Poster session 15: Peripheral arterial disease
P15.01
The future of wearable devices - injectable oxygen sensors for continuous monitoring
of peripheral artery disease - a proof of concept study
Kristen Helton, PROFUSA, South San Francisco, CA, United States
Kityee Au-Yeung, PROFUSA, South San Francisco, CA, United States
Natalie Wisniewski, PROFUSA, South San Francisco, CA, United States
David Armstrong, University of Arizona College of Medicine, Tucson, AZ, United States
Miguel Montero-Baker, University of Arizona, Tucson, AZ, United States
More than half of patients with diabetes and tissue loss have clinical signs of peripheral
arterial disease (PAD)., The incidence of diabetes and PAD are increasing globally. There
does not exist a technology for conveniently monitoring tissue oxygen, an important indicator
of tissue health., There is a need for a tissue oxygen monitor to enable frequent monitoring
using a convenient form factor that allows rapid evaluation by the healthcare provider.,
Ideally, tissue oxygen in at-risk tissue would be monitored frequently by the patient
themselves with a robust technology that gives them the freedom to measure at home., The
purpose of this study is to show the proof of concept for a novel injectable O2 sensor, the
MOXY (Micro Oxygen sensor)., The MOXY consists of a tissue-like sensor the size of a
small suture, which is injected into the tissue and is measured optically and painlessly
through the tissue., A total of 4 volunteers had 1-2 MOXY sensors injected into the arm or
foot and measurements were collected using a custom reader periodically for over one year.,
We assessed the response of the MOXY to changes in tissue oxygen by obstructing blood
flow (pressure cuff) and then releasing the cuff to reestablish flow., Tissue oxygen data
collected using the MOXY were compared to data collected from transcutaneous tissue
oxygen and showed the same trends in an occlusion/reperfusion model., Additionally, we
present MOXY data in patients with diabetes and PAD (n=6) and compare to volunteers'
data., Miniaturization of the MOXY reader to a wearable and wireless form factor will finally
enable convenient, at-home monitoring of tissue oxygen by patients in the comfort of their
home., Increasing the frequency of monitoring will greatly impact patient care and improve
outcomes.
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P15.02
Endoarterectomy revisited: hybrid procedures (HP) are effective for limb-salvaging in
critical limb ischemia with multi-vessel disease
Michele Marconi, University of Pisa, Pisa, Italy
Davide Maria Mocellin, University of Pisa, Pisa, Italy
Fabrizia Virgilio, University of Pisa, Pisa, Italy
Alberto Piaggesi, University of Pisa, Pisa, Italy
Daniele Adami, University of Pisa, Pisa, Italy
Elisabetta Iacopi, University of Pisa, Pisa, Italy
Raffaella Berchiolli, University of Pisa, Pisa, Italy
Mauro Ferrari, University of Pisa, Pisa, Italy
Aim: To evaluate the safety and effectiveness of common femoral endoarterectomy (CFE) at
the level of the femoral bifurcation (FB) in critical limb ischemia (CLI), when associated, with
proximal and distal endovascular angioplasties (HP), in diabetic and non diabetic patients.
Methods: We retrospectively analyzed all the patients, admitted in our Department of
Vascular Surgery, Jan. 2008 - Dec. 2011, who underwent one-staged HP. Patients were
divided into three groups according to the sites of angioplasties: Group 1 = endovascular
reconstruction proximal to the CFE; Group 2 = endoluminal procedures distal to the CFE;
Group 3 = both proximal and distal endovascular procedures. Patients were evaluated for
clinical and vascular outcomes at 6 and 36 months after the procedures, and the cumulative
follow-up was of 42 ± 20 3 months.
Results: 43 (79% men ; aged 74 4 ± 8 6 yrs) out of 635 (5.5%) patients operated for CLI
fulfilled the inclusion criteria; 23 (53 5%) had type 2 diabetes (DM2). DM2 were younger than
controls (72 ± 8 8 vs 77 ± 7 6; p=0 048) but not differed for any other feature. Patients'
distribution was: 14 in Group 1 (32.5%), 24 in Group 2 (55.8%) and 5 in Group 3 (11.7%).
CFE was successful in all cases, while associated endovascular procedures were successful
in 90 7% of the patients. Peri-operative morbidity and mortality were 11 6% and 2 3%,
respectively. Survival rates at 6 and 36 months were 93% and 71 9%, respectively., 3
patients (6 98%) underwent to a major amputation after the revascularization. After 6 months
the cumulative limb salvage was 95 2% and 92 1% at 36 months. Primary and assisted
primary patency at 6 months was 85 3% and 90 3%, and 82 2% and 87 1% at 36 months,
respectively. No recurrent CFA stenosis or occlusion was observed during the follow-up
period. No differences in survival, amputation and patency rates emerged, between diabetic
and non diabetic patients. There were no significant differences between the three groups of
endovascular revascularization.
