This matter involves the death of a 45 year old previously healthy man who developed a series complicated coronary and neurological events over a 4 month period ending in his death. We have concerns over a discrete aspect of this treatment involving the medication Eliquis.
History
1. A 45 yo male with no significant medical history presented with complaints of chest pain radiating to his back for the past several hours, progressively worsening. CT/PE showed possible dissecting aortic aneurysm. The aorta was found to be nearly circumferentially dissected, and the arch was resected and replaced with a 26 mm Dacron graft. He was also found to have a bicuspid aortic valve, meaning a valve with 2 leaflets instead of the usual tricuspid/3 leaflets, which was mildly calcified, so it was replaced along with the ascending aorta, with a 27mm bovine pericardial composite Inspiris Valvegraft, followed by the reimplantation of the coronary arteries. He was on cardiopulmonary bypass pump for the surgery. The op report notes no complications.
2. 12/10/18: An EKG revealed atrial tachycardia with a variable A-V block, with an atrial rate of 264 BPM, and ventricular rate of 95 bpm. He underwent a cardioversion procedure during which a 200 joule externally delivered synchronous shock successfully restored sinus rhythm. It was noted he tolerated the procedure well, and was discharged home. As of 12/13/18, his medications included Eliquis, diltiazem, metoprolol and nicotine patch.
3. 1/7/19- 1/17/19 Pt admitted and diagnosed with endocarditis emanating from a vegetative growth on the aortic graft. Antibiotic therapy started. Eliquis was stopped.
4. He was discharged home on 1/17/19 to continue home antibiotic therapy. He and his wife were cautions regarding the s/s of stroke as during this hospitalization a piece of the vegetative growth has migrated to his hand.
5. 1/31/19 He returned to the hospital with severe head pain. He was noted to have left-sided facial palsy as well as neglect and some left-sided weakness and a CT of his head demonstrated diffuse right-sided subarachnoid hemorrhage within the sylvian fissure as well as early hydrocephalus. He had a seizure and was loaded with antiepileptic medication. He was slightly somnolent at the time and received a right sided external ventricular drain. CTA (CT angiogram) demonstrated possible mycotic aneurysm of the right MCA. He demonstrated altered mental status shortly after placement of his right-sided external ventricular drain associated with hemorrhage within the drain and malfunction. Repeat CT demonstrated interval enlargement of his subarachnoid hemorrhage. A left frontal external ventricular drain was emergently placed, which demonstrated markedly elevated intracranial pressure to 50. The left sided drain also revealed intraventricular hemorrhage. He then blew a pupil (pupil became huge and nonreactive), and he was taken emergently to the OR for decompressive craniectomy and temporal lobectomy. When the dura was lifted after removal of the cranial window, the right hemisphere herniated out of the dural defect, the entire brain was noted to be hemorrhagic throughout the cortex consistent with diffuse and malignant intracranial hypertension. A right-sided lobectomy was attempted, but there was continuous profuse bleeding and progressive herniation, so they elected to “quickly whip-stitch close” the wound with staples. Thereafter the patient died on 2/1/19. A hospital entry prior to the 1/31 surgery states that “family reports he is not on anticoagulants”
This is our issue. The administration of Eliquis stopped in the hospital during the 1/7/19-1/17/19 admission. However, the patient had an active prescription for Eliquis at home, filled on 1/2/19.
His family have testified as follows:
a) No one at the hospital said anything to anyone about stopping any of his home medication upon discharge on 1/17/19;
b) The wife doesn’t know what Eliquis is, didn’t know that it was an anticoagulant and assumed her husband was taking his meds during the period after 1/17/19 until his readmission on 1/31
c) No surgeon, resident or nurse said anything to his wife or sister prior to the brain surgeries on 1/31/19
The neurosurgeon has testified that the patient was cleared for surgery. He didn’t speak to his family as that is done by some member of his team. Bleeding would not have been a risk as the patients PTT test results were OK.
Question presented
1. If the patient was still on his Eliquis after discharge on 1/17/18 could that have contributed to the development of the mycotic aneurysm?
2. If the patient was on Eliquis on 1/31/19 would that have had dire consequences when they opened his head and began to operate?
3. Can a person on Eliquis have normal PT/PTT test results?
4. What can be done for a patient who is on Eliquis and need emergency surgery? Is there a reversal drug?
Files:
No questions yet!
Do you believe there might have been medical error?
