GUIDELINES FOR AJMALINE CHALLENGE FOR BRUGADA SYNDROME. Medical Director. Medicine Specialities. November 2018 N/A. Outcome 9

Transcription

1 Index No: GUIDELINES FOR AJMALINE CHALLENGE FOR BRUGADA SYNDROME Version: 1.0 Date ratified: November 2015 Ratified by: (Name of Committee) Name of originator/author, job title and department: Director Lead (Trust-wide policies) Associate Medical Director (local Policies) Clinical Management Team / Directorate Applicable to Name of responsible committee for the policy: Medicines Management Committee Hina Mistry (Advanced Cardiorespiratory Pharmacist) Medical Director Medicine Specialities Medicines Management Committee Date issued for publication: November 2015 Review date: September 2018 Expiry date: (Date 3 months following review date) Equality impact assessed by: (name, job title and department) Date impact assessed: Registration Requirements Outcome Number(s) (CQC) November 2018 N/A N/A Outcome 9 Page 1 of 13

2 CONTRIBUTION LIST Individuals involved in developing the document Name Hina Mistry Simon Hetherington Andrew Whittaker Designation Advanced Cardio-respiratory Pharmacist Consultant Cardiologist Consultant Cardiologist Circulated to the following individuals for consultation Name Dave Love Karen Roberts Designation Ward Manager Cath Lab Ward Manager Coronary Care Unit Page 2 of 13

3 Index No. Approval and Authorisation Completion of the following signature blocks signifies the review and approval of this process. Name Job Title Signature Date Mr Robin Lee Chair of MMC 11 November 2015 Local Committee approval (where applicable) Name of Committee Medicines Management Committee Change History Name of Chairperson Mr Robin Lee Date of Approval 11 November 2015 Version Date Author Reason Impact Assessment This clinical guideline does not involve direct engagement with staff, patients, carers, visitors, the public or others and therefore does not require an Impact Assessment in line with Procedure D10a. A translation service is available for this policy. The Interpretation/Translation Policy, Guidance for Staff (I55) is located on the library intranet under Trust wide policies. Page 3 of 13

4 CONTENTS 1. Introduction 5 2. Guideline for the Ajmaline challenge Ajmaline pre-challenge check-list Ajmaline challenge Termination criteria Positive ECG tests Reversal of Ajmaline challenge with Isoprenaline Post test procedure 5 3. Monitoring 7 4. Plan for dissemination and implementation 7 5. References 7 6. Appendix 1: Ajmaline challenge form 8 7. Appendix 2: Drugs that prolong the QT interval Appendix 3: Patient information leaflet for Ajmaline 11 Page 4 of 13

5 INTRODUCTION Brugada syndrome is a rare inherited heart rhythm disturbance that restricts the flow of sodium ions into the heart cells. As a result, the flow of electrical impulses through the heart is disrupted, which can lead to life-threatening heart rhythms 1. Ajmaline is an anti-arrhythmic drug used in the diagnosis of Brugada syndrome. When given to a patient with a suspected Brugada pattern, it can reveal the abnormal ECG pattern characteristic of the syndrome. This guideline explains how Ajmaline should be administered to reveal the Brugada pattern on an ECG in patients suspected of the syndrome. It is a specialist investigation which should only be undertaken by staff familiar with the test and where ECG monitoring and immediate advanced resuscitation facilities are available. GUIDELINE FOR THE AJMALINE CHALLENGE Because of the small risk of inducing life-threatening ventricular arrhythmia with Ajmaline in patients with Brugada Syndrome, it is recommended that the procedure should only be undertaken in the cardiac catheter lab, where full resuscitation facilities and senior help is available. Continuous 12 lead monitoring is performed by the Cardiac Physiologist via the lab haemodynamic system, allowing accurate measurement of QRS duration at appropriate time intervals and full disclosure recording. Ajmaline pre-challenge check-list Before beginning the Ajmaline challenge, all necessary pre-test checks must be completed by the professional undertaking the investigation. See appendix 1 for the protocol check list form. Once pre-test checks have been completed and satisfactory the test may be performed. Ajmaline challenge 1. Draw up 20ml of 5mg/ml ajmaline solution (= 100mg ajmaline) 2. Perform a 12 lead ECG at baseline with leads V1 and V2 in the conventional 4 th ICS and leads V5 and V6 in modified position (V1 and V2 in the 2 nd or 3 rd ICS). 3. Inject 2ml (10mg) of ajmaline solution over 30 seconds followed by 5ml saline bolus every 1 to 2 minutes until termination criteria is met (see below), or maximum weight adjusted dose is given (1mg/kg body weight up to maximum of 100mg, maximum administration rate 10mg per minute) 4. Repeat ECG every 2 minutes assessing for typical changes, QRS duration, QT interval, PR interval and presence of ventricular arrhythmia Page 5 of 13

