Accepted Manuscript Spliced arm vein grafts are a durable conduit for lower extremity bypass Katharine Lillian McGinigle, MD, MPH, Luigi Pascarella, MD, Cynthia K. Shortell, MD, Mitchell W. Cox, MD, Richard L. McCann, MD, Leila Mureebe, MD, MPH PII:
S0890-5096(15)00065-5
DOI:
10.1016/j.avsg.2014.11.013
Reference:
AVSG 2245
To appear in:
Annals of Vascular Surgery
Received Date: 7 March 2014 Revised Date:
29 October 2014
Accepted Date: 7 November 2014
Please cite this article as: McGinigle KL, Pascarella L, Shortell CK, Cox MW, McCann RL, Mureebe L, Spliced arm vein grafts are a durable conduit for lower extremity bypass, Annals of Vascular Surgery (2015), doi: 10.1016/j.avsg.2014.11.013. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 Spliced arm vein grafts are a durable conduit for lower extremity bypass Presented at the 37th Annual Meeting of the Southern Association for Vascular Surgery, Paradise Island, The Bahamas, January 23-26, 2013.
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Address correspondence to: Leila Mureebe Duke University DUMC Box 3467 2301 Erwin Road Durham, NC 27710 Office: 919-681-2800 Fax: 919-668-5284 Cell: 646-275-4093 Email: [email protected]
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
ACCEPTED MANUSCRIPT 2 ABSTRACT
2
Introduction: Many patients with peripheral vascular disease (PAD) requiring
3
revascularization do not have adequate ipsilateral greater saphenous vein for constructing
4
a bypass due to intrinsic vein disease or prior harvesting for limb or coronary bypass.
5
Prosthetic conduits have poor long-term patency, especially for distal bypass. With
6
advancing endovascular sophistication, tibial angioplasty may be a good
7
revascularization option, but we hypothesize that using spliced arm vein for distal lower
8
extremity bypass is still a well-tolerated and more durable solution.
9
Methods: A retrospective chart review was conducted of all PAD patients undergoing
10
lower extremity bypass or tibial angioplasty for lifestyle limiting claudication or critical
11
limb ischemia at a single institution over a 7 year period. Statistical analysis was
12
conducted by Kaplan-Meier survival analysis and Cox proportional hazards model.
13
Statistical significance was set at p=0.05.
14
Results: From 2005-2012, there were 120 patients who underwent infrageniculate
15
revascularization with conduit other than greater saphenous vein (GSV). Over half (66
16
patients, 71.2% male, mean age 62) underwent bypass operations using arm vein conduit,
17
and 88% of those bypasses were to tibial vessels. Patency was 100% at one year and 85%
18
at two years. There was no impact on patency or amputation rate based on source of vein
19
or the number of splices. Forty-three patients underwent tibial angioplasty and patency
20
was 70% at one year and 50% at two years.
21
Conclusion: When GSV is not available, spliced arm vein grafts provide durable lower
22
extremity revascularization with favorable patency and limb preservation rates. Spliced
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1
ACCEPTED MANUSCRIPT 3 arm vein grafts should be considered over prosthetic grafts and angioplasty alone in
2
patients with distal occlusive disease.
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1
ACCEPTED MANUSCRIPT 4 1 2
INTRODUCTION Lower extremity bypasses are often recommended for patients with infrainguinal peripheral arterial disease, which can manifest as lifestyle limiting claudication, ischemic
4
rest pain, or tissue loss. The ideal bypass originates from a healthy donor inflow artery
5
and terminates in a healthy recipient outflow artery using good conduit. The ideal conduit
6
is great saphenous vein (GSV) harvested from the ipsilateral lower extremity. In the
7
absence of suitable ipsilateral GSV, there are several other approaches for lower
8
extremity revascularization, and choosing the approach for each patient is a critical aspect
9
of decision-making as it can affect long-term patency and limb preservation.
