The 81-year-old female patient had a history of recurrent SFA disease and repeated procedures by her interventional cardiologist. In August 2018, he did a left SFA atherectomy and drug-eluting coated balloon angioplasty. In December 2019, he did another left SFA angioplasty, atherectomy, drug-eluting balloon angioplasty, and drug-eluting stent placement. In February 2021, he did another left SFA atherectomy and drug-eluting stent placement. And on December 9, 2021, he did a left SFA "complex intervention" with thrombectomy, thrombolytic therapy, angioplasty, and yet another drug-eluting stent placement, as well as angioplasty to the left anterior tibial artery. The procedure was considered successful.
On December 16, the patient was seen in the emergency department for complaints of LLE swelling and erythema. She was found not to have a DVT, and was started on cephalexin for suspected cellulitis. The interventional cardiologist saw her in follow-up on 12/23, and noted that the cephalexin "ha[d] not helped" and the patient still had some LLE swelling with erythema, along with +1 pitting edema BLE. He noted, "On exam, she has great pulses."
She was seen again by the interventional cardiologist on 1/27, and he noted that her LLE arterial flow appeared intact, she had +2 pitting edema in the LLE and +1 in the RLE, DP pulse was intact in both extremities.
On March 7, the patient emailed the interventional cardiologist's office that her left leg felt cold, numb, stiff, and painful. They emailed her back 3 days later to say that the doctor was out of town for 2 weeks, and advised her to go the the ER, which she did not do.
On March 22, she was seen again by the interventional cardiologist. He noted that she had ulcers on her left shin that had been present for 2 weeks but started draining yesterday. He noted that her claudication had returned and were progressing, and he suspected reocclusion of her left femoral artery. The plan was to "obtain abdominal aortogram with runoff via right femoral access at [local hospital] as soon as possible." He put in a "case request" to the cath lab for aortogram with runoffs, and angioplasty LLE.
The procedure was apparently scheduled to take place on May 2. Before then, on April 18, the patient was seen by her primary care doctor, who noted increased redness of her left leg and no pulse in her left foot. He sent her to the emergency room, where an arterial duplex showed an occluded left SFA, left popliteal artery, and tibioperoneal trunk, with "nonvisualization" of the proximal and mid anterior tibial artery. She was also noted to have a nonhealing wound to the anterior compartment. The patient was seen by a vascular surgeon, who planned for a CTA with runoff on 4/19 and an endarterectomy, resection of the proximal stent, profundaplasty, and femoral to TP trunk bypass with cryo vein on 4/22. He wanted a cardiology clearance first, and in the meantime the patient was started on heparin. The CTA on 4/19 showed that the SFA stent "abruptly occlude[d]," described as a complete occlusion, with distal reconstitution of the distal popliteal artery, as well as segmental occlusion of the anterior tibial artery, but with 3-vessel runoff at the level of the ankle with flow to the DP artery and plantar branches.
Unfortunately, on 4/20, the patient began having aphasia and right-sided weakness. A stroke alert was called and she was found to have a large left intraparenchymal hemorrhage. Protamine was given, but the bleed worsened over the next day. By 4/23 she no longer had any flow to the left tibial artery, and the vascular surgeon determined that she was not a candidate for revascularization because of her inability to be anticoagulated and a fairly poor prognosis with regard to her stroke recovery. On 5/2, they proceeded with an above-knee amputation of her left leg. She was discharged to rehab a week later alert and appropriate, but with right hemiplegia and aphasia.
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Q: Was the patient being treated with antiplatelets/anticoagulants because of the patient's continued blockages development in the legs
A: —
Do you believe there might have been medical error?
