Cardiac contractility modulation therapy in elderly patients with chronic heart failure: results of the 12-month follow-up

Aim. This study aimed to evaluate the efficacy and safety of cardiac contractility modulation (CCM) therapy in elderly patients with heart failure with reduced ejection fraction (HFrEF).Methods. Sixteen patients older than 65 years old (median age 70 years) undergoing CCM Optimizer (Impulse Dynamics) device implantation due to HFrEF (NYHA class II - 9 (56%), III - 4 (25%), IV - 3 (19%)) were enrolled in this two-center observational study. Before implantation 6-minute walk test (6MWT), transthoracic echocardiography (TTE) was performed on all patients, and NTproBNP levels were assessed. The follow-up duration was 12 months with 2, 6, 12-month follow-up visits. Control 6MWT, TTE and NTproBNP tests were performed at 6-month and 12-month follow-up visits.Results. Two patients died during follow-up due to HF decompensation. The remaining patients showed a significant improvement in 6MWT (350 m vs 402.5 m, p=0,01). We also noted a tendency towards the left ventricular EF improvement (33% vs 40%, p=0,2) and lower values of NTproBNP levels (1112 pg/ml vs 527 pg/ml, p=0,19).Conclusion. CCM therapy is a safe and efficient additional treatment option to manage elderly patients with HFrEF for reducing signs and symptoms of HF.

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Two-year follow-up of patients with heart failure with reduced ejection fraction receiving cardiac contractility modulation

Russian Journal of Cardiology ◽

10.15829/1560-4071-2020-3853 ◽

2020 ◽

Vol 25 (7) ◽

pp. 3853

Author(s):

M. A. Vander ◽

E. A. Lyasnikova ◽

L. A. Belyakova ◽

M. A. Trukshina ◽

V. L. Galenco ◽

...

Keyword(s):

Heart Failure ◽

Independent Predictor ◽

Nyha Class ◽

Cardiac Contractility ◽

Composite Endpoint ◽

Class Ii ◽

Cardiac Contractility Modulation ◽

Reduced Ejection Fraction ◽

Patients With Heart Failure

Aim. To assess the 2-year prognosis of patients with heart failure with reduced ejection fraction (HFrEF) receiving cardiac contractility modulation (CCM).Material and methods. This single-center observational study included 55 patients (46 men, mean age 53±11 years) with NYHA class II-III HFrEF receiving optimal medical therapy, with sinus rhythm, QRS <130 ms or QRS<150 ms with nonspecific intraventricular conduction delay. NYHA class II and III were established in 76% and 24% of patients, respectively. All patients were implanted with CCM devices between October 2016 and September 2017. Follow-up visits were carried out every 3 months during the 1st year and every 6 months during the 2nd year of observation. The primary composite endpoint was mortality and heart transplantation. Secondary composite endpoints included death, heart transplantation, paroxysmal ventricular tachycardia/ ventricular fibrillation, hospitalizations due decompensated HFResults. The one-year and two-year survival rate was 95% and 80%, respectively. Primary endpoint was observed in 20% of patients. NYHA class III and higher levels of N-terminal pro-brain natriuretic peptide (NTproBNP) were associated with unfavorable prognosis (p=0,014 and p=0,026, respectively). NTproBNP was an independent predictor of survival (p=0,018). CCM contributed to a significant decrease in hospitalizations due to decompensated HF (p<0,0001). The secondary endpoint was observed in 18 (33%) of patients during the 1st year. The predictor for the secondary composite endpoint was NTproBNP (p=0,047).Conclusion. CCM is associated with a significant decrease in hospitalization rate due to decompensated HF. The 2-year survival rate of patients with NYHA class II-III HF receiving CCM was 80%. The NTproBNP level was an independent predictor of survival in patients receiving CMM for 2 years. Further longer-term studies of the CCM efficacy are required.

