Running Head: CLINICAL QUESTION

Clinical Question Paper

Brandie Zimmerman
Ferris State University

Running Head: CLINICAL QUESTION

Abstract
Cardiogenic shock complicated by AMI is associated with high mortality rates despite
revascularization and initiation of an IABP (Seyfarth, 2008). The Impella is a newer LVAD

device that has been developed to improve patient outcomes. It is unknown if the Impella device
reduces both short and long term mortality rates when compared to the IABP. This research
found the initial patient outcomes to be improved with the application of the Impella device as
evidenced by improved cardiac index; however no significant differences in long term mortality
rates are noted when comparing the two devices.

Running Head: CLINICAL QUESTION

Clinical Question Paper

Nursing theorists and researchers develop clinical questions to improve nursing practice.
These clinical questions are then researched to develop evidence-based nursing practices that are
proven through research to be the best practices in nursing (Nieswiadomy, 2012, pg. 282). A
clinical question can be developed by identifying problem areas through the utilization of the
PICOT [patient, intervention, current practice, outcome and time] format (Nieswiadomy, 2012,
pg. 282). The purpose of this assignment is to develop a clinical PICOT question and to reflect
on how nursing knowledge is utilized in personal and professional practice (Ursuy, 2014). This
paper will identify a clinical PICOT question, discuss the methodology used for research,
critique 3 articles utilized for research and identify the significance this question presents in
nursing practice.
Clinical Question
Cardiogenic shock is a complication associated with acute myocardial infarction [AMI],
in which the heart is unable to effectively pump blood throughout the body and results in high
mortality rates for this patient population (Seyfarth, et al., 2008). The mortality rate for patients
that develop cardiogenic shock as a complication of AMI is approximately 40-50%, both with or
without revascularization and the use of an Intra-aortic balloon pump [IABP] (Seyfarth, et al.,
2008). The high mortality rates associated with AMI induced cardiogenic shock have led to the
development of newer left ventricular assist devices [LVADs] in an attempt to improve patient
outcomes and reduce both short and long term mortality rates (Seyfarth, et al., 2008). The
Impella 2.5 and Impella 5.0 are recently developed LVADs. It is unknown if the use of Impella
devices improve both short and long term patient outcomes when compared to the IABP. The
clinical question that this paper will discuss is whether or not Impella devices improve, both

Running Head: CLINICAL QUESTION

short and long term mortality rates, for patients presenting with cardiogenic shock as a
complication of AMI, when compared to an IABP for the same patient population.
The PICOT format assists in writing a clinical question that is specific by identifying a
specific patient population, interventions or areas of interest, comparison interventions or current
practices, desired patient outcomes, and a timeline to achieving desired outcomes (Nieswiadomy,
2012, pg. 282). The clinical question PICOT format is utilized in this paper to determine if
Impella devices improve patient outcomes; at 30 minutes and 30 days post device initiation in
comparison to the IABP. The population for this PICOT question is patients who present with
cardiogenic shock as a complication of AMI. The area of interest for this PICOT question is to
determine if Impella devices improve patient outcomes, both short and long term, when
compared to IABPs. The Impella devices and IABP will be compared in this specific patient
population to determine if significant improvements in patient outcomes are achieved as a result
of using Impella devices versus the use of IABP. The timeline for achieving improved patient
outcomes in this PICOT question is compared at 30 minutes post device initiation and at 30 days
post device initiation for both the Impella and IABP devices.
The purpose of nursing research is to improve patient outcomes by providing the best
nursing practices that are developed through research and based on evidence. Evidence-based
practices are developed by nurses asking clinical questions to improve quality and safety, which
improve patient outcomes (Nieswiadomy, 2012, pg. 282-283). The high mortality rates
associated with AMI complicated by cardiogenic shock despite revascularization and the use of
an IABP, calls for improvements in quality, safety and current practices. The Impella, as stated
above, is a newer LVAD that was developed to improve patient outcomes for this patient
population. This PICOT question will assist in determining if improved patient outcomes and

