MED.B.010 Cardiovascular System

(a)Examination Exercise electrocardiography An exercise ECG when required as part of a cardiovascular assessment should be symptom limited and completed to a minimum of Bruce Stage IV or equivalent.

(b)General

(1)Cardiovascular risk factor assessment

(i)Serum lipid estimation is case finding and significant abnormalities should be reviewed, investigated and supervised by the AeMC or AME in consultation with the medical assessor of the licensing authority.

(ii)Applicants with an accumulation of two or more risk factors should undergo a cardiovascular evaluation by the AeMC or AME, if necessary in consultation with the medical assessor of the licensing authority.

(iii)Cardiovascular risk factor assessment should be performed using risk calculators relevant for the target population and taking into consideration the latest guidelines on cardiovascular disease prevention.

(iv)Cardiovascular risk factor assessment should take place at least once every 5 years for applicants 40 to 49 years old, once every 3 years for applicants 50 to 59 years old and once every 2 years thereafter. A more frequent assessment of the cardiovascular risk factors may be considered when risk factors have been identified.

(2)Cardiovascular assessment

(i)Reporting of resting and exercise electrocardiograms should be by the AME or an accredited specialist.

(ii)The extended cardiovascular assessment should be undertaken at an AeMC or may be delegated to a cardiologist.

(iii)For applicants involved in single-pilot HEMS operations who have reached the age of 60, the extended cardiovascular assessment should include at least the following elements:

(A)resting ECG;

(B)exercise ECG;

(C)serum lipids;

(D)glycosylated haemoglobin test (HbA1c);

(E)echocardiography;

(F)arterial doppler ultrasound carotid arteries, and at clinical indication thoracic or abdominal aorta could be considered.

(c)Peripheral arterial disease If there is no significant functional impairment, a fit assessment may be considered provided:

(1)applicants without symptoms of coronary artery disease have reduced any vascular risk factors to an appropriate level;

(2)applicants should be on appropriate secondary prevention treatment;

(3)exercise electrocardiography is satisfactory. Further tests may be required which should show no evidence of myocardial ischaemia or significant coronary artery stenosis.

(d)Aortic aneurysm

(1)Applicants with an aneurysm of the infra-renal abdominal aorta of less than 5 cm in diameter may be assessed as fit before surgery, with an OML subject to satisfactory evaluation by a cardiologist. Follow-up by ultra-sound scans or other imaging techniques, as necessary, should be determined by the medical assessor of the licensing authority.

(2)Applicants may be assessed as fit with an OML after surgery for an aneurysm of the thoracic or abdominal aorta if the blood pressure and cardiovascular evaluation is satisfactory. Regular evaluations by a cardiologist should be carried out.

(e)Cardiac valvular abnormalities

(1)Applicants with previously unrecognised cardiac murmurs should undergo evaluation by a cardiologist and assessment by the medical assessor of the licensing authority. If considered significant, further investigation should include at least 2D Doppler echocardiography or equivalent imaging.

(2)Applicants with minor cardiac valvular abnormalities may be assessed as fit. Applicants with significant abnormality of any of the heart valves should be assessed as unfit.

(3)Aortic valve disease

(i)Applicants with a bicuspid aortic valve may be assessed as fit if no other cardiac or aortic abnormality is demonstrated. Follow-up with echocardiography, as necessary, should be determined by the medical assessor of the licensing authority.

(ii)Applicants with aortic stenosis may be assessed as fit provided the left ventricular function is intact and the mean pressure gradient is less than 20 mmHg. Applicants with an aortic valve orifice with indexation on the body surface of more than 0.6 cm2/m2 and a mean pressure gradient above 20 mmHg, but not greater than 50 mmHg, may be assessed as fit with an OML. Follow-up with 2D Doppler echocardiography, as necessary, should be determined by the medical assessor of the licensing authority in all cases. Alternative measurement techniques with equivalent ranges may be used. Regular evaluation by a cardiologist should be considered. Applicants with a history of systemic embolism or significant dilatation of the thoracic aorta should be assessed as unfit.

(iii)Applicants with trivial aortic regurgitation may be assessed as fit. A greater degree of aortic regurgitation should require an OML. There should be no demonstrable abnormality of the ascending aorta on 2D Doppler echocardiography. Follow-up, as necessary, should be determined by the medical assessor of the licensing authority.

