Sample Consent Form: Cardiac Catheterization

Cardiac Catheterization

Informed consent is a discussion between a patient and a clinician who is preparing to perform a procedure for that patient’s care. This is an opportunity to understand the risks and benefits of a procedure, to understand the alternatives, to ask questions, or to refuse a procedure. Patients are encouraged to take part in informed consent discussion.

Description

Your Cardiologist, ______________________, has discussed Cardiac Catheterization with you. This procedure is used to view the anatomy and function of your heart and the blood vessels that bring blood to your heart. During a Cardiac Catheterization you receive a local anesthesia in the groin or arm, and sedation for your comfort. An intravenous line is placed in your arm to provide access for medications. Your Cardiologist inserts a catheter (a long hollow tube) through a needle into your artery. The catheter is guided to your heart using special x-rays (fluoroscopy). Angiography, injection of a dye into the catheter, is performed to visualize the flow of blood through your arteries to your heart. Heart pressures and oxygen level measurements are also recorded. After viewing the blood vessels, the catheter is removed, and pressure is applied to the insertion site to limit bleeding. If serious complications arise, your Cardiologist may refer you to a Cardiac Surgeon for emergency coronary artery bypass surgery.

Alternatives

• Cardiovascular Stress Testing.
• Myocardial Perfusion Study and Computerized Tomography (CT).

Benefits

• Usually provides critical information about heart structures and functions.

Risks

• Infection, bleeding, swelling, or scarring at the site of catheter insertion.
• Discomfort, nausea, and vomiting.
• Temporary changes in heart rhythms and blood pressures. Serious changes may require treatment with emergency defibrillation (application of electrical shock to the heart).
• Allergic reaction to, or uncomfortable feeling from the dye used in angiography, including headache, sneezing, chills, fever, hives, itching, or shock.
• Nerve injury causing temporary or permanent localized weakness or numbness in the affected area.
• Damage, bruising or rupture of the artery or heart wall. Any of these problems may require open heart or vascular surgery to repair damage.
• Severe bleeding, stroke, and emboli.
• Slight risk of harm to your body due to radioactive exposure.
• Slight risk of harm to the fetus during the first trimester due to radiation exposure.
• Risks associated with anesthesia.
• Please inform your clinician prior to the procedure if you are pregnant. Lead shielding over the pelvis is available to protect the fetus when possible.
• Your condition may not be diagnosed and additional diagnostic procedures may be necessary.

Depending on your specific medical condition, there may be additional risks to this procedure. Your clinician will review these details with you. There is no assurance this procedure will work as planned and there may be problems not connected to this treatment that are natural risks.

Consent for Cardiac Catheterization

I recognize that during the course of treatment, unforeseeable conditions may require additional or different treatment or procedures than those listed above or discussed with me. I request and authorize my physician and other qualified medical personnel to perform such other treatment or procedures as are, in their judgment, necessary and appropriate.

• I certify that I have read or had read to me the contents of this form.
• I have read or had read to me and will follow any patient instructions related to this procedure.
• I have had the opportunity to ask questions and all of my questions have been answered to my satisfaction. I consent to the above procedures as deemed necessary or appropriate by my physician or credentialed provider.
• I have been given the option to have my cardiac catheterization procedure performed at any facility I so choose.

My provider has answered my questions. I authorize Dr. ______________________________________ and such associates or assistants as may be selected by this provider to proceed.

________________________________________________________
Patient Name
________________________________________________________
Dr. Name

PROVIDER: I have explained the risks, benefits, alternatives, and nature of this procedure to the patient. I understand the patient has no further questions and appears to have understood the information provided:

WITNESS: I have witnessed the patient’s signature and verify it is authentic. I understand the patient has consented to this procedure without coercion and appears competent to provide consent:

________________________________________________________
Witness (optional) Witness Signature (optional)

________________________________________________________
Date/Time

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