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Cardiac Contractility Modulation Therapy for Heart Failure – First Romanian Experience

Romanian Journal of Cardiology ◽

10.47803/rjc.2021.31.3.609 ◽

2021 ◽

Vol 31 (3) ◽

pp. 609-614

Author(s):

Diana TINT ◽

◽

Sorin MICU ◽

Keyword(s):

Heart Failure ◽

Nyha Class ◽

Cardiac Contractility ◽

Case Series ◽

Cardiac Resynchronization ◽

Cardiac Contractility Modulation ◽

Reduced Ejection Fraction ◽

Cardiac Contractile ◽

Patients With Heart Failure

Aim: The purpose of this study is to present the first Romanian case-series of patients with heart failure with reduced ejection fraction (HFrEF), supported with the newest generation of cardiac contractility modulation (CCM) device. Methods and results: 16 patients (15 men), aged 66.6±7.49 years, were supported with OPTIMIZER® smart IPG CCMX10 device and followed-up for an average duration of 385.75±326.32 days. The etiology of HF was ischemic in 13 patients (81%), 8 patients (50%) had atrial fibrillation, mean creatinine clearance value was 55.8±13.87 ml/min, and 5 patients (31,2%) had diabetes mellitus. All patients were supported with an implanted cardio verter-defibrillator (ICD), while 5 patients (31.2%) had cardiac resynchronization therapy (CRT) on top. The pharma cological treatment has been optimized in all patients. Six months after implantation, the LVEF has increased from 25.93%±6.21 to 35.5%±4.31 (p=0.00002), NYHA class improved from 3.18±0.4 to 1.83±0.38 (p<0.0001), and exercise tolerance evaluated with 6 minute walking test (6MWT) increased (from 321.87±70.63m to 521.41±86.43m; p<0,00001). Three patients (18,7%) died during the follow-up period after 48, 108 and 545 days (one non-cardiac death). Conclusions: Cardiac contractile therapy is a feasible, safe, and useful therapy for patients with HFrEF whose symptomatology is not improved with optimal standard therapy.

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164 Effect of cardiac contractility modulation therapy on myocardial work in patients with heart failure with reduced ejection fraction

European Heart Journal Supplements ◽

10.1093/eurheartj/suab139.024 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Daniele Masarone ◽

Stefano De Vivo ◽

Vittoria Errigo ◽

Antonio D’ Onofrio ◽

Giuliano D’Alterio ◽

...

Keyword(s):

Heart Failure ◽

Ejection Fraction ◽

Cardiac Contractility ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Cardiac Contractility Modulation ◽

Reduced Ejection Fraction ◽

Constructive Work ◽

Global Work ◽

The Impact

Abstract Aims Cardiac contractility modulation therapy (CCMT) has been shown to reduce hospitalizations and to improve quality of life in heart failure patients with reduced ejection fraction (HFrEF) who remain symptomatic despite disease-modifying therapies. Strain imaging derived myocardial work (MW) is an emerging tool for evaluating left ventricular mechanics by incorporating systolic deformation and afterload burden in the analysis. To evaluate prospectively the impact of CCMT in HFrEF patients on MW derived parameters in relation to standard echocardiographic indices. Methods and results We recruited 12 HFrEF patients with indications to CCMT according to current clinical practice. A comprehensive echo-Doppler evaluation, including speckle tracking derived assessment of global longitudinal strain (GLS), was performed before and after three months from the CCM device implantation. Parameters of MW such as global work index (GWI), global constructive work (GCW) global wasted work (GWW), and global work efficiency (GWE) were calculated according to standardized procedures. Median values (interquartile range) were compared for all those parameters from baseline and 3-month follow-up with Wilcoxon Rank Sum test for continuous variables. At three months from CCM implant an improvement of LVEF [from 32% (27–34) to 36% (29–39), P < 0.05], GLS [from 7.4% (6.2–11.2) to 9.9% (7.5–9.4), P < 0.05], GWI [from 461 mmHg (372–613) to 589 mmHg (413–696), P < 0.05], GCW [from 800 mmHg (620–930) to 970 mmHg (644–1009), P = 0.236], and GWE [from 73% (65–78) to 85% (78–87), P < 0.05] was observed, with a consistent reduction of GWW [from 161 mmHg (148–227) to 125 mmHg (101–188), P < 0.05]. We also found a positive correlation between the magnitude of LVEF improvement and the baseline values of GCW (r = 0.727, P = 0.011). Conclusions At 3 months, CCMT significantly improves standard and advanced left ventricular systolic function indices. This improvement is due to the increase of constructive work and a reduction of wasted work. In addition, the increase of left ventricular ejection fraction can be predicted by the global constructive work levels at baseline.

