Percutaneous repair or surgery for mitral regurgitation.
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ABSTRACT:
SUBMITTER: Gorman RC
PROVIDER: S-EPMC4071614 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Interest in percutaneous mitral valve repair has increased during recent years. This is mainly driven by the significant number of patients being declined for mitral valve surgery because of a high risk of surgery-related complications or death. In this subset of patients, percutaneous edge-to-edge repair using the MitraClip device (Abbott, Menlo Park, CA, USA) has become an established treatment option, proven to be safe, efficient and associated with improved functional status. In contrast to primary mitral regurgitation (MR), clinical outcomes after mitral valve surgery appear to be less favourable as regards secondary MR due to heart failure. In the MITRA-FR and COAPT trials, patients with moderate to severe and severe secondary MR with reduced left ventricular function received either medical treatment (control group) or MitraClip implantation plus medical treatment (device group). Results were conflicting, with only the COAPT trial showing better clinical outcomes in the device group. However, both trials are now seen as complementary and provide useful information especially regarding patient selection for MitraClip therapy. The goal of this review is to delineate which subset of patients with secondary MR will potentially benefit from percutaneous mitral valve repair.
| S-EPMC7190777 | biostudies-literature
Project description:We aimed to identify predictors of mitral regurgitation recurrence (MR) after percutaneous mitral valve repair (PMVR) in patients with functional mitral regurgitation (FMR). Patients with FMR were enrolled who underwent PMVR using the MitraClip® device. Procedural success was defined as reduction of MR of at least one grade to MR grade ≤ 2 + assessed at discharge. Recurrence of MR was defined as MR grade 3 + or worse at one year after initially successful PMVR. A total of 306 patients with FMR underwent PMVR procedure. In 279 out of 306 patients (91.2%), PMVR was successfully performed with MR grade ≤ 2 + at discharge. In 11.4% of these patients, MR recurrence of initial successful PMVR after 1 year was observed. Recurrence of MR was associated with a higher rate of heart failure rehospitalization during the 12 months follow-up (52.0% vs. 30.3%; p = 0.029), and less improvement in New York Heart Association (NYHA) functional class [68% vs. 19% of the patients presenting with NYHA functional class III or IV one year after PMVR when compared to patients without recurrence (p = 0.001)]. Patients with MR recurrence were characterized by a higher left ventricular sphericity index {0.69 [Interquartile range (IQR) 0.64, 0.74] vs. 0.65 (IQR 0.58, 0.70), p = 0.003}, a larger left atrium volume [118 (IQR 96, 143) ml vs. 102 (IQR 84, 123) ml, p = 0.019], a larger tenting height 10 (IQR 9, 13) mm vs. 8 (IQR 7, 11) mm (p = 0.047), and a larger mitral valve annulus [41 (IQR 38, 43) mm vs. 39 (IQR 36, 40) mm, p = 0.015] when compared to patients with durable optimal long-term results. In a multivariate regression model, the left ventricular sphericity index [Odds Ratio (OR) 1.120, 95% Confidence Interval (CI) 1.039-1.413, p = 0.003)], tenting height (OR 1.207, 95% CI 1.031-1.413, p = 0.019), and left atrium enlargement (OR 1.018, 95% CI 1.000-1.038, p = 0.047) were predictors for MR recurrence after 1 year. In patients with FMR, baseline parameters of advanced heart failure such as spherical ventricle, tenting height and a large left atrium might indicate risk of recurrent MR one year after PMVR.
| S-EPMC8379112 | biostudies-literature
Project description:BackgroundMitral regurgitation (MR) is one of the most prevalent valvular diseases in our society. Transcatheter mitral valve repair (TMVR) with the MitraClip® system is increasingly used for treating this condition. The aim of our study is to analyse morphological mitral valve changes related to the procedure and its correlation with the degree of regurgitation at mid-term follow-up and with the combined endpoint of heart failure and all-cause mortality.MethodsA single-centre, prospective and observational study including consecutive patients admitted between October 2015 and October 2019 for TMVR was designed. The mitral valve annulus (MVA) was analyzed using the three-dimensional MVQ QLAB mitral valve quantification software (Philips; Amsterdam, The Netherlands). Clinical data was collected retrospectively.ResultsEighty-two MitraClip® were implanted. Control echocardiograms showed a significant decrease in the three measures: annular diameters, perimeter and area. Patients with functional MR had greater left ventricular and mitral annular dimensions and experienced greater reductions in anteroposterior diameter and mitral valve area compared with organic MR patients. The anteroposterior diameter reduction (OR 0.90; 95% CI: 0.82-0.99), as well as posterior leaflet grasping (OR 0.94; 95% CI: 0.89-0.99) were associated with the probability of significant MR recurrence. Posterior leaflet grasping and left ventricle ejection fraction were associated with the combined endpoint of heart failure and any cause death.ConclusionsMitraClip® implantation results in secondary changes in the mitral annular morphology. The magnitude of these morphological changes varies depending on the etiology of the mitral valve regurgitation. Posterior leaflet grasping and anteroposterior diameter reduction after clip are factors associated with relevant clinical and echocardiographic endpoints.