1. Eliquis would have nothing to do with the development of an infection. 2. If the patient was on Eliquis at the time of surgery, he would have had significant bleeding. 3. A person on Eliquis will usually have normal PT/PTT results. 4. There is a reversal agent for Eliquis named Andexxa (andexanet) but it was only approved by the FDA on 5/3/18 People with endocarditis can throw emboli which can subsequently cause a hemorrhagic stroke. You would have to prove that Eliquis was on-board using an anti-Xa level done at the time of surgery. Otherwise, you would need to obtain the original vial of medication and do a pill count to show that he had been taking it.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The only error I see from a hematologic standpoint is that the patient wasn't clearly advised to stop Eliquis (in general, one doesn't use anticoagulation in the setting of endocarditis.
What makes you a good expert for this case?
Over 20 years of practice in Hematology at the world's largest medical center. Prior successful outcomes with other cases.
How often do you encounter cases similar to this one in your practice?
I deal with Eliquis on a daily basis. Endocarditis resulting in ICH is rare.
Do you believe there might have been medical error?
One. I don’t think Eliquis could’ve contributed to the micotic aneurysm. This is clearly a not uncommonly seen complication of infective endocarditis. Anticoagulation in the setting of infective endocarditis has risks and benefits. If he had a prosthetic mechanical valve, the risk of clock would’ve been higher, and he would’ve needed anticoagulation. With a bioprosthetic valve, he did not need anticoagulation long term, and with infective endocarditis it would’ve been contraindicated. 2. If he was on Eliquis when they performed craniotomy, that could lead to life-threatening bleeding. Number three. PT and PTT are usually normal when a patient is on therapeutic Eliquis. PT and PTT are not used to determine if a patient is anticoagulated, while he is taking Eliquis. Number four. If reversal of Eliquis is needed, there are medication approved for this. One could use a prothrombin complex concentrate, or the drug andexanet.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I think patient had a bad outcome because he had infective endocarditis that led to a mycotic aneurysm in the brain which likely ruptured and caused bleeding. I don’t see how him not taking Eliquis would’ve contributed to this or worsened it.
What makes you a good expert for this case?
I am a hematologist/oncologist who has been in practice for greater than 25 years. I am frequently called upon by surgeons to help manage coagulopathy, thrombosis, and bleeding issues in preoperative, perioperative, and postoperative settings.
How often do you encounter cases similar to this one in your practice?
A serious issue such as this, with possible need for reversal of anticoagulation while on a directoral anti-thrombin inhibitor is unusual. I may see two or three cases a year.
Do you believe there might have been medical error?
This is our issue. The administration of Eliquis stopped in the hospital during the 1/7/19-1/17/19 admission. However, the patient had an active prescription for Eliquis at home, filled on 1/2/19. I DON'T KNOW WHAT AN "ACTIVE PRESCRIPTION IS." MOST PATIENTS HAVE A TREASURE TROVE OF MEDICATIONS AT HOME THAT HAVE BEEN STOPPED. MOST OF THEM RESUME THEM WHEN THE THINK IT WILL HELP THEM. THIS IS WHY A LIST OF MEDICATIONS IN A DOCTORS NOTE OR IN A HOSPITAL COMPUTER IS WORTHLESS. THE ONLY THING THAT MATTERS IS WHAT IS THE PATIENT ACTUALLY PUTTING IN HIS MOUTH. MAKING THIS DETERMINATION IS CALLED MEDICATION RECONCILIATION AND IT IS ONE OF THE MOST DIFFICULT TASKS IN MEDICINE AND IT IS OFTEN DELEGATED TO THE LOWEST MEMBER ON THE TEAM. PATIENTS DON'T LIKE TO PARTICIPATE IN THIS ACTIVITY BECAUSE THEY BELIEVE THE INFORMATION IS "IN THE COMPUTER." THIS CASE SHOWS HOW DIFFICULT THIS TASK IS. TOO OFTEN PATIENTS ARE ASKED IF "ANYTHING HAS CHANGED," AND THEY SAY "NO" - BUT WHAT DOES THAT MEAN IF THEY DON'T SEE THE LIST? WHAT