ATCO.MED.B.010 Cardiovascular system
Regulation (EU) 2015/340
(a) Examination:
(1) A standard 12-lead resting electrocardiogram (ECG) and report shall be completed at the examination for the initial issue of a medical certificate and then:
(i) every 4 years until the age of 30;
(ii) at all revalidation or renewal examinations thereafter; and
(iii) when clinically indicated.
(2) An extended cardiovascular assessment shall be completed:
(i) at the first revalidation or renewal examination after the age of 65;
(ii) every 4 years thereafter; and
(iii) when clinically indicated.
(3) Estimation of serum lipids, including cholesterol, shall be required at the examination for the initial issue of a medical certificate, at the first examination after having reached the age of 40, and when clinically indicated.
(b) Cardiovascular system — General:
(1) Applicants with any of the following conditions shall be assessed as unfit:
(i) aneurysm of the thoracic or supra-renal abdominal aorta before surgery;
(ii) significant functional or symptomatic abnormality of any of the heart valves;
(iii) heart or heart/lung transplantation.
(2) Applicants with an established history or diagnosis of any of the following conditions shall be referred to the licensing authority before a fit assessment may be considered:
(i) peripheral arterial disease before or after surgery;
(ii) aneurysm of the thoracic or supra-renal abdominal aorta after surgery;
(iii) aneurysm of the infra-renal abdominal aorta before or after surgery;
(iv) functionally insignificant cardiac valvular abnormalities;
(v) after cardiac valve surgery;
(vi) abnormality of the pericardium, myocardium or endocardium;
(vii) congenital abnormality of the heart, before or after corrective surgery;
(viii) recurrent vasovagal syncope;
(ix) arterial or venous thrombosis;
(x) pulmonary embolism;
(xi) cardiovascular condition requiring systemic anticoagulant therapy.
(c) Blood pressure:
(1) Blood pressure shall be recorded at each examination.
(2) The applicant's blood pressure shall be within normal limits.
(3) Applicants shall be assessed as unfit when:
(i) they have symptomatic hypotension; or
(ii) when their blood pressure at examination consistently exceeds 160 mmHg systolic and/or 95 mmHg diastolic, with or without treatment.
(4) The initiation of medication for the control of blood pressure shall require a period of temporary unfit assessment to establish the absence of significant side effects.
(d) Coronary artery disease:
(1) Applicants with any of the following conditions shall be assessed as unfit:
(i) symptomatic coronary artery disease;
(ii) symptoms of coronary artery disease controlled by medication.
(2) Applicants with any of the following conditions shall be referred to the licensing authority and undergo cardiological evaluation to exclude myocardial ischaemia before a fit assessment may be considered:
(i) suspected myocardial ischaemia;
(ii) asymptomatic minor coronary artery disease requiring no anti-anginal treatment.
(3) Applicants with a history or diagnosis of any of the following conditions shall be referred to the licensing authority and undergo a cardiological evaluation before a fit assessment may be considered:
(i) myocardial ischaemia;
(ii) myocardial infarction;
(iii) revascularisation and stenting for coronary artery disease.
(e) Rhythm/Conduction disturbances:
(1) Applicants for a class 3 medical certificate with any significant disturbance of cardiac conduction or rhythm, intermittent or established shall be referred to the licensing authority and undergo cardiological evaluation with satisfactory results before a fit assessment may be considered. These disturbances shall include any of the following:
(i) disturbance of supraventricular rhythm, including intermittent or established sinoatrial dysfunction, atrial fibrillation and/or flutter and asymptomatic sinus pauses
(ii) complete left bundle branch block;
(iii) Mobitz type 2 atrioventricular block;
(iv) broad and/or narrow complex tachycardia;
(v) ventricular pre-excitation;
(vi) asymptomatic QT prolongation;
(vii) Brugada pattern on electrocardiography.
(2) Applicants with any of the conditions listed in points (i) to (viii) may be assessed as fit in the absence of any other abnormality and subject to satisfactory cardiological evaluation:
(i) incomplete bundle branch block;
(ii) complete right bundle branch block;
(iii) stable left axis deviation;
(iv) asymptomatic sinus bradycardia;
(v) asymptomatic sinus tachycardia;
(vi) asymptomatic isolated uniform supra-ventricular or ventricular ectopic complexes;
(vii) first degree atrioventricular block;
(viii) Mobitz type 1 atrioventricular block.
(3) Applicants with a history of any of the following conditions shall be referred to the licensing authority and undergo cardiological evaluation with satisfactory results before a fit assessment may be considered:
(i) ablation therapy;
(ii) pacemaker implantation.
