A Detailed Checklist in Cardio-Thoracic Surgery: The Isala safety Check-Juniper Publishers
JUNIPER PUBLISHERS-OPEN ACCESS JOURNAL OF CARDIOLOGY & CARDIOVASCULAR THERAPY
In various fields of complex environments,
checklists have been introduced, mainly to improve procedural related
aspects like logistics, personnel support and equipment. However, in
order to pursue better outcome, major patient-related factors may be
likewise important to check immediately before surgical procedures.
Therefore, a specific checklist, the Isala Safety Check, was developed
in a high-volume cardio-thoracic surgery unit. It concerns a short list
focusing on the presence of potential sources for peri-operative
complications, including actual information of cardiac function,
pulmonary comorbidities, renal impairment, neurological condition,
predisposing factors for postoperative infections and risk of
transfusion. Special attention is paid to the on-site information
obtained by standard transesophageal echo, particularly the
visualization of the condition of the ascending aorta. After anesthesia
induction, but just before skin incision, these items are discussed in
the presence of the entire team, by means of a checklist. Consensus is
achieved to whether there are any adaptations required for the
operation. This method has shown to increase team awareness, stimulate
communication and may improve outcome. Details of the Isala Safety Check
and the application of this checklist in routine and emergency cardiac
surgery are discussed.
Abbreviations: TEE: Transesophageal Echo; WHO: World Health Organization; GFR: Glomerular Filtration Rate
Introduction
Careful pre-procedural evaluation of patients is one
of the cornerstones of preventing complications in many complex
procedures, including cardio-thoracic surgery. A stop moment, like the
time-out immediately before surgery, has demonstrated its importance and
has become routine in many complex team-driven specialties, in medical
and non-medical surroundings [1]. In addition, several specific
checklists have been developed, and proved highly effective in
decreasing complications [2]. However, for cardio-thoracic surgery
patients important items are not addressed during a standardized
time-out. Also, time-out checklists focus primarily on procedural issues
and still lack optimal communication about patient specific risk
factors between the team members before incision [2]. This of interest,
because the current guidelines provide only a few recommendations of
evaluating patients for cardio thoracic surgery [3]. Although our unit
has established good outcome results over many years, we developed an
extended checklist. This is based on the fact that a substantial number
of cardiac surgery related deaths is avoidable [4]. Introducing a
specific checklist, by professionals and intended for professionals,
covering patient-specific items with respect to risk factors for
perioperative complications, we assumed to improve patient-related
outcome and team performance [5]. The checked items are discussed just
before skin incision, because at this moment all information is
up-to-date and complete, including standard pre-procedural
transesophageal echo (TEE), and there is still an opportunity to adapt
the surgical strategy. Details of the Isala Safety Check, backgrounds
and suggestions for implementation are discussed in this paper.
The routine pre-operative assessment of cardiac patients for
non-cardiac surgery is well studied and described [6]. However,
there is limited literature on the content of a structured
routine pre-operative evaluation of patients for cardiothoracic
surgery. Furthermore, although the guidelines give only few
recommendations, particularly on pulmonary and renal function,
a structured approach to a complete pre-operative evaluation is
lacking and therefore may be variable [3].
The World Health Organization (WHO) has developed
a surgical safety checklist in 2005. This checklist has found
wide adoption and is now used in all fields of surgery even in
minimal invasive procedures [7]. Since 2009, a standard timeout
procedure is mandatory in all Dutch hospitals for every
surgical intervention [8]. The checklist for this procedure is
summarized in (Table 1). This checklist focuses on procedural aspects. Checking these items minimizes wrong patient/
procedure/site complications and prevents intra-operative
delay due to equipment problems. The time-out procedure has
proven its effectiveness in the field of mixed surgical population,
general surgery, orthopedic surgery, otorhinolaryngology and
neurosurgery [9-11]. Despite a few negative reports [12], a
significant reduction was demonstrated in overall complication
rate and even in mortality [13]. In the SURPASS study, the WHO
checklist was extended to a multistage, multidiscipline document
covering the entire patient course from admission to discharge.
This approach reduced in hospital mortality from 1.5 to 0.8%
and total complication rate from 27.3 to 16.7% [2].
