English - Abbott TREK RX Manual Del Usuario

TREK RX and MINI TREK RX
Coronary Dilatation Catheter
CAUTION
CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE
ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE
INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
DESCRIPTION
The TREK RX and MINI TREK RX Coronary Dilatation Catheters have an
integrated shaft system and a balloon near the distal tip. The shaft has a
combination of single lumen and dual lumen tubing. One lumen is used
for inflation of the balloon with contrast medium. The second lumen, in
the distal shaft, permits the use of a guide wire to facilitate advancement
of the dilatation catheter to and through the stenosis to be dilated. The
dilatation catheter is coated with HYDROCOAT hydrophilic coating, which
is activated when wet.
This device has several markers. The balloon has radiopaque marker(s) to
aid in positioning the balloon in the stenosis, and is designed to provide an
expandable segment of known diameter and length at a specific pressure.
The proximal shaft has proximal markers that aid in gauging dilatation
catheter position relative to the guiding catheter tip (marker located
closest to the dilatation catheter adapter is for femoral guiding catheters
and the other marker is for brachial guiding catheters).
The design of this dilatation catheter does not incorporate a lumen for
distal dye injections and distal pressure measurements.
HOW SUPPLIED
Sterile – This device is sterilized with ethylene oxide gas. Non-pyrogenic.
Do not use if the package is open or damaged.
This single use device cannot be reused on another patient, as it is
not designed to perform as intended after the first usage. Changes in
mechanical, physical, and / or chemical characteristics introduced under
conditions of repeated use, cleaning, and / or resterilization may compromise
the integrity of the design and / or materials, leading to contamination due
to narrow gaps and / or spaces and diminished safety and/or performance
of the device. Absence of original labeling may lead to misuse and eliminate
traceability. Absence of original packaging may lead to device damage, loss
of sterility, and risk of injury to the patient and / or user.
Contents – One (1) TREK RX or MINI TREK RX Coronary Dilatation
Catheter, one (1) primary flushing tool, one (1) protective sheath, one (1)
dilatation catheter clip, and one (1) compliance card
Storage – Store in a dry, dark, cool place.
INDICATIONS
The TREK RX and MINI TREK RX Coronary Dilatation Catheters are
indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass
graft stenosis, for the purpose of improving myocardial perfusion
• Balloon dilatation of a coronary artery occlusion, for the purpose
of restoring coronary flow in patients with ST-segment elevation
myocardial infarction
• Balloon dilatation of a stent after implantation (balloon models
2.00 mm – 5.00 mm only)
CONTRAINDICATIONS
The TREK RX and MINI TREK RX Coronary Dilatation Catheters are not
intended to be used to treat patients with:
• An unprotected left main coronary arte ry
• A coronary artery spasm in the absen ce of a significant stenosis
WARNINGS
This device is intended for one time use only. DO NOT resterilize and /
or reuse it, as this can compromise device performance and increase the
risk of cross contamination due to inappropriate reprocessing.
Percutaneous transluminal coronary angioplasty (PTCA) should only be
performed at hospitals where emergency coronary artery bypass graft
surgery can be quickly performed in the event of a potentially injurious or
life-threatening complication.
PTCA in patients who are not acceptable candidates for coronary
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artery bypass graft surgery requires careful consideration, including
possible hemodynamic support during PTCA, as treatment of this patient
population carries special risk.
Use only the recommended balloon inflation medium. Never use air or any
gaseous medium to inflate the balloon.
Balloon pressure should not exceed the rated burst pressure (RBP).
The RBP is based on results of in vitro testing. At least 99.9% of the
balloons (with a 95% confidence) will not burst at or below their RBP.
Use of a pressure-monitoring device is recommended to prevent
overpressurization.
To reduce the potential for vessel damage, the inflated diameter of the
balloon should approximate the diameter of the vessel just proximal and
distal to the stenosis.