SC
M AN U
10
RI PT
3
Alternative conduits include contralateral GSV, cephalic or basilic veins from the upper extremity, cadaveric cryopreserved GSV or human umbilical vein, and prosthetic
12
graft. Bypasses to the tibial arteries utilizing cryopreserved veins or prosthetic graft have
13
achieved very limited success with patency rates of 58% at 1 year and 30% at 3
14
years.1,2,3,4 Spliced composite prosthetic-autologous conduits (utilizing GSV) show no
15
improvement in long-term patency compared to prosthetic only bypasses.3 Adjunctive
16
techniques such as the creation of arterio-venous fistulae and/or the interposition of vein
17
cuffs at the distal anastomosis have led to mixed results but have not demonstrated a clear
18
advantage.3
EP
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19
TE D
11
Some surgeons may choose to use the contralateral GSV, but depending on the
20
level of disease in the patient’s contralateral lower limb, others will preserve the
21
contralateral GSV to provide the “best available conduit” and a better chance of limb
22
salvage if the contralateral leg requires operation. In other instances, neither GSV may be
23
available if they have already been harvested for previous coronary or lower extremity
ACCEPTED MANUSCRIPT 5 revascularizations. The use of arm vein as an alternate autogenous conduit was first
2
reported in 1969.5 Since then, several large series have shown the superiority of arm vein
3
compared to prosthetic conduits for popliteal and tibial artery disease with overall
4
cumulative 5 year patency rates of 57.5% and limb salvage of 71.5%.6
5
RI PT
1
More recently, percutaneous therapies have influenced the management of patients with infrainguinal disease. However, the results of percutaneous tibial
7
intervention, as shown by the final analysis of the long-term results of the Bypass versus
8
Angioplasty in Severe Ischemia of the Leg (BASIL) trial, demonstrated a benefit to open
9
surgical tibial revascularization compared angioplasty at 2-year follow-up for patients
M AN U
SC
6
10
with critical limb ischemia. Thus, bypass may be the preferred modality in patients
11
requiring a durable procedure.7
12
The purpose of this study is to review the clinical outcomes of a tertiary center in the subset of patients with lifestyle-limiting claudication who failed non-operative
14
management or with critical limb ischemia and absence of a viable GSV requiring
15
infrainguinal revascularization. In the era of improved primary and secondary patency
16
due to increasing sophistication with endovascular interventions, we hypothesize that
17
spliced arm vein is still a more durable intervention than revascularization with
18
angioplasty.
20 21
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TE D
13
MATERIALS AND METHODS Patients. From January 1, 2005 through June 1, 2012 there were 120 lower
22
extremity revascularizations to distal target arteries in patients without viable GSV. All
23
included patients had severe disease with short-distance claudication who failed
ACCEPTED MANUSCRIPT 6 nonoperative therapy or critical limb ischemia (defined as rest pain or tissue loss). Sixty-
2
six operations were performed using spliced arm vein (43 patients) or a single arm vein
3
(23 patients). Forty-three patients underwent tibial angioplasty, and approximately 75%
4
of those patients also had percutaneous intervention in their femoropopliteal segment at
5
the same time. The remaining 11 operations used a prosthetic conduit (all with
6
polytetrafluorethylene, PTFE), but these patients were eliminated from the analysis
7
because the only time infrageniculate prosthetic material was used was for acute rather
8
than chronic limb ischemia.
SC
Surgical technique. All of our patients undergo pre-operative upper extremity
M AN U
9
RI PT
1
color duplex ultrasound (CDU) to document the patency and quality of the veins
11
available for use as conduit. Criteria used for selecting veins are diameter >3mm, absence
12
of stenotic segments, and absence of thrombus. The infrapopliteal vessels and the
13
common femoral artery are exposed. To reduce operative time, a second operator
14
simultaneously makes continuous incisions over the lateral and medial aspects of the arm
15
for the vein harvest. The cephalic and basilic veins are visually inspected to assess quality
16
and diameter. All the segments were reversed and spliced with a modified Carrel veno-
17
venostomy with 7-0 Prolene (Ethicon, Sommerville, NJ). This geometric configuration is
18
critical to avoid elbowing at the venovenostomies. The proximal anastomosis is then
19
created. The distal anastomosis is constructed after having passed the spliced conduit
20
through a previously constructed subfascial tunnel using a sheathed tunneling device.