Although the WHO surgical checklist reduced both
complication rate and mortality, there are some limitations of
this approach. Whereas it focuses on the procedural aspects,
communication on patient information concerning risk factors
and comorbidity might receive little attention. Furthermore,
a checklist on itself does not require interaction or discussion
[14]. Therefore, there is a possibility that after the first
introduction of a checklist the behavior of the performing team
changes into a “ticking” culture instead of actual awareness and
concern for the situation [15]. In Ontario, the introduction of the
surgical safety checklist has not led to a measurable change in
outcome [12]. One of the reasons might have been that, besides
the short period of evaluation, the standard checklist is not
directly calling for actions by all members of the operating team
[16]. Finally, the surgical safety checklist is, by design, a general
checklist. This implies that items concerning a specific type of
operation or patient category are lacking. Therefore, checklists
especially designed for certain operations, like transphenoidal
neurosurgery, were developed [17-18]. Cardiac surgery is also
such a type of operation, with specific risk factors and a patient
population with extensive comorbidity, requiring a specific
cardiac surgery checklist.
The items that are checked are represented in (Table 2).
It is essential that the total procedure is done by the complete
team, comprising the cardiac surgeon, the assisting, scrub
nurse, anesthesiologist, anesthetic nurse and perfusionist. The
first checked item by the team is whether the regular time-out
was indeed performed. If the regular time-out procedure was
not performed, the surgeon is urged to perform. Especially in
the setting of life threatening emergency cases this step might
have been skipped initially but should be performed at this
moment, or it should be documented that the team decides
that the regular time-out cannot be performed. To increase
the awareness for every team member with regard to the
expected mortality of the procedure, the calculated EuroSCORE
is repeated. Accordingly, patients are divided into three groups:
low, intermediate and high risk [19]. The third step is to identify
other specific peri- and postoperative risks and complications
with focus on six main organ specific topics: cardiac, pulmonary,
renal, neurologic, inflammation and coagulation. Cardiac risk
factors include reduced ventricular function, hypertrophy,
critical coronary artery stenosis, intra-cardiac shunts, valvular
dysfunction and pulmonary hypertension. Each of these findings
may require additional measures.
Pulmonary risk factors include mainly COPD, bronchiectasis
and restrictive pulmonary function. These conditions may urge to
reduce tidal volume, focusing on lung protective ventilation and
careful fluid balance [20]. Increased risk for renal dysfunction
may arise from an already decreased glomerular filtration rate
(GFR), but also previous periods of (reversible) renal failure.
Anticipation may involve the use of additional filtration on the
extracorporeal circuit or targeted perfusion pressure [21]. It
may be indicated that postoperative strategies are discussed
here already. Factors that lead to a higher risk of adverse
neurologic outcome are discussed. Previous stroke, transient
ischemic attacks and known carotid artery stenosis are the most
prominent factors. Preventive measures may include higher
perfusion pressures, additional monitoring of the ascending
aorta and postoperative anticoagulant therapy. Conditions that
increased the risk of infectious complications are discussed, like diabetes, depressed immune system, urinary tract problems or
chronic pulmonary disease. Special attention is paid to the risk
factors for postoperative wound infection. Preventive measures
include avoidance of bilateral mammalian artery use and
continued use of antibiotics postoperatively. Cardiac surgery
interferes with the hemostatic system and patients are mostly on
anti-coagulant therapy. Careful discussion on the management
of this therapy is mandatory. Therefore, the risk factors for
hemostatic complications and possible preventive measures are
to be discussed.
The fourth step of the Isala Safety check consists of
information from actual transesophageal echocardiography
(TEE) images, obtained immediately after induction of anesthesia.
The required images include a stepwise identification of global
myocardial contractility, possible sources of intra-cardiac
emboli, the oval foramen, all cardiac valves and the ascending
aorta. If any atherosclerosis with a grade of 3 or more based on
the Katz classification [22] of the visible part of the ascending
aorta or descending aorta is found, additional imaging of the
ascending aorta using modified TEE [23] should be considered
in order to increase the diagnostic accuracy of TEE [24]. The
results of this so-called focused TEE investigation are discussed
within the team. The fifth and final step is to summarize and
discuss the findings of the first steps, and decide whether an
adaptation of the surgical plan is necessary. This can vary from
additional monitoring by epi-aortic scanning in order to guide
changes in the canulation or clamping site, or to a total change
in surgical approach, as example change from on-pump CABG to
off-pump CABG.
