P4725Prognostic relevance of the COAPT inclusion criteria in real-world patients with secondary mitral regurgitation undergoing mitraclip implantation

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Iliadis ◽  
C Metze ◽  
M I Koerber ◽  
S Baldus ◽  
R Pfister

Abstract Background The recently published Cardiovascular Outcomes Assessment of the mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) randomized trial has shown a huge benefit in the survival of patients with systolic heart failure and functional mitral regurgitation treated with MitraClip. However, patients in COAPT were highly selected and the clinical course in real-world patients with and without fulfilment of the trial inclusion criteria is unclear. Methods Our study examined the clinical outcome in consecutive patients from our Heart Centre with reduced left-ventricular ejection fraction (EF<50%) undergoing mitraclip for mitral regurgitation of dominant functional etiology by the presence of the inclusion criteria of the COAPT trial (left ventricular ejection fraction >20%, left ventricular end-systolic dimension <70 mm, non-commissural primary jet, estimated pulmonary artery systolic pressure <70 mmHg, mitral valve orifice area >4 cm2, no prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure). The composite endpoint of all-cause mortality or heart failure hospitalization and the endpoint of heart failure hospitalization were analysed. Results Among 123 patients who underwent mitraclip implantation 60.2% fulfilled the inclusion criteria of COAPT. Overall, 54 patients (46.6%) died or were hospitalized for heart failure during a median follow-up time of 19 months. The composite endpoint was significantly less frequent (p=0.01) in patients fulfilling the COAPT selection criteria than in those not fulfilling the criteria, with an estimated 1-year event rate of 24.6% vs 49.1%. Patients with COAPT inclusion criteria had a 49% lower hazard of the composite endpoint (95% CI 12–70%, p=0.015). Heart failure hospitalization was significantly less frequent (p=0.039) in patients fulfilling COAPT selection criteria than in those who did not, with an estimated 1-year event rate of 19% vs. 36.8%. Patients with COAPT inclusion criteria had a 50% lower hazard for heart failure hospitalization (95% CI 1–75%, p=0.046). Of note, the 1-year all-cause mortality in our patients fulfilling COAPT inclusion criteria was lower compared to the renowned COAPT trial (10% vs. 19%). Conclusion In this single center study the outcome of patients with functional mitral regurgitation undergoing mitraclip therapy was significantly worse in patients not fulfilling COAPT inclusion criteria, indicating that these criteria might help identify futility. The remarkable difference in outcome between real-world patients and COAPT trial patients warrants further study to elucidate underlying causes, which might affect the transferability of the COAPT results.

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Serena Serratore ◽  
Alberto Polimeni ◽  
Annalisa Mongiardo ◽  
Carmen Spaccarotella ◽  
Sabato Sorrentino ◽  
...  

Abstract Aims The COAPT randomized trial has shown a huge benefit in the survival of patients with s heart failure and functional mitral regurgitation treated with MitraClip. However, patients in COAPT were highly selected and the clinical course in real-world patients with and without fulfilment of the trial inclusion criteria is unclear. Methods The present study examined the clinical outcome in consecutive patients with symptomatic moderate-to-severe or severe MR of dominant functional aetiology undergoing MitraClip therapy by the presence of the inclusion criteria of the COAPT trial (left ventricular ejection fraction &gt;20%, left ventricular end-systolic dimension &lt;70 mm, non-commissural primary jet, estimated pulmonary artery systolic pressure &lt;70 mmHg, mitral valve orifice area &gt;4 cm2, no prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure). Results The composite endpoint of all-cause mortality or heart failure hospitalization and the endpoint of heart failure hospitalization were analysed. Among 118 patients who underwent MitraClip implantation 61% fulfilled the inclusion criteria of COAPT. The composite endpoint was significantly less frequent (P = 0.05) in patients fulfilling the COAPT selection criteria than in those not fulfilling the criteria, with an estimated 1-year event rate of 25% vs. 49%. Heart failure hospitalization was significantly less frequent (P = 0.04) in patients fulfilling COAPT selection criteria than in those who did not, with an estimated 1-year event rate of 19% vs. 36.8%. Conclusions In this single centre study the outcome of patients with functional mitral regurgitation undergoing MitraClip therapy was significantly worse in patients not fulfilling COAPT inclusion criteria, indicating that these criteria might help identify futility.


