Download Testosterone_Case Review

John XXXX
DOB: 07/03/YYYY
John XXXX – AndroGel/Testosterone Case Review
Parameter
First name
Initial
Last name
DOB
Gender
Past Medical History and
Risk Factors
Social History (Smoking,
alcohol, drug use, etc.)
Family History
Drug Interactions If Any
Age at the time of
Testosterone use (> or <
65 years)
Weight, Height, BMI
Details of the patient (At
the time of Testosterone
use)
AndroGel/Testosterone
Use Details
Findings
John
D
XXXX
07/03/YYYY
Male
History Of Cardiac Problems: Longstanding hypertension
Stroke: No
Valve prolapse: No
Coronary Artery Disease: No
Has he ever been a tobacco user? Yes
Period of time smoking: Unknown
Heaviness of smoking: 20 pack year exposure
Has she quit smoking? Yes
When did she quit: 20 years ago
DM: (List all family members diagnosed with DM): No
Heart Disease: No
None
67 years (> 65 years)
PDF Ref
14
17
14
14
56
56
Per visit dated 02/14/YYYY;
Height: 5 feet, 9 inches
Weight: 81 kg
Body Mass Index (BMI): 25 kg/m2
Reason for Use: Andropause
20
Topical/Supplemental therapy: Topical
86
86
148, 151153
9, 148,
151-153,
171-174
Start Date: 08/28/YYYY
Duration: 08/28/YYYY, 08/29/YYYY, 10/10/YYYY, 10/24/YYYY (Per
medical records)
Stop Date: Unknown
Dosage: AndroGel 5 gm
Testosterone lab values
(One month prior and
after adverse event)
*Reviewer's comment: Pharmacy records are not available to know the
AndroGel usage details.
09/04/YYYY: Testosterone – 6.6 nmol/L (Ref. range: 6.0-27.0 nmol/L)
33
*Reviewer's comment: Testosterone lab value one month after adverse event is
not available for review.
Yes
56-61
Diagnosed with Adverse
Events (Heart
attack/Stroke/DVT/Blood Date of diagnosis: 10/10/YYYY
clots/other
1 of 9
John XXXX
Cardiovascular events)
Whether Testosterone
was discontinued?
(When and Why)
Hospitalization for the
adverse event
(Admission, length of
hospital stay)
DOB: 07/03/YYYY
Adverse Event Diagnosis: ST-segment Elevation Myocardial Infarction
(STEMI) with identified triple vessel Coronary Artery Disease (CAD) and
Ventricular Septal Defect (VSD)
Did the adverse event occur within 30 days of Testosterone therapy? Yes
No
*Reviewer's comment: The discharge medications for hospitalization for
myocardial infarction contain AndroGel 5 gm.
1st Hospitalization – For STEMI with identified triple vessel CAD and
VSD: 10/10/YYYY-10/24/YYYY (15 days)
2nd Hospitalization - For Congestive Heart Failure (CHF): 10/25/YYYY10/28/YYYY (4 days)
171-174
56-61, 8687, 88-92,
100-101,
96-97,
102-103,
185-187
3rd Hospitalization – For refractory CHF: 11/12/YYYY-11/20/YYYY (9
days)
4th Hospitalization – For acute decompensated heart failure: 11/20/YYYY12/02/YYYY (13 days)
Complications after
Adverse Event Diagnosis
Current Condition of
Patient (as per last
available record)
Prior Medical History
5th Hospitalization – For patch dehiscence and VSD: 12/02/YYYY12/08/YYYY (7 days)
10/25/YYYY-10/28/YYYY: CHF
11/12/YYYY-11/20/YYYY: Refractory CHF
11/20/YYYY-12/02/YYYY: Acute decompensated heart failure
12/02/YYYY-12/08/YYYY: Patch dehiscence and VSD
06/05/YYYY: Patient denies chest pain, SOB and Paroxysmal Nocturnal
Dyspnea (PND). Prescribed Nitro-Glycerin for CAD/CHF.
