Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison.

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.

Impact of Intraprocedural Mitral Regurgitation and Gradient Following Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation.

BACKGROUND: The impact of intraprocedural results following transcatheter edge-to-edge repair (TEER) in primary mitral regurgitation (MR) is controversial. OBJECTIVES: This study sought to investigate the prognostic impact of intraprocedural residual mitral regurgitation (rMR) and mean mitral valve gradient (MPG) in patients with primary MR undergoing TEER. METHODS: The PRIME-MR (Outcomes of Patients Treated With Mitral Transcatheter Edge-to-Edge Repair for Primary Mitral Regurgitation) registry included consecutive patients with primary MR undergoing TEER from 2008 to 2022 at 27 international sites. Clinical outcomes were assessed according to intraprocedural rMR and mean MPG. Patients were categorized according to rMR (optimal result: ≤1+, suboptimal result: ≥2+) and MPG (low gradient: ≤5 mm Hg, high gradient: > 5 mm Hg). The prognostic impact of rMR and MPG was evaluated in a Cox regression analysis. The primary endpoint was 2-year all-cause mortality or heart failure hospitalization. RESULTS: Intraprocedural rMR and mean MPG were available in 1,509 patients (median age = 82 years [Q1-Q3: 76.0-86.0 years], 55.1% male). Kaplan-Meier analysis according to rMR severity showed significant differences for the primary endpoint between rMR ≤1+ (29.1%), 2+ (41.7%), and ≥3+ (58.0%; P < 0.001), whereas there was no difference between patients with a low (32.4%) and high gradient (42.1%; P = 0.12). An optimal result/low gradient was achieved in most patients (n = 1,039). The worst outcomes were observed in patients with a suboptimal result/high gradient. After adjustment, rMR ≥2+ was independently linked to the primary endpoint (HR: 1.87; 95% CI: 1.32-2.65; P < 0.001), whereas MPG >5 mm Hg was not (HR: 0.78; 95% CI: 0.47-1.31; P = 0.35). CONCLUSIONS: Intraprocedural rMR but not MPG independently predicted clinical outcomes following TEER for primary MR. When performing TEER in primary MR, optimal MR reduction seems to outweigh the impact of high transvalvular gradients.

Transcatheter Edge-to-Edge Mitral Valve Repair versus Minimally Invasive Mitral Valve Surgery: An Observational Study.

Background: Minimally invasive mitral valve surgery (MIC-MVS) has been established as preferred treatment of mitral regurgitation (MR), but mitral transcatheter edge-to-edge valve repair (M-TEER) is routinely performed in patients at high surgical risk and is increasingly performed in intermediate risk patients. Methods: From 2010 to 2021, we performed 723 M-TEER and 123 isolated MIC-MVS procedures. We applied a sensitivity analysis by matching age, left ventricular ejection fraction (LVEF), EuroSCORE II and etiology of MR. Results: Baseline characteristics showed significant differences in the overall cohort (p < 0.01): age 78.3 years vs. 61.5 years, EuroSCORE II 5.5% vs. 1.3% and LVEF 48.4% vs. 60.4% in M-TEER vs. MIC-MVS patients. Grade of MR at discharge was moderate/severe in 24.5% (171/697) in M-TEER vs. 6.5% (8/123) in MIC-MVS (p < 0.01). One-year survival was 91.5% (552/723) in M-TEER vs. 97.6% (95/123) in MIC-MVS (p = 0.04). A matching with 49 pairs (n = 98) showed comparable survival during follow-up, but a numerically higher mean mitral valve gradient of 4.1 mmHg (95% CI: 3.6-4.6) vs. 3.4 mmHg (95% CI: 3.0-3.8) in M-TEER (p = 0.04). Conclusions: Patients undergoing M-TEER had lower one-year survival than MIC-MVS, but differences disappeared after matching. Reduction in MR was less effective in M-TEER patients and postprocedural mitral valve gradients were higher.

Outcomes of Transcatheter Tricuspid Edge-to-Edge Repair in Patients With Right Ventricular Dysfunction.

BACKGROUND: We assessed the safety profile of tricuspid transcatheter edge-to-edge repair (TEER) in patients with right ventricular (RV) dysfunction. METHODS: We identified patients undergoing TEER to treat tricuspid regurgitation from June 2015 to October 2021 and assessed tricuspid annular plane systolic excursion (TAPSE) and RV fractional area change (RVFAC). RV dysfunction was defined as TAPSE <17 mm and RVFAC <35%. The primary end point was 30-day mortality after TEER. We also investigated the change in the RV function in the early phase and clinical outcomes at 2 years. RESULTS: The study participants (n=262) were at high surgical risk (EuroSCORE II, 6.2% [interquartile range, 4.0%-10.3%]). Among them, 44 patients met the criteria of RV dysfunction. Thirty-day mortality was 3.2% in patients with normal RV function and 2.3% in patients with RV dysfunction (P=0.99). Tricuspid regurgitation reduction to ≤2+ was consistently achieved irrespective of RV dysfunction (76.5% versus 70.5%; P=0.44). TAPSE and RVFAC declined after TEER in patients with normal RV function (TAPSE, 19.0±4.7 to 17.9±4.5 mm; P=0.001; RVFAC, 46.2%±8.1% to 40.3%±9.7%; P<0.001). In contrast, those parameters were unchanged or tended to increase in patients with RV dysfunction (TAPSE, 13.2±2.3 to 15.3±4.7 mm; P=0.011; RVFAC, 29.6%±4.1% to 31.6%±8.3%; P=0.14). Two years after TEER, compared with patients with normal RV function, patients with RV dysfunction had significantly higher mortality (27.0% versus 56.3%; P<0.001). CONCLUSIONS: TEER was safe and feasible to treat tricuspid regurgitation in patients with RV dysfunction. The decline in the RV function was observed in patients with normal RV function but not in patients with RV dysfunction.

