PC is a 64 year old gentleman with a significant cardiac history including cad, bypass, hypertension, hyperlipidemia, carotid stenosis. Currently taking ASA, Plavix, Goes to large hospital for elective peripheral angiogram with possible intervention. He's been having significant claudication symptoms and obvious signs of peripheral vascular disease. Procedure was initially without complication, successful rights common and external iliac artery stenting with overlapping covered stents.
Post-operatively PC had lower abdominal pain and suprapubic fullness. Began to get acutely hypotensive and had a drop in hemoglobin from 16 to 11. CT angiogram of the abdomen of pelvis revealed R groin arterial bleed from the catheter site into the common femoral artery with large hematoma in the extraperitoneal space.
CT ABD Results:
1. LARGE VOLUME ARTERIAL CONTRAST EXTRAVASATION ARISING FROM THE
PROXIMAL RIGHT COMMON FEMORAL ARTERY, LIKELY THE ARTERIOTOMY SITE
FROM RECENT PROCEDURE, WITH A LARGE VOLUME EXTRAPERITONEAL
HEMATOMA NOTED IN BOTH PELVIS AS WELL AS DECOMPRESSING ALONG THE RIGHT HEMIABDOMEN AND INTO THE POSTERIOR RIGHT PARARENAL SPACE.
OF NOTE, THE COMPRESSIVE DEVICE IN THE UPPER RIGHT THIGH IS INFERIOR TO
THE ARTERIAL EXTRAVASATION/ARTERIOTOMY SITE. EMERGENT INTERVENTION IS
RECOMMENDED.
Notation from cardiology states that he was brought back to the cath lab for balloon tamponade and vascular surgery was consulted within approx 2 hours from the time the swelling was discovered. PC was intubated and vascular surgery was able to repair the arterial injury. PC required three units of packed RBCs. PC was brought to ICU for recovery, however continue to be hypotensive. Later that evening, PC found a have acute left-sided hemiparesis and a stroke alert was called. CT the head showed encephalomalacia in the right temporal lobe and medial right occipital lobe.
Procedure Note for Peripheral Angio in cath lab:
DESCRIPTION OF PROCEDURE: Arterial access was obtained in the right femoral artery using a 4-French short sheath. Abdominal angiogram was performed using a 4-French Omniflush catheter. The same catheter was pulled down to iliac bifurcation. Bilateral iliac angiogram was performed. Bilateral lower extremity angiogram was performed with the catheter in this location because the left common iliac artery and external iliac arteries were occluded
ANGIOGRAPHY FINDINGS: Abdominal angiogram demonstrated horrendously calcified abdominal aorta. Left renal artery appeared to have a significant stenosis. The right renal artery appeared to have moderate stenosis. There was a Small abdominal aortic aneurysm.
Bilateral iliac angiography: Bilateral iliac angiography demonstrated a chronic total occlusion of the left common iliac artery with horrendous calcification. The left external iliac artery was occluded. The left common femoral artery reconstituted The left superficial femoral artery was heavily calcified with severe 80% to 90% stenosis. The left popliteal artery appeared to have a significant stenosis and there was left anterior tibial artery and peroneal artery with 2-vessel runoff to the left foot Selective right lower extremity angiography: Selective right lower extremity angiography demonstrated horrendously calcified, severe 90% stenosis of the right common iliac artery and right external iliac artery. The right internal iliac artery was occluded. The right common femoral artery was patent with 50% calcified stenosis. The right superficial femoral artery had heavily calcified 80% to 90% stenosis in multiple areas throughout its course. The right popliteal artery appeared to have a 70% to 80% stenosis. The right anterior tibial artery and posterior tibial artery appeared to be diffusely diseased. Right anterior tibial artery was occluded. Right peroneal artery and was a single vessel runoff to the right foot
DESCRIPTION OF INTERVENTIONAL PROCEDURE: The patient complained of severe right lower extremity claudication. We decided to proceed with right iliac artery stenting. This would allow us to either consider fem-fem bypass surgery on a separate occasion for the left side or if the symptoms on the left side were not severe to manage it medically or consider percutaneous revascularization including stenting of the left common and external artery chronic total occlusion. Since the symptoms were predominant on the right side and right lower extremity we decided to proceed with right iliac artery stenting. The right common and external iliac artery stenosis was crossed with a Supra Core wire The 4-French sheath was exchanged for a 7-French Brite Tip sheath. The right common and external iliac artery lesions were crossed with a Supra Core wire and the wire was exchanged for a V-18 wire. The right common iliac artery and external iliac artery lesions were treated with balloon angioplasty using a 6.0 x 100 mm balloon. The right common iliac artery and external iliac artery then subsequently were treated with a 7.0 x 80 mm balloon. Following that, the right common iliac artery was stented with an 8.0 x 58 mm balloon expandable covered stent. Covered stent was used because of the horrendous calcification and the risk of perforation. The right external iliac artery was then treated with an overlapping 8.0 x 58 mm stent. The distal external iliac artery was then treated with an 8.0 x 29 mm Omnilink balloon expandable stent The stented segments in the common iliac artery and external iliac artery were postdilated with a 9.0 x 40 mm balloon Final angiogram demonstrated no residual stenosis, no dissection, prompt TIMI 3 flow in the iliac artery. There was a calcified stenosis of the right common iliac artery, about 50%, hence, no closure device was used. The plan was to pull this and hold manual pressure. The patient left the lab in a stable condition with no complication
CONCLUSIONS
1. Horrendously calcified peripheral arterial disease
2. Small abdominal aortic aneurysm
3.Severe left renal artery stenosis.
