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Background: Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated., Objectives: The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk., Methods: Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory., Results: The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR., Conclusions: This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years., Competing Interests: Funding Support and Author Disclosures This work was funded by Medtronic. Dr Bapat has received personal fees for consultancy and speaker service from Medtronic; and has served as a consultant for Edwards Lifesciences, 4C, and Boston Scientific. Dr Weiss has received personal and institutional consulting fees from Medtronic and Baxter. Dr Bajwa has received personal and institutional consulting fees from Medtronic. Dr Thourani has been an advisor to or received research grants from Artivion, Atricure, Abbott Vascular, Boston Scientific, Dasi Simulations, Edwards Lifesciences, Medtronic, and JenaValve. Dr Yadav is a proctor and speaker for Edwards Lifesciences; and a consultant for and holds stock in Shockwave Medical. Dr Thaden has received institutional consulting fees from Medtronic; and speaker fees from Edwards Lifesciences. Dr Lim has received institutional grant support from Abbott Vascular, Boston Scientific, Corvia, Edwards Lifesciences, Medtronic, NXT, V Wave, and WL Gore; and has received consulting fees from Philips, Valgen Medtech, and Venus. Dr Reardon has received institutional consulting fees from Medtronic, W.L. Gore & Associates, Boston Scientific, and Abbott Vascular. Dr Pinney has received consulting fees from Abbott, ADI, Ancora, BMS, CareDx, Cordio, Impulse Dynamics, Medtronic, Nuwellis, Procyrion, Restore Medical, Transmedics, and Valgen Medtech. Dr Adams is national coprincipal investigator for Medtronic APOLLO FDA Pivotal Trial, the NeoChord ReChord FDA Pivotal Trial, the Medtronic CoreValve US Pivotal Trial, and the Abbott TRILUMINATE Pivotal Trial; and his institution, the Icahn School of Medicine at Mount Sinai, receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr Yakubov has received research grants from Medtronic and Boston Scientific; serves on advisory boards for Medtronic and Boston Scientific; and is a principal investigator, steering committee member, and screening committee member for the CoreValve clinical trials. Dr Modine is a consultant for Abbott, Boston Scientific, Cephea, Edwards Lifesciences, GE Healthcare, Medtronic, and MicroPort; and is a proctor for and receives speaker fees from Medtronic. Dr Redwood has received speaker fees from Edwards Lifesciences. Dr Walton has served as a proctor and received advisory board fees and grant support from Medtronic, Abbott, and Edwards Lifesciences. Dr Spargias has received grant support and proctor fees from Medtronic, Abbott Vascular, and Edwards Lifesciences. Ms Zhang is an employee of Medtronic. Dr Mack is on the executive board for the APOLLO trial sponsored by Medtronic; and is coprincipal investigator for the PARTNER 3 and COAPT trials sponsored by Edwards Lifesciences and Abbott Vascular. Dr Leon has received personal and institutional grant support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: There is currently no established recommendation for antithrombotic treatment following transcatheter mitral valve replacement (TMVR). However, based on the analogy with surgical mitral bioprosthesis, vitamin K antagonists (VKAs) are predominantly used., Objectives: The purpose of this study was to compare bleeding and thrombotic events associated with direct oral anticoagulants (DOACs) or VKAs in a prospective cohort of TMVR patients., Methods: We enrolled consecutive patients who underwent transseptal TMVR using a SAPIEN family prosthesis at our center between 2011 and 2023. The primary outcome was the occurrence of bleeding. VKAs were administered to patients until October 2019, after which DOACs were prescribed. The median follow-up was 4.7 months (Q1-Q3: 2.6-6.7 months)., Results: A total of 156 patients were included. The mean age was 65 ± 18.5 years, and 103 patients (66%) were women. The median EuroSCORE II was 7.48% (Q1-Q3: 3.80%-12.97%). Of the participants, 20.5% received DOACs and 79.5% were treated with VKAs. The primary outcome was observed in 50 (40%) patients in the VKA group and 3 (9%) patients in the DOAC group (adjusted HR: 0.21; 95% CI: 0.06-0.74; P = 0.02). Treatment with DOAC was associated with a shorter length of hospital stay. No significant differences were found in terms of thrombotic events, major vascular complications, stroke, or death., Conclusions: The use of DOACs after TMVR, compared with VKAs, appears to reduce the risk of bleeding complications and decrease the length of hospital stay for patients, without a significant increase in the risk of thrombotic events., Competing Interests: Funding Support and Author Disclosures Dr Himbert is a proctor for Edwards Lifesciences and Abbott. Dr Brochet is a proctor for Abbott. Prof Urena has received speaker fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The study aimed to evaluate the early feasibility of endovascular replacement of ascending aorta, aortic root (including aortic valve, AV), and mitral valve (MV) in one procedure with two self-expandable prostheses. Aortic valved-fenestrated-bifurcated (AVFB) and MV endografts of 10 healthy pigs (60-65kg) were customized and delivered through transapical and transseptal approach, respectively. Both endografts were successfully deployed in nine pigs (90%). Eight survived over 24 h, and the acute success rate was 80%. There was no significant increase in the mean trans-aortic, trans-mitral, and trans-LVOT pressure gradients after the operation. No coronary artery or LVOT obstruction and other electrocardiographic abnormality occurred. The transvalvular and paravalvular leak rates were low for both valves. Endovascular replacement of ascending aorta, AV, and MV in one procedure might be feasible. Combined transcatheter replacement of aortic root and mitral valve in one procedure., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: The aim of this study was to evaluate outcomes of commercial transcatheter mitral valve replacement (TMVR) for annular rings and calcification using contemporary techniques., Background: TMVR is evolving in the absence of other viable treatment options for severe mitral annular calcification and failing ring repairs. The concomitant use of laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction and pre-emptive alcohol septal ablation is not well studied in clinical practice., Methods: A single-center study was conducted of valve-in-mitral annular calcification (ViMAC) and valve-in-ring (ViRing) TMVR from September 2015 to April 2020. In-hospital and 30-day outcomes were assessed., Results: Forty patients underwent TMVR (28 ViMAC and 12 