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This clinical trial compared mitral-valve repair with replacement for severe ischemic mitral regurgitation. There were no significant between-group differences in left ventricular remodeling and clinical outcomes, but replacement was associated with more durable correction. Functional ischemic mitral regurgitation affects 1.6 million to 2.8 million patients in the United States and is associated with a doubling in mortality among patients with mild or greater degrees of mitral regurgitation after myocardial infarction. 1 – 3 Ischemic mitral regurgitation is a consequence of adverse left ventricular remodeling after myocardial injury with enlargement of the left ventricular chamber and mitral annulus, apical and lateral migration of the papillary muscles, leaflet tethering, and reduced closing forces. These processes lead to malcoaptation of the leaflets and variable degrees of mitral regurgitation that can fluctuate dynamically as a function of volume status, afterload, . . .

Current echocardiographic data reporting the impact of concomitant mitral regurgitation (MR) on outcome in patients who undergo transcatheter aortic valve replacement (TAVR) are conflicting. Using cardiovascular magnetic resonance (CMR) imaging, this study aimed to assess the impact of MR severity on cardiac reverse remodeling and patient outcome. 85 patients undergoing TAVR with CMR pre- and 6 m post-TAVR were evaluated. The CMR protocol included cines for left (LV) and right ventricular (RV) volumes, flow assessment, and myocardial scar assessment by late gadolinium enhancement (LGE). Patients were dichotomised according to CMR severity of MR fraction at baseline (‘non-significant’ vs ‘significant’) and followed up for a median duration of 3 years. Forty-two (49%) patients had ‘significant MR’ at baseline; they had similar LV and RV size and function compared to the ‘non-significant MR’ group but had greater LV mass at baseline. In those with significant MR at baseline, 77% (n = 32) had a reduction in MR post-TAVR, moving them into the ‘non-significant’ category at 6-months, with an overall reduction in MR fraction from 34 to 17% (p < 0.001). Improvement in MR was not associated with more favourable cardiac reverse remodeling when compared with the ‘non-improvers’. Significant MR at baseline was not associated with increased mortality at follow-up. Significant MR is common in patients undergoing TAVR and improves in the majority post-procedure. Improvement in MR was not associated with more favourable LV reverse remodeling and baseline MR severity was not associated with mortality.

BackgroundMitral regurgitation (MR) is the most common valvular heart disease and the most common comorbidities of atrial fibrillation (AF), which is prevalent with age. Nonetheless, the prognosis of MR in elderly patients with AF has not been fully elucidated.AimThis study is a post hoc analysis of the CABANA (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial.MethodsPatients were classified into two groups: those with moderate or severe MR (msMR) and those with no or mild MR (nmMR). The primary endpoint was a composite of death, disabling stroke, serious bleeding or cardiac arrest. The secondary endpoints included all-cause mortality and the composite of all-cause mortality and heart failure hospitalisation. Quality of life was assessed at baseline, 3 and 12 months, and annually up to 60 months.ResultsOverall, 1368 participants were included in the final analysis (mean age: 65.6±8.2; female 61.3%), including 135 patients with msMR and 1233 with nmMR. The primary endpoint occurred in 7.2% of patients with nmMR versus 14.1% with msMR (HR 1.97, 95% CI 1.20 to 3.25; p=0.008). The secondary endpoint rates for nmMR versus msMR, respectively, were 4.7% vs 8.8% for all-cause mortality (HR 1.73, 95% CI 0.92 to 3.25; p=0.089) and 10.8% vs 15.5% for the composite of death and heart failure hospitalisation (HR 1.25, 95% CI 0.78 to 1.99; p=0.357).ConclusionsAmong elderly patients with AF, msMR is associated with an increased risk of the primary composite endpoint of death, disabling stroke, serious bleeding or cardiac arrest.Trial registration numberNCT00911508.

This report describes the 12-month outcomes of the a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe (ACCESS-EU postapproval study of MitraClip therapy) with respect to preprocedural left ventricular ejection fraction (LVEF). Transcatheter deployment of the MitraClip device may be considered for patients who are not suitable for conventional surgery. A total of 567 patients with significant mitral regurgitation (MR) underwent MitraClip therapy. Of those, 393 had functional MR (FMR) and were subdivided by preprocedural LVEF (A: 10% to 20%, B: >20% to 30%, C: >30% to 40%, D: >40%). Procedural safety and efficacy and treatment outcomes including MR grade, New York Heart Association (NYHA) functional class, 6-minute walk test, and the Minnesota Living with Heart Failure Questionnaire were analyzed at baseline, 30 days, and 12 months. Baseline mean logistic EuroSCORE was 25 ± 19; 87% of patients were in NYHA classes III or IV (A: 96%, B: 83%, C: 90%, D: 86%). There was no incidence of death or stroke intraprocedurally. Eleven patients died within 30 days with no differences among subgroups. Kaplan–Meier survival at 12 months was 81.8% (A: 71%, B: 79%, C: 87%, D: 86%). There was a significant improvement in MR severity at 30 days and 12 months (p <0.0001). At 12 months, all subgroups experienced similar improvements in NYHA class, 6-minute walk test, and Minnesota Living with Heart Failure Questionnaire. This real-world registry reports promising results of MitraClip therapy in patients with FMR. In conclusion, the low rates of hospital mortality and adverse events in patients with FMR—even in patients with severely reduced LVEF—provide additional evidence of substantial benefits after MitraClip implantation.

PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm2 or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm2 (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04). Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.

Abstract Aims Functional mitral regurgitation (FMR) is associated with adverse outcomes in patients with heart failure, and current guideline-directed medical therapy (GDMT) offers limited efficacy in managing FMR. This study aims to evaluate the therapeutic impact of the sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin in patients with moderate or severe FMR. Methods and results In this randomized controlled trial, 104 patients with moderate or severe FMR were assigned in a 1:1 ratio to receive either dapagliflozin 10 mg once daily or no additional treatment alongside current GDMT for FMR, with a follow-up period of 3 months. The primary endpoint was the change in effective regurgitant orifice area (EROA) of mitral regurgitation (MR). Secondary endpoints included changes in regurgitant volume (RV), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left ventricular mass (LVM), left ventricular mass index (LVMI), left ventricular ejection fraction (LVEF), E/e′ ratio, and left atrial volume index (LAVI). The incidence of hospitalization for heart failure or cardiovascular death was also compared between the groups. As a result, dapagliflozin significantly reduced the EROA of FMR (−0.074 ± 0.099 vs. −0.030 ± 0.058 cm2 for dapagliflozin vs. control, P = 0.008). It also significantly decreased RV (−9.08 ± 15.27 vs. −2.98 ± 9.28 mL, P = 0.017), E/e′ ratio (−5.88 ± 7.41 vs. −1.98 ± 7.63, P = 0.011), and LAVI (−2.50 ± 4.75 vs. −0.43 ± 3.14 mL/m2, P = 0.011) while improving LVEF (6.57 ± 10.10 vs. 1.92 ± 9.57%, P = 0.017). No significant differences were observed in changes in LVEDV, LVESV, LVM, and LVMI between groups (P > 0.05). Hospitalization for heart failure occurred in 9.6% of the dapagliflozin group and 15.3% of the control group (hazard ratio, 0.60; 95% CI, 0.20–1.83; P = 0.368). Cardiovascular death occurred in 1.9% of the dapagliflozin group compared to 3.8% of the control group (hazard ratio, 0.49; 95% CI, 0.04–5.41; P = 0.561) during the 3-month follow-up. Conclusions Dapagliflozin demonstrates the potential to further reduce the degree of MR and enhance myocardial remodelling in patients with FMR when used in addition to current GDMT. These findings suggest the importance of SGLT2i in heart failure patients with FMR as an additive positive effect on echocardiographic parameter and possibly outcome.

Purpose of ReviewIschemic mitral regurgitation (MR), which occurs in about 20–30% patients with a prior myocardial infarction, is associated with worsening heart failure and an increase in cardiovascular mortality. It should be treated surgically if certain hemodynamic severity criteria are met and in patients who continue to experience symptoms of heart failure despite optimal medical therapy. However, current guidelines do not suggest which of the available approaches to mitral valve surgery-mitral valve (MV) repair or replacement (MVR) is superior for this indication. While MV repair is reported to confer improved survival, MVR may provide higher rates of freedom from recurrent MR. This article attempts to provide the reader with a comprehensive review and comparison of current techniques of mitral valve surgery in patients with severe ischemic MR.Recent FindingsThe first randomized trial to compare MV repair versus MVR in patients with severe ischemic MR, the Cardiothoracic Surgical Trials Network (CTSN) trial, was recently concluded and reported no significant difference in the primary outcome of left ventricular end systolic volume index between the two approaches at either 1- or 2-year follow-ups.SummaryData comparing approaches of MV repair and MVR for ischemic MR is largely limited to small, non-randomized retrospective trials. The only randomized trial data to examine this issue suggested no difference in mortality with either MVR or MV repair; however, MVR was shown to be consistently associated with higher rates of MR recurrence. Certain echocardiographic features have been reported to predict poor outcomes with MVR and may help refine the selection of the surgical approach in the individual patient.

