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AAA Commentary common iliac artery aneurysm complications CTA EVAR innovation ruptured AAA techniques training

Lifelong surveillance after EVAR -is it worth it?

About ten years ago, I had a patient who came to see me for moderate carotid disease. While his carotid disease was asymptomatic, he also had metastatic colon cancer. With colectomy, cryoablation of liver mets, and chemotherapy, he was in remission. Every 6 to twelve months he had some kind of CT scan with contrast. His renal function was poor and this was blamed on his chemotherapy. While it had nothing to do with this patient, I thought to myself, “Having an aortic stent graft was a lot like having metastatic cancer in remission.” After a stent graft, the patient is forever tied to the health care system. Without surveillance, there may be an endoleak, sac expansion, rupture, and even death. Patients and vascular surgeons can make choices that lengthen life, improve its quality, and avoid the complications of disease. But what if a treatment becomes a condition and a burden on healthcare resources and the patient’s finances?

Fool me once…

Type Ib Endoleak Causing re-Rupture of a previous r-AAA after no surveillance

Take this patient who had previously ruptured his AAA and undergone EVAR. Several years out from his rupture, he ruptured again from a type Ib endoleak due to aneurysmal degeneration of his right common iliac artery. Per his family, he never followed up. Perhaps he assumed he was cured of his disease? Repairing this was tricky, primarily because I hopped up and down, thinking, “I could cure this!” An open revision with a bifurcated graft would eliminate the need for EVAR surveillance, avoid abdominal compartment syndrome, and the physiologic consequences of a large retroperitoneal hematoma. But who wants a laparotomy? Not this patient, who was hypovolemic shock, and whose family chose the minimally invasive option that everyone assumes is better.

Not a clamp

I took him to the hybrid operating room, balloon occluding to stabilize his blood pressure, embolizing the normal internal iliac artery and extending the stent graft into the external iliac artery.

Completion -there is an Amplatzer plug in the right internal iliac artery

This patient stabilized and had abdominal tightness due to his large hematoma which did not need evacuation. After a stay lengthened by concern for abdominal compartment syndrome, moderate pain, fevers, and bilirubinemia (due to the hematoma), he was discharged and never showed up for followup. None of the phone numbers work. Without followup, EVAR is a menace. We will keep trying.

Regrets, I’ve Had a Few…

The great feature of EVAR is that the complications up-front at the time of surgery are wonderfully low. This patient pictured above here presented in middle age with a rupture into the retroperitoneum. He was unconscious and had hemorrhagic shock.

The decision to perform EVAR was made late in the transfer because I did not have the images from the transferring hospital (another subject for another blog post) so I set up for both open repair and EVAR. En route to the OR, I scanned, slowly, through the CT images sent via CD-ROM, and my internal discussion went something like this.

He’s a 50-something smoker in shock with a contained rupture of a 8cm infrarenal AAA with a good neck. Let’s take care of this in 30 minutes with a percutaneous endovascular aneurysm repair (p-EVAR).”

He’s a 50-something smoker in shock with a contained rupture with a good neck -let’s take care of this in 90 minutes with a tube graft, open aortic repair (OAR).”

With p-EVAR, he’s going to have just two groin punctures and much lower complication rate, shorter length of stay, similar to lower mortality. Look -his blood pressure is 75mmHg systolic!

That hypotension is permissive to minimize bleeding. With OAR, he’ll avoid abdominal hypertension and complications of a giant hematoma. Because he’s young, he’ll avoid lifelong surveillance. If anyone can clamp this AAA, it’s me...”

Pride cometh before the fall. Get this man off the table and figure out the logistics later. p-EVAR. You open him up, he’ll exsanguinate and expire before you get the clamp on.

I sighed, looked up at the gathered team, and announced, “p-EVAR.” The percutaneous EVAR is something I’ve been doing since 2004, long before it was a big deal, and we were done under an hour. His blood pressure stabilized, but general surgery was consulted for his abdominal compartment syndrome. With sedation, fluids and time, his urine out put recovered but his belly remained distended and his bladder pressures which were never seriously elevated, trended down.

It was made known to me that the patient had very limited insurance making followup surveillance challenging. Due to his coverage, he had to have his imaging done at designated hospitals, so I wrote a detailed note -basically the timings of his followup CT scan, and asked that the reports should be sent to me. I ordered a CTA prior to discharge which showed a type II endoleak adjacent to the graft and connected to both lumbar and inferior mesenteric arteries (first image above). After some thinking, I took the patient for an aortogram, accessed the IMA via the SMA and coiled into his AAA sac and the IMA.

It was only a few weeks ago one of my colleagues across town contacted me that the patient had been admitted with abdominal pain, a CT showing a type II endoleak from his lumbars, but a smaller AAA sac than his pre-repair size of 8.5cm. The patient is seeking to repatriate, and I doubt he would be able to get adequate followup in his home country without paying in cash. Happy that the patient survived his rupture, I still have persistent regrets at not getting him through an open repair, which I am sure he would have done fine with… Or maybe not.

Je Ne Regret Rien…

Recently I admitted a patient, in his 70’s, with a symptomatic 6.5cm infrarenal AAA with bilateral common iliac artery aneurysms, the right being 25mm, the left over 30mm. Because of the pandemic, he was stuck here, seeking to repatriate. Over ten years before, he had a segment of descending thoracic aorta repaired for a traumatic tear -probably one of the last before the wide adoption of thoracic stent grafts which work great by the way.

