Navigating the "Optimal Implantation Depth" With a Self-Expandable TAVR Device in Daily Clinical Practice.

OBJECTIVES: This study sought to predict whether different methods of calculating the implantation depth (ID) influence clinical and hemodynamic outcome reporting in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expandable device. BACKGROUND: Different approaches exist to calculate the ID, which may influence uniform and reliable reporting because the updated Valve Academic Research Consortium (VARC-2) criteria do not provide specific instructions. METHODS: The clinical and hemodynamic outcomes of 258 patients undergoing TAVR with a third-generation self-expandable device were analyzed with regard to the method used to assess the ID as follows: arithmetic mean, the arithmetic mean of the measured distances from the noncoronary cusp and the left coronary cusp to the distal prosthesis end; noncoronary cusp distance, the distance from the noncoronary cusp to the distal prosthesis end; and deepest edge, the deepest edge of the distal prosthesis end. RESULTS: Regardless of the measurement method, the optimal ID (OID) was reached in <30% (arithmetic mean, 25.4%; noncoronary cusp distance, 28.4%; deepest edge, 20.5%; p = 0.008). The deepest edge method is the most stringent to differentiate the relevant outcome parameters, such as the need for permanent pacemaker implantation (OID 3.7% vs. no OID 14.6%; p = 0.033). The hemodynamic outcome (i.e., mean pressure gradient reduction after TAVR: OID 7.4 ± 3.4 mm Hg vs. no OID 8.3 ± 4.0 mm Hg; p = 0.093) was not affected. CONCLUSIONS: The OID was reached in <30% of TAVR procedures. The various methods applied for ID calculation significantly influence the outcome reporting and do not allow a uniform perception of the ID. (Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation; NCT01805739).

Micro-dislodgement during transcatheter aortic valve implantation with a contemporary self-expandable prosthesis.

OBJECTIVES: To evaluate the incidence, risk factors and the clinical outcome of micro-dislodgement (MD) with a contemporary self-expandable prosthesis during transcatheter aortic valve implantation. METHODS: MD was defined as movement of the prosthesis of at least 1.5 mm upwards or downwards from its position directly before release compared to its final position. Patients were grouped according to the occurrence (+MD) or absence (-MD) of MD. Baseline characteristics, imaging data and outcome parameters were retrospectively analyzed. RESULTS: We identified 258 eligible patients. MD occurred in 31.8% (n = 82) of cases with a mean magnitude of 2.8 mm ± 2.2 in relation to the left coronary cusp and 3.0 mm ± 2.1 to the non-coronary cusp. Clinical and hemodynamic outcomes were similar in both groups with consistency over a follow-up period of three months. A larger aortic valve area (AVA) (-MD vs. +MD: 0.6 cm2 ± 0.3 vs. 0.7cm2 ± 0.2; p = 0.014), was the only independent risk factor for the occurrence of MD in a multivariate regression analysis (OR 5.3; 95% CI: 1.1-24.9; p = 0.036). CONCLUSIONS: MD occurred in nearly one third of patients and did not affect clinical and hemodynamic outcome. A larger AVA seems to be a potential risk factor for MD.

The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement: Matched Comparison of the Evolut PRO and Evolut R.

OBJECTIVES: The aim of this study was to investigate the hemodynamic and clinical performance of the Evolut PRO compared with its direct predecessor, the Evolut R. BACKGROUND: Recently, the newest commercially available generation of the self-expandable Medtronic CoreValve prosthesis, the CoreValve Evolut PRO, was introduced to the market. This prosthesis is based on the previous Evolut R model and specifically designed to mitigate paravalvular leakage. Because of the design changes, the Evolut PRO needs a larger sheath size (16-F vs. 14-F). METHODS: Patients receiving either the Evolut R (n = 148) or the Evolut PRO (n = 74) from September 2015 to January 2018 were compared in a 2:1 fashion after propensity score matching. Baseline characteristics, cardiovascular imaging, and pre- and periprocedural outcomes were prospectively collected and assessed. RESULTS: Both cohorts represent a high-risk, real-world collective with increased perioperative mortality risk (logistic European System for Cardiac Operative Risk Evaluation score, Evolut R vs. Evolut PRO: 24.7 ± 13.7% vs. 25.1 ± 12.5%; p = 0.881). Procedural success was 100%, and the mean transvalvular pressure gradient was substantially reduced (Evolut R vs. Evolut PRO: 7.9 ± 3.9 mm Hg vs. 7.5 ± 3.5 mm Hg; p = 0.348). Mild paravalvular leakage was observed in 16.2% of Evolut R patients and in 14.9% of Evolut PRO patients (p = 0.794). In the Evolut R group, moderate aortic regurgitation was documented in 2 patients (Evolut R vs. Evolut PRO: 1.4% vs. 0%; p = 1.000). No differences regarding clinical parameters, such as major bleeding events (Evolut R vs. Evolut PRO: 1.4% vs.1.3%; p = 0.868) and vascular complications were observed. CONCLUSIONS: Both prostheses show excellent hemodynamic performance with a low incidence of paravalvular leakage and comparable clinical outcomes.