6 Termination Criteria Stop the infusion if: 1. A typical type-1 Brugada pattern appears in more than one right precordial lead (V1-V3) 2. Ventricular arrhythmias (VE s or VT) are seen. 3. QRS duration prolongs >30% from baseline 4. Sinus arrest 5. Type 2 or 3 AV Block 6. Maximum dose given Ajmaline is deactivated quickly and its effects wear off after a few minutes. Monitor until the ECG has normalised. The patient may experience cutaneous flushing and eyelid twitching. Other side effects are rare. Positive ECG tests In the case of a negative baseline ECG, a J-wave elevation of >2 mm absolute amplitude with typical cove-type pattern in lead V1 and V2 and/or V3 with or without RBBB is considered positive. Conversion of a type 2 or 3 ECG to a type 1 is considered positive if the above criteria are met. An increase in the J-wave amplitude of more than 2 mm without the development of a type 1 configuration is also considered significant, but is rarely observed. If ventricular arrhythmias are observed, treatment is with intravenous Isoprenaline (Isoproterenol) infusion as below. Reversal of Ajmaline challenge with Isoprenaline Commence intravenous isoprenaline infusion (0.2mg isporenaline/100ml 0.9% sodium Chloride 0.9%) at 2 micrograms / min (= 1ml/min) for 30 minutes Monitor ECG continuously and repeat 12-lead ECG hourly until Brugada changes resolve Patients may be discharged four hours after isoprenaline infusion has finished if deemed clinically safe to do so. Page 6 of 13

7 Post challenge procedure For patients with a negative result If test is negative (no Brugada ECG changes and no complications) patient can be discharged two hours after last dose of ajmaline was injected For patients with a positive result If test is positive patient should remain on ECG monitor with hourly ECGs until changes resolve (this should take no more than 3 hours). Medications that impair conduction or prolong the QT interval should be avoided if at all possible (Appendix 2 provides a list of drugs that prolong the QT interval and should be avoided by the patient in future). MONITORING ARRANGEMENTS FOR COMPLIANCE AND EFFECTIVENESS Aspect of compliance or effectiveness being monitored The document is intended to guide clinicians. Adherence is not mandatory and so compliance monitoring is not required. Monitoring method See above Responsibility for monitoring See above Frequency of monitoring See above Responsible committee for monitoring and implementation of required actions See above PLAN FOR DISSEMINATION AND IMPLEMENTATION This guideline will be implemented and disseminated via the following methods: Placed on the hospital intranet sites Available in areas where the Ajmaline challenge is likely to be carried out, for example on coronary care unit (CCU) and the Cardiac centre. REFERENCES Rolf. S (2003) The Ajmaline challenge in Brugada syndrome: Diagnostic impact, safety and recommended protocol. European Heart Journal. 24, Page 7 of 13

8 APPENDIX 1 AJMALINE CHALLENGE FORM Allergies/Sensitivities Patient weight: (Space for patient identification label) Pre-challenge check-list: 1. No contraindications to Ajmaline challenge Tick Moderate LV systolic function or worse Complete RBBB or LBBB Myocardial infarction in past three months Evidence of sinus node disease 2nd-degree AV-nodal block Hypertrophic cardiomyopathy QTC prolongation Myasthenia gravis Diagnostic Brugada pattern already present on ECG Allergic to Ajmaline 2. Medications stopped on the day of the Ajmaline challenge If possible all medications should be avoided on the day of the test. Medications that impair conduction or prolong the Q-T interval should be avoided if at all possible (see appendix). The test can be performed if medications have been taken, but risk of arrhythmia is higher. 3. Advanced Life Support facilities immediately accessible 4. U&E and LFTs satisfactory within last four weeks: 5. No previous adverse reactions to ajmaline 6. Clear fluids only for 6 hours prior to test: 7. Patient consented 8. Patient weight documented 9. Baseline heart rate, blood pressure and ECG documented 10. Ajmaline prescribed Proceed with test if all pre-challenge check list criteria are met. Check completed by: Signature: Print name: Date: Page 8 of 13