ViRing). Sixteen ViMAC (57%) and 5 ViRing (42%) patients underwent attempted laceration of the anterior mitral valve leaflet to prevent left ventricular outflow tract obstruction. Three patients underwent pre-emptive alcohol septal ablation. The median index hospitalization was 7 days. Six patients died within 30 days of the procedure, 6 (21%) in the ViMAC group and none in the ViRing group. Five patients (13%) had left ventricular outflow tract obstruction: 4 (14%) in the ViMAC cohort and 1 (8%) in the ViRing cohort. Five patients (13%) had either intraprocedural valve embolization or late migration (4 ViMAC and 1 ViRing). Technical success defined according to Mitral Valve Academic Research Consortium criteria was present in 25 patients (63%): 9 (75%) in the ViRing cohort and 16 (57%) in the ViMAC cohort. At 30 days, the mitral valve gradient was significantly reduced (5.5 ± 2.1 vs. 10.6 ± 4.8; p < 0.01). Three patients (8%) had at least moderate residual mitral regurgitation., Conclusions: Transcatheter ViMAC and ViRing can be successfully performed but frequently require the use of contemporary adjunctive techniques., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system., Background: Transseptal TMVR may offer a less invasive option than surgery for mitral regurgitation (MR) with greater efficacy and fewer anatomic limitations than transcatheter repair., Methods: Patients were treated with the EVOQUE TMVR system from September 2018 to October 2019. Key inclusion criteria were moderate or greater MR, New York Heart Association functional class ≥II, and high or prohibitive surgical risk. The primary outcome was technical success, defined by Mitral Valve Academic Research Consortium criteria., Results: Fourteen patients were treated, all with at least moderate to severe MR. The median age was 84 years, and the median Society of Thoracic Surgeons score was 4.6%. MR was degenerative in 4 (28.6%), functional in 3 (21.4%), and mixed in 7 (50%). Technical success was achieved in 13 patients (92.9%), and 1 patient was converted to surgery. At 30 days there was 1 noncardiovascular mortality (7.1%), 2 strokes (14.3%), no myocardial infarctions, and no rehospitalizations. Two patients (14.3%) underwent paravalvular leak closure. One patient (7.1%) underwent alcohol septal ablation for left ventricular outflow tract obstruction. Including the 2 patients with paravalvular leak closure, MR was mild or less in all implanted patients at 30 days, with no MR in 10 (83.3%). Mean mitral gradient was 5.8 mm Hg (median). New York Heart Association functional class improved to ≤II in 9 patients (81.8%)., Conclusions: This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system. Further clinical studies are required to establish safety and clinical outcomes., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to describe the anatomic and functional changes in left-sided chambers using computed tomographic angiography (CTA) from baseline to 1 month after transcatheter mitral valve replacement (TMVR) with the Tendyne prosthesis., Background: Data on changes in left atrial and left ventricular (LV) volumes after TMVR implantation are very limited., Methods: Patients who underwent TMVR with the Tendyne prosthesis between 2015 and 2018 were analyzed. Changes in LV end-diastolic volume, ejection fraction, LV mass, left atrial volume, and global longitudinal strain were assessed at baseline and 1 month after TMVR using CTA. Specific Tendyne implant characteristics were identified and correlated with remodeling changes., Results: A total of 36 patients (median age 74 years; interquartile range [IQR]: 69 to 78 years; 78% men; 86% with secondary mitral regurgitation) were included in this study. There were significant decreases in LV end-diastolic volume (281 ml [IQR: 210 to 317 ml] vs. 239 ml [IQR: 195 to 291 ml]; p < 0.001), LV ejection fraction (37% [IQR: 31% to 48%] vs. 30% [IQR: 23% to 40%]; p < 0.001), LV mass (126 g [IQR: 96 to 155 g] vs. 116 g [IQR: 92 to 140 g]; p < 0.001), left atrial volume (171 ml [IQR: 133 to 216 ml] vs. 159 ml [IQR: 125 to 201 ml]; p = 0.027), and global longitudinal strain (-11% [IQR: -17% to -8%] vs. -9% [IQR: -12% to -6%]; p < 0.001) from baseline to 1-month follow-up. Favorable LV end-diastolic volume reverse remodeling occurred in the majority (30 of 36 patients [83%]). Closer proximity of the Tendyne apical pad to the true apex (24 mm [IQR: 21 to 29 mm] vs. 35 mm [IQR: 26 to 40 mm]) was predictive of favorable remodeling (p = 0.037)., Conclusions: TMVR with Tendyne results in favorable left-sided chamber remodeling in the majority of patients treated, as detected on CTA at 1 month after implantation. CTA identifies favorable post-TMVR changes, which could be related to specific characteristics of the device implantation., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve repair (TMVR) has shown to be a safe and effective treatment option for symptomatic severe mitral regurgitation (MR) in patients who are at prohibitive surgical risk. Whether age and comorbidities impact the inpatient safety outcomes of TMVR versus surgical mitral valve repair (SMVR) is unknown., Methods: Using the national inpatient sample, patients undergoing either elective TMVR or SMVR between 2012 and 2015 were analyzed. Logistic, generalized logistic, and linear regression were used to compare inpatient complications, discharge disposition, and length of stay (LOS). Heterogeneity in the effect of TMVR versus SMVR across Charlson comorbidity index (CCI, categorized as <2 and ≥2) and age (categorized as <75 years old and ≥75 years old) were assessed for effect modification., Results: Overall, 8,716 hospitalizations were included, 7,950 (91%) SMVR and 766 (9%) TMVR. Compared with SMVR, patients undergoing TMVR were older (median age 79 vs. 62 years) and more likely to be female (45% vs. 40%) with a higher CCI score (median CCI 2 vs. 1). Despite being older with a higher comorbidity burden, patients undergoing TMVR had a lower incidence of permanent pacemaker implantation (OR 0.23, 95% CI: 0.11, 0.50), cerebrovascular accidents (OR 0.37, 95% CI: 0.15, 0.92), and major bleeding (OR 0.39, 95% CI: 0.32, 0.47). TMVR patients were also discharged 3 days earlier (CIE -3.26; 95% CI: -3.72, -2.80) and were less likely to be discharged to a skilled nursing facility (OR 0.72, 95% CI 0.55, 0.93). Additionally, the relative reduction in complications after TMVR versus SMVR was significantly higher in older (age ≥75 years) and more comorbid (CCI ≥2) patients (p for interaction <.05 for both)., Conclusion: Patients treated with TMVR, as compared with SMVR, were older and had more comorbidities, but had a lower incidence of inpatient complications, shorter LOS, and better discharge disposition. Therefore, TMVR may be a safer option than SMVR in older patients and those with a higher burden of comorbidities., (© 2019 Wiley Periodicals, Inc.)

