6.4
Instructions for Use & Clinical Reference Manual (US)
STUDY POPULATION DEMOGRAPHICS AND BASELINE CHARACTERISTICS
The patient baseline characteristics are summarized in Table 6.1. The overall age was 59±15 years old.
Among all patients, 88.5% presented with congestive heart failure (CHF), 60% had history of arrhythmia,
57% had ICD or pacemaker implanted, 53% had diabetes, 37.5% had chronic kidney disease, and 20%
had prior CVA. Of note, 60% of the patients had received blood products and 78.6% were in NYHA
class IV prior to device implant.
Table 6.1 Patient characteristics
Patient Characteristics
All Patients
(N=30)
Cohort A
(N=18)
Cohort B
(N=12)
Age
Mean±SD (N)
59.2±15.2 (30)
55.8±13.9 (18)
64.3±16.2 (12)
Gender
Male
76.7% (23/30)
83.3% (15/18)
66.7% (8/12)
Female
23.3% (7/30)
16.7% (3/18)
33.3% (4/12)
Race
White
53.3% (16/30)
55.6% (10/18)
50.0% (6/12)
Black or African American
40.0% (12/30)
38.9% (7/18)
41.7% (5/12)
Asian
6.7% (2/30)
5.6% (1/18)
8.3% (1/12)
Body Surface Area (m2)
Mean±SD (N)
1.94±0.22 (30)
2.01±0.23 (18)
1.85±0.18 (12)
Hypertension
80.0% (24/30)
77.8% (14/18)
83.3% (10/12)
Coronary Artery Disease
66.7% (20/30)
66.7% (12/18)
66.7% (8/12)
Congenital Heart Disease
12.5% (3/24)
6.7% (1/15)
22.2% (2/9)
Congestive Heart Failure
88.5% (23/26)
100.0% (18/18)
62.5% (5/8)
NYHA Classification
I
3.6% (1/28)
0.0% (0/18)
10.0% (1/10)
II
3.6% (1/28)
5.6% (1/18)
0.0% (0/10)
III
14.3% (4/28)
16.7% (3/18)
10.0% (1/10)
IV
78.6% (22/28)
77.8% (14/18)
80% (8/10)
Myocardial Infarction
46.7% (14/30)
50.0% (9/18)
41.7% (5/12)
PCI
46.7% (14/30)
50.0% (9/18)
41.7% (5/12)
CABG
13.3% (4/30)
5.6% (1/18)
25.0% (3/12)
Arrhythmia
60.0% (18/30)
66.7% (12/18)
50.0% (6/12)
Cerebrovascular Accident
16.7% (5/30)
5.6% (1/18)
33.3% (4/12)
Stroke
20.0% (1/5)
0.0% (0/1)
25.0% (1/4)
TIA
60.0% (3/5)
0.0% (0/1)
75.0% (3/4)
Smoking
44.8% (13/29)
52.9% (9/17)
33.3% (4/12)
Chronic Obstructive Pulmonary
Disease
12.0% (3/25)
16.7% (3/16)
0.0% (0/9)
Diabetes
53.3% (16/30)
61.1% (11/18)
41.7% (5/12)
Chronic Kidney Disease
37.5% (9/24)
37.5% (6/16)
37.5% (3/8)
Subject is On Dialysis
0.0% (0/9)
0.0% (0/6)
0.0% (0/3)
LVAD Implantation
16.7% (5/30)
0.0% (0/18)
41.7% (5/12)
HeartMate (Thoratec)
40.0% (2/5)
N/A
40.0% (2/5)
