Skip to main content
Erschienen in: Herz 8/2017

18.01.2017 | Original articles

The safety and efficacy of cardiac contractility modulation in heart failure

A meta-analysis of clinical trials

verfasst von: X. Liu, MD, H. J. Yang, MD, H. Q. Ping, MD, S. Qiu, MD, S. Shi, MD, PhD, Prof. B. Yang, MD, PhD

Erschienen in: Herz | Ausgabe 8/2017

Einloggen, um Zugang zu erhalten

Abstract

Background

Cardiac contractility modulation (CCM) has developed as a promising treatment device for heart failure (HF). This meta-analysis aimed at systematically reviewing the latest available published trials to provide evidence on the safety and efficacy of CCM in patients with HF.

Methods

We searched the Cochrane Central Resister of Controlled Trials, PubMed, and EMBASE in May 2016 to identify eligible clinical trials comparing CCM with sham treatment or with usual care. All-cause mortality, all-cause hospitalization, and serious cardiopulmonary adverse effects were considered to be the primary outcomes of interest in evaluating the safety of CCM for patients with HF. Peak oxygen consumption and 6‑min walk tests were performed as the second outcomes of interest to assess efficacy. Risk ratio (RR), standard mean difference (SMD), and 95% confidence intervals (CIs) were calculated.

Results

Four studies enrolling 723 participants were included. Compared with the control arm, CCM did not significantly improve all-cause mortality or all-cause hospitalizations. No differences were observed for adverse effects of CCM, possibly due to the low number of studies. By contrast, CCM significantly improved peak oxygen consumption (standard mean difference 0.233, 95% CI, 0.065–0.401 ml/kg/min, p = 0.006) and the 6‑min walk test distance (standard mean difference 0.924, 95% CI, 0.001–0.334 m, p = 0.049).