(4)Mitral valve disease

(i)Asymptomatic applicants with an isolated mid-systolic click due to mitral leaflet prolapse may be assessed as fit.

(ii)Applicants with rheumatic mitral stenosis should normally be assessed as unfit.

(iii)Applicants with minor regurgitation may be assessed as fit. Periodic cardiological review should be determined by the medical assessor of the licensing authority.

(iv)Applicants with moderate mitral regurgitation may be considered as fit with an OML if the 2D Doppler echocardiogram demonstrates satisfactory left ventricular dimensions and satisfactory myocardial function is confirmed by exercise electrocardiography. Periodic cardiological review should be required, as determined by the medical assessor of the licensing authority.

(v)Applicants with evidence of volume overloading of the left ventricle demonstrated by increased left ventricular end-diastolic diameter or evidence of systolic impairment should be assessed as unfit.

(f)Valvular surgery Applicants who have undergone cardiac valve replacement or repair should be assessed as unfit. A fit assessment may be considered in the following cases:

(1)Mitral leaflet repair for prolapse is compatible with a fit assessment, provided post-operative investigations reveal satisfactory left ventricular function without systolic or diastolic dilation and no more than minor mitral regurgitation.

(2)Asymptomatic applicants with a tissue valve or with a mechanical valve who, at least 6 months following surgery, are taking no cardioactive medication may be considered for a fit assessment with an OML. Investigations which demonstrate normal valvular and ventricular configuration and function should have been completed as demonstrated by:

(i)a satisfactory symptom limited exercise ECG. Myocardial perfusion imaging/stress echocardiography should be required if the exercise ECG is abnormal or any coronary artery disease is suspected;

(ii)a 2D Doppler echocardiogram showing no significant selective chamber enlargement, a tissue valve with minimal structural alteration and a normal Doppler blood flow, and no structural or functional abnormality of the other heart valves. Left ventricular fractional shortening should be normal. Follow-up with exercise ECG and 2D echocardiography, as necessary, should be determined by the medical assessor of the licensing authority.

(3)Where anticoagulation is needed after valvular surgery, a fit assessment with an OML may be considered if the haemorrhagic risk is acceptable and the anticoagulation is stable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 international normalised ratio (INR) values are documented, of which at least 4 are within the INR target range. The INR target range should be determined by the type of surgery performed.

(g)Thromboembolic disorders Applicants with arterial or venous thrombosis or pulmonary embolism should be assessed as unfit. A fit assessment with an OML may be considered after a period of stable anticoagulation as prophylaxis, after review by the medical assessor of the licensing authority. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range and the haemorrhagic risk is acceptable. In cases of anticoagulation medication not requiring INR monitoring, a fit assessment with an OML may be considered after review by the medical assessor of the licensing authority after a stabilisation period of 3 months. Applicants with pulmonary embolism should also be evaluated by a cardiologist. Following cessation of anticoagulant therapy, for any indication, applicants should undergo a re-assessment by the medical assessor of 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 and/or myocardial perfusion imaging/stress echocardiography and 24-hour ambulatory ECG. Coronary angiography may be indicated. Frequent review and an OML may be required after fit assessment.

(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 evaluation. No cardioactive medication is acceptable. Investigations may include 2D Doppler echocardiography, exercise ECG and 24-hour ambulatory ECG. The potential hazard of any medication should be considered as part of the assessment. Particular attention should be paid to the potential for the medication to mask the effects of the congenital abnormality before or after surgery. Regular cardiological evaluations should be carried out.

(i)Syncope

(1)In the case of a single episode of vasovagal syncope which can be explained and is compatible with flight safety, a fit assessment may be considered.

(2)Applicants with a history of recurrent vasovagal syncope should be assessed as unfit. A fit assessment may be considered after a 6-month period without recurrence, provided cardiological evaluation is satisfactory. Such evaluation should include:

(i)a satisfactory symptom limited 12 lead exercise ECG to Bruce Stage IV, or equivalent. If the exercise ECG is abnormal, myocardial perfusion imaging/stress echocardiography or equivalent test should be carried out;

(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.

(3)A tilt test, or equivalent, carried out to a standard protocol showing no evidence of vasomotor instability may be required.

(4)Neurological review should be required.

