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The association, if any, between the effective regurgitant orifice area (EROA) to left ventricular end-diastolic volume (LVEDV) ratio and 1-year mortality is controversial in patients who undergo mitral transcatheter edge-to-edge repair (m-TEER) with the MitraClip system (Abbott Vascular, Santa Clara, CA). This study's objective was to determine the association between EROA/LVEDV and 1-year mortality in patients who undergo m-TEER with MitraClip. In patients with severe secondary (functional) mitral regurgitation (MR), we analyzed registry data from 11 centers using generalized linear models with the generalized estimating equations approach. We studied 525 patients with secondary MR who underwent m-TEER. Most patients were male (63%) and were New York Heart Association class III (61%) or IV (21%). Mitral regurgitation was caused by ischemic cardiomyopathy in 51% of patients. EROA/LVEDV values varied widely, with median = 0.19 mm 2 /ml, interquartile range [0.12,0.28] mm 2 /ml, and 187 patients (36%) had values <0.15 mm 2 /ml. Postprocedural mitral regurgitation severity was substantially alleviated, being 1+ or less in 74%, 2+ in 20%, 3+ in 4%, and 4+ in 2%; 1-year mortality was 22%. After adjustment for confounders, the logarithmic transformation (Ln) of EROA/LVEDV was associated with 1-year mortality (odds ratio 0.600, 95% confidence interval 0.386 to 0.933, p = 0.023). A higher Society of Thoracic Surgeons risk score was also associated with increased mortality. In conclusion, lower values of Ln(EROA/LVEDV) were associated with increased 1-year mortality in this multicenter registry. The slope of the association is steep at low values but gradually flattens as Ln(EROA/LVEDV) increases., Competing Interests: Declaration of competing interest Dr. Lim reports a relation with Abbott that includes funding grants; a relation with Boston Scientific Corp. that includes funding grants; a relation with Corvia Medical that includes funding grants; a relation with Edwards Lifesciences Corporation that includes funding grants; a relation with Medtronic Inc. that includes funding grants; a relation with Trisol that includes funding grants; a relation with Philips that includes consulting or advisory; a relation with Valgen that includes consulting or advisory; and a relation with Venus that includes consulting or advisory. Dr. Rodriguez reports a relation with Abbott that includes consulting or advisory, funding grants, and speaking and lecture fees. Dr. Zahr reports a relation with Medtronic Inc. that includes board membership, consulting or advisory, and funding grants; a relation with Edwards Lifesciences Corporation that includes funding grants; and a relation with SIEMENS that includes: funding grants. Dr. Ailawadi reports a relation with Medtronic Inc. that includes consulting or advisory; a relation with Abbott that includes consulting or advisory; a relation with Edwards Lifesciences Corporation that includes consulting or advisory; a relation with Gore that includes consulting or advisory; a relation with Anteris that includes consulting or advisory; a relation with AtriCure Inc. that includes consulting or advisory; a relation with CryoLife that includes consulting or advisory; a relation with Philips that includes consulting or advisory; and a relation with Johnson & Johnson that includes consulting or advisory. Dr. Rogers reports a relation with Abbott that includes consulting or advisory and funding grants; a relation with Boston Scientific Corp that includes consulting or advisory and funding grants; and a relation with Baylis Medical Company, Inc. that includes consulting or advisory. Dr. Chen reports a relation with Philips that includes consulting or advisory; a relation with Abbott that includes consulting or advisory; and a relation with Akura Medical that includes consulting or advisory. Dr. Vannan reports a relation with Abbott that includes funding grants and speaking and lecture fees. Dr. Duggal reports a relation with Medtronic Inc. that includes consulting or advisory. Dr. Sodhi