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Background: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study., Methods: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year., Results: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients., Conclusions: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801., Competing Interests: Dr Malaisrie reports institutional research grants from Edwards Lifesciences, Medtronic, and Terumo Medical Corporation and consulting/speaker fees from Edwards Lifesciences, Terumo Medical Corporation, and Artivion; Dr Guerrero reports institutional research grants from Edwards Lifesciences; Dr Davidson reports institutional research grants from Edwards Lifesciences and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Williams reports institutional research grants from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific and consulting/speaker fees from Medtronic; Dr de Brito is a proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; Dr Shah reports institutional research grants from Edwards Lifesciences, Medtronic, and Abbott Vascular and consulting/speaker fees from Edwards Lifesciences; Dr Kaneko reports consulting/speaker fees from Edwards Lifesciences, Medtronic, and Abbott Vascular; Dr Poon reports institutional research grants from Edwards Lifesciences and consulting/speaker fees from Edwards Lifesciences and Anteris; Dr Yu is an employee of Edwards Lifesciences; Dr Pibarot reports institutional research grants from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success; Dr Hahn reports speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; she has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic and Novartis; she is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials, for which she receives no direct industry compensation; Dr Blanke reports consulting/speaker fees from Edwards Lifesciences and LARALAB; Dr Leon reports institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; Dr Mack has served as trial coprimary investigator for Edwards Lifesciences and Abbott Vascular and has served as a study chair for Medtronic; Dr Zajarias reports consulting/speaker fees from Edwards Lifesciences and Medtronic. The other authors report no conflicts.

Background: 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., Aims: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR., Methods: 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., Results: 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)., Conclusions: 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.

Background: Treatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak., Aims: The aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC., Methods: Twenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days., Results: In all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients., Conclusions: In patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.

Background: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported., Objectives: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR., Methods: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years., Results: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005)., Conclusions: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514)., Competing Interests: Funding Support and Author Disclosures The present paper is an analysis of the first 100 patients treated in the Expanded Clinical Study of the Tendyne Mitral Valve System (Global Feasibility Study; NCT02321514) supported by Abbott. Dr Muller has served as a consultant for Medtronic, Abbott, and Edwards Lifesciences; and has received research grant support from Abbott and Medtronic. Dr Sorajja has served as a consultant for Abbott Structural, Boston Scientific, and Medtronic. Dr Duncan has served as a proctor and consultant for Abbott, Edwards Lifesciences, Medtronic, and Neochord. Dr Bethea has served as a consultant for Abbott. Dr Grayburn has served as a consultant for Abbott, Edwards Lifesciences, Valtech Cardio, and Neochord; and has received research grants from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Valtech Cardio, and Neochord. Drs Babaliaros and Denti have served as a consultant for Edwards Lifesciences and Abbott. Dr Guerrero has served as a consultant for Edwards Lifesciences and Abbott; and has received research grant support from Edwards Lifesciences. Dr Thourani has served as a consultant for and received research grant support from Abbott. Dr Dumonteil has served as a proctor and consultant for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Modine has served as a proctor and consultant for Abbott, Edwards Lifesciences, and Medtronic. Dr Blanke has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Leipsic has received institutional grant support from Edwards Lifesciences, Abbott, Medtronic, Boston Scientific, MVRX, and Neovasc. Dr Badhwar has served as an uncompensated consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Longitudinal outcomes of transcatheter therapies for secondary mitral regurgitation (MR) have been variable. This study examined predictors of one-year outcome following transcatheter mitral valve implantation (TMVI) with the Tendyne device., Methods and Results: The first 100 consecutive patients with moderate-severe or severe MR enrolled in the Tendyne CE Mark trial were examined. Multivariable analyses assessed the impact of preoperative clinical and echocardiographic characteristics on one-year freedom from death or heart failure hospitalisation (HFH). All 100 patients underwent Tendyne TMVI without operative mortality. Univariate analysis was performed on implanted subjects, followed by multivariate analysis in those with complete predictive variable data. Patient characteristics: 76.5% male, 60.8% NYHA Class III/IV, age 75.6±7.5 years and Society of Thoracic Surgeons predicted risk of mortality of 8.5±6.1%. Increased left ventricular end-diastolic dimension was associated with one-year Tendyne benefit following univariate analysis (OR 0.35, p=0.010). Following multivariable adjustment, only severe MR, defined as a composite of effective regurgitant orifice area ≥0.3 cm2 or regurgitant volume ≥45 ml, was associated with freedom from death or HFH at one year (OR 0.16, p=0.032)., Conclusions: Preoperative severe MR was predictive of improved one-year outcome following Tendyne TMVI. These results may inform therapy selection for the management of secondary MR and left ventricular dilatation.