(5)An OML should be required until a period of 5 years has elapsed without recurrence. The medical assessor of the licensing authority may determine a shorter or longer period of OML according to the individual circumstances of the case.

(6)Applicants who experienced loss of consciousness without significant warning should be assessed as unfit.

(j)Blood pressure

(1)The diagnosis of hypertension should require cardiovascular evaluation to include potential vascular risk factors.

(2)Anti-hypertensive treatment should be agreed by the medical assessor of the licensing authority. Acceptable medication may include:

(i)non-loop diuretic agents;

(ii)ACE inhibitors;

(iii)angiotensin II receptor blocking agents (sartans);

(iv)channel calcium blocking agents;

(v)certain (generally hydrophilic) beta-blocking agents.

(3)Following initiation of medication for the control of blood pressure, applicants should be re-assessed to verify that satisfactory control has been achieved and the treatment is compatible with the safe exercise of the privileges of the applicable licence(s).

(k)Coronary artery disease

(1)Chest pain of uncertain cause should require full investigation. Applicants with angina pectoris should be assessed as unfit, whether or not it is alleviated by medication.

(2)In suspected asymptomatic coronary artery disease, exercise electrocardiography should be required. Further tests may be required, which should show no evidence of myocardial ischaemia or significant coronary artery stenosis.

(3)Applicants with evidence of exercise-induced myocardial ischaemia should be assessed as unfit.

(4)After an ischaemic cardiac event or revascularisation procedure, applicants should have reduced cardiovascular risk factors to an appropriate level. Medication, when used to control cardiac symptoms, is not acceptable. All applicants should be on appropriate secondary prevention treatment.

(i)A coronary angiogram obtained around the time of, or during, the ischaemic myocardial event or revasculisation procedure and a complete, detailed clinical report of the ischaemic event and of any operative procedures should be made available to the medical assessor of the licensing authority:

(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)Applicants with an untreated stenosis greater than 30 % in the left main or proximal left anterior descending coronary artery should be assessed as unfit.

(ii)At least 6 months from the ischaemic myocardial event or revascularisation procedure, the following investigations should be completed (equivalent tests may be substituted):

(A)an exercise ECG showing neither evidence of myocardial ischaemia nor rhythm or conduction disturbance;

(B)an echocardiogram 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 stress echocardiogram, 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, or equivalent test, should also be carried out;

(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 annual (or more frequently, if necessary) to ensure that there is no deterioration of the cardiovascular status. It should include a review by a cardiologist, exercise ECG and cardiovascular risk assessment. Additional investigations may be required by the medical assessor of the licensing authority.

(A)After coronary artery bypass grafting, a myocardial perfusion scan, or equivalent test, should be performed if there is any indication, and in all cases within 5 years from the procedure.

(B)In all cases, coronary angiography should be considered at any time if symptoms, signs or non-invasive tests indicate myocardial ischaemia.

(iv)Successful completion of the 6-month or subsequent review will allow a fit assessment with an OML.

(l)Rhythm and conduction disturbances

(1)Applicants with significant rhythm or conduction disturbance should undergo evaluation by a cardiologist before a fit assessment with an OML, as necessary, may be considered. Appropriate follow-up should be carried out at regular intervals. Such evaluation should include:

(i)exercise ECG to the Bruce protocol or equivalent. Bruce stage 4 should be achieved and no significant abnormality of rhythm or conduction, or evidence of myocardial ischaemia should be demonstrated. Withdrawal of cardioactive medication prior to the test should normally 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 (equivalent tests may be substituted):

(iv)24-hour ECG recording repeated as necessary;

(v)electrophysiological study;

(vi)myocardial perfusion imaging;

(vii)cardiac magnetic resonance imaging (MRI);

(viii)coronary angiogram.

(2)Applicants with frequent or complex forms of supra ventricular or ventricular ectopic complexes require full cardiological evaluation.

(3)Where anticoagulation is needed for a rhythm disturbance, a fit assessment with an OML may be considered if the haemorrhagic risk is acceptable and the anticoagulation is stable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. In cases of anticoagulation medication not requiring INR monitoring, a fit assessment with an OML may be considered after review by the medical assessor of the licensing authority after a stabilisation period of 3 months.

(4)Ablation Applicants who have undergone ablation therapy should be assessed as unfit. A fit assessment may be considered following successful catheter ablation and should require an OML for at least one year, unless an electrophysiological study, undertaken at a minimum of 2 months after the ablation, demonstrates satisfactory results. For those whose long-term outcome cannot be assured by invasive or non-invasive testing, an additional period with an OML and/or observation may be necessary.

