Running head: ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS A Comparison of the Effectiveness of Endovascular and Open Repairs of Popliteal Aneurysms Research Paper Submitted to Kennesaw Mountain High School by CHRISTINA LEE Kennesaw, Georgia December 2014
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Running head: ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS
A Comparison of the Effectiveness of Endovascular and Open Repairs of Popliteal Aneurysms
Research Paper
Submitted to Kennesaw Mountain High School
by
CHRISTINA LEE
Kennesaw, GeorgiaDecember 2014
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS
Abstract
Popliteal artery aneurysms (PAAs) pose a significant threat of limb loss due to the high rates of
thromboembolic complications. The goal of this qualitative exploratory case study was to
compare the post-operative complication rates of open bypass repairs and endovascular stent
graft repairs of PAAs in order to determine if an endovascular repair or open repair results in a
lower post-operative complication rate. To assess the post-operative complications rates for
open bypass repairs and endovascular stent graft repairs, I utilized an online database to examine
each patient’s history and record the age, gender, type of PAA repair, and the presence or lack of
the following: post-operative infection, post-operative endoleaks, post-operative thrombosis,
post-operative stenosis, and necessary reintervention for a poorly functioning stent graft or
bypass. My convenience sample included all endovascular stent graft and open bypass repairs of
PAAs from January 2010 to December 2012 at a vascular surgical office in a large suburban
county in Georgia. Within these confines, surgeons performed 10 open bypass repairs and 13
endovascular stent graft repairs on 16 males from the ages 62 to 85. In this study, the relative
post-operative complication rates differed for each procedure, prompting the need for further
research on the matter. With further research, new evidence could support that one treatment
results in a lower post-operative complication rate, and doctors may be encouraged to select the
safer repair with knowledge of the lower post-operative complication rate. For the purposes of
this study, I defined the safer repair as the repair that resulted in fewer post-operative
complications
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS
Acknowledgements
Thank you to all of the following for your eagerness to help me excel and succeed throughout the
course of this research:
Dr. David Hafner, M.D.
Mrs. Kelly Ingle
Ms. Kristen Younker
Dr. Mimi Dyer, Ed. D.
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS
Table of Contents
Introduction......................................................................................................................................1Statement of the Problem............................................................................................................1Purpose of the Study...................................................................................................................2Research Questions.....................................................................................................................3Definition of Key Terms.............................................................................................................4
Review of Literature........................................................................................................................5Causes of PAAs...........................................................................................................................5Risk Factors Associated with PAAs...........................................................................................6Diagnosing PAAs........................................................................................................................6Open Bypass Approach to Repairing PAAs...............................................................................7Endovascular Stent Graft Approach to Repairing PAAs............................................................8Findings of Past Studies Comparing Open and Endovascular Repairs.......................................8Limiting Factors in Past Studies.................................................................................................9Summary.....................................................................................................................................9
Research Method...........................................................................................................................10Population and Sample..............................................................................................................11Instrumentation.........................................................................................................................12Data Collection Procedure........................................................................................................12Analysis Plan.............................................................................................................................13Assumptions..............................................................................................................................13Limitations................................................................................................................................14Delimitations.............................................................................................................................14Ethical Assurances....................................................................................................................15Summary...................................................................................................................................15
Findings.........................................................................................................................................15Results.......................................................................................................................................16Evaluation of Findings..............................................................................................................18Summary...................................................................................................................................18
Implications, Recommendations, and Conclusions.......................................................................19Implications...............................................................................................................................20Recommendations.....................................................................................................................22Conclusion.................................................................................................................................23
and necessary reintervention for a poorly functioning stent graft or bypass. I collected data
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 13
intermittently over the course of 4 weeks.
Analysis Plan
I grouped data for each procedure and examined each endovascular stent graft repair or
open bypass repair as an individual case in this qualitative exploratory case study. Examining
the data in this way resulted in 23 total cases: 10 open bypass repairs and 13 endovascular stent
graft repairs performed on 16 males from the ages 62 to 85. I catalogued and calculated
percentages for the respective number of post-operative infections, post-operative endoleaks,
post-operative thrombosis, post-operative stenosis, and necessity for reintervention for each
procedure. Researchers cannot compute statistical analysis with small samples (Leedy &
Ormrod, 2005). Due to the rarity of PAAs and the resulting small number of cases available for
analysis through Vascular Surgical Associates, I could not compute statistical analysis with this
data set. According to the protocol for qualitative analysis, researchers may only observe trends
and patterns with small data sets (Leedy & Ormrod, 2005). I utilized the trends and patterns
observed in this study to draw casual conclusions or generalizations about the population.