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Proportion of Patients Eligible for Cardiac Contractility Modulation: Real-Life Data from a Single-Center Heart Failure Clinic

Cardiology ◽

10.1159/000512946 ◽

2021 ◽

pp. 1-6

Author(s):

Dávid Pilecky ◽

Balázs Muk ◽

Zsuzsanna Majoros ◽

Dénes Vágány ◽

Krisztina Kósa ◽

...

Keyword(s):

Heart Failure ◽

Nyha Class ◽

Cardiac Contractility ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Class Iii ◽

Single Center ◽

Inclusion Criteria ◽

Treatment Optimization ◽

Cardiac Contractility Modulation

Introduction: Based on recently published randomized controlled trials, cardiac contractility modulation (CCM) seems to be an effective device-based therapeutic option in symptomatic chronic heart failure (HF) (CHF). The aim of the current study was to estimate what proportion of patients with CHF and left ventricular ejection fraction (LVEF) <50% could be eligible for CCM based on the inclusion criteria of the FIX-HF-5C trial. Methods: Consecutive patients referred and followed up at our HF clinic due to HF with reduced or mid-range LVEF were retrospectively assessed. After a treatment optimization period of 3–6 months, the inclusion criteria of the FIX-HF-5C trial (New York Heart Association (NYHA) class III/IV, 25% ≤ LVEF ≤45%, QRS <130 ms, and sinus rhythm) were applied to determine the number of patients eligible for CCM. Results: Of the 640 patients who were involved, the proportion of highly symptomatic patients in NYHA class III/IV decreased from 77.0% (n = 493) at baseline to 18.6% (n = 119) after the treatment optimization period (p < 0.001). Mean LVEF increased significantly from 29.0 ± 7.9% to 36.3 ± 9.9% (p < 0.001), while the proportion of patients with 25% ≤ LVEF ≤45% increased from 69.7% (n = 446) to 73.3% (n = 469) (p < 0.001). QRS duration was below 130 ms in 63.1% of patients, while 30.0% of patients had persistent or permanent atrial fibrillation. We found that the eligibility criteria for CCM therapy based on the FIX-HF-5C study were fulfilled for 23.0% (n = 147) of patients at baseline and 5.2% (n = 33) after treatment optimization. Conclusion: This single-center cohort study showed that 5% of patients with CHF and impaired LVEF immediately after treatment optimization fulfilled the inclusion criteria of the FIX-HF-5C study and would be candidates for CCM.

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The assessment of left ventricular myocardial work in patients with chronic heart failure receiving cardiac contractility modulation therapy

European Heart Journal ◽

10.1093/eurheartj/ehab724.0135 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

S Dobrovolskaya ◽

M Saidova ◽

A Safiullina ◽

T Uskach ◽

A Belevskaya ◽

...

Keyword(s):