Background: Treatment of mitral regurgitation (MR) in the setting of severe mitral annular calcification (MAC) is challenging due to the high risk for fatal atrioventricular groove disruption and significant paravalvular leak., Objectives: The objective of this study was to evaluate the potential for transcatheter mitral valve replacement in patients with severe MAC using an anatomically designed mitral prosthesis., Methods: Nine patients (77 ± 6 years of age; 5 men) were treated with the valve, using transapical delivery performed under general anesthesia and with guidance from transesophageal echocardiography and fluoroscopy., Results: Device implantation was successful with relief of MR in all 9 patients. There were no procedural deaths. In 1 patient, left ventricular outflow tract obstruction occurred due to malrotation of the prosthesis, and successful alcohol septal ablation was performed. During a median follow-up of 12 months (range 1 to 28 months), there was 1 cardiac death, 1 noncardiac death, no other mortality, and no prosthetic dysfunction, and MR remained absent in all treated patients. Rehospitalization for heart failure occurred in 2 patients who did not die subsequently. Clinical improvement with mild or no symptoms occurred in all patients alive at the end of follow-up., Conclusions: Transcatheter mitral valve replacement in severe mitral annular calcification with a dedicated prosthesis is feasible and can result in MR relief with symptom improvement. Further evaluation of this approach for these high-risk patients is warranted., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve replacement (TMVR) is a rapidly evolving therapy. Follow-up of TMVR patients remains limited in duration and number treated., Objectives: The purpose of this study was to examine outcomes with expanded follow-up for the first 100 patients who underwent TMVR with the prosthesis., Methods: The Global Feasibility Study enrolled symptomatic patients with either primary or secondary mitral regurgitation (MR) who were at high or prohibitive surgical risk. The present investigation examines the first 100 patients treated in this study. Clinical outcomes through last clinical follow-up were adjudicated independently., Results: In the cohort (mean age 75.4 ± 8.1 years; 69% men), there was a high prevalence of severe heart failure symptoms (66%), left ventricular dysfunction (mean ejection fraction 46.4 ± 9.6%), and morbidities (Society of Thoracic Surgeons Predicted Risk of Mortality, 7.8 ± 5.7%). There were no intraprocedural deaths, 1 instance of major apical bleeding, and no acute conversion to surgery or need for cardiopulmonary bypass. Technical success was 96%. The 30-day rates of mortality and stroke were 6% and 2%, respectively. The 1-year survival free of all-cause mortality was 72.4% (95% confidence interval: 62.1% to 80.4%), with 84.6% of deaths due to cardiac causes. Among survivors at 1 year, 88.5% were New York Heart Association function class I/II, and improvements in 6-min walk distance (p < 0.0001) and quality-of-life measurements occurred (p = 0.011). In 73.4% of survivors, the Kansas City Cardiomyopathy Questionnaire score improved by ≥10 points., Conclusions: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile. Further study to optimize the impact on long-term survival is needed., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option., Objectives: The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system., Methods: This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days., Results: Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died., Conclusions: Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Amid rapid growth in transcatheter valvular interventions computed tomography (CT) has emerged as a pivotal noninvasive imaging resource that can be used throughout many stages of the transcatheter heart valve process, enhancing procedural success and efficacy. It affords a