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The Catheterization Laboratory 5
Box 1-2 Complications of Cardiac Catheterization
Major
Cerebrovascular accident
Death
Myocardial infarction
Ventricular tachycardia, fibrillation, serious arrhythmia
Other
Aortic dissection
Cardiac per foration, t amponade
Congestive heart failure
Contrast reaction (anaphylaxis, nephrotoxicity)
Heart block, asystole
Hemorrhage (local, retrop eritoneal, pelvic)
Infection
Protamine reaction
Supraventricular tachyarrhythmia, atrial fibrillation
Thrombosis, embolus, air embolus
Vascular injur y, pseudoaneur ysm
Vasovagal reaction
Box 1-3 Conditions of Patients at Higher Risk for
Complications of Catheterization*
Acute myocardial infarction
Advanced age (>75 years)
Aortic aneurysm
Aortic stenosis
Congestive heart failure
Diabetes
Extensive three -vessel coronary artery disease
Left ventricular dysfunction (left ventricular ejection fraction <35%)
Obesit y
Prior cerebrovascular accident
Renal insufficiency
Suspected or known lef t main coronary stenosis
Uncontrolled hyper tension
Unstable angina
*See also Chapter 8.
digitally stored format, as well as cardiac output and blood oxygen
saturation measurements.
Preparation of the Patient
Consent for the Procedure
Consent may be obtained by the operator or his or her assistant but is
usually obtained by a physician. The person obtaining consent should
do the following:
1. Explain in simple terms what procedure will take place, for what
reason each step of the procedure will occur, the roles of the team
performing the procedure, and what is expected to be learned from
the test.
2. Explain the risks for routine cardiac catheterization. Major risks
in clude stroke, myocardial infarction, and death. Minor risks include vascular injury, allergic reaction, bleeding, hematoma, and
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The Catheterization Laboratory
Table 1-3
Incidence of Major Complications of
Diagnostic Catheterizations
Procedure-Related Complications in Patients Without STEMI
PCI Patients
Without STEMI
(n = 787,980)
Complications (%)
Any adverse event 4.53 1.35
Cardiogenic shock 0.47 0.24
Heart failure 0.59 0.38
Pericardial tamponade 0.07 0.03
CVA/stroke 0.17 0.17
Total strokes that
were hemorrhagic
New requirement for
dialysis
In-hospital mor talit y:
Non–risk-adjusted 0.65 0.72
Non–risk-adjusted
excluding CABG
patients
CABG performed
during admission
CABG status
Salvage/emergency 0.01/0.17 0.01/0.27
Urgent/elective 0.47/0.16 5.27/1.92
CABG indication
PCI failure without
clinical deterioration
PCI complication 0.14
Bleeding complications (%)
Any bleeding event
within 72 hours of
procedure
Any other vascular
complication requiring
treatment
RBC/whole- blood
transfusion
From Dehmer GJ, Weaver D, Mat thew T, et al: A co ntemporary view of diagnosti c
cardia c cat heteriz ation and p ercut aneous coronary inter vention in the United
States. A repor t from the CathPCI Registr y of the Natio nal Cardiovascular Data
Registry, 2010 through June 2011. J Am Coll Cardiol 60:2017–2031, 2012.
CABG, Coronary artery bypass graf t; CVA, cerebrovascular accident; N/A, not
applicable; P CI, p ercut aneous coronary inter vention; RBC, red blood cell; STEMI,
ST-seg ment elevation myocardial infarction.
15.6 9.16
0.19 0.14
0.62 0.60
0.81 7.47
0.26
1.40 0.49
0.44 0.15
2.07 N/A
Diagnostic Catheterization
Only Patients Without
STEMI (n = 1,091,557)
infection. If PCI is anticipated, consent for this should be obtained
as well discussing options for medical therapy, stenting, or coronary bypass surgery in advance of the procedure.