reports a relation with Medtronic Inc that includes consulting or advisory; and a relation with Boston Scientific Corp that includes consulting or advisory. Dr. Sorajja reports a relation with 4C Medical Technologies Inc. that includes consulting or advisory; a relation with Anteris that includes consulting or advisory; a relation with Abbott that includes consulting or advisory; a relation with Boston Scientific Corp that includes consulting or advisory; a relation with Edwards Lifesciences Corporation that includes consulting or advisory; a relation with Evolution Medical that includes consulting or advisory; a relation with Foldax that includes consulting or advisory; a relation with GLG that includes consulting or advisory; a relation with Medtronic Inc. that includes consulting or advisory; a relation with Philips that includes consulting or advisory; a relation with SIEMENS that includes consulting or advisory; a relation with Shifamed that includes consulting or advisory; a relation with WL Gore that includes consulting or advisory; a relation with vDyne that includes consulting or advisory; and a relation with xDot that includes consulting or advisory. Dr. Yadav reports a relation with Edwards Lifesciences Corporation that includes consulting or advisory and speaking and lecture fees; a relation with Abbott that includes consulting or advisory and speaking and lecture fees; a relation with Boston Scientific Corp. that includes consulting or advisory and speaking and lecture fees; and a relation with Dasi Simulations that includes board membership. Dr. Chadderdon reports a relation with Medtronic Inc that includes consulting or advisory; a relation with Edwards Lifesciences Corporation that includes consulting or advisory; and a relation with GE Healthcare that includes funding grants. Dr. Chetcuti reports a relation with Medtronic Inc. that includes consulting or advisory and funding grants; a relation with Boston Scientific Corp. that includes consulting or advisory and funding grants; a relation with Jena that includes funding grants; a relation with Abbott that includes funding grants; a relation with Edwards Lifesciences Corporation that includes funding grants; and a relation with Gore that includes funding grants. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: To assess the impact of pulmonary hypertension (PH) on outcomes of patients with severe mitral annular calcification (MAC) undergoing transcatheter mitral valve replacement (TMVR)., Background: PH is associated with poor outcomes after mitral valve surgery. Whether the presence of PH in patients with MAC undergoing (TMVR) is associated with poor outcomes, is unknown., Methods: Retrospective evaluation of 116 patients from 51 centers in 11 countries who underwent TMVR with valve in mitral annular calcification (ViMAC) using balloon-expandable aortic transcatheter valves (THVs) from September 2012 to March 2017. Pulmonary artery systolic blood pressure (PASP) by echocardiogram was available in 90 patients. The subjects were stratified based on PASP: No PH = PASP ≤35 mmHg (n = 11); mild to moderate PH = PASP 36-49 mmHg (n = 21) and severe PH = PASP ≥50 mmHg (n = 58). Clinical, procedural, and echocardiographic outcomes were assessed., Results: Mean age was 72.7 (±12.8) years, 59 (65.6%) were female, Society of Thoracic Surgeons score was 15.8 + 11.8% and 90.0% where in New York Heart Association (NYHA) class III-IV. There was no significant difference in all-cause mortality at 30 days (no PH = 27.3%, mild-moderate PH = 19.0%, severe PH = 31.6%; p = 0.55) or at 1 year (no PH = 54.5%, mild-moderate PH = 38.1%, severe PH = 56.1%; p = 0.36). No difference in adverse events, NYHA class or amount of residual mitral regurgitation at 1 year were observed between the groups., Conclusion: This study suggests that the presence of PH in patients with predominantly mitral stenosis with MAC undergoing TMVR does not impact mortality or adverse events. Further studies are needed to fully understand the effect of PH in this group of patients., (© 2022 Wiley Periodicals LLC.)