(4) Applicants with any of the following conditions shall be assessed as unfit:
(i) symptomatic sinoatrial disease;
(ii) complete atrioventricular block;
(iii) symptomatic QT prolongation
(iv) an automatic implantable defibrillating system;
(v) a ventricular anti-tachycardia pacemaker.
AMC1 ATCO.MED.B.010 Cardiovascular system
ED Decision 2015/010/R
(a) Electrocardiography
(1) An exercise electrocardiogram (ECG) when required as part of a cardiovascular assessment should be symptom-limited and completed to a minimum of Bruce Stage IV or equivalent.
(2) Reporting of resting and exercise ECGs should be carried out by the AME or an appropriate specialist.
(b) General
(1) Cardiovascular risk factor assessment
(i) Serum/plasma lipid estimation is case finding and significant abnormalities should require investigation and management under the supervision of the AeMC or AME in consultation with the licensing authority if necessary.
(ii) An accumulation of risk factors (smoking, family history, lipid abnormalities, hypertension, etc.) should require cardiovascular evaluation by the AeMC or AME in consultation with the licensing authority if necessary.
(2) Extended cardiovascular assessment
(i) The extended cardiovascular assessment should be undertaken at an AeMC or by a cardiologist.
(ii) The extended cardiovascular assessment should include an exercise ECG or other test that will provide equivalent information.
(c) Peripheral arterial disease
Applicants with peripheral arterial disease, before or after surgery, should undergo satisfactory cardiological evaluation including an exercise ECG and 2D echocardiography. Further tests may be required which should show no evidence of myocardial ischaemia or significant coronary artery stenosis. A fit assessment may be considered provided: (1) the exercise ECG is satisfactory; and (2) there is no sign of significant coronary artery disease or evidence of significant atheroma elsewhere, and no functional impairment of the end organ supplied.
(d) Aortic aneurysm
(1) Applicants with an aneurysm of the infra-renal abdominal aorta may be assessed as fit following a satisfactory cardiological evaluation.
(2) Applicants may be assessed as fit after surgery for an aneurysm of the thoracic or abdominal aorta if the blood pressure and cardiovascular evaluation are satisfactory.
Regular evaluations by a cardiologist should be carried out.
(e) Cardiac valvular abnormalities
(1) Applicants with previously unrecognised cardiac murmurs should require cardiological evaluation. If considered significant, further investigation should include at least 2D Doppler echocardiography.
(2) Applicants with minor cardiac valvular abnormalities may be assessed as fit by the licensing authority. Applicants with significant abnormality of any of the heart valves should be assessed as unfit.
(3) Aortic valve disease
(i) Applicants with bicuspid aortic valve may be assessed as fit if no other cardiac or aortic abnormality is demonstrated. Regular cardiological follow-up, including 2D Doppler echocardiography, may be required.
(ii) Applicants with mild aortic stenosis may be assessed as fit. Annual cardiological follow-up may be required and should include 2D Doppler echocardiography.
(iii) Applicants with aortic regurgitation may be assessed as fit only if regurgitation is minor and there is no evidence of volume overload. There should be no demonstrable abnormality of the ascending aorta on 2D Doppler echocardiography. Cardiological follow-up including 2D Doppler echocardiography may be required.
(4) Mitral valve disease
(i) Applicants with rheumatic mitral stenosis may only be assessed as fit in favorable cases after cardiological evaluation including 2D echocardiography.
(ii) Applicants with uncomplicated minor regurgitation may be assessed as fit. Regular cardiological follow-up including 2D echocardiography may be required.
(iii) Applicants with mitral valve prolapse and mild mitral regurgitation may be assessed as fit.
(iv) Applicants with evidence of volume overloading of the left ventricle demonstrated by increased left ventricular end-diastolic diameter should be assessed as unfit.
(f) Valvular surgery
Applicants with cardiac valve replacement/repair should be assessed as unfit. After a satisfactory cardiological evaluation, fit assessment may be considered.
(1) Asymptomatic applicants may be assessed as fit by the licensing authority six months after valvular surgery subject to:
(i) normal valvular and ventricular function as judged by 2D Doppler echocardiography.
(ii) satisfactory symptom-limited exercise ECG or equivalent;
(iii) demonstrated absence of coronary artery disease unless this has been satisfactorily treated by re-vascularisation;
(iv) no cardioactive medication is required;
(v) annual cardiological follow-up to include an exercise ECG and 2D Doppler echocardiography. Longer periods may be acceptable once a stable condition has been confirmed by cardiological evaluations.