3. Explain any portions of the study used for research and the associated risks (e.g., electrophysiologic study—perforation, arrhythmia
[<1:500]; pharmacologic study—varies depending on drug and
study duration; intracoronary imaging or sensor-pressure wire
study—spasm, myocardial infarction, embolus, dissection [<1:500]).
4. Provide the necessary information and explanation but do not
overwhelm the patient. It is good practice to include the family
when explaining what will happen and possible outcomes you
expect.
After explaining all aspects of the cardiac catheterization for
informed consent, it is important to remember that the final decision
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to undergo the procedure is always the patient’s. Informed consent
entails a shared decision-making process, in which there is a two-way
exchange of pertinent information. This information allows the patient
(and family) to make a fully informed decision based on his or her
expectations, risks of the procedure, and choice of alternatives. If the
patient is reluctant to have the catheterization, the procedure can be
deferred until the referring physician speaks to the patient to clarify
why the procedure is necessary. A reluctant patient should never sign
the consent form. When possible, the family should be present when
the procedure is discussed. This approach encourages a cooperative
and generally sympathetic appreciation of the procedure, the risks,
and expected outcome.
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The Catheterization Laboratory 7
Communication with Patients: A Nonmedical
Person’s Understanding
The clinician establishes rapport and builds the patient’s confidence
by listening and explaining. The procedure should be discussed with
the patient in terms that he or she can understand. The purpose of the
procedure should be clear—“to look at the arteries in the heart (coronary arteries)” and “to examine the heart muscle (ventricular function).” Simple terms are best so that the patient can grasp the concepts.
The clinician should explain what small catheters are (plastic tubes
similar in size to spaghetti) and that they will be used to put x-ray
contrast media (“dye”) into the arteries supplying blood to the heart.
Explain that the procedure is not painful because the arteries are
generally not sensitive to the passage of the small catheters. The heart
muscle may be weakened (infarcted) in certain areas, and the way to
identify this weakness is to take x-ray pictures of the “main pumping
chamber” (i.e., the left ventricle). This example of a simple, forthright
explanation facilitates the operator team–patient relationship so that
confidence in the operator and team performing the procedure is
established.
Laboratory Atmosphere: The Patient’s
Confidence Builder
1. In the laboratory, a confident, professional attitude should be
adopted by all personnel at all times. Straightforward routine communication should occur quietly and without alarming tones.
Patients should be addressed directly, by name, to let them know
what their instructions are, as opposed to requests or communications to co-workers.
2. The circulating team members should be confident, reassuring,
and professional in every respect. The patient feels helpless and is
tuned in to all types of stimuli (especially verbal).
3. Extraneous conversation is distracting for the patient and the oper-
ators. In the laboratory, all “players” should be in the game; that is,
focused on the patient’s needs and safety, which become paramount goals.
4. Communication with the patient (and family) before, during, and
after the procedure ensures a satisfied and well-cared-for individual. Communication among the team members in a professional,
courteous, and quiet tone builds patient confidence and helps the
procedure go smoothly.
5. Factory worker attitudes of “another coronar y” or “another
ST-segment elevation myocardial infarction (STEMI)” should be
avoided. Each procedure is potentially life threatening and should
be undertaken seriously and with concern as if each patient were
a family member.
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6. Cardiac catheterization is stressful to the patient and the operator
7. General catheterization orders:
8. Patients should wear their glasses and dentures in the laboratory
The Catheterization Laboratory
team. This stress should be minimized by thoughtful preparation
and professional attention to detail.
Practical notes for the new operator include the following:
a. Immediately before the catheterization in the laboratory, a brief
reiteration of the history ensures that no interval change has
occurred since the last interview.
b. A reexamination of the patient’s ECG is essential.
c. A brief examination of the patient—checking heart sounds,
breath sounds, and carotid and peripheral pulses—should be
routine immediately before and after cardiac catheterization. No
patient should be studied without the operator’s full understand-
ing of the clinical conditions and results of previous catheteriza-
tions and other pertinent laboratory data.