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.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Benito Gonzalez ◽  
X Freixa ◽  
C Godino ◽  
M Taramasso ◽  
R Estevez-Loureiro ◽  
...  

Abstract Background Limited information has been reported regarding the impact of percutaneous mitral valve repair (PMVR) on ventricular arrhythmic (VA) burden. The aim of this study was to address the incidence of VA and appropriate antitachycardia implantable cardiac defibrillator (ICD) therapies before and after PMVR. Methods We retrospectively analyzed all consecutive patients with heart failure with reduce left ventricular ejection fraction, functional mitral regurgitation grade 3+ or 4+ and an active ICD or cardiac resynchronizer who underwent PMVR in any of the eleven recruiting centers. Only patients with complete available device VA monitoring from one-year before to one year after PMVR were included. Baseline clinical and echocardiographic characteristics were collected before PMVR and at 12-months follow-up. Results 93 patients (68.2±10.9 years old, male 88.2%) were enrolled. PMVR was successfully performed in all patients and device success at discharge was 91.4%. At 12-months follow-up, we observed a significant reduction in mitral regurgitation severity, NT-proBNP and prevalence of severe pulmonary hypertension and severe kidney disease. Patients also referred a significant improvement in NYHA functional class and showed a non-significant trend to reserve left ventricular remodeling. After PMVR a significant decrease in the incidence of non-sustained ventricular tachycardia (VT) (5.0–17.8 vs 2.7–13.5, p=0.002), sustained VT or ventricular fibrillation (0.9–2.5 vs 0.5–2.9, p=0.012) and ICD antitachycardia therapies (2.5–12.0 vs 0.9–5.0, p=0.033) were observed. Conclusion PMVR was related to a reduction in arrhythmic burden and ICD therapies in our cohort. Proportion of patients who presented ven Funding Acknowledgement Type of funding source: None


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.


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
C M Van De Heyning ◽  
P Debonnaire ◽  
P B Bertrand ◽  
P Mortelmans ◽  
S Deferm ◽  
...  

Abstract Background Percutaneous mitral valve repair using MitraClip offers symptomatic benefit and improves rest and exercise hemodynamics in patients with severe functional mitral regurgitation (MR). Recent randomized trials have shown contradictory results regarding the impact of MitraClip on mid-term survival in functional MR. It is unknown whether improved hemodynamics are related to patients" outcome. Purpose To assess whether residual MR and altered resting and exercise hemodynamics are predictors of outcome in patients with functional MR treated with MitraClip. Methods Consecutive patients (n = 45, 72 ± 10years, left ventricular ejection fraction (LVEF) 34 ± 9%) with symptomatic severe functional MR were prospectively evaluated by Doppler echocardiography at rest and during symptom-limited exercise on a semi-supine bicycle pre- and 6 months post-MitraClip procedure. LVEF, MR severity, cardiac output (CO), systolic pulmonary artery pressure (SPAP) and a flow-corrected SPAP/CO ratio were assessed at rest and peak exercise. 2-year follow-up clinical data were collected from patient records. Results During 2-year follow-up post-MitraClip, 15 patients (33%) experienced major cardiac events (hospitalization for heart failure (n = 14) and/or cardiac death (n = 5)). Age, gender, a history of coronary artery disease, diabetes, baseline MR severity and baseline SPAP/CO ratio at rest and during exercise were not related to a worse event-free survival. In contrast, patients with events at 2-year follow up had more often a history of hospitalization for heart failure (73 vs. 37%, p = 0.029), lower baseline LVEF (30 ± 8 vs. 36 ± 10%, p = 0.041), more residual MR at 6 months post-MitraClip (MR jet area/left atrial area 27 ± 14 vs. 15 ± 10%, p = 0.004) and higher SPAP/CO ratios at rest and during exercise 6 months post-MitraClip (13.9 ± 5.3 vs. 9.9 ± 3.4mmHg/L/min, p = 0.007 and 13.6 ± 4.9 vs. 9.4 ± 4.6mmHg/L/min, p = 0.009, respectively). When corrected for baseline LVEF, residual MR 6 months post-MitraClip remained an independent predictor for worse 2-year outcome. Residual MR was moderately correlated to a worse SPAP/CO ratio 6 months post-MitraClip (Pearson Rho 0.518, p &lt; 0.001). Conclusions In patients with functional MR treated with MitraClip, residual MR at 6-month follow-up is associated with impaired hemodynamics, and is an independent predictor of cardiac events at 2-year follow-up.