(2) Applicants with implanted mechanical valves may be assessed as fit subject to documented exemplary control of their anti-coagulant therapy. Age factors should form part of the risk assessment.
(g) Thromboembolic disorders
Applicants with arterial or venous thrombosis or pulmonary embolism should be assessed as unfit during the first six months of anticoagulation. A fit assessment, with a limitation if necessary, may be considered by the licensing authority after six months of stable anticoagulation. Anticoagulation should be considered stable if, within the last six months, at least five international normalised ratio (INR) values are documented, of which at least four are within the INR target range and the haemorrhagic risk is acceptable. In cases of anticoagulation medication not requiring INR monitoring, a fit assessment may be considered after review by the licensing authority after a period of three months. Applicants with pulmonary embolism should also be evaluated by a cardiologist. Following cessation of anticoagulant therapy, for any indication, applicants should undergo a reassessment by the licensing authority.
(h) Other cardiac disorders
(1) Applicants with a primary or secondary abnormality of the pericardium, myocardium or endocardium should be assessed as unfit. A fit assessment may be considered following complete resolution and satisfactory cardiological evaluation which may include 2D Doppler echocardiography, exercise ECG, 24-hour ambulatory ECG, and/or myocardial perfusion scan or equivalent test. Coronary angiography may be indicated. Regular cardiological follow-up may be required.
(2) Applicants with a congenital abnormality of the heart should be assessed as unfit. Applicants following surgical correction or with minor abnormalities that are functionally unimportant may be assessed as fit following cardiological assessment. No cardioactive medication is acceptable. Investigations may include 2D Doppler echocardiography, exercise ECG and 24-hour ambulatory ECG. Regular cardiological follow-up may be required.
(i) Syncope
(1) Applicants with a history of recurrent episodes of syncope should be assessed as unfit. A fit assessment may be considered after a sufficient period of time without recurrence provided cardiological evaluation is satisfactory.
(2) A cardiological evaluation should include:
(i) a satisfactory symptom exercise ECG. If the exercise ECG is abnormal, a myocardial perfusion scan or equivalent test should be required;
(ii) a 2D Doppler echocardiogram showing neither significant selective chamber enlargement nor structural or functional abnormality of the heart, valves or myocardium;
(iii) a 24-hour ambulatory ECG recording showing no conduction disturbance, complex or sustained rhythm disturbance or evidence of myocardial ischaemia;
(iv) a tilt test carried out to a standard protocol showing no evidence of vasomotor instability.
(3) Neurological review should be required.
(j) Blood pressure
(1) Anti-hypertensive treatment should be agreed by the licensing authority. Medication may include:
(i) non-loop diuretic agents;
(ii) Angiotensin Converting Enzyme (ACE) inhibitors;
(iii) angiotensin II receptor blocking agents;
(iv) long-acting slow channel calcium blocking agents;
(v) certain (generally hydrophilic) beta-blocking agents.
(2) Following initiation of medication for the control of blood pressure, applicants should be re-assessed to verify that the treatment is compatible with the safe exercise of the privileges of the licence.
(k) Coronary artery disease
(1) Applicants with chest pain of an uncertain cause should undergo a full investigation before a fit assessment may be considered. Applicants with angina pectoris should be assessed as unfit, whether or not it is abolished by medication.
(2) Applicants with suspected asymptomatic coronary artery disease should undergo a cardiological evaluation including exercise ECG. Further tests (myocardial perfusion scanning, stress echocardiography, coronary angiography or equivalent) may be required, which should show no evidence of myocardial ischaemia or significant coronary artery stenosis.
(3) After an ischaemic cardiac event, including revascularisaton, applicants without symptoms should have reduced any vascular risk factors to an appropriate level. Medication, when used to control cardiac symptoms, is not acceptable. All applicants should be on acceptable secondary prevention treatment.
(i) A coronary angiogram obtained around the time of, or during, the ischaemic myocardial event and a complete, detailed clinical report of the ischaemic event and of any operative procedures should be available.
(A) there should be no stenosis more than 50 % in any major untreated vessel, in any vein or artery graft or at the site of an angioplasty/stent, except in a vessel subtending a myocardial infarction;
(B) the whole coronary vascular tree should be assessed as satisfactory by a cardiologist, and particular attention should be paid to multiple stenoses and/or multiple revascularisations;
(C) an untreated stenosis greater than 30 % in the left main or proximal left anterior descending coronary artery should not be acceptable.