Heart Failure ◽

Chronic Heart Failure ◽

Ejection Fraction ◽

Nyha Class ◽

Cardiac Contractility ◽

Left Ventricular ◽

Cardiac Contractility Modulation ◽

Device Implantation ◽

Echocardiographic Parameters ◽

Global Work

Abstract Introduction A new non-invasive technology for the assessment of left ventricular myocardial work (LVMW) is based on speckle-tracking echocardiography and considers LV pressure. Changes in LVMW are described in patients with different cardiovascular diseases. In patients with chronic heart failure (CHF), LVMW is associated with long-term prognosis and favorable response to cardiac resynchronization therapy. Purpose To study echocardiographic parameters, including LVMW, in patients with CHF receiving cardiac contractility modulation therapy. Methods The study included 40 patients (31 men and 7 women) aged 60.5 [55.0; 66.0] years with heart failure with reduced ejection fraction (NYHA class II or III) in combination with atrial fibrillation. Before implantation of cardiac contractility modulation (CCM) device and 2, 6 and 12 months after, the patients underwent transthoracic echocardiography with an assessment of the main structural and functional parameters. Also, initially and after 12 months of CCM therapy, an assessment of global longitudinal strain (GLS) and LVMW was performed (global work index (GWI), global constructive work (GCW), global wasted work, global work efficiency (GWE)). Results Initially, the patients included in the study had enlarged left heart chambers and decreased left ventricular ejection fraction (LVEF). CCM therapy was accompanied by significant increase in LVEF from 30.0 [26.5; 37.0]% before device implantation up to 34.4 [27.0; 40.0]% (p=0.016) after 2 months and up to 38.0 [30.5; 42.0]% (p<0.01) after 6 months of treatment. One year after device implantation, a significant increase in LVEF was maintained as compared with initial data (39 [31; 45]%, p<0.01). We also analyzed the dynamics of echocardiographic parameters depending on etiology of CHF (ischemic and non-ischemic). As in general group of patients regardless of CHF etiology there was a significant increase in LVEF, that reached maximum values after 12 months of therapy (36 [30; 42]% in group with ischemic etiology, p<0.01 and 37 [30; 45]% in group with non-ischemic etiology, p<0.01). The assessment of GLS before and 12 months after device implantation revealed no significant dynamics (−7 [−9; −4]% and −8 [−9; −5]%, p=0.93). However, we observed significant changes in LVMW: an increase in GWI from 429 [332; 744] to 635 [401; 815] mm Hg% (p=0.01) and GWE (from 73 [68; 79] to 74 [70; 87] %, p=0.02) due to an increase in GCW (from 791 [530; 1031] to 836 [708; 1109] mm Hg%, p=0.03). Conclusions A significant increase in LVEF, GWI and GWE in patients with CHF (NYHA class II or III) receiving CCM therapy indicates an improvement in LV systolic function and the effectiveness of CCM therapy. The modern echocardiographic technologies open great opportunities for detailed assessment of the effectiveness of treatment of patients with CHF, including the use of CCM devices. FUNDunding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Ministry of Health of Russian Federation

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Sacubitril/valsartan reduces indications for arrhythmic primary prevention in heart failure with reduced ejection fraction: insights from DISCOVER-ARNI, a multicenter Italian register

European Heart Journal Open ◽

10.1093/ehjopen/oeab046 ◽

2021 ◽

Author(s):

Maria Concetta Pastore ◽

Giulia Elena Mandoli ◽

Alberto Giannoni ◽

Giovanni Benfari ◽

Frank Lloyd Dini ◽

...

Keyword(s):

Heart Failure ◽

Primary Prevention ◽

Ejection Fraction ◽

Nyha Class ◽

Global Longitudinal Strain ◽

Left Ventricular ◽

Volume Index ◽

Early Therapy ◽

Reduced Ejection Fraction

Abstract Background This sub-study deriving from a multicenter Italian register (DISCOVER-ARNI) investigated whether sacubitril/valsartan in adjunction of optimal medical therapy(OMT) could reduce the rate of implantable cardioverter-defibrillator(ICD) indications for primary prevention in heart failure with reduced ejection fraction(HFrEF) according to European guidelines indications, and its potential predictors. Methods In this observational study, consecutive patients with HFrEF eligible for sacubitril/valsartan from 13 Italian centers were included. Lack of follow-up or speckle tracking data represented exclusion criteria. Demographic, clinical, biochemical and echocardiographic data were collected at baseline and after 6 months from sacubitril/valsartan initiation. Results Of 351 patients, 225(64%) were ICD carriers and 126(36%) were not ICD carriers (of whom 13 had not indication) at baseline. After 6 months of sacubitril/valsartan, among 113 non-ICD carriers despite having baseline left ventricular (LV)EF≤35% and New York Heart Asscociation(NYHA) class=II-III, 69(60%) did not show ICD indications; 44(40%) still fulfilled ICD criteria. Age, atrial fibrillation, mitral regurgitation>moderate, left atrial volume index(LAVi), and LV global longitudinal strain(GLS) significantly varied between the groups. With ROC curves, age≥75 years, LAVi≥42ml/m2 and LV GLS≥-8.3% were associated with ICD indications persistence (AUC=0.65,=0.68,=0.68 respectively). With univariate and multivariate analysis, only LV GLS emerged as significant predictor of ICD indications at follow-up in different predictive models. Conclusions Sacubitril/valsartan may provide early improvement of NYHA class and LVEF, reducing the possible number of implanted ICD for primary prevention in HFrEF. Baseline reduced LV GLS was a strong marker of ICD indication despite OMT. Early therapy with sacubitril/valsartan may save infective/hemorrhagic risks and unnecessary costs deriving from ICDs.

