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.
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.
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.
Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality.
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.
Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team.
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).
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.
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.
Prespective
What is known: Reduced cardiac output (CO) critically affects cognitive function (CF). Severe tricuspid regurgitation (TR) aggravates CO reduction in patients with heart failure with persevered ejection fraction (HFpEF) for which therapeutics option were so far limited, while transcatheter tricuspid (TTVI) valve intervention has been demonstrated to re‐establish CO to a significant extent.
What is new: TTVI results in improved CF in HFpEF patients, especially concerning executive function and memory and these improvements are closely correlating with more effective hemodynamics reflected by increased CO, exercise capacity and quality of life.
What is next: The presence of HFpEF should further entail the assessment of TR as TTVI is emerging as a therapeutic tool to treat late‐stage complications in HFpEF patients with TR.
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 cm
2
, 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 cm
2
(PASCAL) and 0.70 0.50–0.90 cm
2
(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.
Graphic abstract
Tricuspid valve transcatheter edge-to-edge repair (T-TEER) is the most widely used transcatheter therapy to treat patients with tricuspid regurgitation (TR).BACKGROUNDTricuspid valve transcatheter ...edge-to-edge repair (T-TEER) is the most widely used transcatheter therapy to treat patients with tricuspid regurgitation (TR).The aim of this study was to develop a simple anatomical score to predict procedural outcomes of T-TEER.OBJECTIVESThe aim of this study was to develop a simple anatomical score to predict procedural outcomes of T-TEER.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.METHODSAll 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.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.RESULTSThe 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.The GLIDE score is a simple, 5-component score that is readily obtained during patient imaging and can predict successful T-TEER.CONCLUSIONSThe GLIDE score is a simple, 5-component score that is readily obtained during patient imaging and can predict successful T-TEER.
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.
This study sought to characterize patients who screen fail for TTVr with respect to their clinical characteristics and cardiac morphology.
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.
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%).
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.
Display omitted
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).
The aim of this study was to provide data on the persistence and clinical significance of acute RCA deformation following Cardioband implant procedures.
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.
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.
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.
PDF