Objectives: The purpose of this study was to characterize the anatomic relationship between the inferior vena cava (IVC) and tricuspid annulus (TA) and its potential impact on the performance of transcatheter TV interventions., Background: Transcatheter tricuspid valve (TV) interventions are emerging as a therapeutic alternative for the treatment of severe, symptomatic tricuspid regurgitation (TR). Progression of TR is associated with right heart dilatation. These anatomic changes may distort the IVC-TA relationship and impact successful implantation of transcatheter devices., Methods: Fifty patients who presented with symptomatic TR for consideration of transcatheter TV therapy with an available CT were included in the study. Comprehensive transesophageal echocardiogram and CT analyses were performed to assess the right-sided cardiac chambers, TA and IVC-TA relationship., Results: The mean age of the study cohort was 78.4 ± 8.9 years. Torrential TR was present in 54% (n = 27). There was considerable variation in the short axis mid-IVC to mid-TA offset (SAX MID 18.2 ± 7.9 mm, range 4.7-42.1 mm)., Conclusions: The IVC-to-TA relationship exhibits significant variability in patients with symptomatic TR. CT analysis of the tricuspid anatomy, including the relationship to the surrounding structures and the IVC, is essential for planning transcatheter TV interventions. Further studies are needed to define whether the IVC-to-TA relationship is a predictor of technical success in the context of specific transcatheter delivery systems., (© 2022 Wiley Periodicals LLC.)

Competing Interests: Funding Support and Author Disclosures This study was funded by Edwards Lifesciences. Drs. Davidson, Smith, Grayburn, Gray, and Lim have received grant support/consulting fees from Edwards Lifesciences. Dr. Hahn is a speaker and consultant for Edwards Lifesciences and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Drs. Deuschl and Feldman are employees of Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: We present our initial experience with the fourth-generation MitraClip™ (G4) system and propose preliminary criteria for device selection., Background: The MitraClip™ G4 system recently underwent a "controlled release" for transcatheter edge-to-edge mitral valve repair. The four new devices include technical improvements such as controlled gripper actuation (independent leaflet capture) and continuous left atrial pressure monitoring. To date, a patient-specific device selection algorithm, and the technology's impact on procedural times and success, have not been described., Methods: We present an initial multi-center experience and short-term outcomes with the new system, suggest procedural and imaging considerations, and propose initial guidance for device selection., Results: Sixty-one procedures performed by three operators at two centers between November 2019 and May 2020 were analyzed. At 30-day follow-up, there were three deaths (4.9%), four neurological events (6.6%), and seven re-hospitalizations (11.5%). Fifty-nine patients achieved device and procedural success (96.7%), and there was one device-related technical issue (1.6%). Compared to the same operators utilizing the third generation MitraClip™, the G4 system resulted in a significant reduction in the median number of clips used per patient (1 IQR 1-2 vs. 2 IQR 1-3, p = .023) and a trend toward shorter device times., Conclusion: Based on our initial experience, we found that the MitraClip™ G4 system is associated with high procedural success and fewer devices needed per procedure. The expanded device options may allow a more targeted approach to the myriad of pathologic presentations of mitral regurgitation. This early experience should provide a foundational opportunity for further refinement., (© 2021 Wiley Periodicals LLC.)

Objectives: The aim of this study was to evaluate 1-year outcomes of valve-in-mitral annular calcification (ViMAC) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial., Background: The MITRAL trial is the first prospective study evaluating the feasibility of ViMAC using balloon-expandable aortic transcatheter heart valves., Methods: A multicenter prospective study was conducted, enrolling high-risk surgical patients with severe mitral annular calcification and symptomatic severe mitral valve dysfunction at 13 U.S. sites., Results: Between February 2015 and December 2017, 31 patients were enrolled (median age 74.5 years [interquartile range (IQR): 71.3 to 81.0 years], 71% women, median Society of Thoracic Surgeons score 6.3% [IQR: 5.0% to 8.8%], 87.1% in New York Heart Association functional class III or IV). Access was transatrial (48.4%), transseptal (48.4%), or transapical (3.2%). Technical success was 74.2%. Left ventricular outflow tract obstruction (LVOTO) with hemodynamic compromise occurred in 3 patients (transatrial, n = 1; transseptal, n = 1; transapical, n = 1). After LVOTO occurred in the first 2 patients, pre-emptive alcohol septal ablation was implemented to decrease risk in high-risk patients. No intraprocedural deaths or conversions to open heart surgery occurred during the index procedures. All-cause mortality at 30 days was 16.7% (transatrial, 21.4%; transseptal, 6.7%; transapical, 100% [n = 1]; p = 0.33) and at 1 year was 34.5% (transatrial, 38.5%; transseptal, 26.7%; p = 0.69). At 1-year follow-up, 83.