Discussion: HP involving CFE and proximal or distal endovascular angioplasties are safe
and effective in patients with type 2 diabetes as in controls with CLI and multilevel lesions
involving FB, and they should be taken in consideration whenever there are the indications.
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P15.03
Lower extremity non-invasive arterial testing in patients with diabetes: a guide for the
foot and ankle surgeon
Katherine Raspovic, MedStar Georgetown University Hospital, Washington, DC, DC, United
States
Dane Wukich, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United
States
Aim: To compare the findings of noninvasive arterial testing in patients with diabetic foot
problems and diabetic patients with routine foot problems.
Methods: The ABI, TBI and great toe pressures were measured in 203 patients. PAD was
defined as an ABI < 0.91 on either extremity and/or TBI < 0.71. Patients with diabetic foot
disease (ulcers, Charcot neuroarthropathy, infections or neuropathic fractures) were
compared to diabetic patients with routine foot problems.
Results: (Table 1) Patients on dialysis had a 7.4 times likelihood of having PAD compared
to patients not on dialysis [OR 7.4, (95% CI 1.6-33.6), p=0.0097]. Patients with absent
pulses were 4.9 more likely to have PAD than patients with a normal exam [4.9, (95% CI 2.69.4), p<0.0001]. 21% of patients had noncompressible vessels or unreliable ABI’s.
Conclusion: Combining the ABI with TBI improves the ability to diagnose PAD in diabetic
patients because the ABI has high specificity (low false positives) and the TBI has high
sensitivity (low false negatives). The TBI is more reliable than ABI in patients with
noncompressible arteries and/or neuropathy. Our results are similar to the Eurodiale study
which found that 49% of patients presenting for diabetic foot ulcers had PAD., A surprising
finding of our series is the high rate of PAD observed in patients without diabetic foot
disease, although 69 % of these patients had neuropathy. Surgeons should be aware of the
guidelines and recommendations from national and international consensus groups. Due to
the relative incompressibility of calcified distal arteries in patients with DM, the ABI may be
within normal limits in patients with PAD. This false negative result may lead surgeons to
assume that normal perfusion is present.
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Comparison of results between study groups
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P15.04
Second toe systolic pressure measurements are valid substitutes for big toe systolic
pressure measurements in patients with diabetes
Venu Bhamidipaty, Western Health, Melbourne, Australia
Anastasia Dean, Western Health, Melbourne, Australia
Swee Leong Yap, Western Health, Melbourne, Australia
Julia Firth, Western Health, Melbourne, Australia
Michaela Barron, Western Health, Melbourne, Australia
Bernard Allard, Western Health, Melbourne, Australia
Stephen Chan, Western Health, Melbourne, Australia
Background: Toe systolic pressure is a component of the standard vascular and diabetic
foot assessment., Until now, clinicians have only measured big toe pressure given a lack of
evidence for measurements of the other toes., In patients with diabetes, big toe
measurements are often not possible due to ulceration or amputation., It was hypothesized
that the adjacent second toe systolic pressure measurements would be interchangeable with
those of the big toe.
Methods: A prospective study was performed on 100 participants with diabetes mellitus.,
Duplicate systolic toe pressures were measure in the big toe and adjacent second toe using
the SystoeTM Automated Toe Pressure System, SystoeTM Photophlethysmograph Sensor
Cuff and occlusion cuffs measuring 120 x 25mm for the big toe and 90 x 15mm for the
second toe. Ordinary Least Products regression was used to detect and distinguish fixed
and proportional bias between the two toe measurements., The acceptable limits of
interchangeable results were defined as 5 to 10mmHg.
Results: No fixed or proportional bias was found between the two methods of measurement:
second toe systolic pressure = (-0.579) + (1.038)* big toe systolic pressure., Ninety-five
percent confidence interval for the intercept was -7.487 to 6.329; for the slope 0.970 to
1.106., Repeatability analysis showed a 0.5% variation between duplicate measurements.
Conclusion and clinical relevance:
This is the first study which demonstrates that second toe systolic pressures are
interchangeable with those of the big toe., Second toe pressures can be used in patients
with diabetes whose big toe pressures cannot be assessed., This ensures appropriate and
timely assessment of a patients’ vascular status which leads to improved clinical decision
making.
