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

Tricuspid valve transcatheter edge-to-edge repair has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR). 

Transcatheter Valve Repair for Tricuspid Regurgitation

AIMS
Transcatheter tricuspid edge-to-edge repair (T-TEER) has gained widespread use for the treatment of tricuspid regurgitation in symptomatic patients with high operative risk. Although secondary TR is the most common pathology, some patients exhibit primary or predominantly primary TR. Characterization of patients with these pathologies in the T-TEER context has not been systematically performed.


METHODS AND RESULTS
Patients assigned to T-TEER by the interdisciplinary Heart Team were consecutively recruited in two European centers over 4 years. Echocardiographic images were evaluated to distinguish between primary and secondary causes of TR. Both groups were compared concerning procedural results. 339 patients were recruited, 13% with primary TR and 87% with secondary TR. Patients with primary TR had a smaller right ventricle (basal diameter 45 vs. 49 mm, p = 0.004), a better right ventricular function (fractional area change 45 vs. 41%, p = 0.001), a smaller right (28 vs. 34cm², p = 0.021) and left (52 vs. 67 ml/m², p = 0.038) atrium, and a better left ventricular ejection fraction (60 vs. 52%, p = 0.005). The severity of TR was similar in primary and secondary TR at baseline (TR vena contracta width pre-interventional 13 ± 4 vs. 14 ± 5 mm, p = 0.19), and T-TEER significantly reduced TR in both groups (TR vena contracta width post-interventional 4 ± 3 vs. 5 ± 5 mm, p = 0.10). These findings remained stable after propensity score matching. Complications were similar between both groups.


CONCLUSION
T-TEER confers equally safe and effective reduction of TR in patients with primary and secondary TR.

Tricuspid edge-to-edge repair for tricuspid valve prolapse and flail leaflet. Feasibility in comparison to patients with secondary tricuspid regurgitation.

Abstract Tricuspid regurgitation (TR) is the most common pathology of the tricuspid valve (TV), with significant mortality in severe cases. A well-established strategy to treat TR is represented by the clover surgical technique, which consists of stitching together the free edges of TV leaflets, producing a clover-shaped valvular orifice. Transcatheter treatments for TR constitute a valuable alternative for high-risk patients. In this work we investigated haemodynamic performances and safety of a novel device (StarTric device (STD)) aiming to perform the clover technique via percutaneous access. To assess haemodynamic performances, STD and clover were applied on porcine pathological TVs and tested. Fluid dynamic indexes of both strategies were compared to the pathological model. To evaluate device safety, forces exchanged between device and leaflets were compared to the extraction force (EF) required to STD to completely pass through the leaflet. Clover technique and STD induced a comparable TV backflow reduction (48% and 47%, respectively), with associated increase of TV flow in all tested conditions. Diastolic transvalvular pressure similarly increased indicating a reduction, though not significant, of the valvular orifice. Forces ranged from 1N to 1.71N, compared to an EF of 22.16 ± 8.6N. Force varied significantly amongst different working conditions (normotensive, mild, and severe hypertensive) for each leaflet, whilst no significative variation was found on different leaflets in the same working condition. In the adopted experimental scenario, STD demonstrated comparable efficacy to the surgical strategy in restoring TV haemodynamic. The forces acting on the leaflets following STD implantation were far lower when compared to EFs. 

A Novel Transcatheter Device for the Edge-to-Edge Treatment of Tricuspid Regurgitation: A Preliminary Evaluation.

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

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

Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery.

https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/ccd.30450

Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30‐day results


 
 
 The edge-to-spacer PASCAL repair system was recently approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data with the MitraClip XT device which shows similar size and leaflet grasping features are lacking.
 
 
 
 Aim of this study was to compare the procedural and short-term safety and efficacy of two transcatheter mitral leaflet approximation devices, the PASCAL P10 and the MitraClip XT.
 
 
 
 Overall, 566 patients underwent transcatheter mitral valve repair (TMVR) with PASCAL P10 (n=309) or MitraClip XT (n=257). The PASCAL P10 cohort included patients treated at 10 tertiary care centres in Germany between February and December 2019, while the MitraClip XT cohort consisted of patients treated at three of these 10 centres between May 2018 and September 2022. Propensity score (PS) matching based on the parameters gender, age, left ventricular ejection fraction, NYHA class, left ventricular end-diastolic diameter, left atrial volume index, vena contracta width, MR aetiology, and mean gradient resulted in 191 well balanced patient pairs. Primary efficacy endpoints were technical success, degree of residual MR at discharge and at 30-days as well as device success at 30-days. Primary safety endpoint was the rate of major adverse events (MAE) at 30-days.
 
 
 
 Technical success was 95.8% in the PASCAL group and 95.3% in the MitraClip group (P>0.99). An MR ≤2+ at discharge was numerically more frequent in the PASCAL than in the MitraClip group (PASCAL: 91.5% vs. MitraClip: 85.9%; P=0.101). An MR ≤1+ at discharge was achieved more frequently in the PASCAL group (PASCAL: 68.3% vs. MitraClip: 56.5%; P=0.025). This difference was sustained at 30-days with numerically more patients with residual MR ≤2+ (PASCAL: 89.7% vs. MitraClip: 82.4%; P=0.071) and significantly more patients with MR ≤1+ (PASCAL: 64.7% vs. MitraClip: 51.6%; P=0.021) in the PASCAL group than in the MitraClip group. At 30-days, the mean gradient was similar between the two groups (PASCAL: 3.0 [2.3–4.0] mmHg vs. MitraClip: 3.1 [2.7–4.2] mmHg], P=0.218). Device success at 30 days was achieved with an equal frequency in both groups (PASCAL: 78.8% vs MitraClip: 71.3%; P=0.129). At 30-days, MAE occurred more often in the MitraClip than in the PASCAL group (PASCAL: 3.7% vs. MitraClip: 12.6%; P=0.002).
 
 
 
 In this PS-matched study comparing the PASCAL P10 with the MitraClip XT, safety and efficacy were comparable at 30-days.


Early outcomes of the PASCAL P10 and the MitraClip XT transcatheter mitral leaflet approximation devices - A propensity score matched multicentre comparison

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Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30‐day results

Early outcomes of the PASCAL P10 and the MitraClip XT transcatheter mitral leaflet approximation devices - A propensity score matched multicentre comparison