Conclusion

In our meta-analysis of published clinic trials we found that CCM did not lower the risk of severe cardiovascular adverse events; however, it was associated with remarkable improvements in functional cardiopulmonary capacity. Therefore, CCM may serve as an alternative option for patients with advanced HF.
Literatur
1.
Zurück zum Zitat Norton C, Georgiopoulou VV, Kalogeropoulos AP, Butler J (2011) Epidemiology and cost of advanced heart failure. Prog Cardiovasc Dis 54(2):78–85CrossRefPubMed Norton C, Georgiopoulou VV, Kalogeropoulos AP, Butler J (2011) Epidemiology and cost of advanced heart failure. Prog Cardiovasc Dis 54(2):78–85CrossRefPubMed
2.
Zurück zum Zitat Choi AJ, Thomas SS, Singh JP (2016) Cardiac resynchronization therapy and implantable cardioverter defibrillator therapy in advanced heart failure. Heart Fail Clin 12(3):423–436CrossRefPubMed Choi AJ, Thomas SS, Singh JP (2016) Cardiac resynchronization therapy and implantable cardioverter defibrillator therapy in advanced heart failure. Heart Fail Clin 12(3):423–436CrossRefPubMed
3.
Zurück zum Zitat Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L (2006) Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase. Eur Heart J 27(16):1928–1932CrossRefPubMed Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L (2006) Longer-term effects of cardiac resynchronization therapy on mortality in heart failure [the CArdiac REsynchronization-Heart Failure (CARE-HF) trial extension phase. Eur Heart J 27(16):1928–1932CrossRefPubMed
4.
Zurück zum Zitat Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM (2004) Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 350(21):2140–2150CrossRefPubMed Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM (2004) Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 350(21):2140–2150CrossRefPubMed
5.
Zurück zum Zitat Yip GW, Fung JW (2011) Cardiac resynchronisation therapy for heart failure with narrow or normal QRS. Heart 97(13):1029–1031CrossRefPubMed Yip GW, Fung JW (2011) Cardiac resynchronisation therapy for heart failure with narrow or normal QRS. Heart 97(13):1029–1031CrossRefPubMed
6.
Zurück zum Zitat Zhang Q, Yu CM (2011) Could exercise unveil the mystery of non-response to cardiac resynchronization therapy? Europace 13(6):768–769CrossRefPubMed Zhang Q, Yu CM (2011) Could exercise unveil the mystery of non-response to cardiac resynchronization therapy? Europace 13(6):768–769CrossRefPubMed
7.
Zurück zum Zitat Burkhoff D, Ben-Haim SA (2005) Nonexcitatory electrical signals for enhancing ventricular contractility: rationale and initial investigations of an experimental treatment for heart failure. Am J Physiol Heart Circ Physiol 288(6):H2550–H2556CrossRefPubMed Burkhoff D, Ben-Haim SA (2005) Nonexcitatory electrical signals for enhancing ventricular contractility: rationale and initial investigations of an experimental treatment for heart failure. Am J Physiol Heart Circ Physiol 288(6):H2550–H2556CrossRefPubMed
8.
Zurück zum Zitat Butter C, Rastogi S, Minden H, Meyhöfer J, Burkhoff D, Sabbah HN (2008) Cardiac contractility modulation electrical signals improve myocardial gene expression in patients with heart failure. J Am Coll Cardiol 51(18):1784–1789CrossRefPubMed Butter C, Rastogi S, Minden H, Meyhöfer J, Burkhoff D, Sabbah HN (2008) Cardiac contractility modulation electrical signals improve myocardial gene expression in patients with heart failure. J Am Coll Cardiol 51(18):1784–1789CrossRefPubMed
9.
Zurück zum Zitat Winter J, Brack KE, Ng GA (2011) Cardiac contractility modulation in the treatment of heart failure: initial results and unanswered questions. Eur J Heart Fail 13(7):700–710CrossRefPubMed Winter J, Brack KE, Ng GA (2011) Cardiac contractility modulation in the treatment of heart failure: initial results and unanswered questions. Eur J Heart Fail 13(7):700–710CrossRefPubMed
10.
Zurück zum Zitat Gupta RC, Mishra S, Wang M, Jiang A, Rastogi S, Rousso B, Mika Y, Sabbah HN (2009) Cardiac contractility modulation electrical signals normalize activity, expression, and phosphorylation of the NA+-CA2+ exchanger in heart failure. J Card Fail 15(1):48–56CrossRefPubMed Gupta RC, Mishra S, Wang M, Jiang A, Rastogi S, Rousso B, Mika Y, Sabbah HN (2009) Cardiac contractility modulation electrical signals normalize activity, expression, and phosphorylation of the NA+-CA2+ exchanger in heart failure. J Card Fail 15(1):48–56CrossRefPubMed
11.
Zurück zum Zitat Borggrefe M, Burkhoff D (2012) Clinical effects of cardiac contractility modulation (CCM) as a treatment for chronic heart failure. Eur J Heart Fail 14(7):703–712CrossRefPubMed Borggrefe M, Burkhoff D (2012) Clinical effects of cardiac contractility modulation (CCM) as a treatment for chronic heart failure. Eur J Heart Fail 14(7):703–712CrossRefPubMed
13.
Zurück zum Zitat Roubertie F, Eschalier R, Zemmoura A, Thambo JB, Rooryck C, Labrousse L, Ploux S, Ritter P, Haissaguerre M, Dos SP, Bordachar P (2016) Cardiac contractility modulation in a model of repaired tetralogy of fallot: a sheep model. Pediatr Cardiol 37(5):826–833CrossRefPubMed Roubertie F, Eschalier R, Zemmoura A, Thambo JB, Rooryck C, Labrousse L, Ploux S, Ritter P, Haissaguerre M, Dos SP, Bordachar P (2016) Cardiac contractility modulation in a model of repaired tetralogy of fallot: a sheep model. Pediatr Cardiol 37(5):826–833CrossRefPubMed
14.
Zurück zum Zitat Liu M, Fang F, Luo XX, Shlomo B, Burkhoff D, Chan JYS, Chan C, Cheung L, Rousso B, Gutterman D, Yu C (2016) Improvement of long-term survival by cardiac contractility modulation in heart failure patients: a case–control study. Int J Cardiol 206:122–126CrossRefPubMed Liu M, Fang F, Luo XX, Shlomo B, Burkhoff D, Chan JYS, Chan C, Cheung L, Rousso B, Gutterman D, Yu C (2016) Improvement of long-term survival by cardiac contractility modulation in heart failure patients: a case–control study. Int J Cardiol 206:122–126CrossRefPubMed
15.