4. Occluded left common and external iliac artery with horrendous calcification with reconstitution of the left common femoral artery.
5. Severe heavily calcified stenosis of the right common iliac artery and external iliac artery.
6. Bilateral superficial femoral artery with heavily calcified stenosis
7. Patent left anterior tibial artery and peroneal artery with 2 vessel loops of the left foot
8. Occluded right anterior tibial artery and diseased left posterior tibial artery with single vessel peroneal artery runoff to the right foot.
9. Successful balloon angioplasty and stenting of the right common iliac artery and right external iliac artery with overlapping balloon expandable covered stents
RECOMMENDATIONS: Continue current medical therapy. Continue aspirin, continue Plavix. The patient was noted to have an internal blood pressure of 180 while the cuff pressure was 120 to 130 suggesting there is a 50 point difference between internal blood pressure and right sided cuff pressure in him suggesting the presence of subclavian or brachiocephalic artery stenosis, This has to be kept in mind while monitoring his blood pressure in the future. From a vascular perspective, now that the iliac artery is stented we will evaluate his symptoms and if there Is significant improvement in his claudication then no further revascularization will be undertaken. If he continues to have symptoms, then we can consider right SFA revascularization as well as left common and external iliac artery revascularization either percutaneously or surgically, We will discuss these options with the patient if he continues to have claudication. He will be discharged home with outpatient followup in 2 to 3 weeks
Vascular repair note:
Patient from Interventional Cardiology after intervention earlier today and the patient had hypotension, which was recognized. The patient was found to have retroperitoneal and anterior wall hematoma with extravasation from the right common femoral artery. I was called to the cath lab where the patient has been intubated and decision was made on my part for immediate exploration of the right groin. Upon my arrival in the cath lab, the patient was intubated and sedated. The patient unfortunately Is a severe vasculopath with multiple areas of occlusion. I utilized ultrasound guidance to access the right brachial artery and placed a 4-French micropuncture sheath for an arterial line. Waveform was not good in the arm, likely due to proximal disease. At that point in time, Anesthesia was present and placing a central line. Decision was made to prep the right groin for access to repair the bleeding. At this point in time, the right groin was prepped and draped with Betadine prep and paint. Linear incision was made in the right groin after emergency timeout and | dissected down to the level of the common femoral artery where there was some active bleeding from the anterior wall of the common femoral artery, which was a heavily diseased vessel. | utilized 6-0 Prolene suture and repaired the arteriotomy. There was no further active bleeding seen in the groin. At this point in time, | retrograde stuck the common femoral artery directly with micropuncture needle and exchanged out for a 5-French sheath, which was hooked up then to arterial monitoring and we were able to accurately get a blood pressure for the patient. Anesthesia continued resuscitation at that time with blood products and fluid and | then, with ultrasound guidance, prepped and placed left brachial arterial line 4-French micropuncture sheath, which was then hooked up to Aline tubing and gave us the same blood pressure as in the right groin. At this point in time, | then scrubbed back in and removed the arterial line from the right groin as we now had accurate measurement of the patient's blood pressure. We repaired the arteriotomy with a 6-0 Prolene suture, similarly to what we had done with the actively bleeding pseudoaneurysm. At that point in time, | then placed my hand into the large abdominal wall hematoma and evacuated a large amount of clot. | chose not to continue removing any more clot for concerns for stirring up more venous bleeding, which may have tamponaded with the hematoma We then irrigated in the right groin and utilized Vicry! suture to place a few interrupted deep sutures overlying the common femoral artery A wound VAC sponge was then placed in the groin. It was 10 cm long x 8 cm wide x 8 cm in depth This was hooked up to 125 mmHg suction The patient left the operating room intubated for the ICU, receiving blood products and bicarbonate for acidosis and pressors had been weaned down appropriately as resuscitation was ongoing. | was present for my portion of the case As this was as an emergency case, there was no sponge, needle and instrument count at the end of the case and x-ray had been obtained which showed no foreign bodies in the field
PC was eventually able to be weaned off of the tube however, due to dysphagia required feeding tube. In addition, also developed acute kidney injury and cdiff. Hospital was recommending palliative care, However the family refused. PC discharged to advanced Care long-term facility.
