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.

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.

Left ventricular reverse remodeling after transcatheter aortic valve implantation in patients with low-flow low-gradient aortic stenosis.

OBJECTIVES: Left ventricular reverse remodeling (LVRR) is associated with improved outcome in patients with heart failure. Factors associated with and predictive of LVRR in patients with low-flow low-gradient aortic stenosis (LFLG AS) after transcatheter aortic valve implantation (TAVI) and its impact on outcome were assessed. METHODS: Pre- and postprocedural left ventricular (LV) function and volume were investigated in 219 patients with LFLG. LVRR was defined as an absolute increase of ≥10% in LV ejection fraction (LVEF) and reduction of ≥15% in LV end-systolic volume (LVESV). The primary endpoint was the combination of all-cause mortality and rehospitalization for heart failure. RESULTS: The mean LVEF was 35.0 ± 10.0%, with a stroke volume index (SVI) of 25.9 ± 6.0 mL/m2 and LVESV of 94.04 ± 46.0 mL. At a median of 5.2 months (interquartile range, 2.7-8.1 months), 77.2% (n = 169) of the patients showed echocardiographic evidence of LVRR. A multivariate model revealed three independent factors for LVRR after TAVI: SVI of <25 mL/m2 (hazard ratio [HR], 2.31; 95% confidence interval [CI], 1.08-3.58; p < 0.01), LVEF of <30% (HR, 2.76; 95% CI, 1.53-2.91; p < 0.01), and valvulo-arterial impedance (Zva) of <5 mmHg/mL/m2 (HR, 5.36; 95% CI, 1.80-15.98; p < 0.01). Patients without evidence of LVRR showed a significantly higher incidence of the 1-year combined endpoint (32 [64.0%] vs. 75 [44.4%], p < 0.01). CONCLUSIONS: The majority of patients with LFLG AS show LVRR after TAVI, which is associated with favorable outcomes. An SVI of <25 mL/m2, LVEF of <30%, and Zva < 5mmHg/mL/m2 represent predictors of LVRR.

Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison.

OBJECTIVE: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant. METHODS: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus. RESULTS: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR. CONCLUSION: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities.

Percutaneous trans-axilla transcatheter aortic valve replacement.

The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives.

Risk of mortality following transcatheter aortic valve replacement for low-flow low-gradient aortic stenosis.

BACKGROUND: Low-flow low-gradient (LF-LG) aortic stenosis (AS) is associated with high mortality, even after transcatheter aortic valve replacement (TAVR). Further knowledge of risk indicators is needed and a clinical risk score would be desirable for optimizing patient selection and therapeutic strategy. METHODS: The study cohort comprised of 219 consecutive LF-LG AS patients undergoing TAVR from 2008 to 2018 in two high-volume German centers. Predictive factors for one-year all-cause mortality were defined according to a Cox proportional hazard model. RESULTS: At one-year follow-up after TAVR, 28% of patients had died. A multivariate model revealed six independent predictors of one-year mortality: history of myocardial infarction (HR 2.05, 95%CI 1.13-3.72), eGFR < 30 ml/min/1.73m2 (HR 2.75, 95%CI 1.48-5.11), tricuspid regurgitation moderate or more (HR 2.06, 95%CI 1.14-3.72), stroke volume index < 25 mL/m2 (HR 2.03, 95%CI 1.14-3.62), self-expandable device (HR 2.72, 95%CI 1.17-6.27), and non-transfemoral approach (HR 3.42, 95%CI 1.28-9.14). The Rhineland Risk Score (RRS) consisting of these variables (c statistic 0.75, 95%CI 0.68-0.82, p < 0.001) was superior to the EuroSCORE II (c statistic 0.63) and STS-PROM score (c statistic 0.69) at predicting one-year mortality. Patients with a RRS ≥ 8 had a prohibitive risk of one-year mortality of 67.6% (95%CI 52.0-82.4%). CONCLUSION: In patients with LF-LG AS, history of myocardial infarction, renal dysfunction, tricuspid regurgitation, a low stroke volume index, self-expandable device, and non-femoral approach were associated with increased 1-year mortality after TAVR. The RRS might serve as a helpful tool for risk prediction and patient selection for TAVR in patients with LF-LG AS.