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P15.05
Role of ankle-brachial index and TcPO2 measurements in predicting arterial lessions
in critical limb ishemia in diabetic patients
Iztok Štotl, University Medical Centre Ljubljana, Ljubljana, Slovenia
Vinko Boc, University Medical Centre Ljubljana, Ljubljana, Slovenia
Simona Ferjan, University Medical Centre Ljubljana, Ljubljana, Slovenia
Vilma Urbančič, University Medical Centre Ljubljana, Ljubljana, Slovenia
Aim: Arteriographic lesions of diabetic patients presenting with critical limb ischemia (CLI)
can be categorized according to morphologic classification described by Graziani et al.
Graziani has observed a weak inverse correlation between morphologic class and
transcutaneous oximetry (TcPO2) in CLI. We wanted to describe the distribution of
morphologic changes in our population of patients presenting with CLI and to investigate the
correlation between morphologic class and ankle-brachial index (ABI).
Methods:, In 143 diabetic patients, average age 74.1 (s = 9.2), that were hospitalized for
treatment of critical limb ischemia at our department, clinical data and radiographic images
were collected prospectively and analyzed., We have excluded patients with prior vascular
intervention, patients with acute ischemia, patients with lesions on iliac arteries and patients
that could not be classified according to the classification proposed by Graziani. We have
categorized the patients into morphologic categories as proposed by Graziani. Correlation
between morphologic class and TcPO2 (evaluated on the dorsum of the foot) or ABI was
analyzed by Spearman correlation test.
Results: The distribution of vascular lesions in our population of patients was very similar as
in the sample studied by Graziani et al, with types 4 and 6 being the most common and type
1 very rare. Distribution of morphologic categories in our sample: Type 1 (3%), Type 2
(10%), type 3 (18%), type 4 (25%), type 5 (8%), type 6 (28%) and type 7 (8%). TcPO2
values were weakly correlated with angiographic score, but not statistically significant
(n=120; r = -0.097, p = 0.2896). ABI, values were negatively correlated with angiographic
score. The correlation was strong and statistically highly significant (n=142; r = -0.55, p =
1.22e-12).
Conclusions:, Ankle-brachial index is much stronger predictor of severity of arterial lesions
in diabetic patients presenting with critical limb ishemia than TcPO2 measurement.
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P15.06
Prevalence and management of limb ischaemia in moderate-to-severe diabetic foot
ulcers
Alessia Scatena, San Donato Hospital Arezzo, Arezzo, Italy
Francesco Liistro, San Donato Hospital Arezzo, Arezzo, Italy
Italo Porto, San Donato Hospital Arezzo, Arezzo, Italy
Giorgio Ventoruzzo, San Donato Hospital Arezzo, Arezzo, Italy
Filippo Turini, San Donato Hospital Arezzo, Arezzo, Italy
Filippo Maioli, San Donato Hospital Arezzo, Arezzo, Italy
Guido Bellandi, San Donato Hospital Arezzo, Arezzo, Italy
Leonardo Bolognese, san Donato Hospital Arezzo, Arezzo, Italy
Lucia Ricci, San Donato Hospital Arezzo, Arezzo, Italy
Aims: To evaluate the prevalence of ischemia, the management and the outcomes in a
diabetic population with significant lower limb complications.
Methods: We retrospectively evaluated all patients referred from January 1st 2012 to
December 31st 2013 to a high-volume Diabetic Foot Clinic with a new moderate-to-severe
ulceration (Texas University Classification grade ≥ 2).
Results: We reviewed 374 patients (62% males), with a new, deep ulceration. Mean age
was 73.8±11 years; 361 (97%) had type 2 diabetes; mean diabetes duration was 18.3±12.1
years. 139 (37%) pts had a creatinine value above 1.5 mg/dl and 35(9%) pts were dialysed.
Mean ulcer duration at the first visit was 38.1±29.3 days. Sensory-motor neuropathy was
recognized in 338 (90%) pts. A pathologic ABPI (<0.9 or calcified) and/or a TcpO2 value <30
mmHg were present in 236 (64%) pts. Considering the TUC, ulcers 2B were 69 (18%), 2D
were 42 (12%), 3B were 69 (18%) and 3D were 194 (52%). 204 (87%) of the 236 pts in
2D/3D classes underwent revascularization, whereas 32 (13%) were excluded because of
general conditions or technical unfeasibility. Of those revascularized, almost all patients
(98%) were treated with a Percutaneous Transluminal Angioplasty (PTA), and only three pts
underwent by-pass surgery. PTA site was proximal (iliac, femoropopliteal) in 161 (47%)
cases and distal (tibiopedal) in 184 (53%), whereas in 97 (48%) pts PTA affected more than
one site. Fifty-seven (28%) pts needed more than one PTA procedure, because of
restenosis or to optimize the flow to the wound. After local surgery, appropriate wound care
and antibiotic therapy when needed, 348 (93%) pts healed with an healing time of 141.9±89
days, 19 pts (5%) are still under care at the time of writing, and only 6 (1 6%) pts underwent,
a major amputation. At the end of a mean follow-up of 66±27 weeks, 56 (15%) pts died, of
which 47 (84%) for cardiovascular events.