(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)Atrial fibrillation/flutter

(A)For initial applicants, a fit assessment should be limited to those with a single episode of arrhythmia which is considered by the medical assessor of the licensing authority to be unlikely to recur.

(B)For revalidation, applicants may be assessed as fit if cardiological evaluation is satisfactory and the stroke risk is sufficiently low. A fit assessment with an OML may be considered after a period of stable anticoagulation as prophylaxis, after review by the medical assessor of the licensing authority. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. In cases of anticoagulation medication not requiring INR monitoring, a fit assessment with an OML may be considered after review by the medical assessor of the licensing authority after a stabilisation period of 3 months.

(ii)Applicants with asymptomatic sinus pauses up to 2.5 seconds on resting electrocardiography may be assessed as fit if exercise electrocardiography, echocardiography and 24-hour ambulatory ECG are satisfactory.

(iii)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 should require full cardiological evaluation and may be assessed as fit in the absence of distal conducting tissue disease.

(7)Complete right bundle branch block

(i)Applicants with complete right bundle branch block should undergo a cardiological evaluation on first presentation. A fit assessment may be considered if there is no underlying pathology.

(ii)Applicants with bifascicular block may be assessed as fit with an OML after a satisfactory cardiological evaluation. The OML may be considered for removal if an electrophysiological study demonstrates no infra-Hissian block, or a 3-year period of satisfactory surveillance has been completed.

(8)Complete left bundle branch block

(i)A fit assessment may be considered subject to satisfactory cardiological evaluation and a 3-year period with an OML, and without an OML after 3 years of surveillance and satisfactory cardiological evaluation.

(ii)Investigation of the coronary arteries is necessary for applicants over age 40.

(9)Ventricular pre-excitation

(i)Asymptomatic initial applicants with pre-excitation may be assessed as fit if an electrophysiological study, including adequate drug-induced autonomic stimulation reveals no inducible re-entry tachycardia and the existence of multiple pathways is excluded.

(ii)Asymptomatic applicants with pre-excitation may be assessed as fit at revalidation with limitation(s) as appropriate. Limitations may not be necessary if an electrophysiological study, including adequate drug-induced autonomic stimulation, reveals no inducible re-entry tachycardia and the existence of multiple accessory pathways is excluded.

(10)Pacemaker Applicants with a subendocardial pacemaker should be assessed as unfit. A fit assessment with an OML may be considered at revalidation no sooner than 3 months after insertion provided:

(i)there is no other disqualifying condition;

(ii)a bipolar lead system, programmed in bipolar mode without automatic mode change has been used;

(iii)the applicant is not pacemaker dependent; and

(iv)the applicant has a follow-up at least every 12 months, including a pacemaker check.

(11)QT prolongation Applicants with asymptomatic QT prolongation may be assessed as fit with an OML subject to 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.

(a)Examination Exercise electrocardiography An exercise ECG when required as part of a cardiovascular assessment should be symptom-limited and completed to a minimum of Bruce Stage IV or equivalent.

(b)General

(1)Cardiovascular risk factor assessment Cardiovascular risk factor assessment should take place at least once every 5 years for applicants 40 to 59 years old, and once every 2 years thereafter. A more frequent assessment of the cardiovascular risk factors may be considered when risk factors have been identified. Applicants with an accumulation of two or more risk factors should undergo a cardiovascular evaluation by the AeMC or AME.

(2)Cardiovascular assessment Reporting of resting and exercise electrocardiograms should be by the AME or an accredited specialist.

(c)Peripheral arterial disease A fit assessment may be considered for an applicant with peripheral arterial disease, or after surgery for peripheral arterial disease, provided there is no significant functional impairment, any vascular risk factors have been reduced to an appropriate level, the applicant is receiving acceptable secondary prevention treatment, and there is no evidence of myocardial ischaemia.

(d)Aortic aneurysm

(1)Applicants with an aneurysm of the infra-renal abdominal aorta of less than 5 cm in diameter may be assessed as fit, subject to satisfactory cardiological evaluation. Regular cardiological evaluations should be carried out.

