Goitein, Orly

Introduction: The Innovalve TMVR is a novel self-expandable trans-catheter mitral valve prosthesis, delivered trans-septally using femoral venous access. It is deployed in an intra-valvular posterior position after sub-valvular anchoring by rotation of 6 circumferential arms. LV outflow tract (LVOT) compromise is of great concern in TMVR. A predicted Neo LVOT area of 170 mm 2 is the currently accepted cut-off for LVOT obstruction. Hypothesis: CT can accurately predict the Neo LVOT area prior to Innovalve TMVR procedure. Methods: CT was performed as a screening tool to evaluate the Neo LVOT area prior to Innovalve TMVR procedure. CT protocol: Retrospectively ECG gated with full cardiac cycle coverage. CT was performed before and after the procedure. Predicted Neo LVOT (pNLVOT) was calculated using a dedicated simulation valve prior to TMVR, actual Neo LVOT (aNLVOT) was calculated with the inserted valve in place following TMVR. The native LVOT (nLVOT) area, the predicted % LVOT reduction (nLVOT area-pNLVOT area /nLVOT area), the actual % LVOT reduction (nLVOT area-aNLVOT area /nLVOT area) and the difference between them (pNLVOT%-aNLVOT%) were calculated. Results: One hundred patients were screened for Innovalve TMVR procedure based on Neo LVOT criteria. pNLVOT≥ 170 mm 2 was found in 11 patients (11%), (7 males) average age 68±10 years, these patients underwent Innovalve TMVR procedure. The median calculated LVOT was 647.8+/-260 mm 2 (range 373-1312), the median pNLVOT reduction was 16% ±15 (range 3-53), the median aNLVOT reduction was 5%±14 (range -5-40) and the median difference between the pNLVOT and aNLVOT was 8±12 (range -4-31). In 8/11 patients (73%), the aNLVOT was larger than the pNLVOT (range difference 1 to 31%). In 3/11 patients (27%), the aNLVOT was smaller than the pNLVOT (range difference -1 to -4%). Conclusions: Underestimation of neoLVOT reduction, was uncommon and documented only minor and clinically insignificant difference between the pNLVOT and aNLVOT. As overestimation of NLVOT reduction allows a margin of safety for MTVR, we conclude that CT can serve as reliable NLVOT screening tool.

Introduction: Transcatheter Mitral Valve Replacement (TMVR) using a trans-septal approach is a new therapeutic option for patients with severe mitral regurgitation (MR). However, both surgical as well as currently under-testing trans-catheter approach, are shown to cause decrease in LV function. The Innovalve TMVR is a novel self-expandable transcatheter mitral valve prosthesis, delivered trans-septally using femoral venous access. It is deployed in an intravalvular posterior position after subvalvular anchoring by rotation of 6 circumferential arms Hypothesis: TMVR procedure (Innovalve system) leads to LV anatomical and functional changes Methods: CT was performed before the Innovalve TMVR procedure, and after 3 to 6 months. CT protocol included retrospective ECG gating with full cardiac cycle coverage. LV end diastolic and end systolic diameters (LVEDD, LVESD) were measured in the left ventricular outflow tract orientation at the most basal level. Tip to tip papillary muscle distance was measured in the short axis orientation at the most basal slice demonstrating the papillary muscle tips. LV ejection fraction (LVEF) was calculated using the end systolic and end diastolic volumes. All measurements were performed at end systole and end diastole before MTVR and after 3-6 months using a dedicated platform (3Mensio). Results: Ten patients (7 males) average age 69+/-10 years, underwent the Innovalve TMVR procedure. Average LVESD decreased from 52±15 mm at baseline to 44±15mm (P=0.016) at 3-6 months. Similarly, LVEDD decreased from 60±14 mm at baseline, to 52±13mm at 3-6 months (P=0.039). Average papillary muscle tip to tip distance at end diastole (ED) decreased from 31.7±7mm at baseline to 28.4±6.5mm at 3-6 months (P=0.047).A trend of LVEF improvement was evident with an increase from 35%±12 average at baseline compared with 39%±12 average after 3-6 months (P=0.346). Conclusions: These preliminary results show that the TMVR procedure using the Innovalve system may result in favourable LV reverse remodelling changes including reduction of LVESD, LVEDD and ED papillary muscle distances, with improved LVEF. This encouraging data might suggest favourable postprocedural structural LV change.

Background Although endothelial function is a marker for cardiovascular risk, endothelial dysfunction assessment is not routinely used in daily clinical practice. A growing challenge has emerged in identifying patients prone to cardiovascular events. We aim to investigate whether abnormal endothelial function may be associated with adverse 5-year outcomes in patients presenting to a chest pain unit (CPU). Methods Following endothelial function testing using EndoPAT 2000 in 300 consecutive patients without a history of coronary artery disease, patients underwent coronary computerized tomographic angiography (CCTA) or single-photon emission computed tomography according to availability. Results Mean 10-year Framingham risk score (FRS) was 6.6 ± 5.9%; mean 10-year atherosclerotic cardiovascular disease (ASCVD) risk was 7.1 ± 7.2%; median reactive hyperemia index (RHI) as a measure of an endothelial function 2.0 and mean was 2.0 ± 0.4. During a 5-year follow-up, the 30 patients who developed major adverse cardiovascular events (MACE), including all-cause mortality, nonfatal myocardial infarction, hospitalization for heart failure or angina pectoris, stroke, coronary artery bypass grafting, and percutaneous coronary interventions, had higher 10-year FRS (9.6 ± 7.8 vs. 6.3 ± 5.6%; P = 0.032), higher 10-year ASCVD risk (10.4 ± 9.2 vs. 6.7 ± 6.9%; P = 0.042), lower baseline RHI (1.6 ± 0.5 vs. 2.1 ± 0.4; P < 0.001) and a greater degree of coronary atherosclerotic lesions (53 vs. 3%, P < 0.001) on CCTA compared with patients without MACE. Multivariate analysis demonstrated that RHI below the median was an independent predictor of 5-year MACE (odds ratio 5.567, 95% confidence interval 1.955–15.853; P = 0.001). Conclusion Our findings suggest that noninvasive endothelial function testing may contribute to clinical efficacy in triaging patients in the CPU and in predicting 5-year MACE. Clinical Trials.gov Identifier NCT01618123