VIRGINIA CARDIAC SURGERY QUALITY INITIATIVE (VCSQI)
ATRIAL FIBRILLATION PROPHYLAXIS PROTOCOL
BY: VCSQI QUALITY COMMITTEE
(December 29, 2004)
The purpose of this quality improvement initiative is to lower the incidence of complications among patients undergoing a CABG or valve repair/replacement surgery in
VCSQI member heart centers. We hope to demonstrate that by lowering the incidence of post-operative atrial fibrillation, hospital costs and resources used will be contained while clinical processes are improved. We hope to improve clinical quality through sharing information and collaborating in the analysis of outcomes data.
VCSQI’s objective has been to design and implement a pre-surgical medication protocol that is statistically successful in reducing the incidence of new post operative atrial fibrillation in cardiac surgery patients. A copy of the prophylaxis protocol is located in
Attachment 1 . The supplemental data collection form is in Attachment 2 , a sample patient information sheet in Attachment 3 and information on the cost of Amiodarone in
Attachment 4 .
We are not conducting a randomized clinical trial to evaluate the effectiveness of this protocol. However, we hope to track changes in rates of atrial fibrillation, permanent strokes, ICU hours, and patient lengths of stay for each participating heart center. Data collected on the supplemental form can be used to determine (1) the time the protocol was started, (2) reasons for exclusion, (3) patients’ pre-operative vital signs, (4) the time of onset of break-though new post-operative atrial fibrillation, (5) and the patients heart rate and rhythm at discharge. The supplemental form can be tied to a custom field set up in VCSQI’s Armus database with a patient identifier.

I.
Context
Atrial fibrillation is a common post operative complication seen in the cardiac surgical patient population. When this complication occurs it can be associated with delayed surgical recovery of patients, longer length of stay, and higher hospital costs.
Objective To design and implement a pre surgical medication protocol that is statistically successful in reducing the incidence of new post operative atrial fibrillation in cardiac surgery patients.
Participants Prospective protocol implementation and clinical record review of Cardiac surgery patients from the members of the Virginia Cardiac
Surgery Quality Initiative (VCSQI). The VCSQI group plans to implement the protocol January 3 rd
, 2005 and use supplemental data collection form for this CQI study in conjunction with the standard STS national database collection tool...
One VCSQI member has a Protocol in place as standard of practice for more than 2 years. This site will act as the control for this CQI Study initiative.
II.
Protocol Medications The two primary medications in this protocol will be
Amiodarone and Lopressor.
Exclusion Criteria for Amiodarone includes Patients with:
Interstitial Lung Disease or Pulmonary Fibrosis
Bradycardia with pulse < 55 bpm
Untreated or uncontrolled Thyroid Disease
With known Chronic Atrial Fibrillation
With Allergy to Iodine or Amiodarone
Exclusion Criteria for Lopressor includes patients with:
Bradycardia with pulse < 55 bpm
Active Congestive Heart Failure
Bronchospasm or Asthmatic Pulmonary disease
Already receiving Beta Blocker Therapy
III.
Prevention Medications
A.
Amiodarone - Start 400 mg. p.o. TID if weight > 70 Kg. or 200 mg p.o.
TID if weight < 70 Kg. five days to 24 hours prior to cardiac surgery unless the patient meets one of the medication exclusion criteria above.
B.
All other patients should receive 400mg if weight > 70 Kg. or 200 mg. if weight < 200 mg. by mouth with sip water only, on the morning of surgery on the day of surgery.

C.
Patients with NO PRE OP loading dose should receive Amiodarone 1200 mg. PO on the day of surgery OR alternative intravenous dose as follows:
D.
Amiodarone 150 mg IV after coming off CPB then Amiodarone 900 mg in
500 cc D5W to infuse at 1 mg/min over 6 hours then 0.5 mg/min until empty.
E.
Post operatively, all patients should receive 200 mg TID via NGT or by mouth until discharge or post operative day 10, which ever comes first..
F.
If heart rate < 55 bpm, FIRST Hold Beta Blocker for 8 -24 hours before holding Amiodarone medication.
G.
Stop Verapamil before starting Amiodarone.
Prevention Medications
H.
Beta blockade - Start Lopressor 25 mg Q 12 hours five days to 24 hours prior to cardiac surgery for all patients that have normal LV function. unless patient meets one of the medication exclusion criteria above.
I.
Post operatively, give Lopressor 5 mg IV or 25mg PO via NGT Q 6 hours while patient intubated Administer the day of surgery only after hemodynamic stability attained post operatively.
J.
Do not hold beta blocker unless native heart rate is less than 55 bpm.
K.
Continue atrial pacing during the periop period if needed.
L.
After extubation, Lopressor 25 mg by mouth BID
M.
On the day of discharge, patients should be switched to their preoperative beta blocker or Lopressor 25 mg. BID.
IV.
Treatment of Breakthrough post operative Atrial Fibrillation
A.
Follow institution specific protocols for post operative atrial fibrillation.
B.
B. Hold PO Amiodarone when receiving Amiodarone via IV infusion
C.
Discharge medications as outlined by institution specific protocol
D.
If Atrial Fibrillation > 24 hours start Coumadin. Do not start Heparin infusion. For patients in and out of atrial fibrillation for

48 hours, discuss with surgeon.
E.
Patients, who remain in atrial fibrillation for 24 hours, consider increasing dose of Amiodarone, adding an additional agent, or DC cardioversion.
Discuss DC cardioversion vs. anticoagulation and home management of atrial fibrillation.
V. Post Discharge Management of Atrial Fibrillation
A. Maintain medication management of atrial fibrillation
B.
Maintain beta blocker. Discuss with surgeon appropriate combination therapy.
C.
Continue Coumadin with target level of 2-2.5 INR. Identify physician to manage
Anticoagulation and PT/INR levels.