Conclusions: Considering deep diabetic foot wounds, in this population ischemia
prevalence is higher (64%) than the prevalence described in a large European survey(1).
Early vascular diagnosis and treatment, have the potential to salvage limbs and improve
prognosis.
Bibliography
L. Prompers et al. Baseline results from the Eurodiale study. Diabetologia (2007) 50:18–25
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P15.07
Double antiplatelet medications on delaying PAD: A, followed up three years
randomized single-blinding clinical trial
Xian Lin, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Li Yan, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Li Fu, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Jinyu Ying, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Jin Li, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Wan Lu, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Meng Ren, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Chuan Yang, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Background: Peripheral vascular disease(PAD) plays the most important role in diabetes
foot in China. To study see the benefits on delay the PAD with type 2 diabetes mellitus by
giving double antiplatelet medications for long time, we designed a randomized one-blind
clinical trial. The three years follow up data was shown here.
Method: Patients with type 2 diabetes were divided into 2 groups randomly and single-blind.
The patients in group A were given Beraprost Sodium(PGI2 analogue) and Aspirin, and in
group B were just given Aspirin. All the patients were followed up for 3 years.
Atherosclerosis was evaluated by some indexes, including inner diameter, the largest plaque
rate and the largest stenosis rate of arteries in lower limbs, media arterial calcification, PWV,
ECG and all-cause mortality.
Result: 1. Between group A and B, it was not differences significantly in the PAD risk
factors, such as age, smoking, blood glucose, serum lipid, blood pressure and so on. 2. The
artery largest plaque rate of posterior tibial and dorsalis pedis become serious, but the speed
was slower in Group A then group B(Table 1). The media arterial calcification was critical in
three years, however in Group B the media arterial calcification was more serious then
Group A(Table 1). In group A, 45.80% patients the PWV became slower and in group B was
35.7%. 4. The patients in group A whose ECG turned worse were 8.67%, while in group B
were 24.00%. The all-cause mortality of group A in 3 years was 3.13%, and that of group B
was 9.38%.
Conclusion: Giving Beraprost Sodium and Aspirin could get more benefits on delaying PAD
with type 2 diabetes mellitus than just getting Aspirin.
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P15.08
Phase 1 open label study to evaluate the safety and efficacy of human placentaderived cells (pda-002) in subjects who have DFU with PAD
Stephanie Wu, Rosalind Franklin University, Chicago, United States
Richard Pollak, Endeavor Clinical Trials PA, San Antonio, United States
Robert Frykberg, Phenix VA Health Care System, Phoenix, United States
Caporusso Joseph, Complete Family Foot Care, McAllen, United States
Peter Lawrence, Ronald Reagan UCLA Medical Center, Los Angeles, United States
Wei Zhou, VA Palo Alto Health Care System, Palo Alto, United States
Mark Rudinski, Celgene, Warren, United States
Karnoub Maha, Celgene, Warren, United States
Vilma Hernandez, Celgene, Warren, United States
Steve Fischkoff, Celgene, Warren, United States
Denesh Chitkara, Celgene, Warren, United States
Aim: PDA-002 is a mesenchymal-like cell population derived from normal, full term, human
placenta. PDA-002 has demonstrated the ability to secrete angiogenic factors, and improve
blood flow in animal ischemia models. For subjects who have DFU with PAD, therapeutic
angiogenesis using PDA-002 offers a promising therapeutic option., The primary objective of
this study was to assess the safety of, PDA-002 in subjects who have DFU with PAD.
Methods:, Subjects were enrolled sequentially into each of 4 dose cohorts (3 x 106, 10 x
106, 30 x 106, and 100 x 106 cells) administered intramuscularly on Day 1 and 8. The study
population included subjects with diabetes, PAD (defined as ABI>0.5-≤0.9 or TBI >0.35-≤
0.7), and a DFU (Wagner Grade 1 full thickness only or Grade 2) present for at least 1
month despite standard of care. Fifteen subjects were enrolled in the study (n=3 for cohorts
1-3, and n=6 for cohort 4).