Cardiac risk evaluation revealed an ejection fraction of 35% with reversible ischemia on nuclear stress test. CTA of the coronaries revealed triple vessel coronary artery disease corroborated by catheterization. Off-pump CABG was planned which would eliminate the effects of cardiopulmonary bypass.

Preparations were made for EVAR with IBE of the left iliac aneurysm as a contingency, but there was no question that if the patient recovered well from his CABG, he would undergo open repair. This was because bell-bottoming or IBE must have regular coordinated surveillance which was not going to be easy with the patient leaving for another country in the middle of a pandemic. It is difficult to get followup to happen in normal circumstances (see above cases). I expressed my opinion to the patient and family and we agreed to see how the patient responded to off-pump CABG.

He underwent off-pump CABG with three vessels revascularized. He was extubated POD#1 and mobilized. By POD #4, he was on a regular patient floor, being co-managed by hospital medicine who takes care of all of our patients. The patient expressed readiness for the next operation. His kidney function remained normal. He was transfused 2 units of PRBC to bring his hematocrit to 30%. He was taken off Plavix, but kept on aspirin. On POD#6, he was taken back to the operating room for open aortic bypass. This would not have been possible without close coordination of cardiology, cardiac surgery, and vascular surgery. Choosing off-pump CABG was a critical element in being able to proceed with open aortic surgery.

Right branch taken to iliac bifurcation, separate bypasses sent to left internal and external iliac bypasses.

I do several things to decrease the physiologic impact of the operation. First is keeping all the viscera retracted under the skin. This simple move has the effect of decreasing the rate of intestinal paralysis and amount of fluid shifts that occur postop, akin to going retroperitoneal. This decreases the space you potentially have if you use standard clamps, but I use the Cherry Supraceliac clamp (image), DeBakey Sidewinder (transverse), or just a Satinsky clamp oriented transversely. This minimizes the occupation of volume over the anastomosis which always happens with standard aortic cross clamps. The anastomosis is easier without the clamp taking up valuable space.

Cherry Supraceliac Aortic Clamp

The iliacs are always clamped with Wylie Hypogastric clamps, again, with the principle of eliminating clamp overhang. Suturing is done with 4-0 Prolene on SH needles -this is plenty (link). The proximal anastomosis wants to bleed, and sewing to a fully cut ring of aorta ensures good posterior bites but also allows for sliding a band of graft down over the anastomosis (Dan Clair calls this a gusset) which works well at creating a hemostatic proximal anastomosis rapidly-trust me, getting this done well is the key step of the operation. Before closing, I infiltrate the rectus sheath and preperitoneum bilaterally with local anesthesia -lidocaine 1% with epinephrine 1:1 with bupivicaine 0.5%. The skin is closed with absorbable dermal sutures because staples create as many problems as they solve. The patient had cell salvage through the case and no extra units of transfused blood.

The patient was extubated that night and started on clear liquid diet. The next day his lines were removed and he was moved to the floor and started on regular diet when he expressed hunger. On POD#2, he was pacing floor, asking when he could be discharged.

Sternotomy and Laparotomy POD#2, walking the floor

As he was eating, walking, talking, breathing, evacuating bowel and urine, and pain free (well controlled), I saw no reason to keep him beyond POD #3 AAA/#9 CABG. I have kept in touch with him and his family and he is doing well and has given permission for this posting.

Satisfaction

This final case has confirmed several of my beliefs. First, calling something high risk can drive one to make bad choices and in fact endanger patients. This last patient would qualify as high risk on any international criteria, and you would not be wrong in quoting upwards of 30% major morbidity and mortality for cardiac revascularization and AAA repair, but you would also be tying your hands from offering the best solution for this man who fortunately was able to undergo two prodigious operations. He will not require much in the way of followup. Coronary revascularization with arterial conduit and open aortic grafting frees him from the need for close followup and reassures us that his repair is durable.

Second, calling something advanced and minimally invasive gives one cachet in the marketplace but forgoes careful discussion and consideration of what is being abandoned. The first two patients survived their ruptures but now face the consequences of having stent grafts. It is a shame when podium speakers at international symposia declare surgery to represent failure because this affects training by encouraging abandonment of hard to acquire skills. It seeps into patient perceptions and expectations. I hope that a balanced approach prevails. You have to be capable of both open and endovascular approaches to be able to offer the best treatment for a particular patient.

Finally, these old operations are cost efficient and there is a lot of room to improve these procedures with new perspectives, techniques, and data. I don’t operate the same way I trained, and it is only through continued application of operations that improvements can come about. As budgets tighten and economies are stressed, cost efficacy will rein in much of the interest and demand in new stuff unless it adds value. That said, I am grateful to our stent graft representatives who have worked to get us bell bottoms and IBE’s for when they will be needed. These grafts will be used when the time is right.

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innovation Technology

Amazon Set Your Kindles Free

My Lenovo Yogabook C930 recently got a firmware update where the main screen image gets cloned to the e-ink display. By putting the device into tent mode, the LCD screen turns off and you now have a PC on an e-ink screen. Linked to a Bluetooth keyboard, it is a low power focused writing station, albeit with lag. Like other e-Ink screens, there is lag -kind of like a typewriter, but you can see it in full sunlight and theoretically there should be a benefit to battery life although I am holding my horses given the Intel chip burning in this device. I have been advocating for this feature for my e-ink Kindle readers. Imagine if you can write a book on a Kindle! It would be a simple OS update. Come on Amazon! Turn on a simple text editor and sync to the Amazon cloud and call it “Author.”