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.1 mm Hg (IQR: 5.6 to 7.1 mm Hg), and all patients had ≤1+ mitral regurgitation., Conclusions: At 1 year, ViMAC was associated with symptom improvement and stable transcatheter heart valve performance. Pre-emptive alcohol septal ablation may prevent transcatheter mitral valve replacement-induced LVOTO in patients at risk. Thirty-day mortality of patients treated via transseptal access was lower than predicted by the Society of Thoracic Surgeons score. Further studies are needed to evaluate safety and efficacy of ViMAC., Competing Interests: Funding Support and Author Disclosures This study was supported by an unrestricted research grant from Edwards Lifesciences. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, Materialise, and HighLife Medical; and has received grant support from Boston Scientific. Dr. Salinger has served as a proctor for Boston Scientific and Edwards Lifesciences. Dr. Kodali has served as a consultant for Admedus, Meril Lifesciences, Abbott Vascular, JenaValve, and Claret Medical; and has ownership interest in Dura Biotech, Thubrikar Aortic Valve, Microinterventional Devices, and Supira Medical. Dr. George has served as a consultant for Boston Scientific, Medtronic, Edwards Lifesciences, and W.L. Gore & Associates. Dr. Bapat has served as a consultant for Edwards Lifesciences, Medtronic, and Sorin. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and has served on the advisory board for Boston Scientific. Dr. Tang is a physician proctor for Medtronic; and is a consultant for Medtronic, Abbott Structural Heart, and W.L. Gore & Associates. Dr. Reisman has served as a consultant for Edwards Lifesciences. Dr. Feldman is an employee of Edwards Lifesciences. Dr. Hahn has received speaker fees from Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural Heart, Edwards Lifesciences, W.L. Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio Medical Imaging; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. O’Neill has served as a consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. 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.)

Objectives: The aim of this study was to assess 1-year clinical outcomes among high-risk patients with failed surgical mitral bioprostheses who underwent transseptal mitral valve-in-valve (MViV) with the SAPIEN 3 aortic transcatheter heart valve (THV) in the MITRAL (Mitral Implantation of Transcatheter Valves) trial., Background: The MITRAL trial is the first prospective study evaluating transseptal MViV with the SAPIEN 3 aortic THV in high-risk patients with failed surgical mitral bioprostheses., Methods: High-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis due to failed surgical mitral bioprostheses were prospectively enrolled. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year)., Results: Thirty patients were enrolled between July 2016 and October 2017 (median age 77.5 years [interquartile range (IQR): 70.3 to 82.8 years], 63.3% women, median Society of Thoracic Surgeons score 9.4% [IQR: 5.8% to 12.0%], 80% in New York Heart Association functional class III or IV). The technical success rate was 100%. The primary performance endpoint in survivors was achieved in 96.6% (28 of 29) at 30 days and 82.8% (24 of 29) at 1 year. Thirty-day all-cause mortality was 3.3% and was unchanged at 1 year. The only death was due to airway obstruction after swallowing several pills simultaneously 29 days post-MViV. At 1-year follow-up, 89.3% of patients were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.6 mm Hg (interquartile range: 5.5 to 8.9 mm Hg), and all patients had MR grade ≤1+., Conclusions: Transseptal MViV in high-risk patients was associated with 100% technical success, low procedural complication rates, and very low mortality at 1 year. The vast majority of patients experienced significant symptom alleviation, and THV performance remained stable at 1 year., Competing Interests: Funding Support and Author Disclosures Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences and Boston Scientific; has received research grant support from Boston Scientific assigned to her employer, Henry Ford Health; and holds equity in Encompass Technologies. Dr. Kodali has served as a consultant for Admedus, Meril Lifesciences, Abbott Vascular, JenaValve, and Claret Medical; and has ownership interest in Dura Biotech, Thubrikar Aortic Valve, Micro Interventional Devices, and Supira Medical. Dr. George has served as consultant for Cardiomech, VDyne, MitreMedical, and Neptune Medical. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and has served on the advisory board for Boston Scientific. Dr. Reisman has served as consultant for Edwards Lifesciences. Dr. Hahn has received speaker fees from Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. O’Neill has served as a consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. Dr. Feldman is an employee of Edwards Lifesciences. 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.)