Zurück zum Zitat Neelagaru SB, Sanchez JE, Lau SK, Greenberg SM, Raval NY, Worley S, Kalman J, Merliss AD, Krueger S, Wood M (2006) Nonexcitatory, cardiac contractility modulation electrical impulses: Feasibility study for advanced heart failure in patients with normal QRS duration. Heart Rhythm 3(10):1140–1147CrossRefPubMed Neelagaru SB, Sanchez JE, Lau SK, Greenberg SM, Raval NY, Worley S, Kalman J, Merliss AD, Krueger S, Wood M (2006) Nonexcitatory, cardiac contractility modulation electrical impulses: Feasibility study for advanced heart failure in patients with normal QRS duration. Heart Rhythm 3(10):1140–1147CrossRefPubMed
16.
Zurück zum Zitat Borggrefe MM, Lawo T, Butter C, Schmidinger H, Lunati M, Pieske B, Misier AR, Curnis A, Bocker D, Remppis A, Kautzner J, Stuhlinger M, Leclerq C, Taborsky M, Frigerio M, Parides M, Burkhoff D, Hindricks G (2008) Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure. Eur Heart J 29(8):1019–1028CrossRefPubMed Borggrefe MM, Lawo T, Butter C, Schmidinger H, Lunati M, Pieske B, Misier AR, Curnis A, Bocker D, Remppis A, Kautzner J, Stuhlinger M, Leclerq C, Taborsky M, Frigerio M, Parides M, Burkhoff D, Hindricks G (2008) Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure. Eur Heart J 29(8):1019–1028CrossRefPubMed
17.
Zurück zum Zitat Kadish A, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N, Obel O, Weiner S, Wish M, Carson P, Ellenbogen K, Bourge R, Parides M, Chiacchierini RP, Goldsmith R, Goldstein S, Mika Y, Burkhoff D, Abraham WT (2011) A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. Am Heart J 161(2):329–337CrossRefPubMed Kadish A, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N, Obel O, Weiner S, Wish M, Carson P, Ellenbogen K, Bourge R, Parides M, Chiacchierini RP, Goldsmith R, Goldstein S, Mika Y, Burkhoff D, Abraham WT (2011) A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. Am Heart J 161(2):329–337CrossRefPubMed
18.
Zurück zum Zitat Myers J, Gullestad L, Vagelos R, Do D, Bellin D, Ross H, Fowler MB (2000) Cardiopulmonary exercise testing and prognosis in severe heart failure: 14 mL/kg/min revisited. Am Heart J 139(1 Pt 1):78–84CrossRefPubMed Myers J, Gullestad L, Vagelos R, Do D, Bellin D, Ross H, Fowler MB (2000) Cardiopulmonary exercise testing and prognosis in severe heart failure: 14 mL/kg/min revisited. Am Heart J 139(1 Pt 1):78–84CrossRefPubMed
19.
Zurück zum Zitat Francis DP, Shamim W, Davies LC, Piepoli MF, Ponikowski P, Anker SD, Coats AJ (2000) Cardiopulmonary exercise testing for prognosis in chronic heart failure: continuous and independent prognostic value from VE/VCO (2)slope and peak VO (2). Eur Heart J 21(2):154–161CrossRefPubMed Francis DP, Shamim W, Davies LC, Piepoli MF, Ponikowski P, Anker SD, Coats AJ (2000) Cardiopulmonary exercise testing for prognosis in chronic heart failure: continuous and independent prognostic value from VE/VCO (2)slope and peak VO (2). Eur Heart J 21(2):154–161CrossRefPubMed
20.
Zurück zum Zitat Demers C, McKelvie RS, Negassa A, Yusuf S (2001) Reliability, validity, and responsiveness of the six-minute walk test in patients with heart failure. Am Heart J 142(4):698–703CrossRefPubMed Demers C, McKelvie RS, Negassa A, Yusuf S (2001) Reliability, validity, and responsiveness of the six-minute walk test in patients with heart failure. Am Heart J 142(4):698–703CrossRefPubMed
21.
Zurück zum Zitat Kuschyk J, Roeger S, Schneider R, Streitner F, Stach K, Rudic B, Weiss C, Schimpf R, Papavasilliu T, Rousso B, Burkhoff D, Borggrefe M (2015) Efficacy and survival in patients with cardiac contractility modulation: long-term single center experience in 81 patients. Int J Cardiol 183:76–81CrossRefPubMed Kuschyk J, Roeger S, Schneider R, Streitner F, Stach K, Rudic B, Weiss C, Schimpf R, Papavasilliu T, Rousso B, Burkhoff D, Borggrefe M (2015) Efficacy and survival in patients with cardiac contractility modulation: long-term single center experience in 81 patients. Int J Cardiol 183:76–81CrossRefPubMed
22.
Zurück zum Zitat Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE (2010) Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach. J Am Coll Cardiol 56(5):392–406CrossRefPubMedPubMedCentral Kramer DG, Trikalinos TA, Kent DM, Antonopoulos GV, Konstam MA, Udelson JE (2010) Quantitative evaluation of drug or device effects on ventricular remodeling as predictors of therapeutic effects on mortality in patients with heart failure and reduced ejection fraction: a meta-analytic approach. J Am Coll Cardiol 56(5):392–406CrossRefPubMedPubMedCentral
23.
Zurück zum Zitat Kloppe A, Mijic D, Schiedat F, Bogossian H, Mügge A, Rousso B, Lemke B (2016) A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report. Cardiol J 23(1):114–119CrossRefPubMed Kloppe A, Mijic D, Schiedat F, Bogossian H, Mügge A, Rousso B, Lemke B (2016) A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report. Cardiol J 23(1):114–119CrossRefPubMed
24.
Zurück zum Zitat Zhang Q, Chan Y, Liang Y, Fang F, Lam Y, Chan C, Lee AP, Chan KC, Wu EB, Yu C (2013) Comparison of left ventricular reverse remodeling induced by cardiac contractility modulation and cardiac resynchronization therapy in heart failure patients with different QRS durations. Int J Cardiol 167(3):889–893CrossRefPubMed Zhang Q, Chan Y, Liang Y, Fang F, Lam Y, Chan C, Lee AP, Chan KC, Wu EB, Yu C (2013) Comparison of left ventricular reverse remodeling induced by cardiac contractility modulation and cardiac resynchronization therapy in heart failure patients with different QRS durations. Int J Cardiol 167(3):889–893CrossRefPubMed
Metadaten
Titel
The safety and efficacy of cardiac contractility modulation in heart failure
A meta-analysis of clinical trials
verfasst von
X. Liu, MD
H. J. Yang, MD
H. Q. Ping, MD
S. Qiu, MD
S. Shi, MD, PhD
Prof. B. Yang, MD, PhD
Publikationsdatum
18.01.2017
Verlag
Springer Medizin
Erschienen in
Herz / Ausgabe 8/2017
Print ISSN: 0340-9937
Elektronische ISSN: 1615-6692
DOI
https://doi.org/10.1007/s00059-016-4514-5

