Abstract Background The MitraClip is the worldwide established transcatheter edge-to-edge repair system with over 100,000 treated patients. The recently approved PASCAL repair system is well adopted in the field of percutaneous mitral regurgitation (MR) treatment with growing acceptance both in mitral and tricuspid valves. The aim of this retrospective multicenter study was to compare the Edwards' PASCAL System with the Abbott MitraClip System in terms of procedural results and short-term outcome. Methods We retrospectively evaluated patient data of three high volume German centers that performed percutaneous edge to edge procedures either with the MitraClip or the PASCAL repair system. Primary endpoint was the amount of MR reduction. Secondary endpoints were residual MR at discharge, technical success, device success and 30-day mortality. Results Between 2018 and 2020 a total of 412 procedures were performed in the three centers. 216 cases were performed with the MitraClip compared to 196 procedures done with the PASCAL repair system. Patients were male in 55.6% of the cases (50.5% in the MitraClip cohort compared to 61.2% in the PASCAL cohort, p=0.028), mean Logistic Euro-Score II was 4.42 (3.58 in the MitraClip and 3.23 in the PASCAL cohort, p=0.038) and reduced LVEF beyond 45% was seen in 42.6% of the cases (49.5% in the MitraClip compared to 35.3% in the PASCAL cohort, p=0.004). Severe MR at baseline was seen in 98.5% in the MitraClip cohort compared to 98.6% in the PASCAL cohort, p=0.909). Mean number of implanted devices was 1.41±0.56 in the MitraClip cohort and 1.37±0.55 in the PASCAL cohort (p=0.401). Procedures were successfully conducted with both edge-to-edge systems (device success rate 93.2% in the MitraClip cohort and 94.0% in the PASCAL cohort, p=0.775), leading to comparably good results (final MR ≤2 in 94.4% with the MitraClip compared to 95.9% with the PASCAL system, p=0.448) and very good results (final MR ≤1 in 72.6% in the MitraClip compared to 79.5% in the PASCAL cohort, p=0.102). After propensity score matching for adjustment of major differences among the two treatment strategies (including age, gender, MR etiology, EROA, Severe MR (III and IV), reduced LVEF and Mitral Valve orifice area) the achieved mean MR reduction remains comparable (2.29±0.82 with the MitraClip compared to 2.46±0.82 with the PASCAL system, p=0.191). In multivariate regression analysis STS Score independently correlates with a very good final result while device choice did not show a significant impact in this cohort. Conclusion In this retrospective multicenter study both the MitraClip and PASCAL system performed excellent with comparable procedural success rates. Achieved final average reduction of MR Grade was 2.29±0.82 with the MitraClip and 2.46±0.82 with the PASCAL system. Funding Acknowledgement Type of funding sources: None.
Abstract Aims Prevalence of mitral regurgitation (MR) and comorbidity burden rise with age. Mitral valve transcatheter edge‐to‐edge repair (M‐TEER) is increasingly performed in elderly patients, but only limited data are available for this specific subgroup. In this study, outcomes of octogenarians and nonagenarians undergoing M‐TEER were analysed using a large real‐world dataset. Methods This retrospective study included consecutive patients undergoing M‐TEER at the Ulm University Heart Center between January 2010 and December 2021. The cohort was divided into an elderly group and a younger group based on the cohorts' median age. Group differences regarding 1 and 3 year mortality and heart failure hospitalization rates were assessed using Kaplan–Meier survival analysis and Cox proportional hazard models. Results A total of 1118 patients [median age 79 (inter‐quartile range 74–83) years; 42% female] were included and divided into 513 elderly (≥80 years) and 605 younger (<80 years) patients. Primary MR was more frequent in the elderly group (56% vs. 27%, P < 0.001). Pre‐procedural and post‐procedural MR grades were comparable between groups (pre‐procedural MR grade 4: 69% in the elderly group vs. 71% in the younger group, P = 0.67; post‐procedural MR grade 1: 60% in the elderly group vs. 58% in the younger group, P = 0.77) as well as in‐hospital mortality rates (0.2% vs. 0.3%, P = 0.66). Three‐year heart failure hospitalization rates did not differ significantly between both groups (30.7% in the older age cohort vs. 36.0% in the younger cohort, P = 0.191). While 1 year all‐cause mortality rates were comparable (18% vs. 16.4%, P = 0.577), 3 year all‐cause mortality was significantly higher in the elderly [43.1% vs. 33.0%; hazard ratio (HR) 1.29 (95% confidence interval 1.02–1.65), P = 0.035]. Pre‐procedural N‐terminal pro‐brain natriuretic peptide (NT‐proBNP) ≥3402 pg/mL [HR 2.29 (95% CI 1.34–3.90), P = 0.002], pre‐interventional MR grade [HR 1.79 (95% CI 1.01–3.17), P = 0.045] and European System for Cardiac Operative Risk Evaluation (EuroSCORE) II [HR 1.06 (95% CI 1.03–1.08), P < 0.001] were identified as independent predictors of 3 year mortality in the elderly. Conclusions M‐TEER displays a safe and effective treatment option for elderly patients with symptomatic MR, offering symptom relief and comparable 1 year outcomes to younger patients. Elderly patients with elevated EuroSCORE II and advanced heart failure might benefit from additional care to further reduce 3 year mortality.