Objectives: The authors report 1-year outcomes of high-risk patients with failed surgical annuloplasty rings undergoing transseptal mitral valve-in-ring (MViR) with the SAPIEN 3 aortic transcatheter heart valve (THV)., Background: The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study evaluating transseptal MViR with the SAPIEN 3 aortic THV in high-risk patients with failed surgical annuloplasty rings., Methods: Prospective enrollment of high-risk patients with symptomatic moderate to severe or severe mitral regurgitation (MR) or severe mitral stenosis and failed annuloplasty rings at 13 U.S. sites. The primary safety endpoint was technical success. The primary THV performance endpoint was absence of MR grade ≥2+ or mean mitral valve gradient ≥10 mm Hg (30 days and 1 year). Secondary endpoints included procedural success and all-cause mortality (30 days and 1 year)., Results: Thirty patients were enrolled between January 2016 and October 2017 (median age 71.5 years [interquartile range: 67.0 to 76.8 years], 36.7% women, median Society of Thoracic Surgeons score 7.6% [interquartile range: 5.1% to 11.8%], 76.7% in New York Heart Association functional class III or IV). Technical success was 66.7% (driven primarily by need for a second valve in 6 patients). There was no intraprocedural mortality or conversion to surgery. The primary performance endpoint was achieved in 85.7% of survivors at 30 days (24 of 28) and 89.5% of patients alive at 1 year with echocardiographic data available (17 of 19). All-cause mortality at 30 days was 6.7% and at 1 year was 23.3%. Among survivors at 1-year follow-up, 84.2% were in New York Heart Association functional class I or II, the median mean mitral valve gradient was 6.0 mm Hg (interquartile range: 4.7 to 7.3 mm Hg), and all had ≤1+ MR., Conclusions: Transseptal MViR was associated with a 30-day mortality rate lower than predicted by the Society of Thoracic Surgeons score. At 1 year, transseptal MViR was associated with symptom improvement and stable THV performance., Competing Interests: Funding Support and Author Disclosures This study was supported by an unrestricted research grant from Edwards Lifesciences. The authors had absolute control of the study design, data collection, analysis and interpretation of data, writing of this paper, and take full responsibility for this report. Dr. Guerrero has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, Materialise, and HighLife Medical; and has received grant support from Boston Scientific. Dr. Salinger has served as a proctor for Boston Scientific and Edwards Lifesciences. Dr. Kodali has served as a consultant for Admedus, Meril Lifesciences, Abbott Vascular, JenaValve, and Claret Medical; and has ownership interest in Dura Biotech, Thubrikar Aortic Valve, Microinterventional Devices, and Supira Medical. Dr. Meduri has served as a consultant for Medtronic and Boston Scientific; and has served on the advisory board for Boston Scientific. Dr. Reisman has served as consultant for Edwards Lifesciences. Dr. Hahn has received speaker fees from Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, W.L. Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Feldman is an employee of Edwards Lifesciences. Dr. O’Neill has served as consultant for Abiomed, Boston Scientific, and Edwards Lifesciences. 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.)