When on the catheterization table, the patient remembers two
major potentially painful points of a case: (1) the initial introduction of the local anesthetic (and sometimes radial sheath introduction) and (2) any discomfort experienced after the study has
been completed. Such discomfort usually occurs while the operator or nurse is holding the femoral puncture site. If the local anesthetic injection is performed too quickly or if the arterial closure or
compression after the procedure is difficult or painful, the patient
will remember that the physician who performed the catheterization “hurt me.” The period between the two events is often forgotten
(thanks to premedication), but these two points should be kept in
mind as the major new-operator “take-home” messages. Patients
cannot discern the operator’s skill or level of accomplishment
during the procedure, but they judge the operator (and the team)
on the manner and care they receive at the beginning and end of
the study. Skill and accomplishment during the procedure are
essential, and these are developed during the new operator’s training period.
• Before catheterization, preferably the preceding night, precath-
eterization orders should be written.
•
All medications and procedural premedications should be tai-
lored to the patient and timing of the catheterization. If the
patient is using long-acting insulin (neutral protamine Hagedorn [NPH]), the dose should be reduced by 50% and the
patient should not eat breakfast. The patient should be watched
carefully for hypoglycemic reactions (e.g., shaking, confusion,
slurred speech).
•
A more recent suggestion to avoid dehydration and increased
chance of contrast-induced nephropathy is to permit or encour-
age the patient to drink water before the procedure and confine
the nothing-by-mouth (NPO) orders to solid foods or dairy
products before the procedure.
to make communication easier.
In-Laboratory Preparations and the
“Time Out”
The staff of the cardiac catheterization laboratory is responsible for
patient preparation before the start of the procedure. On the patient’s
arrival in the laboratory, a staff member should review a brief checklist
to ensure that all preprocedural requirements have been met. A
sample checklist follows:
•
Check the patient’s ID band and known allergies.
• Check laboratory results (key tests: hemoglobin, platelet count,
electrolytes including blood urea nitrogen, creatinine).
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The Catheterization Laboratory 9
• Check blood pressure, all pulses (arms and legs), and baseline
ECG.
•
Anticoagulant status: Check the international normalized ratio
(INR) and partial thromboplastin time (PTT) and, if on heparin,
the activated clotting time (ACT).
•
Recheck childbearing potential (patient may need β-human
chorionic gonadotropin level).
•
Verify that the proper paperwork has been copied, filled out for
the procedure, and confirm that the consent form is signed.
•
Assess the patient’s understanding of the procedure and answer
the patient’s questions.
•
Check that the oral airway forms for the procedure are signed
and in the chart. If not, make arrangements for their completion
before the procedure.
•
Check that the intravenous (IV) line is secure and patent.
• Check that the patient has ingested nothing solid by mouth
before the procedure.
•
Check whether premedications were given as ordered.
• Start documentation of the precatheterization condition and
note any physical deficits (abnormal neurologic examination,
bruising or bleeding sites).
Cautionary Note
The cardiac catheterization laboratory, like any operating area in a
hospital, has potential injury risks to both patients and staff. Common
risks of any operating room are listed in Table 1-4. Good sense and
proven work routines help the lab take precautions against accidents.
Specific situations in which patient-related accidents should also be
considered and attended to include the transfer and centering of the
patient on the table and removing any sharps or hard-edged objects
from contact with the patient.