9 Ajmaline Administration Unlicensed product information Batch number Expiry date Prescription Date Drug Infusion instructions Dose/infusion rate Prescriber s signature Ajmaline 100mg of Ajmaline in 20ml syringe Inject 2ml (10mg) over 30 seconds followed by a 5ml bolus of Sodium chloride 0.9%. Wait 1-2 minutes and record heart rate, blood pressure and ECG. If no changes repeat administration of 10mg doses as above and complete the test. Infusion administration record Time Ajmaline dose Heart rate Blood pressure Pre-Ajmaline +ve ECG (Yes / No) 10mg 20mg 30mg 40mg 50mg 60mg 70mg 80mg 90mg 100mg Page 9 of 13

10 APPENDIX 2: Drugs that prolong the QT interval This is a list of drugs that have been associated with a risk of prolongation of the QT interval. The risk is not the same with all drugs, but there is some risk of prolongation of the QT interval with all of these agents. Adrenaline Ajmaline Albuterol Alfuzosin Almokalant Amantidine Amiodarone Amitriptyline Amoxapine Amphetamine Anagrelide Apomorphine Arformoterol Aripiprazole Arsenic trioxide Astemizole Atomoxetine Azelastine Azimilide Azithromycin Bepridil Bretylium Chloral hydrate Chloroquine Chlorpromazine Cibenzoline Ciprofloxacin Cisapride Citalopram Clarithromycin Clobutinol Clomipramine Clozapine Cocaine Cotrimoxazole d-sotalol Dabrafenib Desipramine Dexemedetomidine Dihydroquinidine Diphenhydramine Disopyramide Dobutamine Dofetilide Dolasetron Domperidone Dopamine Doxepin Dronedarone Droperidol Ebastine Encainide Ephedrine Epinephrine Ersentilide Erythromycin Felbamate Fenfluramine Flecainide Fluconazole Fluoxetine Fluphenazine Formeterol Foscarnet Fosphenytoin Galantamine Gatifloxacin Geldanamycin Gemifloxacin Granisetron Grepafloxacin Halofantrine Haloperidol Hydrochlorthiazid e Hydroxyzine Ibutilide Imipramine Indapamide Isradipine Itraconazole Ivabradine Ketanserin Ketoconazole Levalbuterol Levofloxacin Levomethadyl Lidoflazine Lithium Maprotiline Mesoridazine Metaproterenol Methadone Methylphenidate Mexiletine Midodrine Mifepristone Mirabegron Moexipril Moxifloxacin Naratriptan Nelfinavir Nicardipine Nifekalant Noradrenaline Norepinephrine Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paroxetine Pasireotide Pentamidine Perflutren lipid microspheres Pericycline Phentermine Phenylephrine Pimozide Pirmenol Prenylamine Probucol Procainamide Prochlorperazine Propafenone Protriptyline Pseudoephidrine Quetiapine Quinidine Quinine Ranolazine Rilpirivine Risperidone Ritodrine Roxithromycin Salbutamol Salmeterol Sematilide Sertindole Sertraline Sibutramine Solifenacin Sotalol Sparfloxacin Spiramycin Sulpiride Sumatriptan Sunitib Tacrolimus Tamoxifen Telavancin Telithromycin Terbutaline Terfenadine Terikalant Terodiline Tetrabenazine Thioridazine Tizanidine Tolterodine Trazodone Trifluoperazine Trimethoprim Trimipramine Vardenafil Vasopressin Venlafaxine Voriconazole Vorinostat Zimeldine Ziprasidone Zolmitriptan Page 10 of 13

11 APPENDIX 3: Patient Information Leaflet Page 11 of 13

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