In patients with increased surgical risk and hemodynamically significant mitral disease, a transcatheter strategy for mitral valve replacement (TMVR) may be suitable; however, is also not without procedure risk. Obstruction of the left ventricular outflow tract (LVOT) is one of the most dreaded complications of TMVR, requiring careful consideration of potential candidates with preprocedural imaging and ex vivo valvular fit simulation as part of risk assessment for postprocedure obstruction. In patients at high risk of LVOT obstruction, early studies have shown that alcohol septal ablation or electrosurgical laceration of the anterior mitral leaflet (LAMPOON) procedure prior to TMVR may mitigate the risk of LVOT obstruction. We describe the recent successful management of a patient with severe mitral valve disease, mitral annular calcification (MAC), and high risk of post-TMVR LVOT obstruction, who underwent a sequential strategy of ASA followed by electrosurgical leaflet resection with the LAMPOON procedure prior to TMVR to successfully prevent LVOT obstruction. To our knowledge, this is the first time this dual strategy has been reported, and it may allow more patients with severe mitral valve disease to undergo TMVR in the future.

Background: While rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology., Main Body: We reviewed the existing literature on mitral and tricuspid transcatheter therapies. Mitraclip is becoming an established therapy for secondary mitral regurgitation in selected patients with disproportionately severe regurgitation associated with moderate left ventricle dysfunction. Evidence is less convincing for primary mitral regurgitation. Transcatheter mitral valve replacement is a promising emerging alternative to transcatheter repair, for secondary as well as primary mitral regurgitation. But further development is needed to improve delivery. Transcatheter tricuspid intervention arrives late after similar technologies have been developed for aortic and mitral valves and is currently at its infancy. This is likely due in part to previously under-recognized impact of tricuspid regurgitation on patient outcomes. Edge-to-edge repair is the most advanced transcatheter solution in development. Data on tricuspid annuloplasty and replacement is limited, and more research is warranted., Conclusion: The future appears bright for transcatheter mitral therapies, albeit their place in clinical practice is yet to be clearly defined. Tricuspid transcatheter therapies might address the unmet need of tricuspid regurgitation treatment.

