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

Objectives: The objective of this study is to describe and compare the use of the MitraClip therapy in mitral regurgitation (MR) patients with degenerative MR (DMR) and functional MR (FMR)., Introduction: Percutaneous edge-to-edge repair of severe MR using the MitraClip device is approved for use in the USA for high risk DMR while European guidelines include its use in FMR patients as well., Methods: The MitraClip in the Asia-Pacific Registry (MARS) is a multicenter retrospective registry, involving eight sites in five Asia-Pacific countries. Clinical and echocardiographic characteristics, procedural outcomes and 1-month outcomes [death and major adverse events (MAE)] were compared between FMR and DMR patients treated with the MitraClip., Results: A total of 163 patients were included from 2011 to 2014. The acute procedural success rates for FMR (95.5%, n = 84) and DMR (92%, n = 69) were similar (P = 0.515). 45% of FMR had ≥2 clips inserted compared to 60% of those with DMR (P = 0.064).The 30-day mortality rate for FMR and DMR was similar at 4.5% and 6.7% respectively (P = 0.555). The 30-day MAE rate was 9.2% for FMR and 14.7% for DMR (P = 0.281). Both FMR and DMR patients had significant improvements in the severity of MR and NYHA class after 30 days. There was a significantly greater reduction in left ventricular end-diastolic diameter (P = 0.002) and end systolic diameter (P = 0.017) in DMR than in FMR., Conclusions: The MitraClip therapy is a safe and efficacious treatment option for both FMR and DMR. Although, there is a significantly greater reduction in LV volumes in DMR, patients in both groups report clinical benefit with improvement in functional class. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Aims: Percutaneous MitraClip therapy has been shown to be safe and efficacious in mitral regurgitation (MR). Our aim was to describe early outcomes in patients from the Asia- Pacific region., Methods and Results: The MitraClip Asia-Pacific Registry (MARS) includes data from eight different centres in five countries in the Asia-Pacific region. The primary efficacy outcome was reduction in MR to ≤2+ at 30 days. The safety outcome was 30-day freedom from major adverse events (MAE), defined as the composite of death, myocardial infarction, non-elective cardiac surgery, renal failure, transfusion of ≥2 units of blood, ventilation for >48 hours, septicaemia, and new onset atrial fibrillation. A total of 142 patients underwent the MitraClip procedure from February 2011 to October 2013. Fifty-three point five percent (76) of patients had functional MR, 45.8% (65) had degenerative MR and 0.7% (1) had mixed MR. The acute procedural success rate was 93.7% (133). Thirty-one point seven percent of the patients were in NYHA Class I-II at baseline, compared to 82.1% at 30 days (p<0.001). Zero percent (0) of the patients had ≤2+ MR at baseline compared to 76.8% (109) at 30 days (p<0.001)., Conclusions: Results from the Asia-Pacific region show that the MitraClip procedure is effective in reducing mitral regurgitation and has favourable short-term safety outcomes.

Left ventricular assist device (VAD) implantation via thoracotomy is a safe operation with potential advantages compared to conventional sternotomy. One proposed advantage is improved inflow cannula (IFC) positioning due to better visualisation. We investigated the difference in IFC angles for patients with HVADs implanted via these techniques and compared post-operative as well as long term outcomes. 42 patients were retrospectively selected from our VAD database. 28 in the sternotomy group and 14 in the thoracotomy group. We included all thoracotomy implants performed at our centre and consecutive sternotomy implants from 2015-2019. Inclusion required a minimum support time of 30 days. Patients with concomitant procedures were excluded. The first post-operative CT chest scan was used to measure the angle between the IFC and mitral valve in axial and coronal planes. There was no significant difference in gender, INTERMACS score, BMI or age between the two groups. Median support time was not significantly different between the thoracotomy and sternotomy groups (328 vs 360 days, p=0.9). Median cardiopulmonary bypass (CPB) time was higher in the thoracotomy group (104 vs 78 minutes, p<0.01). Median ICU length of stay for the thoracotomy group was 5 days compared to 8 days in the sternotomy group, p=0.08. There was no significant difference in median IFC angle on the axial plane between the thoracotomy group and the sternotomy group (9 degrees v 10 degrees, p=0.3). Similarly, there was no difference in the coronal plane (9 degrees vs 12 degrees, p=0.9). Rates of pump thrombosis, stroke and GI bleeding were not significantly different between the two groups. In our sample size of 42 patients, the thoracotomy group had a slightly longer CPB time, however, there was no difference in IFC angle, pump thrombosis, GI bleeding, stroke or ICU length of stay. In saying this, there may be other benefits to the thoracotomy approach such as facilitating easier sternal entry upon transplantation. [ABSTRACT FROM AUTHOR]

M itral regurgitation (MR) is a predictor of poor outcomes in patients with severe left ventricular dysfunction (LV) and options for repairing the valve have yielded conflicting results. We compared one-year echocardiographic and clinical outcomes of patients with grade 3-4MR and severe LV dilatation (end-diastolic dimension [LVEDD] above 65mm) undergoing either left ventricular assist device (LVAD) insertion alone or mitral valve repair (surgical minimally invasive repair or transcatheter edge-to-edge repair). This is a single-center, retrospective, observational cohort study of patients with grade 3-4MR and severe LV dilatation who underwent either LVAD or MVR between 2008-2018. Baseline and post-operative transthoracic echocardiograms were analysed for LV-ejection fraction (EF), LV EDD and MR. Functional class, re-hospitalisation, cardiovascular morbidity and mortality was obtained. Fifty-two patients (27 LVAD; 25 MVR; 44 men) with grade 3-4MR and pre-existing LV systolic dysfunction (47 [90%] NYHA class III-IV) underwent either LVAD or MVR. There was no significant between group difference in NYHA class, however LVAD patients were younger (49±14 vs 60±17years; P=0.01) with lower LVEF baseline (21±7% vs 29±12%, P=0.01). MVR patients had more severe pre-operative MR (P=0.01). Less than 2+ (mild-moderate) MR was achieved in 84% of LVAD patients with a reduction in LVEDD (Pre-76±7mm/68±8mm; Post- 69mm±11mm/62±12mm; P=0.01). Less than 2+ MR was achieved in 77% of MVR patients with a corresponding reduction in LVEDD (Pre- 71±7mm/53±12mm; Post- 68mm±8mm/51±11mm;P=0.01). 82% of LVAD patients (P=0.01) and 100% of MVR patients (P=0.01) reported mild or no symptoms at 12-month follow-up. There was no significant difference between groups in re-hospitalisation rates, and all cause cardiovascular morbidity and mortality at one year (P=0.29). Patients undergoing isolated LVAD insertion have an improvement in MR severity comparable to patients with end-stage MR undergoing MVR. Unloading of the LV by LVAD with consequent reduction in left ventricular end-diastolic and end-systolic dimensions is associated with a significant improvement in MR. This may explain the lack of additional benefit of MVR in LVAD patients shown in large registries. [ABSTRACT FROM AUTHOR]