Impact and limitations of 3D computational modelling in transcatheter mitral valve replacement-a two-centre Dutch experience.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) has emerged as a minimally invasive alternative to mitral valve surgery for patients at high or prohibitive operative risk. Prospective studies reported favourable outcomes in patients with annulus calcification (valve-in-mitral annulus calcification; ViMAC), failed annuloplasty ring (mitral valve-in-ring; MViR), and bioprosthetic mitral valve dysfunction (mitral valve-in-valve; MViV). Multi-slice computed tomography (MSCT)-derived 3D-modelling and simulations may provide complementary anatomical perspectives for TMVR planning. AIMS: We aimed to illustrate the implementation of MSCT-derived modelling and simulations in the workup of TMVR for ViMAC, MViR, and MViV. METHODS: For this retrospective study, we included all consecutive patients screened for TMVR and compared MSCT data, echocardiographic outcomes and clinical outcomes. RESULTS: Sixteen out of 41 patients were treated with TMVR (ViMAC n = 9, MViR n = 3, MViV n = 4). Eleven patients were excluded for inappropriate sizing, 4 for anchoring issues and 10 for an unacceptable risk of left ventricular outflow tract obstruction (LVOTO) based on 3D modelling. There were 3 procedure-related deaths and 1 non-procedure-related cardiovascular death during 30 days of follow-up. LVOTO occurred in 3 ViMAC patients and 1 MViR patient, due to deeper valve implantation than planned in 3 patients, and anterior mitral leaflet displacement with recurrent basal septum thickening in 1 patient. TMVR significantly reduced mitral mean gradients as compared with baseline measurements (median mean gradient 9.5 (9.0-11.5) mm Hg before TMVR versus 5.0 (4.5-6.0) mm Hg after TMVR, p = 0.03). There was no residual mitral regurgitation at 30 days. CONCLUSION: MSCT-derived 3D modelling and simulation provide valuable anatomical insights for TMVR with transcatheter balloon expandable valves in ViMAC, MViR and MViV. Further planning iterations should target the persistent risk for neo-LVOTO.

Complete filter-based cerebral embolic protection with transcatheter aortic valve replacement.

OBJECTIVES: To evaluate the value of left vertebral artery filter protection in addition to the current filter-based embolic protection technology to achieve complete cerebral protection during TAVR. BACKGROUND: The occurrence of cerebrovascular events after transcatheter aortic valve replacement (TAVR) has fueled concern for its potential application in younger patients with longer life expectancy. Transcatheter cerebral embolic protection (TCEP) devices may limit periprocedural cerebrovascular events by preventing macro and micro-embolization to the brain. Conventional filter-based TCEP devices cover three extracranial contributories to the brain, yet leave the left vertebral artery unprotected. METHODS: Patients underwent TAVR with complete TCEP. A dual-filter system was deployed in the brachiocephalic trunk and left common carotid artery with an additional single filter in the left vertebral artery. After TAVR all filters were retrieved and sent for histopathological evaluation by an experienced pathologist. RESULTS: Eleven patients received a dual-filter system and nine of them received an additional left vertebral filter. In the remaining two patients, the left vertebral filter could not be deployed. No periprocedural strokes occurred. We found debris in all filters, consisting of thrombus, tissue derived debris, and foreign body material. The left vertebral filter contained debris in an equal amount of patients as the Sentinel filters. The size of the captured particles was similar between all filters. CONCLUSIONS: The left vertebral artery is an important entry route for embolic material to the brain during TAVR. Selective filter protection of the left vertebral artery revealed embolic debris in all patients. The clinical value of complete filter-based TCEP during TAVR warrants further research.

Echocardiography Core Laboratory Methodology for TAVR: A Transatlantic Consensus.

Inter-echocardiography core laboratory (ECL) harmonization is pivotal to consider data from different ECLs interchangeable. On the basis of the experience of the first trans-Atlantic harmonization of 2 established ECLs in the field of transcatheter aortic valve replacement (TAVR) trials, this review describes the harmonized ECL methodology in analyzing and adjudicating the post-TAVR echocardiographic endpoints according to Valve Academic Research Consortium 3 definitions. This review presents the feasibility and intra- and inter-ECL reproducibility, explains the root cause of potential important inter-ECL variability, and formulates ECL recommendations for optimal post-TAVR echocardiographic image acquisition. The implementation of inter-ECL harmonization may further define the best practice of ECLs and have logistic and regulatory implications for the realization of future TAVR trials.

