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displays the severity of MR at 12 and 24 months according to the degree of 30-day residual MR in the TMVr plus GDMT and GDMT alone groups. The reductions in MR at 30 days achieved with TMVr were significantly more durable during follow-up than the 30-day reductions in MR achieved by GDMT alone.
Source publication
Background: In the randomized COAPT trial, among 614 heart failure (HF) patients with 3+ or 4+ secondary mitral regurgitation (MR), transcatheter mitral valve repair (TMVr) with the MitraClip reduced MR, HF hospitalizations (HFH), and mortality and improved quality of life compared with guideline-directed medical therapy (GDMT) alone. We sought to...
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Background
The change in right-ventricular function (RVF) after transcatheter mitral valve repair is still poorly understood. We assessed the early response of RVF to the MitraClip procedure and its clinical relevance.
Methods
We analyzed consecutive patients who underwent a MitraClip procedure to treat MR between August 2010 and March 2019 in the...
Background:
The aim of the study was to assess some parameters of right ventricle (RV) function as predictors of short-term mortality in patients with severe secondary mitral regurgitation (SMR) after mitral valve surgery.
Methods:
We conducted a retrospective analysis of 112 consecutive patients with severe SMR who had undergone mitral valve repa...
Aims:
Baroreflex activation therapy (BAT) is an innovative treatment option for advanced heart failure (HFrEF). We analysed patients' BAT acceptance and the outcome of BAT patients compared with HFrEF patients solely treated with a guideline-directed medical therapy (GDMT) and studied effects of sacubitril/valsartan (ARNI).
Methods:
In this pros...
Aims
This multicentre study investigated the association of periprocedural changes in the levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) with clinical outcomes after transcatheter edge-to-edge mitral valve repair (TMVR).
Methods and results
Patients were retrospectively analysed who underwent TMVR with the MitraClip system (Abbott...
Citations
... In the randomized COAPT trial, residual mild MR was not associated with improved outcomes when compared to residual mild-to-moderate MR in terms of mortality and hospitalization for heart failure [21]. The same results were reported in a retrospective substudy of the randomized Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation (MITRA-FR) trial, which had a similar setting to the COAPT trial, but showed neutral results in terms of mortality and hospitalization for heart failure in the whole trial population [22]. ...
Mitral valve transcatheter edge-to-edge repair (M-TEER) and replacement (TMVR) have evolved as guideline-recommended treatment approaches for mitral regurgitation (MR). Even though they are supported by a growing body of evidence from either randomized trials or large registries, there are still several unsolved challenges in the field of interventional MR treatment. In the present review, we discuss the ten most important open questions regarding M-TEER and TMVR.
... RV-PA coupling, which represents the association between the right ventricular contractility and pulmonary afterload, was defined as TAPSE-to-SPAP ratio (mm/ mm Hg). Severity of mitral regurgitation (MR) and tricuspid regurgitation (TR) was scored on a scale ranging from 1 + (mild) to 4 + (severe) 15 and 1 + (mild) to 5 + (torrential) 16 , respectively. None or trivial regurgitation was categorized as 0. MR and TR vena contracta (VC) were evaluated during the mid-systolic phase. ...
The right ventricular (RV) impairment can predict clinical adverse events in patients following transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). Limited reports have compared impact of the left ventricular (LV) and RV disorders. This retrospective study evaluated two-year major adverse cardiac and cerebrovascular events (MACCE) in patients following TAVR for severe AS. RV sphericity index was calculated as the ratio between RV mid-ventricular and longitudinal diameters during the end-diastolic phase. Of 239 patients, 2-year MACCE were observed in 34 (14%). LV ejection fraction was 58 ± 11%. Tricuspid annular plane systolic excursion (TAPSE) and RV sphericity index were 20 ± 3 mm and 0.36 (0.31–0.39). Although the univariate Cox regression analysis demonstrated that both LV and RV parameters predicted the outcomes, LV parameters no longer predicted them after adjustment. Lower TAPSE (adjusted hazard ratio per 1 mm, 0.84; 95% confidence interval, 0.75–0.93) and higher RV sphericity index (adjusted hazard ratio per 0.1, 1.94; 95% confidence interval, 1.17–3.22) were adverse clinical predictors. In conclusion, the RV structural and functional disorders predict two-year MACCE, whereas the LV parameters do not. Impact of LV impairment can be attenuated after development of RV disorders.
... In addition, residual or recurrent MR is another concern of TEER, which was associated with worse outcomes. 16,17 Compared with TEER, TMVR can completely reduce MR. 9,18 Due to complexity of the mitral valve disease, the number of TMVR procedures is still liminted. ...