Weitere Artikel der Ausgabe 8/2017

Herz 8/2017 Zur Ausgabe

Screening-Mammografie offenbart erhöhtes Herz-Kreislauf-Risiko

26.04.2024 Mammografie Nachrichten

Routinemäßige Mammografien helfen, Brustkrebs frühzeitig zu erkennen. Anhand der Röntgenuntersuchung lassen sich aber auch kardiovaskuläre Risikopatientinnen identifizieren. Als zuverlässiger Anhaltspunkt gilt die Verkalkung der Brustarterien.

Niedriger diastolischer Blutdruck erhöht Risiko für schwere kardiovaskuläre Komplikationen

25.04.2024 Hypotonie Nachrichten

Wenn unter einer medikamentösen Hochdrucktherapie der diastolische Blutdruck in den Keller geht, steigt das Risiko für schwere kardiovaskuläre Ereignisse: Darauf deutet eine Sekundäranalyse der SPRINT-Studie hin.

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

25.04.2024 Hypertonie Nachrichten

Beginnen ältere Männer im Pflegeheim eine Antihypertensiva-Therapie, dann ist die Frakturrate in den folgenden 30 Tagen mehr als verdoppelt. Besonders häufig stürzen Demenzkranke und Männer, die erstmals Blutdrucksenker nehmen. Dafür spricht eine Analyse unter US-Veteranen.

Adipositas-Medikament auch gegen Schlafapnoe wirksam

24.04.2024 Adipositas Nachrichten

Der als Antidiabetikum sowie zum Gewichtsmanagement zugelassene Wirkstoff Tirzepatid hat in Studien bei adipösen Patienten auch schlafbezogene Atmungsstörungen deutlich reduziert, informiert der Hersteller in einer Vorab-Meldung zum Studienausgang.

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.