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Good Evening. My name is Doctor Suzuki. I am a certified wound specialist and medical director of the Tower Wound Care Center in Los Angeles, California.
Production of this PRESENT lecture was brought to you by a generous grant from Vasamed; delivering better diagnostics into circulation.
This lecture is 3 parts. First, I will present a brief review of Peripheral Arterial disease, and then I am going to review 5 common noninvasive vascular tests, then finish up with a few case studies.
This is the cartoon of PAD or peripheral arterial disease. PAD is a metabolic disease that causes progressive build-up of cholesterol and calcified plaques that constrict normal blood flow to the legs and feet, And in severe cases, the ischemia can lead to tissue necrosis and major leg amputations. We try not to use the term PVD- Peripheral Vascular Disease, as it is too vague, and confuses artery and venous problems.
By far, diabetes and smoking are the 2 biggest risk factors for peripheral arterial disease. Itâs a little known fact but 1/3 of diabetic patients in the United States have PAD. Advanced age is also directly correlated with peripheral arterial disease, and the older you are, the more likely you are going to develop PAD, as you see on the graphs above.
Poly-vascular disease is a newer terminology that describes the atherothrombotic diseases, collectively from head to toe. In fact, the incidences of all these diseases-MI, strokes, angina, PAD- often overlap.
In this particular study called REACH registry, we found that many of these vascular diseases overlap, as all these vascular beds are interconnected, as you see on the diagram on your right. In other words, if you see a new patient tomorrow, with history of coronary bypass surgery in the past, you should suspect that the patient may have PAD.
There are 12 million peripheral arterial disease patients in the United States. PAD is very, very common as you can see in comparison and it is projected to increase as the United States population grows older and diabetes becomes more common.
This is one of my key slides of this lecture. PAD is deadly if undiagnosed and untreated. This is why screening and accurate diagnosis is very important. As you can see from this slide, PAD is not just a cumbersome disease that causes leg cramps, it really is a deadly disease that rivals colorectal cancer and strokes.
This is the breakdown of initial clinical presentation of peripheral arterial disease. Although we often associate PAD with leg cramping or claudication as the initial presentation, claudication actually accounts for as little as 10% of all cases. In other words, 90% of the PAD patients may present to your clinic, initially with vague symptoms in legs, or may be completely asymptomatic. Also, 1-2% of patients may present to your clinic initially with critical limb ischemia.
Critical limb ischemia or CLI is the most severe form of PAD. At this stage, the ischemia is so severe that the legs ache for oxygen even when these patients are resting, which is called rest pain. Once the ischemic ulcers on toes and heels turn gangrenous, it is an ominous sign that the ischemia needs to be reversed as quickly as possible.
This is a data from TASCII, Trans-Atlantic Collaboration of 16 medical and surgical specialties. The latest data on CLI treatment is pretty dismal. As you can see on the left, 1/4 of the CLI patients receive major leg amputations as the primary treatment. One year later; 1/4 of the CLI patients are dead, and the other 30% are alive but have had major leg amputations.
For CLI patients, the fate after below the knee amputations is also dismal, as 10% of them die preoperatively. Two year later, 40% is fully mobile, 30% dead and 30% are most likely bed-ridden because of major leg amputations. Again, the lesson here is to diagnose and treat the PAD patients early, so we do not have to deal and treat these CLI patients.
You may have seen these statistics before. For diabetes patients, below the knee amputations is very deadly. In fact, its 5 year mortality rate is estimated as high as 80%, which is equivalent to stage 4 lung cancer. This is why we have to pour our resources on wound care and limb salvage and by avoiding unnecessary amputation we can actually save lives.
The analogy that I use is this: PAD equals Cancer. I donât see why not? Both diseases are equally common, equally deadly, and disabling and disfiguring. Itâs also true that both diseases need comprehensive screening and aggressive treatment to save lives. REACH registry included over 50,000 patients in 30 countries, and the conclusion is PAD is grossly under diagnosed and therefore grossly under-treated and this is quite natural. If you donât make the diagnosis, you canât treat a disease.