One unresolved issue is how to protect patients from falling or
rolling off the catheterization table and whether all patients should be
restrained on the catheterization lab table (Fig. 1-2). Patients who are
at high risk for falls include high–body mass index (BMI) patients,
those who cannot follow simple instructions, or patients who are
agitated or uncooperative. Patients who cannot keep their arms at
their sides, or keep their legs or body still on the table, are also at high
risk. These are the same patients who may also fall during transfer on
or off the catheterization table. There is no formal algorithm for deciding who is truly at “high risk.” All labs use operator and nurse judgment
at the time of the procedure. Table restraints are not always effective
Table 1-4
Safety Hazards
Safety Hazards in the Catheterization L ab Person at Risk
Ionizing radiation, electricity, impact with
stationary equipment
Blood products, microor ganisms Staf f, patient
Pharmaceutical agents Patient
Chemical solvents, acids, bases, cleansers Staff
Ergonomic injury (lifting in awkward positions,
working in tight spaces, slipping on wet
floors)
Falls from table, gurney, floor Patient (possibly staff
Staf f, patient
Staf f
during rescue at tempt)
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Figure 1-2 Strap for holding patient on catheterization table. Despite
restraints, patient should be closely attended to while the potential of falling
is present. (Reprinted with permission from the Cath Lab Digest. Copyright
HMP Communications.)
The Catheterization Laboratory
to prevent falls off of the catheterization table. It is good practice that
during the time out and after the administration of conscious sedation,
all patients should be assessed for their fall risk.
1
After all precatheterization requirements have been fulfilled, the
patient may be taken to the angiographic suite and the technical
preparations can be completed.
Catheterization Suite Preparations
Before the start of the catheterization procedure, the staff performs
the following tasks:
1. Establish ECG monitoring. The ECG should be considered the first
of the two major “lifelines.” The heartbeat is monitored for rate and
rhythm during the entire procedure. It is the responsibility of the
staff to place the electrodes and lead wires in such a fashion that
a quality trace is obtained. Care must be taken that the electrodes
and lead wires do not interfere with the movement of the x-ray and
cineangiographic unit. All leads should be secure, and a good
signal should be present before the application of sterile drapes;
reaching under the sterile drapes to reattach loose lead wires once
the procedure has begun is difficult. Radiolucent leads permit complete 12-lead ECG monitoring but are more prone to breakage than
heavier cable leads.
2. Establish IV access. The second lifeline is IV access for routine
medications and fluids as well as for emergency resuscitation measures. Without good IV access, emergency drugs to counteract
vagal or allergic reactions will not be effective. When the patient
is in the laboratory, the nurse or physician may identify the need
for additional sedation or analgesia before the start of the procedure. The IV line is also important for hydration after cardiac
catheterization.
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The Catheterization Laboratory 11
Caution must be exercised when premedicating elderly patients.
If meperidine (Demerol), fentanyl, or morphine is used, a narcotic
antagonist, such as naloxone (Narcan), should be available. Flumazenil (a benzodiazepine antagonist) should also be available if diazepam
(Valium) or midazolam (Versed) is used.
The Time Out
In any catheterization laboratory, preparations can be hectic, perhaps
even frantic at times. This frenetic pace can cause problems, important steps can be missed, and patient safety can be compromised. As
part of procedural safety, every patient coming to the laboratory must
be assessed for his or her suitability for conscious sedation and potential complications of the catheterization procedure. Every laboratory
is required to perform a preprocedure safety review, called the time
out (Fig. 1-3). In the time out before sedation, the team verifies the
right patient is in the room; the right procedure is going to be performed; the right operative site will be used; and whether the patient
has renal failure, allergies, or is being treated with anticoagulants so
that the team has no concerns about whether to proceed. At this time,
Figure 1-3 The “time out” towel is a reminder to conduct a safety check
before proceeding with the procedure. (Reprinted with permission from the
Cath Lab Digest. Copyright HMP Communications.)
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the team agrees to proceed and then specifies what analgesia
and sedation dose will be given. Time out is a Joint Commission
requirement.
The Catheterization Laboratory
When Should the Time Out Occur?
The time out, the immediate preprocedure pause, must occur in the
location where the procedure is to be done (catheterization laboratory
suite). The time out may precede anesthesia, or in the operating room
it may occur after the patient is anesthetized (participation by the
patient is not expected in surgical procedures, but is recommended
for catheterization laboratory procedures) but just before starting the
procedure.