Past Medical History: Longstanding hypertension, gout
86-87, 8892, 100101, 96-97,
102-103,
185-187
11
56, 86, 151
Past Surgical History: Umbilical hernia repair, colonoscopy
Social History: As on 10/28/YYYY: Former smoker – 20 pack year exposure,
quit 20 years ago; Excess alcohol consumption, drinking as much as 10-12
drinks in the past per day, but has been abstinent of alcohol for the last year
Family History: Non-contributory
Allergy: Beer only insofar
AndroGel/Testosterone Intake Details (From Pharmacy Bills) Not available
*Reviewer's comment: Pharmacy records are not available to know the AndroGel usage details.
Duration
Medication
Prescribed By
2 of 9
Dispensing Pharmacy
PDF Ref
John XXXX
Not available
DOB: 07/03/YYYY
Not available
Not available
Not available
Not available
Missing Medical Record:
What Records
are Needed
Pharmacy records
Hospital/
Medical Provider
Date/Time
Period
Why we need the
records?
Is Record Missing
Confirmatory or
Probable?
Unknown
08/28/YYY
Y10/24/YYY
Y
To know the exact
duration of
AndroGel use
Confirmatory
Hint/Clue that
records are
missing
Medical records
have evidence
for AndroGel
use
Detailed Chronology
DATE
PROVIDER
01/06/YYY Multiple
YProviders
09/04/YYY
Y
10/10/YYY Provider/Hosp
Yital
10/24/YYY
Y
OCCURRENCE/TREATMENT
Multiple visits for umbilical hernia:
08/28/YYYY: Patient is diagnosed to have andropause. Prescribed AndroGel pump 5
gm, scheduled 30 days. (PDF Ref: 9)
09/04/YYYY - Labs: (PDF Ref: 33)
Testosterone – 6.6 nmol/L (Ref. range: 6.0-27.0 nmol/L)
Hospitalization for acute ventricular septal defect complicating inferior ST
elevation Myocardial Infarction (MI):
Admission diagnosis: ST-segment Elevation Myocardial Infarction (STEMI) with
identified triple vessel coronary artery disease and Ventricular Septal Defect (VSD)
Secondary diagnoses:
 ST elevation MI 10/10/YYYY (Late presentation), cardiogenic shock.
 Gout - Takes Allopurinol for maintenance
 Hypertension
 Remote smoker
Interventions and major investigative procedures:
10/10/YYYY: Coronary Artery Bypass Grafting (CABG) times 3; Left Internal
Mammary Artery (LIMA) to Left Anterior Descending (LAD), Saphenous Vein Graft
(SVG) to diagonal one and Obtuse Marginal (OM) and infarct to VSD with VSD repair
with pericardial patch.
10/20/YYYY: Left elbow X-ray shows no acute fracture or dislocation post fall.
10/21/YYYY: Postoperative chest X-ray reveals bibasilar atelectasis with small
bilateral pleural effusions.
10/22/YYYY: Postoperative echocardiogram to assess VSD shows a 1.0 cm residual
VSD and residual tissue around the VSD site.
During his hospital stay this patient was transfused with 4 units of frozen plasma, 1 unit
of pooled platelets and 1 unit of Packed Red Blood Cells (PRBCs).
Course in hospital: Patient presented on 10/10/YYYY with a late presentation inferior
3 of 9
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REF
22-23,
25-28,
3-6,
180181, 79, 14, 33
56-57,
35-36,
62-63,
66-75,
108115, 83,
182, 5861
John XXXX
DATE
PROVIDER
DOB: 07/03/YYYY
OCCURRENCE/TREATMENT
PDF
REF
ST elevation MI and heart failure. Investigations revealed triple vessel Coronary Artery
Disease (CAD) and a VSD. The patient was taken to the Operating Room (OR) on
10/10/YYYY. He underwent CABG and VSD repair with Dr. Xxxx. The procedure was
well tolerated. This patient had a prolonged stay in Cardiovascular Intensive Care Unit
(CV ICU). He remained there until postoperative day #6.
His issues there included:
 Intraaortic balloon pump which was inserted preoperatively was removed on
postoperative day #1.
 Patient was intubated until postoperative day #2.
 Patient was received to CV ICU on Milrinone, Levophed and Vasopressin. All
were discontinued by postoperative day #3.
 Patient was fluid volume overloaded requiring treatment with BiPAP and
diuresing.