Kudos to Lenovo for the firmware update. I feel like I am part of a giant beta as the Yogabook C930 is gloriously half-baked. The fingerprint reader is still dreck. Freewrite should take note and hurry up with Traveler!

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acute limb ischemia aortoiliac occlusive disease (AIOD) innovation limb salvage PAD skunk works techniques ultrasound

The shunt as temporary bypass -a modest proposal

The rise of cardiopulmonary bypass life support has also given a rise to the need to keep large, obstructive cannulas in femoral arteries. ECMO cannulas are often kept in for days, and it is not uncommon to discover limb ischemia and infarction relatively late. This can be avoided by placing a distal perfusion cannula to shunt blood to the leg early in the ECMO process. The ECMO cannulas have a convenient side port to send a little flow to a 6F sheath placed in the femoral or popliteal artery. This is an established technique (reference 1, sketch below), and it works despite the modest flows achieved because it does not take much to keep the leg alive. These patients are not walking, nor are they need to heal leg wounds, so just enough blood flow means something just a little more than what they get when the common femoral artery is completely occluded by the life support cannulas. What is fascinating to me is that these shunts can pptentially help to save limbs when used as temporary extracorporeal bypasses when definitive vascular surgical care is not immediately available.

brachial to femoral shunt sketch

 

When I was a medical student, I took on a research project after my first year where I had a Langendorff preparation of a rat heart (below).

langendorff prep in MRI
an isolated, perfused, beating rat heart placed in a superconducting magnet for NMR spectra acquisition 

My project was to take a rat heart and keep it alive, beating, and even working, through a perfusion apparatus and place this inside a superconductive magnet to obtain Phosphorus nuclear magnetic resonance spectra -intracellular metabolism data including concentration of ATP, intracellular pH, and ATP/ADP ratio. While the project was successful -I am quite proud to have been the only person at Columbia to have successfully acquired NMR-S data with living beating heart, I moved on to other interests and took away this concept: with oxygenated, glucose enriched, isoosmolar fluid perfused at arterial pressure, any organ can be kept alive, possibly indefinitely, including a brain which only recently others have found possible (reference 2) in reputable scientific circles, but the the Nature publishing Yalies were scooped by the Simpsons decades ago (below), and maybe Mary Shelley centuries before,

simpsons head

This is the simple idea. Revascularization is keeping the target vascular bed alive by delivering oxygenated blood. With a shunt, it could be little, it could be a lot, but it certainly is better than zero, and even a little can buy you time.

The breakthrough that I had was several years ago, a patient arrived from another hospital with an Impella pump which did not have a side port like an ECMO cannula. It is a large catheter that augments cardiac output and in the patient that I was asked to see this patient as their leg was cold and pulseless. Their cardiac output was very poor, and they were sustaining an augmented systolic pressure in the 90’s. There was no way to get this patient to the operating room for a revascularization of any sort. It did strike me that the patient had the misfortune of having catastrophic heart failure in the absence of significant athersclerosis and had normal brachial arteries. After discussing the ramifications with the ICU and family, I placed a brachial artery 5F cannula, and connected it to a 5F sheath I placed in the superficial femoral artery below the occlusive common femoral sheath (figure below). A doppler on the tubing connecting the two cannulas confirmed flow and the patient’s left hand maintained a pulsatile oximetry waveform. The leg pinked up and eventually there was a signal in the foot. This managed to perfuse the leg which did better than the patient who succumbed to multiorgan failure from heart failure. The leg did great.

Which leads me to these thoughts. Most hospitals are good at diagnosing large vessel occlusion via CTA. Most hospitals have doctors who can place arterial lines with ultrasound guidance. In the instance of aortoiliac occlusion or femoral occlusion from thromboemboliem, time is a critical limiting factor to limb salvage. Many hospitals do not have vascular surgeons. Many hospitals transfer these patients with a heparin drip but in the ischemic condition. Transfer arrangements may take hours. Why not ameliorate this situation by having an appropriate physician -an anesthesiologist, an intensivist, an EM physician, place an ultrasound guided radial or brachial arterial line, connect to arterial line tubing to a dorsalis pedis arterial line. Tape it all down on the patient after confirming flow (crude sketch below). This would be better than the three extra hours of ischemia the patient gets hit with on transfer. No one would transport a donor kidney without adequate perfusion and protection, but dying legs get transferred all the time with established warm ischemia. If done well, it might turn an emergency procedure into an urgent, semi-elective one. Have the vascular surgeon video conference in to confirm the absence of blood flow and appropriateness of temporary shunting.

radial to dp shunt
radial artery to dorsalis pedis artery shunt

If we are to live in  a world with less vascular surgeons, then the radius of survival has to be extended with use of technology and simple ideas such as this. Comments are welcome.

Reference
1. Foltan M, Philipp A, Göbölös L, Holzamer A,
Schneckenpointner R, Lehle K, Kornilov I, Schmid C, Lunz D. Quantitative assessment of peripheral limb perfusion using a modified distal arterial cannula in venoarterial ECMO settings. Perfusion. 2019 Mar 13:267659118816934. doi: 10.1177/0267659118816934.

2. Vrselja, Z., Daniele, S. G., Silbereis, J., Talpo, F., Morozov, Y. M., Sousa, A. M. Mario, S., Mihovil, P., Navjot, K., Zhuan, Z. W., Liu, Z., Alkawadri, R., Sinusas, A. J., Latham, S.R., Waxman, S. G., & Sestan, N. (2019). Restoration of brain circulation and cellular functions hours post-mortem. Nature, 568(7752), 336–343.