Who Should Participate in the Time-Out Process?
The time out must involve the entire operative team. At a minimum,
this includes the catheterization laboratory operator, his or her assistant, any anesthesia provider, and the circulating nurse. Participation
with active (out-loud) verbal communication by all members of the
team is required. (“I concur” is the proper acknowledgment.) In particular, if there is concern about a possible error, no one should be
afraid to speak up and protect the patient. Even when there is only
one person doing the procedure, a brief pause to confirm the correct
patient, procedure, and site is appropriate. It is not necessary to engage
others in this verification process if they would not otherwise be
involved in the procedure.
The out-loud verbal acknowledgment is an important safety
behavior at other times as well for instructions given during the procedure and received by the circulating team. Active acknowledgment
of orders eliminates confusion, redundant requests, and frustration.
The Reverse Time Out or “I Need 2 Minutes”
The time out before the procedure is a routine safety requirement.
However, another kind of time out is sometimes needed when the case
goes too fast. This is especially true with overeager fellows and catheterization laboratory attending physicians who sometimes want to
work so fast that they outstrip the ability of the catheterization laboratory team to keep up with their demands or become confused by
conflicting or changing orders from the operators. Whenever this
happens, anyone working in the laboratory can call a time out, which
is stated out loud as “I need 2 minutes.” The operators should stop and
take a breath. This gives the person (and the team) who called time
out a couple of minutes of uninterrupted time for him or her to get
everything caught up and correct. For example, when the circulating
nurse is asked, “Please give the patient NTG, give me a JR4 6F, set the
injector at 12 for 36, and show me the ECG … ,” it is clear that this is
too much to do quickly enough for the smooth operation of the lab,
so the nurse should call for a 2-minute time out. The called 2-minute
time out is the request back to the operators to give the nurse, technician, or team 2 minutes to get all the steps, equipment, or setup going
and correctly brought together. During complex procedures, the nurse
can say, “I need 2 minutes to do xyz.” Everyone will hear and should
understand. The operators will relax and wait for the team to catch
up. Of course the called time out would not be appropriate if there
was a critical situation occurring in which the patient could not wait
for an emergency drug or other life-sustaining intervention (e.g., left
ventricular [LV] support device or an intraaortic balloon pump [IABP]
insertion).
Sterile Preparations
Cardiac catheterization occurs in an operating room environment,
and all preparations for the procedure must be performed using
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aseptic technique, with personnel in scrubs, protective hats, masks,
and gowns. Some labs do not require masks during the back-table
setup.
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The Catheterization Laboratory 13
Vascular Access Site Preparation
The most common vascular access sites are the right groin for the
femoral approach and the right wrist for the radial artery approach.
Of course, the left-side arteries are available as well when needed. The
usual sterile preparation begins by clipping the area of hair and vigorously applying an antiseptic solution. Shaving should be avoided
because of micro lacerations or abrasions breaking the skin barrier to
infection.
During patient preparation, the staff should always be aware of
the patient’s need for privacy. Curtains in the viewing area should be
drawn. The patient should be kept covered as much as possible. In
addition, procedure rooms are typically cold; ever y effort should be
made to keep the patient warm and comfortable.
Sterile Field Preparation and Patient Draping
A staff member assigned to assist the physician in the procedure puts
on hair and shoe covers and a surgical face mask and washes the
hands and forearms as a surgical scrub. He or she then puts on a sterile
surgical gown and gloves. An equipment stand is prepared in a sterile
fashion to hold all the catheters and other equipment to be used
during the procedure. At this time, a circulating staff member hands
opens the sterile packaged catheters and necessar y equipment not
included in the sterile catheter laboratory pack to be taken by the
scrub nurse or technician. A sterile drape is placed over the patient,
starting at the patient’s upper chest and extending to the foot, covering
the entire examination table. Special arm boards and drapes are used
for radial procedures.
