1384MitraClip treatment of functional mitral regurgitation - A meta-analysis

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.

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Agata Bielecka-Dabrowa ◽  
Ibadete Bytyçi ◽  
Stephan Von Haehling ◽  
Stefan Anker ◽  
Jacek Jozwiak ◽  
...  

Abstract Background The role of statins in patients with heart failure (HF) of different levels of left ventricular ejection fraction (LVEF) remains unclear especially in the light of the absence of prospective data from randomized controlled trials (RCTs) in non-ischemic HF, and taking into account potential statins’ prosarcopenic effects. We assessed the association of statin use with clinical outcomes in patients with HF. Methods We searched PubMed, EMBASE, Scopus, Google Scholar and Cochrane Central until August 2018 for RCTs and prospective cohorts comparing clinical outcomes with statin vs non-statin use in patients with HF at different LVEF levels. We followed the guidelines of the 2009 PRISMA statement for reporting and applied independent extraction by multiple observers. Meta-analyses of hazard ratios (HRs) of effects of statins on clinical outcomes used generic inverse variance method and random model effects. Clinical outcomes were all-cause mortality, cardiovascular (CV) mortality and CV hospitalization. Results Finally we included 17 studies (n = 88,100; 2 RCTs and 15 cohorts) comparing statin vs non-statin users (mean follow-up 36 months). Compared with non-statin use, statin use was associated with lower risk of all-cause mortality (HR 0.77, 95% confidence interval [CI], 0.72–0.83, P < 0.0001, I2 = 63%), CV mortality (HR 0.82, 95% CI: 0.76–0.88, P < 0.0001, I2 = 63%), and CV hospitalization (HR 0.78, 95% CI: 0.69–0.89, P = 0.0003, I2 = 36%). All-cause mortality was reduced on statin therapy in HF with both EF < 40% and ≥ 40% (HR: 0.77, 95% Cl: 0.68–0.86, P < 0.00001, and HR 0.75, 95% CI: 0.69–0.82, P < 0.00001, respectively). Similarly, CV mortality (HR 0.86, 95% CI: 0.79–0.93, P = 0.0003, and HR 0.83, 95% CI: 0.77–0.90, P < 0.00001, respectively), and CV hospitalizations (HR 0.80 95% CI: 0.64–0.99, P = 0.04 and HR 0.76 95% CI: 0.61–0.93, P = 0.009, respectively) were reduced in these EF subgroups. Significant effects on all clinical outcomes were also found in cohort studies’ analyses; the effect was also larger and significant for lipophilic than hydrophilic statins. Conclusions In conclusion, statins may have a beneficial effect on CV outcomes irrespective of HF etiology and LVEF level. Lipophilic statins seem to be much more favorable for patients with heart failure.


Author(s):  
Pedro M Lopes ◽  
Francisco Albuquerque ◽  
Pedro Freitas ◽  
Francisco Gama ◽  
Eduarda Horta ◽  
...  

Abstract Aims The concept of proportionate/disproportionate functional mitral regurgitation (FMR) has been limited by the lack of a simple way to assess it and by the paucity of data showing its prognostic superiority. The aim of this study was to evaluate the prognostic value of an individualized method of assessing FMR proportionality. Methods and results We retrospectively identified 572 patients with at least mild FMR and reduced left ventricular ejection fraction (&lt;50%) under medical therapy. To determine FMR proportionality status, we used an approach where a simple equation determined the individualized theoretical regurgitant volume (or effective regurgitant orifice area) threshold associated with haemodynamically significant FMR. Then, we compared the measured with the theoretical value to categorize the population into non-severe, proportionate, and disproportionate FMR. The primary endpoint was all-cause mortality. During a median follow-up of 3.8 years (interquartile range: 1.8–6.2), 254 patients died. The unadjusted mortality incidence per 100 persons-year rose as the degree of FMR disproportionality worsened. On multivariable analysis, disproportionate FMR remained independently associated with all-cause mortality [adjusted hazard ratio: 1.785; 95% confidence interval (CI): 1.249–2.550; P = 0.001]. The FMR proportionality concept showed greater discriminative power (C-statistic 0.639; 95% CI: 0.597–0.680) than the American (C-statistic 0.583; 95% CI: 0.546–0.621; P for comparison &lt;0.001) and European guidelines (C-statistic 0.584; 95% CI: 0.547–0.620; P for comparison &lt;0.001). When added to any of the before-mentioned guidelines, FMR proportionality also improved risk stratification by reclassifying patients into lower and higher risk subsets. Conclusion Disproportionate FMR is independently associated with all-cause mortality and improves the risk stratification of current guidelines.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
E D Merkel ◽  
A Behon ◽  
W R Schwertner ◽  
A Pinter ◽  
I Osztheimer ◽  
...  