Running Head: CLINICAL QUESTION

mortality rates are achieved with Impella devices when compared to current standards of practice
utilizing IABPs.
Methodology
A research question can be written using several different methodologies. The
interrogative form analyzes data to decide if a correlation between variables exists
(Nieswiadomy, 2012, pg. 63). The research question clearly defines the problem in an
interrogative form sentence; it defines the population of interest, includes variables and is
clinically testable (Nieswiadomy, 2012, pg. 63). The clinical PICOT question for the purposes of
this paper defines the population of interest as patients presenting with cardiogenic shock as a
complication of AMI, it includes the variables of short and long term mortality rates when
comparing the Impella and IABP devices and tests these variables at 30 minutes post device
initiation and at 30 days post device initiation.
Search Criteria
A literature review was conducted using Ferris State Universitys online library and
utilized specific search criteria. The first database researched was the CINAHL database. The
key words and phrases used to search this database were: Impella versus IABP. The search
resulted in 25 articles meeting the search criteria. The second database researched was the
PUBMED database. The key words or phrases used for the search criteria were: Does the
Impella improve patient outcomes versus IABP? The search resulted in a total of 21 articles
meeting the search criteria. The third database researched was the AHRQ database, but no
applicable data resulted from this database. The fourth database searched was the Cocharane
Reviews database. The key words or phrases used to search this database were: Impella versus
IABP. This search resulted in 10 articles meeting the search criteria. The next step in the research

Running Head: CLINICAL QUESTION

process was to use exclusion criteria to narrow the articles down to 3-5 articles that had pertinent
information to answering the clinical PICOT question.
Exclusion Criteria
The exclusion criteria used to narrow this search down was to first determine which
articles pertained to the specific PICOT question. Articles that did not concern patients
presenting with cardiogenic shock as a complication of AMI and those greater than 5 years old
were excluded. Articles that did not involve the use of the Impella device were excluded entirely.
This search found that only 1 of the 25 CINAHL articles was pertinent to answering the PICOT
question and lead to the discovery of 1 pertinent article on the Science Direct database. The
PUBMED database search found 1 article that met all of the exclusion criteria. A total of 3
articles meeting the exclusion criteria were obtained and used for this research.
Levels of Evidence
Levels of evidence are used to rank the results of studies by the strength of the research
design from a level I study, which is considered the most reliable to a level VII, which is
considered an experts opinion (Melnyk & Fineout-Overholt, 2011). The articles used for this
research paper to answer the clinical PICOT question are level II and level III research designs.
A level II research design obtains evidence that is derived from at least one randomized control
trial and a level III research design obtains evidence that is derived from controlled trials that are
not randomized (Melnyk & Fineout-Overholt, 2011). It is important to utilize the best level of
evidence possible to ensure accuracy and reliability in the research design.
Discussion of Literature
A review of the literature and critique of the research studies is used to define the
applicability of the studies in nursing practice (Ursuy, 2014). An article critique analyzes the

Running Head: CLINICAL QUESTION

research process used as a framework to improve quality and safety practices in nursing. A
critique of the 3 articles used for this clinical PICOT question assists in deciding the
appropriateness of the research and adequacy of the research findings for the use in nursing
practice as they pertain to patient outcomes (Ursuy, 2014).
Article 1: The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients
presenting with severe and profound cardiogenic shock (Engstrom, et al., 2011).
The purpose of this nursing research study was to describe the experience with Impella
systems in patients presenting with cardiogenic shock as a result of experiencing a STEMI (STelevation myocardial infarction) (Engstrom, et al., 2011). This study was approved by the
Academic Medical Centers Institutional Review Board and waived the need for informed
consent of research participants, because it was a level 3 retrospective study from the years 20042010 (Engstrom, et al., 2011). This study was conducted in: The Academic Medical Centers
ICU [intensive care unit] (Engstrom, et al., 2011). It was a quantitative and comparative study of
34 patients that presented with cardiogenic shock as a complication of a STEMI (Engstrom, et
al., 2011). The Impella 2.5 was initiated in 25 patients and of those 25 patients, 8 were upgraded
to the Impella 5.0 after the initial Impella 2.5 initiation (Engstrom, et al., 2011). A total of 9
patients were initiated on the Impella 5.0 at the beginning of the study (Engstrom, et al., 2011).
This study measured the number of patients that were alive after 48 hours on the Impella device
with results of: 14/25 patients in the Impella 2.5 group (5/14 patients were upgraded to Impella
5.0) and 8/9 patients in the Impella 5.0 group (Engstrom, et al., 2011). The number of patients
alive at 30 days post device initiation was: 6/25 patients in the Impella 2.5 group (3 of which
were upgraded to Impella 5.0) and 3/9 patients in the Impella 5.0 group (Engstrom, et al., 2011).