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Cardiac contractility modulation efficacy: is there a difference between ischemic vs. non-ischemic patients?

European Heart Journal ◽

10.1093/ehjci/ehaa946.1117 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

C Fastner ◽

I Akin ◽

G Yuecel ◽

B Rudic ◽

I El-Battrawy ◽

...

Keyword(s):

Risk Score ◽

Nyha Class ◽

Cardiac Contractility ◽

Mortality Rates ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Reverse Remodeling ◽

Cardiac Contractility Modulation ◽

Over Time

Abstract Background/Introduction Cardiac contractility modulation (CCM) is an FDA approved device therapy for systolic heart failure patients with narrow QRS complex who are symptomatic despite optimal medical therapy. It is used in patients with a wide range of different cardiomyopathies. However, little is known whether the therapy is comparably effective in different entities. Purpose This work investigated the long-term therapeutic effect in patients with ischemic (ICMP) compared to patients with non-ischemic cardiomyopathy (NICMP). Methods 102 patients of our single center registry with known form of cardiomyopathy were included in this retrospective analysis (from 2011–2019). In 68 patients data of a clinical 3-year follow-up were available. The actual mortality rate within one and three years was compared with the one predicted by the MAGGIC risk score and compared between the two groups. In addition, changes in NYHA class, left ventricular ejection fraction (LVEF), LV end-diastolic diameter (LVEDD) and NT-proBNP values were compared as functional parameters. Results Patients with an ICMP (65%) were older (67±1 vs. 57±2 years (SD±SEM); p<0.001) but had a comparable MLHFQ score (42±3 vs. 48±6; p=NS), mean peak VO2 (9.7±1.2 vs. 14.5±2.2 ml/kg/min; p=NS) and QRS width (115±3 vs. 112±4 ms; p=NS). Both groups initially had a comparably advanced limitation during physical activity (median NYHA class III; p=NS); 40% of patients responded with an improvement of at least 1 NYHA class within 3 years (p=NS). The LVEF was 24±1 vs. 22±1% in the beginning and improved to 32±2 vs. 38±2% within 3 years (+33 vs. +73%; p<0.001 in comparison over time; p<0.001 in comparison of the percentage changes ICMP vs. NICMP). While LVEDD was initially significantly wider in NICMP patients (51±2 vs. 67±2 mm; p<0.001), this was offset under therapy, mainly due to a reduction in LVEDD in NICMP patients (+3±2 vs. −7±3 mm; p=0.023). The NT-proBNP values decreased from 4872±776 vs. 5354±1153 to 2051±578 vs. 843±363 ng/l (−58 vs. −84%; p=NS in comparison over time; p=0.093 in comparison of the percentage changes ICMP vs. NICMP). ICMP patients had a higher MAGGIC risk score (27±1 vs. 24±1; p=0.019). Mortality rates at 1 year were 7.4 vs. 17.1% and at 3 years 40.5 vs. 35.5% (each p=NS) compared to mortality rates estimated from the MAGGIC risk score of 21.2 vs. 16.0% (p=0.028) and 44.0 vs. 37.2% (p=0.071), respectively. Chi-square test for comparison of observed and expected frequencies revealed that the number of deaths during 1-year follow-up was significantly lower than predicted only in ICMP patients (p=0.018 compared to the estimated risk). Conclusions NICMP patients had a significantly greater increase in LVEF. Moreover, reverse remodeling with reduction of the LVEDD was only observed in NICMP patients. In summary, significant differences in functional therapy response could be identified between ICMP vs. NICMP patients. Funding Acknowledgement Type of funding source: None

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P3523Cardiac contractility modulation provides improved ventilatory efficiency and reduces oscillatory breathing pattern

European Heart Journal ◽

10.1093/eurheartj/ehz745.0387 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

D Schoene ◽

A Aweimer ◽

L Boesche ◽

P Patsalis ◽

J Zeidler ◽

...