ObjectivesThe association of pulmonary hypertension (PH) with the outcome after mitral transcatheter edge-to-edge repair (M-TEER) focusing on the new ESC/ERS guidelines definition for PH.BackgroundPH is frequently found in patients with mitral regurgitation and is associated with lower survival rates. Recent studies were based on echocardiographic parameters, but results based on invasive haemodynamics differentiating distinct types of PH using the new definition for PH are missing.Methods449 consecutive M-TEER-treated patients from December 2009 to February 2015 were included in this retrospective analysis. All patients were stratified by the distinct types of PH (no PH, precapillary PH, isolated postcapillary PH, combined post-PH and precapillary PH) according to the definitions of the ESC/ERS guidelines for the diagnosis of PH from 2015 (meanPA cut-off <25 mm Hg, pulmonary capillary wedge pressure (PCWP) cut-off ≤15 mm Hg, diastolic pulmonary gradient cut-off ≥7 mm Hg or pulmonary vascular resistance (PVR) >3 WU) and 2022 (meanPA cut-off ≤20 mm Hg, PCWP cut-off ≤15 mm Hg, PVR cut-off ≥3 WU).ResultsPatients with any type of PH (2015: meanPA cut-off 25 mm Hg; 2022: meanPA cut-off >20 mm Hg) showed a higher risk of death after M-TEER compared with patients with no PH (2015: HR 1.61 (95% CI 1.25 to 2.07); p<0.001 and 2022: HR 2.09 (95% CI 1.54 to 2.83); p<0.001). Based on the new PH definition, each PH subgroup showed a lower survival after M-TEER compared with patients with no PH. Echocardiographic estimated systolic PAP showed a correlation with invasively measured mean pulmonary artery pressure (mPAP) (r=0.29, p<0.001) and systolic pulmonary arterial pressure (r=0.34,p<0.001). Cox-regression analysis showed higher invasive diastolic, systolic and mean pulmonary pressures were associated with higher all-cause mortality (p<0.001). In addition, invasive measured higher right atrial pressure, lower pulmonary arterial compliance, higher PVR and higher wedge pressure were identified as predictors of all-cause mortality after M-TEER.ConclusionsThe new PH definition discriminates PH groups and mortality better than the old definition. The lower threshold of mPAP of 20mmHg improved prognostication in this cohort of patients.

BackgroundCoaptation gap (CG) is one of the challenging anatomies of mitral transcatheter edge-to-edge repair (TEER), but its impact on patient outcomes is unclear. This study aimed to evaluate the impact of CG on procedural and clinical outcomes in patients with functional mitral regurgitation (MR).MethodsData from 2140 patients undergoing TEER for functional MR were analysed, focusing on the presence of CG, which is a missing leaflet coaptation between the anterior and posterior leaflets during systole. The primary outcome was a composite of death, heart failure hospitalisation and mitral valve reintervention.ResultsOf the 2140 patients, 219 (10%) had CG and 1921 (90%) did not, as assessed by baseline transoesophageal echocardiography. In patients with CG, baseline MR grade and New York Heart Association (NYHA) functional class were more severe, and long/wide clip types were used more frequently. Post-TEER, patients with CG had significantly lower achievement of MR grade ≤2+ (93%) and ≤1+ (65%) compared with patients without CG (97%, p<0.01; 82%, p<0.01, respectively). NYHA functional class at 1 year was similar in both groups. The cumulative incidence of the primary outcome was comparable between CG and non-CG groups (51% vs 53% at 3 years, p=0.71). While residual MR grade 2+ was associated with the higher primary outcome incidence compared with ≤1+ in patients without CG (p<0.01), no significant difference was found in patients with CG (p=0.51).ConclusionCG was associated with less MR reduction but with no clear difference in adverse clinical outcomes after TEER. Similar outcomes between residual MR grade 2+ and ≤1+ in CG patients highlight the importance of procedural endpoint in anatomically challenging cases.Trial registration numberUMIN000023653.

Secondary mitral regurgitation (SMR) occurs as a result of multifactorial left atrioventricular dysfunction and maleficent remodelling. It is the most common and undertreated form of mitral regurgitation (MR) and is associated with a very poor prognosis. Whether SMR is a bystander reflecting the severity of the cardiomyopathy disease process has long been the subject of debate. Studies suggest that SMR is an independent driver of prognosis in patients with an intermediate heart failure (HF) phenotype and not those with advanced HF. There is also no universal agreement regarding the quantitative thresholds defining severe SMR and indeed there are challenges with echocardiographic quantification. Until recently, no surgical or transcatheter intervention for SMR had demonstrated prognostic benefit, in contrast with HF medical therapy and cardiac resynchronisation therapy. In 2018, the first two randomised controlled trials (RCTs) of edge-to-edge transcatheter mitral valve repair versus guideline-directed medical therapy in HF (Percutaneous Repair with the MitraClip Device for Severe (MITRA-FR), Transcather mitral valve repair in patients with heart failure (COAPT)) reported contrasting yet complimentary results. Unlike in MITRA-FR, COAPT demonstrated significant prognostic benefit, largely attributed to the selection of patients with disproportionately severe MR relative to their HF phenotype. Consequently, quantifying the degree of SMR in relation to left ventricular volume may be a useful discriminator in predicting the success of transcatheter intervention. The challenge going forward is the identification and validation of such parameters while in parallel maintaining a heart-team guided holistic approach.