Failure to diagnose and treat thrombosis

Presentation
A 66-year-old man came to his internist with complaints of shortness of breath and chest pain that had been present for three to four weeks. His history included a metallic prosthetic aortic valve replacement for aortic stenosis two years prior with subsequent warfarin therapy.
 

Physician action
The internist ordered a transthoracic echocardiogram (TTE), which showed abnormal valve function and evidence of thrombus formation on the artificial valve. Prosthetic aortic valve thrombosis is a very serious condition with risks of stroke, heart failure, and sudden death. Metallic valves require continuous, lifelong full dose anticoagulation (INR 2.5 to 3.5 range). Lab values suggested that the patient was not taking warfarin at all (INR 1.0). The internist placed the patient on subcutaneous enoxaparin sodium injection therapy due to the low INR. The patient was referred to his cardiologist for follow up at the hospital where the valve replacement surgery was performed.

Four days later, on a Friday, the patient came to the hospital for follow up with his cardiologist. A transesophageal echocardiogram (TEE) was performed and confirmed the presence of a thrombus on the aortic valve and valve dysfunction. However, the patient was found to be stable, with no heart failure. The cardiologist arranged to perform chemical thrombolysis therapy of the thrombotic valve debris on the following Monday.

In the meantime, the cardiologist recommended the continuation of subcutaneous enoxaparin sodium injection therapy. The patient protested the delay in treatment, expressed concern about his shortness of breath, and asked to be admitted to the hospital. The cardiologist reasoned that the necessary personnel for the procedure were not available before Monday. The patient was not admitted to the hospital.

The patient returned to the ED later that evening with worsening symptoms. The patient was diagnosed with congestive heart failure by the cardiologist on call. An endotracheal intubation was performed and the patient was placed on a respirator. Thrombolysis therapy was performed emergently on the patient. The thrombolysis treatment, along with anticoagulation therapy with heparin, successfully eliminated the thrombus. The prosthetic valve function was also normalized. However, the patient experienced complications from treatment including groin hematoma, blood transfusion, acute renal failure, pulmonary edema, and pneumonia. The patient eventually recovered from all complications.

 

Allegations
A lawsuit was filed against the cardiologist. The allegations included:

  • failure to listen to the patient’s descriptions of the symptoms;
  • failure to take immediate action to treat the thrombosis;
  • failure to perform an adequate physical examination;
  • failure to diagnose congestive heart failure; and
  • failure to reasonably and prudently diagnose and treat the patient.

It was further alleged that the cardiologist put his own personal schedule before the treatment of the patient.
 

Legal implications
The main criticism in this case is that the cardiologist did not admit the patient to the hospital after the TEE confirmed thrombotic valve disease with valve dysfunction. Two defense experts both agreed that the cardiologist could have admitted the patient after the Friday appointment and started thrombolytic therapy with the on-call surgeon or admitted the patient and waited for the treating surgeon.

One of the experts stated that the cardiologist’s failure to immediately treat the patient, or to utilize on-call personnel to begin treatment, was in violation of the standard of care. The expert felt that thrombosis on an aortic valve is a serious, life-threatening condition, and that the standard of care requires that a cardiologist take immediate action to dissolve a clot. He further stated that, by postponing treatment, he believed the cardiologist placed the patient in a life-threatening situation.

The second expert opined that the cardiologist underestimated the condition of the patient when he came for treatment. While the cardiologist’s notes documented the patient’s shortness of breath and chest pain with exertion, the notes also report clear lungs and no findings of severe heart failure. It is possible the condition of the patient worsened acutely from the cardiologist’s consult to the ED visit later that night.

The second expert also questioned the actions of the internist, whom the patient saw four days before the cardiologist. The expert wondered why the internist did not admit the patient to inpatient care upon finding abnormal valve function and evidence of thrombus formation on the artificial valve. The internist’s lack of action supports this expert’s opinion that the patient may not have been in extremis when meeting with the cardiologist. The expert was also critical of the internist prescribing subcutaneous enoxaparin sodium injection therapy, as it does not have FDA approval for prosthetic valve coagulation. The FDA approves only heparin, given intravenously in a hospital setting, for anticoagulation for prosthetic valves in the absence of warfarin therapeutic levels.
 

Disposition
The case was settled on behalf of the cardiologist.
 

Risk management considerations
Thorough contemporaneous documentation of care is part of good patient care, as with the passing of time and a physician’s memory, details of the patient encounter may become obscure. Complete documentation includes rationale for thought processes or decisions made by the physician. When a physician’s thought processes are documented in the record, it can assist his or her defensibility if the need arises. The Texas Medical Board guidelines require that a patient’s medical record should accurately and objectively contain the assessment, findings, procedures, diagnoses, and decisions that support the physician’s care.

Regarding the physician’s choice and route of anticoagulant for the patient, it is good risk management for the physician to stay current with the most recent guidelines of his specialty including careful consideration of medication choices.

 

These closed claim studies are based on an actual malpractice claims from TMLT. These cases illustrates how action or inaction on the part of physicians led to allegations of professional liability, and how risk management techniques may have either prevented the outcome or increased the physician’s defensibility. These studies have been modified to protect the privacy of the physicians and patients.

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Reporter 2017 Cardiology

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