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There are various devices under clinical investigation for transcatheter mitral valve intervention and transcatheter tricuspid valve intervention (TTVI); however, the exclusion rates remain high. We aimed to investigate the exclusion rates for transcatheter mitral valve repair (TMVr), transcatheter mitral valve replacement (TMVR), transcatheter tricuspid valve repair (TTVr), and transcatheter tricuspid valve replacement (TTVR). There were 129 patients who were referred to St. Francis Hospital & Heart Center valve clinic and completed screening between January 2021 and July 2022. The causes for exclusion were classified into 4 categories: patient withdrawal, anatomic unsuitability, clinical criteria, and medical futility. In 129 patients, the exclusion rates for TMVr, TMVR, TTVr, and TTVR were 81%, 85%, 91%, and 87%, respectively. Patient withdrawal and medical futility were leading etiologies for exclusion, followed by anatomic unsuitability. TMVr had the highest rate of patient withdrawal (64%) and the lowest anatomic unsuitability (5%) because of short posterior leaflet length. Replacement interventions have a higher anatomic unsuitability (33%) than repair interventions (17%) (p = 0.04). Most exclusions of anatomic unsuitability were because of mitral stenosis or small annulus size for TMVR and large annulus size for TTVR. A total of 50% of exclusions from TTVr were because of the presence of pacemaker/defibrillator leads. In patients excluded from their respective trials, patients being referred for TMVr had the highest recurrent hospitalization and repair group had a higher mortality (p <0.01 and p = 0.01, respectively). In conclusion, the exclusion rates for transcatheter mitral valve intervention and TTVI trials remain high because of various reasons, limiting patient enrollment and treatment. This supports the need for further device improvement or exploring alternative means of therapy., Competing Interests: Declaration of competing interest Dr. Khalique has consulting agreements with Edwards, Abbott Structural, Restore medical, Triflo, and Croivalve and has equity in Triflo. Dr. Ali has consulting agreements with Abiomed, Astra Zeneca, Boston Scientific, Cathworks, Opsens, Phillips, and Shockwave; has equity in Elucid, Lifelink, Spectrawave, Shockwave, and VitalConnect; and receives institutional grant from Abbott, Abiomed, Acist, Amgen, Boston Scientific, Cathworks, Canon, Conavi, Heartflow, Inari, Medtronic Inc, National Institute of Health, Nipro, Opsens Medical, Medis, Philips, Shockwave, Siemens, Spectrawave, and Teleflex. Dr. Khan has equity in Transmural Systems and serves as a proctor for Edwards Lifesciences and Medtronic and receives institutional grant from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Philips. Dr. Cohen has consulting agreements with Edwards Lifesciences, Abbott, and Medtronic and receives institutional grant from Edwards Lifesciences, Abbott, and Boston Scientific. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy., Objectives: The aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculoplasty in patients with MR and either heart failure with reduced ejection fraction or preserved ejection fraction and in subjects with prior edge-to-edge repair but persistent or recurrent symptomatic MR., Methods: The National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study (NCT03929913) was an investigator-initiated prospective multicenter study. The primary endpoint was technical success measured at exit from the catheterization laboratory. Follow-up included heart failure quality-of-life assessments and serial imaging with echocardiography and cardiac computed tomography., Results: Nineteen subjects consented and underwent cerclage, 63% with heart failure with reduced ejection fraction and 37% with heart failure with preserved ejection fraction, with ischemic cardiomyopathy in 26% and nonischemic cardiomyopathy in 74%. There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was met in 17 subjects. Cerclage induced sustained reductions in mitral regurgitant volume (-41%) and effective orifice area (-33%) after a median of 337 days. Cerclage resulted in improvements in 6-minute walking distance (+78 m) and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (+22 points) at 30 days that were maintained after a median of 265 days. New complete heart block developed in 6 of 17 subjects. Three deaths occurred on postprocedural days 79, 159, and 756, unrelated to cerclage., Conclusions: Transcatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life assessments., Competing Interests: Funding Support and Author Disclosures This work is supported by the NHLBI DIR (grant Z01-HL006040) and by an NHLBI small business innovation research contract (HHSN268201500008C) to Transmural Systems. Dr Rogers is a consultant and physician proctor for Edwards Lifesciences and Medtronic; is a Medtronic advisory board member; and has an equity interest in Transmural Systems. Drs Rogers and Lederman are coauthors on patents, assigned to the National Institutes of Health, for cerclage-related devices. Drs Babaliaros and Greenbaum have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, Jena