate into the impact of TMVR on cognitive impairment, exercise capacity, and quality of life. Methods: Cognitive function (executive, naming, memory, attention, language, abstraction, and orientation) was assessed with the standardized Montreal Cognitive Assessment test (MoCA; range between 0 and 30 points) before and 3 months after TMVR in 72 consecutive patients alongside echocardiographic examination and assessment of exercise capacity (six-minute walk test) as well as quality-of-life questionnaires (Minnesota living with heart failure questionnaire, MLHF-Q). Results: Patients' median age was 81 [76.0; 84.5] years, 39.7% were female with a median EuroScore II of 4.4% [2.9; 7.7]. The assessment of cognitive function showed a significant improvement of the cumulative MoCA-Test result (from 22.0 [19.0; 24.5] to 24 [22.0; 26.0]; p < 0.001) with significant changes in the subcategories executive (p < 0.001), attention (p < 0.001), abstraction (p < 0.001), and memory (p < 0.001). In addition, quality of life (from 47.5 [25.0; 69.3] to 24.0 [12.0; 40.0]; p < 0.001) and exercise capacity (from 220.0 m [160.0; 320.0] to 280.0 m [200.0; 380.0]; p = 0.003) increased significantly 3 months after the TMVR procedure. Conclusions: TMVR leads to a significant improvement of cognitive function, exercise capacity, and quality of life in patients with chronic heart failure in 3 months follow up and again highlights the benefit of the evermore established TMVR procedure for patients with high operative risk.

Pre-Procedural Right Ventricular Longitudinal Strain and Post-Procedural Tricuspid Regurgitation Predict Mortality in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI).

BACKGROUND: Right ventricular (RV) dysfunction has been linked to worse outcomes in patients undergoing TAVI. Assessment of RV function is challenging due to its complex morphology. RV longitudinal strain (LS) assessed by speckle-tracking echocardiography (STE) is a novel measure that may overcome most of the limitations of conventional echocardiographic parameters of RV function. The aim of current study was to assess the prognostic value of RV LS in patients undergoing TAVI and to assess echocardiographic predictors of long-term mortality. METHODS AND RESULTS: A retrospective analysis of all consecutive patients who underwent TAVI at our hospital between 1 January 2015 and 1 June 2016. Indication for TAVI was approved by a local heart-team. Echocardiographic data at baseline and after TAVI were re-analyzed and RV LS was measured in all patients with adequate image quality. A total of 229 patients were included in our study (mean age 83.8 ± 5 years, 62% women, mean EuroSCORE II 5.7 ± 5%). All-cause mortality occurred in 17.3% over a mean follow-up of 929 ± 373 days. In multivariate analysis, only baseline average RV free-wall LS (HR 1.05, 95% CI (1.01 to 1.10), p = 0.049) and more than mild tricuspid valve regurgitation (TR) after TAVI (HR 4.39, 95% CI (2.22 to 8.70), p < 0.001) independently increased the risk of all-cause mortality at long- term follow-up (2.5 years), while conventional echocardiographic parameters of RV function did not predict mortality. CONCLUSION: Pre-procedural RV LS and post-procedural tricuspid regurgitation significantly predicted long-term all-cause mortality in patients undergoing TAVI while conventional echocardiographic parameters of RV function failed in predicting long-term outcome. RV longitudinal strain by STE should be considered in the routine echocardiographic assessments of patients with severe AS.

Transcatheter Treatment of Secondary Tricuspid Regurgitation With Direct Annuloplasty: Results From a Multicenter Real-World Experience.

[Figure: see text].

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.

BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). CONCLUSIONS: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation.

BACKGROUND: The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow's disease. METHODS: 38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint. RESULTS: Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5-85.3] years (PASCAL) and 82.5 [76.5-86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68-0.83] cm2 (PASCAL) and 0.70 [0.50-0.90] cm2 (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured. CONCLUSION: In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.

Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study.

AIMS: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study. METHODS AND RESULTS: Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively. CONCLUSIONS: These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.

Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system.

BACKGROUND: The Cardioband tricuspid valve reconstruction system is a size-adjustable tricuspid reconstruction device for interventional treatment of tricuspid regurgitation (TR). Contraction of the device after successful implantation can be associated with an acute deformation of the right coronary artery (RCA). AIMS: The aim of this study was to provide data on the persistence and clinical significance of acute RCA deformation following Cardioband implant procedures. METHODS: Data from all patients with intraprocedural RCA deformation during Cardioband implantation were collected from four centres between October 2018 and January 2020. Control angiographies were performed in all of these patients before discharge. RESULTS: RCA deformation occurred in 14 out of 51 patients. Follow-up coronary angiography showed a complete resolution of deformation in all cases while patients remained clinically asymptomatic and had an uneventful post-interventional course. Intraprocedural coronary stent implantation was performed in two of the earlier cases according to the personal assessment of the implanters. CONCLUSIONS: RCA deformation is relatively frequent following interventional tricuspid annuloplasty but appears to be completely reversible in the absence of flow impairment or vascular damage. Based on our early experience watchful waiting is the most appropriate strategy to avoid unnecessary coronary interventions.