Sequential Alcohol Septal Ablation to Resolve LV Outflow Tract Obstruction After Transcatheter Mitral Valve Replacement.

Left ventricular outflow tract obstruction (LVOTO) is a notorious complication of transcatheter mitral valve replacement (TMVR). Computed tomography-derived simulations can predict neo-LVOTO post-TMVR, whereas alcohol septal ablation (ASA) can mitigate neo-LVOTO risk. We report a case of sequential ASA of 2 adjacent septal branches to resolve unexpected neo-LVOTO post-TMVR.

Echocardiography Core Laboratory Validation of a Novel Vendor-Independent Web-Based Software for the Assessment of Left Ventricular Global Longitudinal Strain.

BACKGROUND: Global longitudinal strain (GLS) is an accurate and reproducible parameter of left ventricular (LV) systolic function which has shown meaningful prognostic value. Fast, user-friendly, and accurate tools are required for its widespread implementation. We aim to compare a novel web-based tool with two established algorithms for strain analysis and test its reproducibility. METHODS: Thirty echocardiographic datasets with focused LV acquisitions were analyzed using three different semi-automated endocardial GLS algorithms by two readers. Analyses were repeated by one reader for the purpose of intra-observer variability. CAAS Qardia (Pie Medical Imaging) was compared with 2DCPA and AutoLV (TomTec). RESULTS: Mean GLS values were -15.0 ± 3.5% from Qardia, -15.3 ± 4.0% from 2DCPA, and -15.2 ± 3.8% from AutoLV. Mean GLS between Qardia and 2DCPA were not statistically different (p = 0.359), with a bias of -0.3%, limits of agreement (LOA) of 3.7%, and an intra-class correlation coefficient (ICC) of 0.88. Mean GLS between Qardia and AutoLV were not statistically different (p = 0.637), with a bias of -0.2%, LOA of 3.4%, and an ICC of 0.89. The coefficient of variation (CV) for intra-observer variability was 4.4% for Qardia, 8.4% 2DCPA, and 7.7% AutoLV. The CV for inter-observer variability was 4.5%, 8.1%, and 8.0%, respectively. CONCLUSIONS: In echocardiographic datasets of good image quality analyzed at an independent core laboratory using a standardized annotation method, a novel web-based tool for GLS analysis showed consistent results when compared with two algorithms of an established platform. Moreover, inter- and intra-observer reproducibility results were excellent.

Determinants of aortic regurgitation after transcatheter aortic valve implantation. An observational study using multi-slice computed tomography-guided sizing.

BACKGKGROUND: The aim of this paper was to explore the determinants of aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using multi-slice computed tomography (MSCT) instead of echocardiography-guided sizing. METHODS: Determinants of AR were assessed in 313 consecutive patients who underwent TAVI with the Medtronic (MCS, N.=259) or Edwards Sapien or XT (ESV, N.=54) using MSCT-guided sizing. AR was assessed by angiography immediately after TAVI (N.=313, Sellers) and by echocardiography at discharge (N.=285, VARC-2). Distinction was made between patients with grade 0-1 and grade ≥2 AR post-TAVI. RESULTS: AR≥2 post-TAVI was seen in 91 patients or 29% (MCS 85/259: 33% vs. ESV 6/54:11%) by angiography and 94 patients or 33% (MCS 87/239:36% vs. ESV 7/46:15%) by echocardiography. By univariable analysis, patients with AR≥2 post TAVI had more AR≥2 at baseline (70% vs. 52%, P=0.003), a larger mean and maximal annulus diameter (25.0 [23.5-26.3] vs. 24.0 [22.6-26.0], P=0.025 and 27.9±2.7 mm vs. 27.0±2.8 mm, P=0.018, respectively) and a higher Agatston Score (3.9 [2.9-5.3] vs. 2.6 [1.8-3.8], P≤0.001). AR≥2 post-TAVI was more frequent after MCS than ESV (33% vs. 11%, P=0.001). There was no difference in nominal valve size relative to the patient's annulus, nor depth of implantation. By propensity score adjusted multivariable analysis, AR≥2 at baseline (odds 2.407 [95% CI: 1.472-3.938]) but above all MCS (odds: 6.047 [95% CI; 1.307- 27.976]) were independent determinants of AR≥2 post-TAVI. The latter was also confirmed by propensity score adjusted multivariable analysis in the echocardiography population (N.=285) (odds: 5.259 [95% CI; 1.070-25.851]). CONCLUSIONS: AR≥2 is more prevalent after MCS valve implantation and is an independent determinant of AR also when using MSCT guided-sizing.