Transcatheter Mitral Valve Replacement Research Articles

Accuracy of Three-Dimensional Neo Left Ventricular Outflow Tract Simulations With Transcatheter Mitral Valve Replacement in Different Mitral Phenotypes.

Transcatheter mitral valve replacement (TMVR) is emerging in the context of annular calcification (valve-in-MAC; ViMAC), failing surgical mitral annuloplasty (mitral-valve-in-ring; MViR) and failing mitral bioprosthesis (mitral-valve-in-valve; MViV). A notorious risk of TMVR is neo left ventricular outflow tract (neo-LVOT) obstruction. Three-dimensional computational models (3DCM) are derived from multi-slice computed tomography (MSCT) and aim to predict neo-LVOT area after TMVR. Little is known about the accuracy of these neo-LVOT predictions for various mitral phenotypes. Preprocedural 3DCMs were created for ViMAC, MViR and MViV cases. Throughout the cardiac cycle, neo-LVOT dimensions were semi-automatically calculated on the 3DCMs. We compared the predicted neo-LVOT area on the preprocedural 3DCM with the actual neo-LVOT as measured on the post-procedural MSCT. Across 12 TMVR cases and examining 20%-70% of the cardiac phase, the mean difference between predicted and post-TMVR neo-LVOT area was -23 ± 28 mm2 for MViR, -21 ± 34 mm2 for MViV and -73 ± 61 mm2 for ViMAC. The mean intra-class correlation coefficient for absolute agreement between predicted and post-procedural neo-LVOT area (throughout the whole cardiac cycle) was 0.89 (95% CI 0.82-0.94, p < 0.001) for MViR, 0.81 (95% CI 0.62-0.89, p < 0.001) for MViV, and 0.41 (95% CI 0.12-0.58, p = 0.002) for ViMAC. Three-dimensional computational models accurately predict neo-LVOT dimensions post TMVR in MViR and MViV but not in ViMAC. Further research should incorporate device host interactions and the effect of changing hemodynamics in these simulations to enhance accuracy in all mitral phenotypes.

Transcatheter mitral replacement: what are the outcomes of un-eligible patients compared to treated?

Abstract Background/Introduction Transcatheter mitral valve replacement (TMVR) is emerging in recent years as a promising tool to treat mitral regurgitation, however its applicability in the real world remains limited. Purpose The aim of the study is to assess the real-world screening success rate of TMVR in native anatomy and the 1-year outcomes of both accepted and refused patients as well as clinical results. Methods Retrospective analysis was performed on all patients screened for TMVR at our Valve Center, eligible for 1-year follow-up. In-hospital data of all patients admitted to our Department are prospectively collected. Follow-up was done through outpatient visits and/or telephone calls. Results Out of 3400 patients referred to mitral treatment at our department between January 2016-January 2022, 92 were submitted to screening for TMVR. Among these, 48 patients (49%) were accepted and treated with TMVR while 44 (44.8%) were refused (RG). The main reasons for rejection were anatomy unfeasibility in 25 patients (59%) and frailty in 5(11%). Main reasons for anatomy unfeasibility were risk LVOT obstruction (n=15; 60%), annular dimension (n=8; 33%) and ventricular dimension (n=2; 8,3%).Major baseline characteristics between groups were similar including age (85 vs 84), STS (12 vs 13), ejection fraction and LVEDD. However, refused patients had higher filtration rate than TMVR (80 vs 45 ml/min respectively (p=0.001)).All patients accepted were treated with TMVR: 7 patients received Tiara and 24 Tendyne. Procedure success in the TMVR group was 96% (46/48). Patients refused from TMVR were treated with Mitraclip in 5(11%) cases, 37(84%) were left in medical therapy and 2 (4,5%) underwent surgery. 1-year overall survival 65.2±51.3 vs 54.8±36.5 in TMVR and refused group respectively (p=0.002)(Figure 1). 6 deaths (2 cardiac, 33%) occurred in the TMVR compared to 37 (32 cardiac, 86%) in the refused group. Freedom from Cardiac death was 98±19% TMVR vs 75±65% (p&amp;lt;0.001)(Figure 2). NYHA class improved in 98% of cases in TMVR group but worsened in 80% in refused group, (p&amp;lt;0.001). TMVR screening failure is associated with increased cardiac death (HR 12 [1,51;95], p&amp;lt;0,019) and death for any causes (HR 17,5 [6,02;51], p&amp;lt;0,001). Conclusion(s) In the present experience, approximately 50% of patients screened for TMVR were accepted. The most frequent reasons for screening failure were anatomical issues. With a baseline similar clinical profile, treatment with TMVR provided significant 1-year survival and symptoms improvement compared to those of patients refused, whose prognosis is indeed remarkably poor. These data underline the importance of proper patient selection for TMVR to achieve good outcomes but also the need for technological improvement of devices to expand the proportion of patients who can be treated. Given the small numbers currently available, more data are needed to confirm the present findings, which must be considered hypothesis-generating.Figure 1Figure 2