It is important for all personnel to understand sterile techniques
to avoid accidentally contaminating any sterile fields. As a basic rule,
no unsterile object may be passed over a sterile field. A sterile gown
and gloves, rather than gloves alone, should be worn when preparing
the back table and patient, especially for team members who are very
short or wide or whose body may accidentally contact the sterile areas.
When moving around a crowded angiographic room, all personnel
should be careful to avoid bumping into or passing hands or arms over
the sterile tray, table, or patient drapes. Personnel should not walk
between the sterile table or equipment tray and the patient. Avoid
touching the ends of any catheters, extension tubes, or syringe tips in
a sterile field or the exposed power injector syringe tip.
Rules for Observers in the Laboratory
Some hospitals have policies that limit nonhospital personnel from
being in the catheterization laboratory without prior consent of the
patient. Any observers in the angiographic room should respect the
professional atmosphere and keep extraneous conversation to a
minimum. Observers should adhere to the policy of the laboratory and
wear scrubs or paper gowns and a lead apron as protection against
scattered radiation. Observers should avoid sterile fields and should
be aware of the precautions necessary for protection from blood and
other body fluids.
No one but catheterization laboratory personnel should ever
manipulate or adjust any device, equipment, or medication system
in the laboratory. To prevent observers who are not laboratory personnel from becoming overly enthusiastic and attempting to assist the
nurses or physicians, they should never be given sterile gloves. This is
an important potential liability issue for the laboratory, hospital, and
staff.
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The Catheterization Laboratory
Conscious Sedation for Invasive
Cardiac Procedure
The purpose of conscious sedation is to minimize patient anxiety,
discomfort, and pain associated with the procedure. The following
criteria define conscious sedation:
1. The patient at no time loses protective reflexes.
2. The patient retains the ability to maintain an open airway continuously without help.
3. The patient responds appropriately to verbal and physical
stimulation.
If the patient can no longer do the things listed, the sedative
technique evolves to deep sedation or general anesthesia. At this
point, the monitoring and care of the patient must be elevated to avoid
an adverse outcome.
A conscious sedation protocol has four major components: (1)
preprocedural baseline assessment, (2) drug dosage and administration, (3) patient monitoring, and (4) postprocedure monitoring and
assessment and discharge criteria.
Preprocedural Assessment
Before the administration of sedative agents, the patient should have
a complete assessment of his or her current physical condition. The
clinician should pay particular attention to any preexisting conditions
that would put the patient at risk for an adverse outcome if sedatives
are administered. A preprocedural evaluation should include a review
of the major organ systems, the time and type of the last oral intake,
a history of drug and alcohol use, a history of smoking, and a history
of previous experience with sedative agents.
Preprocedural fasting is the rule. Sedative agents may impair
airway reflexes, placing the patient at increased risk for aspirating
gastric contents. For elective procedures these risks can be minimized
by allowing sufficient time for gastric emptying before the procedure.
The patient should be NPO for solids and nonclear liquids after midnight or at least 8 hours before the start of the procedure. Clear liquids
may be appropriate 1 to 3 hours before the procedure, depending on
the type and dose of the sedative agent to be used.
Physical Examination and
Airway Assessment
An airway assessment should be part of the preprocedural routine.
Most preprocedural check lists include the Mallampati classification,
which is used to predict the ease of intubation. Mallampati scoring is
as follows:
Class 1: Full visibility of tonsils, uvula, and soft palate
Class 2: Visibility of hard and soft palate, upper portion of tonsils,
and uvula
Class 3: Soft and hard palate and base of the uvula are visible
Class 4: Only hard palate is visible
A high Mallampati score (class 4) is associated with more difficult
intubation as well as a higher incidence of sleep apnea. Factors associated with difficult airway management also include the following:
1. A history of sleep apnea, snoring, or stridor
2. Dysmorphic jaw or facial features
3. Advanced rheumatoid arthritis
4. A short neck with limited extension caused by obesity, mass, or
injury
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