scholarly journals Closed loop stimulation in heart failure patients with severe chronotropic incompetence: responder versus non-responders

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
J Proff ◽  
B Merkely ◽  
R Papp ◽  
C Lenz ◽  
P Nordbeck ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Biotronik SE & Co. KG Woermannkehre 1 12359 Berlin Background The prevalence of chronotropic incompetence (CI) in heart failure (HF) population is high and negatively impacts prognosis. Rate-adaptive pacing (RAP) is an important treatment option for CI. However, only a proportion of HF patients treated with cardiac resynchronisation therapy (CRT) devices benefit from accelerometer-based RAP in terms of exercise tolerance, functional capacity, and quality of life (QoL). Further research is needed to identify patient characteristics predicting positive response to RAP, and to evaluate performance of alternative sensors such as closed loop stimulation (CLS) driven by cardiac impedance measurements. An optimal outcome measure is represented by ventilatory efficiency (VE) slope during cardio-pulmonary exercise test (CPX) because of superior prognostic value. Purpose The purpose of the BIO|Create pilot study was to assess the benefit of CLS in CRT patients with CI. In this predefined subanalysis, we identify predictors of positive response to CLS (reduction of VE slope by ≥5%) and compare study outcomes in responders vs non-responders. Methods The study enrolled CRT patients with NYHA class II or III and severe CI (<75% of age-predicted maximum heart rate [HR] or <50% of HR reserve utilised at end-exercise). Patients were randomised to DDD-CLS mode or to DDD pacing at 40 beats/min for 1 month, followed by crossover for another month. At 1- and 2-month follow-ups, exercise tolerance was assessed by treadmill CPX, functional capacity by 6-min walk test, and QoL by the EQ-5D-5L and Minnesota Living with HF (MLHFQ) questionnaires. Results Among 17 patients with full follow-up datasets, 8 (47%) were responders to CLS. Compared to non-responders, responders had larger left ventricular (LV) ejection fraction at baseline (46 ± 3 vs 36 ± 9 %; p = 0.0070), smaller end-diastolic (121 ± 34 vs 181 ± 41 ml; p = 0.0085) and end-systolic (65 ± 23 vs 114 ± 39 ml; p = 0.0076) LV volumes, and were predominantly in NYHA class II (p = 0.0498). For study outcomes, the mean difference between DDD-CLS and DDD-40 modes in responders vs non-responders was - 6.1 (-16.4%) vs +2.7 (+6.8%) for VE slope (both p < 0.05), +0.5 vs -0.2 ml/min (O2 uptake efficiency slope), +1.3 vs -0.3 ml/kg/min (peak O2 uptake), +1.4 vs -0.75 mmHg (end-exercise end-tidal CO2), 16 vs 7 m (6-min walk distance), 0.08 vs 0.06 (EQ-5D-5L index), 1.9 vs 0 (EQ-5D-5L scale), and -2.5 vs +1.75 (MLHFQ). Conclusions For the first time, predictors for positive outcome of RAP in CRT patients have been identified. Patients with less advanced HF were responders to RAP driven by CLS principle. In addition, a consistent increase in exercise and functional capacity and QoL in these patients could be achieved. In contrast, patients with advanced HF experienced worse exercise capacity and QoL during RAP, suggesting caution if RAP is desirable due to CI. Further clinical research is needed to evaluate if positive response to RAP can improve hard clinical outcomes.

2014 ◽  
Vol 8 ◽  
pp. CMC.S14016 ◽  
Author(s):  
Carlo Lombardi ◽  
Valentina Carubelli ◽  
Valentina Lazzarini ◽  
Enrico Vizzardi ◽  
Filippo Quinzani ◽  
...  