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innovation open aneurysm surgery opinion Practice training vascular lab

Innovating Our Way Out of Not Having Enough Vascular Surgeons

view out window
View out of my balcony, sometimes you need many pieces to assemble a beautiful whole

Innovating Our Way Out of Not Having Enough Vascular Surgeons

This year’s SVS meeting featured a sobering assessment about the vascular manpower deficit affecting North America at the E. Stanley Crawford Critical Issues Forum, moderated by Dr. Michel Makaroun, MD, president-elect of the SVS. 35-45% of practicing vascular surgeons plan on retiring in the next decade by conservative estimates. We are not attracting enough candidates for the training programs. The solutions, including decreasing the length of training, public relations campaigns, and incentivizing retention have had mixed results, but we have yet to see a sustainable rise in vascular surgeon numbers.

Burnout driven by lack of work-life balance, the advent of electronic medical records optimized for billing, the passing of the private practice era, and the constant need to adapt to new techniques, create a persistent downdraft on staffing. So as some hospital face the reality of having to contract services, little attention is given to delivering best care with the staffing that we have. Changing how we practice is the only viable solution.

There are an estimated 3000 active vascular surgeons in the US. Imagine if all the cheese needs of this country could only be met by 3000 artisanal cheesemakers who make cheeses one at a time and want to live in places with international airports, BMW dealerships, and major league sports teams, and must have 3-4 partners to share cheese call. If you are a rural hospital in dire need of vascular surgery services and your one vascular surgeon is retiring, you are probably SOL.

When I was training, vascular surgery was oft touted as a primary care specialty. And that is how many of us still practice, managing risk factors, monitoring mild disease, as well as planning and performing interventions and operations. As much as I enjoy that kind of interaction, the half hour to an hour visit for a head to toe cardiovascular survey and discussion, educating patients and families about pipes and pumps, is incredibly inefficient. A healthcare system, a hospital, facing a staffing shortfall, has to do everything possible keep that vascular surgeon in the OR during work hours.

What is the core function of a vascular surgeon? Making good decisions and executing plans well. Decisions require data. What is this data? We laud the history and physical examination, but this is a throwback to another era. If you look at the diagnosis of myocardial infarction, it is not standard practice for a cardiologist to come and get a history, examine the patient, and declare that the patient is having a heart attack based solely on history and physical examination. It is a triage nurse in the ED who draws labs and orders an EKG which is read by a machine. These data points will tell you if heart muscle is being damaged. A process is started which triggers a team to come and take care of this patient. The hospitals focused on this actually drill their cath lab teams like pit crews. A stopwatch starts with the goal of revascularization under an hour.

Not so with peripheral vascular disease. The ischemic foot might have only a few hours depending on its presentation before it is irretrievably lost, but no matter -they sit in the ED until a vascular surgeon comes to speak to the patient and family, examine them, and then order tests, admission, consults, and operating room -typically all by themselves. Getting these patients into the operating room is in many places hampered by the lack of dedicated OR staffing, radiology techs, anesthesiologists, space, equipment, and critical care capacity. During work hours, there are scheduled cases that have to be delayed or canceled for another time, which takes time to do. After hours, the patient may have too many comorbidities to handle safely with the available staff. The vascular surgeon may have to bargain and cajole, to align several factions whose attention is demanded by many equally important concerns. If you decide to hold a lavish dinner party of twenty important guests -reserving space, calling caterers, inviting guests, arranging transportation – on short notice, you might pull it off once, but if you do this regularly, you are a masochist of the first order.

In the heart attack model, the history and physical examination is relegated to a series of yes/no or how long questions, and positive responses trigger a series of coordinated actions of a system -a reflex. In the leg attack model, there is no such system. I have to blame the vascular surgeons for preserving the current model.  Vascular surgeons are organized as a guild. Guilds are protective of their monopolies on skills and markets and fiercely resist change. Most vascular surgeons are terrified by loss of control, and cling to the notion of being misunderstood and unappreciated saviors. We can do better.

The area that needs streamlining is at the point of referral. The majority of time of a vascular surgeon is spent working up normal blood vessels, varicose and spider veins, leg edema and pain, and mild and moderate arterial atherosclerosis. This work initially does not require a vascular surgeon but rather a focused set of policies and initial diagnostic studies that can be administered or ordered by any caregiver. Reducing the need for vascular surgeons at this point in vascular care will go a long way in extending the vascular work force at hand.

 

Point of Care Blood Flow Evaluation

Finding and declaring blood vessels to be normal is challenging and too often time consuming. Streamlining this will go a long way in freeing vascular surgeons to take care of disease.

The average caregiver is an inconsistent pulse taker. The palpable pulses are not always easy to find. Asking over the phone or as policy for someone to examine pedal pulses -the posterior tibial artery and dorsalis pedis artery pulses, is challenging. A positive is just as likely to be true or false as a negative. No cardiologist would ask a similarly detailed and technical question about an MI. In fact, they can’t ask, “Is there a pulse in the LAD?” Cardiologists make do with tests easy to obtain and interpret with certainty -the plasma troponin level and the EKG. The EKG is read by an algorithm so established and so tested, that it should stand as an example of early machine intelligence taking over a human job -but I digress.