 This patient was in a junctional rhythm from postoperative day zero to
postoperative day #2. He then reverted to a sinus rhythm and remained in sinus
rhythm throughout the course of his stay.
The patient was transferred to the Cardiac Surgery ward on postoperative day #6. The
patient had some confusion on postoperative day #7. It was identified that he had not
been sleeping well. He was treated with Seroquel. This improved his sleep wake pattern
and resolved his hallucinations and confusion. This was continued for a duration of
three days.
This patient remained in sinus rhythm throughout his postoperative course. He remained
on telemetry until postoperative day #8.
This patient was found to have a systolic ejection murmur on postoperative day #11.
Echocardiogram was repeated and showed a small residual VSD of 1.0 cm. As the
patient was asymptomatic it was not felt that any intervention was required at this time.
The patient was advised to monitor for signs of heart failure. He was advised to weigh
himself daily, monitor for peripheral edema and shortness of breath. The patient has no
dizziness at the time of discharge and again did not have any arrhythmias while in
hospital. I have requested this patient see Dr. Xxxx in approximately one week with a
repeat echo.
The patient’s only other postoperative issue was that of gout. He had an acute gout
attack of the left forefoot. He was treated with Colchicine and had quick resolution of
his symptoms. This patient is anticoagulated for six months for a VSD patch. Target
INR is 2.0 to 3.0. INR at the time of discharge is 3.1.
Patient is being discharged home to the support of his family on postoperative day #14,
10/24/YYYY.
10/25/YYY Provider/Hosp
Yital
10/28/YYY
Y
Most responsible diagnosis: Triple vessel coronary artery disease and VSD.
Hospitalization for congestive heart failure:
History reviewed. Patient was discharged last Thursday after he had an inferior MI and
within a few hours was readmitted through the Emergency Department (ED) at XYZ
4 of 9
37-39,
84, 8687
John XXXX
DATE
PROVIDER
DOB: 07/03/YYYY
OCCURRENCE/TREATMENT
PDF
REF
Memorial Hospital with Congestive Heart Failure (CHF), has diuresed over the last
three days with good response. (ED reports are not available). He says he is feeling
back to normal. He has had no arrhythmias documented, no chest pains. His troponin
has declined from his previous infarct. No secondary bump. His ECG has shown
evidence for his inferior MI but no acute changes.
On examination, blood pressure is 100/60, heart rate is 65. He is in a sinus rhythm.
Chest examination reveals diminished air entry to both bases but I did not hear any
crackles or wheezes. Heart sounds reveal a harsh systolic murmur at the left sternal
border, heard throughout the precordium, also into the back. There are no diastolic
murmurs heard. Jugular Venous Pulse (JVP) is at the sternal angle with a negative
Hepatojugular Reflux (HJR). The sternal and leg wound sites appear to be healing.
10/28/YYYY – Discharge summary: Patient’s Echocardiogram (ECG) shows grade IIIII Left Ventricular (LV), Ejection Fraction (EF) 40% with inferior wall severe
hypokinesis, mild global hypokinesis, about a 1 cm residual VSD with a QP QS of 1.7.
No pericardial effusion but left pleural effusion is still noted. Pulmonary pressures are
mildly elevated. Right Ventricular Systolic Pressure (RVSP) is in the mid 40-45 range.
His ECG shows evolving changes of his inferior MI but no acute changes. There were
no arrhythmias documented. His renal function has tolerated the bump up of the
diuresis.
11/01/YYY Provider/Hosp
Y
ital
His chest X-ray is showing some resolution of his congestive heart failure. His blood
work did show him to be anemic, hemoglobin was 10.3. He is therapeutic with an INR
of 2.4 on adjusted dose Warfarin, having received 1 mg of Warfarin today. He has
diuresed well and is doing well. The congestive heart failure could be representative of
his recent MI, LV impairment, residual VSD and volume overload there-from. This
does not represent a secondary acute ischemic event. He is eager for discharge home
and as he is clinically stable, discharged to home today. He has been put on Nitro-Dur
0.4 mcg patch. He has been reminded to carry Nitro and to seek medical attention for
any refractory symptoms. Subsequent followup has been organized and cardiac
rehabilitation through my office.