Objectives: To describe the outcomes of urgent/emergent transcatheter edge-to-edge mitral valve repair (TMVr) and compare the clinical, echocardiographic, and procedural characteristics of survivors and nonsurvivors., Background: TMVr is a treatment strategy for select patients with severe primary or secondary mitral regurgitation. However, knowledge regarding outcomes for urgent/emergent TMVr is limited., Methods: All urgent or emergent TMVr procedures using MitraClip performed at the University of Washington Medical Center between January 2018 and March 2019 were identified and clinical, echocardiographic, hemodynamic, procedural, and outcomes data were obtained by chart review. Outcomes included all-cause mortality, hospital mortality, procedural success, periprocedural complications, and hospital readmission., Results: Of the 20 patients who underwent urgent/emergent TMVr, eight were treated for cardiogenic shock (CS), four for acute decompensated heart failure (ADHF) with hypoxemic respiratory failure requiring mechanical ventilation, and eight for ADHF with failure of inpatient medical therapy. Mechanical circulatory support (MCS) was used in six patients; preceding TMVr in three patients and immediately post-TMVr in three patients. Overall, 30-day mortality and hospital readmission rates were 21 and 13%, respectively. Over a median 153 days (IQR 20-491) of follow-up, 10 patients (50%) died. Preprocedure CS, new or ongoing MCS post-TMVr, refractory respiratory failure post-TMVr, and acute kidney injury post-TMVr were associated with mortality., Conclusions: In a single-center retrospective analysis, urgent/emergent TMVr in high-risk patients with ADHF or CS was associated with high short-term mortality and periprocedural complications. Prospective studies are warranted to inform patient selection and periprocedural management for urgent/emergent TMVr., (© 2020 Wiley Periodicals LLC.)

Objectives: The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR)., Background: Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited., Methods: In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee., Results: The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30 days. Between baseline and 30 days, septolateral tricuspid annular diameter was reduced by 13% (p < 0.001), 85% of patients had ≥1 grade TR reduction and 44% had ≤moderate TR, 75% were in New York Heart Association functional class I to II (p < 0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p < 0.001)., Conclusions: In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457)., Competing Interests: Author Disclosures This work was funded by Edwards Lifesciences. Drs. Davidson, Lim, Smith, Grayburn, and Gray have received grant support or consulting fees from Edwards Lifesciences. Dr. Hahn has served as a speaker and consultant for Edwards Lifesciences and is the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she has received no direct industry compensation. Drs. Deo, Vandrangi, Deuschl, and Feldman are employees of Edwards Lifesciences. 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.)

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.)

Aims: The aim of this meta-analysis was to evaluate the evidence regarding the rates of procedural success and the incidence of adverse outcomes following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in patients with failed bioprosthetic aortic valves., Methods and Results: A systematic search of major electronic databases was conducted for studies relevant to patients with failed bioprosthetic aortic valves undergoing VIV-TAVR. The primary outcome was procedural success. A total of 5,553 patients from 24 studies were included. The mean Society of Thoracic Surgeons (STS) score was 7.84±5.14. The procedural success rate was high (97%, 95% confidence interval [CI]: 94-98%). At 30 days, all-cause mortality was 5% (95% CI: 3-6%), stroke 2% (95% CI: 1-2%), myocardial infarction 1% (95% CI: 1-2%), permanent pacemaker placement 6% (95% CI: 5-8%), and aortic regurgitation 7% (95% CI: 5-10%). At one year, the incidence of all-cause mortality was 12% (95% CI: 10-14%), stroke 3% (95% CI: 2-4%), myocardial infarction 1% (95% CI: 0-2%), and permanent pacemaker placement 7% (95% CI: 5-11%). At three years, the incidence of all-cause mortality was 29% (95% CI: 25-34%) and stroke 6% (95% CI: 5-9%)., Conclusions: VIV-TAVR appears to be associated with high procedural success rates and low adverse outcomes during the short-term and midterm follow-up period.