This is the evidence based PAD treatment strategy that we follow, which is advocated by TASC II and American College of Cardiology and American Heart Association. As PAD is a metabolic disease, you have to reverse and normalize the risk factors first with emphasis on controlling blood glucose and smoking cessation. Medical management with Aspirin and Clopidogrel is known to decrease cardio vascular mortality rate. And if there is already an ischemic ulcer or tissue loss present, we move on to surgical management by consulting your vascular specialists; namely vascular surgeons, interventional cardiologists, and interventional radiologists.
Now letâs talk about surgical options regarding revascularization. Open leg bypass entails harvesting leg veins, removing valves from inside, reconnecting to leg arteries to increase flow to the leg which quite durable and works well, but may be taxing on older sicker patients. The alternative is endovascular therapy. In the last 5 years, we have made significant technological advances to intervene and improve these ischemic limbs using endovascular devices from the inside the arteries. Some of these procedures can be done under local anesthesia and with minimal stress to our patients. Stem cell therapy which is injecting bone marrow to legs to induce angiogenesis is interesting in concept, but it is probably 10 years away before wide-spread use.
As you can see on this table, there are many ways to revascularize an ischemic limb, with limb salvage rate of 80 to 90%. The take-home lesson here, is that if your patient was told that they need a major leg amputation due to ischemia, I would like you to investigate and make sure that they have gotten a thorough work-up, and 2nd opinion by a vascular specialist who can perform endovascular treatment. Remember, you can save lives by preserving these limbs and avoiding unnecessary amputations.
As a wound care specialist in a wound care center, PAD means a great deal to me. PAD is a huge component of my practice, because ischemic wounds do not heal no matter what you do.
I should also mention that 75% of foot ulcers are caused by ischemia or neuro-ischemia from diabetes as you can see on your left. For example if your patient has a gangrenous heel wound it can be immediately limb threatening and this is another reason as a wound care physician to invest in a vascular study is very important. In the United States up to 70% of lower extremity ulcers are known to be venous etiology. However, those venous ulcers over the medial ankle and lower legs are fairly easy to treat and heal with compression therapy, and venous ulcers rarely lead to major leg amputations.
This is the basic step wise approach on wound care. Perfusion assessment, meaning checking for circulation is the essential first step. So you can perform debridement and compression of the lower extremity wounds safely.
I would like to show you a quick CLI case study. This diabetic patient had a ABI of 1.0, which is normal value indicating adequate perfusion. Then he was scheduled for sharp wound debridement in OR.
Following the sharp wound debridement in OR, the wound turned black, dry, and gangrenous. Unfortunately, this patient had an ischemic leg that was misdiagnosed with ABI.
So debride or not to debride? That is the question. If you recklessly debride or compress ischemic legs, you can actually enlarge the wound because the tissue cannot support the extra demand for perfusion to heal the wound. In fact, podiatrists have been sued successfully for not properly diagnosing PAD in ischemic limbs.
This is my step-wise approach to PAD work up. First you take the patientâs history careful to check to see if the patient has diabetes or if the patient has a smoking history as well as the history of poly-vascular disease such as coronary artery disease or strokes. Next, you move on to physical exams, and then you confirm your diagnosis with non-invasive vascular testingâs, microcirculation tests.
Letâs review physical exams of the lower extremity. First, visual exam. Ischemia is known to cause atrophic skin change, thickening and yellowing of the nails, and lack of hair growth. Next, pulse palpations. You can describe it numerically. Personally I like to use descriptive terms such as palpable, weakly palpable or non-palpable pulses. The main problems with physical exams are that they can be highly variable and inaccurate depending on who performs the physical exams and when.
And when this study came out in 2006, it was a rude awakening to most clinicians. As it turns out, the physical examinations are not accurate at all, and we cannot rely on it to rule in or rule out PAD with certainty. Basically we need objective and non-invasive vascular testing tools to confidentially and accurately make the diagnosis of PAD. And physical exams I would of course still perform and document it but again you cannot rely on it to make a diagnosis.
