Download 心臓・血管カテ－テル検査説明・同意書

Explanation and Consent Form for
the Catheterization of the Heart and Blood Vessel
Name of patient Mr./ Mrs./ Ms
Explained the statements as below on
/
/
:
(yyyy/mm/dd hh;mm).
Doctor
(Self-written or Name and Seal)
Person at presence
(Self-written or Name and Seal)
１．Name of Sickness and Symptoms
□ Angina
□ Myocardinal Infarction
□ Heart Failure
□ Arteriosclerosis Obliterans
□
２．Examination Method (Date of Examination：
/
/
) (yyyy/mm/dd)
After the antisepsis/ local anesthesia, a short tube called a catheter sheath will be indwelled from the groin, elbow or wrist into the
artery (or vein, depending on the examination). This is done in order to reduce the bleeding or strain applied on the vessel when the
catheter in either inserted or removed from the vessel. This is seen through the X-ray, and the catheter is then advanced through a soft
guide wire into the blood vessel, heart or other parts, and if necessary, the examinations below will be performed.
【Coronary Angiography】
：A vessel which provides blood to the heart muscle: A catheter will be inserted into the coronary artery, and
contrast medium will be injected in order to examine the existence of stenosis(constriction) or occlusion(blockage). Medicine will be
used in order to test the induction of coronary spasm, depending on the situation.
【Right Heart Catheterization】：A catheter is inserted into the vein to evaluate the cardiac function, pressure monitoring and
measurement of the cardiac output of the right atrium, right ventricle and pulmonary artery will be done. X-rays may be taken
injecting a contrast medium depending on the situation.
【Left Ventriculography (LVG)】
：Being the most important pump chamber, the left ventricle systolic function will need to be evaluated.
And for that, a catheter will be inserted in the left ventricle, pressure measurement will be done and contrast medium will be injected
for X-rays.
【Kidney/ Lower Limb Vessel Imaging】
：Blood vessels which provides blood to the kidney/ lower limb blood vessels will be X-rayed in
order to examine the existence of stenosis(constriction) or occlusion(blockage).
【Myocardinal Biopsy】
：Dilated cardiomyopathy(DCM)・hypertrophic cardiomyopathy(HCM) or other secondary cardiomyopathy, if any
degeneration of the cardiac muscle is suspected, a part of the muscle from the left or right ventricle will be collected for a pathological
examination.
【Others】
：Other additional examinations will be done complied with the symptoms：
（
）
The catheter and catheter sheath will be removed after the examination, and the bleeding will be stopped by oppression. If the
examination is done at the groin, the patient will need to lay quiet on the bed in the room for about 4 to 6 hrs, depending on the
hemostasis condition. If the examination is done through the elbow or wrist, generally, the patient will be able to walk straight away
after returning to the room. Needless to say, during oppression and after the release from the oppression, do not place any pressure, and
in case of bleeding, swelling or if you feel any abnormality, please inform the staff immediately. Also, the data before, after and data
during the examination might be used for future examinations, treatments and for medical progression.
３．The risks and complication of the examination
We cannot assure that there are absolutely no risks in the heart catheter examination. Since medical apparatus and medications are
inserted/ dosed into the body, we have to keep in mind that contingency situations might occur. The possibilities of complication from the
heart catheterization are from 0.8% to 3.6%, but critical complications are rare, and the death rates are below 0.1%. Generally,
complications stated below are reported.
① Pain at the indwelling catheter: the usage of local anesthetic tape or injection may reduce the pain, but some pain may still be
felt. Additional local anesthetic will be dosed if the pain is strong.
② Bleeding & damaged blood vessels: It is rare that the blood vessels get damaged and bleed due to the guide wire and catheter for
it is made of soft material, but it the damage or bleeding ever happens, a surgery to stop the bleeding will be performed under
general anesthetic. If there is a case where it bleeds beneath the skin, you might feel pain until the hematoma is absorbed, or
the color of blood under the skin may stay for a while. There are cases where it can be fatal, but the chances are very rare.