Objectives: This study aims to establish a computed tomography (CT)-based scoring system for grading mitral annular calcification (MAC) severity and potentially aid in predicting valve embolization during transcatheter mitral valve (MV) replacement using balloon-expandable aortic transcatheter heart valves., Background: Transcatheter MV replacement is emerging as an alternative treatment for patients with severe MAC who are not surgical candidates. Although cardiac CT is the imaging modality of choice in the evaluation of candidates for valve-in-MAC (ViMAC), a standardized grading system to quantify MAC severity has not been established., Methods: We performed a multicenter retrospective review of cardiac CT and clinical outcomes of patients undergoing ViMAC. A CT-based MAC score was created using the following features: average calcium thickness (mm), degrees of annulus circumference involved, calcification at one or both fibrous trigones, and calcification of one or both leaflets. Features were assigned points according to severity (total maximum score = 10) and severity grade was assigned based on total points (mild ≤3, moderate 4 to 6, and severe ≥7 points). The association between MAC score and device migration/embolization was evaluated., Results: Of 117 patients in the TMVR in MAC registry, 87 had baseline cardiac CT of adequate quality. Of these, 15 were treated with transatrial access and were not included. The total cohort included 72 (trans-septal = 37, transapical = 35). Mean patient age was 74 ± 12 years, 66.7% were female, and the mean Society of Thoracic Surgery risk score was 15.4 ± 10.5%. The mean MAC score was 7.7 ± 1.4. Embolization/migration rates were lower in higher scores: Patients with a MAC score of 7 had valve embolization/migration rate of 12.5%, MAC score ≥8 had a rate of 8.7%, and a MAC score of ≥9 had zero (p = 0.023). Patients with a MAC score of ≤6 had 60% embolization/migration rate versus 9.7% in patients with a MAC score ≥7 (p < 0.001). In multivariable analysis, a MAC score ≤6 was in independent predictor of valve embolization/migration (odds ratio [OR]: 5.86 [95% CI: 1.00 to 34.26]; p = 0.049)., Conclusions: This cardiac CT-based score provides a systematic method to grade MAC severity which may assist in predicting valve embolization/migration during trans-septal or transapical ViMAC procedures., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS)., Methods: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up., Results: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years., Conclusions: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up., Trial Registration Number: NCT01940120., Competing Interests: Competing interests: SK is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, WL Gore, Mitralign, Edwards. TF is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, Edwards and WL Gore. AQ has received research grant from Abbott. DSL is a consultant for and has received research grants from Abbott. RWS has received grant support from Abbott Vascular. HCH has received institutional research support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, St Jude Medical, Medtronic, Cardiokinetx, Gore and Mitraspan; is a consultant for Edwards Lifesciences and Siemens; and has equity ownership in Microinterventional Devices. LM’s institution has received research grants from Abbott Vascular, Boston Scientific, Cordis, Medtronic, Eli Lilly, Daiichi Sankyo, Bristol-Myers Squibb and Sanofi-Aventis. All other authors have reported they have no relationships relevant to the contents of this paper to disclose., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study., Background: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction., Methods: Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images., Results: Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR., Conclusions: BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk., (Published by Elsevier Inc.)

Objectives: The authors sought to define the feasibility and performance of 3-dimensional (3D) vena contracta area (VCA) measurement in evaluating total residual mitral regurgitation (MR) following percutaneous edge-to-edge clip (E-EC) mitral valve repair., Background: Residual MR severity after percutaneous repair is not only a determinant of procedural success, but also a major prognostic factor. To date, no single echocardiographic method has been recommended for post-procedural MR quantification, with the evaluation currently relying on a complex, multiparametric appraisal., Method: The authors performed a retrospective study of patients undergoing the E-EC procedure, for which baseline and post-repair 3D color Doppler transesophageal echocardiogram datasets were available. Total VCA was recorded as the sum of individual VCAs (if more than 1) and compared with an expert multiparametric appraisal of MR severity as the reference standard. Receiver-operating characteristic analysis was performed., Results: 155 patient studies were available for review. Total VCA correlated with hemodynamic parameters and was significantly reduced after E-EC. Receiver-operating characteristic analysis demonstrated a VCA threshold of 0.27 cm 2 for identification of ≥moderate MR, with good diagnostic accuracy (area under the curve 0.81) and a negative predictive value of 92%. Smaller VCA was associated with clinical New York Heart Association functional class improvement at 30-day follow-up., Conclusions: Measurement of VCA is feasible using 3D color Doppler transesophageal echocardiography and provides reliable quantification of MR following E-EC transcatheter mitral valve repair., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures., Objectives: The goal of this study was to evaluate 1-year outcomes in this registry., Methods: This study was a multicenter retrospective review of clinical outcomes., Results: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm 2 , mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation., Conclusions: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Moving transcatheter valve intervention towards atrioventricular (AV) valves implies increasing complexity. Some of the knowledge that has been generated during the development of mitral devices can be applied to the tricuspid valve (TV). A deep understanding of the peculiar anatomy of the TV and of the right heart chambers, with differences and similarities between the two AV valves, is fundamental to overcoming the specific challenges related to transcatheter TV therapies. The aim of this report is to explore similarities and differences between the mitral and tricuspid valve apparatus, and their interventional implications.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses., (© 2018 American Heart Association, Inc.)