So, before I review the non-invasive vascular tests, I would like to go back to basics and tell you about the difference between macro and micro circulations. As you see on the left, macro circulation means these large leg arteries that you have seen in a cadaver labs. Microcirculation is on your right. These are capillaries that you can only see with a microscope.
This is a cross section of the lower leg. When I say macro-circulation, I mean three large arteries feeding the foot and ankle- anterior tibial artery, posterior tibial artery, and peroneal arteries. And when I say microcirculation I mean these skin capillaries within the skin layer.
Again, here is macro and micro comparison. Macro circulation is pulsatile arteries that vascular surgeons may perform bypass surgery on, by looking at it with naked eyes. Microcirculation means something that can only be seen with microscope as you can see on the picture on the right and there is a diameter difference as you can see on the bottom.
And of these 5 non-Invasive vascular I am going to review with you there is a clear difference between macro and micro circulation. ABI, TBI, PVR macro circulation testing, while TCOM or transcutaneous partial pressure oxygen (meter?) or transcutaneous oximetry or skin perfusion pressure SPP- those two are microcirculation testing.
So letâs review ABI, ankle brachial index. ABI is calculated by taking ankles systolic pressure divided by brachial systolic pressure. ABI is most commonly used macro circulatory test. It is a quick and cost effective test. And in terms of interpretation terms of 0.9 or lower is considered diagnostic of peripheral arterial disease.
A known problem with ABI is, it is highly inaccurate in diabetes and chronic renal failure patients. The graph you see is a comparison between ABI and the wound healing probability and as you can see on the black curvy line ABI is correlated with the wound healing probability. However as you can see diabetic and chronic renal patients, ABI was clinically useless.
ABI is a widely used diagnostic test for PAD, but it is not perfect by any means. Abnormal ABI such as low values 0.9 or less is diagnostic of PAD and if the ABI is higher than 1.3 it is calcified arteries, it is abnormal finding. The problem is if the ABI values is somewhere between 0.9 and 1.2 it has no clinical value as calcified arteries can falsely elevate ABI in false negative manner.
Toe pressure or TBI, toe brachial index is a cousin of ABI so to speak. You measure blood pressure on the great toe by using a special small cuff as you can see on the picture on the bottom there. And TBI is said to be more accurate as it is less effected by arterial calcifications.
The major problem with TBI in wound care setting is physical limitations and many of my patients do not have great toe because they have been amputated previously and many of my patients do have wounds under neither their great toe and I cannot measure accurate toe pressure in these patients.
PVR or Pulse Volume Recording evaluates the changes in arterial blood volume within each pulse using a blood pressure cuff. It is my microcirculatory test of choice as it is not affected by calcified leg arteries. On the bottom, it is an example of normal PVR waveforms that resemble EKG.
As the PAD progresses the flow obstruction within the artery progress, you will see more blunted peaks and crests with slower up strokes and down strokes as you can see on the screen there. Once the flow becomes severely stenotic, the waveform almost becomes a flat line, as you can see on the bottom.
And in terms of microcirculation, there are only two kinds of tests that are commercially available today. TCOM- Trans-cutaneous Oximetry and SPP, Skin Perfusion Pressure.
TcPO2- transcutaneous partial pressure oxygen or affectionally called TCOM- Transcutaneous oximetry was originally invented for neo-natal monitoring and now we have been using TCOM for assessing the tissue oxygenation status of adult in the wound care setting and hyperbaric oxygen clinics.
The normal TCOM are said to be 60 or above and the number drops as PAD and critical limb ischemia progresses. Also, TCOM is not affected by calcified leg vessels. However it is influenced by cellulitis and edema significantly.
One of the problems we have with TCOM is the large margin of error. Here you see a graph of TCOM values versus wound healing probability and data lines that you see are the margin of error; 95% confidence intervals.