(ii) At least six months from the ischaemic myocardial event, including revascularization, the following investigations should be completed:
(A) an exercise ECG showing neither evidence of myocardial ischaemia nor rhythm or conduction disturbance;
(B) an echocardiogram or equivalent test showing satisfactory left ventricular function with no important abnormality of wall motion (such as dyskinesia or akinesia) and a left ventricular ejection fraction of 50 % or more;
(C) in cases of angioplasty/stenting, a myocardial perfusion scan or equivalent test, which should show no evidence of reversible myocardial ischaemia. If there is any doubt about myocardial perfusion, in other cases (infarction or bypass grafting), a perfusion scan should also be required;
(D) further investigations, such as a 24-hour ECG, may be necessary to assess the risk of any significant rhythm disturbance.
(iii) Follow-up should be conducted annually (or more frequently, if necessary) to ensure that there is no deterioration of the cardiovascular status. It should includea cardiological evaluation, exercise ECG and cardiovascular risk assessment. Additional investigations may be required.
(iv) After coronary artery vein bypass grafting, a myocardial perfusion scan or equivalent test should be performed on clinical indication, and in all cases within five years from the procedure.
(v) In all cases, coronary angiography, or an equivalent test, should be considered at any time if symptoms, signs or non-invasive tests indicate myocardial ischaemia.
(vi) Applicants may be assessed as fit after successful completion of the three-month or subsequent review.
(l) Rhythm and conduction disturbances
(1) Applicants with any significant rhythm or conduction disturbance may be assessed as fit after cardiological evaluation and with appropriate follow-up. Such evaluation should include:
(i) exercise ECG which should show no significant abnormality of rhythm or conduction, and no evidence of myocardial ischaemia. Withdrawal of cardioactive medication prior to the test should be required;
(ii) 24-hour ambulatory ECG which should demonstrate no significant rhythm or conduction disturbance;
(iii) 2D Doppler echocardiogram which should show no significant selective chamber enlargement or significant structural or functional abnormality, and a left ventricular ejection fraction of at least 50 %.
Further evaluation may include:
(iv) 24-hour ECG recording repeated as necessary;
(v) electrophysiological study;
(vi) myocardial perfusion imaging or equivalent test;
(vii) cardiac magnetic resonance imaging (MRI) or equivalent test;
(viii) coronary angiogram or equivalent test.
(2) Applicants with supraventricular or ventricular ectopic complexes on a resting ECG may require no further evaluation, provided the frequency can be shown to be no greater than one per minute, for example on an extended ECG strip.Applicants with asymptomatic isolated uniform ventricular ectopic complexes may be assessed as fit, but frequent or complex forms require full cardiological evaluation.
(3) Where anticoagulation is needed for a rhythm disturbance, a fit assessment may be considered if the haemorrhagic risk is acceptable and the anticoagulation is stable. Anticoagulation should be considered stable if, within the last six months, at least five INR values are documented, of which at least four are within the INR target range. In cases of anticoagulation medication not requiring INR monitoring, a fit assessment with an appropriate limitation may be considered after review by the licensing authority after a period of three months.
(4) Ablation
(i) Applicants who have undergone ablation therapy should be assessed as unfit for a minimum period of two months.
(ii) A fit assessment may be considered following successful catheter ablation provided an electrophysiological study (EPS) demonstrates satisfactory control has been achieved.
(iii) Where EPS is not performed, longer periods of unfitness and cardiological follow-up should be considered.
(iv) Follow-up should include a cardiological review.
(5) Supraventricular arrhythmias
Applicants with significant disturbance of supraventricular rhythm, including sinoatrial dysfunction, whether intermittent or established, should be assessed as unfit. A fit assessment may be considered if cardiological evaluation is satisfactory.
(i) For initial applicants with atrial fibrillation/flutter, a fit assessment should be limited to those with a single episode of arrhythmia which is considered to be unlikely to recur.
(ii) For revalidation, applicants may be assessed as fit if cardiological evaluation is satisfactory and the stroke risk is sufficiently low. A fit assessment may be considered after a period of stable anticoagulation as prophylaxis, after review by the licensing authority. Anticoagulation should be considered stable if, within the last six months, at least five INR values are documented, of which at least four are within the INR target range. In cases of anticoagulation medication not requiring INR monitoring, a fit assessment may be considered after review by the licensing authority after a period of three months.
(iii) Applicants with asymptomatic sinus pauses up to 2.5 seconds on a resting ECG may be assessed as fit if exercise ECG, 2D echocardiography and 24-hour ambulatory ECG are satisfactory.
