scholarly journals TCT-88 6-Month Outcomes of an Early Feasibility Study of the AccuCinch Left Ventricular Repair System in Patients With Heart Failure and Functional Mitral Regurgitation

2019 ◽  
Vol 74 (13) ◽  
pp. B88 ◽  
Author(s):  
Mark Reisman ◽  
James Wudel ◽  
Steven Martin ◽  
Hosakote Nagaraj ◽  
Guilherme Silva ◽  
...  
2020 ◽  
Vol 75 (5) ◽  
pp. 514-522
Author(s):  
Alexey S. Ryazanov ◽  
Konstantin I. Kapitonov ◽  
Mariya V. Makarovskaya ◽  
Alexey A. Kudryavtsev

Background. Morbidity and mortality in patients with functional mitral regurgitation (FMR) remains high, however, no pharmacological therapy has been proven to be effective.Aimsto study the effect of sacubitrile/valsartan and valsartan on functional mitral regurgitation in chronic heart failure.Methods.This double-blind study randomly assigned sacubitrile/valsartan or valsartan in addition to standard drug therapy for heart failure among 100 patients with heart failure with chronic FMR (secondary to left ventricular (LV) dysfunction). The primary endpoint was a change in the effective area of the regurgitation hole during the 12-month follow-up. Secondary endpoints included changes in the volume of regurgitation, the final systolic volume of the left ventricle, the final diastolic volume of the left ventricle, and the area of incomplete closure of the mitral valves.Results.The decrease in the effective area of the regurgitation hole was significantly more pronounced in the sacubitrile/valsartan group than in the valsartan group (0.070.066against0.030.058sm2; p=0.018)in the treatment efficacy analysis, which included 100patients (100%). The regurgitation volume also significantly decreased in the sacubitrile/valsartan group compared to the valsartan group (mean difference:8.4ml; 95%CI, from 13.2 until 1.9;р=0.21). There were no significant differences between the groups regarding changes in the area ofincomplete closure of the mitral valves and LV volumes, with the exception of the index of the final LV diastolic volume (p=0.07).Conclusion.Among patients with secondary FMR, sacubitril/valsartan reduced MR more than valsartan. Thus, angiotensin receptor inhibitors and neprilysin can be considered for optimal drug treatment of patients with heart failure and FMR.


2019 ◽  
Vol 13 (1) ◽  
pp. 30-34
Author(s):  
Mehmet Ali Elbey ◽  
Luis Augusto Palma Dallan ◽  
Guilherme Ferragut Attizzani ◽  

Patients with heart failure who have secondary severe mitral regurgitation due to left ventricular dysfunction have a poor prognosis, with high rates of rehospitalization and mortality. Percutaneous mitral valve repair using the MitraClip (Abbott) has been shown to be safe and effective in secondary severe mitral regurgitation with heart failure. The number of MitraClip procedures performed has increased significantly, as recently published large, randomized clinical studies have shown. However, these studies have drawn different conclusions. This review aims to summarize the current evidence for the MitraClip procedure and provide information for its safe and successful implementation, comparing the studies that examined the use of MitraClip versus medical therapy alone or surgical repair for severe secondary mitral regurgitation.


2021 ◽  
Vol 8 ◽  
Author(s):  
Masakazu Miura ◽  
Shinichi Okuda ◽  
Kazuhiro Murata ◽  
Hitoshi Nagai ◽  
Takeshi Ueyama ◽  
...  