| S-EPMC7475407 | biostudies-literature
Project description:Background and objectiveEndothelial dysfunction is predictive for cardiovascular events and may be caused by decreased bioavailability of nitric oxide (NO). NO is scavenged by cell-free hemoglobin with reduction of bioavailable NO up to 70% subsequently deteriorating vascular function. While patients with mitral regurgitation (MR) suffer from an impaired prognosis, mechanisms relating to coexistent vascular dysfunctions have not been described yet. Therapy of MR using a percutaneous mitral valve repair (PMVR) approach has been shown to lead to significant clinical benefits. We here sought to investigate the role of endothelial function in MR and the potential impact of PMVR.Methods and resultsTwenty-seven patients with moderate-to-severe MR treated with the MitraClip® device were enrolled in an open-label single-center observational study. Patients underwent clinical assessment, conventional echocardiography, and determination of endothelial function by measuring flow-mediated dilation (FMD) of the brachial artery using high-resolution ultrasound at baseline and at 3-month follow-up. Patients with MR demonstrated decompartmentalized hemoglobin and reduced endothelial function (cell-free plasma hemoglobin in heme 28.9±3.8 ?M, FMD 3.9±0.9%). Three months post-procedure, PMVR improved ejection fraction (from 41±3% to 46±3%, p = 0.03) and NYHA functional class (from 3.0±0.1 to 1.9±1.7, p<0.001). PMVR was associated with a decrease in cell free plasma hemoglobin (22.3±2.4 ?M, p = 0.02) and improved endothelial functions (FMD 4.8±1.0%, p<0.0001).ConclusionWe demonstrate here that plasma from patients with MR contains significant amounts of cell-free hemoglobin, which is accompanied by endothelial dysfunction. PMVR therapy is associated with an improved hemoglobin decompartmentalization and vascular function.
| S-EPMC4795750 | biostudies-literature
Project description:The role of percutaneous mitral valve repair (PMVr) in management of high-risk patients with severe mitral regurgitation (MR) and acute decompensated heart failure (ADHF) is undetermined. We screened all patients who underwent PMVr between October 2015 and March 2020. We evaluated immediate, 30-day, and 1-year outcomes in patients who underwent PMVr during hospitalization due to ADHF as compared to elective patients. From a cohort of 237 patients, we identified 46 patients (19.4%) with severe MR of either functional or degenerative etiology who underwent PMVr during index hospitalization due to ADHF, including 17 (37%) critically ill patients. Patients' mean age was 75.2 ± 9.8 years, 56% were males. There were no differences in background history between ADHF and elective patients. Patients with ADHF were at higher risk for surgery, reflected in higher mean EuroSCORE II, compared with elective patients. After PMVr, we observed higher 30-day mortality rate in ADHF patients as compared to the elective group (10.9% vs. 3.1%, respectively, p = 0.042). One-year mortality rate was similar between the groups (21.7% vs. 17.9%, p = 0.493). Clinical and echocardiographic follow-up showed improvement of NYHA functional class and sPAP reduction in both groups ((54 ± 15 mmHg to 50 ±15 in the elective group (p = 0.02), 58 ± 13 mmHg to 52 ± 12 in the ADHF group (p = 0.02)). PMVr could be an alternative option for treatment of patients with severe MR and ADHF.
| S-EPMC8704045 | biostudies-literature
Project description: Not available
| S-EPMC7649506 | biostudies-literature
Project description:Percutaneous mitral valve repair has been increasingly performed worldwide after approval. We sought to investigate predictors of clinical outcome in patients with mitral regurgitation undergoing percutaneous valve repair. The MITRA-UMG study, a single-centre registry, retrospectively collected consecutive patients with symptomatic moderate-to-severe or severe MR undergoing MitraClip therapy. The primary endpoint was the composite of cardiovascular death or rehospitalization for heart failure. Between March 2012 and July 2018, a total of 150 consecutive patients admitted to our institution were included. Procedural success was obtained in 95.3% of patients. The composite primary endpoint of cardiovascular death or rehospitalization for HF was met in 55 patients (37.9%) with cumulative incidences of 7.6%, 26.2%, at 30 days and 1-year, respectively. In the Cox multivariate model, NYHA functional class and left ventricular end-diastolic volume index (LVEDVi), independently increased the risk of the primary endpoint at long-term follow-up. At Kaplan-Meier analysis, a LVEDVi > 92 ml/m2 was associated with an increased incidence of the primary endpoint. In this study, patients presenting with dilated ventricles (LVEDVi > 92 ml/m2) and advanced heart failure symptoms (NYHA IV) at baseline carried the worst prognosis after percutaneous mitral valve repair.