One-year outcomes of transcatheter mitral valve replacement in patients with severe mitral regurgitation

Abstract Background Mitral valve regurgitation (MR) is a prevalent valvular heart disease, and a subset of patients face challenges in undergoing surgical treatment. Transcatheter mitral valve replacement (TMVR) has emerged as a viable option for selected patients with severe MR deemed unsuitable for traditional valve surgery. Purpose This study aims to evaluate the feasibility, safety, durability, and clinical outcomes of a novel transapical mitral valve system (MitraFix valve) in treating moderate to severe MR patients. Methods The early feasibility study of the MitraFix TMVR transapical system is a multicenter, prospective, nonrandomized study. All patients underwent evaluation by a multidisciplinary heart team and were deemed suitable for mitral valve intervention. Clinical events were adjudicated by an independent clinical events committee. Results From June 2021 to July 2022, 10 patients (mean age: 71.2 ± 7.4 years, 40% male) were enrolled. The mean Society of Thoracic Surgeons(STS) predicted risk of mortality was 7.5 ± 2.7%. All implants were successful, with a mean operational time of 45.2 ± 25.9 min. One patient was converted to open cardiac surgery after successfully implanting the valve due to persistent apical bleeding. At 1-year follow-up, all-cause mortality was 20%, with a cardiovascular mortality at 10.0%. Among survival patients, 87.5% of surviving patients had MR ≤1+ and 75% patients were in NYHA functional class I or II at 1 year. The overall KCCQ score significantly increased from 55.8 (42.9, 72.9) points at baseline to 77.5 (73.7, 88.6) points at 1-year follow up (P = 0.012). Left ventricular ejection fraction showed no significant change from basline (51.5%) to 1 year (50.0%) (P=0.799). No evidence of mitral stenosis or left ventricular outflow tract (LVOT) obstruction was observed. Conclusions The MitraFix TMVR transapical system demonstrated excellent valve function, low mortality, sustained MR elimination and clinical improvement up to one year in this study. Further studies, encompassing a larger cohort of patients and an extended follow-up duration, are needed to confirm these findings.Change in MR and NYHA functional classChange in Quality-of-Life Assessment

Vía transapical para reemplazo percutáneo de válvula mitral por valvulopatía: una experiencia ibérica

Introduction and objectives: Transcatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure.Methods: We conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year.Results: A total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively.Conclusions: Treatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

Institutional Variation in Patient Radiation Doses During Transcatheter Valve Interventions: A Statewide Experience

BackgroundLittle is known about institutional radiation doses during transcatheter valve interventions. ObjectivesThe authors sought to evaluate institutional variability in radiation doses during transcatheter valve interventions. MethodsUsing a large statewide registry, transcatheter edge-to-edge mitral valve repair, transcatheter mitral valve replacement, and transcatheter aortic valve replacement procedures between January 1, 2020, and December 31, 2022, with an air kerma (AK) recorded were analyzed. Patient and procedural characteristics were compared between cases with AK ≥2 and <2 Gy. Associations of variables with AK ≥2 Gy were investigated using Bayesian random effects modeling and median ORs for the performing hospital. ResultsAmong 9,446 procedures across 30 hospitals, median (Q1-Q3) procedural AK was 0.592 Gy (0.348-0.989 Gy) with AK ≥2 Gy in 533 cases (5.6%). Wide variation in procedural AK was observed, with an institutional frequency of AK ≥2 Gy ranging from 0.0% to 29.5%. Bayesian modeling identified the performing hospital as more strongly associated with the odds of a procedural AK ≥2 Gy than any patient or procedural factors (hospital median OR: 3.54 [95% credible interval: 2.52-16.66]). ConclusionsIn a large, multicenter state-wide registry, there is wide institutional variability in patient-level radiation doses during transcatheter valve interventions, with the performing hospital having a higher odds of an AK ≥2 Gy than any patient or procedural factors. Future interventions are warranted to reduce procedural-related variation in radiation exposure.

