Table 2: A summary of reported adverse events and frequency.

FIX-HF-5 Pilot [12]FIX-CHF-4 [13]FIX-HF-5 [20]FIX-HF-5C [21]
CCM
(N =25)
OMT
(N = 24)
CCM
ON (N =160)
CCM
OFF (N = 161)
CCM
(N = 210)
OMT
(N = 212)
CCM
(N = 74)
OMT
(N = 86)

General Cardiopulmonary Event1423605832

General Medical31016988177

Arrhythmia (VF, VT, AF, SVT)1264403032

Worsening HF2378728537

ICD/Pacemaker malfunction or Sensing Defect101013720

BleedingNANANANA8801

SepsisNANANANA11211

Localized InfectionNANANANA333614

Neurologic DysfunctionNANANANA31400

Thromboembolism (non-neurologic)NANANANA3511

Optimizer MalfunctionNANA1NA30NA6NA

Total81820223713262725

Complications Related to CCM procedure/Device2 lead dislodgements
One event of “chest sensation” during CCM signal application resolved with parameter adjustment of signals
2 optimizer pocket infections
1 pericardial effusion
1 inappropriate ICD firing
3 Lead dislodgements
5 Device pocket infections
2 Pericardial effusion
4 Bleedings at CCM site
3 Lead fracture
6 RV Lead Dislodgement
6 RA lead dislodgement
3 CCM pocket dehiscence/erosion
2 CCM pocket infection
2 CCM pocket stimulation
1 CCM pocket bleeding
2 Lead perforation
2 Sensation due to CCM
1 Extracardiac stimulation
5 lead dislodgements
1 DVT
1 Generator Erosion requiring pocket revision and lead replacement

CCM: cardiac contractility modulation, OMT: optimal medical therapy, VF: ventricular fibrillation, VT: ventricular tachycardia, AF: atrial fibrillation, SVT: supraventricular tachycardia, HF: heart failure, and DVT: deep vein thrombosis.
Due to either T-wave oversensing or the need for ICD lead repositioning.