What is our EKG? It is not the ABI -the ankle brachial index, because it is terrible at identifying disease, and is difficult to obtain reliably without practice. The closest thing to an EKG we have in terms of simplicity and accuracy is the pulse volume recording, the PVR (figure below). A FloLab machine, the machine used to obtain PVRs, will basically run itself once the cuffs are correctly applied on the leg, and the tracings are very easy to interpret. Unlike an EKG, there are no electrodes whose locations you must memorize. If the closest vascular surgeon is an hour away by ambulance, the transfer of a patient with flat waveforms and ischemic foot does not require a consultation on site. The patient would go to the vascular surgeon with no time wasted and no kidneys injured by CTA’s that too often fail to travel with the patient. Unlike an EKG which can be performed by many caregivers, a PVR requires both the equipment and a vascular technologist. A vascular technologist is not available 24-7 in most hospitals, and FloLab machines purchased for vascular labs are not meant to be dragged around the hospital.

PVR graphic.png

So let’s think out of the box about another box in every triage nurse’s cell, every ER and ICU bed, and on every hospital nursing floor. These are pulse oximeters with a digital tracing, and bonus points, some come with strip printers! Placing a pulse oximeter probe on the second toe and comparing to an erstwhile normal wave signal such as on an index finger can provide qualitative information about normality and disease. Normal waveforms and abnormal ones can be easily discerned. A flat line is another obvious finding when in comparison, a finger or an ear on the same patient has normal signals.

digital ppg foot.png

digital ppg hand.png

How much better would a vascular surgeon feel about a transfer call that has this information, “digital waveforms are flat in this patient with rest pain and a bruised toe.” How much better would a vascular surgeon feel about a call about a patient with “digital wave forms are normal in this patient with toe pain and a bruised toe. We got an x-ray and there was a fracture.” The communication can be quite detailed and refined. For example: “The patient had no pulses, we think. Digital wave forms were dampened but pulsatile in a patient with a bruised toe, we’ll send to vascular clinic in the morning.”

A study comparing pulse oximetry signals and ABI in type 2 Diabetes Mellitus found the following results (link).[i]

Method Sensitivity Specificity PPV NPV
Pulse oximetry 74.1% 95.7% 83.3% 92.7%
ABI 70.3% 87.1% 61.3% 91.0%

These data suggests pulse oximetry signal is equal to and somewhat better than ABI. Why is this important? Cost. This information is better than asking unsure people, “Is there a pulse?” A vascular technologist need not be on call 24/7. Extra FloLabs for ED, ICU, and floors need not be purchased. The pulse oximeter with waveform tracing is nearly ubiquitous wherever patient’s oxygenation needs to be assessed in most hospitals. While not perfect, it has great potential for serving as vascular surgery’s EKG machine for critical limb ischemia. Policies and algorithms can be built out in collaboration with Emergency Departments and nursing departments that can effectively determine if blood flow is normal or abnormal at point of care. Effective emergency responses to critical limb ischemia can be authored triggered by abnormal findings. Acute limb ischemia protocols based on time sensitive responses can be initiated. All of these can flow from referring entities being able to determine objectively normal or abnormal blood flow.

Clinic

The vascular clinic is a sorting process where patients are determined to be normal or have mild, moderate, or severe disease. The vast majority of the time spent in clinic can be spent in triage by trained nurses and testing by technologists. Clear pathways and guidelines can dictate the ordering of vascular laboratory tests obviating the need for vascular consultation at this stage. Patients with normal blood vessels and vascular function are sent back to their physicians with the normal report. Patients with mild disease and moderate disease are sent to a physician with specialization in cardiovascular medicine for management of risk factors and periodic surveillance. At any point in the process, a vascular surgeon can be called to provide guidance and direct patients to different tests and consultations. The patients needing operations, based on correct indications and imaging are sent to a focused clinic where the surgeon and interventional team can review films, determine the urgency of indications balanced against risk, and plan and schedule procedures. Currently, vascular surgeons do all of this by themselves, as well as make hospital rounds, perform procedures, and interpret vascular laboratory studies, seeing one patient at a time.

In introductory computer sciences courses, search algorithms are taught to be brute force if you look at one item at a time for the thing you want, and to be efficient if you have presorted those items because every time you look, you can exclude part of the data set, ever shrinking the pool in which you search, making the search shorter and faster

The shortfalls in vascular surgeon numbers have as much to do with this dependence on the star chef cooking up one meal at a time, rather than a team working off recipes, with the chef directing the flow and occasionally jumping by the fire to make the most difficult of dishes. The first restaurant can seat three parties. The latter, easily ten times the number. Everyone gets fed.

Only asking how many vascular surgeons you need misses the big picture because there are many equally important questions. How many vascular technologists do you need? An accredited laboratory provides the critical diagnostics upon which decisions are made, and the surgeon should oversee but not be directly involved in the initial screening. Nurses trained to triage and order vascular laboratory tests and even perform the simpler ones is the second need. Third, is the cardiovascular medicine physician who manages those patients discovered to have mild to moderate disease, and depending on symptoms, refers severely symptomatic moderate disease and severe disease to a scheduling clinic. The scheduling clinic is composed of both interventionalists and vascular surgeons who plan interventions and operations.

Surgeons must be in the operating room to be effective. A well thought out and organized system, with interlocking teams, and well disseminated basic knowledge and awareness of vascular diseases reduces the need for a vascular surgeon to be present all the time in many places and ultimately increases the effectiveness of the vascular surgeons that are available by keeping them in the operating room. The system needs to be set up by the surgeon to allow clinic to be a setting mostly for consenting the patient for an operation or a discussion of treatment options.