Keyword(s):

Heart Failure ◽

Breathing Pattern ◽

Cardiac Contractility ◽

Cardiopulmonary Exercise Testing ◽

Control Group ◽

Cardiac Contractility Modulation ◽

Ventilatory Efficiency ◽

Reduced Ejection Fraction ◽

Patients With Heart Failure

Abstract Introduction Cardiac Contractility Modulation (CCM) is a treatment for patients with heart failure with reduced ejection fraction (HFrEF) providing improved myocardial molecular and biochemical characteristics and thus improved exercise tolerance and quality of life by application of electrical signals during the absolute refractory period. Cardiopulmonary exercise testing is an integrative method to assess exercise tolerance in heart failure patients providing insights in circulatory, respiratory and metabolic reactions during exercise. The VE/VCO2-Slope (minute ventilation/carbon dioxide production) and an oscillatory breathing pattern have widely been demonstrated to have strong prognostic value for patients with chronic heart failure. Methods Between February 2017 and January 2019 15 patients (mean age 64.4±7.9 years, NYHA 2.93±0.58) with standard indication for CCM-therapy have been enrolled in a single center in Germany. Prior to implantation of the Optimizer Smart System, symptom-limited cardiopulmonary exercise testing was performed using a bicycle ramp protocol (25W+10W/min). The Follow-up was conducted 6 weeks post implantation. The control group consisted of 45 patients (mean age 64.8±7.9 years, NYHA 2.2±0.72) with stable systolic heart failure and reduced ejection fraction. Statistical Analysis was performed by paired and unpaired t tests. Results 6 weeks after CCM-implantation the VE/VCO2-Slope showed a significant decrease (39.6±11.1 vs. 36.6±8.9, p<0.05) showing changes in ventilatory efficiency whereas the control-group showed stable measurements with even an increasing tendency (33.6±7.4 vs. 34.2±7.4, p=0.43). The absolute change of the VE/VCO2-Slope between the CCM-group and control-group highlights the improvement after the intervention (−2.99±5.07 vs. 0.63±4.79, p<0.05). The number of patients presenting an oscillatory breathing pattern markedly decreased with CCM-therapy (11 of 15 vs. 6 of 15, p<0.05), whereas even one additional patient of the control group showed an oscillatory breathing pattern at follow up (15 of 45 vs. 16 of 45). In contrast, subjects showed no significant changes in watt-measurements (72.67 W ± 19.2 W vs. 76.57 W ± 18.5 W) or maximal oxygen uptake (1034 ml/min ± 247 ml/min vs. 1104 ml/min ± 256 ml/min) compared to baseline. Similarly, the control-group showed stable measurements for external load (79.9 W ± 16.4 W vs. 77.1 W ± 17.5 W) and peak oxygen uptake (1097 ml/min ± 225 ml/min vs. 1116 ml/min ± 330 ml/min). Conclusion Cardiac Contractility Modulation provides improved ventilatory efficiency measures by VE/VCO2-slope and reduces oscillatory breathing pattern during exercise at follow up. As the low ventilatory efficiency observed in patients with heart failure constitutes an important predictor of cardiovascular mortality these results provide an interesting insight of therapeutic effects of Cardiac Contractility Modulation apart from VO2-measurements.

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279 Medical treatment with ARNI may reduce indications for primary prevention of sudden cardiac death in heart failure with reduced ejection fraction: insights from discover-ARNI, a multicentre Italian register

European Heart Journal Supplements ◽

10.1093/eurheartj/suab139.039 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Maria Concetta Pastore ◽

Giulia Elena Mandoli ◽

Alberto Giannoni ◽

Giovanni Benfari ◽

Frank Lloyd Dini ◽

...