DOES THAT MEAN IF THEY DON'T KNOW WHAT EACH MEDICATION IS FOR. AND THEY ALWAYS FORGET WHEN A DRUG HAS BEEN STOPPED, OR A NEW ONE PRESCRIBED, OR THEY START TAKING AGAIN A DRUG THEY HAVE AT HOME. His family have testified as follows: a) No one at the hospital said anything to anyone about stopping any of his home medication upon discharge on 1/17/19; THIS SHOULD BE DOCUMENTED IN THE MEDICAL RECORD. HOSPITALS ALWAYS GIVE PATIENTS A LIST OF WHAT TO STOP, WHAT TO START, AND WHAT TO CONTINUE. b) The wife doesn’t know what Eliquis is, didn’t know that it was an anticoagulant and assumed her husband was taking his meds during the period after 1/17/19 until his readmission on 1/31 THIS IS UNFORGIVABLE. IT SOUNDS LIKE THERE MAY WELL HAVE BEEN A MEDICAL ERROR - I CANNOT TELL WITHOUT SEEING THE RECORDS, BUT IT ALSO SOUNDS LIKE THE PATIENT AND WIFE COMMITTED A GRIEVOUS ERROR IN NOT KNOWING WHAT ELIQUIS IS. MY MOST UNEDUCATED PATIENTS KNOW WHEN THEY ARE TAKING A BLOOD THINNER AND THAT IT CAN MAKE THEM BLEED AND THAT IT MUST BE STOPPED FOR SURGERY. c) No surgeon, resident or nurse said anything to his wife or sister prior to the brain surgeries on 1/31/19 IT IS UNCLEAR WHAT THIS STATEMENT MEANS. The neurosurgeon has testified that the patient was cleared for surgery. He didn’t speak to his family as that is done by some member of his team. Bleeding would not have been a risk as the patients PTT test results were OK. OH, MY, WHAT DOES "CLEARED FOR SURGERY" MEAN? THAT IS SUCH A MEANINGLESS TERM - JUST AWAY TO TRY TO SHIFT BLAME FOR A BAD OUTCOME TO SOMEONE ELSE. THE MAN WHO WILL CUT INTO SOMEONE ELSE'S SKULL DID NOT SPEAK TO THE FAMILY? WHETHER THAT IS A MEDICAL ERROR MAY BE QUESTIONED, BUT SHOCKING TO SEE THAT IN PRINT. HOW CAN YOU YOU OPERATE ON SOMEONE IF YOU DON'T KNOW THAT THERE ARE NEW ANTICOAGULANTS THAT HAVE NOW BEEN AROUND FOR MORE THAN 10 YEARS THAT DON'T AFFECT THE PTT: ELIQUIS, XARELTO, PRADAXA, ASPIRIN, PLAVIX, EFFIENT, ETC. UPTODATE STATES THAT: "normal coagulation testing cannot be used as evidence that the anticoagulant effect has resolved or to eliminate the need for aggressive interventions." Question presented 1. If the patient was still on his Eliquis after discharge on 1/17/18 could that have contributed to the development of the mycotic aneurysm? NO. I THINK THOSE ARE INDEPENDENT ISSUES. 2. If the patient was on Eliquis on 1/31/19 would that have had dire consequences when they opened his head and began to operate? YES. THE PROPER TEST IS ANTI-FACTOR Xa 3. Can a person on Eliquis have normal PT/PTT test results? YES. 4. What can be done for a patient who is on Eliquis and need emergency surgery? Is there a reversal drug? WAIT 5 HALF-LIVES BEFORE CUTTING (2-3 DAYS SINCE LAST DOSE). ANTI-FIBRINOLYIC AGENTS CAN BE GIVEN OR ACTIVATED VIIA OR PROTHROMBIN COMPLEXES, OR THE NEWER AGENT Andexanet alfa.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I cannot tell without reviewing the medical records. I cannot tell if the patient was anticoagulated or not. It depends upon what the medication list shows he was treated with in the hospital. It depends upon how much time had elapsed since his last dose of Eliquis if he was taking it. It depends on his serum creatinine. It depends on whether he had DIC from his mycotic infection. This is a very complex case. The way it is presented makes it sound as if there is causation and possibly error, but without reviewing the records in detail I cannot be sure.
What makes you a good expert for this case?
I have reviewed many cases that hinge on the communication between and among staff and patient and family. I also have struggled in my own practice with the difficulties of medication reconciliation, and patient education.
How often do you encounter cases similar to this one in your practice?
With regard to issues of medication reconciliation, whether a patient is on a certain drug or not, when a patient should stop Eliquis before surgery, why a patient bled during surgery - daily. With regard to such a disaster as this one, fortunately never.
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