Finally, vascular surgeons must be aligned with all the resources of the hospital including the considerable numbers of interventional cardiologists and radiologists, neurologists, and nephrologists. There is no reason someone should wait a month to get on the OR list for an iliac angioplasty and stent if an equally skilled and privileged cardiologist or radiologist has an opening the next day. The surgeon’s special talent should be open surgery and hybrid surgery -that which mixes open surgery and intervention in optimal measures which is not possible from a purely percutaneous approach. The key is frequent and easy communication between specialities and trust built by being in one shared cardiovascular institute.

Execution

There is a critical need of good operators. The acuity of disease and their solutions demand the continued presence and availability of open surgery. The fact is, many solutions are optimal in a hybrid fashion and for peripheral vascular disease, these options can only be offered via a vascular surgeon trained in both open surgery and peripheral interventions, or in a combined effort of open surgeon and interventionalist. And many disease categories can only be managed by open surgery.

The reality is that silos, economics, and practice patterns prevent this kind of combined effort. Market forces have pushed the training of vascular surgeons forcefully into the interventional realm at the cost of open surgical training. Some of the geographic maldisdribution of vascular surgeons has to do with younger vascular surgeons flocking to established practices where there are senior surgeons more comfortable in opening a belly or chest (or both). The trap they and hospital systems fall into is then allowing these new recruits to become the interventional specialist of that group, relegating the aging open surgeon to a narrow role, and then finding that the hospital has a problem when that surgeon announces retirement at 60. Every year, millennia of surgical experience retires to beaches and golf courses. The hospital systems should recognize this brain drain as a crisis and create work arounds that keep these skills going. The other opportunity lost is close coordination with interventional cardiologists, radiologists, and nephrologists who in many cases compete with vascular surgeons for the same patients but treat the patients based on their training and skill sets to the exclusion of potentially better operations offered by surgeons. This disjointed care creates both suboptimal outcomes for patients and high costs for hospital systems.

Commerce should never dictate the fate of a patient. A particular point is where competencies and privileging overlap, and guidelines recommend intervention over surgery as in the case of a TASC A or B iliac artery lesion. A patient should not be kept waiting weeks for a spot on a busy surgeon’s OR schedule when an open interventional cardiologist or radiologist slot is available for a iliac stent the next day. It should be a matter of practice that these cases are discussed and distributed, optimally in a shared indication clinic or rounds. Patients bumped off of a surgeon’s elective schedules for emergencies who could be cared for by an interventional partner without an added delay should be given that option. This kind of change requires a commitment to continual reorganization and optimization into a vascular institute.

 

Conclusion

The perfect vascular surgeon is a unicorn -well skilled, and experienced in open vascular surgery, but also versatile, innovative, and skillful in wielding a wire. I can name just a handful of unicorns. An apt analogy from the book Moneyball is the signing of superstars in baseball on the free agent market. The upshot of that book is that you can arbitrage for the valued metrics through signing several utility players with an aptitude for one thing or another which in sum equals or exceeds that superstar and get the final result -wins, in the same proportions as overspending on a superstar. Rather than searching for that unicorn, it is more important to set up the right system. Screening, testing, and management of mild vascular disease by a nurses and cardiovascular medicine physicians, while directing operations and interventions to vascular surgeons, cardiologists, and interventional radiologists should be the next step in the evolution of vascular care systems. There will never be enough vascular surgeons in the current system. The critical and rare competency is open vascular surgical skill. A surgeon who performs only interventions is not an “advanced minimally invasive practitioner” but rather someone equally privileged as an interventional cardiologist or radiologist, and therefore easily replaceable by an interventional cardiologist or radiologist specializing in peripheral vascular disease. A surgeon skilled in open vascular surgery is becoming rarer every year, but they are still out there, looking at brochures of real estate in sunny places. A team consisting of a cardiovascular medicine physician, many vascular  technologists, nurses specializing in vascular diseases, several interventionalists, and a vascular surgeon skilled in open vascular surgery working as a single unit, is far more easy to assemble than finding and recruiting a herd of unicorns.

 

[i] Kumar MS et al. J Assoc Physicians India. 2016;64(8): 38-43.  https://www.ncbi.nlm.nih.gov/pubmed/27762107

Categories
AAA Commentary Endoleak EVAR innovation open aneurysm surgery opinion techniques ultrasound

Video Presentation: Removing Stent Grafts and It’s Implications for Putting Them In

This was presented at Dia De La Patología Aortíca Marbella organized by Dr. Fernando Gallardo.

Here is the link.

 

Categories
AAA Commentary complications CTA Endoleak EVAR graft infection innovation open aneurysm surgery opinion taaa techniques TEVAR thoracabdominal aortic aneurysm training

A lot of people can put in a stent graft, unfortunately only a few can take them out.

 

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Drs. Roy Miler and Xiao Yi Teng performing anastomosis on open coversion of an aortic stent graft, now graduated and in practice. A significant part of their open aortic experience is in addressing failing stent grafts.

I recently had to remove a stent graft for infection and got to thinking about how the number of people who could comfortably and confidently manage that has thinned out in the world through the unintended consequence of the medical device market place. In every surgical specialty over the past twenty years, many open procedures were replaced with a minimally invasive option which generally involved adoption of new technology and large costs to the hospital. These newer procedures were touted as easier on the patient while being easier to perform for the average physician than the open procedure that they were replacing. That was the other selling point -that one could do several of these operations in the time it took one open procedure. In most cases, they were at best almost as good as the open procedure but at higher cost.