Background: Transcatheter mitral valve repair (TMVr) for the treatment of mitral regurgitation (MR) is a complex procedure that requires development of a unique skillset., Objectives: The purpose of this study was to examine the relationship between operator experience and procedural results of TMVr., Methods: TMVr device procedures from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry were analyzed with operator case number as a continuous and categorical (1 to 25, 26 to 50, and >50) variable. Outcomes of procedural success, procedural time, and in-hospital procedural complications were examined. The learning curve for the procedure was evaluated using generalized linear mixed models adjusting for baseline clinical variables., Results: All TMVr device procedures (n = 14,923) performed by 562 operators at 290 sites between November 2013 and March 2018 were analyzed. Optimal procedural success (≤1+ residual MR without death or cardiac surgery) increased across categories of operator experience (63.9%, 68.4%, and 75.1%; p < 0.001), while procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or cardiac surgery) also increased with operator experience, but the differences were smaller (91.4%, 92.4%, and 93.8%; p < 0.001). These associations remained significant in adjusted, continuous variable analyses. Visual inflection points in the learning curves for procedural time, procedural success, and procedural complications were evident after approximately 50 cases, with continued improvements observed out to 200 cases., Conclusions: For TMVr device procedures, operator experience was associated with improvements in procedural success, procedure time, and procedural complications. The effect of operator experience was greater when considering the goal of achieving 1+ residual MR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study proposes a physiologic assessment of left ventricular outflow tract obstruction (LVOTO) that accommodates changes in systolic flow and accounts for the dynamic neo-left ventricular outflow tract (LVOT)., Background: Patients considered for transcatheter mitral valve replacement trials often screen-fail because of the perceived risk of LVOTO. In the Intrepid Global Pilot Study, assumed risk of LVOTO was based on computed tomography estimates of the neo-LVOT area computed at end-systole. However, this may overestimate actual risk., Methods: Retrospective analyses were performed for screen-failed patients for potential LVOTO (n = 33) and treated patients (n = 29) with available dynamic computed tomography. A multiphase assessment of the neo-LVOT area was performed and represented as: 1) multiphase average; and 2) early systolic value. Prospective evaluation was performed in 9 patients approved for enrollment with multiphase and early systole methods that would have previously screen-failed with the end-systolic approach., Results: Of 166 patients screened for possible inclusion; 32 were screen-failed for nonanatomical reasons. Screen failure for assumed LVOTO risk occurred in 37 of 134 (27.6%) patients. Retrospective analysis indicated a potential enrollment increase of 11 of 33 (33.3%) and 18 of 33 (54.5%) patients using multiphase and early systolic assessment methods. In the prospective cohort, there were no clinical observations of LVOTO 30 days post-procedure, despite assumed risk based on end-systolic estimates., Conclusions: Multiphase, and specifically early systolic, assessment of the neo-LVOT may better determine risk of LVOTO with transcatheter mitral valve replacement compared with end-systolic estimates. This novel approach has the potential to significantly increase patient eligibility, with over one-half of patients previously screen-failed now eligible for treatment., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Severe mitral regurgitation (MR) is fairly common in the general population and is associated with significant morbidity and mortality. Although surgical mitral valve (MV) repair and replacement are well established treatment options for MV disease, as much as one-half of patients with severe, symptomatic MR are not referred for surgery due to prohibitive procedural risk. Novel transcatheter alternatives are therefore being developed to provide an alternative treatment for these patients. A growing experience with transcatheter MV replacement (TMVR) strategies is accumulating and promising early results have been reported. However, the risk of transcatheter heart valve (THV) thrombosis seems to be relevant after TMVR, potentially higher than that observed after transcatheter aortic valve replacement, and routine anticoagulant therapy appears to be necessary to mitigate this risk. Hereafter, the authors: 1) review available evidence on thrombotic risk after TMVR (including new dedicated THVs for native MV, valve-in-valve, valve-in-ring, and valve-in-mitral annular calcification); and 2) discuss the antithrombotic treatment strategies after TMVR., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to examine the relation between institutional experience and procedural results of transcatheter mitral valve repair., Background: Transcatheter mitral valve repair for the treatment of mitral regurgitation (MR) is a complex procedure requiring navigation of the left atrium, left ventricle, and mitral valve apparatus using echocardiographic guidance., Methods: MitraClip procedures from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry were stratified into tertiles on the basis of site-specific case sequence (1 to 18, 19 to 51, and 52 to 482). In-hospital outcomes of procedural success, procedural time, and procedural complications were examined. To evaluate the learning curve for the procedure, generalized linear mixed models were developed using case sequence number as a continuous variable., Results: MitraClip procedures (n = 12,334) performed at 275 sites between November 2013 and September 2017 were analyzed. Optimal procedural success (≤1+ residual MR without mortality or need for cardiac surgery) increased across tertiles of case experience (62.0%, 65.5%, and 72.5%; p < 0.001), whereas procedural time and procedural complications decreased. Acceptable procedural success (≤2+ residual MR without death or need for cardiac surgery) also increased across tertiles of case experience, but the differences were smaller (91.2%, 91.2%; and 92.9%; p = 0.006). In the learning-curve analysis, visual inflection points for procedural time, procedural success, and procedural complications were evident after about 50 cases, with continued improvements observed up to 200 cases., Conclusions: For transcatheter mitral valve repair with the MitraClip, increasing institutional experience was associated with improvements in procedural success, procedure time, and procedural complications. The impact of institutional experience was larger when considering the goal of achieving optimal MR reduction., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Transcatheter Mitral Valve Replacement (TMVR) is currently under clinical investigation as a viable treatment option for mitral regurgitation (MR). Therefore, it is important to outline the key functional requirements of a TMVR prosthesis in order to provide an overall approach to assessing mitral valve replacement devices utilizing a combination of in vitro and preclinical methods. This article provides a review of the mitral valve disease as well as general considerations and guidance for developing a TMVR device based on International Industry Standards. Specific details pertaining to the mitral valve apparatus, morphology of mitral valve disease, assessment of specific patient population as well as hazard analysis to evaluate and develop a TMVR device to treat a specific patient population have been included. The details contained within this report are not all inclusive or explicate for every technology being developed but rather thought of as a general guide on how a TMVR technology could be developed in alignment with International Industry Standards. Key learnings from the Transcatheter Aortic Valve Replacement (TAVR) experience has also been considered and taken into account when outlining this general guidance for TMVR. Key learning points from the TAVR development experience included the following: quantification of acceptable levels of paravalvular leak, valve migration potential using various anchoring methods and overall implant frame failure modes when treating the native aortic valve. It should be noted that TAVR is over a decade further along in development and clinical experience compared to TMVR. These key learnings from the early experience with TAVR should be considered with all transcatheter development projects.

In review of the current cardiac surgical literature, the care for complex pathology continues to make big strides forward. Much of this "progress" is driven by new technology or new applications for technology. In both mitral disease and type A dissection management, technology is changing the way the pathologies are approached. This article addresses some of the advances demonstrated in the literature and gives a perspective on how they affect current practice.

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.)

Objectives: This study shows the impact of secondary mitral regurgitation (sMR) and transcatheter mitral valve repair (TMVR) with the MitraClip system on sympathetic nerve activity (SNA)., Background: An increase in SNA is associated with worse outcomes and limited survival in patients with chronic heart failure (CHF)., Methods: Twenty CHF-patients without relevant sMR and 30 CHF patients with symptomatic sMR were enrolled prospectively. All patients underwent standardized laboratory testing and microneurography. Sixteen patients from the sMR group underwent the MitraClip procedure; 10 patients after TMVR and 9 untreated sMR patients completed 6 months of follow-up., Results: Comparing groups according to presence of sMR, we found no differences in left ventricular dimensions, and serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) and noradrenaline; sMR was associated with increased MSNA (106 ± 60 burst/min vs. 74 ± 48 burst/min, d = 0.58), an impaired sympathetic baroreflex gain (10 ± 7 burst/mm Hg vs. 5 ± 5 burst/mm Hg, d = 0.61), and a higher heart rate (90 ± 27/beats/min vs. 78 ± 12/beats/min, d = 0.58). TMVR led to improved New York Heart Association functional class (d > 0.05), reduced levels of NT-proBNP (5,251 ± 3,760 pg/ml vs. 3,710 ± 2,464 pg/ml; d = 0.58) improvement in 6-minute walk test (204 ± 33 m vs. 288 ± 45 m, d = 0.64), but unchanged levels of noradrenaline. TMVR decreased MSNA burst-frequency (130 ± 78 bursts/min vs. 74 ± 21 bursts/min; d = 0.58) and baroreflex gain (7 ± 4 burst/mm Hg vs. 4 ± 1 burst/mm Hg; d = 0.61)., Conclusions: In patients with CHF, concomitant sMR is associated with increased sympathetic nerve activity, which was independent from measured levels of NT-proBNP, noradrenaline, and left ventricular dimensions. Reduction of sMR with the MitraClip procedure reduced SNA and improved baroreflex gain, in line with improvements of functional capacity., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.)

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.)