TCT-622 Nationwide Outcomes of Transcatheter and Surgical Mitral Valve Replacement

TCT-622 Nationwide Outcomes of Transcatheter and Surgical Mitral Valve Replacement

TCT-80 Accuracy of Annular Sizing Using Semiautomated 4D Transesophageal Echocardiography for Transcatheter Mitral Valve Replacement

TCT-80 Accuracy of Annular Sizing Using Semiautomated 4D Transesophageal Echocardiography for Transcatheter Mitral Valve Replacement

TCT-612 Clinical Outcomes of Patients Anatomically Unsuitable for Transcatheter Mitral Valve Replacement

TCT-612 Clinical Outcomes of Patients Anatomically Unsuitable for Transcatheter Mitral Valve Replacement

TCT-943 Durable Valve Prosthesis Performance and Sustained Symptom Relief: 2-Year Outcomes Following Transseptal Transcatheter Mitral Valve Replacement in the HighLife TSMVR Feasibility Study

TCT-943 Durable Valve Prosthesis Performance and Sustained Symptom Relief: 2-Year Outcomes Following Transseptal Transcatheter Mitral Valve Replacement in the HighLife TSMVR Feasibility Study

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

Transcatheter mitral valve replacement (TMVR) has emerged as aminimally 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. We aimed to illustrate the implementation of MSCT-derived modelling and simulations in the workup of TMVR for ViMAC, MViR, and MViV. For this retrospective study, we included all consecutive patients screened for TMVR and compared MSCT data, echocardiographic outcomes and clinical outcomes. Sixteen out of 41patients were treated with TMVR (ViMAC n = 9, MViR n = 3, MViV n = 4). Eleven patients were excluded for inappropriate sizing, 4for anchoring issues and 10for an unacceptable risk of left ventricular outflow tract obstruction (LVOTO) based on 3D modelling. There were 3procedure-related deaths and 1non-procedure-related cardiovascular death during 30days of follow-up. LVOTO occurred in 3ViMAC patients and 1MViR patient, due to deeper valve implantation than planned in 3patients, and anterior mitral leaflet displacement with recurrent basal septum thickening in 1patient. 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 30days. 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.

Never Give Up: A Case Report on Transcatheter Mitral Valve Replacement by MyVal for Degenerated Mitral Bioprosthesis During Hostilities in Ukraine

Never Give Up: A Case Report on Transcatheter Mitral Valve Replacement by MyVal for Degenerated Mitral Bioprosthesis During Hostilities in Ukraine

Valve-in-Ring Transcatheter Mitral Valve Replacement in a Fluoroscopically Invisible Ring

Valve-in-Ring Transcatheter Mitral Valve Replacement in a Fluoroscopically Invisible Ring

Atrial Functional Mitral Regurgitation: From Diagnosis to Current Interventional Therapies.

Mitral regurgitation (MR) is one of the most common valvular pathologies worldwide, contributing to the morbidity and mortality of several cardiovascular pathologies, including heart failure (HF). Novel transcatheter treatment for MR has given the opportunity for a safe and feasible alternative, to surgery, in order to repair the valve and improve patient outcomes. However, after the results of early transcatheter edge-to-edge repair (TEER) trials, it has become evident that subcategorizing the mitral regurgitation etiology and the left ventricular function, in patients due to undergo TEER, is of the essence, in order to predict responsiveness to treatment and select the most appropriate patient phenotype. Thus, a novel MR phenotype, atrial functional MR (AFMR), has been recently recognized as a distinct pathophysiological entity, where the etiology of the regurgitation is secondary to annular dilatation, in a diseased left atrium, with preserved left ventricular function. Recent studies have evaluated and compared the outcomes of TEER in AFMR with ventricular functional MR (VFMR), with the results favoring the AFMR. In specific, TEER in this patient substrate has better echocardiographic and long-term outcomes. Thus, our review will provide a comprehensive pathogenesis and mechanistic overview of AFMR, insights into the echocardiographic approach of such patients and pre-procedural planning, discuss the most recent clinical trials and their implications for future treatment directions, as well as highlight future frontiers of research in the setting of TEER and transcatheter mitral valve replacement (TMVR) in AFMR patients.

Valve-in-valve transcatheter mitral valve replacement versus redo-surgical mitral valve replacement for degenerated bioprosthetic mitral valves: A systematic review and meta-analysis

Bioprosthetic mitral valve degeneration is traditionally treated with Redo-SMVR, but the latest ViV-TMVR procedure offers a less invasive and lower risk alternative. A systematic literature search was conducted on Cochrane Central, Scopus, and Medline (PubMed interface) electronic databases from inception till 15th April 2024. We used risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We included a total of eleven studies with 11,931 patients in the final quantitative and qualitative analysis. When comparing ViV-TMVR with Redo-SMVR, no significant difference was found for 30-day mortality (P = 0.13) and 1-year mortality (P = 0.91), whereas patients in the ViV-TMVR showed significantly reduced incidence of stroke (P < 0.00001), In-hospital mortality (P), bleeding complications (P = 0.003), AKI (P = 0.0006), arrhythmias (P = 0.01), LVOT obstruction (P = 0.04), and PPI (P < 0.00001). Furthermore, no significant difference was observed between either group when comparing vascular complications (P = 0.97), 2-year mortality (P = 0.60) and 3-year mortality. ViV-TMVR was associated with a significant risk of paravalvular leakage (P = 0.008). Although, ViV-TMVR reduces the risk of complications associated with Redo-SMVR, larger studies are imperative to reach conclusive results.

