Subgroup Analysis of a Randomized Controlled Trial Evaluating the Safety and Efficacy of Cardiac Contractility Modulation in Advanced Heart Failure

Abraham, William T.; Nademanee, Koonlawee; Volosin, Kent J.; Krueger, Steven K.; Neelagaru, Suresh; Raval, Nirav; Obel, Owen; Weiner, Stanislav; Wish, Marc; Carson, Peter E.; Ellenbogen, Kenneth A.; Bourge, Robert C.; Parides, Michael K.; Chiacchierini, Richard P.; Goldsmith, Rochelle L.; Mika, Yuval; Burkhoff, Daniel; Kadish, Alan H.

doi:10.1016/j.cardfail.2011.05.006

Cited by 93 publications

(69 citation statements)

References 15 publications

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“…Furthermore, trends toward an improvement were observed with peak VO 2 (by 1.48 ± 2.35), 6MWD (by 31.3 ± 101.3), and EF (by 2.3 ± 7.0). The clinical improvement vs. baseline was of similar magnitude to that described previously using 5 h/day and 7 h/day of CCM [6][7][8].…”

Section: Resultssupporting

confidence: 83%

See 1 more Smart Citation

A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report

et al. 2016

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Section: Resultssupporting

confidence: 83%

“…Subsequent analysis of patient subgroups revealed that CCM improves multiple objective parameters of exercise tolerance, including ventilatory anaerobic threshold, in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and ejection fraction (EF) of at least 25% [6].…”

Section: Introductionmentioning

confidence: 99%

A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report

et al. 2016

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“…A subsequent evaluation study (subgroup analysis) has already suggested a particular patient group that responds exceptionally well to CCM therapy. The patients were characterized by a disease severity of NYHA class III and a left ventricular ejection fraction of ≥ 25% [25,26]. Cardiac contractility modulation has proven to be effective and safe in randomized controlled trials involving several hundred patients [27][28][29][30].…”

Section: Cardiac Contractility Modulation (Ccm)mentioning

confidence: 99%

Cardiac Contractility Modulation Device and Subcutaneous Implantable Cardioverter Defibrillator Combination: A New Hope for Heart Failure Patients with Low Ejection Fraction and Narrow QRS Complex

Al‐Ghamdi¹

2016

J Cardiovasc Med Cardiol

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“…Over time transition rates to different NYHA classes were estimate from the subgroup analysis of the FIX-HF-5 clinical trial 21 . Follow up data on number of patients per NYHA class and therapy arm were available in 12, 24 and 50 weeks.…”

Section: Nyha Class Transition Ratesmentioning

confidence: 99%

“…Based on the data available from FIX-HF-5 subgroup analysis 21 all cause hospitalizations and re-hospitalizations were estimated at 3.5% on a monthly basis. These reflect mainly NYHA class III patients.…”

Section: Hospitalization Ratesmentioning

confidence: 99%

Economic Evaluation of Cardiac Contractility Modulation (CCM) Therapy with the Optimizer IVs in the Management of Heart Failure Patients

Maniadakis¹,

Fragoulakis²,

Mylonas³

et al. 2015

ICFJ

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Background: Heart failure represents a major burden for health systems and societies. Cardiac contractility modulation (CCM) therapy was developed in recent years for patients with normal QRS in whom optimal pharmacological (OMT) treatment has failed to control symptoms adequately. This study presents an economic evaluation of CCM therapy for the UK.Methods: A Markov model was built to simulate the management of patients under two therapy scenarios, on OMT alone and CCM+OMT respectively. The horizon is the patient’s life time and the cycle is 4 weeks. The model estimates life year (LYs), quality adjusted life years (QALYs) and overall treatment costs. Data to populate it came from relevant CCM trials, the literature and other sources.Results: The total mean life-time cost was £37,467 in the CCM+OMT arm and £16,885 in the OMT arm. Patients in the OMT arm gained 7.00 LYs and 4.00 QALYs and those on CCM+OMT 7.96 and 5.26 respectively. The incremental cost per QALY was £16,405and the incremental cost per LY £21,415. Sensitivity analysis indicates that the results are pretty stable and stochastic analysis indicates that at a £30,000 per QALY threshold the likelihood of CCM+OMT being cost-effective is 99.8% and at £25,000 per QALY 97%.Conclusion: The present analysis indicates that CCM may be cost-effective therapy. This early conclusion should be viewed in the light of the caveats of the modeling methods used, due to data availability. Long-term studies directly collecting hospitalization and mortality data should be undertaken to provide more robust evidence.

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Subgroup Analysis of a Randomized Controlled Trial Evaluating the Safety and Efficacy of Cardiac Contractility Modulation in Advanced Heart Failure

Cited by 93 publications

References 15 publications

A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report

A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report

Cardiac Contractility Modulation Device and Subcutaneous Implantable Cardioverter Defibrillator Combination: A New Hope for Heart Failure Patients with Low Ejection Fraction and Narrow QRS Complex

Economic Evaluation of Cardiac Contractility Modulation (CCM) Therapy with the Optimizer IVs in the Management of Heart Failure Patients

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