The mitral valve is a highly complex structure, the competency and function of which relies on the harmonious action of its component parts. Minimally invasive cardiac surgery (MICS) for mitral valve repair or replacement (MVR/r) has been performed successfully with incremental improvements in techniques over the past decade. These minimally invasive procedures, while attractive to patients and referring physicians, should meet the same high bar for optimal clinical outcomes and long-term durability of valve repair as traditional sternotomy procedures. The majority of MICS MVR/r procedures are performed via a right minithoracotomy approach with direct or camera-assisted visualization, with a minority of centers performing robotic MVR/r. Outcomes with MICS MVR/r have been shown to have similar morbidity and mortality rates as traditional sternotomy MV procedures but with the advantage of reduced transfusions, postoperative atrial fibrillation, and time to recovery. More recently, transcatheter mitral valve repair and replacement (TMVR/r) has become a reality. Percutaneous MV repair technology is currently FDA approved for patients with nonsurgical high-risk degenerative mitral regurgitation. Other TMVR/r technology is at various levels of preclinical and clinical investigation, although these devices are proving to be more challenging compared to transcatheter aortic valve replacement (TAVR) due to the significantly more complex mitral anatomy and the greater heterogeneity of mitral disease requiring treatment. In this article, we review current techniques for MICS MVR/r and upcoming catheter-based therapies for the mitral valve.

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.)

Objective: Because of its durability, the mechanical valve is typically chosen for young patients undergoing mitral valve replacement (MVR). However, a bioprosthetic valve might have the benefit of valve-in-valve transcatheter valve replacement when valve failure occurs. We examined the outcomes in patients who had undergone mechanical valve MVR (MVRm) versus bioprosthetic valve MVR (MVRb) in patients aged <65 years., Methods: A total of 768 consecutive patients aged <65 years, who had undergone MVR from January 1991 to June 2012 were identified. Propensity matching was used to derive a case-control subset for analysis. Long-term outcomes were collected by chart review, routine patient follow-up, and query of the Social Security Death Index. The postoperative and long-term outcomes of interest included combined stroke and embolic events, reoperations, and mortality., Results: Of 768 consecutive patients, 627 were in the MVRm and 141 in the MVRb group. Propensity score matching yielded a cohort of 125 MVRb (89%) and 125 control MVRm patients with similar etiology mixes. The groups were similar in age (MVRm, 53.2 ± 9.0 years; MVRb, 53.8 ± 10.6 years; P = .617) and other preoperative characteristics. The postoperative outcomes were also similar between the 2 groups, including reoperation for bleeding, stroke, deep sternal infection, sepsis, and length of hospital stay. The operative mortality was also similar (MVRm, 5.6%; MVRb, 8.0%; P = .617). However, Kaplan-Meier analysis showed the MVRb group had a greater reoperation rate (P = .001) and shorter estimated survival (11.3 vs 13.5 years, P = .004). The incidence of bleeding and stroke or embolic events between the 2 groups was similar., Conclusions: In the present report, MVRb for patients <65 years old was associated with a high reoperation rate and decreased survival. Although a future transcatheter valve-in-valve technique for a failed bioprosthetic valve might reduce the risk of reoperation, this finding confirms the safety of mechanical valves in this group., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Trans‐catheter mitral valve replacement (TMVR) procedures had emerged as an alternative solution for patients who are at high risk for mitral valve surgery. Although cardiac computed tomography (CT) remains the standard method for procedural planning, there is no full agreement on the best systolic phase for quantitation of the neoLVOT. Furthermore, a new three‐dimensional trans‐esophageal echocardiography (3DTEE) based software was developed to serve as filter and or an alternative for patients who cannot have CT due to any contraindication. Aim: To determine the systolic phase of the cardiac cycle that shows the narrowest NeoLVOT area in order to standardize the way of using these software and then to validate the 3DTEE‐based software against the CT‐based one as a gold standard, in mitral valve annulus (MA) and NeoLVOT assessment. Methods: A single center, observational, retrospective study. Initially, a sample of 20 patients (age 62 ± 4 years, 70% men) had CT‐based analysis at mid‐diastole (80%), early‐systole (10%), mid‐systole (20%), late‐systole (30%–40%), in order to detect the best systolic phase at which the neoLVOT area is the narrowest after TMVR. Then, the end systolic phase was standardized for the analysis of 49 patients (age 57 ± 6 years, 60% men), using both the commercially available CT‐based software and the newly available 3DTEE‐based software (3mensio Structural Heart, Pie Medical Imaging, The Netherlands). The 3DTEE derived parameters were compared with the gold standard CT‐based measurements. Results: The neoLVOT area was significantly narrower at end‐systole (224 ± 62 mm2), compared to early‐systole (299 ± 70 mm2) and mid‐systole (261 ± 75 mm2), (p =.005). Excellent correlation was found between 3DTEE and CT measurements for MA AP diameter (r =.96), IC diameter (r =.92), MA area (r =.96), MA perimeter (r =.94) and NeoLVOT area (r =.96), (all p‐values <.0001). Virtual valve sizing was based on annulus measurement and was identical between CT and 3DTEE. Interobserver and intraobserver agreements were excellent for all the measurements with ICCs >.80. Conclusions: End‐systole is the phase that shows the narrowest neoLVOT and hence should be the standard phase used during the analysis. The 3DTEE based analysis using this new software is reliable compared to the CT‐based analysis and can be serve as an alternative analysis tool in patients who cannot have CT for any clinical contraindication or as a screening test and/or filter for all patients before proceeding to a detailed CT scan. [ABSTRACT FROM AUTHOR]

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it's crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations. [ABSTRACT FROM AUTHOR]

Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described. Three consecutive patients with severe functional MR underwent TMVR implantation using an atrial only fixation technology and a low-profile transseptal delivery system. Technical success was achieved in 100 % of the patients with a clinically significant reduction in MR. Longer-term follow-up (up to 6-months) has demonstrated a sustained reduction in MR and significant improvement in quality of life for all patients. Longer-term outcomes in our patients showed persistent reduction in MR, sustained implant performance, and notable improvements in NYHA Class and quality of life. There were no major adverse events. Follow-up CT data showed no evidence of device-related thrombosis, with stable valve position and integrity. The atrial fixation TMVR technology may have benefits in preserving the dynamics of the native mitral valve annulus thereby reducing the overall risk of LVOT obstruction. We present a single-center experience of three consecutive patients with severe functional MR treated with the AltaValve using a low-profile transseptal delivery system. A clinically significant reduction in mitral regurgitation was achieved in all patients, and longer-term follow-up has demonstrated sustained clinical benefits. • AltaValve provides a treatment option for a wide range of mitral valve anatomies. • Straightforward, single-stage, 29-Fr transseptal delivery. • AltaValve's 29-Fr transseptal system is fully recapturable prior to final release. • Patients treated with AltaValve show sustained reduction in MR (6-months). • Atrial fixation TMVR may preserve the dynamics of the native mitral valve annulus. [ABSTRACT FROM AUTHOR]

Valve-in-ring procedures represent a feasible solution for high-risk patients with surgical repair failure. The risk of left ventricular outflow tract obstruction increases the challenge, and transcatheter approaches to prevent it are technically demanding and often do not resolve it. We demonstrate the feasibility and safety of a transseptal balloon-assisted translocation of the anterior mitral leaflet for valve-in-ring implantation.

Aims The procedural planning of transcatheter mitral valve replacement (TMVR) requires a specific imaging assessment to establish patient eligibility. Computed tomography (CT) is considered the reference method. In this setting, data regarding the role of transoesophageal echocardiography (TOE) are lacking. We evaluated the feasibility and reliability of a comprehensive 3D-TOE screening in TMVR candidates. Methods and results We performed a retrospective observational study including 72 consecutive patients who underwent a pre-procedural CT and 3D-TOE for TMVR evaluation. The measurements of mitral annulus (MA), length of anterior mitral leaflet (AML), native left ventricular outflow tract (LVOT), and predicted neo-LVOT acquired with CT and 3D-TOE were compared using a novel semi-automated software for post processing analysis (3 mensio Structural Heart 10.1—3mSH, Pie Medical Imaging, Bilthoven, Netherlands). The final suitability decision was given by the valve manufacturer based on CT measurements and clinical conditions. Among 72 patients screened, all patients had adequate image quality for 3D-TOE analysis. 3D-TOE and CT measurements for AML length (r = 0.97), MA area (r = 0.90), perimeter (r = 0.68), anteroposterior (r = 0.88), and posteromedial-anterolateral (r = 0.74) diameters were found highly correlated, as well as for native LVOT (r = 0.86) and predicted neo-LVOT areas (r = 0.96) (all P -values <0.0001). An almost perfect agreement between CT and 3DTOE was found in assessing the eligibility for TMVR implantation (Cohen kappa 0.83, P < 0.001). Conclusion 3D-TOE appraisements showed good correlations with CT measurements and high accuracy to predict TMVR screening success. [ABSTRACT FROM AUTHOR]

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it’s crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations.

The morphological assessment of the geometry and the deformation of the mitral annulus has the potential to support the development of minimally invasive solutions for patients suffering from mitral valve regurgitation. Cardiac 4D-CT allows such a morphological assessment, which is, however, often performed manually, by annotating the mitral annulus and other cardiac landmarks. The goal of this study is to automate the annotation of cardiac landmarks in 4D-CT by propagating them from one reference phase to all others. The method proposed is based on non-rigid image registration, and four alternative variations have been tested, based on pairwise and groupwise registration. Their accuracy is evaluated against inter-observer variability on eight 4D-CTs. The results show that the pairwise and groupwise approaches using independent 3D transforms have a comparable performance, with an accuracy comparable with the inter-observer variability; however, the latter approach was computationally more expensive. Instead, the spatio-temporal groupwise approach obtained significantly worse results. The technology has, therefore, the potential to make an efficient analysis of the deforming heart more attainable. Moreover, the manual annotation process confirms that the mitral annulus deforms significantly during the cardiac contraction, supporting the use of 4D imaging for a reliable morphological assessment. [ABSTRACT FROM AUTHOR]

Transcatheter mitral valve replacement (TMVR) has emerged as a feasible alternative to surgical reoperation in failed bioprostheses and rings. Residual mitral regurgitation following TMVR can present as a valve-in-valve paravalvular leak (PVL) and is associated with increased morbidity and mortality. Current therapies for valve-in-valve PVL are limited. We present a case of a symptomatic patient with severe valve-in-valve PVL after TMVR for a previous surgical bioprosthesis leak, who then underwent a second TMVR as a valve-in-valve-in-valve implantation with a 29 mm Edwards? SAPIEN 3 valve via transseptal approach using three-dimensional (3D) echocardiography. This unique case highlights the complexity of this clinical entity and recognizes 3D transesophageal echocardiography as a valuable tool to guide valve-in-valve PVL closures. [ABSTRACT FROM AUTHOR]

Abstract Background Although transcatheter technology has achieved some success in the field of mitral valves, the feasibility of applying it to patients with degenerated mitral valve bioprostheses (valve-in-valve, ViV), failure of mitral valvuloplasty (valve-in-ring, ViR) and serious mitral annulus calcification (vale-in-MAC, ViMAC) has not been effectively evaluated. Methods By searching published literature before December 5, 2020 in four databases, we found all the literature related to the evaluation of feasibility assessment of TMViV, TMViR and TMViMAC. Outcomes focused on all-cause mortality within 30 days, bleeding and LVOT obstruction. Results A total of six studies were included, and all of them were followed up for at least 30 days. After analysis of the ViV–ViR group, we obtained the following results: the all-cause mortality within 30 days of the ViV group was lower than that of the ViR group. Life-threatening or fatal bleeding was more likely to occur in the ViR group after surgery. At the same time, the ViR group was more prone to left ventricular outflow tract obstruction. However, in the ViMAC–ViR group, only the all-cause mortality within 30 days and stroke were statistically significant. In the indirect comparison, we found that TMViV had the best applicability, followed by TMViR. There were few TMViMAC available for analysis, and it requires further studies to improve the accuracy of the results. Conclusion TMViV and TMViR had good applicability and could benefit patients who underwent repeat valve surgery. The feasibility of TMViMAC needs to be further explored and improved.