(2)Applicants with an aneurysm of the thoracic or supra-renal abdominal aorta of less than 5 cm in diameter may be assessed as fit with an ORL or OSL, subject to satisfactory cardiological evaluation. Regular follow-up should be carried out.

(3)Applicants may be assessed as fit after surgery for an infra-renal abdominal aortic aneurysm, subject to satisfactory cardiological evaluation. Regular cardiological evaluations should be carried out.

(4)Applicants may be assessed as fit with an ORL or OSL after surgery for a thoracic or supra-renal abdominal aortic aneurysm, subject to satisfactory cardiological evaluation. Regular cardiological evaluations should be carried out.

(e)Cardiac valvular abnormalities

(1)Applicants with previously unrecognised cardiac murmurs should undergo further cardiological evaluation.

(2)Applicants with minor cardiac valvular abnormalities may be assessed as fit.

(3)Aortic valve disease

(i)Applicants with a bicuspid aortic valve may be assessed as fit if no other cardiac or aortic abnormality is demonstrated. Follow-up with echocardiography, as necessary, should be determined in consultation with the medical assessor of the licensing authority.

(ii)Applicants with aortic stenosis may be assessed as fit provided the left ventricular function is intact and the mean pressure gradient is less than 20 mmHg. Applicants with an aortic valve orifice of more than 1 cm2 and a mean pressure gradient above 20 mmHg, but not greater than 50 mmHg, may be assessed as fit with an ORL or OSL. Follow-up with 2D Doppler echocardiography, as necessary, should be determined in consultation with the medical assessor of the licensing authority in all cases. Alternative measurement techniques with equivalent ranges may be used. Regular cardiological evaluation should be considered. Applicants with a history of systemic embolism or significant dilatation of the thoracic aorta should be assessed as unfit.

(iii)Applicants with trivial aortic regurgitation may be assessed as fit. Applicants with a greater degree of aortic regurgitation may be assessed as fit with an OSL. There should be no demonstrable abnormality of the ascending aorta on 2D Doppler echocardiography. Follow-up, as necessary, should be determined in consultation with the medical assessor of the licensing authority.

(4)Mitral valve disease

(i)Asymptomatic applicants with an isolated mid-systolic click due to mitral leaflet prolapse may be assessed as fit.

(ii)Applicants with rheumatic mitral stenosis should be assessed as unfit.

(iii)Applicants with minor regurgitation may be assessed as fit. Periodic cardiological review should be determined in consultation with the medical assessor of the licensing authority.

(iv)Applicants with moderate mitral regurgitation may be considered as fit with an ORL or OSL if the 2D Doppler echocardiogram demonstrates satisfactory left ventricular dimensions and satisfactory myocardial function is confirmed by exercise electrocardiography. Periodic cardiological review should be determined in consultation with the medical assessor of the licensing authority.

(v)Applicants with evidence of volume overloading of the left ventricle demonstrated by increased left ventricular end-diastolic diameter or evidence of systolic impairment should be assessed as unfit.

(f)Valvular surgery

(1)Applicants who have undergone cardiac valve replacement or repair may be assessed as fit without limitations subject to satisfactory post-operative cardiological evaluation and if no anticoagulants are needed.

(2)Where anticoagulation is needed after valvular surgery, a fit assessment with an ORL or OSL may be considered after cardiological evaluation if the haemorrhagic risk is acceptable. The review should show that the anticoagulation is stable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. The INR target range should be determined by the type of surgery performed. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence(s) if the INR is within the target range, may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months.

(g)Thromboembolic disorders Applicants with arterial or venous thrombosis or pulmonary embolism should be assessed as unfit. A fit assessment with an ORL or OSL may be considered after a period of stable anticoagulation as prophylaxis in consultation with the medical assessor of the licensing authority. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range and the haemorrhagic risk is acceptable. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence(s) if the INR is within the target range may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months. Applicants with pulmonary embolism should also undergo a cardiological evaluation. Following cessation of anticoagulant therapy for any indication, applicants should undergo a re-assessment in consultation with the medical assessor of the licensing authority.

(h)Other cardiac disorders

(1)Applicants with a primary or secondary abnormality of the pericardium, myocardium or endocardium may be assessed as fit subject to satisfactory cardiological evaluation.

(2)Applicants with a congenital abnormality of the heart, including those who have undergone surgical correction, may be assessed as fit subject to satisfactory cardiological evaluation. Cardiological follow-up may be necessary and should be determined in consultation with the medical assessor of the licensing authority.