Running Head: CLINICAL QUESTION

This study presents with a small sample size and participants were considered to be
exceptionally unstable and ill, which could represent biased results (Engstrom, et al., 2011). This
study utilized hemodynamic measurements obtained through routine practices to determine
patient outcomes, plan of care and the need to upgrade to the Impella 5.0, rather than a set
protocol for obtaining measurements, which could alter results (Engstrom, et al., 2011).
Additionally, upgrading to the Impella 5.0 was based on physician discretion, which could also
alter results without a set protocol for upgrading the device in place (Engstrom, et al., 2011).
This article did not compare the Impella to an IABP, but it did show how the Impella can
improve hemodynamic measurements and mortality rates at 30 days post device initiation. This
study concluded that the Impella devices are proven to improve hemodynamic measurements and
reduce the risk of mortality at 30 days post device initiation. It also showed that the Impella 5.0
had a higher success rate in comparison to the Impella 2.5, but requires an arterial cut down for
insertion and is therefore used as a last resort of the 2 devices (Engstrom, et al., 2011).
Article 2: A randomized clinical trial to evaluate the safety and efficacy of a percutaneous
left ventricular assist device versus intra-aortic balloon pumping for treatment of
cardiogenic shock caused by myocardial infarction (Seyfarth, et al., 2008).
The purpose of this study was to determine if hemodynamic support provided by the
Impella 2.5 was superior when compared to the IABP (Seyfarth, et al., 2008). This was a level 2
quantitative and comparative study that was approved by the institutional ethics committee
(Seyfarth, et al., 2008). The sample size for this nursing research study was 26 patients that
presented with cardiogenic shock as a result of an AMI and was divided randomly into 2 groups
(Seyfarth, et al., 2008). The first group was comprised of 13 patients that received IABP therapy
and the second group was comprised of 12 patients that received Impella 2.5 therapy (note: 1

Running Head: CLINICAL QUESTION

patient died before the device was initiated) (Seyfarth, et al., 2008). All of the patients were
taken to the catheterization lab for coronary angiography and the randomly assigned device was
placed after revascularization and obtaining baseline hemodynamic measurements (Seyfarth, et
al., 2008). Hemodynamic measurements were then obtained at 30 minutes post device initiation
and primary endpoints were determined by changes in cardiac index from the baseline
measurement to determine hemodynamic improvements (Seyfarth, et al., 2008). Secondary
endpoints were determined by hemodynamic and metabolic parameters that were assessed 30
days post device initiation using the MODS score (multisystem organ dysfunction score) and the
sepsis related organ failure assessment [SOFA] (Seyfarth, et al., 2008). The results showed that
the Impella 2.5 group had a greater improvement in the primary endpoint as measured by a
greater cardiac index when compared to the IABP group at 30 minutes post device initiation, but
there was no significant difference in either group when comparing secondary endpoints at 30
days post device initiation (Seyfarth, et al., 2008).
This study is limited by the small sample size of only 26 patients. The study was
controlled and randomized, which reduces bias, however, vasopressors and inotropes were used
in some of the patients, but did not follow a specific protocol, which could change outcomes for
some patients and not others (Seyfarth, et al., 2008). Additionally, the primary endpoint of 30
minutes post device initiation may have been too early to determine if mortality rates were
changed by longer hemodynamic support with the Impella 2.5 device (Seyfarth, et al., 2008).
This study did not have a set protocol for the length of time each group of patients was on the
assistive device, which could also alter the mortality rates in either group (Seyfarth, et al., 2008).
The Impella 2.5 did show greater improvement in cardiac index when compared to the IABP, but