③ Damage of the nerve: Regional anesthetic and the insertion of a sheath or puncture of a needle, and also oppression after the
surgery and taking the same position for a long period of time can cause oppression and stimulation due to the damage of the
blood vessels stated as above, which can lead to numbness and paralysis due to the damage of the nerve. Inform us immediately
once you feel numb either during puncture, oppression or inserting other tube.
④ Allergy due to contrast dye or anesthetic, etc.: If you have an allergy against contrast dye, anesthetic or other necessary
medication, symptoms such as discomfort, low blood pressure, breathing difficulty may appear. We will get conformation before
the examination, but since we cannot have predictions for everything, we will immediately take appropriate measure if we find
an allergic reaction. Generally, 1 in about 100,000 people gets fatal complications due to contrast dye.
⑤ Heparin induced Thrombocytopenia (HIT): An anticoagulant (a drug which prevents blood from forming clots easily) called
heparin is used during the examination to prevent the blockage of blood vessels. Patients dosed with this drug before rarely
form antibodies inside them, and if heparin is used in this situation, the body may overreact to the drug making the blood in the
vessels clot, which leads to a complication of cardiac infarction, brain infarction and pulmonary embolism. If the patient is
suspicious in having HIT, the use of heparin will be cancelled, and the anticoagulant will be switched over to a special
medication. (0.5~5%)
⑥ Arrhythmia: There is a possibility that various kinds of arrhythmia may set up due to the stimulation of the catheter or the
contrast dye. We proceed with the examinations with appropriate measures in case severe arrhythmia sets up.
⑦ Cardiac infarction: There are cases where the occlusion of the coronary artery occurs due to the usage of guide wire, catheter,
and depending on the situation it might be necessary to have a coronary artery bypass surgery. (Less than 0.05%)
⑧ Brain infarction: There are cases where the patient gets paralyzed due to brain infarction, when the catheter peels off the lump
of cholesterol in the harden arteries which blocks the blood vessels in the brain. (Less than 0.06%)
⑨ Blockage of the peripheral artery: There are also rare cases where the blood vessels of the renal and legs are blocked due to the
peeling off of the cholesterol and flowed into the periphery. The prognosis is said to be bad if the kidney (renal) function declines
or the treatment is belated, however this case is rarely frequent.
⑩ Kidney failure: There are cases where the kidney function worsens when the patient, whom the kidney function is already
decline before the examination, uses the contrast dye. If the kidney system is declining before the examination, we will do our
best not to worsen the kidney functioning by limiting the amount of contrast dye, giving a drip after the examination or internal
medication. However, dialysis will be necessary if the kidney function worsens.
⑪ Infection: It is rare to get bacterial infection since hygiene operations for the catheter examinations are done same as all general
surgeries, but if the patient gets infected, appropriate antibiotics will be given.
⑫ X-ray exposure: Due to the exposure of X-ray, radiation damage such as red patch on skin, ulcer, hair loss may occur. This is due
to the long hour exposure to the X-ray, and it is highly rare that this occur just by heart catheterization.
⑬ Others: There are possibilities that contingency situations may occur, but we will take appropriate measures.
4. Please answer the allergy inquiries below.
・Have you ever had allergy such as hives(rash), asthma, pollen allergy
(
Yes
/
No
)
・Do you have relatives who have got allergy
(
Yes
/
No
)
・Have you ever undergone an examination which uses vascular contrast medium
(
Yes
/
No
)
・Have you experienced an allergic reaction while using vascular contrast medium
(
Yes
/
No
)
I agree to undergo the examination, understanding the explanations given regarding the examination purpose, methods, and
complications regarding the heart catheter examination. Thus, I will also agree to the course of medical treatment the doctor in charge
diagnosed as necessary concerning the examination.
Date:
/
Name of Patient
(If the patient cannot sign) Name of Legal Representative
Received Duplicate copy.
Recipient
/
(Self-written or Name and Seal)
(Self-written or Name and Seal )
Relationship
(Self-written or Name and Seal)