When the catheter is exposed to the vascular system, it should be
manipulated while under high quality fluoroscopic observation. Do not
advance or retract the catheter unless the balloon is fully deflated under
vacuum. If resistance is met during manipulation, determine the cause of
the resistance before proceeding.
Do not use, or attempt to straighten, a catheter if the shaft has become
bent or kinked; this may result in the shaft breaking. Instead, prepare a
new catheter.
Do not torque the catheter more than one (1) full turn.
Treatment of moderately or heavily calcified lesions is considered to
be moderate risk, with an expected success rate of 60 – 85% and
increases the risk of acute closure, vessel trauma, balloon burst, balloon
entrapment, and associated complications. If resistance is felt, determine
the cause before proceeding. Continuing to advance or retract the
catheter while under resistance may result in damage to the vessels and /
or damage / separation of the catheter.
In the event of catheter damage / separation, recovery of any portion
should be performed based on physician determination of individual
patient condition and appropriate retrieval protocol.
PRECAUTIONS
Note the "Use by" date specified on the package.
Inspect all product prior to use. Do not use if the package is open or damaged.
This device should be used only by physicians trained in angiography and
PTCA, and / or percutaneous transluminal angioplasty (PTA).
Prior to angioplasty, the dilatation catheter should be examined to verify
functionality and ensure that its size is suitable for the specific procedure
for which it is to be used.
During the procedure, appropriate anticoagulant and coronary vasodilator
therapy must be provided to the patient as needed. Anticoagulant therapy
should be continued for a period of time to be determined by the physician
after the procedure.
The design and construction of these catheters do not provide the user
with distal pressure monitoring capability.
If the surface of the TREK RX or MINI TREK RX Coronary Dilatation
Catheter becomes dry, wetting with heparinized normal saline will
reactivate the coating.
Do not reinsert the TREK RX or MINI TREK RX Coronary Dilatation Catheter
into the coil dispenser after procedural use.
With 4.5 mm and 5.0 mm balloon dilatation catheters, some increased
resistance may be noted upon insertion or withdrawal into or out of the
guiding catheter. Choosing a larger guiding catheter size may minimize this.
ADVERSE EFFECTS
Possible adverse effects include, but are not limited to, the following:
• Acute myocardial infarction
• Arrhythmias, including ventricular fibrillation
• Arteriovenous fistula
• Coronary artery spasm
• Coronary vessel dissection, perforation, rupture, or injury
• Death
• Drug reactions, allergic reaction to contrast medium
• Embolism
• Hemorrhage or hematoma
• Hypo / hypertension
• Infection
• Restenosis of the dilated vessel
• Total occlusion of the coronary artery or bypass graft
• Unstable angina
CLINICAL AND LABORATORY RESULTS
To evaluate the safety and effectiveness of direct PTCA as a treatment
for patients with ST-segment elevation acute myocardial infarction, ACS
conducted a multicenter, prospective, randomized clinical trial using
primarily ACS coronary dilatation catheters. The GUSTO II Direct PTCA
Substudy (GUSTO IIb) evaluated treatment of patients presenting within
12 hours of ST-segment elevation myocardial infarction with direct PTCA
or accelerated recombinant tissue plasminogen activator (t-PA). The
primary hypothesis was that for patients with suspected acute myocardial
infarction, with ST-segment elevation, direct PTCA would result in a lower
rate of 30-day mortality, nonfatal reinfarction, and nonfatal disabling
stroke, when compared with thrombolytic therapy.
A total of 1138 patients were enrolled in this trial at 60 centers in 9
countries from North America, Europe, and Australia over a period of 17
months. Investigator selection criteria included those physicians who
had significant experience performing primary angioplasty for patients
with acute myocardial infarctions, who fulfilled the 1993 ACC volume
criteria of at least 50 to 75 cases of angioplasty per year. Investigational
institutions were required to have performed at least 200 angioplasties
per year and have a 24-hour on call team with an established system
for operating room backup. Five hundred sixty-five patients were
assigned to primary angioplasty and 573 to accelerated recombinant
(t-PA). At initial enrollment, the first 1012 patients were also randomized
in a factorial design, to intravenous heparin or intravenous hirudin, as
part of the GUSTO II trial. Thereafter, all patients received intravenous
heparin. At enrollment, patients were given chewable aspirin (160 mg
were recommended) followed by a daily dose of 80 to 325 mg. Patients
received standard medical care post assigned treatment. Other testing
and adjunctive therapies were left up to the discretion of the physician.