Background
Transcatheter mitral valve replacement (TMVR) has become an alternative for high‐risk patients with severe mitral regurgitation (MR). The aim of this study was to evaluate the safety and feasibility of the Mi‐thos TMVR system (NewMed Medical) for high‐risk patients with severe MR.
Methods
This was a prospective, two‐center, single‐arm early feasibility study. Baseline characteristics, procedural data and 30‐day follow‐up outcomes were collected and analyzed. The primary endpoint was intraoperative success rate of device implantation. The second endpoints were all‐cause mortality and major post‐procedural complications. Echocardiographic data were evaluated by an independent core laboratory. Clinical events were adjudicated by a clinical events committee.
Results
Ten high‐risk patients with severe MR were enrolled at two sites from August 2021 to November 2022. The median age was 70.5 years, and 60% of patients were female. The median Society of Thoracic Surgeons Predicted Risk of Mortality was 9.5%. The Mi‐thos TMVR system was successfully implanted via transapical access in all patients. There was no pericedural mortality or major postpericedural complications during the 30‐day follow‐up. All implanted prosthetic valves had no or trace valvular or paravalvular MR, and the median mitral valve gradient at 30 days was 2.0 mmHg (IQR: 2.0–3.0 mmHg). There was one mild left ventricular outflow tract obstruction.
Conclusions
The favorable short‐term outcomes of the Mi‐thos TMVR system demonstrated that it might be a feasible and safe therapeutic alternative for high‐risk patients with severe MR. Nevertheless, further evaluation of the Mi‐thos TMVR system is warranted.
... 17 These findings are similar to a subanalysis of the COAPT trial, which found a strong relation between residual mitral regurgitation after TEER and long-term outcomes. 18 However, Kaddoura et al 10 included studies conducted between 1999 and 2018. Still, since November 2019, the fourth generation of the MitraClip device system (capable of independent leaflet grasping) has been available, translating into enhanced technical success rates and treating more complex anatomies. ...
... Procedural failure with residual MR 3+/4+ at discharge has been reported to be a strong predictor of death and HF rehospitalization. [7][8][9] On the other hand, there was no significant difference in clinical outcomes between patients with residual MR 2+ and 1+ or less in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. 9 Therefore, whether residual MR 2+ can affect the clinical outcomes is still controversial. ...
... [7][8][9] On the other hand, there was no significant difference in clinical outcomes between patients with residual MR 2+ and 1+ or less in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial. 9 Therefore, whether residual MR 2+ can affect the clinical outcomes is still controversial. The objective of this study was to investigate 1-year clinical outcomes after TEER with the MitraClip device and evaluate the impact of residual MR on the clinical outcomes. ...
... [19][20][21] A recent study of patients with secondary MR have reported that patients with residual 2+ MR at discharge had higher event rates than those with residual ≤1+. 22 However, the COAPT trial showed the similar mortality and HF 9 In our large-cohort study, both residual MR 2+ and 3+/4+ were independently associated with worse clinical outcomes, and the adverse effects of residual MR 2+ relative to residual MR 1+ were more strongly observed in patients with primary MR. In patients with secondary MR, myocardial disease creates valvular disease, and not only MR severity but also advanced cardiomyopathy is related to the clinical outcomes after TEER. ...
Background
Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge‐to‐edge repair in the large Asian‐Pacific cohort.
Methods and Results
From the Optimized Catheter Valvular Intervention (OCEAN‐Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge‐to‐edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P < 0.001) and 3+/4+ (32.4%; P = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; P < 0.001, and adjusted HR, 1.73; P = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; P < 0.001) and MR 2+ (6.4%; P < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; P = 0.02).
Conclusions
The OCEAN‐Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge‐to‐edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge‐to‐edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+.
Registration Information
https://upload.umin.ac.jp . Identifier: UMIN000023653.
... When trying to understand the limitation described, we found an important observation that has been noted and described in different articles to support our theory. TEER has shown a prognostic benefit in terms of hospitalization and mortality, with no significant difference between patients with none, 1+, or 2+ grade of residual MR [9]. In addition, hemodynamic methods, such as left atrial pressure changes, showed a prognostic benefit, regardless of the color-Doppler-based residual MR severity [10]. ...
... This trend is also compatible with prognostic outcomes in other studies. As described in Kal et al. [9], the major prognostic difference was between grade 2+ on the one hand, and the 3+ and 4+ grades on the other hand. While severe residual MR (3+ and 4+ grades) presented the expected clinical manifestation, moderate MR (2+ grade) had the same clinical outcome as "none" or mild MR. ...
