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Background: Transoesophageal echocardiography (TOE) provides accurate evaluation of mitral valve (MV) function following mitral transcatheter edge-to-edge repair (M-TEER) and may better detect complications in case of suboptimal result., Aims: We aimed to evaluate midterm anatomical changes and structural complications after M-TEER using TOE and investigate their association with clinical outcomes at 2 years., Methods: A follow-up TOE at 6 months was systematically recommended to all patients included in our institutional prospective M-TEER registry until December 2021. We assessed changes in the incidence of mitral regurgitation (MR), MV stenosis (≥5 mmHg), and partial or complete single leaflet device attachment (SLDA) between the index procedure and follow-up and evaluated MV area and annular dimensions in a subset of patients with available three-dimensional (3D) datasets. The clinical endpoint was a composite of mortality and heart failure (HF) rehospitalisation at 2 years., Results: Among the 373 patients included in the registry between February 2012 and December 2021, 128 patients (34%) underwent elective TOE at 6 months. Using TOE, severe MR was observed in 13.3% (n=17) of the patients. The number of patients with an elevated MV gradient increased from 17 (13.3%) after the procedure to 23 (18%) at 6 months, and a new partial or complete SLDA was detected in 7.8% (n=10). Based on 3D TOE measurements, significant increases in MV area, annular area, annular perimeter, and intercommissural (but not anteroposterior) diameter were observed compared to intraprocedural images. A mean MV gradient ≥5 mmHg (hazard ratio [HR] 2.30, 95% confidence interval [CI]: 1.10-4.81; p=0.023) and the presence of severe MR at 6 months (HR 3.26, 95% CI: 1.18-8.99; p=0.023) were associated with the primary endpoint, which was met in 34 (26.6%) patients at 2 years., Conclusions: TOE follow-up allowed the detection of complications that would not be diagnosed using transthoracic echocardiography only and should therefore be used liberally in the patients presenting with a suboptimal result. A mean MV gradient ≥5 mmHg and severe MR, diagnosed at the 6-month TOE follow-up, were associated with adverse clinical outcomes.

Background: New postprocessing software facilitates 3-dimensional (3D) echocardiographic determination of mitral annular (MA) and neo-left ventricular outflow tract (neo-LVOT) dimensions in patients undergoing transcatheter mitral valve replacement (TMVR)., Objectives: This study aims to test the accuracy of 3D echocardiographic analysis as compared to baseline computed tomography (CT)., Methods: A total of 105 consecutive patients who underwent TMVR at 2 tertiary care centers between October 2017 and May 2023 were retrospectively included. A virtual valve was projected in both baseline CT and 3D transesophageal echocardiography (TEE) using dedicated software. MA dimensions were measured in baseline images and neo-LVOT dimensions were measured in baseline and postprocedural images. All measurements were compared to baseline CT as a reference. The predicted neo-LVOT area was correlated with postprocedural peak LVOT gradients., Results: There was no significant bias in baseline neo-LVOT prediction between both imaging modalities. TEE significantly underestimated MA area, perimeter, and medial-lateral dimension compared to CT. Both modalities significantly underestimated the actual neo-LVOT area (mean bias pre/post TEE: 25.6 mm 2 , limit of agreement: -92.2 mm 2 to 143.3 mm 2 ; P < 0.001; mean bias pre/post CT: 28.3 mm 2 , limit of agreement: -65.8 mm 2 to 122.4 mm 2 ; P = 0.046), driven by neo-LVOT underestimation in the group treated with dedicated mitral valve bioprosthesis. Both CT- and TEE-predicted-neo-LVOT areas exhibited an inverse correlation with postprocedural LVOT gradients (r 2  = 0.481; P < 0.001 for TEE and r 2  = 0.401; P < 0.001 for CT)., Conclusions: TEE-derived analysis provides comparable results with CT-derived metrics in predicting the neo-LVOT area and peak gradient after TMVR., Competing Interests: Funding Support and Author Disclosures Dr Bartkowiak has received grants from Novartis Foundation. Dr Windecker has received grants to the institution without personal remuneration from Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Braun, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardinal Health, CardioValve, Cordis Medical, Corflow Therapeutics, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Farapulse Inc, Fumedica, Guerbet, Idorsia, Inari Medical, InfraRedx, Janssen-Cilag, Johnson and Johnson, Medalliance, Medicure, Medtronic, Merck Sharp and Dohm, Miracor Medical, MonarQ, Novartis, Novo Nordisk, Organon, OrPha Suisse, Pharming Tech, Pfizer, Polares, Regeneron, Sanofi-Aventis, Servier, Sinomed, Terumo, Vifor, and V-Wave; has served as advisory board member and/or member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Boston Scientific, Biotronik, Bristol Myers Squibb, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Recardio, Sinomed, Terumo, and V-Wave with payments to the institution but no personal payments; and has been a member of a steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration. Dr George has received consulting fees from Zimmer Biomet, Atricure, Neosurgery, Neptune Medical, Abbvie, Johnson and Johnson, Durvena, Boston Scientific, Edwards Lifesciences, Medtronic, Help-TheraX, 3ive, Encompass, Summus Medical, Abbott SJM, BCI, and Xeltis; has been on advisory boards for Edwards Surgical, Medtronic Surgical, Medtronic Structural Mitral and Tricuspid, Trisol Medical, Valcare Medical, Durvena, Abbvie, Johnson and Johnson, Foldax Medical, Zimmer Biomet, Neosurgery, Abbvie, Boston Scientific, Summus Medical, BCI Equity: Valcare Medical, Durvena, CardioMech, Vdyne, MitreMedical, MITRx, and BCI; and has received institutional funding to Columbia University from Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, and JenaValve. Dr Kodali has received institutional grants from Edwards Lifesciences, Medtronic, and Abbott; has received consulting fees from Abbott, Admedus, and Meril Lifesciences; and has equity options from Biotrace Medical and Thubrikar Aortic Valve Inc. Dr Praz has been compensated for travel expenses from Edwards Lifescicences, Abbott Vascular, Medira, Polares Medical, and Siemens Healthineers. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, Medtronic, and Philips Healthcare; has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Edwards Lifesciences, Medtronic, and Novartis; and the is Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored tricuspid valve trials for which she receives no direct industry compensation. 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.)

Background and Aims The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. Methods Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000–21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. Results At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P <.001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P <.001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016–21. Conclusions The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000–21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification. [ABSTRACT FROM AUTHOR]