21
After completion of the distal anastomosis, pulses and signals are assessed, and a
22
completion arteriogram is routinely obtained to assess for technical defects. Post-
23
operatively, patients were followed by physical exam and CDU at 3 months, 6 months,
AC C
EP
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10
ACCEPTED MANUSCRIPT 7 1 2
and every 6 months thereafter. Data and statistical methods. All candidate procedures were performed at Duke University Medical Center, and were identified by Current Procedural Terminology
4
codes describing the use of arm vein (35500) or spliced vein (35682, 35683) and cross-
5
referenced to the bypass procedure performed. Records were reviewed through the
6
hospitals electronic databases after approval by the Institutional Review Board. Nominal
7
demographic variables were compared between groups by Chi-squared testing.
8
Continuous variables were compared between groups by one-way analysis of variance
9
(ANOVA). The Mann-Whitney U test was used to assess the difference between two
10
independent groups when non-normally distributed. A student’s t-test was used when
11
continuous variables were normally distributed. Kaplan-Meier survival analyses were
12
used to calculate primary patency, limb-salvage, and survival rates. Comparison between
13
life table curves was by the Mantel-Cox log-rank test for significance. Figures are
14
represented as the mean plus or minus standard error and 95% Confidence Intervals (95%
15
CI). Statistical significance was assumed at p values less than .05. All computations were
16
performed using Stata Release 12 (StataCorp LP, College Station, Tx, USA, 2012).
17
19
RESULTS
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18
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3
The demographics of the patients who underwent reviewed procedures are shown
20
in Table I. The indication for procedure was lifestyle-limiting claudication that had failed
21
a trial of nonoperative management or critical limb ischemia (detailed in Table II).
22
Follow-up ranged from 182-1830 days (mean 1336 ± 549.72 days). The 30-day survival
23
was >97%, and there was no difference in survival between groups. As expected,
ACCEPTED MANUSCRIPT 8 operative time and blood loss were both greater for the bypass group compared to the
2
angioplasty group, but notably the operative time was not significantly longer when
3
spliced arm veins rather than a single arm vein were used (314 +/- 84 minutes versus 291
4
+/- 102 minutes, p-value 0.107).
5
RI PT
1
Only 46% of patients had prior revascularization attempts (either open or
percutaneous). The mean number of prior interventions was 0.88 (range 0-4), and was
7
different based on study group with twice as many prior interventions in the arm vein
8
bypass groups (p = .000, Table II). Of patients who had undergone prior intervention,
9
there was no difference in indication for the current procedure. The majority of targets
11
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SC
6
were tibial or pedal arteries (Table III).
Mortality and complication rates. The 30-day mortality rate was similar in both groups (Table II). We observed no difference between groups in the prevalence of
13
neuropathy, stroke, myocardial infarction, venous thromboembolic events (deep venous
14
thrombosis or pulmonary embolus) or other late complications. The perioperative
15
myocardial infarction rate was 4.54% in the arm vein group and6.45% in the angioplasty
16
group which is not statistically or clinically significantly different. The surgical site
17
infection rate was higher in the arm vein group; however, these were almost all groin
18
wound infections and were consistent with the national rate of infections in this area (arm
19
vein group 25.75%, angioplasty group 5.13%, p = .008).
EP
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12
Graft patency and limb salvage. Figure 1 demonstrates the primary patency of
21
the two groups. There are more early failures in the tibial angioplasty group. Due to the
22
relatively low number of patients in this study, the 95% confidence intervals are close,
23
but patency is inferior in the angioplasty group in the long term as well. Primary assisted
ACCEPTED MANUSCRIPT 9 1
patency was also better in the arm vein group, though this did not reach statistical
2
significance and patients in each group required second interventions to maintain primary
3
assisted patency (arm vein group 16.1%, angioplasty group 30.6%, Table II). Figure 2 demonstrates there is no effect of the number of splices on graft failure
RI PT
4 5
rate. This was not clinically or statistically significant at either the early time periods
6
(Log-rank p = .3719) or later time periods (Wilcoxon p = .3352).
8
Amputations were twice as common in the tibial angioplasty group, occurring in >10% of those patients (Table II).
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7
Discussion
The choice of management for patients with life-style limiting claudication who
12
fail non-operative management and critical limb ischemia (CLI) should be dictated by a
13
careful evaluation of the patient’s current clinical status, co-morbidities, anatomy and
14
goals of treatment. Other groups have reported a strategy of preferential use of spliced
15
arm vein when ipsilateral saphenous vein is unavailable (used for prior lower extremity
16
revascularization attempt, coronary bypass) or inadequate (based on diameter or
17
stenosis).8 Our data supports this practice of aggressive utilization of arm vein as conduit.