Results:, The mean duration of DFU was 60.6 weeks. No subjects met the study stopping
rules or the criteria for a dose limiting toxicity. There were no treatment-related SAE’s. There
was 1 non-treatment related death. Three months efficacy data were available for 9 subjects
at the time of abstract submission., Four subjects had complete healing, and 1 subject had
50% healing of their index ulcer within 3 months. The mean increase in ABI from screening
to, dosing was 0.028. The mean increase in ABI at 3 months following dosing was 0.23.
PDA-002 was safe and well tolerated in subjects who have DFU with PAD.
Conclusion:, Subjects with chronic DFU that did not previously respond to conventional
therapy experienced healing of their ulcers and increases in their ABI after treatment with
PDA-002. A placebo-controlled Phase 2 study (NCT02264288) has been initiated to
evaluate PDA-002 in subjects who have DFU with PAD.
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P15.09
Treatment of NIDDM PAD, Endovascular Therapy OR Antiplatelet Medicine?
Chuan Yang, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Liu Dan, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Chuan Wang, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Ying Liang, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Yiqing Qi, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Gugeng Xu, the second hospital of Guangdong Province, Guangzhou, China
Xiaopei Chao, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Lifang Mai, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Meng Ren, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Wanting Feng, Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Yicheng Guo, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Zhuyi Jiang, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China,
Li Yan, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
The prevalence of diabetes in China is rapidly increasing. The incidence of diabetic foot is
also increasing every year. The peripheral arterial disease(PAD) is the main reason for
occurrence and development of diabetic foot. The endovascular revascularization has
become the first choice option for severe PAD. To observate the effect of endovascular
interventions on incidence of ischemia foot ulcer and gangrene among diabetes patients with
PAD, we designed a prospective multicenter open-label randomized study in 2010. We got
some primary results and found some interested phenomenon.
Materials and Methods: 60 patients with stenosis ≥30% to occlusion of any vascular by
arteriography, aged from 40 to 80 years-old (35 male, 25 female) were recruited in this
prospective, randomized, antiplatelet medicine -controlled, open-label clinical trial. They
were randomized into two groups, one treated with Beraprost Sodium 20ug po TID and
Aspirin 100mg PO QD, the other with Endovascular Therapy and then get the internal
treatment for 3 years. But now we just got 18 patients for 2 year results.
Results: Age, Blood Pressure, HbA1c BMI, smoking status had no differences between the
two groups. The VPT(vibration perception threshold) ABI AND TcPO2 significantly changed
in each group(see table 1). We could found the primary outcomes: DSA therapy can rapidly
improve PAD. The improvement of DSA may decline over time. Antiplatelet medicine could
be beneficial to ABI and TcPO2 for long-term therapy. This means that the diabetic foot
would be prevented by antiplatelet medicines. Special the TcPO2 was improved better than
the ABI.
Conclusion: We maybe could get the conclusion that the formation of collateral circulation
would be promoted by antiplatelet medicine.
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P15.10
Management of peripherial arterial disease in the reduction of amputations of lower
limbs in diabetic patients in cote d'ivoire
Dago Pierre Koffi, Chu of pointe-à-pitre, pointe-à-pitre, France
Jacko Abodo, Chu Yopougon, Abidjan, Cote d'Ivoire (Ivory Coast)
Franck Kouassi, Chu Yopougon, Abidjan, Cote d'Ivoire (Ivory Coast)
Adrien Lokrou, Chu Yopougon, Abidjan, Cote d'Ivoire (Ivory Coast)
Aim: Identify the arterial lesions of diabetic foot and specify the treatment of theses lesions.
Methods: It was a retrospective study carried out of a ten-year period at the university,
hospital of yopougon Abidjan from 2002 to 2012. It focused on the analysis of 514 records of
patients hospitalized nfor diabetic foot in the endocrinology department. 251 diabetic patients
had arterial doppler Ultrasound of lower limbs.
Results: The prevalence of foot with arteritis was 87.1%. the mean time of consultation of
our patients was 42.128 days. The duration of diabetes was on average 14 years with
extremes of 3 and 24 years. Diabetes was inbalanced in 91% of cases ( HBA1C: 8.7%).
hypertension was found in 5 cases, dyslipidemia in 10 cases, polyneuropathy in 92.1%,
coronary disease was found in 22cases, and stroke was found in 18 cases. Arterial Doppler
Ultrasound demonstrated: stenosis 50%, occlusion (22.37%), medial arteriosclerosis
(17.53%) and slender arteries. Radical treatment was performed in 29.9% of cases and
consevative treatment ( no amputation) was found in 70.1% of cases and 9 cases of death.
Conclusion: Arterial lesions are common in diabetic foot Its specific treatment reduced the
rate of lower limb amputation
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