Amino acids (AAs) availability is reduced in patients with heart failure (HF) leading to abnormalities in cardiac and skeletal muscle metabolism, and eventually to a reduction in functional capacity and quality of life. In this study, we investigate the effects of oral supplementation with essential and semi-essential AAs for three months in patients with stable chronic HF. The primary endpoints were the effects of AA's supplementation on exercise tolerance (evaluated by cardiopulmonary stress test and six minutes walking test (6MWT)), whether the secondary endpoints were change in quality of life (evaluated by Minnesota Living with Heart Failure Questionnaire—MLHFQJ and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. We enrolled 13 patients with chronic stable HF on optimal therapy, symptomatic in New York Heart Association (NYHA) class II/III, with an ejection fraction (EF) <45%. The mean age was 59 ± 14 years, and 11 (84.6%) patients were male. After three months, peak VO2 (baseline 14.8 ± 3.9 mL/minute/kg vs follow-up 16.8 ± 5.1 mL/minute/kg; P = 0.008) and VO2 at anaerobic threshold improved significantly (baseline 9.0 ± 3.8 mL/minute/kg vs follow-up 12.4 ± 3.9 mL/minute/kg; P = 0.002), as the 6MWT distance (baseline 439.1 ± 64.3 m vs follow-up 474.2 ± 89.0 m; P = 0.006). However, the quality of life did not change significantly (baseline 21 ± 14 vs follow-up 25 ± 13; P = 0.321). A non-significant trend in the reduction of NT-proBNP levels was observed (baseline 1502 ± 1900 ng/L vs follow-up 1040 ± 1345 ng/L; P = 0.052). AAs treatment resulted safe and was well tolerated by all patients. In our study, AAs supplementation in patients with chronic HF improved exercise tolerance but did not change quality of life.


2020 ◽  
Vol 19 (7) ◽  
pp. 592-599 ◽  
Author(s):  
Bruno Miguel Delgado ◽  
Ivo Lopes ◽  
Bárbara Gomes ◽  
André Novo

Background: Decompensated heart failure patients are characterised by functional dependence and low exercise tolerance. Aerobic exercise can improve symptoms, functional capacity and an increase in exercise tolerance. However, the benefits of early rehabilitation have not yet been validated. Objective: To evaluate the safety and feasibility of an aerobic exercise training programme in functional capacity of decompensated heart failure patients. Methodology: A single centre, parallel, randomised controlled, open label trial, with 100 patients. The training group (TG, n=50) performed the training protocol and the control group (CG, n=50) performed the usual rehabilitation procedures. The London chest activity of daily living (LCADL) scale, the Barthel index (BI) and the 6 minute walking test (6MWT) at discharge were used to evaluate the efficacy of the protocol. Safety was measured by the existence of adverse events. Results: The mean age of the patients was 70 years, 20% were New York Heart Association (NYHA) class IV and 80% NYHA class III at admission. The major heart failure aetiology was ischaemic (35 patients) and valvular disease (25 patients). There were no significant differences between groups at baseline in terms of sociodemographic or pathophysiological characteristics. There was a statistically significant difference of 54.2 meters for the training group ( P=0.026) in the 6MWT and at LCADL 12 versus 16 ( P=0.003), but the BI did not: 96 versus 92 ( P=0.072). No major adverse events occurred. Conclusions: The training protocol demonstrated safety and efficacy, promoting functional capacity. This study elucidated about the benefits of a systematised implementation of physical exercise during the patient’s clinical stabilisation phase, which had not yet been demonstrated. Trial registration: Clinicaltrials.gov NCT03838003, URL: https://clinicaltrials.gov/ct2/show/NCT03838003 .


2012 ◽  
Vol 69 (10) ◽  
pp. 840-845 ◽  
Author(s):  
Dragana Stanojevic ◽  
Svetlana Apostolovic ◽  
Ruzica Jankovic-Tomasevic ◽  
Sonja Salinger-Martinovic ◽  
Milan Pavlovic ◽  
...  