Running Head: CLINICAL QUESTION

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neither was superior to the other when comparing long term mortality rates with either device at
30 days post device initiation (Seyfarth, et al., 2008).
Article 3: Percutaneous left ventricular assistance in post cardiac arrest shock:
Comparison of intra-aortic balloon pump and IMPELLA Recover LP2.5 (ManzoSilberman, et al., 2013).
The purpose of this study was to compare the Impella 2.5 and the IABP in patients who
presented with cardiogenic shock as a result of AMI and to determine feasibility, safety and
patient outcomes when using the Impella 2.5 device (Manzo-Silberman, et al., 2013). The sample
size for this nursing research study was 78 patients (Manzo-Silberman, et al., 2013). It is a
retrospective and observational single center study from the year 2007-2010 (Manzo-Silbterman,
et al., 2013). This study involved 2 groups: 35 patients in the Impella 2.5 group and 43 patients
in the IABP group (Manzo-Silberman, et al., 2013). Both groups consisted of out of hospital
cardiac arrest patients that were directly admitted to the cardiac catheterization lab and
underwent percutaneous coronary intervention (Manzo-Silberman, et al., 2013). Therapeutic
hypothermia was initiated in all of the patients post coronary intervention and device insertion
(Manzo-Silberman, et al., 2013). The survival rate at 28 days post device insertion was 23% for
the Impella 2.5 group and 29.5% for the IABP group (Manzo-Silberman, et al., 2013). Both
groups had bleeding as a complication of the device with the Impella group requiring transfusion
in 26% of patients and the IABP group requiring transfusion in 9% of the patients (ManzoSilberman, et al., 2013). It was concluded that the Impella was feasible and safe for use in
patients presenting with cardiogenic shock complicated by AMI, but it was not determined to be
superior to the IABP (Manzo-Silberman, et al., 2013).

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This study may have been limited as a result of it being non-randomized, retrospective,
observational study and consisted of a relatively small sample size. The Impella 2.5 group could
have had higher instances of complications as a result of the patients being selected for Impella
2.5 insertion being in sever cardiogenic shock and essentially sicker than the IABP group. This
could be the result of the IABPs long standing history for treatment in cardiogenic shock, nonrandomization and providers choice for device insertion (Manzo-Silberman, et al., 2013). This
study did not have a set protocol for determining which device would be used or length of time
to discontinuation of the device chosen. The study may also have been limited by not having a
set protocol for measuring or defining successful outcomes and simply states that the Impella 2.5
is feasible for use in cardiogenic shock as a result of AMI.
Significance in Nursing
The findings from this research can be integrated into nursing practice by understanding
the differences in the Impella and IABP devices. Understanding the evidence behind the use of
either of these devices will improve patient safety and outcomes. The Impella devices have been
proven to improve patient safety through evidence-based practice, which are a part of the Quality
and Safety Education for Nurses [QSEN] (2014) competencies. These competencies were
developed to improve the knowledge, skills and attitudes needed to improve the quality and
safety of healthcare and healthcare practices (QSEN, 2014). The Impella device was developed
through evidence-based practice and research as a result of high mortality rates associated with
cardiogenic shock complicated by AMI, in an attempt to improve patient outcomes and decrease
mortality rates for this patient population. Evidence-based practice and research utilizes current
knowledge to guide nursing practice and develop improvements, such as, the Impella device into
practice (American Nurses Association [ANA], 2010, pg. 51).

