75-year-old male patient with history of PVD, CAD, MI and TIA.
- 7/6/2021: Right femoral to below-knee popliteal bypass using Goretex.
- 6/27/2022: Outpatient balloon catheter angioplasty for known LICA stenosis s/p CEA and planning future TCAR. Vascular surgeon went into through right groin and used a Mynx closure device. At home after, patient had pain and weakness in the right leg, went to ER where he had no distal pulses palpable or on Doppler. Admitted for exploratory surgery, had open thrombectomy of bypass, percutaneous balloon angioplasty of distal graft stenosis and XenoSure patch angioplasty of proximal graft. Later note said "acute occlusion of the RLE bypass 2/2 distal graft stenosis and probably closure device." Patient reports he was told the closure device had caused the problem. Started on Plavix and discharged home 6/28/2022.
- 7/_/2022: Diagnosed with right groin infected hematoma and Pseudomonas aeruginosa bacteremia.
- 7/29/2022: I&D of seroma/hematoma and wound VAC.
- 8/28/2022: Back to ED in acute renal failure, with peripheral leukocytosis and signs of right groin infection. Placed on IV antibiotics (possibly for 2nd time).
- 8/29/2022: To OR for exploration of right groin, repair of right common femoral artery, antibiotic bead placement, and wound VAC-assisted closure. Intra-op findings showed graft was exposed. Blood and intra-op cultures grew Pseudomonas again.
- 8/31/2022: TEE showed small vegetation on mitral valve; diagnosed with infective endocarditis and vascular graft infection.
- 9/2/2022: right groin exploration with repair of arterial patch, placement of gracilis muscle flap with Prevena VAC.
- 9/7/2022: discharged home on long-term IV antibiotics. Continued to have complications.
My questions: Was it below the standard of care to use the Mynx closure device on the leg with a previous bypass graft? If so, was that the most likely caused of the complications? Also, should the patient have been on Plavix earlier? Would that have made a difference? Any other thoughts or opinions also welcome, of course, and thanks.
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Do you believe there might have been medical error?
So in general, it is not unreasonable to perform percutaneous access on femoral vessels that have a bypass, but access is the key. It sounds like perhaps the access went thru the bypass and then the device would occlude the bypass graft. Patient should also have a duplex of the bypass performed in recent due to the fact the sheath can be occlusive so you do not want to occlude flow for extended periods of time, especially if there are low velocities within the bypass graft. Some key information should be within the angiogram pictures (if surgeon took of access) when performing the balloon angioplasty and the operative dictation of the surgeon when he explored the groin initially.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I think given the temporal relation to the bypass going down, it is likely the procedure was the cause of his bypass occluding. As above, it would be interesting to see what the pictures and full operative dictation reveals.
What makes you a good expert for this case?
I am a board certified vascular surgeon trained at Stanford now practicing in academic medicine in VA. We perform a high number of percutaneous interventions along with bypass surgeries for PAD, carotid stenosis.
How often do you encounter cases similar to this one in your practice?
Percutaneous interventions on patients with existing bypasses are not very rare. We perform I would estimate at least one a month if I had to guess. There are certain nuances and considerations for this case.
Do you believe there might have been medical error?
Several issues with this case: a. The Mynx device like most arterial access closure devices is not indicated for use in the setting of a previous femoral to popliteal bypass (that is a prosthetic bypass, https://cordis.com/apac/products/close/endovascular/mynx-control-vascular-closure-device). That said many surgeons and interventionalist will sue off label for access thus not necessarily a breach in “standard of care” b. The patient underwent an angioplasty of the internal carotid artery after a previous carotid endarterectomy – there is no indication for this type of treatment – this seems like a breach of care to me. c. The patient clearly had an access complication that required intervention as described in the case, again the issue is why did he have the non-indicated angioplasty of his internal carotid artery in the first place. d. The patient subsequently had a groin infection (known complications) that led to his heart value being infected. e. Plavix should be used in these patients, but aspirin is often considered standard of care.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Yes, please see points above. In particular there is no known indication to undertake an angioplasty in the providers outpatient center prior to the definitive re-operative approach to this patient, that is a trans carotid artery revascularization (TCAR).
What makes you a good expert for this case?
I undertake and/or oversee several of these types of operative cases on the internal carotid artery as well as lower extremity bypass procedures. My experience included managing groin infections and/or systemic complications of it.
How often do you encounter cases similar to this one in your practice?
As stated above, I have had experience with this type of complication. I do not use the Mynx closure device, that said I have operated on several patients in the past with complications from this device.
Do you believe there might have been medical error?
Answers to posed questions: -Mynx relies on a "plug" of PEG to seal. Whether this was the "best" closure choice is really a matter of debate, as there are no clear "absolutes" in that choice. The real questions to ask are "Why not access above the bypass graft in the common femoral--or via the opposite groin to avoid this risk altogether?" "Was ultrasound used to gain access?" (US is considered SOC). FInally, there are some instances of intravascular presence of the sealant after use, that "may" have contributed to the thrombosis: American Journal of Neuroradiology October 2010, 31 (9) 1737-1740 -The causation for the infection may simply be either break in sterile technique--or poor hygiene after the procedure. Infection is a KNOWN RISK--published at 1-3% in the usual literature. -Clopidogrel (Plavix) is an antiplatelet medication, not a true "blood thinner/anticoagulant". Earlier use of this is also debatable as far as risk for the thrombosis. Other thoughts: The graft, once infected with Pseudomonas, likely needed removal, as this is an aggressive organism that is difficult to clear with topical antibiotic. See Wilson SE. New alternatives in management of the infected vascular prosthesis. Surg Infect (Larchmt) 2001;2(2):171–5
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Once infected, despite multiple attempts at debridement, thrombectomy and antibiotic beads with muscle flap coverage, the graft was destined for removal. Alternate conduit with autologous vein from the opposite leg, arm vein, or cadaveric vein, tunneled via alternative "clean" tissue planes from a "clean" source is all that can be done to attempt limb salvage. These are DIFFICULT problems to treat and solve, and much disparate literature has been published attempting to "fix" the problem, with variable resulting success. Bottom line: there is no clear consensus as to how to approach these and anything done here could be supported by some form of literature.
What makes you a good expert for this case?
I am a practicing vascular surgeon of 20 years and the senior surgeon of a group of 6 (not including our 10 CT partners), who performs dozens of these endovascular and bypass procedures annually.
How often do you encounter cases similar to this one in your practice?
Graft infections are thankfully rare for my practice--within the 1-6% mentioned in the literature for prosthetic bypass placement. I access prosthetic grafts for various reasons multiple times a year--with rare complication. I do NOT use the Mynx device, as there are other mechanical closure choices available that work effectively for our entire group.
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