three-dimensional assessment of the aortic and challenging saddle-shaped mitral annulus, facilitating appropriate device selection, sizing, and preprocedural prediction angles for prosthetic deployment. Postprocedural imaging allows documentation of procedural success, evaluation of prosthesis positioning, and identifying asymptomatic complications. This article provides an overview of the role of CT in both trancatheter aortic valve repair (TAVR) and transcatheter mitral valve replacement (TMVR)., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The role of noninvasive imaging to help guide transcatheter aortic valvular interventions is well established and has grown with the advances in the procedure. With the rapid development of new transcatheter mitral valve interventions there is both an opportunity and a challenge for noninvasive imaging to grow understanding of mitral valve anatomy and disease, help with patient selection, and improve downstream clinical outcomes. This review will discuss the role of both echocardiography and multidetector CT in the diagnosis of mitral regurgitation, as well as grading of its severity and defining its etiology. Additionally, new concepts including measurements pertaining to mitral annular sizing, segmentation of mitral annular calcium, prediction of neo-left ventricular out flow tract obstruction, hybrid or fusion multidetector CT/echocardiographic imaging, and CT-based fluoroscopic guidance will be discussed., (© RSNA, 2018.)

Adaptation and evolution of transcatheter aortic valve replacement (TAVR) technologies has led to approval of TAVR for consideration in patients at intermediate risk for surgical aortic valve intervention. As TAVR becomes more mainstream, attention is shifting toward percutaneous mitral valve (MV) repair and transcatheter MV replacement (TMVR) techniques. Transcatheter heart valves (both purpose-built and off-label-use TAVR valves) are being implanted during TMVR procedures to treat clinically significant MV disease (native disease, degenerated bioprosthetic valves, and dysfunctional surgical MV annuloplasty repairs) when the risk of open heart MV surgery is prohibitive. The success of these high-risk procedures is directly related to accurate periprocedural imaging with echocardiography and other modalities. Although a multidisciplinary heart valve team approach is necessary for optimal patient selection, a multimodality team-based imaging approach and comprehensive understanding of the MV are required for safe procedural planning. Collaboration between noninvasive cardiac imagers and the intraprocedural interventional imaging team and translation of the periprocedural imaging to the implanting team are crucial to the success of TMVR technology. Currently, the TMVR procedures discussed here are conducted either as part of clinical research or off label. The US Food and Drug Administration-approved mitral valve-in-valve procedures for the treatment of degenerated mitral bioprosthetic valves are not discussed here., (Copyright © 2018 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Recent advancements in transcatheter valvular interventions have resulted in a growing demand for advanced cardiac imaging to help guide these procedures., Recent Findings: Both echocardiography and multi-detector computed tomography have played essential roles in the maturation of transcatheter aortic valve replacement and are now building on these experiences and helping inform the nascent field of transcatheter mitral interventions. Advanced imaging is essential to aid in the diagnosis and determination of the mechanism of mitral regurgitation. In addition, they are integral to annular sizing, determination of the suitability of patient anatomy for specific devices and increasingly important in the determination of the risk of left ventricular outflow tract obstruction and providing appropriate patient-specific fluoroscopic angulation in advance of the procedure.