MitraClip transcatheter edge-to-edge repair is used to treat mitral regurgitation (MR). While MR is reduced, diastolic left ventricular flows are altered. An in vitro left heart simulator was used to assess a porcine mitral valve in the native, MR, and MR plus MitraClip cases. Velocity, vorticity, and Reynolds shear stress (RSS) were quantified by particle image velocimetry. Peak velocity increased from 1.20 m/s for native to 1.30 m/s with MR. With MitraClip, two divergent jets of 1.18 and 0.61 m/s emerged. Higher vorticity was observed with MR than native and lessened with MitraClip. MitraClip resulted in shear layer formation and downstream vortex formation. Native RSS decreased from 33 Pa in acceleration to 29 Pa at peak flow, then increased to 31 Pa with deceleration. MR RSS increased from 27 Pa in acceleration to 40 Pa at peak flow to 59 Pa during deceleration. MitraClip RSS increased from 79 Pa in acceleration to 162 Pa during peak flow, then decreased to 45 Pa during deceleration. After MitraClip, two divergent jets of reduced velocity emerged, accompanied by shear layers and recirculation. Chaotic flow developed, resulting in elevated RSS magnitude and coverage. Findings help understand consequences of MitraClip on left ventricular flow dynamics. [ABSTRACT FROM AUTHOR]

Background Mitral valved stents tend to migrate or to develop paravalvular leakage due to high–left ventricular pressure in this cavity. Thus, this study describes a newly developed mitral valved stent anchoring technology. Methods Based on an existing mitral valved stent, four anchoring units with curved surgical needles were designed and fabricated using three-dimensional (3D) software and print technology. Mitral nitinol stents assembled with four anchoring units were successively fixed on 10 porcine annuli. Mechanical tests were performed with a tensile force test system and recorded the tension forces of the 10 nitinol stents on the annulus. Results The average maximum force was 28.3 ± 5.21 N, the lowest was 21.7 N, and the highest was 38.6 N until the stent lost contact with the annulus; for the break force (zero movement of stent from annulus), the average value was 18.5 ± 6.7 N with a maximum value of 26.9 N and a minimum value of 6.07 N. It was additionally observed that the puncture needles of the anchoring units passed into the mitral annulus in all 10 hearts and further penetrated the myocardium in only one additional heart. The anchoring units enhanced the tightness of the mitral valved stent and did not destroy the circumflex coronary artery, coronary sinus, right atrium, aortic root, or the left ventricular outflow tract. Conclusion The new anchoring units for mitral nitinol stents were produced with 3D software and printing technology; with this new type of anchoring technology, the mitral valved stent can be tightly fixed toward the mitral annulus. [ABSTRACT FROM AUTHOR]

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Background: Although transcatheter technology has achieved some success in the field of mitral valves, the feasibility of applying it to patients with degenerated mitral valve bioprostheses (valve-in-valve, ViV), failure of mitral valvuloplasty (valve-in-ring, ViR) and serious mitral annulus calcification (vale-in-MAC, ViMAC) has not been effectively evaluated.Methods: By searching published literature before December 5, 2020 in four databases, we found all the literature related to the evaluation of feasibility assessment of TMViV, TMViR and TMViMAC. Outcomes focused on all-cause mortality within 30 days, bleeding and LVOT obstruction.Results: A total of six studies were included, and all of them were followed up for at least 30 days. After analysis of the ViV-ViR group, we obtained the following results: the all-cause mortality within 30 days of the ViV group was lower than that of the ViR group. Life-threatening or fatal bleeding was more likely to occur in the ViR group after surgery. At the same time, the ViR group was more prone to left ventricular outflow tract obstruction. However, in the ViMAC-ViR group, only the all-cause mortality within 30 days and stroke were statistically significant. In the indirect comparison, we found that TMViV had the best applicability, followed by TMViR. There were few TMViMAC available for analysis, and it requires further studies to improve the accuracy of the results.Conclusion: TMViV and TMViR had good applicability and could benefit patients who underwent repeat valve surgery. The feasibility of TMViMAC needs to be further explored and improved. [ABSTRACT FROM AUTHOR]

Transcatheter mitral valve replacement (TMVR) offers a valuable treatment option for inoperable patients suffering from a degenerated mitral valve after previous ring annuloplasty. Dynamic obstruction of the left ventricular outflow tract(LVOT) is a procedural risk with detrimental consequences and can be estimated upfront using a multi-slice computed tomography(MSCT) derived 3D computational model(3DCM). This study explored the accuracy of pre-procedural neo-LVOT prediction in TMVR using 3DCMs of multiple cardiac phases. We obtained both pre- and post-procedural MSCT scans of a patient who underwent uncomplicated TMVR and derived 3DCMs from each cardiac phase. Virtual implantations of the deployed valve were performed and neo-LVOT dimensions were semi-automatically calculated in the pre-procedural models and matched with the post-procedural models. Predicted and post-procedural neo-LVOTs were compared between 3DCMs. From cardiac phases 20–70%, 11 matched 3DCM pairs were generated. The mean difference between predicted and post-TMVR neo-LVOT area was 3 ± 23 mm2. The intra-class correlation coefficient for absolute agreement between predicted and post-procedural neo-LVOT area was 0.86 (95%CI 0.56–0.96, p < 0.001). 3DCMs could accurately predict post-TMVR neo-LVOT dimensions in a patient with a pre-existing mitral annular ring. Prospective research is warranted to demonstrate the accuracy of these models in larger samples and different mitral annular phenotypes. • Dynamic LVOT obstruction is a notorious risk of TMVR. • A CT-derived 3D computational model(3DCM) might aid in procedural risk assessment. • The accuracy of multi-phase LVOT prediction post-TMVR using 3DCMs was examined. • 3DCMs could accurately predict post-TMVR neo LVOT dimensions, however prospective research is required. [ABSTRACT FROM AUTHOR]

