Failure to diagnose and treat deep vein thrombosis and pulmonary embolism

Presentation

On September 6, 2019, a 63-year-old woman was admitted to Hospital A for a cardiac catheterization with angiography and coronary stent placement.

The patient’s history included atherosclerotic cardiovascular disease, hypertension, heart failure with preserved ejection fraction, mitral valve insufficiency, obesity, COPD, and smoking one pack of cigarettes a day for 25 years.

Physician action

Cardiologist A planned to insert a catheter through the right groin using a micropuncture kit. As the procedure started, Cardiologist A inserted a 6 French gauge (FR) standard sheath into the right femoral artery but then changed it to a 7 FR destination sheath into the right femoral artery and over the guidewire.

Cardiologist A noted that twice during the procedure the stent was removed over the wire due to it being unable to cross the lesion. He later advanced the stent across the target lesion, after the balloon catheter was advanced across the target lesion.

A postoperative CT of the abdomen/pelvis revealed extensive dense intraperitoneal fluid throughout the deep pelvic peritoneum compatible with blood. Soft tissues revealed inflammatory changes within the right groin above the arterial access site, “likely related to recent catheterization and small hematoma.”

After reviewing the CT report, Cardiologist A transferred the patient to the ICU for hemoglobin and hematocrit (H&H) monitoring. The patient improved, and she was cleared for discharge by Cardiologist A on September 10.

On September 15, the patient came to a standalone ED reporting pelvic pain radiating to both legs, urinary incontinence, and shortness of breath. A CT scan showed an enlarged hematoma in the pelvis that was pressing on her bladder causing urinary incontinence. Cardiologist A was contacted and arranged for the patient to be returned by ambulance and admitted to Hospital A for telemetry and surgical consult.

In the early morning hours of September 16 at Hospital A, Internal Medicine (IM) Physician A examined the patient and noted her abdomen was soft and mildly distended with lower abdominal tenderness upon palpation. His assessment included pelvic hematoma, hypertension, and coronary artery disease. The patient was transferred to the ICU for H&H monitoring, and a urinary catheter was placed. A consult with Cardiologist A and a cardiovascular surgeon was ordered along with a request for guidance on antiplatelet therapy.

Cardiologist A saw the patient in the ICU. He documented that the previous catheterization was complicated by bleeding into the peritoneum due to failure of a vascular closure device and a probable high stick in the setting of a very scarred groin. The patient received two units of blood and remained stable for 48 hours with a stable H&H.

Another CT was scheduled to ensure there was no active bleeding. Dual antiplatelet therapy (clopidogrel and aspirin) was started on September 17.

On September 18, a repeat CT of the abdomen and pelvis with contrast revealed a pseudoaneurysm associated with the right common femoral artery, and a large pelvic hematoma. On September 19, a venous Doppler ultrasound of the right lower leg revealed that the right pseudoaneurysm measured 2.8 cm x 2 cm x 3.9 cm; the right pelvic hematoma measured 6.9cm x 7.2 cm x 7 cm.

Cardiothoracic Surgeon A performed a right common femoral artery exploration with arteriorrhaphy. His operative report notes that after further dissecting the superficial femoral artery he “exposed the bifurcation.”

He further noted that “dissection was taken up to and under the inguinal ligament” and he oversewed what he determined to be the catheter site with a synthetic polypropylene suture. He “found no significant hematoma below the inguinal ligament, but it appeared to track proximally along the vessels.” The wound was irrigated with antibiotic solution before closing.

Cardiologist A examined the patient later the same morning and documented that the patient’s groin was better. There was no mention of the right pelvic hematoma in the operative notes. He deferred to Cardiothoracic Surgeon A for management of the pelvic hematoma. Aspirin and clopidogrel were held pending clearance from the surgical team.

On September 20, the patient was improving, and discharge was recommended in 24-48 hours. At 9 p.m. a nurse practitioner ordered metoprolol 5 mg for the patient due to elevated heart rate, but the drug was ineffective. Attempts to lower the patient’s heart rate with medication continued throughout the night into the morning. The patient’s heart rate remained elevated, and her vital signs were unstable.

Cardiologist B saw the patient and noted her pulse was sinus tachycardic, 110 bpm, and blood pressure was 120/90 mmHg. She placed the patient on a diltiazem drip and ordered a saline bolus.

Her impression was that the patient had onset of sinus tachycardia from the day before and was at risk for possible deep vein thrombosis (DVT) secondary to pelvic hematoma. She further ordered sodium chloride and an ultrasound duplex of the legs to rule out a thrombus.

On September 21, Radiologist A interpreted the ultrasound as normal. Cardiologist B documented that the patient developed an episode of tachycardia the night before. The patient was on dual antiplatelet therapy and was also given beta blockers for tachycardia and IV fluids. Cardiologist B ordered verapamil and metoprolol that evening and again the following morning.

On September 22, the patient said she felt better and wanted to go home. Her vital signs stabilized through the day, and she was discharged. Later that afternoon, the patient experienced shortness of breath at home. 911 was called and EMS transported the patient back to Hospital A.

Upon arrival at the hospital, the patient was in cardiopulmonary arrest, unresponsive, and no pulse was found. Resuscitation efforts were not successful, and the patient died.

An autopsy revealed a blood clot in the right lung; an enlarged heart; and severe atherosclerosis of the left anterior descending artery, left circumflex artery, and right coronary artery. The cause of death listed as pulmonary artery thromboembolism with secondary contributing factors of atherosclerotic and hypertensive cardiovascular disease.

Allegations

A lawsuit was filed against Cardiologists A and B, IM Physician A, and Radiologist A. Allegations included failure to timely diagnose and treat DVT and pulmonary embolism (PE) and unsafely discharging the patient home.

Legal implications

Consultants for the defense expressed mixed opinions of the care provided in this case.

• A cardiovascular surgeon felt the care provided was reasonable and the standard of care was met. He further offered that there was no evidence that missed diagnoses of DVT and PE or a failure of treatment occurred. Instead, an ultrasound on September 21 ruled out DVT. This ultrasound was also an appropriate follow-up to the previous study from two days earlier. This consultant also argued that there was no compelling evidence to suggest a PE.
  
  Given the lack of findings, this consultant stated his belief that the providers could not be faulted for not pursuing a chest CT with contrast. If one had been performed, it is likely the PE would not have been present at the time. He felt it was most likely that a DVT developed asymptomatically after the normal ultrasound study on September 21 and then traveled to the lungs as a PE when the patient got home on September 22.
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• A pathologist consultant for the defense asserted that the DVT probably formed approximately six hours before the patient’s discharge on September 22. He believed the clot in the lungs originated in deep veins or pelvic veins.
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• A cardiologist defense consultant stated that Cardiologist A and B’s actions were appropriate, and there was nothing about the patient’s condition at discharge that would have suggested the patient be kept in the hospital.
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Consultants for the plaintiff stated that after the September 19 ultrasound revealed findings common with femoral venous thrombosis, they believed the patient’s shortness of breath, tachycardia, and pulmonary imaging findings were all consistent with DVT and PE. These findings would have called for systemic anticoagulation. They noted that IM Physician A did not recognize the findings of all venous ultrasound studies as representative of DVT in a patient with vascular injury and thrombophilia.

These consultants also argued that the patient should have been kept in the hospital another 5-7 days and placed on anticoagulation medication. They believed if the patient had been anticoagulated, she may have survived the thromboembolic event. 

Disposition

The case was settled on behalf of Cardiologists A and B, IM Physician A, and Radiologist A.

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