Abstract Background Heart failure patients with diabetes mellitus (DM) have a higher risk for all-cause mortality and also for sudden cardiac death. We lack data on the effect of adding an implantable cardioverter defibrillator (ICD) to cardiac resynchronization therapy (CRT) on all-cause mortality in diabetic heart failure patients. Purpose We aimed to investigate the risk of DM on all-cause mortality in CRT patients, and to examine the beneficial effect of adding an ICD on all-cause mortality by left ventricular ejection fraction in CRT patients with or without DM. Methods We examined retrospectively 2525 patients who underwent CRT implantation based on the current guidelines at our clinic between June 2000 and September 2018, of which 928 (36%) had diabetes. The primary endpoint was all-cause mortality, also expressed as events per 100 person-year by quintiles of ejection fraction (EF) with or without an ICD or DM. Time to event data was investigated by Kaplan Meier and multivariate Cox regressional analysis. Results During our mean follow-up time of 4.6 years, 1432 (56%) patients reached the primary endpoint, of which 553 (38%) had DM. In the DM group, hypertension (82% vs. 66%; p‹0.01), ischemic etiology (56% vs. 44%; p‹0.01), myocardial infarction (43% vs. 36%; p‹0.01) was more frequent compared to non-DM group. There was no difference between the two groups regarding the implantation of an ICD (54% vs. 53%; p = 0,84). Those with DM showed a 25% higher risk of all-cause mortality (HR 1.25; 95% CI 1.12-1.40; p‹0.01), also observable after adjusting for relevant clinical covariates such as age, gender, atrial fibrillation and the addition of an ICD (HR 1.17; 95% CI 1.06-1.31; p‹0.01). Examined as all-cause mortality per 100 person-year follow up, patients with EF›30% and DM (13,7 events/ 100 person-year follow-up for an EF 30-35%) showed similar risk as those without DM and a severely impaired left ventricular function with EF‹25% (14 events/100 person-year follow-up for an EF &lt;25%). Investigating the composite end-point of all-cause mortality and heart failure hospitalization, those with DM showed a 21% higher risk than non-DM CRT patients (HR 1.21; CI 1.09-1.34; p = 0 &lt; 0.001). Adding an ICD for CRT patients with DM reduces the risk of all-cause mortality significantly by 32% (HR 0,68; CI 0,56 to 0,82; p &lt; 0.001) during the first six years but diminished on longer follow-up time. Conclusions Diabetes was found as an independent predictor of all-cause mortality in CRT patients. Those with a left ventricular ejection fraction above 30% have comparable risk of mortality as non-diabetic patients with a severely impaired left ventricular function. In diabetic CRT patients the addition of an ICD reduces the risk of all-cause mortality mostly seen in the first six years. These findings might implicate the relevance of adding an ICD to CRT even at a higher ejection fraction in those with severe comorbidities such as diabetes. Abstract Figure. All-cause mortality in CRT, DM patients


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Noutsias ◽  
M Matiakis ◽  
B Bigalke ◽  
D Sedding ◽  
A Rigopoulos

Abstract Background Moderate-to-severe or severe functional mitral regurgitation (FMR) is associated with higher rates of hospitalizations and with increased mortality in heart failure (HF). 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 HF patients with moderate-to-severe or severe FMR treated by either medical treatment (MT) only versus TMVrMC+MT by meta-analysis. Methods and results By systematic search of bibliographic databases, we evaluated publications comparing HF 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 TMVrMC+MT (OR: 0.65; CI 95% 0.53–0.79), compared with the MT only patients. At 24 months, a significant reduction of all-cause mortality in the TMVrMC+MT patient group (OR: 0.54; CI: 95%: 0.43–0.67; p&lt;0.001) was calculated. 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&lt;0.001) and at 24 months (OR: 0.53; 95% CI: 0.39–0.71; p&lt;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 up to 24 months after MitraClip implantation. However, the discordant results of 2 randomized controlled trials (MITRA-FR and COAPT) warrant further clarification, i.e. of the eligible FMR patient profiles who might benefit from TMVrMC+MT in terms of improvement of prognosis. These data imply additional evidence for TMVrMC in eligible HF patients with relevant FMR, which might be important for an update of the corresponding guidelines. Funding Acknowledgement Type of funding source: None