Introduction: To facilitate coaxial device deployment in transcatheter mitral valve replacement (TMVR), a coaxial approach to the mitral annular plane is needed. We sought to establish a method to determine an 'orthogonal' left ventricular (LV) access point for transapical TMVR and to quantitatively characterize its location in patients with severe mitral regurgitation using cardiac computed tomography., Methods: Cardiac CT data sets of 54 patients with moderate-severe mitral regurgitation evaluated for potential TMVR were analyzed. The D-shaped mitral annular contour was segmented and a 2-dimensional annular plane was derived, allowing for subsequent definition of the perpendicularly oriented mitral annular trajectory. The 'orthogonal' LV access point was defined as the transection point of mitral trajectory with the LV epicardial surface. The location of the access point was quantified by its epicardial distance from the true apex and by the rotational offset from a 3-chamber view., Results: LV access points orthogonal to the mitral annular plane were most frequently located in the anterolateral (n = 22, 40.7%) and anterior (n = 16, 29.6%), less frequently anteroseptal (n = 6, 11.1%) and inferolateral (n = 5, 9.3%) ventricular segment; none inferior or inferoseptal. The mean distance to the LV apex was 17.6 ± 7.7 mm. The mean forward rotational offset from the 3-chamber view was 96.4 ± 43.4°, relating to a mean forward rotational offset of 6.4 ± 43.4° in regard to a hypothetical, secondary 90° x-plane view. No significant difference between patients with degenerative mitral valve disease or functional mitral regurgitation was observed., Conclusion: The location of the LV access point that provides an orthogonal trajectory to the mitral annular plane exhibits relevant inter-individual variability. It is commonly not identical with the true apex, and frequently localized in the anterolateral or anterior ventricular segments., (Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Transcatheter interventions to treat mitral and tricuspid valve disease are becoming increasingly available because of the growing number of elderly patients with significant comorbidities or high operative risk. Thorough clinical and imaging evaluation in these patients is essential. The latter involves both characterization of the mechanism and severity of valvular disease as well as determining the hemodynamic consequences and extent of ventricular remodeling, which is an important predictor of future outcomes. Moreover, an assessment of the suitability and risk of complications associated with device-specific therapies is also an important component of the preprocedural evaluation in this cohort. Although echocardiography including 2-dimensional and 3-dimensional methods has an important role in the initial assessment and procedural guidance, cross-sectional imaging, including both computed tomographic imagning and cardiac magnetic resonance imaging, is increasingly being integrated into the evaluation of mitral and tricuspid valve disease. In this review, we discuss the role of cross-sectional imaging in mitral and tricuspid valve disease, primarily valvular regurgitation assessment, with an emphasis on the preprocedural evaluation and implications for transcatheter interventions., (© 2017 American Heart Association, Inc.)

Aims: Transcatheter mitral valve replacement (TMVR) is an emerging technology with the potential to treat patients with mitral regurgitation at excessive risk for mitral valve surgery. Geometrical measurements of the mitral valvular complex may have implications for the design of TMVR devices and for patient selection. This study sought to quantify the dynamic geometry of the mitral valvular complex in patients with significant functional mitral regurgitation (FMR) using multi-slice computed tomography (MSCT)., Methods and Results: MSCT images were acquired in 32 patients with symptomatic, significant FMR. Two independent observers analysed image sets using a dedicated software package and a standard measurement methodology. In patients with FMR, the mean mitral annulus intercommissural and aorto-mural diameters were, respectively, 41.5±5.2 mm and 38.7±5.9 mm in systole, and were 41.5±4.4 mm and 40.0±4.7 mm in diastole. In patients without MR, the diameters were, respectively, 33.6±5.1 mm and 28.8±8.0 mm in systole, and 36.2±4.5 mm and 31.6±7.9 mm in diastole. The obstacle-free zone below the mitral annulus averaged more than 20.0 mm and varied by less than 1 mm between systole and diastole, which is not statistically significant. The aorto-mitral angle was 129.7±10.5° in systole and 131.0±9.4° in diastole., Conclusions: The mitral annulus is larger in dimension, more circular, and less dynamic in patients with FMR. The obstacle-free zone below the mitral annulus is relatively constant during the cardiac cycle. Measurements of the mitral valvular apparatus vary considerably between patients, which suggests that tridimensional imaging will play an important role in the sizing of TMVR devices.