Follow-up visit status post MI, CABG and VSD:
10
Patient complains of shortness of breath and chest pain.
11/12/YYY Provider/Hosp
Yital
11/20/YYY
Y
Assessment and plan: MI and VSD – Follow-up in 2 weeks.
Hospitalization for refractory CHF:
Course in hospital: Patient presented to Emergency Room (ER) on 11/12/YYYY
because of acute onset Shortness of Breath (SOB) associated with cough and
generalized weakness. He was put on a strict 1.5 grams salt and 1.5 liters fluid restricted
diet and was diuresed with Intravenous (IV) Lasix and addition of Metolazone. Advise
was given by Dr. Pppp for this patient’s management and since he did not respond
much to the diuretics resulting in creatinine creeping up from 148 to 170, bicarbonate
increasing from 27 to 38 and a moderate luck with urine output his case was discussed
with Dr. Xxxx who transferred him over to ABC Hospital and reevaluated him for the
ventricular septal detect, which was most likely contributing to his refractory heart
failure. He did have elevated Liver Function Tests (LFTs) with an alkaline phosphatase
5 of 9
88-92,
44-45,
100-101
John XXXX
DATE
PROVIDER
DOB: 07/03/YYYY
OCCURRENCE/TREATMENT
PDF
REF
of 298, Alanine Transaminase (ALT) of 228, Aspartate Transaminase (AST) of 98. This
bump in the liver enzymes is most likely secondary to congestion from his heart failure.
A chest X-ray showed unchanged stable bilateral airspace disease and pleural effusions.
During this hospitalization, he did complete a 7-day course of Levaquin and had mild
elevation in his white count 13.6; however, his symptoms did not support the diagnosis
of pneumonia. I would leave it for the Physicians to decide in ABC whether they want
to treat him with another round of antibiotics. After discussing with Dr. Xxxx, his
Coumadin was discontinued and he was bridged on Tinzaparin for a possible surgical
intervention in the near future. He was discharged on Ferrous Gluconate 300 mg, Lasix
60 mg and Aspirin 81 mg.
11/20/YYY Provider/Hosp
Yital
12/02/YYY
Y
Final diagnosis: Refractory CHF secondary to recent MI resulting in VSD
Hospitalization for acute decompensated heart failure:
Admitting diagnosis: Acute decompensated heart failure
Secondary diagnosis: Significant large residual VSD with a left-to-right shunt
Interventions and major investigative procedures: Patient had a 2-D echo that
revealed grade I to II out of IV Left Ventricular (LV) function, septal bounce. Basal
inferior aneurysmal area. Remaining LV had normal function. The LV was dilated. The
Right Ventricle (RV) was hypokinetic and dilated. There was a VSD with a left-to-right
shunt, evidence of bilateral pleural effusion, query echodense structure near the Left
Ventricular Outflow Tract (LVOT). They wondered if this was part of the VSD closure.
His RVSP was 44 mmHg.
The CT of his chest 11/26/YYYY showed mixed air space disease and ground glass
density in both upper lobes which may be due to edema and infection. Bilateral pleural
effusions, larger on the left side with left lower lobe atelectasis.
He also had a Transesophageal Echocardiogram (TEE) performed on 11/28/YYYY
which showed aortic sclerosis, mild Mitral Regurgitation (MR), mild Tricuspid
Regurgitation (TR), RVSP was 46 to 50 mm Hg, the VSD patch was visualized just
below the AV valve near the LVOT, and there was evidence of a large residual left-toright shunt.
Most responsible diagnosis: Acute decompensated heart failure secondary to a 3 cm
hemodynamically significant VSD
Post-admit comorbidities: Include refractory heart failure as well as concerns for
embolic phenomenon as he did develop black spots in his nail beds of the fingers
bilaterally which was felt to be compatible with embolic phenomenon likely from the
pericardial patch tissue now in the LV and LVOT as described. He has been on fulldose Enoxaparin during his admission.
Summary: Patient remains on a Lasix infusion but has had refractory heart failure. Dr.