2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
P Lopes ◽  
F Albuquerque ◽  
P Freitas ◽  
F Gama ◽  
E Horta ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background   Despite its theoretical appeal, the concept of Proportionate and Disproportionate FMR has been limited by the lack of a simple way to assess it and by the paucity of data showing its prognostic superiority over currently established ways of grading FMR. Objectives This study sought to evaluate the prognostic value of a new and individualized method of assessing Functional Mitral Regurgitation (FMR) Proportionality. Methods Patients with at least mild FMR and reduced left ventricular ejection fraction (&lt; 50%) under optimal guideline-directed medical therapy were retrospectively identified at a single-center. To determine FMR proportionality status, we used a novel approach where two simple equations establish an individual cut-off of regurgitant volume/effective regurgitant orifice area, categorizing the study population into non-severe, proportionate and disproportionate FMR (Figure 1). The primary endpoint was all-cause mortality. Results A total of 572 patients (median age 70 years; 76% male) were included. Median LVEF was 35% (IQR 28-40) and LVEDV was 169 ml (IQR 132-215). Disproportionate FMR was present in 109 patients (19%) with a median EROA of 26 mm2 (IQR 22-31) and a median RegVol of 40 ml (IQR 34-48), proportionate FMR in 148 patients (26%) with a median EROA of 16mm2 (IQR 12-21) and a median RegVol of 26 ml (IQR 19-32). During a median follow-up of 3.8 years (interquartile range: 1.8 to 6.2 years) there were 254 deaths (44%). The unadjusted mortality incidence per 100 persons-year rose as the degree of FMR disproportionality worsened. On multivariable analysis, disproportionate FMR remained independently associated with all-cause mortality (adjusted hazard ratio: 1.785; 95% confidence interval [CI]: 1.249 to 2.550; P = 0.001). The FMR proportionality concept showed greater discriminative power (C-statistic 0.639; 95% CI: 0.597 to 0.680) than the American (C-statistic 0.588; 95% CI: 0.550 to 0.626; P for comparison = .001) and European guidelines (C-statistic 0.563; 95% CI: 0.534 to 0.591; P for comparison &lt; .001). It was also able to increase the net reclassification index (0.167 [P &lt; 0.001] and 0.084 [P = 0.001], respectively). Conclusions A new, simplified and individualized method of assessing FMR Proportionality showed that disproportionate FMR is independently associated with all-cause mortality. This approach seems to outperform the risk stratification of current guidelines. Abstract Figure 1


2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
J Grand ◽  
K Miger ◽  
A Sajadieh ◽  
L Kober ◽  
C Torp-Pedersen ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): The Danish Heart Foundation Background In acute heart failure (AHF), low systolic blood pressure (SBP) has been associated with poor outcome. Less is known of the risk related to normal versus elevated SBP and interaction with left ventricular ejection fraction. Purpose The aim of the present study was to assess the association between baseline SBP and short- and long-term outcome in a large cohort of AHF-patients. Methods A pooled cohort of four randomized controlled trials investigating the vasodilator serelaxin versus placebo in patients admitted with AHF and an SBP from 125 to 180 mmHg. Endpoints were 180-day all-cause mortality and a short-term composite endpoint (worsening heart failure, all-cause mortality or hospital readmission for HF through Day 14). Left ventricular ejection fraction (LVEF) was categorized into HFrEF (&lt;40%) and HFpEF (= &gt;40%). Multivariable Cox regression was used and adjusted for age, sex, baseline body mass index, HFrEF, serum estimated glomerular filtration rate, allocated treatment (placebo/serelaxin), diabetes mellitus, ischemic heart disease, and atrial fibrillation/flutter. Measurements and Main Results A total of 10.533 patients with a mean age of 73 (±12) years and median SBP of 140 (130-150) mmHg were included within mean 8.2 hours from admission. LVEF was assessed in 8493 (81%), and of these, 4294 (51%) had HFrEF. Increasing SBP as a continuous variable was inversely associated with 180-day mortality (HRadjusted: 0.93 [0.88-0.98], p = 0.004 per 10 mmHg increase) and with the composite endpoint (HRadjusted: 0.90 [0.85-0.95], p &lt; 0.0001 per 10 mmHg increase). A significant interaction was observed regarding LVEF, revealing that SBP was not associated with mortality in patients with HFpEF  (HRadjusted: 1.01 [0.94-1.09], p = 0.83 per 10 mmHg increase), but SBP was associated with increased mortality in HFrEF (HRadjusted: 0.80 [0.73-0.88], p &lt; 0.001 per 10 mmHg increase) (Figure). Conclusions Elevated SBP is independently associated with favorable short- and long-term outcome in AHF-patients. The association between SBP and mortality was, however, not present in patients with preserved LVEF. Abstract Figure. Survival plots by SBP and LVEF


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