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.

The Unclampable: Strategies for Managing a Heavily Calcified Infrarenal Aorta

Leriche Syndrome -one of those disease names that adds to our work in a way that an ICD codes and even the “aortoiliac occlusive disease” fails to describe. When I hear someone described as having Leriche Syndrome, I think about a sad, chain smoking man, unmanned, complaining of legs that cramp up at fifty feet, pulseless.

The CT scan will occasionally show an aorta ringed by calcium in the usual places that are targetrs for clamping below and above the level of the renal arteries. Even without the circumferential calcium, a bulky posterior plaque presages the inability to safely clamp the aorta. Woe to the surgeon who blithely clamps a calcified lesion and finds that the rocky fragments have broken the aorta underneath the clamp! The first way to deal with this is to look for ways not to clamp the aorta, by planning an endovascular procedure, but circumstances may necessitate the need to control the aorta despite the unclampability.

The traditional methods of avoiding clamping the calcifed peri-renal aorta are extra-anatomic bypasses including femorofemoral bypass and axillo-femoral bypass. I propose these following options for the consideration when the patient needs a more durable solution while avoiding a heavily diseased aorta.

Not Clamping I:

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An EndoABF (actually EndoRE-ABF)

EndoABF does work to avoid clamping -these are common femoral endarterectomies supplemented by stenting of the aortoiliac segment, including in those with appropriate anatomy, a bifurcated aortic stent graft. This is often not possible to treat both sides, but one side is usually more accessible. Often, people will compromise and perform an AUI-FEM-FEM, but I have found the fem-fem bypass to be the weak link, as you are drawing flow for the lower half of the body through a diseased external iliac artery. The orientation of the proximal anastomosis is unfavorable and in the instance of highly laminar or organized flow, the bypass is vulnerable to competitive flow on the target leg, leading to thrombosis.

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AUI prior to fem-fem bypass for acute aortoiliac occlusion causing critical limb ischemia

The femorofemoral bypass is the option of patients whose options have largely run out. It is made worse when fed by an axillofemoral bypass. Sometimes, you have no choice, but in the more elective circumstance, you do.

 

Not Clamping II:

The second method is performing a aorto-uni-iliac stent graft into a conduit sewn end to end to the common iliac aftery, oversewing the distal iliac bifurcation.

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The conduit is 12mm in diameter, the key is to deliver the stent graft across the anastomosis, sealing it. The conduit is then sewn to the side of a fem-fem bypass in the pelvis, maintaining antegrade flow to both legs. The other option is to sew the conduit to a 14×7 bifurcated graft. Illustrated above is this 12mm conduit sewn end to end to the diseased common iliac artery with wire access into the aorta and a aorto-uni-iliac device. Typically, a small AUI converter (Cook, Medtronic) can be used, but the aorta is often too small even for a 24mm device, and an iliac limb with a generous sized docking segment (Gore) ending in a 12mm diameter fits nicely. Below is a CTA from such a case, where the stent graft is deployed across the anastomosis, sealing it off from anastomotic leaks (exoleaks).

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Not Clamping III:

Often, the infrarenal aorta is soft anteriorly and affected only by posterior plaque at the level of the renal arteries. While a clamp is still not entirely safe (I prefer clamping transversely in the same orientation as the plaque with a DeBakey sidewinder clamp), a balloon is possible. I do this by nicking the aorta -simple application of a finger is sufficient to stop the bleeding if you have ever poked the ascending aorta to place cardioplegia line.

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A Foley catheter is inserted and inflated. The Foley’s are more durable and resist puncture better than a large Fogarty. This is usually sufficient for control, although supraceliac control prior to doing this step is advised. The aorta can be endarterectomized and sewn to the graft quite easily with this non-clamp. conduit2.png

This has worked well, Although pictured above with an end-to end anastomosis planned, it works just as well end-to-side. I actually prefer end to side whenever possible because it preserves the occluded native vessels for future intervention in line.

The Non-Thoraco-Bi-Femoral Bypass

The typical board answer for the non-clampable aorta is taking the inflow from the thoracic aorta or from the axillary artery -neither of which are good options. The first because the patient is positioned in right lateral decubitus and tunneling is not trivial. The second because of long term durability. The supraceliac aorta, technically it is the thoracic aorta, is often spared from severe plaque and clampable. Retropancreatic tunelling is straightforward, and a 12 or 14mm straight graft can be tunelled in this fashion from the lesser sac to the infrarenal retroperitoneum. It then sewn to the supraceliac aorta and then anastomosed to a 12x6mm or 14x7mm bifurcated aorto-bifemoral bypass, of which limbs are tunneled to the groins.