Background: Hospitalized patients with acute decompensated heart failure (ADHF) frequently exhibit aggravating mitral regurgitation (MR). Those patients do not always undergo surgical mitral valve repair, but particularly in the elderly, they are often treated by conservative medical therapy. This study was aimed to investigate factors affecting 6-month outcomes in hospitalized patients with heart failure (HF) harboring surgically untreated MR.Methods: We screened the presence of MR in hospitalized patients with HF between September 2017 and May 2020 in the Yamaguchi Prefectural Grand Medical (YPGM) center. At the time of discharge of these patients, individuals with surgically unoperated MR, including primary and secondary origin, were consequently recruited to this single-center prospective cohort study. The patients with severe MR who undergo surgical mitral valve treatment were not included in this study. The primary endpoint was all-cause readmission or all-cause death and the secondary endpoint was HF-related endpoint at 6 months after discharge. The Cox proportional hazard regression analyses were employed to assess the predictors for the composite endpoint.Results: Overall, 489 patients with ADHF were admitted to the YPGM center. Of those, 146 patients (30% of total patients with HF) (median age 83.5 years, 69 men) were identified as harboring grade II MR or greater. Consequently, all the recruited patients were diagnosed as functional MR. During a median follow-up of 186.0 days, a total of 55 patients (38%) reached the primary or secondary endpoints (HF death and readmission in 31 patients, other in 24 patients). As a result of multivariate analysis, geriatric nutritional risk index [hazard ratio (HR) = 0.932; 95% CI = 0.887–0.979, p = 0.005], age (HR = 1.058; 95% CI = 1.006–1.112, p = 0.027), and left ventricular ejection fraction (HR = 0.971; 95% CI = 0.945–0.997, p = 0.030) were independent predictors of all-cause death or all-cause admission. Body mass index (HR = 0.793; 95% CI = 0.614–0.890, p = 0.001) and ischemic heart disease etiology (HR = 2.732; 95% CI = 1.056–7.067, p = 0.038) were also independent predictors of the HF-related endpoints.Conclusion: Malnutrition and underweight were substantial predictors of adverse outcomes in elderly patients with HF harboring surgically untreated moderate-to-severe functional MR.


2016 ◽  
Vol 72 (2) ◽  
Author(s):  
Gabriella Malfatto ◽  
Paola Cuoccio ◽  
Caterina Bizzi ◽  
Giovanna Branzi ◽  
Alessandra Villani ◽  
...  

Background - Color-Doppler ecocardiography and cardiopulmonary stress test are pivotal in the evaluation of patients with heart failure. Besides determining systolic function through left ventricular ejection fraction (EF), color-Doppler ecocardiography evaluates the presence and degree of functional mitral regurgitation and the severity of diastolic dysfunction. Moreover, in addition to the aerobic capacity indicated by peak O2 consumption, other parameters of cardiopulmonary stress have proven useful for diagnostic purposes, such as the peak VE/VCO2 ratio or ventilatory efficiency. Since in elderly patients with heart failure the functional impairment often is a combination of the effects of aging with those of disease, the relationship between symptoms, i.e. the NYHA class, ventricular pump function and aerobic performance is sometimes difficult to estabilish. Materials and methods - In 60 elderly with systolic heart failure (75+3 years, EF 30+6%), we correlated symptoms (i.e. NYHA class) with [1] degree of functional mitral regurgitation (FMR) determined by color-Doppler echocardiography; [2] degree of left ventricular diastolic dysfunction, measured by Doppler analysis of transmitralic and pulmonary veins flow; [3] VO2 e VE/VCO2 at peak exercise at cardiopulmonary test. Results - In all patients, NYHA class was only weakly related with EF and peakVO2, with wide overlap of individual values among patients with different NYHA class. Instead, we observed a tight relationship between NYHA class, FMR degree, and severity of diastolic dysfunction and VE/VCO2 ratio at peak exercise (p<0.001), with a more evident partition among patients in different NYHA classes. Conclusions - In elderly heart failure patients, the reduced effort tolerance expressed by the NYHA classification is only weakly associated with reduced aerobic capacity and pump function, but rather is related with the presence of mitral regurgitation, left ventricular diastolic dysfunction, and a poor ventilatory efficiency during exercise.