TCOM also has many physical limitations. The first of all, the sensors need to be attached to skin with the adhesives. Therefore flaky, dry skin or macerated, webbed or moist skin, the TCOM values cannot be measured. Next, for the TCOM value to be measured oxygen molecules has to pass thru the skin therefore plantar skin or callused thick skin, TCOM values cannot be measured in those sites. As I mentioned previously edema to the feet or cellulitis TCOM values significantly drops and it is clinically helpful.
Probably the biggest limiting factor for us to use TCOM is how long it takes to measure TCOMs accurately. First TCOM requires daily maintenance and before you can measure the patient needs to be shaved and prepped and you start the TCOM test, you are required to wait at least 30 minutes, up to 45 minutes before you get the most accurate results.
SPP or skin perfusion pressure is a newer technology that is alternative to TCOM in terms of microcirculatory tests. It is a laser Doppler based skin perfusion pressure monitor and it a blood pressure of the skin following occlusion cuff. On the screen you see a setup on the left, itâs a computer controlled cuff with a laser sensor and box that inflate and deflate the cuff automatically and on your right you see the graph of skin perfusion pressure.
Skin perfusion pressure is my microcirculatory test of choice over TCOM as it not affected by calcified arteries and it has been clinically validated. It has many advantages over TCOM. It can be used in edema patients. It can be used in plantar feet. There is no calibration needed and maintenance is really null and each measurement can be taken in 2-3 minutes. Only drawback is that in shaky patients, skin perfusion pressure may be difficult to measure.
This is a cartoon, kind of mental picture of skin perfusion pressure. Think of putting a blood pressure cuff on your skin capillary. The laser sensor shoots and detects the laser beam reflected by red blood cells within the skin layer. That is basically, a skin perfusion pressure, measured by this particular machine.
Dr. Castronuovo is a vascular surgeon who did a seminal study on SPP. He used skin perfusion pressure as the alternative diagnostic tool to ABI. In this prospective, double blind study, SPP values were compared I guess, clinical assessment of outcome. There results were skin perfusion pressure was 80% accurate with critical limb ischemia diagnosis when it was set at 30 mm mercury. In the meantime, ABI did not predict critical limb ischemia, amputation, or outcome of these patients.
This is the same study with Dr. John Castronuovo and others. This is the graph of skin perfusion pressure versus wound healing probability. As you can see, it is a nice sigmoid curve. At 40mm mercury or above, most wounds have healed. As SPP value drops below 30mm mercury, which is diagnostic of critical limb ischemia, the wound healing probability dropped significantly.
Dr. (Techan?) Lo is a critical care physician in Loma Linda University in Los Angeles. Dr. Lo and his associates did a head to head evaluation of SPP versus TCOMs. There results, SPP were found that to be 92% accurate, while TCOM was 67% accurate in wound healing prediction, with statistical significance.
This is a newer Japanese study published in 2006. They first diagnosed PAD by using the latest multi-slice CT angiogram. Then, they compared against SPP, TCOM, Toe Pressure, ABI in double-blind like fashion. The conclusion was SPP was 85% 85% sensitivity, while ABI was only 30% sensitive in PAD diagnosis. This is a striking data. This means ABI missed 70% of PAD diagnosis in this particular patient population. The conclusion of the study was SPP is the most useful tool for detecting PAD in hemodialysis patients.
SensiLase system is what we used in our wound care center. It is a comprehensive perfusion testing device that combines macro and micro testing of choice, SPP and PVR. It is manufactured in the United States by Vasamed but it is widely embrace and is starting to catch in Japan. It is used as an alternative to ABI, TBI and TCOM and used widely in cath labs, non-invasive vascular labs and wound care clinics.
Again, the key of using SPP and PVR is that those tests are not affected by calcified arteries so I can trust this data in diabetic patients and chronic renal failure or dialysis patients who are known to have calcified leg arteries. By combining SPP and PVR, I can diagnosis PAD and CLI accurate assess and predict wound healing and determine the best amputation level if amputation is needed and validate revascularization before and after.