Aims: Transcatheter mitral valve replacement (TMVR) is an emerging technology with the potential to treat patients with severe mitral regurgitation at excessive risk for surgical mitral valve surgery. Multimodality imaging of the mitral valvular complex and surrounding structures will be an important component for patient selection for TMVR. Our aim was to describe and evaluate a systematic multi-slice computed tomography (MSCT) image analysis methodology that provides measurements relevant for transcatheter mitral valve replacement., Methods and Results: A systematic step-by-step measurement methodology is described for structures of the mitral valvular complex including: the mitral valve annulus, left ventricle, left atrium, papillary muscles and left ventricular outflow tract. To evaluate reproducibility, two observers applied this methodology to a retrospective series of 49 cardiac MSCT scans in patients with heart failure and significant mitral regurgitation. For each of 25 geometrical metrics, we evaluated inter-observer difference and intra-class correlation. The inter-observer difference was below 10% and the intra-class correlation was above 0.81 for measurements of critical importance in the sizing of TMVR devices: the mitral valve annulus diameters, area, perimeter, the inter-trigone distance, and the aorto-mitral angle., Conclusions: MSCT can provide measurements that are important for patient selection and sizing of TMVR devices. These measurements have excellent inter-observer reproducibility in patients with functional mitral regurgitation.

The treatment of both aortic and now mitral valvular disease has been transformed through transcatheter valvular interventions. TAVR has rapidly become the treatment of choice for symptomatic severe aortic stenosis in both high, and now intermediate-risk patients. Building upon this success the last two years have seen the clinical introduction of transcatheter mitral valve replacement (TMVR), with a number of devices being utilised in first-in-man and feasibility studies. These experiences have helped determine the anatomical requirements and specifications that enable successful device deployment and avoidance of complications. A unique strength of cardiac CT is the ability to identify and characterise calcification of the aortic and mitral apparatus, en-abling a deeper understanding of the relationship of calcification and procedural complications.

Aims: Transcatheter mitral valve implantation (TMVI) is a novel approach that may enable a less invasive effective reduction of mitral regurgitation (MR). A limitation of the MitraClip is that definitive implantation of a clip precludes future therapy with TMVI. The purpose of this paper is to describe contemporary treatment considerations in patients with mitral valve regurgitation., Methods and Results: In this report we describe an attempted MitraClip implantation which resulted in no reduction of MR severity. There was a consensus that additional clips would probably not be effective. MitraClip implantation was therefore abandoned and the clip was removed, allowing subsequent successful TMVI with the Tiara™ system three weeks later. Echocardiography revealed secure seating of the prosthesis with good mitral valve function, trivial paravalvular leakage and transvalvular gradient of 3 mmHg. The patient recovered rapidly and was discharged four days post implant., Conclusions: The clinical approach towards high-risk patients with significant MR may change in the next few years. In selected patients, in whom an initial attempt with MitraClip implantation results in only limited efficacy, the clip may be retrieved during the index procedure to allow subsequent TMVI.

Background: Previously, through the use of computed tomography (CT), it has been proposed that D-shaped versus saddle-shaped mitral annulus (MA) segmentation is more biomechanically appropriate to determine transcatheter mitral valve implantation size and eligibility., Methods and Results: Forty-one patients with severe mitral regurgitation being considered for transcatheter mitral valve implantation who had undergone cardiac CT and 3-dimensional transesophageal echocardiography (3D-TEE) were retrospectively evaluated. A standardized segmentation protocol for the D-shaped MA was developed using Philips Q-Laboratory mitral valve quantification software. MA dimensions were compared using Spearman's rank correlation and Bland-Altman analysis. Inter- and intraobserver agreement was quantified by intraclass correlation coefficient and Bland-Altman analysis. Mean age was 77±14 years; 71% male (n=29); mitral regurgitation pathogenesis was functional in 54% (n=22) and myxomatous in 46% (n=19). Mean MA area and circumference by 3D-TEE and CT were 11.3±2.7 versus 11.4±3.0 (P=0.67) and 124.1±15.6 versus 123.9±15.5 (P=0.79), respectively, with excellent correlation between modalities (r=0.84 and r=0.86; P<0.0001) and no systematic bias (-0.20±1.8 cm(2) [-3.7 cm(2); 3.3 cm(2)], 0.37±9 mm [-18.0 mm; 17.27 mm]). Mean septal-to-lateral and inter-trigone distances by 3D-TEE and CT were 33.2±4.7 versus 32.5±4.4 (P=0.24) and 31.7±3.5 versus 32.6±3.6 (P=0.06), respectively, with good correlation (r=0.69 and r=0.71; P<0.0001) and no systematic bias (0.77±3.8 mm [-6.7 mm; 8.2 mm], -1.5±3.1 mm [-4.6 mm; 7.6 mm]). There was excellent intra- and interobserver agreement according to intraclass correlation coefficients >0.90 for all parameters., Conclusions: Similar to cardiac CT, 3D-TEE allows for D-shaped MA segmentation with no systematic difference in MA dimensions between modalities. This study supports the utilization of 3D-TEE as a complementary tool to CT assessment of the D-shaped MA to determine transcatheter mitral valve implantation size., (© 2016 American Heart Association, Inc.)