Assumptions
A necessary assumption was that the doctors, physician’s assistants, and surgeons at
Vascular Surgical Associates correctly diagnosed patients with PAAs. This assumption is
acceptable because all employees at Vascular Surgical Associates who may have diagnosed the
patients are trained professionals. It was also necessary to assume that patient records were
accurate concerning basic patient information, history, PAA treatment, and post-operative care of
the PAAs. I warranted this assumption because health care professionals make it a priority to
truthfully and accurately record patient information, and insurance companies require accurate
information for their coverage. For the purposes of this study, I assumed that all surgeons
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 14
performed the endovascular stent graft repairs and open bypass repairs to the same standards and
with the same amount of care. I made this assumption because of the standardized procedural
protocol that exists for both repairs. I also assumed that all post-operative complications relate
directly to the repair of a PAA with an endovascular stent graft or an open bypass, instead of an
outstanding medical condition or failure to follow post-operative orders from the surgeons.
While this assumption may have decreased the validity of the study, it was necessary in order to
make generalizations or draw casual conclusions. There was no way to quantify a patient’s
noncompliance, and most patients do not report their noncompliance to doctors, thus the doctors
did not record the information the patients’ charts.
Limitations
Patient confidentiality, sampling method, and sample size limited this study. The
restraints of patient confidentiality prevented the collection of data from patient records not
directly affiliated with Vascular Surgical Associates. This necessitated convenience sampling
and led to a small sample size for endovascular repairs and open repairs. Convenience sampling
made it impossible to generalize the results of this study beyond patients treated at the
experiment location. Researchers cannot compute statistical analysis on small samples and,
without statistical data, they can only draw casual conclusions (Leedy & Ormrod, 2005).
Therefore, I drew only casual conclusions from the data in this study.
Delimitations
For the purpose of this study, I did not consider patient history and current medical
conditions. Although a history of smoking, drug abuse, alcoholism, hypertension, blood clotting
disorders, or heart disease can affect the effectiveness of an open bypass repair or endovascular
stent graft repair, time restraints prevented the collection and analysis of this data.
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 15
Ethical Assurances
I closely followed ethical guidelines associated with medical research. I maintained
patient identity and confidentiality. I completed all necessary Wellstar and Vascular Surgical
Associates paperwork prior to commencing data collection and followed all Wellstar and
Vascular Surgical Associates research protocols during data collection. I carefully and precisely
collected all data to ensure the correct data retained its original association to particular patients
and procedures. I did not falsify any data. I reported and referenced all information truthfully.
Summary
A qualitative exploratory case study was the proposed research method for this study.
The population in this study was limited to all PAA repairs performed by a vascular surgical
office in a large suburban county in Georgia. The convenience sample included all endovascular
stent graft repairs and open bypass repairs of PAAs from January 2010 to December 2012 at a
vascular surgical office in a large suburban county in Georgia. Within these confines, surgeons
performed 10 open bypass repairs and 13 endovascular stent graft repairs on 16 males from the
ages 62 to 85. I utilized an online database to examine each patient’s history and record the age,
gender, type of PAA repair, and the presence or lack of the following: post-operative infection,
post-operative endoleaks, post-operative thrombosis, post-operative stenosis, and necessary
reintervention for a poorly functioning stent graft or bypass. I catalogued and calculated
percentages for the respective number of post-operative infections, post-operative endoleaks,
post-operative thrombosis, post-operative stenosis, and reinterventions for each. I qualitatively
analyzed the results and made generalizations about endovascular stent graft repairs and open
bypass repairs.
Findings
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 16
The goal of this research was to compare the post-operative complication rates of open
bypass repairs and endovascular stent graft repairs of PAAs in order to determine if an
endovascular repair or open repair results in a lower post-operative complication rate, thus
indicating that one procedure is safer. In this study, the relative post-operative complication
rates differed for each procedure, prompting the need for further research on the matter. With
further research, evidence could be found to support that one treatment is safer than the other,
and doctors may be encouraged to select the safer repair with knowledge of the lower post-
operative complication rate. For the purposes of this study, I defined the safer repair as the
repair that resulted in fewer post-operative complications. To assess the post-operative
complications rates for open bypass repairs and endovascular stent graft repairs, I utilized an
online database to examine each patient’s history and record the age, gender, type of PAA repair,
and the presence or lack of the following: post-operative infection, post-operative endoleaks,
post-operative thrombosis, post-operative stenosis, and necessary reintervention for a poorly
functioning stent graft or bypass. I catalogued and calculated percentages for the respective
number of post-operative infections, endoleaks, thrombosis, stenosis, and necessity for
reintervention for each procedure. I employed these percentages to determine if one procedure
resulted in a lower post-operative complication rate.