... While severe residual MR (3+ and 4+ grades) presented the expected clinical manifestation, moderate MR (2+ grade) had the same clinical outcome as "none" or mild MR. This suggests a possible inaccuracy in the 2+ and 1+ MR grades [9]. ...
Objectives: This article aims to evaluate the accuracy of the color-Doppler-based technique to evaluate residual mitral regurgitation post TEER. Background: The evaluation of residual mitral regurgitation (MR) post-mitral transcutaneous edge-to-edge repair (mitral TEER) is a critical determinant in patients’ outcomes. The common methods used today, based on the integration of color flow Doppler parameters, may be misleading because of the multiple jets and high velocities created by the TEER devices. Methods: Patients undergoing TEER at Hadassah hospital were recruited between 2015 and 2019. Post-procedural MR was evaluated using the integrated qualitative approach as recommended by the guidelines. In addition, the MR volume for each patient was calculated by subtracting the forward stroke volume (calculated by multiplying the LVOT area with the velocity time integral of the LVOT systolic flow) from the total stroke volume (calculated by the biplane Simpson method of discs). We compared the two methods for concordance. Results: Overall, 112 cases were enrolled. In 55.4% of cases, the volumetric residual MR was milder than the MR severity assessed by the guidelines’ recommended method. In 25.1%, the MR severity was similar in both methods. In 16.2%, the MR severity was worse when calculated using the volumetric method (pValue < 0.001, Kappameasure of agreement = 0.053). The lower residual MR degree using the volumetric approach was mostly observed in patients classified as “moderate” by the integrated approach. Conclusions: MR severity after TEER is often overestimated by the guideline-recommended integrative method when compared with a volumetric method. Alternative methods should be considered to assess the MR severity after mitral TEER.
... are associated with increased rates of mortality. [9,10,23,24] Elimination of MR represents the 1 central rationale behind the concept of TMVR. In line with previous studies, the present study 2 confirms predictable complete resolution of MR in the vast majority of patients with durable 3 results and functional improvement at follow-up. ...
Background:
Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR).
Aims:
This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry.
Methods:
The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality.
Results:
A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality.
Conclusions:
In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.
... 2 According to the coming from the "Mitral Valve Academic Research Consortium" (MVARC), both rMR and postprocedural mean gradient (ppMG) should be carefully monitored following MV-TEER. 3 However, despite the grade of rMR has been demonstrated to be strongly related to clinical outcomes in both patients suffering DMR and FMR, [4][5][6][7][8] conflicting findings have been reported regarding the role played by ppMG. [9][10][11][12][13][14][15] Our study aimed to evaluate the effects of ppMG after MV-TEER using the MitraClip (Abbott Vascular) system on 1-year outcomes in patients with DMR. ...
... Moreover, in our study, patients with a high ppMG also showed higher rates of rMR ≥ 2+, which has been recognized to be a strong predictor of negative outcomes. 6 Accordingly, it could be speculated that the patients belonging to the highest group of ppMG in our study had lower gradients and higher rMR compared to the ones enrolled by Koell ...
... According to our results, ppMG > 4 mmHg was independently associated with a higher risk of death or rehospitalization at 1-year follow-up only with concomitant rMR ≥ 2+. Moderate/severe rMR following MV-TEER is strongly related to adverse outcomes as rehospitalization and all-cause death, 6 and could potentially play a major role in defining outcomes of this subset of patients. Nevertheless, our study showed that patients with DMR are somehow exposed to experience complex procedural failures which may involve both elevated ppMG and rMR. ...
Background:
The relationship between high postprocedural mean gradient (ppMG) and clinical events following mitral valve transcatheter edge-to-edge repair (MV-TEER) in patients with degenerative mitral regurgitation (DMR) is still debated.
Aim:
The purpose of this study was to evaluate the effect of elevated ppMG after MV-TEER on clinical events in patients with DMR at 1-year follow-up.
Methods:
The study included 371 patients with DMR treated with MV-TEER enrolled in the "Multi-center Italian Society of Interventional Cardiology (GISE) registry of trans-catheter treatment of mitral valve regurgitation" (GIOTTO) registry. Patients were stratified in tertiles according to ppMG. Primary endpoint was a composite of all-cause death and hospitalization due to heart failure at 1-year follow-up.
Results:
Patients were stratified as follows: 187 with a ppMG ≤ 3 mmHg, 77 with a ppMG > 3/=4 mmHg, and 107 with a ppMG > 4 mmHg. Clinical follow-up was available in all subjects. At multivariate analysis, neither a ppMG > 4 mmHg nor a ppMG ≥ 5 mmHg were independently associated with the outcome. Notably, the risk of elevated residual MR (rMR > 2+) was significantly higher in patients belonging to the highest tertile of ppMG (p = 0.009). The association of ppMG > 4 mmHg and rMR ≥ 2+ was strongly and independently associated with adverse events (hazard ratio: 1.98; 95% confidence interval: [1.10-3.58]).