Background: Transcatheter interventions are currently undertaken using "generic" fluoroscopic viewing angles. However, the position and orientation of heart structures may vary across patients and disease-specific remodeling processes., Objective: This study uses multislice computed tomography to determine optimal fluoroscopic viewing angles of the aortic and mitral annuli, the left atrial appendage and the atrial septum. We explored differences between patients with severe aortic stenosis (AS) and severe mitral regurgitation (MR)., Methods and Results: The multislice computed tomographies of 28 patients with severe aortic stenosis (AS) and 32 patients with severe functional mitral regurgitation (MR) were analyzed. For each patient, we evaluated the optimal fluoroscopic viewing angles of the aortic and mitral annuli (en face, maximal and minimal diameters, aortic root with right, left and non coronary sinus in center), left atrial appendage orifice (en face, maximal and minimal diameters), and atrial septum (fossa ovalis) en face. The TAVR implantation view with right coronary sinus in center was LAO 9 - CRA 0 in the AS group and LAO 6 - CAU 5 in the MR group (p = NS). AS and MR patients differed significantly with respect to the fluoroscopic angulation of the aortic annulus en face (8.3°), the aortic annulus maximal (17.7°) and minimal (18.5°) diameters, the mitral annulus aorto-mural diameter (11.3°), and the left atrial appendage orifice en face (11.1°) (all p-values<0.05)., Conclusion: Optimal fluoroscopic viewing angles of left-sided structures vary considerably between patients. Multislice computed tomography is a valuable tool to determine the most procedurally relevant angulations, with the potential to optimize procedural safety, efficacy and duration., (Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to determine D-shaped mitral annulus (MA) dimensions in control subjects without significant cardiac disease and in patients with moderate to severe mitral regurgitation (MR) being considered for transcatheter mitral therapy and to determine predictors of annular size, using cardiac computed tomography., Background: The recently introduced D-shaped method of MA segmentation represents a biomechanically appropriate approach for annular sizing prior to transcatheter mitral valve implantation., Methods: Patients who had retrospectively gated cardiac computed tomography performed at our institution (2012 to 2014) and were free of significant cardiac disease were included as controls (n = 88; 56 ± 11 years of age; 47% female) and were compared with patients with moderate or severe MR due to functional mitral regurgitation (FMR) (n = 27) or mitral valve prolapse (MVP) (n = 32). MA dimensions (projected area, perimeter, intercommissural, and septal-to-lateral distance), maximal left atrial (LA) volumes, and phasic left ventricular volumes were measured., Results: MA dimensions were larger in patients with FMR or MVP compared with controls (area index 4.7 ± 0.6 cm(2)/m(2), 6.0 ± 1.3 cm(2)/m(2), and 7.3 ± 1.7 cm(2)/m(2); perimeter index 59 ± 5 mm/m(2), 67 ± 9 mm/m(2), and 75 ± 10 mm/m(2); intercommissural distance index 20.2 ± 1.9 mm/m(2), 21.2 ± 3.1 mm/m(2), and 24.7 ± 3.2 mm/m(2); septal-to-lateral distance index 14.8 ± 1.6, 18.1 ± 3.3, and 19.5 ± 3.4 mm/m(2) in controls and patients with FMR and MVP, respectively; p < 0.05 between controls and MR subgroups). Absolute MA area was 18% larger in patients with MVP than patients with FMR (13.0 ± 2.9 cm(2) vs. 11.0 ± 2.3 cm(2); p = 0.006). Although LA and left ventricular volumes were both independently associated with MA area index in controls and patients with MVP, only LA volume was associated with annular size in patients with FMR., Conclusions: Moderate to severe MR was associated with increased MA dimensions, especially among patients with MVP compared with control subjects without cardiac disease. Moreover, unlike in controls and patients with MVP, annular enlargement in FMR was more closely associated with LA