In the marketplace, minimally invasive always wins. In many specialties it became untenable to practice without marketing these “advanced minimally invasive” skills. Hence, the wide adoption of robotics in urology outside major academic centers -during those years of rapid adoption the surgeons would get flown to a course, work on an animal model, then for their first case a proctor would be flown out and voila -a minimally invasive specialist is born. The problem comes when learning these skills displaces the learning of traditional open surgical skills. In general surgery, it is not uncommon to hear of residents graduating without having ever having done an open cholecystectomy.  It is also the case that many vascular trainees graduate with but a few if any open aortic cases. What happens when minimally invasive options run out? Who will do my carotid endarterectomy or open AAA repair?

The first case is an elderly man with an enlarging AAA sac despite having had EVAR about seven years prior. No endoleak was demonstrated but the proximal seal was short on CT. Also, it was a first generation graft which is prone to “peek a boo” endoleaks from graft junctions and stent anchoring sutures. On that last point, I use the analogy of a patio umbrella -after seven seasons, they can leak where cloth is sewn to the metal struts. It is very hard to demonstrate leak of this kind on CTA or duplex ultrasound because they are small. The patient had his EVAR because he was considered high risk for open repair at the time of his operation -moderate COPD, mild cardiac dysfunction. His sac had enlarged to over 6cm in a short time, and therefore open conversion was undertaken. No clinical signs of infection were present. A retroperitoneal approach was undertaken. After clamps were positioned, the sac was opened.

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The picture does not show it, but a leak from the posterior proximal seal zone was seen with clamp off. The clamp was reapplied and the graft transected flush to the aortic neck. A bifurcated graft was sewn to this neck incorporating the main body stent graft and aortic neck in a generous running suture. The left iliac limb came out well and the new graft limb sewn to the iliac orifice, the right iliac limb was harder to clamp and therefore I clamped the stent graft and sewed the open graft to the stent graft.

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The patient recovered well and went home within the week. He was relieved at no longer needing annual CT scans.

Who needs annual CT scans? Patients with metastatic cancer in remission.

The second patient was an older man referred for enlarging AAA sac without visible endoleak. The aneurysm had grown over 7cm and was causing discomfort with bending forward. He too had been deemed high risk for open repair prior to his EVAR. If he had had an early generation Excluder graft, the possibility of ultrafiltration would be more likely and relining the graft would be reasonable (link). This was again a cloth and metal stent graft which can develop intermittent bleeding from graft to stent sutures, and I don’t think relining will help.

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The patient was taken for open repair (above), and on opening the AAA sac, bleeding could be seen coming from the flow divider. It stopped with pressure, but I replaced the graft in a limited fashion from the neck to the iliac limbs as in the first case. This patient did very well and was discharged home under a week.

The third patient was another fellow referred from outside who had an EVAR for a very short and angulated neck, and a secondary procedure with an aortic extension in an attempt to seal the leak had been done. This failed to seal the type Ia leak. This patient too was deemed too high risk for open surgery of what was basically a juxtarenal AAA with very tortuous anatomy.

The patient was taken for open repair, and the stent grafts slid out easily (below).

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A tube graft was sewn to the short aortic neck and distally anastomosed to the main body of the stent graft -with pledgets because of the thin PTFE graft material in this particular graft. This patient did well and went home within a week.

All three cases are patients who were deemed originally too high risk for open repair, who underwent EVAR, then underwent explantation of their failing stent graft. Only one involved a patient whose graft was placed off the IFU (short angled neck), but the rationale was that he was too high risk.

What is high risk? In non-ruptured, non-infected explantation of failing stent graft, the mortality is 3% (ref 2) from an earlier series from Cleveland Clinic.  With stent graft infection, the 30-day mortality of surgical management from a multi-institutional series was 11% (ref 3) when there was no rupture. From a Mayo Clinic series, stent graft resection for infection came with a 4% 30-day mortality (ref 4). These were nominally all high risk patients at the time of the original EVAR.

Real world risk is a range at the intersection of patient risk and the expertise of the operating room, critical care, and hospital floor teams. The constant factor is the surgeon.

Endografts for AAA disease (EVAR, endovascular aortic aneurysm repair), makes simple work of a traditionally complex operation, the open aortic aneurysm repair. The issue has been the cost and risks of long term followup as well as endograft failure and aneurysm rupture. The Instructions For Use on these devices recommend a preop, a followup 1 month, 6 month, and 12 month CTA (with contrast) and annual followup with CTA for life. These devices were meant to treat high risk patients but high risk patients with limited life spans do not benefit from EVAR (ref 1, EVAR-2 Trial). These have lead the NHS in the UK to propose that EVAR has no role in the elective repair of abdominal aortic aneurysms in their draft proposal for the NICE guidelines for management of AAA (link). While this is a critical discussion, it is a discussion that is coming at least ten years too late. A generation of surgeons have been brought up with endovascular repair, and to suddenly announce that they must become DeBakey’s, Wiley’s, Imperato’s, and Rutherford’s is wishful thinking at best or wilful rationing of services at worst.

In 2006, Guidant pacemakers were recalled because of a 1000 cases of possible capacitor failure out of 28,000 implants for a failure rate of 3.7% -there were 2 deaths for a fatality rate of 0.00007%. EVAR-1 Trial’s 8 year result (ref 5) reported 16 aneurysm related deaths out of 339 patients (1.3%) in the EVAR group compared to 3 aneurysm related deaths out of 333 patients (0.2%) in the OPEN group.