(iv) Applicants with symptomatic sino-atrial disease should be assessed as unfit.
(6) Mobitz type 2 atrio-ventricular block
Applicants with Mobitz type 2 AV block may be assessed as fit after a full cardiological evaluation confirms the absence of distal conducting tissue disease.
(7) Complete right bundle branch block
Applicants with complete right bundle branch block should require cardiological evaluation on first presentation.
(8) Complete left bundle branch block
A fit assessment may be considered as follows:
(i) Initial applicants may be assessed as fit after full cardiological evaluation showing no pathology. Depending on the clinical situation, a period of stability may be required.
(ii) Applicants for revalidation or renewal of a medical certificate with a de-novo left bundle branch block may be assessed as fit after cardiological evaluation showing no pathology. A period of stability may be required.
(iii) A cardiological evaluation should be required after 12 months in all cases.
(9) Ventricular pre-excitation
Applicants with pre-excitation may be assessed as fit if they are asymptomatic, and an electrophysiological study, including an adequate drug-induced autonomic stimulation protocol, reveals no inducible re-entry tachycardia and the existence of multiple pathways is excluded. Cardiological follow-up should be required including a 24-hour ambulatory ECG recording showing no tendency to symptomatic or asymptomatic tachy-arrhythmia.
(10) Pacemaker
Applicants with a subendocardial pacemaker may be assessed as fit three months after insertion provided:
(i) there is no other disqualifying condition;
(ii) bipolar lead systems programmed in bipolar mode without automatic mode change have been used;
(iii) that the applicant is not pacemaker dependent;
(iv) regular cardiological follow-up should include a symptom-limited exercise ECG that shows no abnormality or evidence of myocardial ischaemia.
(11) QT prolongation
Applicants with asymptomatic QT-prolongation may be assessed as fit subject to a satisfactory cardiological evaluation.
(12) Brugada pattern on electrocardiography
Applicants with a Brugada pattern Type 1 should be assessed as unfit. Applicants with Type 2 or Type 3 may be assessed as fit, with limitations as appropriate, subject to satisfactory cardiological evaluation.
GM1 ATCO.MED.B.010 Cardiovascular system
ED Decision 2015/010/R
MITRAL VALVE DISEASE
(a) Minor regurgitation should have evidence of no thickened leaflets or flail chordae and left atrial internal diameter of less than or equal to 4.0 cm.
(b) The following may indicate severe regurgitation:
(1) LV internal diameter (diastole) > 6.0 cm; or
(2) LV internal diameter (systole) > 4.1 cm; or
(3) Left atrial internal diameter > 4.5 cm.
(c) Doppler indices, such as width of jet, backwards extension and whether there is flow reversal in the pulmonary veins may be helpful in assessing severity of regurgitation.
GM2 ATCO.MED.B.010 Cardiovascular system
ED Decision 2015/010/R
VENTRICULAR PRE-EXCITATION
(a) Asymptomatic applicants with pre-excitation may be assessed as fit at revalidation with an Operational Multi-pilot Limitation (OML) if they meet the following criteria:
(1) no inducible re-entry;
(2) refractory period > 300 ms;
(3) no induced atrial fibrillation.
(b) There should be no evidence of multiple accessory pathways.
GM3 ATCO.MED.B.010 Cardiovascular system
ED Decision 2015/010/R
COMPLETE LEFT BUNDLE BRANCH BLOCK
Left bundle branch block is more commonly associated with coronary artery disease and, thus, requires more in-depth investigation, which may be invasive.
GM4 ATCO.MED.B.010 Cardiovascular system
ED Decision 2015/010/R
PACEMAKER
(a) Scintigraphy may be helpful in the presence of conduction disturbance/paced complexes in the resting ECG.
(b) Experience has shown that any failures of pacemakers are most likely to occur in the first three months after being fitted. Therefore, a fit assessment should not be considered before this period has elapsed.
(c) It is known that certain operational equipment may interfere with the performance of the pacemaker. The type of pacemaker used, therefore, should have been tested to ensure it does not suffer from interference in the operational environment. Supporting data and a performance statement to this effect should be available from the supplier.
GM5 ATCO.MED.B.010 Cardiovascular system
ED Decision 2015/010/R
ANTICOAGULATION
Applicants and licence holders taking anticoagulant medication which requires monitoring with INR testing, should measure their INR on a ‘near patient’ testing system within 12 hours prior to starting a shift pattern and then at least every three days during the shift pattern. The privileges of the license should only be exercised if the INR is within the target range. The INR result should be recorded and the results should be reviewed at each aero-medical assessment.