Xxxx spoke with Dr. Eric Xx at General Hospital for consideration of a percutaneous
closure and therefore he was transferred to General Hospital (TGH) today for an
6 of 9
96-97,
9395,9899, 102103
John XXXX
DATE
PROVIDER
12/02/YYY Provider/Hosp
Yital
12/08/YYY
Y
12/09/YYY Provider/Hosp
Yital
01/01/YYY
Y
DOB: 07/03/YYYY
OCCURRENCE/TREATMENT
opinion regarding this matter. He will be admitted under Dr. Vlad xxxxin the Coronary
Care Unit (CCU) at General. Once their assessment is done he will be repatriated back
to our hospital for discharge planning.
Hospitalization for patch dehiscence and VSD:
PDF
REF
185-187
Patient was transferred to TGH for consideration of percutaneous VSD repair.
Unfortunately after careful review of his clinical status, cardiac MRI and CT by the
Interventional Radiologists here he was not deemed a candidate for percutaneous
procedure. Cardiovascular Surgery was also consulted and it was thought it would be
best for the original Surgeon to operate at ABC who was agreeable to this. During his
stay at the CCU at General he showed signs of increasing heart failure 3:1 right to left
shunt and high wedge pressures. He was treated with Nipride, Milrinone and Lasix
infusions. He also developed delirium and confusion during his stay. CT head did not
show anything acute to explain his confusion.
Follow-up instructions: VSD dehiscence: For repair at ABC where he has been
accepted. Patient is being transferred with infusions of Milrinone, Lasix infusion and
Nipride via air ambulance. Metolazone was also added for management of his heart
failure.
Hospitalization for VSD:
Admitting diagnosis: VSD
Interventions and major investigate procedures:
 12/10/YYYY: Redo VSD repair for dehiscence of old VSD patch, repair of left
false aneurysm and repair of right femoral artery.
 12/10/YYYY: CT head shows a normal exam.
 12/12/YYYY: Feeding tube insertion.
 12/20/YYYY: Thoracentesis for 425 mL on the right side.
 12/20/YYYY: CT chest shows good opposition of sternal fragments with intact
sternal wires.
 12/23/YYYY: Postoperative echo shows a small residual VSD. QT/QS is 0.9.
 12/30/YYYY: Postoperative chest X-ray reveals moderate atelectasis at the
right lung base with a residual moderate pleural effusion which is unchanged
since previous thoracentesis.
During his hospital stay this patient was transfused with 11 units of packed red blood
cells, 4 units of frozen plasma, 1 unit of pooled platelets, 1 unit of platelet apheresis, 10
units of pooled cryoprecipitate.
Course in hospital: Patient underwent redo VSD repair, repair of the left ventricle for
false aneurysm and repair of the right femoral artery on 12/10/YYYY. The operative
course was well tolerated.
The patient had a prolonged stay in CV ICU. His stay was prolonged secondary to:
 Postoperative bleeding requiring transfusions.
 Prolonged intubation. This patient was not extubated until postoperative day #8.
 Small bowel feeding tube inserted on postoperative day #2 for nutritional
7 of 9
189194,
116,
200,
121122,
117-120
John XXXX
DATE
DOB: 07/03/YYYY
PROVIDER
OCCURRENCE/TREATMENT



support while still intubated.
Postoperative delirium. The patient was agitated and had a very slow
neurological progress.
Neurologically he was improving by postoperative day #8.
Postoperative atrial fibrillation treated with Amiodarone and Metoprolol.
The patient was transferred to the Cardiac Surgery ward on postoperative day #9. This
patient continued to have a significant delirium. He was seen by the Geriatric Service as
well as Psychiatry. The patient’s family had a concern that given his history of bipolar
diagnosis that this was something more than a delirium. Neither the Geriatric nor
Psychiatry team felt this was anything other than delirium. The patient had no signs of
infection. He had good effect with treatment with Seroquel. His hallucinations resolved.
His intermittent episodes of confusion also resolved. By the time of his discharge there
were no concerns regarding ongoing delirium from the Nursing Staff, the patient or his
family. It was recommended the patient remain on Seroquel. This has been continued in
the home environment with request for followup with Dr. Ssss for weaning and
discontinuing as appropriate.



This patient is anticoagulated for his VSD. This should continue for 3 months.
