Mintek LV, LV-T Total, 13.3%, 25.3%, Total—All, Categories, Patients and, Other Medical, 6 months – Stratos LV, Observed Adverse Events

Stratos LV/LV-T Technical Manual 31

Table 4: AVAIL CLS/CRT Complication-Free Rate at

6 months – Stratos LV

	Number	% of	Number of	Complications
Category	of			per patient-
		Patients	Complications
	Patients			year
		Other Medical
Worsening	2	2.7%	2	0.03
CHF
Repeat	3	4.0%	3	0.05
Ablation
Non-CHF
cardiac	3	4.0%	3	0.05
symptoms
Other Medical	3	4.0%	3	0.05
Total	10	13.3%	11	0.17
Total—All	19	25.3%	24	0.37
Patients and
Categories

Number of Patients = 75 Number of Patient-Years = 64.4

The freedom from Stratos LV system-related and procedure- related complications was 85.33%, with a one sided lower 95% confidence bound of 76.89%. Therefore, the procedure, lead and device related complication-free rate at 6 months met the pre- specified acceptance criterion of equivalence (non-inferiority) within 10% of 85% (p = 0.0196).

Observed Adverse Events

Adverse events are classified as either observations or complications. Observations are defined as clinical events that do not require additional invasive intervention to resolve. Complications are defined as clinical events that require additional invasive intervention to resolve.

Of the 104 adverse events reported in the Stratos LV study groups, there have been 76 observations in 45 patients and 28 complications in 20 patients with a cumulative enrollment duration of 64.4 patient-years. 26.7% of the enrolled Stratos LV patients have experienced a complication. The rate of complications per patient-year is 0.43. 60.0% of the enrolled study patients have a reported observation. The rate of observations per patient-year is 1.18.