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The research available for the use of the Impella device is somewhat limited as a result of
the Impella device being a relatively new treatment option. The small sample sizes in these
research studies proves the limited information and trials available, but evidence does show
initial improvements in almost all of the patients that received treatment using an Impella device.
Nurses can utilize the evidence to provide safer care for this patient population and improve
patient outcomes by continually researching better ways to standardize the use of the Impella
device. Recommendations for further integration of the Impella device in nursing practice
includes: set protocols for initiation and management of the patients receiving treatment with the
Impella device and continued research to provide evidence-based practice that meets QSEN
competencies for the future of healthcare.
In conclusion, the Impella device improved patient outcomes with initial treatment;
however, it did not have significant differences in long term outcomes when compared with the
IABP. The studies used for this research may have been limited by a lack of set protocols for
treatment initiation, management and limited experience with Impella devices. Additionally,
research findings may have been limited by the small sample sizes and research designs utilized.
Cardiogenic shock complicated by AMI continues to harbor a high mortality rate despite
revascularization and the use of IABPs, but the Impella device is proven through evidence-based
research to improve initial patient outcomes by improving cardiac output (Seyfarth, et al., 2008).
Additional studies with larger sample sizes and level I research designs are needed to determine
if long term mortality rates are superior when comparing the Impella and the IABP devices. This
research paper identified a clinical PICOT question, discussed the methodology used for
research, critiqued 3 articles utilized for research and identified the significance this question
presents in nursing practice.

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References
American Nurses Association. (2010). Nursing Scope and Standards of Practice (2nd ed.). Silver
Spring: American Nurses Association.
Engstrom, A. E., Cocchieri, R., Driessen, A. H., Sjauq, K. D., Vis, M. M., Baan, J., DeJong, M.,
Lagrand, W. K., Sloot, J. A. P., Tijssen, J. G., Winter, R. J., Mol, B. A. S. & Piek, J. J.
(2011). The impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients
presenting with severe and profound cardiogenic shock: The Academic Medical Center
intensive care unit experience. Critical Care Medicine, 39(9), 2072-2079. Retrieved July
7, 2014, from CINAHL database. doi:10.1097/CCM.0b013e31821e89b5
Manzo-Silberman, S., Fichet, J., Mathonnet, A., Varenne, O., Ricome, S., Chaib, A., Zuber, B.,
Spaulding, C. & Cariou, A. (2013). Percutaneous left ventricular assistance in post
cardiac arrest shock: Comparison of intra aortic blood pump and IMPELLA Recover
LP2.5. Resuscitation, 84, 609-615, Retrieved July 18, 2014, from ScienceDirect
Database. doi: 10.1016/j.resuscitation.2012.10.001
Melnyk, B.M. & Fineout-Overholt, E. (2011). Evidence-based practice in nursing and
healthcare: A guide to best practice. Philadelphia: Lippincott, Williams & Wilkins.
Nieswiadomy, R. M. (2012). Foundations of Nursing Research. Upper Saddle River: Pearson.
QSEN: Competencies (2014). QSEN Institute. Retrieved August 1, 2014, from
http://qsen.org/competencies/
Seyfarth, M., Sibbing, D., Bauer, I., Frohlich, G., Bott-Flugel, L., Byrne, R., Dirschinger, J.,
Kastrati, A., & Schomig, A. (2008). A randomized clinical trial to evaluate the safety and
efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon
pumping for treatment of cardiogenic shock caused by myocardial infarction. Journal of

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the American College of Cardiology, 52(19), 1584-1588, Retrieved July 7, 2014, from
PubMed database. doi: 10.1016/j.jacc.2008.05.065
Ursuy, P. (2014). Clinical Question Paper [NURS 350 Course Syllabus]. Retrieved July 29,
2014, from Ferris State University Web site:
https://fsulearn.ferris.edu/webapps/portal/frameset.jsp?tab_tab_group_id=_2_1&url=%2F
webapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3DCourse%26id%3D_1122
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