Valve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have equity interest in Transmural Systems. Dr Foerst is a physician proctor for Edwards Lifesciences and Medtronic. Dr Gleason has received institutional research support from Edwards Lifesciences, Medtronic, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Competing Interests: Funding Support and Author Disclosures Dr Reineke has a consultancy agreement with Abbott; has received proctoring fees from Abbott; and has received travel expenses from Abbott. Dr Pilgrim has received institutional research grants and speaker fees from Biotronik and Boston Scientific; and is a consultant for HighLife SAS. Dr. Khan has served as a proctor for Edwards Lifesciences and Medtronic; and is co-inventor on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; serves as an unpaid advisory board member and/or an unpaid member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, Terumo, V-Wave, and Xeltis (but has not received personal payments from pharmaceutical companies or device manufacturers); and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr Lanz has received a research grant from Boston Scientific to his institution. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. All other authors have reported that they have no relationships relevant to the contents to disclose.

Despite an expanding armamentarium of devices, many patients with mitral regurgitation referred for transcatheter mitral valve repair (TMVr) or replacement (TMVR) do not meet strict clinical trial inclusion and exclusion criteria. We sought to understand the rates that patients were excluded from transcatheter mitral valve therapies and reasons why. We retrospectively analyzed the medical charts and correspondence related to patients referred to our tertiary valve center for TMVr or TMVR between June 2016 and September 2019. Patients were screened for eligibility by our structural Heart Team for either TMVr or TMVR. If TMVr or TMVR was not offered, the reason for screen failure was recorded and categorized. Over the 3-year period, 564 patients were referred for TMVr and orTMVR. Out of these, 15.9% were determined to be eligible for, and underwent, surgical repair or replacement. Ninety-two patients (16.3%) underwent TMVr or TMVR. The majority of patients (343 of 564, 60.8%) ultimately did not undergo intervention. The primary reason for exclusion was clinical in 38.5%, issues related to patient preference of care delivery in 38.8%, anatomical in 13.7%, and futility in 9.0%. In contemporary real-world practice, the majority of patients with mitral regurgitation referred for transcatheter therapies are excluded. Clinical trials testing new transcatheter devices should be encouraged to record and report reasons for screen failure and follow these patients to better understand optimal timing of intervention, address challenging anatomies, and, ultimately, improve penetrance of these novel therapies., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves., Background: LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain., Methods: This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty., Results: Twenty-one patients with a annuloplasty or valve prosthesis-protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time., Conclusions: Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures., Competing Interests: Funding Support and Author Disclosures This work was supported by the Emory Structural Heart and Valve program intramural funds and by National Institutes of Health Grant No. Z01-HL006040. Dr. Lisko’s employer has contracts for BASILICA analysis with Medtronic and Edwards Lifesciences. Dr. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular; has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and owns equity interest in Transmural Systems. Drs. Khan and Rogers have served as a proctor for Edwards Lifesciences and Medtronic. Drs. Khan, Lederman, and Rogers are co-inventors on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration. Dr. Paone has served as a consultant and proctor for Edwards Lifesciences. Dr. McCabe has served as consultant for Edwards Lifesciences, Boston Scientific, and Teleflex. Dr. Grubb has served as a speaker, proctor, and principal investigator for Edwards Lifesciences; served as a speaker, proctor, and advisory board member for Boston Scientific; and served as a speaker, proctor, principal investigator, advisory board member, and national principal investigator for Medtronic. Dr. Lederman has served as the principal investigator on a cooperative research and development agreement between National Institutes of Health and Edwards Lifesciences for transcatheter modification of the mitral valve. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; owns an equity interest in Transmural Systems; and has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: The aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis., Background: Patients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI., Methods: This was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days., Results: MitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet., Conclusions: Transcatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak., (Copyright © 2020. Published by Elsevier Inc.)

