Outcomes of Cardiac Contractility Modulation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

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 Event	1	4	2	3	60	58	3	2
General Medical	3	10	1	6	98	81	7	7
Arrhythmia (VF, VT, AF, SVT)	1	2	6	4	40	30	3	2
Worsening HF	2	3	7	8	72	85	3	7
ICD/Pacemaker malfunction or Sensing Defect	1	0	1	0	13	7	2	0
Bleeding	NA	NA	NA	NA	8	8	0	1
Sepsis	NA	NA	NA	NA	11	2	1	1
Localized Infection	NA	NA	NA	NA	33	36	1	4
Neurologic Dysfunction	NA	NA	NA	NA	3	14	0	0
Thromboembolism (non-neurologic)	NA	NA	NA	NA	3	5	1	1
Optimizer Malfunction	NA	NA	1	NA	30	NA	6	NA
Total	8	18	20	22	371	326	27	25
Complications Related to CCM procedure/Device	2 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.