| S-EPMC7555528 | biostudies-literature
Project description:Papillary muscle rupture is an infrequent and highly morbid mechanical complication of acute myocardial infarction. Surgical repair or replacement is traditionally considered first-line therapy. However, many of these patients present in extremis with prohibitively high surgical risk. Repair of mitral regurgitation with the MitraClip device (Abbot Vascular, Menlo Park, CA, USA) is an established therapy to treat degenerative and functional mitral regurgitation. We present a case of successful repair of severe mitral regurgitation due to papillary muscle rupture in the setting of acute myocardial infarction. A two-clip strategy resulted in mild residual mitral regurgitation with resolution of cardiogenic shock and refractory hypoxemia requiring veno-venous extracorporeal membrane oxygenation. Six-month follow-up echocardiogram identified durable results with mild mitral regurgitation and left ventricular ejection fraction of 63 %. Our case demonstrates that percutaneous mitral valve repair with MitraClip is a well-tolerated procedure that can provide acute and long-term benefit for patients with acute mitral regurgitation due to papillary muscle rupture who are at prohibitively high surgical risk. <Learning Objective: Our case illustrates the role of MitraClip in acute mitral regurgitation due to papillary muscle rupture in cardiogenic shock as an alternative to surgical intervention in extremely high-risk patients.>.
| S-EPMC7588477 | biostudies-literature
Project description:Background The current standard of care for the treatment of patients with primary mitral regurgitation (MR) is surgical mitral valve repair. Transcatheter edge-to-edge repair with the MitraClip device provides a less invasive treatment option for patients with both primary and secondary MR. Worldwide, >150 000 patients have been treated with the MitraClip device. However, in the United States, MitraClip is approved for use only in primary patients with MR who are at high or prohibitive risk for mitral valve surgery. The REPAIR MR (Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery) trial is designed to compare early and late outcomes associated with transcatheter edge-to-edge repair with the MitraClip and surgical repair of primary MR in older or moderate surgical risk patients. Methods and Results The REPAIR MR trial is a prospective, randomized, parallel-controlled, open-label multicenter, noninferiority trial for the treatment of severe primary MR (verified by an independent echocardiographic core laboratory). Patients with severe MR and indications for surgery because of symptoms (New York Heart Association class II-IV), or without symptoms with left ventricular ejection fraction ≤60%, pulmonary artery systolic pressure >50 mm Hg, or left ventricular end-systolic diameter ≥40 mm are eligible for the trial provided they meet the moderate surgical risk criteria as follows: (1) ≥75 years of age, or (2) if <75 years of age, then the subject has a Society of Thoracic Surgeons Predicted Risk Of Mortality score of ≥2% for mitral repair (or Society of Thoracic Surgeons replacement score of ≥4%), or the presence of a comorbidity that may introduce a surgery-specific risk. The local surgeon must determine that the mitral valve can be surgically repaired. Additionally, an independent eligibility committee will confirm that the MR can be reduced to mild or less with both the MitraClip and surgical mitral valve repair with a high degree of certainty. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive the MitraClip device or to undergo surgical mitral valve repair (control group). There are 2 co-primary end points for the trial, both of which will be evaluated at 2 years. Each subject will be followed for 10 years after enrollment. The study has received approval from both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, and enrolled its first subject in July 2020. Conclusions The REPAIR MR trial will determine the safety and effectiveness of transcatheter edge-to-edge repair with the MitraClip in patients with primary MR who are at moderate surgical risk and are candidates for surgical MV repair. The trial will generate contemporary comparative clinical evidence for the MitraClip device and surgical MV repair. Registration https://clinicaltrials.gov/ct2/show/NCT04198870; NCT04198870.
| S-EPMC10111491 | biostudies-literature
Project description:Mitral regurgitation is frequently associated with ventricular dysfunction and carries a high mortality. Guideline-directed medical therapy, surgical mitral valve repair or replacement, and, in the setting of advanced heart failure, heart transplant and left ventricular assist devices have been the mainstay of treatment. However, rapid advancement in the field has resulted in approval of edge-to-edge mitral valve repair with the MitraClip, and there are several novel catheter-based percutaneous options in clinical trials. Percutaneous options, while promising, must be deployed in patients who are most likely to benefit, and thus, understanding the pathophysiology of specific subgroups of patients with functional mitral regurgitation (eg, disproportionate versus proportionate mitral regurgitation) is key to the success of new devices. We review the pathophysiology, percutaneous therapeutic treatment options, and ongoing clinical trials for functional mitral regurgitation.
| S-EPMC8207332 | biostudies-literature