scholarly journals 812 Prognostic impact of the COAPT inclusion and exclusion criteria in real-world patients with secondary mitral regurgitation undergoing MitraClip implantation

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 >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). 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.

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.


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.


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.


Author(s):  
Ayse Demirtola ◽  
Turkan Tan ◽  
Anar Mammadli ◽  
irem Muge Akbulut ◽  
Demet Gerede ◽  
...  

Purpose: Cardiac resynchronization therapy (CRT) has a positive effect on the improvement of functional mitral regurgitation in patients with heart failure with reduced ejection fraction. 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: In this prospective study 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. 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 third month follow-up, whereas ERO and RV values were decreased. posterior leaflet angle was found higher in non-responder group compared to responder group. (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 lower posterior leaflet angle which was measured by 3D TEE in the patient group whose mitral regurgitation improved after CRT.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Naoko Ikeda ◽  
Kohei Wakabayashi ◽  
Kaoru Tanno ◽  
Hiroki Yamaguchi

Introduction: Atrial functional mitral regurgitation (AFMR) is one of the significant factors to worsen the outcomes in heart failure. The optimal therapy for AFMR is still controversial. Previous studies reported AFMR patients underwent mitral valve repair alone frequently had heart failure re-hospitalization or stroke after surgery. New guidelines recommend adding surgical ablation as a concomitant procedure for class I indications. However, many surgeons avoid concomitant procedure especially in patients with extremely enlarged left atrium (LA) and long atrial fibrillation (AF) duration. Hypothesis: Routine strategy of adding surgical ablation and appendectomy and aggressive LA plication to mitral valve repair might improve the outcomes with keeping sinus rhythm and without stroke events in AFMR patients. Methods and Results: We investigated 35 consecutive patients with severe AFMR who underwent surgery in our institute between 2014 and 2018. Our strategy was Cox-maze IV and appendectomy for all patients and if LA volume was more than 200 ml by echocardiography, we added LA plication. In addition to clinical data and conventional echocardiographic assessment (Table), left ventricular (LV) function was evaluated using 2D speckle tracking echocardiography. MR grade improved in all patients. Despite enlarged LA, 76% of patients regained sinus rhythm and atrial kick was detected by pulse doppler method (mean value: 55 ± 19 cm/s). After 2-year follow-up, LV global longitudinal strain and LA peak strain were significantly improved (Table). During 4.1 ± 1.3 years observation, no patient experienced heart failure re-hospitalization and stroke. Conclusions: Majority of AFMR patients had long duration of AF and severely enlarged LA. The routine Cox-maze IV, appendectomy and aggressive LA plication in enlarged LA patients improved LV and LA function. This strategy may contribute to the better long-term outcomes of AFMR compared to mitral valve repair alone.


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.


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


2020 ◽  
Vol 21 (1) ◽  
pp. 52-60 ◽  
Author(s):  
Tomás Benito-González ◽  
Rodrigo Estévez-Loureiro ◽  
Pedro A. Villablanca ◽  
Patrizio Armeni ◽  
Ignacio Iglesias-Gárriz ◽  
...  

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