And this is our work-up protocol in our wound care center. We take history from physical exam. Then we perform SPP and PVR tests using SensiLase. And our cut-off value for SPP is 30 and 50. If the SPP value by the wound is over 50, there is no ischemia and I can perform debridement and compress aggressively and safely. If the value of SPP is somewhere between 30 and 50, I will make a diagnosis of peripheral arterial disease and Iâll perhaps treat the wound conservatively and monitor it closely. If SPP is below 30mm mercury, I will make a diagnosis of critical limb ischemia and I will make an immediate referral to a vascular specialist for a surgical evaluation.
Here, I would like to introduce targeted SPP measurement used in the Angiosome concept. The Angiosome is plastic surgery concept and it is analogous to Dermatome and peripheral nerve distribution. The Angiosome 3D tissue blocks fed by each source artery and we believe that there are 40 angiosomes in the body with 6 angiosomes in each foot macro(?).
Again, this is the cross section of ankle level and there are 6 angiosomes coming from 3 source arteries, anterior tibial, posterial tibial and peroneal arteries.
And these angiosomes concepts were expanded by Dr. Chris Attinger at Georgetown University who works very closely with our friend Dr. John Steinberg. And what you see on the screen is the anterior tibial angiosome, fed by the arterial tibial artery and the dorsalis pedis artery and as you see on the screen, the anterior tibial artery supplies basically anterior leg and entire dorsum of the foot.
Next the posterior tibial artery supplies the posterior tibial artery angiosomes which supplies the entire plantar foot including heel and the medial ankle area.
Next, peroneal artery angiosome supplies plantar lateral heel and lateral ankle as you can see on the screen. And you may have noticed the heel is supplied by two source arteries, the peroneal artery and posterior tibial artery, and we believe this is because our heel is the most traumatized area in our bodies in our varied activities.
And what you see on the screen here is how we measure skin perfusion pressure. At first, laser sensory placed by the foot then blue computer controlled blood pressure cuffs are wrapped around it. Then the skin perfusion pressure measurement is initiated. Next, I would like to show you a few case studies using the Angiosome concept and combine that to skin perfusion pressure measurements.
This is a 70 year old male diabetic patient on dialysis with ischemic toe wound, with distal phalanx exposed. In this patient, ABI was non-compressible over 1.3 and it was not clinically useful.
So we measured plantar and dorsum skin perfusion pressure are here are the results. As you see on the screen its plantar foot skin perfusion pressure was ok at 41 mm mercury. But his dorsum SPP was very low at 21 which are diagnostic of critical limb ischemia. This patient has a compromised anterior tibial angiosomes and he was referred to vascular specialist immediately.
In other words, this patient had a compromised perfusion to the dorsum foot and fairly normal perfusion to the plantar foot as you see there. So I sent him to my vascular specialist and I asked him to do a dimension on the dorsum side which is anterior tibial artery.
Next, following a successful PTA or angioplasty to the arterial tibial artery, I amputated his great toe, which healed uneventfully post-operatively.
Let me show you another case. This is a 90 year old female with critical limb ischemia and a rest pain, and this patient also had a chronic wound on dorsum toes, which is within the anterior tibial angiosomes. The skin perfusion pressure was 22 to 26 on dorsum and plantar foot which is diagnostic of critical limb ischemia.
Next based on the location of these wound, I recommended my vascular specialist to intervene on the anterior tibial artery. So successful angioplasty was performed to the anterior tibial artery and you see the progression from left to right and on the angiogram on your right, you can see the dorsal pedal arch that was not seen before.
As you can see, pre and post angioplasty dorsum foot increased from 22 to 59 mm mercury and interestingly plantar foot SPP also increased mildly probably due to retrograde flow from the dorsum pedal arch.
Clinically the rest pain resolved shortly after the PTA was done and the wounds completely within a couple of weeks after the PTA were successfully performed. And this is another example of targeted revascularization effort using SPP and the angiosome concept, to give you the best possible outcome in ischemic wound care.