The Isala Safety check is performed after induction of
anesthesia, just prior to skin incision. This moment is chosen
because at this time all information is available, whereas there
is still a possibility to change the strategy for the operation and
even to stop the operation. It is essential that all members of the
team are present, including perfusionist, scrub nurse, surgical
assistant, anesthetic nurse, surgeon and anesthesiologist. The anesthesiologist is in the lead together with the surgeon in
communicating about the safety check items. Since all activities
are paused during the checklist maximum awareness is ensured.
Most patients have elective surgery, and in these patients the
Isala Safety check can be performed, with minimal time loss. A
YouTube demonstration has shown that the team communication
will take only 2.09 min and no additional operative time is needed
to obtain the specific TEE images. Although the Isala Safety
Check is primarily designed for elective surgery, emergent cases
may benefit even more, particularly because most complications
occur in emergent cases. Monitoring the results of the Isala
Safety check, by registering adaptations to the operation plan in
combination with outcome of surgery, creates a feedback loop.
Regular update of this information to the healthcare providers
may lead to better preparation of patients and a tapered workup
for specific groups of patients.
The first potential limitation is time loss, due to both
numerating the comorbidity of the patient and the assessment of
a dedicated TEE examination. However, all items addressed in the
Isala Safety Checklist are notified information in the patient file
and the TEE is a focused examination that is performed during
the surgical preparation phase with no increase of operative
time. The second limitation is that the Safety Check is performed
just before skin incision, being late in the entire work-up process.
Changing the operation procedure or even stop the procedure at
this moment will have major (emotional, logistic and financial)
effects. However, this is the final moment to prevent major
complications and a sub-optimal approach. The fact that TEE is
performed during general anesthesia, may influence myocardial
and valve function, and interpretation should be done with
caution. However, experienced echo cardiographers are aware
of this limitation. A counter effect of checking important items
and offering the opportunity to adapt the surgical plan is that
ad hoc decisions may be taken. Although this risk is present, the
Isala Safety Check is not performed to replace the heart team,
where cardiologist and cardiothoracic surgeon decide together
the best treatment strategy for this patient. However, in the case
of unknown or changed important findings, it may be unethical
to ignore this.
If patients are not informed about the performance of
the Isala Safety Check and the possible consequences and
adaptations of the operation plan, this may interfere with the
consent of the patient. Therefore, it is mandatory to inform the
patients of this checklist and the possible consequences, and to
verify that patients agree with its use. Other items may be added
to the content of the Isala Safety Checklist in the future when the
outcome of the data show that certain adaptations appear more
in specific patient groups. It may be mandatory for these selected
groups to adjust the work up for certain operations in order to
realize a safer surgical strategy. Furthermore, the outcome of the
check is depending on the quality and the interpretation of the echo findings and the culture in the operating room to discuss
the strategy. This necessitates skilled professionals and an
open, respectful atmosphere where everyone’s contribution is
appreciated. A final limitation is that until now the benefit of the
Isala Safety Check has not been demonstrated in a randomized
controlled trial. However, the concept of providing a safer cardiac
operation by applying the check will rise no doubt at all.
With reference to the results of checklists in various fields
where professionals perform high-tech interventions in multi
disciplinary teams, it is our believe that the Isala Safety Check in
combination with monitoring results, discussing complications,
a learning attitude and focus on teamwork will reduce both
mortality and complication rate. Evidence based medicine
is the standard of care, and therefore we advocate a registry
of the implementation of the Isala Safety Check, including the
adaptations to the original operation plan. Many checklists have
been introduced and evaluated. To our knowledge, a randomized
clinical trial has not been published; probably due to fact that
double blinding is impossible.
Surgical checklists have proven to reduce perioperative
complications. The addition on top of the timeout procedure of
a specific checklist for cardio-thoracic surgery may increase the
awareness of the team of potential pitfalls, and enable change
of the surgical approach. The Isala Safety Checklist offers an
opportunity to systematically address specific risk factors and
discuss possible interventions. Timing of the checklist just before
skin incision adds actual cardiac information derived from the
images of the pre-operative transesophageal echo to the data of
the patient’s history, and creates the opportunity to adapt the
surgical plan to a safe strategy. Future research is necessary to
evaluate the added value of the Isala Safety Check in the outcome
of cardio thoracic surgery patients.
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