18
In our current series, we demonstrate excellent primary patency of single segment
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19
arm vein and spliced vein conduits as compared to infrapopliteal angioplasties. Many of
20
our patients in both groups had previously undergone a combination of endovascular and
21
open infrapopliteal disease reconstructions. Their demographics reflect a high-risk
22
surgical population and our mortality and complications rates are comparable with other
23
national series.
ACCEPTED MANUSCRIPT 10 1
The BASIL trial showed no difference with regard to amputation free survival and overall survival between angioplasty and open surgery at 2 years. However, in patients
3
surviving more than 2 years, the surgery-first revascularization option showed a clear
4
benefit with regard to amputation free survival.7 In a meta-analysis of 30 articles
5
published between 1981 and 2006 (2577 patients), primary and secondary patency rates
6
after infrapopliteal angioplasty were significantly lower when compared to bypass
7
surgery (48.6% vs. 72.3%) but with comparable limb salvage rates (82.4% vs. 82.3%).9
8
The need for durable vascular reconstruction supports the preferential use of arm vein
9
bypass over less invasive endovascular procedures. Even in the highly morbid patient
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2
population in our study, complication rates were low and patency and limb salvage were
11
high in the group of patients who underwent autogenous vein bypasses. The vascular
12
surgery division favors bypass surgery, especially in patients with claudication, and
13
reserves tibial angioplasty for patients with critical limb ischemia due to the poor long-
14
term patency rates. The majority of the patients in this study who underwent
15
percutaneous tibial intervention did have critical limb ischemia; however, some
16
angioplasties were performed in claudicants by other clinicians who also perform lower
17
extremity interventions at this institution.
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Endovascular intervention is acceptable in patients with prohibitively high
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19
operative risk or limited life expectancy, but the best option to restore in-line flow to the
20
tibial arteries is bypass. In the Project of Ex Vivo graft Engineering via Transfection III
21
(PREVENT III) study, it was observed that predictors of autogenous graft failure at 30
22
days were small conduits (
S0890-5096(15)00065-5
DOI:
10.1016/j.avsg.2014.11.013
Reference:
AVSG 2245
To appear in:
Annals of Vascular Surgery
Received Date: 7 March 2014 Revised Date:
29 October 2014
Accepted Date: 7 November 2014
Please cite this article as: McGinigle KL, Pascarella L, Shortell CK, Cox MW, McCann RL, Mureebe L, Spliced arm vein grafts are a durable conduit for lower extremity bypass, Annals of Vascular Surgery (2015), doi: 10.1016/j.avsg.2014.11.013. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 Spliced arm vein grafts are a durable conduit for lower extremity bypass Presented at the 37th Annual Meeting of the Southern Association for Vascular Surgery, Paradise Island, The Bahamas, January 23-26, 2013.
EP
TE D
M AN U
SC
RI PT
Address correspondence to: Leila Mureebe Duke University DUMC Box 3467 2301 Erwin Road Durham, NC 27710 Office: 919-681-2800 Fax: 919-668-5284 Cell: 646-275-4093 Email: [email protected]
AC C
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
ACCEPTED MANUSCRIPT 2 ABSTRACT
2
Introduction: Many patients with peripheral vascular disease (PAD) requiring
3
revascularization do not have adequate ipsilateral greater saphenous vein for constructing
4
a bypass due to intrinsic vein disease or prior harvesting for limb or coronary bypass.
5
Prosthetic conduits have poor long-term patency, especially for distal bypass. With
6
advancing endovascular sophistication, tibial angioplasty may be a good
7
revascularization option, but we hypothesize that using spliced arm vein for distal lower
8
extremity bypass is still a well-tolerated and more durable solution.
9
Methods: A retrospective chart review was conducted of all PAD patients undergoing
10
lower extremity bypass or tibial angioplasty for lifestyle limiting claudication or critical
11
limb ischemia at a single institution over a 7 year period. Statistical analysis was
12
conducted by Kaplan-Meier survival analysis and Cox proportional hazards model.
13
Statistical significance was set at p=0.05.