Changes in right ventricular function and clinical outcomes following tricuspid transcatheter edge-to-edge repair.

AIMS: Prognostic impact of post-procedural changes in right ventricular (RV) function after tricuspid transcatheter edge-to-edge repair (T-TEER) is still unclear. We investigated association of RV function and its post-procedural changes with clinical outcomes in patients undergoing T-TEER. METHODS AND RESULTS: We retrospectively analysed 204 patients who underwent T-TEER and echocardiographic follow-up at 3 months after T-TEER. RV function was assessed by RV fractional area change (RVFAC), and RV dysfunction was defined as RVFAC <35%. Patients with an increase in RVFAC from baseline to the follow-up were considered as RV responders. Patients were divided into four groups according to baseline RVFAC and the RV responder. The primary outcome was a composite of mortality and hospitalization due to heart failure within 1 year. Forty-five of 204 patients (22.1%) had RVFAC <35% at baseline, and 71 (34.8%) were RV responders. The association between the RV responder and the composite outcome had a significant interaction with RVFAC at baseline. Among patients with baseline RVFAC <35%, RV responders had a lower risk of the composite outcome than RV non-responders, while this association was not significant in those with baseline RVFAC ≥35%. Among patients with baseline RVFAC <35%, a smaller RV diameter and a greater reduction of tricuspid regurgitation were predictors for the RV responder. CONCLUSION: Post-procedural increase in RVFAC after T-TEER is associated with improved outcomes in patients with RV dysfunction. The factors related to the increase in RVFAC may support patient selection for T-TEER in patients with RV dysfunction.

Outcomes of transcatheter edge-to-edge repair for atrial functional mitral regurgitation.

BACKGROUND: The prognostic benefits of transcatheter edge-to-edge repair (TEER) remain unclear in patients with atrial functional mitral regurgitation (AFMR). AIMS: We aimed to investigate the clinical outcomes of TEER for patients with AFMR. METHODS: We retrospectively classified functional mitral regurgitation (FMR) patients undergoing TEER into those with AFMR or ventricular FMR (VFMR). A residual MR ≤1+ at discharge was considered optimal mitral regurgitation (MR) reduction, and an elevated mean mitral valve pressure gradient (MPG) was defined as an MPG ≥5 mmHg at discharge. The primary outcome was a composite of all-cause mortality and hospitalisation due to heart failure within one year. RESULTS: Of 441 FMR patients, 125 patients were considered as having AFMR. Residual MR ≤1+ was associated with a lower risk of the composite outcome in both AFMR and VFMR patients, while an MPG ≥5 mmHg was associated with a higher risk of the composite outcome in patients with AFMR but not with VFMR. AFMR patients with residual MR ≤1+ and an MPG ≥5 mmHg, as well as those with residual MR >1+, had a higher incidence of the composite outcome than those with residual MR ≤1+ and an MPG <5 mmHg (50.7%, 41.8%, and 14.3%, respectively; p<0.001). This association was consistent after adjustment for clinical and echocardiographic characteristics. CONCLUSIONS: An MR reduction to ≤1+ following TEER was associated with a lower risk of clinical outcomes in patients with AFMR, while an MPG ≥5 mmHg was related to a higher risk of clinical outcomes. Optimal MR reduction by TEER may have potential benefits on the prognosis of patients with AFMR, although the prognostic benefit may be attenuated by an elevated MPG.

Cardiac computed tomography-based assessment of mitral annular calcification in patients undergoing mitral transcatheter edge-to-edge repair.

BACKGROUND: The role of assessment of mitral annular calcification (MAC) using cardiac computed tomography (CCT) in mitral transcatheter edge-to-edge repair (TEER) remains unclear. The aim of this study was to investigate the association of MAC assessed by CCT with procedural and clinical outcomes in patients undergoing TEER. METHODS: We retrospectively analyzed 275 patients who underwent pre-procedural CCT prior TEER. Mitral calcium volume (MCV) and MAC score were measured by CCT. Functional procedural success was defined as residual mitral regurgitation of ≤2+ with mean transmitral gradient of <5 â€‹mmHg at discharge. All-cause mortality within two years after TEER was collected. RESULTS: MAC was present in 115 of 275 patients (41.8 %). The median MCV was 198 â€‹mm3 (interquartile range [IQR]: 84 to 863 â€‹mm3), and the median MAC score was 3 (IQR: 2 to 4). Higher MCV and MAC score were inversely related to the rate of functional procedural success, independently of anatomical features of mitral valve. Patients with moderate/severe MAC, defined as MAC score of ≥4, had a lower rate of functional procedural success than those without MAC (56.1 â€‹% vs. 81.3 â€‹%; p â€‹= â€‹0.002). Moreover, higher MCV and MAC score were associated with a higher risk of all-cause mortality within two years, irrespective of baseline characteristics and functional procedural success. CONCLUSIONS: The presence and burden of MAC assessed by CCT were associated with procedural and clinical outcomes in patients undergoing TEER. The CCT-based assessment of MAC may improve patient selection for TEER.