This is an 81 year old female who has been developing recurrent SFA disease managed by the interventional cardiologist from 2018 - 2022. Over the course, it appears that the interventional cardiologist appropriately continued to treat the patient with balloon angioplasty first, then stent placement and then dealt with a complicated procedure requiring another stent placement. Here are few thoughts about possible errors and could be checked. Negligence: 1. Patient was not treated with antiplatelets after each procedure performed. 2. Patient did not have an indication for angioplasty in 2018 to begin with because all of this cascaded afterwards. 3. Indication of starting the patient on heparin is not clear. Was there a diagnosis of thrombosis? If not, then this is not standard of care to start patient on IV heparin. 4. Were PTTs were checked frequently and appropriately and were appropriate measures taken and documented? Delay in care 1/27 - patient had leg edema and appropriate care was provided in terms of diagnosing it and if patient was appropriately assessed for vascular status at that time. 3/7 - patient complained of symptoms of critical limb ischemia which could lead to limb threatening condition. 3 days delay in the response is not appropriate. Was there any testing ordered such as ABIs, duplex, CT angiogram at that time? If the patient did not go to the ER, the patient was supposed to be seen and investigation needed to be performed. 3/22 - patient was seen by the interventional cardiologist. Patient's symptoms had rapidly progressed and endovascular evaluation was necessary at this time. However, it appears that patient was given a date in may 2022. This is 6 weeks later. Was it because patient was advised for conservative therapy such as exercise therapy and medications. If not, then this needed to be performed much earlier. In addition, the ABI or duplex testing or CTA is needed at this time to evaluate the vessels. Was that delayed at this time since information is not provided. 4/18 - patient was seen for acute limb ischemia and was admitted. Patient was found to have disease but this disease that was detected on CTA this time showed 3 vessel run off, which means there was flow to the foot. At this time, there is no diagnosis of thrombosis of the lower extremity which means it is reasonable to intervene on this patient after cardiac clearance.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
1. The indication for starting IV heparin therapy is not clear. 2. There is delay in obtaining imaging and evaluation of the limb
What makes you a good expert for this case?
I will make a good expert because 1. I am interventional cardiologist with experience in treating the patients with vascular disease 2. I believe that patient or doctor should be properly represented and advocated in an ethical way 3. I have some experience of expert witness in the past and I understand how to deal with the jury and the judge.
How often do you encounter cases similar to this one in your practice?
This particular occurrence is a rare occurrence however, many of these peripheral disease patients around 5-10% would develop acute limb thrombosis like this patient did. The degree of bleeding on heparin is pretty low and is in the range of 0.8% which combined with the above probability would constitute around 0.4 - 0.8% cases. In my practice we frequently treat such patients and they do well with the treatment and frequent monitoring. However, if the monitoring is delayed as it appears to happen in this patient, the patient can develop devastating complications.
Do you believe there might have been medical error?
I don’t believe there was any medical error. A different approach could have been surgical consult after recurrent endovascular failure, but this can be higher risk and there is no guarantee that the bypass graft won’t fail either. This is a different approach that doesn’t mean what was done was wrong. Unfortunately heparin May cause bleeding. But from the information provided, it seems she had extension of clot into the anterior tibial artery which is usually treated with blood thinners before taking to the cath lab - in this case OR.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I don’t see any error and I don’t see any causation.
What makes you a good expert for this case?
familiarity with peripheral artery disease and management.
How often do you encounter cases similar to this one in your practice?
unfortunately there is no cure for peripheral artery disease of the legs. This most of the time requires recurrent interventions for symptomatic patients who qualify for these procedures. Bypass surgery isn’t always the answer especially in elderlies, and there is no guarantee the bypass graft will not close. Bleeding from heparin and other blood thinners can happen, it seems they were able to identify it , reversed heparin with protamine. Adverse events happen , sometimes they can not be avoided.
Do you believe there might have been medical error?
Based on the information provided, I do not believe, that there was a deviation from standard of care. The patient appears to be an 81 year, old, female, who presented initially with chronic lower extremity ischemia. The condition appeared to be gradually progressing to the point of severe lower extremity ischemia, when the patient contacted her cardiologist on March 7, who appropriately advised her to refer herself to the emergency room during his absence. According to prior office notes, there is no evidence of lower extremity ischemia, based on the presence of pulses. It is my impression that during the appointment on March 22, the cardiologist got an impression of gradually progressive lower extremity ischemia, but there was no evidence of severe acuity, which would require emergent referral for limb salvage procedure. On April 18, after seeing her primary doctor, the patient was appropriately, referred to the emergency room, where she had appropriate workup.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I do not feel that there was a medical error to begin with. The patient had gradually progressive lower extremity ischemia, which was addressed appropriately.
What makes you a good expert for this case?
I am a board certified interventional cardiologist with many years of practice, occasionally dealing with issues related to ischemic complications of peripheral interventional and coronary procedures.
How often do you encounter cases similar to this one in your practice?
Very rarely. Chronic lower extremity ischemia is a known but uncommon complication of peripheral vascular procedures.
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