Outcomes of Transcatheter Mitral Valve Replacement with Sapien Transcatheter Heart Valve for Degenerated Bioprostheses and Failed Annuloplasty Rings: A Meta-Analysis

Outcomes of Transcatheter Mitral Valve Replacement with Sapien Transcatheter Heart Valve for Degenerated Bioprostheses and Failed Annuloplasty Rings: A Meta-Analysis

An Australian Single Centre Experience of Transcatheter Mitral Valve Replacement With the HighLife System

An Australian Single Centre Experience of Transcatheter Mitral Valve Replacement With the HighLife System

Transapical transcatheter mitral valve replacement for mitral valve disease: an Iberian experience

Introduction and objectivesTranscatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure. MethodsWe conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year. ResultsA total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively. ConclusionsTreatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

3-Dimensional Echocardiographic Prediction of Left Ventricular Outflow Tract Area Prior to Transcatheter Mitral Valve Replacement

BackgroundNew postprocessing software facilitates 3-dimensional (3D) echocardiographic determination of mitral annular (MA) and neo–left ventricular outflow tract (neo-LVOT) dimensions in patients undergoing transcatheter mitral valve replacement (TMVR). ObjectivesThis study aims to test the accuracy of 3D echocardiographic analysis as compared to baseline computed tomography (CT). MethodsA total of 105 consecutive patients who underwent TMVR at 2 tertiary care centers between October 2017 and May 2023 were retrospectively included. A virtual valve was projected in both baseline CT and 3D transesophageal echocardiography (TEE) using dedicated software. MA dimensions were measured in baseline images and neo-LVOT dimensions were measured in baseline and postprocedural images. All measurements were compared to baseline CT as a reference. The predicted neo-LVOT area was correlated with postprocedural peak LVOT gradients. ResultsThere was no significant bias in baseline neo-LVOT prediction between both imaging modalities. TEE significantly underestimated MA area, perimeter, and medial-lateral dimension compared to CT. Both modalities significantly underestimated the actual neo-LVOT area (mean bias pre/post TEE: 25.6 mm2, limit of agreement: −92.2 mm2 to 143.3 mm2; P < 0.001; mean bias pre/post CT: 28.3 mm2, limit of agreement: −65.8 mm2 to 122.4 mm2; P = 0.046), driven by neo-LVOT underestimation in the group treated with dedicated mitral valve bioprosthesis. Both CT- and TEE-predicted-neo-LVOT areas exhibited an inverse correlation with postprocedural LVOT gradients (r2 = 0.481; P < 0.001 for TEE and r2 = 0.401; P < 0.001 for CT). ConclusionsTEE-derived analysis provides comparable results with CT-derived metrics in predicting the neo-LVOT area and peak gradient after TMVR.

Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study.

Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR. This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR. This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed. A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047). This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

Emerging Transcatheter Therapies for Valvular Heart Disease: Focus on Mitral and Tricuspid Valve Procedures.

The emergence of percutaneous treatment options provides novel therapeutic alternatives for older and feeble patients who are at high risk for any surgical procedure. The purpose of our review was to offer an up-to-date analysis of the rapidly expanding field of percutaneous technologies for mitral, tricuspid, and pulmonary procedures. Edge-to-edge repair is an established treatment for secondary mitral regurgitation (MR), while transcatheter mitral valve replacement is a potential and expanding option for managing both secondary and primary MR. However, additional advancements are necessary to enhance the safety and feasibility of this procedure. Transcatheter tricuspid intervention is an emerging option that was conceived after the success of transcatheter procedures in aortic and mitral valves, and it is currently still in the early stages of advancement. This can be attributed, at least in part, to the previously overlooked effect of tricuspid regurgitation on patient outcomes. The development of edge-to-edge repair represents the forefront of innovations in transcatheter procedures. There is a scarcity of data about tricuspid annuloplasty and replacement, and further study is necessary. Transcatheter mitral, tricuspid, and pulmonary procedures show prospects for the future, while their role in clinical practice has not been definitively established.