Background: Intentional laceration of the anterior mitral leaflet (LAMPOON) is an effective adjunct to transcatheter mitral valve replacement that prevents left ventricular outflow tract (LVOT) obstruction. To date, LAMPOON has been performed in over 150 patients using a retrograde approach that can be technically challenging. A modified antegrade transseptal technique may simplify the procedure., Methods: Antegrade LAMPOON was developed and tested in nonsurvival pig experiments. Thereafter, antegrade LAMPOON was performed in patients at prohibitive risk of LVOT obstruction. Clinical, procedural, and angiographic details were abstracted from medical records of their index procedure, and were compared with findings in comparable patients at risk of fixed-LVOT obstruction in the LAMPOON investigational device exemption trial., Results: Eight patients at risk of fixed LVOT obstruction underwent antegrade LAMPOON. Leaflet traversal and laceration were technically successful in all. There were no cases of clinically significant LVOT obstruction (mean LVOT gradient at discharge: 5.4±1.4 mm Hg). One patient suffered a ventricular wire perforation, unrelated to the antegrade LAMPOON technique, and did not survive to discharge. At the time of discharge, no patients had an increase of >10 mm Hg in LVOT gradient compared with baseline. Procedure times (from traversal to transcatheter mitral valve replacement) were shorter, compared with the retrograde technique in the LAMPOON investigational device exemption trial (39±09 versus 65±35 minutes). All patients survived (8/8, 100%) the procedure, and 7/8 (88%) survived to 30 days, similar to subjects in the LAMPOON investigational device exemption trial., Conclusions: Antegrade LAMPOON is an effective, reproducible, and simplified strategy to lacerate the anterior leaflet before transcatheter mitral valve replacement. The authors recommend the technique as the new standard for LAMPOON.

Transcatheter mitral valve replacement (TMVR) is a promising strategy for patients with mitral valve disease and no surgical options. Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of TMVR. Although there are no commercially available devices to prevent LVOT obstruction, the risk of it can be reduced by careful preprocedure planning and the use of novel modifications to commercially available devices. This article summarizes current techniques to prevent LVOT obstruction with an emphasis on electrosurgical strategies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: Exercise‐induced dyspnea caused by lung water is an early heart failure symptom. Dynamic lung water quantification during exercise is therefore of interest to detect early stage disease. This study developed a time‐resolved 3D MRI method to quantify transient lung water dynamics during rest and exercise stress. Methods: The method was evaluated in 15 healthy subjects and 2 patients with heart failure imaged in transitions between rest and exercise, and in a porcine model of dynamic extravascular lung water accumulation through mitral regurgitation (n = 5). Time‐resolved images were acquired at 0.55T using a continuous 3D stack‐of‐spirals proton density weighted sequence with 3.5 mm isotropic resolution, and derived using a motion corrected sliding‐window reconstruction with 90‐s temporal resolution in 20‐s increments. A supine MRI‐compatible pedal ergometer was used for exercise. Global and regional lung water density (LWD) and percent change in LWD (ΔLWD) were automatically quantified. Results: A ΔLWD increase of 3.3 ± 1.5% was achieved in the animals. Healthy subjects developed a ΔLWD of 7.8 ± 5.0% during moderate exercise, peaked at 16 ± 6.8% during vigorous exercise, and remained unchanged over 10 min at rest (−1.4 ± 3.5%, p = 0.18). Regional LWD were higher posteriorly compared the anterior lungs (rest: 33 ± 3.7% vs 20 ± 3.1%, p < 0.0001; peak exercise: 36 ± 5.5% vs 25 ± 4.6%, p < 0.0001). Accumulation rates were slower in patients than healthy subjects (2.0 ± 0.1%/min vs 2.6 ± 0.9%/min, respectively), whereas LWD were similar at rest (28 ± 10% and 28 ± 2.9%) and peak exercise (ΔLWD 17 ± 10% vs 16 ± 6.8%). Conclusion: Lung water dynamics can be quantified during exercise using continuous 3D MRI and a sliding‐window image reconstruction. [ABSTRACT FROM AUTHOR]