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Background: Outcome data following transcatheter mitral valve repair (TMVR) with the MITRACLIP® device are scarce outside the pivotal randomized controlled trials. Methods: The Nationwide Readmission Data base (NRD) was utilized for years 2013–2017 to identify the study population. Thirty-day readmission pattern, in-hospital complications, causes of readmissions, and multivariate predictors for readmission, complications and mortality were explored. Results: We noted a total of 14,647 index admissions related to MITRACLIP of which 48% of procedures were performed at high volume centers (Annual hospital volume ≥ 25). A total of 15% of patients were readmitted within 30 days of discharge most frequently due to cardiac causes. Approximately 33% of patients were discharged within 24 h of the procedure. The in-hospital mortality rate was 2.8% and in-hospital complication rate was 14.6%. The most common complications were cardiac complications (8.2%), bleeding related complications (5.9%) and vascular complications (0.65%). On multivariate modeling, female sex, CHF, Atrial fibrillation, prior PCI, COPD, CKD, transfer to skilled nursing facility, length of stay ≥2 days were associated with a high risk of readmission. Additionally, coagulopathy, chronic kidney disease and lengthier hospital stays were associated with high risk of complication or death. Conclusion: The 30-day readmission rate following commercial treatment with the MITRACLIP device is 15%. Half of these admission were from a cardiac etiology. Heart failure, atrial arrhythmias and clip related complications round out the top 3 cardiac reasons for readmission. There was no impact of hospital size, teaching status or case volume on mortality and in hospital complication rates. • 50% of Mitraclips were implanted at high volume centers, no association between hospital volume and outcomes were noted • Cardiac etiologies account for half of the readmissions within 30 days of discharge after Mitraclip procedure • About 1/3rd of the patients are discharged same day after Mitraclip procedure • Female gender, CHF, Atrial fibrillation, prior PCI, COPDand CKD were associated with high risk of 30-day readmission. [ABSTRACT FROM AUTHOR]

Background Transcatheter aortic valve replacement (TAVR) in combination with a valve-in-valve (V-i-V) transcatheter mitral valve replacement (TMVR) is a rare procedure in comparison to surgical therapy especially in young patients. We report on a young patient at high surgical risk, receiving a double valve implantation with two S3 transcatheter heart valves. Case summary A 59-year-old female patient with two previous mitral valve replacements due to endocarditis and re-endocarditis experienced a new onset of severe mitral valve stenosis in combination with progredient aortic stenosis. She was admitted to the hospital with severe dyspnoea and intermittent non-invasive ventilation [New York Heart Association (NYHA) III–IV]. An interventional transapical transcatheter double valve implantation was planned and carried out due to cardiac decompensation and high comorbidity preoperatively (STS score of 6.92). At 6-month follow-up, the patient presented herself in an improved condition with reduced symptoms (NYHA I–II), a good functional status of both valves and an advanced right and left ventricular function in the echocardiogram. Discussion Even in younger patients at high risk, a combined native TAVR and V-i-V TMVR procedure can be performed. In this case, a transcatheter SAPIEN 3 valve was transapically implanted with good clinical mid-term outcome at 6 months. [ABSTRACT FROM AUTHOR]

Background. Transcatheter edge-to-edge mitral valve repair (TMVR) is increasingly performed. However, its efficacy in comparison with surgical MV treatment (SMV) is unknown. Methods. Consecutive patients with severe mitral regurgitation (MR) undergoing TMVR (68% functional, 32% degenerative) or SMV (9% functional, 91% degenerative) were enrolled. To account for differences in baseline characteristics, propensity score matching was performed, including age, EuroSCORE-II, left ventricular ejection fraction, and NT-proBNP. A composite of heart failure (HF) hospitalization/death served as primary endpoint. Kaplan-Meier curves and Cox-regression analyses were used to investigate associations between baseline, imaging, and procedural parameters and outcome. Results. Between July 2017 and April 2020, 245 patients were enrolled, of whom 102 patients could be adequately matched (73 y/o, 61% females, EuroSCORE-II: 5.7%, p > 0.05 for all). Despite matching, TMVR patients had more co-morbidities at baseline (higher rates of prior myocardial infarction, coronary revascularization, pacemakers/defibrillators, and diabetes mellitus, p < 0.009 for all). Patients were followed for 28.3 ± 27.2 months, during which 27 events (17 deaths, 10 HF hospitalizations) occurred. Postprocedural MR reduction (MR grade p = 0.487) and freedom from HF hospitalization/death (log-rank: p = 0.811) were similar at 2 years. On multivariable Cox analysis, EuroSCORE-II (adj.HR 1.07 [95%CI: 1.00–1.13], p = 0.027) and residual MR (adj.HR 1.85 [95%CI: 1.17–2.92], p = 0.009) remained significantly associated with outcome. Conclusions. In this propensity-matched, all-comers cohort, two-year outcomes after TMVR versus SMV were similar. Given the reported favorable long-term durability of TMVR, the interventional approach emerges as a valuable alternative for a substantial number of patients with functional and degenerative MR.

Introduction: Transcatheter mitral valve replacement (TMVR) is still a recent technology with numerous unknowns but also great promises. The risk of complications reported in observational studies have limited its adoption by interventional cardiology and surgical communities. Areas covered: Some of the major setbacks of TMVR are complications related to the devices and those related to the pathway. Device-related complications include left ventricle outflow tract (LVOT) obstruction, transcatheter heart valve (THV) dislocation or embolization, thrombosis, and stroke. The transapical approach currently remains the main pathway for TMVR but is associated with high risk of major bleeding and residual apical myocardial scarring. Complication prediction and prevention seem possible. Device-related complication prediction is based on pre-operative imaging including multi-slice computed tomography with 3-dimensional reconstructions and echocardiography which allow LVOT obstruction prediction and appropriate sizing aiming at avoiding dislocation. Industry should aim at the development of transfemoral delivery systems. Nevertheless, several recent feasibility observational studies suggested acceptable safety and efficacy of transcatheter mitral valve replacement. Expert opinion: TMVR complications and transapical delivery are some of the main setbacks which need to be addressed for TMVR to be adopted for broad clinical use. [ABSTRACT FROM AUTHOR]