2011 ◽  
Vol 19 (3) ◽  
pp. 396-403 ◽  
Author(s):  
Gabriella Malfatto ◽  
Giovanna Branzi ◽  
Alessia Giglio ◽  
Francesca Ciambellotti ◽  
Alessandra Villani ◽  
...  

Background: Heart failure is increasing in the elderly and represents a socioeconomic burden requiring the correct management for which risk stratification is mandatory. Among younger patients, echocardiogram and cardiopulmonary exercise test are useful in prognostic stratification. Few studies have analyzed the utility of these tests in elderly patients. Methods: We report on 90 patients over 70 years old, on whom cardiopulmonary tests and echocardiograms were performed between 1998 and 2006 (67 M, 23 F; 75 ± 3 years; ejection fraction (EF) 30 ± 6%; NYHA 2.1 ± 0.8; 60% ischemic; therapy according to international guidelines). Echocardiographic variables were (1) left ventricular ejection fraction (EF); (2) severity of diastolic dysfunction on multiparametric examination of Doppler and TDI parameters; (3) severity of functional mitral regurgitation. Cardiopulmonary variables were (1) peak VO2; (2) peak O2 pulse; (3) peak respiratory quotient (RQ); (4) VE/VCO2 slope. Endpoint considered was mortality of any cause at three-years follow-up. Results: Mortality was 21%. At univariate analysis, survivors ( n = 71) and deceased ( n = 19) were similar for age, NYHA class, peakVO2 and RQ; they differed for EF, severity of mitral regurgitation, severity of diastolic dysfunction, O2 pulse and VE/VCO2 slope. At multivariate analysis, only VE/VCO2 slope and severe diastolic dysfunction (restrictive filling pattern) discriminated between the two groups. In particular, the association of restrictive filling pattern and VE/VCO2 slope ≥ 45 predicted 3-year mortality with sensitivity of 84% and specificity of 88%. Conclusions: Echocardiographic and cardiopulmonary data can identify high-risk elderly patients with systolic heart failure, who may need aggressive clinical management.


Author(s):  
E. G. Agafonov ◽  
M. A. Popov ◽  
D. I. Zybin ◽  
D. V. Shumakov

Rationale. Secondary, or functional, mitral regurgitation is the most common complication of heart failure. Dysfunction of one or more mitral valve structures occurs in 39–74% of patients thus complicating the course of the disease and significantly worsening the prognosis in patients with left ventricle dilatation. An unfavorable prognosis in patients with the development of mitral regurgitation is conditioned by the progressive changes that form a vicious circle: the continuing volume overload and dilatation of the left ventricle cause its remodeling, leading to further dilatation of the mitral valve annulus. Dysfunctions of the papillary muscles lead to the increased tension of the left ventricle wall and increased mitral regurgitation. Clinically, this process is manifested by the congestive heart failure progression and worsened prognosis of the further course, which in the future may lead to considering the inclusion of this patient group on the waiting list for heart transplantation.Purpose. The purpose of this article is to review the role of surgical management in patients with heart failure complicated by mitral regurgitation.Conclusions. The main principles of the treatment for functional mitral regurgitation include the reverse left ventricular remodeling and mitral valve repair or replacement surgery which lead to an improved quality of life, the transition of patients to a lower functional class, reduced hospital admission rates, and also to a regression or slower progression of the heart failure and to an improved survival.