A 71-year-old man presented with New York Heart Association (NYHA) class IV heart failure. He had undergone transapical mitral valve replacement for mixed mitral stenosis and mitral regurgitation. At the 1 month follow-up, the patient reported symptom resolution. An echocardiogram revealed a low gradient and no regurgitation. Our case shows that with careful multidisciplinary evaluation, preoperative planning, and patient selection, percutaneous mitral intervention can become an alternative therapy for high-risk patients who cannot undergo conventional surgical therapy., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Transcatheter mitral valve therapy requires an in-depth understanding of the mitral valve apparatus (annulus, leaflets, chordae tendinae, and papillary muscles) and the impact of various disease states. Adjacent structures (left atrium, left ventricular outflow tract, aortic valve, coronary sinus, and circumflex artery) must also be respected. This article reviews the anatomy and function of the normal and diseased mitral valve apparatus and the implications for catheter-based intervention., (Copyright © 2016 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.)

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.)

Objectives: This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR)., Background: TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date., Methods: Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively., Results: From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60)., Conclusions: Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: To identify outcomes of patients undergoing emergency transcatheter aortic valve replacement (TAVR) and determine predictors of in-hospital mortality.Background: Emergency TAVR has emerged as a viable treatment strategy for patients with decompensated severe aortic stenosis and/or regurgitation; however, data on patients undergoing emergency TAVR are limited.Methods: All emergency TAVR procedures were identified from a single tertiary academic center between January 2015 and August 2018.Results: 31 patients underwent emergency TAVR due to cardiogenic shock (26 patients), electrical instability with incessant ventricular tachycardia (2 patients), severe refractory angina (2 patients), and decompensated heart failure with hypoxemic respiratory failure requiring mechanical ventilation (1 patient). Mechanical circulatory support (MCS) was used in 16 (51.6%). MCS initiation occurred immediately prior to TAVR in 10 patients and placed post-TAVR in 6 patients. 6 patients died before hospital discharge (in-hospital mortality 19.4%). 1-year and 2-year survival rates were 61.0% and 55.9%, respectively. Univariate predictors of in-hospital mortality were preprocedural pulmonary artery pulsatility index (PAPi) ≤1.8 (66.7% vs. 20.0%, p=0.01), intraprocedural cardiopulmonary resuscitation (CPR) (83.3% vs 4.0%, p ≤ 0.001), acute kidney injury post-TAVR (80.0% vs. 4.2%, p ≤ 0.001), initiation of dialysis post-TAVR (60.0% vs. 4.2%, p ≤ 0.001), and MCS initiation post-TAVR (50.0% vs. 12.0%, p=0.03). MCS initiation before TAVR was associated with improved survival compared with post-TAVR initiation.Conclusion: Emergency TAVR in extreme risk patients with acute decompensated heart failure or cardiogenic shock secondary to severe aortic valve disease is associated with high in-hospital mortality rates. Careful patient selection taking into account right heart function, assessed by PAPi, and early utilization of MCS may improve survival following emergency TAVR. [ABSTRACT FROM AUTHOR]