dilation., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We report our 8-year experience in transcatheter aortic and mitral valve-in-valve (VinV) implantation., Background: Feasibility and good early outcomes associated with transcatheter aortic and mitral VinV implantation into failed surgical bioprostheses have been confirmed, but the mid-term and long-term outcomes of transcatheter aortic and mitral VinV is unknown., Methods: A total of 73 patients with aortic (n = 42) and mitral (n = 31) bioprosthetic valve dysfunction underwent transcatheter VinV implantation between April 2007 and December 2013. Edwards balloon-expandable transcatheter valves (Edwards Lifesciences Inc., Irvine, California) were used. Median follow-up was 2.52 years with a maximum of 8 years., Results: Seventy-two patients (mean age 79.7 ± 9.4 years, 32 women) underwent successful VinV implantation (success rate 98.6%). At 30 days, all-cause mortality was 1.4%, disabling stroke 1.4%, life-threatening bleeding 4.1%, acute kidney injury requiring hemodialysis 2.7%, and coronary artery obstruction requiring intervention 1.4%. No patient had greater than mild paravalvular leak. Estimated survival rates were 88.9%, 79.5%, 69.8%, 61.9%, and 40.5% at 1, 2, 3, 4, and 5 years, respectively. The small surgical valve size (19 and 21 mm) was an independent risk factor for reduced survival in aortic VinV patients. At 2-year follow-up, 82.8% of aortic and 100% of mitral VinV patients were in New York Heart Association functional class I or II., Conclusions: Transcatheter VinV for failed surgical bioprostheses can be performed safely with a high success rate and minimal early mortality and morbidity. Transcatheter VinV provides encouraging mid-term clinical outcomes in this high-risk elderly cohort of patients. Transcatheter VinV is an acceptable alternative therapy for failed aortic or mitral bioprostheses in selected high-risk patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter mitral valve implantation (TMVI) represents a promising approach to treating mitral valve regurgitation in patients at increased risk of perioperative mortality. Similar to transcatheter aortic valve replacement (TAVR), TMVI relies on pre- and periprocedural noninvasive imaging. Although these imaging modalities, namely echocardiography, computed tomography, and fluoroscopy, are well established in TAVR, TMVI has entirely different requirements. Approaches and nomenclature need to be standardized given the multiple disciplines involved. Herein we provide an overview of anatomical principles and definitions, a methodology for anatomical quantification, and perioperative guidance., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: We sought to determine if preprocedural CT can predict appropriate fluoroscopic angulations to achieve a coplanar view during transcatheter mitral valve implantation (TMVI) and to assess the relationship of the mitral annulus and the coronary sinus to determine the feasibility of using this as an additional landmark on fluoroscopy., Methods: With CT, the mitral annulus was segmented in 25 patients with functional mitral regurgitation. After this, optimal projection curves were plotted and the necessary angulations for specific views parallel to the trigone-to-trigone line (TT view) and septal-to-lateral distance (SL view) were noted. The outer contour of the coronary sinus and great cardiac vein were segmented to simulate a guide wire, and its relation to the annular plane was assessed. Employed angulations and coplanarity of device depiction were investigated in 4 patients who underwent TMVI., Results: The mitral annulus is oriented in an anterior superior fashion with tilting to the right. SL and TT views were found at 29.4 ± 9.0° right anterior oblique (RAO), 20.1 ± 8.7° cranial (CAU) and 81.6 ± 18.9° RAO, 56.7 ± 8.0° caudal (CAU). The optimal projection curve and the relationship of coronary sinus to the mitral annular plane showed a wide intersubject variability. Commonly, the coronary sinus