Results
A total of 23 cases were included in the sample. I detailed all collected data in Table 1
and Table 2. Of which, 10 were open bypass repairs, and 13 were endovascular stent graft
repairs. The age range of patients was 62-85 years, and the average age was 73.81 years. The
sample consisted of only males. Ten percent of open bypass repairs resulted in infection (one
out of ten cases). Conversely, 7.69% of endovascular stent graft repairs resulted in infection
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 17
(one out of 13 cases). Zero percent of open bypass repairs resulted in endoleaks (zero out of ten
cases). 15.38% of endovascular stent graft repairs resulted in endoleaks (two out of 13 cases).
Thirty percent of open bypass repairs resulted in thrombosis (three out of ten cases). 38.46% of
endovascular stent graft repairs resulted in thrombosis (five out of 13 cases). Thirty percent of
open bypass repairs resulted in stenosis (three out of ten cases). 15.38% of endovascular stent
graft repairs resulted in stenosis (two out of 13 cases). Thirty percent of open bypass repairs
required reintervention (three out of ten cases). 23.07% of endovascular stent graft repairs
required reintervention (two out of 13 cases). I summarized a comparison of the percentages in
Figure 1.
Percentage of cases with in-
fection
Percentage of cases with endoleak
Percentage of cases with thrombosis
Percentage of cases with stenosis
Percentage of cases requiring reintervention
0
5
10
15
20
25
30
35
40
45
Open bypass repair
Endovascular stent graft repair
Figure 1. Comparison of post-operative complication rates of open bypass repairs and endovascular stent graft repairs for PAAs.
Figure 1 depicts that open bypass repairs resulted in higher post-operative complication
rates than endovascular stent graft repairs in three of the five categories: infection, stenosis, and
necessity of reintervention. Endovascular stent graft repairs resulted in higher post-operative
complication rates than open bypass repairs in the two of the five categories: endoleaks and
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 18
thrombosis.
Evaluation of Findings
Researchers cannot compute statistical analysis with small samples (Leedy & Ormrod,
2005). Therefore, I could not compute statistical analysis with the data in this study. According
to the protocol for qualitative analysis, researchers may only observe general trends and patterns
in the data (Leedy & Ormrod, 2005). Open bypass repairs resulted in higher post-operative
complication rates than endovascular stent graft repairs in three of the five categories, while
endovascular stent graft repairs resulted in higher post-operative complication rates than open
bypass repairs in two of the five categories. Convenience sampling and a small sample size can
lead to error (Leedy & Ormrod, 2005), and consequently there was an expected amount of error
within the data. It is possible that sampling error attributed to the differences in the post-
operative complication rates. Lovegrove et al. (2008) concluded that neither procedure results in
a higher post-operative complication rate, and that a surgeon should examine each patient
individually in order to determine which procedure is appropriate per the patient’s anatomy,
current health, and lifestyle. Mohan et al. (2006) and Antonello et al. (2005) agreed that neither
procedure was safer; however, as technology in grafts advances, the endovascular approach will
become the superior repair.
Summary
The goal of this research was to compare the post-operative complication rates of open
bypass repairs and endovascular stent graft repairs of PAAs in order to determine if an
endovascular repair or open repair results in a lower post-operative complication rate, thus
indicating that one procedure is safer. Researchers cannot compute statistical analysis with small
samples (Leedy & Ormrod, 2005). Therefore, I could not compute statistical analysis with the
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 19
data in this study. According to the protocol for qualitative analysis, researchers may only
observe general trends and patterns in the data (Leedy & Ormrod, 2005). A total of 23 cases
were included in the sample. Of which, 10 were open bypass repairs, and 13 were endovascular
stent graft repairs. Open bypass repairs resulted in higher post-operative complication rates than
endovascular stent graft repairs in three of the five categories: infection, stenosis, and necessity
of reintervention. Endovascular stent graft repairs resulted in higher post-operative complication
rates than open bypass repairs in the two of the five categories: endoleaks and thrombosis.