He did have some intermittent atrial fibrillation while in hospital. Reassess his
rhythm prior to discontinuing Warfarin therapy. He has maintained a
therapeutic INR in hospital on 2 mg of Warfarin daily.
This patient had hypernatremia on initial transfer to the Cardiac Surgery ward.
This resolved and his sodium was 142 at the time of his discharge.
This patient did initially have a sternal click. This was not appreciated by the
time of his discharge. The patient however did have dehiscence of his distal
sternal incision. At the time of his discharge he was receiving Vac therapy.
There were no signs of infection and cultures had been negative. He is not on
antibiotic therapy at the time of his discharge. Home Care Services have been
requested to monitor the incision and complete dressing changes. Vac/negative
pressure wound therapy has been requested in the community.
This patient did have a significant right pleural effusion in hospital. This was diuresed
on postoperative day #10 for 425 mL. He was left with a residual moderate sized right
pleural effusion. By serial chest X-ray this was not increasing in size.
This patient’s postoperative echo did show a small residual VSD. This was reviewed by
Dr. XXXXX and Dr. XX. The results were then communicated to Dr. Xxxx. It was felt
that this residual VSD was “insignificant.” Dr. Xxxx has identified that no specific
followup is required. Specifically no urgent office assessment or echocardiogram is
required at this time. It was relayed to the patient and his spouse. They know to
continue to monitor for any signs of failure which could be due to LV dysfunction, or
VSD. They also note to monitor for any signs of worsening shortness of breath due to
his pleural effusion.
This patient was discharged home on postoperative day number 22, 01/01/YYYY. He
has been referred to the Cardiac Rehabilitation Program at St. Mars’s General Hospital.
8 of 9
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REF
John XXXX
DATE
PROVIDER
01/02/YYY Provider/Hosp
Y
ital
01/10/YYY Multiple
YProviders
06/05/YYY
Y
DOB: 07/03/YYYY
OCCURRENCE/TREATMENT
Recommendations:
 This patient requires anticoagulation with Warfarin/Coumadin for 3 months for
a VSD repair. He also had intermittent atrial fibrillation postoperatively. Target
INR is 2.0 to 3.0. INR at the time of discharge is 2.6. He has been instructed to
take Warfarin 2 mg orally daily.
 His postoperative echo shows a small residual VSD. QP/QS is essentially
normal. Dr. Xxxx has identified this VSD to be “insignificant.” Patient is aware
of symptoms to monitor for and to seek medical attention should these develop.
 He has a moderate right pleural effusion. This is residual post thoracentesis.
The patient is asymptomatic at the time of his discharge. He is aware to monitor
for signs of shortness of breath and to contact his Physician for assessment
should this develop.
 He has a sternal incision which has dehisced at the distal portion. I have
requested Vac/negative pressure wound therapy in the home setting. Should
there be any concerns regarding the heating of this wound, the patient should
followup with Dr. Xxxx.
 He is on Furosemide and Spironolactone for LV dysfunction.
 He is on Seroquel and should have intermittent ECG assessments for QT
prolongation. I would request that the Family Physician provide the patient with
a requisition for this as it was not provided
Medication sheets:
 Aspirin – 81 mg
 Warfarin – 2 mg
Multiple visits status post CABG and VSD repair:
@ 01/10/YYYY: Patient complains of occasional chest pain, but denies SOB.
@ 01/14/YYYY: Patient is recovering slowly and as expected. He is required to use a
walker. He is unable to bend or stoop and requires assistance in dressing. He is unable
to bath on his own and requires the assistance showering.
@ 02/13/YYYY: Cardiac Rehabilitation: Patient is on Warfarin, will discontinue
Aspirin. Will reassess LV function in 3 months. If EF still less than 30%, may be a
candidate for Automatic Implanted Cardioverter Defibrillator (AICD).
@ 03/18/YYYY: Patient denies chest pain and SOB.
@ 06/05/YYYY: Patient denies chest pain, SOB and Paroxysmal Nocturnal Dyspnea
(PND). Prescribed Nitro-Glycerin for CAD/CHF.
*Reviewer's comment: Further medical records after 06/05/YYYY are not available to
know the progress of the patient.
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132
10, 147,
20, 11