passed along the atrial wall with a mean distance of 13.2 ± 3.7 mm toward the mitral annular plane at P2 and 1.4 ± 3.1 mm anteriorly in alignment with the TT line. Coplanar depiction of the TMVI prosthesis was achieved in all 4 patients, with a compromise view chosen on the optimal projection curve between the TT view and SL view., Conclusion: CT allows for prediction of optimal fluoroscopic angulations to achieve a coplanar view of the mitral annulus. The relationship of the coronary sinus to the mitral annulus is variable and preprocedural CT segmentation may allow for a more patient-specific approach to the use of a coronary sinus guide wire as a fluoroscopic landmark., (Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background: The nonplanar, saddle-shaped structure of the mitral annulus has been well established through decades of anatomic and echocardiographic study. Its relevance for mitral annular assessment for transcatheter mitral valve implantation is uncertain., Objective: Our objectives are to define the methodology for CT-based simplified "D-shaped" mitral annular assessment for transcatheter mitral valve implantation and compare these measurements to traditional "saddle-shaped" mitral annular assessment., Methods: The annular contour was manually segmented, and fibrous trigones were identified using electrocardiogram-gated diastolic CT data sets of 28 patients with severe functional mitral regurgitation, yielding annular perimeter, projected area, trigone-to-trigone (TT) distance, and septal-lateral distance. In contrast to the traditional saddle-shaped annulus, the D-shaped annulus was defined as being limited anteriorly by the TT distance, excluding the aortomitral continuity. Hypothetical left ventricular outflow tract (LVOT) clearance was assessed., Results: Projected area, perimeter, and septal-lateral distance were found to be significantly smaller for the D-shaped annulus (11.2 ± 2.7 vs 13.0 ± 3.0 cm(2); 124.1 ± 15.1 vs 136.0 ± 15.5 mm; and 32.1 ± 4.0 vs 40.1 ± 4.9 mm, respectively; P < .001). TT distances were identical (32.7 ± 4.1 mm). Hypothetical LVOT clearance was significantly lower for the saddle-shaped annulus than for the D-shaped annulus (10.7 ± 2.2 vs 17.5 ± 3.0 mm; P < .001)., Conclusion: By truncating the anterior horn of the saddle-shaped annular contour at the TT distance, the resulting more planar and smaller D-shaped annulus projects less onto the LVOT, yielding a significantly larger hypothetical LVOT clearance than the saddle-shaped approach. CT-based mitral annular assessment may aid preprocedural sizing, ensuring appropriate patient and device selection., (Copyright © 2014 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Catheter-based interventions to improve mitral valve function are dependent on anatomic and functional information provided by noninvasive imaging to plan, perform, and evaluate each intervention. In this review we highlight the importance of imaging guidance for catheter-based interventions on prosthetic mitral valves, surgical rings, and native valve annular calcification. Both repair and replacement procedures are discussed. We review the general features common to this collection of procedures and discuss specific imaging issues and concerns for each procedure. Figures and intraprocedural videos emphasize central messages using case examples. • Computed tomography is an essential imaging modality for patient selection and procedural planning of catheter-based mitral valve interventions on a prosthetic valve or calcified native annulus. • Echocardiography and limited fluoroscopy are principal imaging tools for intraprocedural guidance. Echocardiography is well suited for acute postprocedure functional evaluation. • Accurate prediction of left ventricular outflow tract patency is a specific imaging challenge for these interventions. • Functional evaluation of residual mitral regurgitation and paravalvular regurgitation post procedure are important tasks for the echocardiographer. [ABSTRACT FROM AUTHOR]