Download Dorset Cardiac Centre Patients with Atrial Fibrillation/Flutter

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Dorset Cardiac Centre
Patients with Atrial Fibrillation/Flutter undergoing DC
Cardioversion or Ablation proceduresGuidelines for Novel Oral Anti-coagulants (NOACS) licensed for
this use – February 2015
1. Background / rationale for implementation of guideline
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There are no agreed national guidelines for the use of NOACS in patients
undergoing elective DC Cardio version (DCCV) or ablation procedures.
Where DCCV is indicated in the text, ablation can also be read. These
guidelines have been developed locally and agreed by the Cardiology
Consultants throughout Dorset. The guidelines have been ratified through
Dorset Cardiology sub group.
The justification for using NOACs in these patients is to enable their
procedure to take place in a more timely manner and to reduce the issues that
occur with weekly warfarin testing.
When patients are commenced on NOAC’s they should be able to undergo
DCCV 4 weeks later, thus improving the access time to their procedure and
avoiding unnecessary delays due to sub therapeutic anticoagulation levels.
Patients will remain on NOAC’s until seen in the Atrial fibrillation/ Atrial flutter
(AF/Aflutter) clinic by the Arrhythmia Nurse Specialist 4-6 weeks post
procedure. If patients are to remain anti- coagulated at this point, a further
discussion should occur to decide on continuation of NOAC or a change to
warfarin. This decision will be made with the Cardiology Consultant.
At present there are three licensed NOAC’s available in the UK. Dabigatran is
a direct thrombin inhibitor; Rivaroxaban and Apixaban are factor Xa inhibitors.
All three drugs are licensed to be continued in patients undergoing
cardioversion.
2. Process of identification of suitable patients to be managed on NOAC
therapy
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Patients reviewed in the clinic, who are deemed suitable for DCCV, will be risk
assessed according to their CHA2DS2-Vasc score (table 1) (NICE clinical
guidance 2006 & European Heart Journal 2012). The score outcome will be
discussed with the Cardiology Consultant/registrar.
Table 1 CHA2DS2VASC
Risk Factor
Congestive Heart Failure/LV Dysfunction
Hypertension
Aged > 75 years old
Diabetes mellitus
Stroke/TIA/Thromboembolism
Vascular disease (prior myocardial infarction, peripheral artery disease or aortic plaque
Age 65-74 years old
Pan-Dorset Cardiology Group
NOAC DCCV guidelines February 2015
Score
1
1
2
1
2
1
1
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Sex category - Female
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Patients who are identified for DCCV who have been unstable on warfarin
with TTR < 65% will be converted from warfarin to a licensed NOAC (unless
contraindicated). If warfarin has not yet been initiated in Primary Care, this will
be discussed with the cardiology consultant and it may be decided to initiate
NOAC as the first line anti-coagulant. Patients need to be informed that
further discussion regarding long term anticoagulation will occur 4 – 6 weeks
post DCCV.
3.Management of patients identified as suitable for NOAC therapy prior to
DCCV
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Patients MUST have up to date U&E's, HB, LFTs, baseline clotting and TFTs
4-6 weeks prior to DCCV and again prior to DCCV (see below).
The patient’s medication history will be checked prior to the initiation of NOAC
in clinic to check for interactions (refer to SPC for individual NOAC).
Patients will be counselled regarding the reasons for the initiation of NOAC
the importance of taking it, and its side effects. It will be explained to them that
if they miss a single dose of NOAC their protection is reduced and therefore
their Stroke risk is increased. Patients will be issued with a yellow warning
card to carry, and a “NOAC use in Cardioversion information leaflet”
Patients will be issued with an outpatient prescription for the first 28 days of
NOAC with counselling on initiation and a letter for their GP to confirm this.
On-going prescriptions around the cardio version period should be provided
by primary care.
The Arrhythmia Nurse Specialist or DCCV co-ordinator will contact the patient
to arrange the date for the procedure and she will discuss the necessary
preparations the patient needs prior to DCCV. This includes ensuring that the
patient will receive a further blood test prior to the procedure, in order to check
U&Es (ensuring potassium is above 4mmol/L).
4. Management of patients taking NOAC on day of DCCV procedure
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At the pre assessment appointment and on the day of the DCCV patient
compliance with NOAC MUST be checked prior to proceeding. If the patient
has missed one dose of NOAC leading up to the DCCV date, the procedure
will be postponed and the patient will be placed on the waiting list for the
following month. A NOAC does not have a long half-life. If a dose or two is
missed this may mean the patient is insufficiently anti-coagulated
If DCCV is repeatedly postponed because of missed single doses then
warfarin would be deemed more appropriate.