(i)Syncope

(1)In the case of a single episode of vasovagal syncope which can be explained and is compatible with flight safety, a fit assessment may be considered.

(2)Applicants with a history of recurrent vasovagal syncope should be assessed as unfit. A fit assessment may be considered after a 6-month period without recurrence, providing cardiological evaluation is satisfactory. Neurological review may be indicated.

(j)Blood pressure

(1)When the blood pressure at examination consistently exceeds 160 mmHg systolic and/or 95 mmHg diastolic, with or without treatment, the applicant should be assessed as unfit.

(2)The diagnosis of hypertension requires review of other potential vascular risk factors.

(3)Applicants with symptomatic hypotension should be assessed as unfit.

(4)Anti-hypertensive treatment should be compatible with flight safety.

(5)Following initiation of medication for the control of blood pressure, applicants should be re-assessed to verify that satisfactory control has been achieved and that the treatment is compatible with the safe exercise of the privileges of the applicable licence(s).

(k)Coronary artery disease

(1)Chest pain of uncertain cause requires full investigation.

(2)Applicants with suspected asymptomatic coronary artery disease should undergo cardiological evaluation which should show no evidence of myocardial ischaemia or significant coronary artery stenosis.

(3)Applicants with evidence of exercise-induced myocardial ischaemia should be assessed as unfit.

(4)After an ischaemic cardiac event, or revascularisation, applicants without symptoms should have reduced cardiovascular risk factors to an appropriate level. Medication, when used to control angina pectoris, is not acceptable. All applicants should be on appropriate 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 to the AME.

(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)Applicants with an untreated stenosis greater than 30 % in the left main or proximal left anterior descending coronary artery should be assessed as unfit.

(ii)At least 6 months from the ischaemic myocardial event, including revascularisation, the following investigations should be completed (equivalent tests may be substituted):

(A)an exercise ECG showing neither evidence of myocardial ischaemia nor rhythm disturbance;

(B)an echocardiogram showing satisfactory left ventricular function with no important abnormality of wall motion and a satisfactory left ventricular ejection fraction of 50 % or more;

(C)in cases of angioplasty/stenting, a myocardial perfusion scan or stress echocardiogram, or equivalent test, which should show no evidence of reversible myocardial ischaemia. If there is doubt about revascularisation in myocardial infarction or bypass grafting, a perfusion scan, or equivalent test, should also be carried out;

(D)further investigations, such as a 24-hour ECG, may be necessary to assess the risk of any significant rhythm disturbance.

(iii)Periodic follow-up should include a cardiological evaluation.

(A)After coronary artery bypass grafting, a myocardial perfusion scan (or equivalent test) should be performed if there is any indication, and in all cases within five years from the procedure for a fit assessment without an OSL, OPL or ORL.

(B)In all cases, coronary angiography should be considered at any time if symptoms, signs or non-invasive tests indicate myocardial ischaemia.

(iv)Successful completion of the six-month or subsequent review will allow a fit assessment. Applicants may be assessed as fit with an ORL or OSL having successfully completed only an exercise ECG.

(5)Applicants with angina pectoris should be assessed as unfit, whether or not it is alleviated by medication.

(l)Rhythm and conduction disturbances

(1)Applicants with significant rhythm or conduction disturbance should undergo cardiological evaluation before a fit assessment may be considered with an ORL or OSL, as appropriate. Such evaluation should include:

(i)exercise ECG to the Bruce protocol or equivalent. Bruce stage 4 should be achieved and no significant abnormality of rhythm or conduction, or evidence of myocardial ischaemia should be demonstrated. Withdrawal of cardioactive medication prior to the test should normally 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 (equivalent tests may be substituted):

(iv)24-hour ECG recording repeated as necessary;

(v)electrophysiological study;

(vi)myocardial perfusion imaging;

(vii)cardiac magnetic resonance imaging (MRI);

(viii)coronary angiogram.

(2)Where anticoagulation is needed for a rhythm disturbance, a fit assessment with an ORL or OSL may be considered, if the haemorrhagic risk is acceptable and the anticoagulation is stable. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence(s) if the INR is within the target range may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months.

(3)Ablation A fit assessment may be considered following successful catheter ablation subject to satisfactory cardiological review undertaken at a minimum of 2 months after the ablation.

