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April 1, 2020Circulation Heart Failure

Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System

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Why the study?

Prior studies of CCM used a 3-lead Optimizer system; a new 2-lead system eliminating the atrial lead required testing for safety and effectiveness compared with the 3-lead system.

Does the 2-lead Optimizer system improve peak VO2 in patients with symptomatic heart failure (LVEF 25-45%) compared to a 3-lead system?

Comparison

Optimizer 2-lead system vs historical 3-lead system controls from FIX-HF-5C

Design

Single-arm trial compared with historical trial controls

Follow-up

24 weeks

Authors

PWPhi WiegnRCRodrigo C. ChanCJC Attenhofer Jost

Discussion

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Overview

May cut lead complications and extend CCM to AF; leaves open randomized confirmation versus contemporary GDMT.

Structured PICO

Does the 2-lead Optimizer system improve peak VO2 in patients with symptomatic heart failure (LVEF 25-45%) compared to a 3-lead system?

P
Population
60 patients with New York Heart Association III/IVa symptoms despite medical therapy, left ventricular ejection fraction 25% to 45%, and not eligible for cardiac resynchronization therapy. Mean age 66±9 years, 88% male, mean LVEF 34±6%, 15% with permanent atrial fibrillation.
I
Intervention
Optimizer 2-lead implant for cardiac contractility modulation (CCM)
C
Comparator
Control subjects from the prior FIX-HF-5C (3-lead system) study
O
Outcome
Estimated difference in the change of peak VO2 from baseline to 24 weekssurrogate

The 2-lead Optimizer system for cardiac contractility modulation provides comparable CCM delivery to the 3-lead system with fewer device-related adverse events and improved peak VO2.

Cite This Study

Wiegn et al. (2020) studied this question.

synapsesocial.com/papers/6a810e651325e503433c78bchttps://doi.org/10.1161/circheartfailure.119.006512
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation2018 · 273 citations
  2. 2Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure2008 · 240 citations
  3. 3Clinical effects of long-term cardiac contractility modulation (CCM) in subjects with heart failure caused by left ventricular systolic dysfunction2017 · 44 citations
  4. 4Cardiac Contractility Modulation Improves Long-Term Survival and Hospitalizations in Heart Failure with Reduced Ejection Fraction2019 · 104 citations
  5. 5Cardiac Contractility Modulation: Mechanisms of Action in Heart Failure with Reduced Ejection Fraction and Beyond2018 · 119 citations