The peripheral angiogram and stenting were performed by an interventional cardiologist. There is concern that he fell below the standard of care in the performing of the procedure, which then caused multiple subsequent complications (ie prolonged hypotension leading to encephalomalacia?). Possible it was the manual pull by the post-cath team? ACT was 167. We do not currently have access to those notes/documentation. The PC still has left-sided hemiparesis and is no longer ambulatory, as he was prior to this hospitalization.
If you have any questions, please post. We appreciate your time and opinions in advance.
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Do you believe there might have been medical error?
Based on what's provided the indication of the actual procedure of stenting, the iliac for claudication seemed appropriate again without having seen the pictures and preoperative studies and the degree of the symptoms. Generally stenting of the inflow vessels is a very reasonable strategy for severe qualification. It seems that the complications truly occurred from the access site of the common femoral artery which was identified as disease. Some questions I would be regarding the procedure where exactly was the exercise site, was fluoroscopy or ultrasound used to access it appropriately? Also post procedure did they wait long enough to pull the sheath based on what the ACT was? Did the ACT actually get checked? If the answers to those are yes, that reconfirms best practice. You have a question I have was the patient appropriately observed after the sheath pull and was the pressure held by qualified individual for a long enough period of time.. also, at what point was the bleeding recognized. It certainly plausible that the bleeding was not recognized until the patient started getting hypotensive and having symptoms if that was the case this was just bad luck. But based on my question above, depending on those answers there could've been potential areas for error.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Don't have enough information about some of the details regarding both the procedural access and the post access management situation. But there's certainly a possibility. There was an error in judgment or less than best practice that occurred however, they're just as well could've been best practice in this scenario that led to an unfortunate complication.
What makes you a good expert for this case?
I have 11 years of interventional cardiology experience. I performed vascular procedures for nine years and I perform a lot of large bore femoral axis structural procedures where we deal with femorwl arterial access complications
How often do you encounter cases similar to this one in your practice?
For a complication of this degree of severity bleeding maybe once every 5 years
Do you believe there might have been medical error?
This has been a complication from the puncture site, an unlucky one. But it is possible for this complication to occur. The complication has been handled according to standard of care. The hypotension may hav caused the stroke. Again, this is an uncommon, but reported complication. It has been handled according to standard of care.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
This is a well known complication, in calcified vessels, and smokers to have retroperitoneal bleed from the arteritomy site. Bleeding causes hypotension. This predisposes to stroke. The only question is how the initial access was made, US guidance? Micropuncture?
What makes you a good expert for this case?
I have done hundreds of cases like this and encountered the same complication. This is unfortunate. But I am expertly trained in these cases.
How often do you encounter cases similar to this one in your practice?
Yes, I have. Early detection is key. First sign of abdominal pain and hypotension should prompt a CT. Type and cross and fluids. Emergent vacular surgery consult.
Do you believe there might have been medical error?
Documentation confirms the placement of a 7 F sheath in the severely diseased common femoral artery. Initial diagnostic imaging was performed using 4 F sheath which is a much smaller sheath and was appropriate to be used to perform the diagnostic procedure. Once, it was diagnosed that the PC has significant disease in the femoral artery, extreme care should have been exercised after placement of 7 F sheath. Just the manual compression would not be likely adequate for hemostasis in such a diseased vessel. Given the heavily calcified nature of the vessel, meticulous monitoring of the manual compression is imperative, potentially necessitating post-compression ultrasound to ensure hemostasis. The patient exhibited significant high-risk features as detailed in the note. Ideally, patients with such characteristics should undergo open access for iliac vessel treatment with stents, with consultation from vascular surgery prior to proceeding. In addition, before proceeding with such high risk procedure which is elective, it is imperative to have a discussion with the vascular surgery about the approach and treatment which was not performed per the documentation provided.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Yes, causation is evident in this case. During the diagnostic angiogram, the operator observed significant disease. However, they focused solely on addressing the inflow disease while neglecting the distal disease, which may not effectively benefit the patient given the existing disease along the vessels. Collaboration with vascular surgery should have been sought prior to proceeding with such a high-risk procedure. Moreover, obtaining informed consent, including a thorough discussion of risks versus benefits, is essential, particularly for elective procedures like this one performed for claudication. Any elective procedure carrying heightened risk warrants additional informed consent procedures. The presence of a stroke in the patient is not conclusively indicated. Encephalomalacia, indicative of chronic brain damage, may be present but does not necessarily signify acute harm to the patient.
What makes you a good expert for this case?
I am an interventional cardiologist with vascular training. I have performed these procedures and have been working as an interventional cardiologist for 6+ years.
How often do you encounter cases similar to this one in your practice?
I often encounter such cases in my practice.
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