3 Preparation for Cardiac Catheterization
Informed Consent
Legal Aspects
Obtaining informed consent for procedures is a legal and an ethical necessity. From a legal perspective, performing a diagnostic or therapeutic procedure without properly obtaining the patient’s consent can be considered assault and battery. The patient should be informed about the rationale, benefits, risks, and steps of the procedure and about alternatives.
The physician should provide professional advice, so that the patient can decide whether or not to have the planned procedure. Information should also be provided regarding the consequences of an unsuccessful procedure or procedural complications.
The procedure is discussed with the person who has to provide the informed consent. In general, this is the patient; state laws regulate who can consent for minors or patients not able to provide informed consent themselves (e.g., parents, legal guardian).
Elective Procedure
When the informed consent is obtained depends on the difficulty and extent of the planned procedure. For elective procedures there should be enough time that the patient does not feel coerced. For difficult or problematic interventions, it may be required to have several discussions so that the proper course of action can gradually be decided.
Organizational difficulties in the clinic never justify obtaining informed consent late (e.g., informed consent on the patient table in the catheterization laboratory).
The patient should first be informed about the established or putative diagnosis and then about the procedure. To improve understanding of the procedure and thus compliance, it may be useful to use media such as movies.
Emergency Procedures
In emergency situations where there are no other good alternatives, informed consent may be restricted to the bare minimum and the issue of timing can be ignored. Still, informed consent must be provided and documented, balancing the benefits of discussion with the benefits of rapid intervention. Especially in cases in which the patient has an altered mental status (e.g., a ventilated, resuscitated patient), the physicians should try to establish the probable wishes of the patient, either by consulting with the next of kin or by deciding themselves. This decision process should be clearly documented. States regulate how physicians can deem a patient’s condition an emergency.
Documentation
For potential legal purposes, the physician should document the form, timing, and extent of the discussion.
Forms can never take the place of a discussion with the patient.
By signing the informed consent, patients are supposed to document not only their consent, but also their understanding of the discussion, and that they have no further questions.
Obtaining Informed Consent
The discussion should explain both the procedure and the risks associated with it.
Information Regarding the Procedure
Discuss the medical necessity of the procedure/intervention.
Discuss pre- and postprocedural care.
Discuss what the procedure entails.
Information Regarding Risk
The patient has to be informed about all conceivable complications of the procedure that cannot reliably be avoided.
Rare but typical complications should be mentioned.
Benefits and risks when the procedure is not done have to be discussed.
Alternative approaches should be discussed.
The discussion may be omitted if the patient explicitly waives it; this should be documented.
Examinations Prior to Catheterization
History and Physical Examination
In addition to the patient’s specific cardiac history, there needs to be a special focus on the individual’s risk constellation for cardiac catheterization. This includes the following diseases and findings:
Chronic kidney disease
Diabetes mellitus
Manifest hyperthyroidism
Known allergies or known allergy to contrast media
Severe arterial hypertension
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