Abstract Background Standardization of periprocedural pathways reduces the length of hospital stay and thus healthcare costs and increases patient safety. Post-procedure admission to the intensive care unit (ICU) after transcatheter edge-to-edge tricuspid valve repair (T-TEER) has been the standard of care. Due to the COVID-19 pandemic related decline in high-care hospital beds, our center established primary admission to a dedicated general cardiologic care ward, the valve unit (VU). Aim To assess benefits and risks of admission to the VU instead of ICU after T-TEER. Methods This retrospective observational study included 270 consecutive patients who underwent T-TEER between March 2017 and June 2023 at our university hospital. Patients were admitted to the ICU post-procedure up to April 9th 2020 as standard (ICU-group, n = 53). Subsequent patients were planned for admission to a dedicated VU (VU-group, n = 217). We compared the groups and assessed length of hospital stay and in-hospital complications. In the VU-group, we examined unplanned transfer to the ICU (cross-over) and its predictors. Results Monitoring at the VU included continuous telemetric ECG-recording, oxygen saturation assessment, periodical blood pressure measurements and 24-hours physician presence. In contrast to the ICU, only non-invasive blood pressure measurements, less frequent laboratory controls and less intense fluid monitoring took place. The postinterventional hospital stay of patients with planned VU admission was significantly shorter compared to patients with planned ICU admission (median 4 (interquartile range (IQR) 3 - 5) vs. 4 (IQR 4 - 5) days, p = 0.030). Remarkably, overall complication rates were low and cardiogenic shock, infections, bleeding, vascular complications, delirium and acute kidney injury requiring dialysis were similar in both groups. 37 patients that were planned for VU had to cross over to unplanned ICU admission (17.1 %). Patients that had crossed over to unplanned ICU treatment had significantly higher risk for acute kidney injury (20.0 vs. 10.0%, p = 0.039) and in-hospital mortality (5.6 vs. 0%, p = 0.045). Higher systolic pulmonary artery pressure (sPAP) (OR 1.048, 95 %-CI 1.015 – 1.082, p = 0.003), NYHA functional class >= III (OR 9.176, 95 % CI 1.141 – 74.396, p = 0.037), and pre-interventional tricuspid regurgitation (TR) grade V (OR 2.941, 95 % CI 1.089 – 7.970, p = 0.033) were found to independently predict cross-over to unplanned ICU treatment. Conclusion Postinterventional admission to the VU instead of ICU after T-TEER shortens postprocedural hospital stay. A small proportion of had an unplanned transfer to ICU, which was accompanied by slightly higher complication rates. This cross-over affects patients with more advanced disease indicated by high pulmonary pressures, NYHA class and TR grade. Thus, admission to a valve unit is favorable for most patients after T-TEER, but those with advanced disease should be monitored more closely.
An isotropic 2D six-point Dixon method was applied for assessment of the left arterial appendix (LAA) morphology prior to LAA closure intervention. Sufficient image quality was achieved even in highly arrhythmic patients allowing for the preinterventional quantification of the LAA dimensions as required for proper closure device selection. MR derived diameters were compared to periprocedurally TEE and XR derived values, which were in good agreement. Further, optimal XR angulation providing projections perpendicular to the envisaged landing zone could be identified.
This study sought to determine the potential change in trends in the baseline characteristics of patients with symptomatic severe mitral regurgitation who underwent transcatheter edge-to-edge mitral valve repair (M-TEER) over the last decade in a high-volume center.