VI. Clinic Follow-up
If still in atrial fibrillation at clinic visit, refer patient to a cardiologist.
VII.
Data Collection
A.
All participants will collect the national STS Cardiac Surgery 2.52.1 version
B.
All participants will collect the supplemental data elements identified for this protocol implementation (see attached)
VII. Amiodarone and Lipid Lowering Medication
A. The data on administering both Amiodarone and some lipid lowering medication was clarified with pharmacy PhD. The incidence and risk of side effects is low in the short term dosage the protocol covers. The medication interaction concern relates to the following: May aggravate liver problems and development of leg cramps.

ATTACHMENT 2. ATRIAL FIBRILLATION PROPHYLAXIS PROTOCOL
SUPPLEMENTAL DATA COLLECTION FORM
Patient Identification
Date of Surgery:
Surgical Procedure:
1. On VCSQI Atrial Fibrillation Prophylaxis Protocol
(circle) circle
YES Date protocol begun: insert date
If Amiodarone given IV Day of
Surgery
NO

answer # 2 below:
2. DOCUMENT reason for exclusion: (medication held, duration and reason why held) .
Held Pre op: Beta Blocker
No duration held: Restarted: Yes
(circle reasons)
HR < 55bpm On other BB therapy CAF Allergy COPD Other clinical indication:
Held Pre op : Amiodarone
No
duration held: Restarted: Yes
(circle reasons)
HR < 55bpm On other BB therapy CAF Allergy COPD Other clinical indication:
Held Post op: Beta Blocker
No
(circle reasons) duration held: Restarted: Yes
HR < 55bpm On other BB therapy CAF Allergy COPD Other clinical indication:
Held Post op : Amiodarone
No
duration held: Restarted: Yes
(circle reasons)
HR < 55bpm On other BB therapy CAF Allergy COPD Other clinical indication:
3. Vital Signs Pre Operatively or first vitals signs on Anesthesia Record
Pre Operative:
HR: Rhythm: BP:
Anesthesia Record:
HR: Rhythm: BP:

4. Date/time ONSET OF breakthrough NEW post operative Atrial Fibrillation
(By STS definition, would be any AFIB that was treated)
Date / time Onset:
Fibrillation
Duration: Rhythm: Atrial
HR at Onset: BP at onset of AF:
( Hypothesis: prophylaxis AFIB protocol will either prevent post op occurrence or reduce the rate and duration of post operative onset of AFIB)
5.
Hospital specific protocol instituted for breakthrough NEW POST-operative atrial fibrillation ?
( Would be current Standard of Practice for new Post Operative Atrial fibrillation) if no, why not? Yes No
6. Heart Rate and Rhythm at Patient Discharge :
HR Rhythm

ATTACHMENT 3. COPY: PATIENT INFORMATION SHEET
FOR VCSQI PREVENTIVE ATRIAL FIBRILLATION PROTOCOL
• When your surgeon reviewed with you the need to undergo surgery, he also reviewed the risks related to surgery and included the possible development of an irregular heart rate after surgery. Developing an irregular heart rate after surgery happens in 16 – 22 % of patients who have heart surgery and tends to occur on the 2 nd
to 4 th
day after surgery.
• Our goal, together with the group of heart surgery programs in the Commonwealth of
Virginia, is to greatly reduce the development of this irregular heart rhythm in you after your heart surgery. This will improve your recovery from surgery, not extend your length of stay in the hospital, and improve your heart function.
• We are going to ask you to take two specific medications, one of which you may already be taking, for 5 days before your surgery or as we instruct you. We will continue these medications after your surgery only until you are discharged.
• We will give you a prescription for each medication. These prescriptions may be filled at your local drug store or here at the hospital pharmacy, located ___________________.
• IF you do not already know how to take your pulse rate, we will teach you how and ask that you count your heart rate before you take your medication. Both of these medications help your heart to work better by slowing your heart rate some. IF your heart rate is less than 55 beats a minute, we will ask you to not take one of the medications for that time. IF your heart rate is above 55 beats a minute, you will take each of the medications at the time designated.
• We will provide you handout information on each medication with your prescriptions.
If you have any questions or effects from taking the medications, call:
_______________________

ATTACHMENT 4. ATRIAL FIBRILLATION PROPHYLAXIS PROTOCOL
INFORMATION ON THE COST OF AMIODARONE
Here is a break out of the costs and potential charges for administration of Amiodarone based on information from our pharmacy:
Coradarone 200mg tabs #60 pharmacy cost $13.00 ($0.22 each)
Amiodarone 3 ml vial (150mg) $1.75 (usual loading dose IV)
Amiodarone 18 ml vial (900mg) $9.93 (usual IV dose given overnight as drip)
Our local pharmacy would discount the po drug a sell at $50.64 for 60 tabs, the usual retail charge from other pharmacies would run $100 to $120 without any discount.
Hospital charge for IV administration of drug will be $18.50 for the 150 mg bolus and $189.50 for the overnight 900 mg drip. This does not include charges for the IV fluid carrier, IV tubing, etc.
Our current practice is to switch to oral amiodarone the day following surgery and continue it for 1 month after discharge unless side effects or other problems occur.
To our way of thinking, extending the study to include intravenous administration of the drug will allow us to treat more patients with the protocol and have better control of the amount of drug they are receiving without much patient to patient variation perioperatively. We will also reduce the potential risks of starting an antiarrhythmic drug with beta blocker properties in a group of patients most of whom are already taking a beta blocker.
What I would like to do is make a minor change in the data form to reflect oral vs IV adminstration of the drug. With that, I believe we can achieve consensus among our surgeons and start using the protocol in January.
Paul Frantz, MD, Roanoke Va