Bacground/Aim. Chronic heart failure (CHF) is highly prevalent and constitutes an important public health problem around the world. In spite of a large number of pharmacological agents that successfully decrease mortality in CHF, the effects on exercise tolerance and quality of life are modest. Renal dysfunction is extremely common in patients with CHF and it is strongly related not only to increased mortality and morbidity but to a significant decrease in exercise tolerance, as well. The aim of our study was to investigate the prevalence and influence of the renal dysfunction on functional capacity in the elderly CHF patients. Methods. We included 127 patients aged over 65 years in a stable phase of CHF. The diagnosis of heart failure was based on the latest diagnostic principles of the European Society of Cardiology. The estimated glomerular filtration rate (eGRF) was determined by the abbreviated Modification of Diet in Renal Disease (MDRD2) formula, and patients were categorized using the Kidney Disease Outcomes Quality Initiative (K/DOQI) classification system. Functional capacity was determined by the 6 minute walking test (6MWT). Results. Among 127 patients, 90 were men. The average age was 72.5 ? 4.99 years and left ventricular ejection fraction (LVEF) was 40.22 ? 9.89%. The average duration of CHF was 3.79 ? 4.84 years. Ninty three (73.2%) patients were in New York Heart Association (NYHA) class II and 34 (26.8%) in NYHA class III. Normal renal function (eGFR ? 90 mL/min) had 8.9% of participants, 57.8% had eGFR between 60-89 mL/min (stage 2 or mild reduction in GFR according to K/DOQI classification), 32.2% had eGFR between 30-59 mL/min (stage 3 or moderate reduction in GFR) and 1.1% had eGFR between 15-29 mL/min (stage 4 or severe reduction in GFR). We found statistically significant correlation between eGFR and 6 minute walking distance (6MWD) (r = 0.390, p < 0.001), LVEF (r = 0.268, p < 0.05), NYHA class (? = -0.269, p < 0.05) and age (r = - 0.214, p < 0.05). In multiple regression analysis only patients? age was a predictor of decreased 6MWD < 300 m (OR = 0.8736, CI = 0.7804 - 0.9781, p < 0.05). Conclusion. Renal dysfunction is highly prevalent in the elderly CHF patients. It is associated with decreased functional capacity and therefore with poor prognosis. This study corroborates the use of eGFR not only as a powerful predictor of mortality in CHF, but also as an indicator of the functional capacity of cardiopulmonary system. However, clinicians underestimate a serial measurement of eGFR while it should be the part of a routine evaluation performed in every patient with CHF, particularly in the elderly population.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L.H Lund ◽  
U Zeymer ◽  
A.L Clark ◽  
V Barrios ◽  
T Damy ◽  
...  

Abstract Background In Europe, heart failure (HF) is managed in variable settings and frequently in office-based practice. In HF with reduced ejection fraction (HFrEF) there is now extensive evidence based therapy, but implementation is inconsistent, variable and overall inadequate. The Assessment of Real lIfe cAre –Describing EuropeaN hEart failure management (ARIADNE) registry aimed to assess in detail how outpatients with HFrEF are managed in Europe in contemporary practice. Methods ARIADNE was a prospective non-interventional registry of patients with HFrEF (NYHA class II-IV) treated by office-based cardiologists or selected primary care physicians (recognized as HF specialists) in a real world setting. Patients were enrolled in 687 centres in 17 European countries, and studied at baseline and after 6 and 12 months. Key pre-specified outcomes were deaths, hospitalizations, emergency department visits, and office visits, and their primary reasons. Results Over 20 months, we enrolled 9069 patients; median age 69 (19–96) years, 24% women, with 30% older than 75 years, 61% NYHA class II, with a median EF 35% (30–40%). Over a median follow-up of 353 (1–631) days, 382 patients (4.3%) died, with 171 cardiovascular deaths (1.9%). The rates of total hospitalizations overall, for HF, and for non-HF cardiovascular reasons were 19.3, 8.1, and 4.8 per 100 patient years, respectively; and rates of emergency department visits overall, for HF reasons, and for non-HF CV reason were 7.7, 1.6, and 1.8, respectively. The number of HF office visits were on average 1.0 per patient. Conclusions In this large multinational HFrEF registry with detailed data on cause-specific outcomes and health care utilization, incidence of death was low and outpatient HF visits were few, but incidence of HF and CV hospitalization and emergency department visits was high. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novartis AG, Switzerland


2021 ◽  
Vol 20 (7) ◽  
pp. 3068
Author(s):  
O. A. Osipova ◽  
E. V. Gosteva ◽  
T. P. Golivets ◽  
O. N. Belousova ◽  
O. A. Zemlyansky ◽  
...  