Implications, Recommendations, and Conclusions
With the surgical treatment of PAAs, surgeons aim to isolate and exclude the aneurysm
and allow for the restoration of effective blood flow to the lower extremities (Antonello et al.,
2005). Within the medical community there is debate regarding the relative superiority of
endovascular stent graft repairs and open bypass repairs (Cronenwett & Johnston, 2010). The
goal of this research was to compare the post-operative complication rates of open bypass repairs
and endovascular stent graft repairs of PAAs in order to determine if an endovascular repair or
open repair results in a lower post-operative complication rate, thus indicating that one procedure
is safer. A qualitative exploratory case study was the research method for this study. I utilized
an online database to examine each patient’s history and record the age, gender, type of PAA
repair, and the presence or lack of the following: post-operative infection, post-operative
endoleaks, post-operative thrombosis, post-operative stenosis, and necessary reintervention for a
poorly functioning stent graft or bypass. A total of 23 cases were included in the sample. I
detailed all collected data in Table 1 and Table 2. Of which, 10 were open bypass repairs, and 13
were endovascular stent graft repairs. The overall age range of patients was 62-85 years, and the
average age was 73.81 years. Researchers cannot compute statistical analysis with small
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 20
samples (Leedy & Ormrod, 2005). Therefore, I could not compute statistical analysis with the
data in this study. According to the protocol for qualitative analysis, researchers may only
observe general trends and patterns in the data (Leedy & Ormrod, 2005).
Implications
In this study, I utilized an online database to examine each patient’s history and record
the age, gender, type of PAA repair, and the presence or lack of the following: post-operative
infection, post-operative endoleaks, post-operative thrombosis, post-operative stenosis, and
necessary reintervention for a poorly functioning stent graft or bypass. I catalogued and
calculated percentages for the respective number of post-operative infections, post-operative
endoleaks, post-operative thrombosis, post-operative stenosis, and reinterventions. I observed
general trends in the data and made generalizations about endovascular stent graft repairs and
open bypass repairs.
Concerning post-operative infection, 10% of open bypass repairs resulted in infection,
and 7.69% of endovascular stent graft repairs resulted in infection. A difference of 2.31% does
not imply a substantial difference between the two procedures. Researchers attributed these
similar rates of post-operative infection to the easy access to effective and inexpensive
antibiotics (Taurino et al., 2013). The similar rates contradict the conclusion made by Rosenthal
et al. (2000). Rosenthal et al. (2000) believed that the endovascular approach avoids most
wound complications because it does not require the long incisions required for the open bypass
repair. Regarding post-operative endoleaks, 0% of open bypass repairs resulted in endoleaks,
and 15.38% of endovascular stent graft repairs experienced endoleaks. Due to the ballooning
process involved in the insertion of an endovascular stent graft, a higher rate of post-operative
endoleaks is expected ("Endovascular Stent Graft," n.d.).
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 21
Of the total cases, 30% of open bypass repairs resulted in post-operative thrombosis of
the bypass, and 38.46% of endovascular stent graft repairs resulted in post-operative thrombosis
of the stent graft. Post-operative thrombosis of the stent graft is a common concern of vascular
surgeons and a high rate of post-operative thrombosis for endovascular repairs should be
expected ("Endovascular Stent Graft," n.d.). Conversely, post-operative thrombosis is not a
common occurrence in open bypasses (Cronenwett & Johnston, 2010). Nevertheless, 30% of
open bypass repairs resulted in post-operative thrombosis of the bypass. Such a starch
contradiction between the results of this study and the existing literature written by Cronenwett
and Johnson (2010) reveals the need for further research on the subject.
Concerning post-operative stenosis of the graft, 30% of open bypass repairs resulted in
post-operative stenosis of the bypass, and 15.38% of endovascular stent graft repairs resulted in
post-operative stenosis of the stent graft. I attribute the higher rate of post-operative stenosis in
open bypass repairs to the use of a prosthetic bypass instead of an autologous bypass. Hamish et
al. (2006) and Huang et al. (2007) agreed that utilization of the autologous vein poses lower risks
of post-operative complications in comparison to the utilization of a prosthetic graft.
