Balloon-expandable transcatheter heart valves for treatment of aortic valve stenosis in patients with large aortic annuli: Evaluation of deployment balloon overfilling strategies.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) using balloon-expandable (BE) transcatheter heart valves (THV) in aortic annuli above 29 mm includes particular procedural steps, mainly involving overfilling of the deployment balloon. Data on overfilling strategies in clinical daily practice is scarce. We herein aimed for a retrospective description of utilized overfilling strategies in those patients. METHODS: Between January 2016 and December 2022, 45 patients (100% male, 76.9 ± 6.1 years) received TAVI in aortic annuli above 29 mm using a BE THV. Overfilling volumina of the deployment balloon were left to operators' discretion. Clinical and multislice computed tomography data were retrospectively collected. Clinical endpoints were adjudicated in accordance with the updated standardized VARC-3 definitions. RESULTS: Profound overfilling (+4/5 mL) was used in patients with a mild calcium burden (˂750 mm³) even in aortic annuli of 29.0-30.0 mm. Nominal/slight overfilling (+1 mL) was used in aortic annuli up to 32.5 mm but an intermediate to severe calcific burden (>750-3200 mm³). Accordingly, a low calcification group (˂750 mm³, n = 17) compared to a significant calcification group (≥750 mm³, n = 28), presented with higher overfilling volumina (2.1 ± 1.4 vs. 0.8 ± 1.0; p ˂ 0.001), although aortic annulus diameter was not different (29.8 ± 0.8 vs. 29.9 ± 0.9 mm; p = 0.7). All-cause 30-day mortality was 0%. Device success was 97.8%. Transvalvular mean pressure gradient at discharge was 9.5 ± 3.6 mmHg. No case of PVL >mild was documented. CONCLUSION: Extent of overfilling of the deployment balloon largely depends on calcification burden in addition to aortic annulus diameter with significant and profound overfilling particularly in patients with a calcification burden of the aortic valve complex ˂750 mm³.

Differential effects of anaemia and iron deficiency on long-term outcomes following transcatheter edge-to-edge repair in degenerative vs. secondary mitral regurgitation: results from a large single-center study.

BACKGROUND: Anaemia and iron deficiency (ID) are independently associated with adverse outcomes in patients with cardiovascular diseases, especially in those with heart failure. Here, we aimed to clarify the long-term effect of anaemia and ID on outcomes in patients undergoing transcatheter mitral edge-to-edge repair (TEER) for relevant mitral regurgitation (MR) as well as to relate these to the underlying MR aetiology. METHODS: 833 patients (median age 77.1 years, 40.7% women, 63.3% secondary MR) treated by TEER between 09/2008 and 07/2019 were included and stratified according to baseline anaemia (hemoglobin < 12 g/dL in women and < 13 g/dL in men) or ID. RESULTS: Anaemia and ID were frequent with 61.6% and 68.1%, respectively. Anaemic patients had a lower functional status at baseline and were less likely to improve after TEER. In addition, anaemia was associated with all-cause mortality (hazard ratio [HR] = 1.68, 95% confidence interval [CI] 1.36-2.07, p < 0.001) and the composite endpoint of death or heart failure (HF) rehospitalization (HR = 1.30, 95% CI 1.10-1.54, p = 0.002). In contrast, ID was not associated with either all-cause mortality or the composite endpoint of death or HF rehospitalization. CONCLUSION: Patients undergoing TEER have high rates of both anaemia and ID. However, anaemia is associated with worse functional baseline status and post-interventional improvements compared to ID. Furthermore, anaemia is linked to higher rates of mortality and HF rehospitalization, particularly in those with secondary MR.

Right ventricular dysfunction predicts outcome after transcatheter mitral valve repair for primary mitral valve regurgitation.

AIMS: Right ventricular dysfunction (RVD), as expressed by right ventricular to pulmonary artery coupling, has recently been identified as a strong outcome predictor in patients undergoing mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation (MR). The aim of this study was to define RVD in patients undergoing M-TEER for primary MR (PMR) and to evaluate its impact on procedural MR reduction, symptomatic development and 2-year all-cause mortality. METHODS AND RESULTS: This multicentre study included patients undergoing M-TEER for symptomatic PMR at nine international centres. The study cohort was divided into a derivation (DC) and validation cohort (VC) for calculation and validation of the best discriminatory value for RVD. A total of 648 PMR patients were included in the study. DC and VC were comparable regarding procedural success and outcomes at follow-up. Sensitivity analysis identified RVD as an independent predictor for 2-year mortality in the DC (hazard ratio [HR] 2.37, 95% confidence interval [CI] 1.47-3.81, p < 0.001), which was confirmed in the VC (HR 2.06, 95% CI 1.36-3.13, p < 0.001). Procedural success (MR ≤2+) and symptomatic improvement at follow-up (New York Heart Association [NYHA] class ≤II) were lower in PMR patients with RVD (MR ≤2+: 82% vs. 93%, p = 0.002; NYHA class ≤II: 57.3% vs. 66.5%, p = 0.09 for with vs. without RVD). In all PMR patients, the presence of RVD significantly impaired 2-year survival after M-TEER (HR 2.23, 95% CI 1.63-3.05, p < 0.001). CONCLUSIONS: Mitral valve edge-to-edge repair is an effective treatment option for PMR patients. The presence of RVD is associated with less MR reduction, less symptomatic improvement and increased 2-year mortality. Accordingly, RVD might be included into pre-procedural prognostic considerations.

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

BACKGROUND: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. METHODS: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. RESULTS: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. CONCLUSIONS: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.

Cardiac extracellular matrix is associated with adverse outcome in patients with chronic heart failure.

AIMS: Accumulation of extracellular matrix (ECM) is known to play a crucial role in the pathophysiology of heart failure (HF). However, its prognostic relevance is poorly investigated. METHODS AND RESULTS: A total of 73 HF patients who underwent LV endomyocardial biopsy were enrolled in our study. ECM area was quantified by TissueFAXS and ImageJ software. Patients were followed-up at 6-month intervals. The study endpoint was defined as hospitalization for a cardiac reason and/or cardiac death. Furthermore, the influence of the ECM on invasively measured haemodynamic parameters was tested. During a median follow-up period of 9.0 months, 34 patients (46.6%) reached the combined endpoint. Median ECM area was 30.5%. Patients with ECM area ≥30.5% experienced significantly more events (67.6% vs. 25.0%, P < 0.001) in comparison with patients with an ECM area <30.5%. ECM area was independently associated with outcome in the total HF cohort [hazard ratio (HR) 1.041, 95% confidence interval (CI) 1.017-1.066, P = 0.001] as well as in HF patients with preserved (HR 1.079, 95% CI 1.001-1.163, P =0 .046) or reduced ejection fraction (HR 1.149, 95% CI 1.036-1.275, P = 0.009). Positive correlations were found between ECM area and LV end-diastolic pressure (P = 0.021, R = 0.303), pulmonary artery wedge pressure (P = 0.042, R = 0.249), mean pulmonary arterial pressure (P = 0.035, R = 0.258), as well as right atrial pressure (P = 0.003, R = 0.353). CONCLUSION: ECM area within the LV myocardium correlates with left and right heart haemodynamics and is associated with clinical course in various non-ischaemic HF types.