User Manual

Lumax Technical Manual 19
The HOME-CARE Observational study, conducted outside the
US on the Kronos LV-T cardiac resynchronization defibrillator
(CRT-D) in patients with congestive heart failure (CHF) involved
45 devices implanted with a cumulative implant duration of
202 months (mean implant duration of 4.5 months).
Of the 31 adverse events reported, there have been
26 observations in 23 patients and 5 complications in 3 patients
with a cumulative implant duration of 202 months (16.8 patient-
years). 6.7% of the enrolled patients have experienced a
complication with two patients experiencing 2 separate
complications. The rate of complications per patient-year was
0.30. 51% of the enrolled study patients had a reported
observation with 3 patients having more than 1 observation. The
rate of observations per patient-year is 1.54. Complications and
observations for the patient group are summarized in Table 2
and
Table 3
, respectively.
Table 2: Summary of Complications – Kronos LV-T
Category
Number
of
Patients
% of
Patient
s
Number
Per
patient-
year
Left Ventricular Lead Related
Dislodgement 1 2.2% 1
0.06
No Capture 1 2.2% 1
0.06
Total 2 4.4% 2
0.12
ICD Lead Related
Dislodgement 1 2.2% 1
0.06
Elevated Pacing
Threshold
1 2.2% 1
0.06
Total 2 4.4% 2
0.12
Unrelated to CRT-D or Leads
Hemathorax 1 2.2% 1
0.06
Total 1 2.2% 1
0.06
Overall
Complication Totals
3 6.7% 5
0.30
Number of Patients = 45, Number of Patient-Years = 16.8