Academic medical centers, behemoths though they are, serve a critical function in that they are critical repositories of human capital. The elders of vascular surgery, that first and second generation of surgeons who trained and received  board certification, are still there and serving a vital role in preserving open aortic surgery. My generation -the ones who trained in both open and endovascular, are still here, but market forces have pushed many of my colleagues into becoming pure endovascularists. The younger generation recognizes this and last year, I sat in on an open surgical technique course at the ESVS meeting in Lyons organized by Dr. Fernando Gallardo and colleagues. It was fully attended and wonderfully proctored by master surgeons. This is of critical importance and not a trivial matter. As in the 2000’s when endovascular training was offered as a postgraduate fellowship in centers of excellence, there is no doubt in my mind that today, exovascular fellowships need to be considered and planned and that current training must reinvigorate and reincorporate their open surgical components.

References

  1. Lancet 2005;365:2187–92.
  2. J Vasc Surg. 2009 Mar;49(3):589-95.
  3. J Vasc Surg. 2016 Feb;63(2):332-40.
  4. J Vasc Surg. 2013 Aug;58(2):371-9.
  5. Lancet 2005;365:2179–86.
Categories
AIOD amputation aortoiliac occlusive disease (AIOD) BKA bypass complications EndoRE innovation PAD remote endarterectromy techniques Wounds

Arterial Restoration -Something New, Something Old

Something that I recently promised Dr. James S.T. Yao, I will be working to publish on my stent removal and extended remote endarterectomy cases and techniques. Meanwhile, here is a talk.

Categories
innovation opinion

In Medicine, We Can All Be Real-World Innovators

By W. Michael Park, MD

 

Innovation has become a virtue in the current culture. There is an  evangelical fervor around it. What are TED Talks but tent revivals for nerds? What is the new Apple campus but a cathedral born out of the values of our time? Yet in elevating the more famous innovators and inventions to lofty heights, we lose sight of its very practical and useful daily application. Rather than treat it like inspiration from the heavens, we should approach it as a trait that we all share in.

 

To make it work for you, you have to think of it as a muscle, and put your reps in. Here are a few “training” tips:

 

  1. If someone (maybe you) complains about something that feels like drudgery, fix it.
  2. Fix it like a life depended on it, because it just may.
  3. Accept that not everyone will get it.
  4. Do this every chance you get.

 

Many of us have stories about how we’ve taken opportunities to innovate. Here’s mine. When I was a second-year resident in the ICU back in 1994, we had a patient with HIV infection and necrotizing pancreatitis, requiring an open abdomen with three times a day sterile dressing change. These operations were performed in the ICU where the patient was left with an open abdomen with the pancreas which had exploded with inflammation was packed. The setup was quite hazardous because all the fluid splashing around was infected with HIV, occasionally bloody. But, it wasn’t just a hazard, it was a drudgery. Frustrated with the process, I came on the idea of inserting chest tubes over the packing and under the sticky adhesive drape, and then placing these on suction. I achieved a seal, and the ICU nursing staff was pleased with the invention. Thinking that I could escape the day without another hazardous dressing change, I took the time to pat myself on the back. Of course, I was called stat to the ICU and was dressed down by the head of the ICU for being both lazy and cavalier with the risk to the patient. Interestingly, though, a company came out several years later with a strikingly similar idea, and now negative pressure wound therapy is the standard of care in such situations. In fact, it’s a multi-billion dollar industry.

 

Of course, money shouldn’t be the sole motivation for innovation. I was motivated by doing less work, reducing the contamination threat for the ICU nurses, and improving care. Many of the best innovations in medicine help the physician care for the patient more efficiently, with better results, and with less suffering. Similarly, the Cleveland Clinic was conceived when American physicians and surgeons, while camped in the vasty fields of northern France during World War I, came to the realization that working collaboratively in a big tent across specialties and disciplines created great efficiencies and rewards, particularly in patient outcome. This innovation, encapsulated in the words “to act as a unit,” brought to the world the first multi-specialty clinics.

Park Compressor.png

Here’s one last, more-recent example. I am frequently called emergently to an operating room to help control bleeding. Typically, these requests are from surgeons here at the Clinic working on severely scarred, radiated, or previously operated tissues. The typical routine is to dig out the vessel and clamp it, which is challenging because dissecting out the vessel can cause further injury to the vessel with more bleeding. I realized that a circular compressor would control bleeding and provide space for placing a repair suture (figure). When it works, it’s surprisingly easy. You can try it yourself; if you get bleeding from a vein on the skin, compress it with the ring handle of a clamp. This idea has gone to our Innovations office, is now patent pending, and is on track to be manufactured.

 

We became the dominant species on this planet through the trait of innovation. We could not migrate and survive on all the continents by waiting to grow fur, wings, or gills. Rather, we sallied forth, and we invented our way through deserts, mountains, ice fields, oceans, and jungles. Yet, inventiveness is not common, and it’s too often viewed poorly as a close cousin to cunning, or even sorcery. Innovation also threatens the status quo, because it brings change, and with that obsolescence. Innovation is risky, and the stakes are even higher in medical innovation. But, it’s also the only way we will solve what ails us.

 

—-

 

  1. Michael Park, MD is a vascular surgeon at the Cleveland Clinic and a 2017-2018 Doximity Fellow. He will be moving abroad to be chief of vascular surgery at Cleveland Clinic Abu Dhabi.
  2. Published Op-(m)ed on Medium link
Categories
innovation Uncategorized

Park Clamp

park-clamp_1

One of the reasons why I moved my family to Cleveland was to participate in innovation at the Clinic. One of the devices that I have been working on has reached the patent stage and I am free to divulge it. Full link below. Innovation is part of the culture here like oxygen in the air.

Clinic link