Bard Stinger Gebrauchsinformationen Seite 4

Adverse Events - Major, Procedural Minor and Deaths
Population: All Patients Enrolled (N=251)
Major Events
Procedural Minor Events
Patients Deaths
Three (3) patients died during the study. None of the deaths were
considered related to the use of the study device.
A total of 37 minor procedural adverse events (as summarized in the
table below) were reported for 29 patients:
Procedural Adverse Events
Population: All Patients Enrolled (N=251)
COSTART Terms
Abnormal ECG
Abnormal Vision
Application Site Reaction
Asthenia
Back Pain
Bundle Branch Block
Chest Pain
Dizziness
Ecchymosis
Fever
Injection Site Pain, Hemorrhage or Mass
Nausea (with or without vomiting)
Neck Pain
Pain
Syncope (vasovagal)
Ventricular Arrhythmia
5.2 Anticipated Adverse Events
Adverse events (in alphabetical order), which may be associated with
catheterization and ablation include, but are not limited to:
• anaphylaxis (allergic reaction) with breathing problems, drop in
blood pressure and possibly death
• angina (chest discomfort)
• arrhythmia (irregular heartbeat)
• arterial/venous thrombosis (clot formation on the inside wall of
the artery at the entry site)
• AV fistula (a communication between the artery and vein at the
site of catheter insertion)
• back pain and/or groin pain
• cardiac perforation (hole in the lining of the heart)
• hematoma formation (bruise or bleeding into body tissue) in
groin area
• hypotension (fall in blood pressure)
• infection
• myocardial infarction (heart attack)
• pericardial effusion or cardiac tamponade (collection of blood in
lining of the heart)
• pneumothorax (an accumulation of air or gas in the pleural
space)
• significant blood loss which may lead to blood transfusion
• skins burns (injury to the skin caused by the electrical current)
• thrombotic events including stroke and pulmonary emboli
• unintentional complete heart block requiring a pacemaker
• vessel wall or valvular trauma which may lead to surgical repair
6. CLINICAL STUDIES
The Stinger* Ablation catheter, used in conjunction with related
accessory devices, was evaluated in a clinical study with the EPT-
1000 TC RF generator for the treatment of supraventricular
tachycardias (SVT).
Number of Number Of
Events Patients
13 11/251
37 29/251
3 3/251
Number of
Occurrences
Total:
Study Design
The Stinger* Ablation catheter was evaluated in a prospective, multi-
center trial. Acute success was defined as the proportion of patients
Percent Of
where treatment with the study device was able to: 1) eliminate the
Patients
functioning of aberrant pathways in patients with symptomatic SVT
4.4%
caused by accessory pathways, 2) eliminate the functioning of
11%
aberrant pathways in patients with symptomatic SVT caused by
AVNRT, 3) ablate the AV node for control of a rapid ventricular
1.2%
response in patients with symptomatic, drug resistant tachycardias.
Long-term (Chronic) success was defined as the proportion of acute
success patients, who, at a minimum of 3 months post ablation,
continue to have:
- absence of symptoms related to the index arrhythmia; or
- effective AV block.
Patients Studied
Patients Enrolled in Study................................................ 251
Patients Treated in Study ................................................. 247
1
Demographics
1
1
1
1
1
6
Age (years)
1
1 Duration of SVT
Symptoms (years)
2
8 Frequency of SVT
Symptoms (times/year) 224
3
1
No. of SVT Episodes
(in Last 6 months)
1
No. of Hospital Visits
7
(in Last 6 months)
1
37
Accessory Pathway - Concealed
Accessory Pathway - Non-concealed
Accessory Pathway - both types
AVNRT
AV Node Ablation for Rate Control
Note: 4 patients had both an Accessory Pathway and AVNRT treated.
Procedure Data
Energy was almost always delivered using the constant temperature
mode. Catheters were most often exchanged due to needing a
different catheter curve (63%, 41/65 energy deliveries). The reason
for terminating the energy delivery was usually based on the desired
time interval being achieved (56%, 882/1588).
mean number of energy deliveries per patient 6.5 ± 6.2
mean duration per delivery ..............................43.3 ± 29.2
mean duration for all of the deliveries
in a single procedure......................................283.4 ± 280.2
temperature setting ..........................................61.2 ± 5.2°C
actual delivered temperature ...........................55.7 ± 7.2°C.
mean ablation (procedure) time.......................63.2 ± 62.5
mean fluoroscopy time.....................................24.4 ± 22.1
PK5014758 / Rev. 11 / Page 4
Patients Discontinued Prior to Study ............................... 4
- target arrhythmia non-inducible ..................................... 3
- target arrhythmia non indicated ..................................... 1
Patient Demographics
Population: All Patients with Treatment Attempted
N=247
Males 68% (167) / Females 32% (80)
N Mean Std. Dev. Minimum
247 51.3
244 13.6
99.6
212 28.1
247 1.1
Number of Arrhythmia Types Treated
ENERGY / TEMPERATURE / PROCEDURE TIME
Maximum Median
15.9 18.0 90.0 50.0
13.6 0.0 69.9 9.6
238.4 0.1 1826.3 12.0
76.7 0.0 600.0 6.0
1.3 0.0 8.0 1.0
Percent of Number of
Patients Arrhythmias
N=247 N=251
10% 25
10% 25
1% 3
66% 163
14% 35
seconds
seconds
minutes
minutes