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This worked very well recently, allowing a middle aged patient with severe medical problems, occluded aorta and iliac arteries, with critical limb ischemia, survive with minimal blood loss and home under 5 days. It delivers excellent flow to both legs in an antegrade fashion. Dr. Lew Schwartz gave me a list of references showing that this is not novel, but represents a rediscovery as the papers were published in the 80’s [reference], and buttresses the principle that innovations in open vascular surgery are exceedingly rare, largely because we have been preceeded by smart people. 

Conclusion: All of these come about through application of some common sense and surgical principles. The most important this is that the aorta is the best inflow source and reconstructing it with the normal forward flow of down each leg and not reversing directions as in a fem-fem bypass gives each of these options a hemodynamic advantage.

 

References for Supraceliac Aorta to Lower Extremity Bypass

  1. Surgery [Surgery] 1987 Mar; Vol. 101 (3), pp. 323-8.
  2. Annals of Vascular Surgery 1986 1(1):30-35
  3. Texas Heart Institute Journal [Tex Heart Inst J] 1984 Jun; Vol. 11 (2), pp. 188-91.
  4. Annals of Thoracic Surgery 1977 23(5):442-448

Salvage: A different approach to graft infections in the groin

The principles of salvage are in rescuing valuable undamaged goods in the setting of catastrophe. This guided me when a patient was flown in from an outside institution to our ICU with a saline soaked OR towel in his right groin -he had had an aorto-bifemoral bypass for aorto-iliac occlusive disease a year prior, but had never properly healed his right groin wound which continued to drain despite VAC therapy and wound care. On revealing his groin, this is what I saw:

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A CT scan was sent with the patient but has been lost to time, and it showed a patent aorto-bifemoral bypass send flow around an occluded distal aorta and iliac arteries. The graft did not have a telltale haze around it nor a dark halo of fluid which signaled to me that it was likely well incorporated and only sick in the exposed part. The patient was not septic, but had grown MRSA from the wound which was granulating from the extensive wound care that had been delivered.

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I felt that it would be possible to move his anastomosis point more proximally on the external iliac in a sterile field (figure above), and then close, then endarterectomize the occluded external iliac artery after removing the distal graft, then after vein patching, cover the repair with a sartorius muscle flap. It would salvage the remaining graft and avoid a much larger, more intense operation which was plan B. To prepare for that, I had his deep femoral veins mapped.

The patient was prepped and draped, the groin was excluded by placing a lap pad soaked in peroxide/betadine/saline solution (recipe for “brown bubbly” liter saline, a bottle of peroxide, a bottle of betadine), and covering with an adesive drape. The rest of the abdomen was then draped with a second large adhesive drape. A retroperitoneal (transplant-type) right lower quadrant incision was made (below) and the external iliac artery and graft were exposed. As predicted on CT, the graft was well incorporated.

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The external iliac artery was opened and focally endarterectomized of occlusive plaque (image below). The adventitia had good quality despite the longstanding occlusion.

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The graft was mobilized and transected and anastomosed end to side to this segment of artery (below). Dissecting was made difficult by how well incorporated it was.

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The wound was irrigated (with brown bubbly) and closed, dressed, and sealed over with the adhesive drape. The groin wound was then revealed and the graft pulled out (below).

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Remote endarterectomy using a Vollmer ring was used -in this case I didn’t use fluoroscopy given the short distance to the terminus of the plaque which i had mobilized in the pelvis.

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The plaque came out easily and was not infected appearing. It is shown below ex vivo.

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A segment of saphenous vein was harvested from the patient medially and the arteriotomy was patched. The sartorius muscle was mobilized and applied as a flap over this. The wound was irrigated with brown bubbly and packed open with the intention of VAC application.

The patient healed very rapidly and remains infection free. I had used this approach on several occasions in the past and twice more recently. It truly is salvage as it preserves the uninfected graft while never exposing it to the infection in the process of operating. It avoids having to remove the whole graft which then damages the left side -I have seen other surgeons take this approach elsewhere taking a all-or-nothing approach to graft infection to considerable morbidity to the patient. It avoids having to harvest deep femoral vein -another large operation to which the body responds truculently. The patient recently came by for his 4 year followup, still smoking, but legs preserved.

Followup At 4 Years

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The patient came back in followup -it has been 4 years since his infection was repaired. He was complaining of short distance claudication. His wound healed well and remains closed. CTA shows along with his short segment SFA occlusion which we will treat, a widely patent R. EIA (below).

CTA 4 year followup

The remote endarterectomy of the external iliac artery remains patent. Compare this to the preop CTA which I found and wasn’t available when I posted this case originally:

 

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The chronically occluded EIA can be readily seen. The artery shown in the current CTA is that recanalized artery.