Author(s):  
R. V. Buriak ◽  
K. V. Rudenko ◽  
O. A. Krykunov

Congestive heart failure resulting from non-ischemic dilated cardiomyopathy (DCM) with secondary functional mitral regurgitation (FMR) is associated with poor prognosis. Medical treatment results in a 1-year survival of 52% to 87% and a 5-year survival of 22% to 54%, with highest survivals observed in more recent years, probably reflecting improvements in medical therapy. Non-surgical interventions involve cardiac resynchronization therapy. In addition to medical treatment, cardiac resynchronization therapy (CRT) should be considered in patients with New York Heart Association (NYHA) class II– IV HF, left ventricular ejection fraction (LVEF) =35%, normal sinus rhythm and left bundle branch block with QRS >150 ms. In these patients, CRT can also facilitate left ventricular (LV) reverse remodeling and reduce associated FMR. The aim of this study was to investigate the features of symptomatology and to analyze the risk factors for acute heart failure (AHF) in patients with DCM and persistent severe functional mitral regurgitation despite CRT and optimal guideline-directed medical therapy (GDMT). Materials and methods. After providing informed consent, 144 patients with severe FMR were involved in the study. Concomitant tricuspid valve regurgitation was registered in 142 (98.6%) cases. The median LVEF was 27.0 (23.0-31.6)%. 40 (27.8%) patients had a permanent form of atrial fibrillation, and 24 (16.7%) patients had a first-degree atrioventricular node block. The median NT-proBNP was 2600 (2133-3200) pg/ml, indicating the presence of severe chronic heart failure. Results. The median term after CRT device implantation was 36 (3.5-60) months. A comparative analysis between DCM patients with and without CRT revealed statistically significant differences between clinical characteristics, namely: age (p=0.020), lower heart rate (p=0.004), lower hemoglobin (p=0.017), higher erythrocyte sedimentation rate (ESR) (p=0.000) and more frequent AHF at the hospital stage (p=0.030). The incidence of AHF at the hospital stage was 13.8% in patients with CRT and 3.5% in those without CRT. The calculated odds ratio of AHF was 4.44 (95% confidence interval (CI) 1.039-18.971), and the relative risk of AHF was 3.966 (95% CI 1.054-14.915). Discussion. FMR has been reported to persist in about 20% to 25% of CRT patients and, in an additional 10% to 15%, it may actually worsen after CRT. In this subset of CRT non-responders, reduced reverse remodeling, increased morbidity, and increased mortality have been reported compared with CRT patients in whom FMR was significantly reduced or abolished. Conclusions. The results of our study demonstrate that severe functional mitral regurgitation despite cardiac resynchronization therapy in patients with dilated cardiomyopathy is a significant risk factor for AHF and subsequent hospitalizations for heart failure.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Noutsias ◽  
M Matiakis ◽  
M Ali ◽  
E Abate ◽  
B Ahmadzada ◽  
...  

Abstract Moderate-to-severe or severe functional mitral regurgitation (FMR) is associated with higher rates of hospitalizations and with increased mortality in heart failure with reduced left ventricular ejection fraction (HFrEF). Transcatheter mitral valve repair by MitraClip® implantation (TMVrMC) may effectively reduce severe MR, and is associated with symptomatic improvement. However, the long-term clinical effects of this procedure are not well defined. Aims We analyzed outcomes for rehospitalization and survival in heart failure patients with moderate-to-severe or severe functional mitral regurgitation (FMR) treated by either medical treatment (MT) only TMVrMC+MT by meta-analysis. Methods and results By systematic search of bibliographic databases, we evaluated publications comparing heart failure patients with FMR treated by MT only versus treatment by MT combined with TMVrMC. Studies with a minimum of 25 enrolled patients and a follow/up period of at least 12 months were deemed eligible for this meta-analysis. We identified n=7 studies enrolling 2,884 HFrEF patients, divided into two study arms: TMVrMC+MT (n=1,618), versus FMR patients receiving MT only (n=1,266). At 12 months, there was a significant reduction in all-cause mortality favoring TMVR+MT (OR: 0.67; CI 95% 0.55–0.81), as well as a reduction of unplanned rehospitalizations (OR: 0.69; 95%; CI 0.53–0.89), compared with the MT only patients. At 24 months, there was a significant reduction of all-cause mortality in the TMVrMC+MT patient group (OR: 0.50; CI: 95%: 0.38–0.66; p<0.001). TMVrMC+MT was associated with significantly lower rates of unplanned re-admissions for heart failure compared with MT only at 12 months (OR: 0.69; 95% CI: 0.53–0.89; p<0.001) and at 24 months (OR: 0.53; 95% CI: 0.39–0.71; p<0.001). In one publication, a survival benefit of TMVrMC+MT over MT alone was shown at 5 years post intervention (HR: 0.75; 95% CI: 0.69–0.94; p=0.012) after weighting for propensity score and controlling for age. Conclusions This meta-analysis on n=2,884 patients with moderate-to-severe or severe FMR reveals that TMVrMC+MT, as compared with MT alone, is associated with a significant reduction of rehospitalizations and improvement of survival. These data imply additional evidence for TMVrMC in eligible heart failure patients with relevant FMR, which might be important for an update of the corresponding guidelines.


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