14
Results: From 2005-2012, there were 120 patients who underwent infrageniculate
15
revascularization with conduit other than greater saphenous vein (GSV). Over half (66
16
patients, 71.2% male, mean age 62) underwent bypass operations using arm vein conduit,
17
and 88% of those bypasses were to tibial vessels. Patency was 100% at one year and 85%
18
at two years. There was no impact on patency or amputation rate based on source of vein
19
or the number of splices. Forty-three patients underwent tibial angioplasty and patency
20
was 70% at one year and 50% at two years.
21
Conclusion: When GSV is not available, spliced arm vein grafts provide durable lower
22
extremity revascularization with favorable patency and limb preservation rates. Spliced
AC C
EP
TE D
M AN U
SC
RI PT
1
ACCEPTED MANUSCRIPT 3 arm vein grafts should be considered over prosthetic grafts and angioplasty alone in
2
patients with distal occlusive disease.
AC C
EP
TE D
M AN U
SC
RI PT
1
ACCEPTED MANUSCRIPT 4 1 2
INTRODUCTION Lower extremity bypasses are often recommended for patients with infrainguinal peripheral arterial disease, which can manifest as lifestyle limiting claudication, ischemic
4
rest pain, or tissue loss. The ideal bypass originates from a healthy donor inflow artery
5
and terminates in a healthy recipient outflow artery using good conduit. The ideal conduit
6
is great saphenous vein (GSV) harvested from the ipsilateral lower extremity. In the
7
absence of suitable ipsilateral GSV, there are several other approaches for lower
8
extremity revascularization, and choosing the approach for each patient is a critical aspect
9
of decision-making as it can affect long-term patency and limb preservation.
SC
M AN U
10
RI PT
3
Alternative conduits include contralateral GSV, cephalic or basilic veins from the upper extremity, cadaveric cryopreserved GSV or human umbilical vein, and prosthetic
12
graft. Bypasses to the tibial arteries utilizing cryopreserved veins or prosthetic graft have
13
achieved very limited success with patency rates of 58% at 1 year and 30% at 3
14
years.1,2,3,4 Spliced composite prosthetic-autologous conduits (utilizing GSV) show no
15
improvement in long-term patency compared to prosthetic only bypasses.3 Adjunctive
16
techniques such as the creation of arterio-venous fistulae and/or the interposition of vein
17
cuffs at the distal anastomosis have led to mixed results but have not demonstrated a clear
18
advantage.3
EP
AC C
19
TE D
11
Some surgeons may choose to use the contralateral GSV, but depending on the
20
level of disease in the patient’s contralateral lower limb, others will preserve the
21
contralateral GSV to provide the “best available conduit” and a better chance of limb
22
salvage if the contralateral leg requires operation. In other instances, neither GSV may be
23
available if they have already been harvested for previous coronary or lower extremity
ACCEPTED MANUSCRIPT 5 revascularizations. The use of arm vein as an alternate autogenous conduit was first
2
reported in 1969.5 Since then, several large series have shown the superiority of arm vein
3
compared to prosthetic conduits for popliteal and tibial artery disease with overall
4
cumulative 5 year patency rates of 57.5% and limb salvage of 71.5%.6
5
RI PT
1
More recently, percutaneous therapies have influenced the management of patients with infrainguinal disease. However, the results of percutaneous tibial
7
intervention, as shown by the final analysis of the long-term results of the Bypass versus
8
Angioplasty in Severe Ischemia of the Leg (BASIL) trial, demonstrated a benefit to open
9
surgical tibial revascularization compared angioplasty at 2-year follow-up for patients
M AN U
SC
6
10
with critical limb ischemia. Thus, bypass may be the preferred modality in patients
11
requiring a durable procedure.7
12
The purpose of this study is to review the clinical outcomes of a tertiary center in the subset of patients with lifestyle-limiting claudication who failed non-operative
14
management or with critical limb ischemia and absence of a viable GSV requiring
15
infrainguinal revascularization. In the era of improved primary and secondary patency
16
due to increasing sophistication with endovascular interventions, we hypothesize that
17
spliced arm vein is still a more durable intervention than revascularization with
18
angioplasty.