Patients may be asked to sign an additional declaration on the consent form
to confirm that they have been fully compliant with the NOAC dosing for the 4
weeks prior to the DCCV procedure and verified on the day of the procedure
by the Arrhythmia Nurse.
If patients have side effects when taking a NOAC then these patients will be
discussed with the Cardiology Consultant.
Pan-Dorset Cardiology Group
NOAC DCCV guidelines February 2015
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5. Management of patients taking NOAC following DCCV procedure
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Post DCCV patients will remain on NOAC until their follow up appointment
with the Arrhythmia Nurse in clinic 4-6 weeks following their procedure. At this
time the patient will be reviewed with regard to maintenance of sinus rhythm
and to assess the need for continuing anticoagulation following discussion
with the Cardiology Consultant / Registrar.
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The choice of anti-coagulation will then be considered with the patient 4-6
weeks post DCCV, if they are to remain on anti-coagulation long term.
6. DOSING
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The dose of NOAC will depend on the drug chosen and the clinical condition
of the patient. Brief details of the recommended dosages can be found below.
Prescribers are advised to check the summary of product characteristics for
the latest information (available from www.medicines.org.uk/emc):
NOAC
Dabigatran:
Dose reduction in:
 Patients > 80 years
 Patients taking Verapamil
Consider reduced dose in:
 Patients between 75 – 80 years of
age (where thromboembolic risk is
low and bleeding risk is high)
 Patients with moderate renal impairment (CrCL 30-50ml/min)
 Patients with gastritis, esophagitis or
gastroesophageal reflux
 Patients at increased risk of bleeding
Rivaroxaban:
Dose reduction in :
 Patients with reduced renal function
with Creatinine clearance between
15 – 49ml/min
Apixaban:
Dose reduction in patients with 2 of the following:
 Age ≥ 80 years
 Body weight ≤ 60kg
Pan-Dorset Cardiology Group
Recommended
dose
Reduced Dose
150mg Twice a
day
110mg twice a
day
20mg Once a day 15mg Once a day
5mg Twice a day
NOAC DCCV guidelines February 2015
2.5mg Twice a
day
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 Serum Creatinine ≥ 133 micromol/l
Where patients are noted to have CrCL 15-29ml/min
a reduced dose of apixaban should be offered.
Contra Indications to NOAC’s
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Hypersensitivity
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Severe renal impairment (CrCL <15 for apixaban and rivaroxaban and <30 for
dabigatran)
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Active clinically significant bleeding
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Concomitant treatment with other anticoagulants
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Hepatic disease associated with coagulopathy and clinically relevant bleeding
risk
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Pregnancy and breast feeding
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Not recommended in patients with prosthetic heart valves
Further information regarding the dose, cautions, contra-indications and
drug interactions can be found in the drug SPC.
7. Follow up clinic
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At 4-6 weeks post DCCV those patients remaining on anticoagulation may be
switched to warfarin therapy. Patients will be switched by referral to the
anticoagulation clinic via their GP. Patients will be given a letter in clinic for
their G.P to confirm choice of anti-coagulation with clear instructions and
guidance.
8. Audit Data for the Arrhythmia Nurse to collect at DCCV & at the patients
4-6 week follow up clinic appointment.
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Any side effects with NOAC.
Any missed doses or issues with adherence
Time to DCCV from referral
CHA2DS2VASc score and success of procedure
Pan-Dorset Cardiology Group
NOAC DCCV guidelines February 2015
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References
National Collaborating Centre for Chronic Conditions. Atrial Fibrillation: National
Clinical Guidelines for management in primary and secondary care. NICE clinical
guideline CG36 full guidance 2006.
European Society of Cardiology. ACC/AHA/ESC 2012 updated guidelines for the\
management of patients with atrial fibrillation – executive summary.
Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Riccardo
Cappato et al. Eur Heart J. 2014; doi: 10.1093/eurheartj/ehu367.
https://www.medicines.org.uk/emc/medicine/24839- Pradaxa 150mg hard capsulesSummary of Product Characteristics. Accessed 1/4/15
https://www.medicines.org.uk/emc/medicine/27220 - Eliquis 5mg film coated tablets –
Summary of Product Characteristics. Accessed 1/4/15
https://www.medicines.org.uk/emc/medicine/25586 - Xarelto 20mg film coated tablets –
Summary of Product Characteristics. Accessed 1/4/15
DMAG Approval Date
Review date
Contact for this Policy
Pan-Dorset Cardiology Group
Nick Bolton, Pharmacist Dorset CCG [email protected]
NOAC DCCV guidelines February 2015