Of the total cases reintervention, 30% of open bypass repairs required reintervention, and
23.07% of endovascular stent graft repairs required reintervention. The difference between these
two rates is the most significant of the study. While the other post-operative complications may
cause the patient undue difficulties and require extra treatment, therapy, or medication, the
necessity for reintervention requires an entire additional procedure that involves more anesthesia,
medication, recovery, and an additional stay in the hospital. For patients who are elderly and in
poor health, reintervention causes undue stress to their bodies (Cronenwett & Johnston, 2010).
The relative rates of a necessity for reintervention differed by 6.93%. A difference of nearly 7%
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 22
calls into question the claims made by Lovegrove et al. (2008) and Cronenwett & Johnston
(2010) who stated that there is no difference in post-operative complication rates or the necessity
for reintervention between open bypass repairs and endovascular stent graft repairs. The
contradictions between the results of this study and the existing literature written by Cronenwett
and Johnson and Lovegrove et al. reveal the need for further research on the subject.
Recommendations
Some of the general trends observed in this study contradict the observations made by
Rosenthal et al. (2000), Cronenwett and Johnston (2010), and Lovegrove et al. (2008). The most
extreme contradictions occurred in the post-operative thrombosis rates of open bypass repairs
and the relative difference between the rates of necessity for reintervention between open bypass
repairs and endovascular stent graft repairs. An experimental study that includes a large, random
sample alleviates the stress of confounding variables (Leedy & Ormrod, 2005), and hence should
be utilized to draw firm conclusions in the presence of the confounding variables inherent to a
medical study. Such a study could contain much needed statistically significant data that
researchers could formulate into concrete conclusions. Additionally, future researchers should
conduct studies that are not limited by patient confidentiality and lack of access to certain patient
records. With unlimited access to patient records, the researcher could discern the pre-operative
condition of the aneurysm. Researchers should asses the pre-operative size of the aneurysm and
the pre-operative thrombosis or stenosis since these could have confounding effects on the post-
operative complication rates. With unlimited access to patient records, it may be possible to
determine the compliance of each patient concerning his/ her own post-operative care. After the
treatment of PAAs, medical professionals prescribe most patients an anti-coagulant medication
and a certain amount of exercise to accomplish each day (Cronenwett & Johnston, 2010). While
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 23
some patients are compliant and follow the surgeon’s orders closely, others are non-compliant.
The patient’s compliancy with the surgeons orders have a direct result on the post-operative
complications the patient will experience. The ability to assess the compliance of each patient
will alleviate the effect of confounding variables on the final rates of post-operative complication
rates.
Conclusion
The goal of this research was to compare the post-operative complication rates of open
bypass repairs and endovascular stent graft repairs of PAAs in order to determine if an
endovascular repair or open repair results in a lower post-operative complication rate, thus
indicating that one procedure is safer. A qualitative exploratory case study was the research
method for this study. I utilized an online database to examine each patient’s history and record
the age, gender, type of PAA repair, and the presence or lack of the following: post-operative
infection, post-operative endoleaks, post-operative thrombosis, post-operative stenosis, and
necessary reintervention for a poorly functioning stent graft or bypass. Some of the general
trends observed in this study contradict the observations made by Rosenthal et al. (2000),
Cronenwett and Johnston (2010), and Lovegrove et al. (2008). The most extreme contradictions
occurred in the post-operative thrombosis rates of open bypass repairs and the relative difference
between the rates of necessity for reintervention between open bypass repairs and endovascular
stent graft repairs. An experimental study that includes a large, random sample alleviates the
stress of confounding variables (Leedy & Ormrod, 2005), and hence should be utilized to draw
firm conclusions in the presence of the confounding variables inherent to a medical study.
Additionally, future researchers should conduct studies that are not limited by patient
confidentiality and lack of access to certain patient records.
ENDOVASCULAR AND OPEN REPAIRS OF POPLITEAL ANEURYSMS 24
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Appendix A: All Collected Data
Table 1
Post-Operative Complication Information from Vascular Surgical AssociatesOpen Bypass Repairs Dating from January 2010 through December 2012Case number Infection Endoleaks Stenosis Thrombosis Reintervention
Note. A dash mark (-) denotes the repair did not result in the post-operative complication. A plus sign (+) denotes the repair resulted in the post-operative complication.
Table 2
Post-Operative Complication Information from Vascular Surgical AssociatesEndovascular Stent Graft Repairs Dating from January 2010 through December 2012Case number Infection Endoleaks Stenosis Thrombosis Reintervention
Note. A dash mark (-) denotes the repair did not result in the post-operative complication. A plus sign (+) denotes the repair resulted in the post-operative complication.