20 21
EP
AC C
19
TE D
13
MATERIALS AND METHODS Patients. From January 1, 2005 through June 1, 2012 there were 120 lower
22
extremity revascularizations to distal target arteries in patients without viable GSV. All
23
included patients had severe disease with short-distance claudication who failed
ACCEPTED MANUSCRIPT 6 nonoperative therapy or critical limb ischemia (defined as rest pain or tissue loss). Sixty-
2
six operations were performed using spliced arm vein (43 patients) or a single arm vein
3
(23 patients). Forty-three patients underwent tibial angioplasty, and approximately 75%
4
of those patients also had percutaneous intervention in their femoropopliteal segment at
5
the same time. The remaining 11 operations used a prosthetic conduit (all with
6
polytetrafluorethylene, PTFE), but these patients were eliminated from the analysis
7
because the only time infrageniculate prosthetic material was used was for acute rather
8
than chronic limb ischemia.
SC
Surgical technique. All of our patients undergo pre-operative upper extremity
M AN U
9
RI PT
1
color duplex ultrasound (CDU) to document the patency and quality of the veins
11
available for use as conduit. Criteria used for selecting veins are diameter >3mm, absence
12
of stenotic segments, and absence of thrombus. The infrapopliteal vessels and the
13
common femoral artery are exposed. To reduce operative time, a second operator
14
simultaneously makes continuous incisions over the lateral and medial aspects of the arm
15
for the vein harvest. The cephalic and basilic veins are visually inspected to assess quality
16
and diameter. All the segments were reversed and spliced with a modified Carrel veno-
17
venostomy with 7-0 Prolene (Ethicon, Sommerville, NJ). This geometric configuration is
18
critical to avoid elbowing at the venovenostomies. The proximal anastomosis is then
19
created. The distal anastomosis is constructed after having passed the spliced conduit
20
through a previously constructed subfascial tunnel using a sheathed tunneling device.
21
After completion of the distal anastomosis, pulses and signals are assessed, and a
22
completion arteriogram is routinely obtained to assess for technical defects. Post-
23
operatively, patients were followed by physical exam and CDU at 3 months, 6 months,
AC C
EP
TE D
10
ACCEPTED MANUSCRIPT 7 1 2
and every 6 months thereafter. Data and statistical methods. All candidate procedures were performed at Duke University Medical Center, and were identified by Current Procedural Terminology
4
codes describing the use of arm vein (35500) or spliced vein (35682, 35683) and cross-
5
referenced to the bypass procedure performed. Records were reviewed through the
6
hospitals electronic databases after approval by the Institutional Review Board. Nominal
7
demographic variables were compared between groups by Chi-squared testing.
8
Continuous variables were compared between groups by one-way analysis of variance
9
(ANOVA). The Mann-Whitney U test was used to assess the difference between two
10
independent groups when non-normally distributed. A student’s t-test was used when
11
continuous variables were normally distributed. Kaplan-Meier survival analyses were
12
used to calculate primary patency, limb-salvage, and survival rates. Comparison between
13
life table curves was by the Mantel-Cox log-rank test for significance. Figures are
14
represented as the mean plus or minus standard error and 95% Confidence Intervals (95%
15
CI). Statistical significance was assumed at p values less than .05. All computations were
16
performed using Stata Release 12 (StataCorp LP, College Station, Tx, USA, 2012).
17
19
RESULTS
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18
EP
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SC
RI PT
3
The demographics of the patients who underwent reviewed procedures are shown
20
in Table I. The indication for procedure was lifestyle-limiting claudication that had failed
21
a trial of nonoperative management or critical limb ischemia (detailed in Table II).
22
Follow-up ranged from 182-1830 days (mean 1336 ± 549.72 days). The 30-day survival
23
was >97%, and there was no difference in survival between groups. As expected,
ACCEPTED MANUSCRIPT 8 operative time and blood loss were both greater for the bypass group compared to the
2
angioplasty group, but notably the operative time was not significantly longer when
3
spliced arm veins rather than a single arm vein were used (314 +/- 84 minutes versus 291
4
+/- 102 minutes, p-value 0.107).
5
RI PT
1
Only 46% of patients had prior revascularization attempts (either open or
percutaneous). The mean number of prior interventions was 0.88 (range 0-4), and was
7
different based on study group with twice as many prior interventions in the arm vein
8
bypass groups (p = .000, Table II). Of patients who had undergone prior intervention,
9
there was no difference in indication for the current procedure. The majority of targets
11
M AN U
10
SC
6
were tibial or pedal arteries (Table III).