And now I would like to finish up my lecture with a few more case studies using SPP and PVR tests combined. Now on the screen you see a picture from a wound care center and on the far right you see the SenseLase SPP monitor in relation to the exam chair.
Ok, this is a 60 year old diabetic patient on dialysis with history of left leg BKA. With a history of major leg amputation, obviously this patient is high risk for peripheral arterial disease and the physical exams were non-palpable pulses, ABI was non-compressible and it was clinically useful.
And this patient did not have a wound at this time but he had a mild in grown toe nail on the right great toe and he requested surgical correction a matrixectomy which he had before on the left leg to alleviate his pain on the right great toe.
So SPP and PVI was measured preoperatively and it was actually below 30. SPP was actually 25 mm of mercury which is diagnostic of critical limb ischemia. PVR as you see on the right was stenotic, indicating moderate to severe obstructions. And in patientâs case, surgical procedure such as matrixectomy is not clearly advised and the patient was referred to a vascular specialist for evaluation.
And this is a hypothetical scenario. What if this patient had a matrixectomy as he requested and my guess is right great toe would have turned gangrenous, and he could have lost his toe or right foot or possibly right leg because of his ischemia?
This is another case. 70 year old female with severe venous status and severe leg wounds bilaterally for over 2 years. This patient had non-palpable pulses and her skin was extremely cold, indicating ischemia.
However SPP and PVR tests show that this patient had actually pretty good perfusion, with no sign of ischemia in both macro and micro prospective.
So, this patient was treated with aggressive debridement and compression therapy. As you can see, this patient responded very well to the treatment and it proved a remarkably every week and this about one interval pictures.
And this patient went on to heal completely in two months, for the wounds that did not heal in over 2 years and this is a good example of how good non-invasive vascular tests such as SPP and PVR can help you in deciding the most appropriate treatment plans for difficult wound cases.
And this is the last case study that Iâm to show you. This is a 80 year old diabetic male on dialysis and he had chronic severe neuropathy and with a neuropathic wound on left plantar foot, with metatarsal head exposed.
And this patient was sent to me by a vascular surgeon, as they could not do any more intervention to patient and as for the physical exams this case was interesting that both legs are almost identical with non-palpable pulses, atrophic skin and lack of hair growth.
As you can see on the left side of the screen, his SPP on the right side of the screen was normal at 63 mm of mercury with a pretty good PVR waveform. In the meantime his effected side, left foot which actually you see on the right side of the screen, he had 34 mm mercury skin perfusion pressure which is very low with compromised PVR waveforms as you see on the right bottom screen. So the conclusion is this, this patient had 34 mm mercury of SPP which represents some healing potential but the wound be treated aggressively in this case.
So here in this patient, I could have done a ray resection with primary closure, but I chose not to because of less than optimal perfusion of this foot. So the treatment plan that I came up for him was metatarsal head resection, with very conservative wound debridement followed by off-loading and delayed primary closure in stages.
And then this patient went on to heal in a little over 3 months, which was a little slow for me but I guess it was expected from the low SPP value that he had.
Okay, so now let me finish up my lecture with 3 key points. Physical exam is not sufficient for PAD diagnosis. You need non-invasive vascular testing tool if you are involved in wound care or if you even perform surgical procedures. ABI is a useful, cost-effective PAD screening tool, if the patient does not have diabetes or chronic renal failure. AVI should not be confused as microcirculatory test in predicting wound healing. SPP and PVR is the most accurate in diagnosing PAD and CLI as they are not affected by calcified arteries. And to remind you SPP is skin perfusion pressure is a microcirculatory test of choice and PVR is the macro circulatory test of choice. Ok and this concludes my lecture on PAD and non-invasive vascular tests. If you have questions, please donât hesitate to contact me and my e-mail is on the title page. This is Dr. Kazu Suzuki and I wish you a good night.
Production of this PRESENT lecture was brought to you by a generous grant from Vasamed; delivering better diagnostics into circulation.