2020 ◽  
Vol 7 ◽  
Author(s):  
Harish Sharma ◽  
Boyang Liu ◽  
Hani Mahmoud-Elsayed ◽  
Saul G. Myerson ◽  
Richard P. Steeds

Secondary mitral regurgitation (sMR) is characterized by left ventricular (LV) dilatation or dysfunction, resulting in failure of mitral leaflet coaptation. sMR complicates up to 35% of ischaemic cardiomyopathies (1) and 57% of dilated cardiomyopathies (2). Due to the prevalence of coronary artery disease worldwide, ischaemic cardiomyopathy is the most frequently encountered cause of sMR in clinical practice. Although mortality from cardiovascular disease has gradually fallen in Western countries, severe sMR remains an independent predictor of mortality (3) and hospitalization for heart failure (4). The presence of even mild sMR following acute MI reduces long-term survival free of major adverse events (1). Such adverse outcomes worsen as the severity of sMR increases, due to a cycle in which LV remodeling begets sMR and vice versa. Current guidelines do not recommend invasive treatment of the sMR alone as a first-line approach, due to the paucity of evidence supporting improvement in clinical outcomes. Furthermore, a lack of international consensus on the thresholds that define severe sMR has resulted in confusion amongst clinicians determining whether intervention is warranted (5, 6). The recent Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial (7) assessing the effectiveness of transcatheter mitral valve repair is the first study to demonstrate mortality benefit from correction of sMR and has reignited interest in identifying patients who would benefit from mitral valve intervention. Multimodality imaging, including echocardiography and cardiovascular magnetic resonance (CMR), plays a key role in helping to diagnose, quantify, monitor, and risk stratify patients for surgical and transcatheter mitral valve interventions.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
A Demirtola ◽  
TS Tan ◽  
A Mammadli ◽  
IM Akbulut ◽  
I Dincer

Abstract Funding Acknowledgements Type of funding sources: None. Purpose Cardiac resynchronization therapy (CRT) has  a positive effect on the improvement of functional mitral regurgitation in patients with low ejection heart failure. However geometric changes in the mitral valve apparatus, subvalvular structures and their contribution to  the improvement of mitral regurgitation after CRT have not  been clearly defined. The aim of our study was to evaluate the geometric parameters of mitral valve apparatus measured with 3Dimensional (3D) transesophageal echocardiography (TEE) before CRT implantation and to determine the parameters predicting the improvement of mitral regurgitation after CRT. Methods Thirty patients with moderate or severe mitral regurgitation with low EF heart failure planned for CRT implantation and had an indication for TEE were included in the study. Effective regurgitant orifice (ERO) and regurgitant volume (RV) measurements were performed before CRT implantation. Detailed quantitative measurements of mitral valve were done from recorded images by 3D TEE. ERO, RV measurements were repeated to evaluate mitral regurgitation at the end of 3rd month. Results There were no significant changes in left ventricular EF and left ventricular diameters at the end of 3rd month, whereas ERO and RV values were decreased. A statistically significant difference was found in  posterior leaflet angle between mitral regurgitation responder and non-responder groups.  (28,93 ± 8,41 vs 41,25 ± 10,90, p = 0,006). Conclusion Heart failure patients with moderate or severe functional mitral regurgitation who underwent CRT implantation were found to have lower posterior leaflet angle measured by 3D TEE in the patient group whose mitral regurgitation improved after CRT. Abstract Figure.


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