Keyword(s):

Heart Failure ◽

Primary Prevention ◽

Ejection Fraction ◽

Nyha Class ◽

Global Longitudinal Strain ◽

Left Ventricular ◽

Volume Index ◽

Early Therapy ◽

Reduced Ejection Fraction

Abstract Aims This sub-study deriving from a multicentre Italian register (DISCOVER-ARNI) investigated whether sacubitril/valsartan in adjunction of optimal medical therapy (OMT) could reduce the rate of implantable cardioverter-defibrillator(ICD) indications for primary prevention in heart failure with reduced ejection fraction (HFrEF) according to European guidelines indications, and its potential predictors. Methods and results In this observational study, consecutive patients with HFrEF eligible for sacubitril/valsartan from 13 Italian centres were included. Lack of follow-up or speckle tracking data represented exclusion criteria. Demographic, clinical, biochemical and echocardiographic data were collected at baseline and after 6 months of therapy. Of 351 patients, 225 (64%) were ICD carriers and 126 (36%) were not ICD carriers (of whom 13 had not indication) at baseline. After 6 months of sacubitril/valsartan, among 113 non-ICD carriers despite having baseline left ventricular (LV)EF ≤ 35% and New York Heart Association (NYHA) class = II–III, 69(60%) did not show ICD indications; 44(40%) still fulfilled ICD criteria (Figure 1). Age, atrial fibrillation, mitral regurgitation>moderate, left atrial volume index (LAVi), and LV global longitudinal strain (GLS) significantly varied between the groups. With ROC curves, age ≥ 75 years, LAVi ≥ 42 ml/m2 and LV GLS ≥ −8.3% were associated with ICD indications persistence (AUC = 0.65, 0.68, and 0.68, respectively). With univariate and multivariate analysis, age and LV GLS emerged as the only significant predictors of ICD indications at follow-up. Conclusions Sacubitril/valsartan provided early improvement of NYHA class and LVEF, reducing the possible number of implanted ICD for primary prevention in HFrEF. Baseline advanced age and reduced LV GLS were markers of ICD indication despite OMT. Early therapy with sacubitril/valsartan may save infective/haemorrhagic risks and unnecessary costs deriving from ICDs.

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P1491Cardiac contractility modulation in patients with chronic heart failure and atrial fibrillation: 6 months of follow-up

EP Europace ◽

10.1093/europace/euaa162.381 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

O Sapelnikov ◽

T M Uskach ◽

D I Cherkashin ◽

I R Grishin ◽

D F Ardus ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Nyha Class ◽

Cardiac Contractility ◽

Left Ventricular ◽

Functional Class ◽

Left Ventricular Ejection ◽

Walk Test ◽

Ventricular Ejection Fraction

Abstract Background Heart failure is developed in 30% of patients with atrial fibrillation (AF). It significantly worsens the prognosis and evaluates the fatal risks for patients. Cardiac Contractility Modulation (CCM) is a new therapeutic device for heart failure, which is used in patients with narrow QRS complexes who are refractory to medical therapy. Purpose The aim of current study is to demonstrate the effects of CCM on patients with heart failure and AF, influencing on NT-proBNP dynamics and 6 min walk test (6-MWT). Methods Fourty patients (40) with symptomatic heart failure (II-III NYHA class), persistent/paroxysmal AF and reduced left ventricular ejection fraction (LVEF ≤ 40%) were included. The average age was 60 ± 6 years. MeanLA-volume was 120± 22 ml and NT-proBNP level was 1336 ± 278pg/ml.A 6-MWT was 246 ± 33 m. All patients were implanted with a CCM Optimizer according to the protocol of implantation without an atrial lead. The study compared the mean state changes from baseline to 6 months’ follow-up. Results In 6 months’ follow-up we observed a significant improvement in functional and symptomatic parameters. NT-proBNP level was 1021 ± 153 pg/ml and mean 6 MWT values were 300 ± 26 m. NYHA improved by at least 1 functional class. MeanLA-volume after 6 months of follow-up was 104,5± 18 ml. Conclusions CCM is an effective and safe technology for patients with symptomatic HF. It significantly improves functional parameters, including a 6-minute walk test and NYHA functional class. CCM may prevent HF progression and may influence the outcome.

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