Of the patients randomized to t-PA, 94.6% (542/573) received t-PA, 1.6%
(9/573) received streptokinase, and 1.7% (10/573) had direct angioplasty.
Eighty-two patients (14.4%) required emergency angiography and 60 (10.5%)
required emergency PTCA. Two hundred seventy (47.3%) had elective
angiography and 61 (10.7%) had elective PTCA. The in-hospital procedural
characteristics for patients randomized to PTCA, were 73.3% (374/510) of the
infarct arteries occluded (TIMI grade 0 or 1 flow) at initial catheterization (core
lab) and 79.2% (446/563) patients received PTCA. Patency after angioplasty
(TIMI grade 2 or 3 flow) was achieved in 93.1% (473/508) of patients (core
lab). Twenty-two (4%) required emergency angiography and 19 (3.5%)
required emergency PTCA. Nineteen (3.5%) had elective angiography, and
5 (0.9%) had elective PTCA. The mean time from arrival at the hospital to
treatment for patients randomized to accelerated t-PA was 1.2 ±0.9 hours
and for the PTCA treatment group was 2.2 ±0.9 hours.
When comparing the treatment of patients with ST-segment elevation
myocardial infarction with direct PTCA to treatment with accelerated
t-PA, PTCA resulted in a statistically significant lower 30 day composite
endpoint rate of death, reinfarction, and non-fatal disabling stroke of 9.6%
versus 13.7%, respectively, (odds ratio = 0.67, p = 0.033). Additionally,
the direct PTCA group had a statistically significant lower rate of recurrent
ischemia at 30 days when compared to the t-PA group 5.5% (29/526)
versus 9.0% (48/532), respectively, (odds ratio = 0.59, p = 0.03). The
overall stroke rate for this study was 1.6% (18/1133). The stroke rate
for patients treated with direct PTCA was 1.3% (7/562) versus 1.9%
(11/571) for patients treated with t-PA (odds ratio = 0.64, p = 0.36). The
accelerated t-PA treatment group had a statistically significant higher
rate of intracranial hemorrhagic strokes when compared to PTCA, 1.5%
(8/571) versus 0%, respectively (odds ratio = 0.06, p = 0.005). There was
a statistically significant higher overall rate of bleeding in the PTCA group
versus the t-PA group 40.3% (227/563) versus 34.2% (195/571) (odds
ratio = 1.30, p = 0.03). The rate of severe or life threatening bleeding
was equivalent in both treatment groups. Seventy percent (161/227)
of bleeding complications in the PTCA treatment group were related to
vascular access and 62.9% (142/227) were mild in nature.
At 180 days, there was no statistical difference in the composite rate of
death, reinfarction, and nonfatal disabling stroke for accelerated t-PA versus
direct PTCA, 16.8% (87/517) versus 14.7% (75/509), respectively, (odds
ratio = 0.88, p = 0.36). The overall rate of re-admission to the hospital for
chest pain, myocardial infarction, stroke, and repeat cardiac procedures was
similar between the two groups. At one year there is no statistical difference
in the rate of death for accelerated t-PA versus PTCA 10.3% (52/507) versus
9.2% (46/500), respectively (odds ratio = 0.89, p = 0.57).
Direct PTCA with ACS Coronary Dilatation Catheters is safe and effective
in eligible patients presenting within 12 hours of ST-segment elevation
myocardial infarction, providing a reduced composite event rate at 30
days with an equivalent clinical outcome at 180 days and one year
compared with accelerated t-PA.