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Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system
AIMS: We assessed long‐term effects of cardiac contractility modulation delivered by the Optimizer Smart system on quality of life, left ventricular ejection fraction (LVEF), mortality and heart failure and cardiovascular hospitalizations. METHODS AND RESULTS: CCM‐REG is a prospective registry study...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Ltd.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8360159/ https://www.ncbi.nlm.nih.gov/pubmed/34002440 http://dx.doi.org/10.1002/ejhf.2202 |
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author | Kuschyk, Jürgen Falk, Peter Demming, Thomas Marx, Oliver Morley, Deborah Rao, Ishu Burkhoff, Daniel |
author_facet | Kuschyk, Jürgen Falk, Peter Demming, Thomas Marx, Oliver Morley, Deborah Rao, Ishu Burkhoff, Daniel |
author_sort | Kuschyk, Jürgen |
collection | PubMed |
description | AIMS: We assessed long‐term effects of cardiac contractility modulation delivered by the Optimizer Smart system on quality of life, left ventricular ejection fraction (LVEF), mortality and heart failure and cardiovascular hospitalizations. METHODS AND RESULTS: CCM‐REG is a prospective registry study including 503 patients from 51 European centres. Effects were evaluated in three terciles of LVEF (≤25%, 26–34% and ≥35%) and in patients with atrial fibrillation (AF) and normal sinus rhythm (NSR). Hospitalization rates were compared using a chi‐square test. Changes in functional parameters of New York Heart Association (NYHA) class, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and LVEF were assessed with Wilcoxon signed‐rank test, and event‐free survival by Kaplan–Meier analysis. For the entire cohort and each subgroup, NYHA class and MLWHFQ improved at 6, 12, 18 and 24 months (P < 0.0001). At 24 months, NYHA class, MLWHFQ and LVEF showed an average improvement of 0.6 ± 0.7, 10 ± 21 and 5.6 ± 8.4%, respectively (all P < 0.001). LVEF improved in the entire cohort and in the LVEF ≤25% subgroup with AF and NSR. In the overall cohort, heart failure hospitalizations decreased from 0.74 [95% confidence interval (CI) 0.66–0.82] prior to enrolment to 0.25 (95% CI 0.21–0.28) events per patient‐year during 2‐year follow‐up (P < 0.0001). Cardiovascular hospitalizations decreased from 1.04 (95% CI 0.95–1.13) events per patient‐year prior to enrolment to 0.39 (95% CI 0.35–0.44) events per patient‐year during 2‐year follow‐up (P < 0.0001). Similar reductions of hospitalization rates were observed in the LVEF, AF and NSR subgroups. Estimated survival was significantly better than predicted by MAGGIC at 1 and 3 years in the entire cohort and in the LVEF 26–34% and ≥35% subgroups. CONCLUSIONS: Cardiac contractility modulation therapy improved functional status, quality of life, LVEF and, compared to patients' prior history, reduced heart failure hospitalization rates. Survival at 1 and 3 years was significantly better than predicted by the MAGGIC risk score. |
format | Online Article Text |
id | pubmed-8360159 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley & Sons, Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-83601592021-08-17 Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system Kuschyk, Jürgen Falk, Peter Demming, Thomas Marx, Oliver Morley, Deborah Rao, Ishu Burkhoff, Daniel Eur J Heart Fail Haemodynamic Changes AIMS: We assessed long‐term effects of cardiac contractility modulation delivered by the Optimizer Smart system on quality of life, left ventricular ejection fraction (LVEF), mortality and heart failure and cardiovascular hospitalizations. METHODS AND RESULTS: CCM‐REG is a prospective registry study including 503 patients from 51 European centres. Effects were evaluated in three terciles of LVEF (≤25%, 26–34% and ≥35%) and in patients with atrial fibrillation (AF) and normal sinus rhythm (NSR). Hospitalization rates were compared using a chi‐square test. Changes in functional parameters of New York Heart Association (NYHA) class, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and LVEF were assessed with Wilcoxon signed‐rank test, and event‐free survival by Kaplan–Meier analysis. For the entire cohort and each subgroup, NYHA class and MLWHFQ improved at 6, 12, 18 and 24 months (P < 0.0001). At 24 months, NYHA class, MLWHFQ and LVEF showed an average improvement of 0.6 ± 0.7, 10 ± 21 and 5.6 ± 8.4%, respectively (all P < 0.001). LVEF improved in the entire cohort and in the LVEF ≤25% subgroup with AF and NSR. In the overall cohort, heart failure hospitalizations decreased from 0.74 [95% confidence interval (CI) 0.66–0.82] prior to enrolment to 0.25 (95% CI 0.21–0.28) events per patient‐year during 2‐year follow‐up (P < 0.0001). Cardiovascular hospitalizations decreased from 1.04 (95% CI 0.95–1.13) events per patient‐year prior to enrolment to 0.39 (95% CI 0.35–0.44) events per patient‐year during 2‐year follow‐up (P < 0.0001). Similar reductions of hospitalization rates were observed in the LVEF, AF and NSR subgroups. Estimated survival was significantly better than predicted by MAGGIC at 1 and 3 years in the entire cohort and in the LVEF 26–34% and ≥35% subgroups. CONCLUSIONS: Cardiac contractility modulation therapy improved functional status, quality of life, LVEF and, compared to patients' prior history, reduced heart failure hospitalization rates. Survival at 1 and 3 years was significantly better than predicted by the MAGGIC risk score. John Wiley & Sons, Ltd. 2021-05-17 2021-07 /pmc/articles/PMC8360159/ /pubmed/34002440 http://dx.doi.org/10.1002/ejhf.2202 Text en © 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Haemodynamic Changes Kuschyk, Jürgen Falk, Peter Demming, Thomas Marx, Oliver Morley, Deborah Rao, Ishu Burkhoff, Daniel Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system |
title | Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system |
title_full | Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system |
title_fullStr | Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system |
title_full_unstemmed | Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system |
title_short | Long‐term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system |
title_sort | long‐term clinical experience with cardiac contractility modulation therapy delivered by the optimizer smart system |
topic | Haemodynamic Changes |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8360159/ https://www.ncbi.nlm.nih.gov/pubmed/34002440 http://dx.doi.org/10.1002/ejhf.2202 |
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