Mortality and complication rates. The 30-day mortality rate was similar in both groups (Table II). We observed no difference between groups in the prevalence of
13
neuropathy, stroke, myocardial infarction, venous thromboembolic events (deep venous
14
thrombosis or pulmonary embolus) or other late complications. The perioperative
15
myocardial infarction rate was 4.54% in the arm vein group and6.45% in the angioplasty
16
group which is not statistically or clinically significantly different. The surgical site
17
infection rate was higher in the arm vein group; however, these were almost all groin
18
wound infections and were consistent with the national rate of infections in this area (arm
19
vein group 25.75%, angioplasty group 5.13%, p = .008).
EP
AC C
20
TE D
12
Graft patency and limb salvage. Figure 1 demonstrates the primary patency of
21
the two groups. There are more early failures in the tibial angioplasty group. Due to the
22
relatively low number of patients in this study, the 95% confidence intervals are close,
23
but patency is inferior in the angioplasty group in the long term as well. Primary assisted
ACCEPTED MANUSCRIPT 9 1
patency was also better in the arm vein group, though this did not reach statistical
2
significance and patients in each group required second interventions to maintain primary
3
assisted patency (arm vein group 16.1%, angioplasty group 30.6%, Table II). Figure 2 demonstrates there is no effect of the number of splices on graft failure
RI PT
4 5
rate. This was not clinically or statistically significant at either the early time periods
6
(Log-rank p = .3719) or later time periods (Wilcoxon p = .3352).
8
Amputations were twice as common in the tibial angioplasty group, occurring in >10% of those patients (Table II).
M AN U
9 10
SC
7
Discussion
The choice of management for patients with life-style limiting claudication who
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fail non-operative management and critical limb ischemia (CLI) should be dictated by a
13
careful evaluation of the patient’s current clinical status, co-morbidities, anatomy and
14
goals of treatment. Other groups have reported a strategy of preferential use of spliced
15
arm vein when ipsilateral saphenous vein is unavailable (used for prior lower extremity
16
revascularization attempt, coronary bypass) or inadequate (based on diameter or
17
stenosis).8 Our data supports this practice of aggressive utilization of arm vein as conduit.
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In our current series, we demonstrate excellent primary patency of single segment
AC C
EP
TE D
11
19
arm vein and spliced vein conduits as compared to infrapopliteal angioplasties. Many of
20
our patients in both groups had previously undergone a combination of endovascular and
21
open infrapopliteal disease reconstructions. Their demographics reflect a high-risk
22
surgical population and our mortality and complications rates are comparable with other
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national series.
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The BASIL trial showed no difference with regard to amputation free survival and overall survival between angioplasty and open surgery at 2 years. However, in patients
3
surviving more than 2 years, the surgery-first revascularization option showed a clear
4
benefit with regard to amputation free survival.7 In a meta-analysis of 30 articles
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published between 1981 and 2006 (2577 patients), primary and secondary patency rates
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after infrapopliteal angioplasty were significantly lower when compared to bypass
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surgery (48.6% vs. 72.3%) but with comparable limb salvage rates (82.4% vs. 82.3%).9
8
The need for durable vascular reconstruction supports the preferential use of arm vein
9
bypass over less invasive endovascular procedures. Even in the highly morbid patient
M AN U
SC
RI PT
2
population in our study, complication rates were low and patency and limb salvage were
11
high in the group of patients who underwent autogenous vein bypasses. The vascular
12
surgery division favors bypass surgery, especially in patients with claudication, and
13
reserves tibial angioplasty for patients with critical limb ischemia due to the poor long-
14
term patency rates. The majority of the patients in this study who underwent
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percutaneous tibial intervention did have critical limb ischemia; however, some
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angioplasties were performed in claudicants by other clinicians who also perform lower
17
extremity interventions at this institution.
EP
Endovascular intervention is acceptable in patients with prohibitively high
AC C
18
TE D
10
19
operative risk or limited life expectancy, but the best option to restore in-line flow to the
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tibial arteries is bypass. In the Project of Ex Vivo graft Engineering via Transfection III
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(PREVENT III) study, it was observed that predictors of autogenous graft failure at 30
22
days were small conduits (