Conclusions:
In a real-world cohort of patients suffering DMR and treated with MV-TEER, isolated ppMG was not associated with the outcome at 1-year follow-up. A high proportion of patients showed both elevated ppMG and rMR and their combination appeared to be a strong predictor of adverse events.
... 5). Similar findings were reported by the COAPT group a year earlier, 48 where postrandomization survival was a function of valve competence in both the interventional and the conservative arm. These data suggest that a durable elimination of MR (irrespective of the underlying pathology or treatment modality) should have the greatest potential to prolong life. ...
PubMed displayed almost 37,000 hits for the search term “cardiac surgery AND 2022.” As before, we used the PRISMA approach and selected relevant publications for a results-oriented summary. We focused on coronary and conventional valve surgery, their overlap with interventional alternatives, and briefly assessed surgery for aorta or terminal heart failure. In the field of coronary artery disease (CAD), key manuscripts addressed prognostic implications of invasive treatment options, classically compared modern interventions (percutaneous coronary intervention [PCI]) with surgery (coronary artery bypass grafting [CABG]), and addressed technical aspects of CABG. The general direction in 2022 confirms the superiority of CABG over PCI in patients with anatomically complex chronic CAD and supports an infarct-preventative effect as underlying mechanism. In addition, the relevance of proper surgical technique to achieve durable graft patency and the need for optimal medical treatment in CABG patients was impressively illustrated. In structural heart disease, the comparisons of interventional and surgical techniques have been characterized by prognostic and mechanistic investigations underscoring the need for durable treatment effects and reductions of valve-related complications. Early surgery for most valve pathologies appears to provide significant survival advantages, and two publications on the Ross operation prototypically illustrate an inverse association between long-term survival and valve-related complications. For surgical treatment of heart failure, the first xenotransplantation was certainly dominant, and in the aortic surgery field, innovations in arch surgery prevailed. This article summarizes publications perceived as important by us. It cannot be complete nor free of individual interpretation, but provides up-to-date information for decision-making and patient information.
... 1 Residual postrepair MR has been a great concern and is known to influence mortality and induce adverse left ventricular (LV) remodeling, recurrence of significant MR, and reoperation. [2][3][4][5][6][7][8][9][10][11][12][13][14][15] Residual MR has been reported to be associated with recurrent severe MR resulting in reoperation, 2,4,6,8,10 even in mild cases. 3,5,9,14 In addition, the prevalence of significant MR after MV repair is relatively higher in anterior valve prolapse (AVP) repair compared with posterior valve prolapse repair. ...
Objective
This study aimed to biomechanically evaluate the force profiles on the anterior primary and secondary chordae after neochord repair for anterior valve prolapse with varied degrees of residual mitral regurgitation using an ex vivo heart simulator.
Methods
The experiment used 8 healthy porcine mitral valves. Chordal forces were measured using fiber Bragg grating sensors on primary and secondary chordae from A2 segments. The anterior valve prolapse model was generated by excising 2 primary chordae at the A2 segment. Neochord repair was performed with 2 pairs of neochords. Varying neochord lengths simulated postrepair residual mitral regurgitation with regurgitant fraction at >30% (moderate), 10% to 30% (mild), and <10% (perfect repair).
Results
Regurgitant fractions of baseline, moderate, mild, and perfect repair were 4.7% ± 0.8%, 35.8% ± 2.1%, 19.8% ± 2.0%, and 6.0% ± 0.7%, respectively (P < .001). Moderate had a greater peak force of the anterior primary chordae (0.43 ± 0.06 N) than those of baseline (0.19 ± 0.04 N; P = .011), mild (0.23 ± 0.05 N; P = .041), and perfect repair (0.21 ± 0.03 N; P = .006). In addition, moderate had a greater peak force of the anterior secondary chordae (1.67 ± 0.17 N) than those of baseline (0.64 ± 0.13 N; P = .003), mild (0.84 ± 0.24 N; P = .019), and perfect repair (0.68 ± 0.14 N; P = .001). No significant differences in peak and average forces on both primary and secondary anterior chordae were observed between the baseline and perfect repair as well as the mild and perfect repair.
Conclusions
Moderate residual mitral regurgitation after neochord repair was associated with increased anterior primary and secondary chordae forces in our ex vivo anterior valve prolapse model. This difference in chordal force profile may influence long-term repair durability, providing biomechanical evidence in support of obtaining minimal regurgitation when repairing mitral anterior valve prolapse.