Background Mitral annular alterations in the context of heart failure often lead to severe functional mitral regurgitation (FMR), which should be treated with transcatheter edge-to-edge repair (M-TEER) according to current guidelines. M-TEER's effects on mitral valve (MV) annular remodeling have not been well elucidated. Methods 141 consecutive patients undergoing M-TEER for treatment of FMR were included in this investigation. Comprehensive intraprocedural transesophageal echocardiography was used to assess the acute effects of M-TEER on annular geometry. Results Average patient age was 76.2 ± 9.6 years and 46.1% were female patients. LV ejection fraction was reduced (37.0% ± 13.7%) and all patients had mitral regurgitation (MR) grade ≥III. M-TEER achieved optimal MR reduction (MR ≤ I) in 78.6% of patients. Mitral annular anterior-posterior diameters (A-Pd) were reduced by −6.2% ± 9.5% on average, whereas anterolateral-posteromedial diameters increased (3.7% ± 8.9%). Overall, a reduction in MV annular areas was observed (2D: −1.8% ± 13.1%; 3D: −2.7% ± 13.7%), which strongly correlated with A-Pd reduction (2D: r = 0.6, p < 0.01; 3D: r = 0.65, p < 0.01). Patients that achieved A-Pd reduction above the median (≥6.3%) showed significantly lower rates of the composite endpoint rehospitalization for heart failure or all-cause mortality than those with less A-Pd reduction (9.9% vs. 28.6%, p = 0.037, log-rank p = 0.039). Furthermore, patients reaching the composite endpoint had an increase in annular area (2D: 3.0% ± 15.4%; 3D: 1.9% ± 15.3%), whereas those not reaching the endpoint showed a decrease (2D: −2.7% ± 12.4%; 3D: −3.6% ± 13.3%), although residual MR after M-TEER was similar between these groups ( p = 0.57). In multivariate Cox regression adjusted for baseline MR, A-Pd reduction ≥6.3% remained a significant predictor of the combined endpoint (OR: 0.35, 95% CI: 0.14–0.85, p = 0.02). Conclusion Our findings indicate that effects of M-TEER in FMR are not limited to MR reduction, but also have significant impact on annular geometry. Moreover, A-Pd reduction, which mediates annular remodeling, has a significant impact on clinical outcome independent of residual MR.
The development of transcatheter tricuspid edge-to-edge repair for tricuspid regurgitation is a therapeutic milestone but a specific periprocedural risk assessment tool is lacking. TRI-SCORE has recently been introduced as a dedicated risk score for tricuspid valve surgery.This study analyzes the predictive performance of TRI-SCORE following transcatheter edge-to-edge tricuspid valve repair.180 patients who underwent transcatheter tricuspid valve repair at Ulm University Hospital were consecutively included and stratified into three TRI-SCORE risk groups. The predictive performance of TRI-SCORE was assessed throughout a follow-up period of 30 days and up to 1 year.All patients had severe tricuspid regurgitation. Median EuroSCORE II was 6.4% (IQR 3.8-10.1%), median STS-Score 8.1% (IQR 4.6-13.4%) and median TRI-SCORE 6.0 (IQR 4.0-7.0). 64 patients (35.6%) were in the low TRI-SCORE group, 91 (50.6%) in the intermediate and 25 (13.9%) in the high-risk groups. The procedural success rate was 97.8%. 30-day mortality was 0% in the low-risk group, 1.3% in the intermediate-risk and 17.4% in the high-risk groups (p < 0.001). During a median follow-up of 168 days mortality was 0%, 3.8% and 52.2%, respectively (p < 0.001). The predictive performance of TRI-SCORE was excellent (AUC for 30-day mortality: 90.3%, for one-year mortality: 93.1%) and superior to EuroSCORE II (AUC 56.6% and 64.4%, respectively) and STS-Score (AUC 61.0% and 59.0%, respectively).TRI-SCORE is a valuable tool for prediction of mortality after transcatheter edge-to-edge tricuspid valve repair and its performance is superior to EuroSCORE II and STS-Score. In a monocentric cohort of 180 patients undergoing edge-to-edge tricuspid valve repair TRI-SCORE predicted 30-day and up to one-year mortality more reliably than EuroSCORE II and STS-Score. AUC area under the curve, 95% CI 95% confidence interval.
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