Aim. To compare the effect of 12-month pharmacotherapy with a betablocker (BB) (bisoprolol and nebivolol) and a combination of BB with a mineralocorticoid receptor antagonist (bisoprolol+eplerenone, nebivolol+eplerenone) on following fibrosis markers: matrix metalloproteinases 1 and 9 (MMP-1, MMP-9) and tissue inhibitor of MMP-1 (TIMP-1) in patients with heart failure with mid-range ejection fraction (HFmrEF) of ischemic origin.Material and methods. The study included 135 patients, including 40 (29,6%) women and 95 (70,4%) men aged 45-60 years (mean age, 53,1±5,7 years). Patients were randomized into subgroups based on pharmacotherapy with BB (bisoprolol or nebivolol) and their combination with eplerenone. The enzyme-linked immunosorbent assay was used to determine the level of MMP-1, MMP-9, TIMP-1 (ng/ml) using the commercial test system “MMP-1 ELISA”, “MMP-9 ELISA”, “Human TIMP-1 ELISA” (“Bender Medsystems “, Austria).Results. In patients with HFmrEF of ischemic origin, there were following downward changes in serum level of myocardial fibrosis markers, depending on the therapy: bisoprolol  — MMP-1 decreased by 35% (p<0,01), MMP-9  — by 56,3% (p<0,001), TIMP-1  — by 17,9% (p<0,01); nebivolol  — MMP-1 decreased by 45% (p<0,001), MMP-9  — by 57,1% (p<0,001), TIMP-1  — by 30,1% (p<0,01); combination of bisoprolol with eplerenone  — MMP-1 decreased by 43% (p<0,001), MMP-9  — by 51,2% (p<0,001), TIMP-1  — by 25,1% (p<0,01); combination of nebivolol with eplerenone  — MMP-1 decreased by 53% (p<0,001), MMP-9 — by 64,3% (p<0,001), TIMP-1 — by 39% (p<0,01). In patients with NYHA class I HFmrEF after 12-month therapy, the decrease in MMP-1 level was 39,9% (p<0,01), MMP-9  — 57,5% (p<0,001). In class II, the decrease in MMP-1 level was 47% (p<0,001), MMP-9 — 49,7% (p<0,001). A significant decrease in TIMP-1 level was revealed in patients with class I by 29% (p<0,01), in patients with class II by 27,1% (p<0,01) compared with the initial data.Conclusion. A significant decrease in the levels of myocardial fibrosis markers (MMP-1, MMP-9, TIMP-1) was demonstrated in patients with HFmrEF of ischemic origin receiving long-term pharmacotherapy. The most pronounced effect was determined in patients with NYHA class I HF.


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0016
Author(s):  
Amalie Erwood ◽  
Gregory Kurkis ◽  
Samuel David Maidman ◽  
Robert Cole ◽  
Shay Ariel Tenenbaum ◽  
...  

Category: Ankle, Ankle Arthritis, Hindfoot, Midfoot/Forefoot Introduction/Purpose: Degenerative conditions of the ankle, hindfoot, and midfoot can markedly limit mobility. The Life-Space Assessment (LSA) is a questionnaire quantifying how patients mobilize after a medical event as they return to their previous daily settings. Current outcome measures do not accurately assess mobility in the geriatric foot and ankle population. In contrast, the effect of congestive heart failure (CHF) on patient mobility is routinely assessed via the New York Heart Association (NYHA) functional classification. The NYHA classification is stratified by limitation of physical activity: I (no limitation), II (some limitation), III (marked limitation), and IV (unable to carry out without discomfort). We hypothesized that degenerative conditions of the foot and ankle would be as mobility limiting as CHF. Methods: Patients over the age of 50 were included in this study. LSA data was prospectively collected from patients with degenerative ankle, hindfoot, and midfoot diagnoses at their preoperative visit and NYHA-classified CHF patients at a cardiology clinic. The degenerative foot and ankle cohort included Achilles tendonitis, ankle joint cartilage defects, ankle arthritis, subtalar arthritis, and midfoot arthritis. Patient demographics and comorbidities were recorded from the electronic medical record. Mean LSA data was analyzed and compared using a Student’s t-test. Results: 28 degenerative foot and ankle patients and 44 CHF patients met inclusion criteria for the study. Patient demographics, including age, gender, and BMI, were not significantly different between the two groups. The foot and ankle cohort had a mean LSA score of 68. Mobility of the foot and ankle group was significantly less compared to NYHA class I patients, who had a LSA score of 103 (p=0.008). There was no significant difference in mobility compared to class II or III congestive heart failure patients, who recorded a mean LSA score of 62 (p=0.60). There was insufficient data available on NYHA class IV patients to make comparisons to this group. Conclusion: Degenerative ankle, hindfoot, and midfoot pathology is associated with similar mobility limitation to that of NYHA class II and III congestive heart failure.


EP Europace ◽  
2001 ◽  
Vol 2 (Supplement_1) ◽  
pp. A91-A91
Author(s):  
O. T. Graco ◽  
A. Cardinalli Neto ◽  
R. V. Ardito ◽  
M. Schaldach

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