(4)Supraventricular arrhythmias

(i)Applicants with significant disturbance of supraventricular rhythm, including sinoatrial dysfunction, whether intermittent or established, may be assessed as fit if cardiological evaluation is satisfactory.

(ii)Applicants with atrial fibrillation/flutter may be assessed as fit if cardiological evaluation is satisfactory and the stroke risk is sufficiently low. Where anticoagulation is needed, a fit assessment with an ORL or OSL may be considered after a period of stable anticoagulation as prophylaxis, in consultation with the medical assessor of the licensing authority. Anticoagulation should be considered stable if, within the last 6 months, at least 5 INR values are documented, of which at least 4 are within the INR target range. Applicants who measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and only exercise the privileges of their licence(s) if the INR is within the target range may be assessed as fit without the above-mentioned limitation. The INR results should be recorded and the results should be reviewed at each aero-medical assessment. Applicants taking anticoagulation medication not requiring INR monitoring, may be assessed as fit without the above-mentioned limitation in consultation with the medical assessor of the licensing authority after a stabilisation period of 3 months.

(iii)Applicants with asymptomatic sinus pauses up to 2.5 seconds on resting electrocardiography may be assessed as fit if cardiological evaluation is satisfactory.

(5)Heart block

(i)Applicants with first degree and Mobitz type 1 AV block may be assessed as fit.

(ii)Applicants with Mobitz type 2 AV block may be assessed as fit in the absence of distal conducting tissue disease.

(6)Complete right bundle branch block Applicants with complete right bundle branch block should undergo a cardiological evaluation on first presentation. A fit assessment may be considered if there is no underlying pathology.

(7)Complete left bundle branch block Applicants with complete left bundle branch block may be assessed as fit with appropriate limitations, such as an ORL, and subject to satisfactory cardiological evaluation.

(8)Ventricular pre-excitation Asymptomatic applicants with ventricular pre-excitation may be assessed as fit with limitation(s) as appropriate, subject to satisfactory cardiological evaluation. Limitations may not be necessary if an electrophysiological study is conducted and the results are satisfactory.

(9)Pacemaker Applicants with a subendocardial pacemaker should be assessed as unfit. A fit assessment may be considered no sooner than 3 months after insertion, providing:

(i)there is no other disqualifying condition;

(ii)a bipolar lead system, programmed in bipolar mode without automatic mode change, has been used;

(iii)the applicant is not pacemaker dependent; and

(iv)the applicant has a follow-up at least every 12 months, including a pacemaker check.

(10)QT prolongation Applicants with asymptomatic QT prolongation may be assessed as fit with an ORL or OSL subject to satisfactory cardiological evaluation.

(11)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 limitation(s) as appropriate, subject to satisfactory cardiological evaluation.

(m)Heart or heart/lung transplantation

(1)Applicants who have undergone heart or heart/lung transplantation may be assessed as fit, with appropriate limitation(s) such as an ORL , no sooner than 12 months after transplantation, provided that cardiological evaluation is satisfactory with:

(i)no rejection in the first year following transplantation;

(ii)no significant arrhythmias;

(iii)a left ventricular ejection fraction ≥ 50%;

(iv)a symptom limited exercise ECG; and

(v)a coronary angiogram if indicated;

(2)Regular cardiological evaluations should be carried out.

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.

VENTRICULAR PRE-EXCITATION Asymptomatic applicants with pre-excitation may be assessed as fit if they meet the following criteria, which may also indicate a satisfactory electrophysiological evaluation:

(a)refractory period > 300 ms;

(b)no induced atrial fibrillation.

ANTICOAGULATION Applicants taking anticoagulant medication which requires monitoring with INR testing, should measure their INR on a ‘near patient’ testing system within 12 hours prior to flight and the privileges of the applicable licence(s) 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.

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.

VENTRICULAR PRE-EXCITATION Asymptomatic applicants with pre-excitation may be assessed as fit if they meet the following criteria:

(a)no inducible re-entry tachycardia;

(b)refractory period > 300 ms;

(c)no induced atrial fibrillation;

(d)no evidence of multiple accessory pathways.

(a)Cardiovascular risk factor assessment A risk calculator is constructed as an equation with regression coefficients for each included risk factor, based on a statistical analysis of data from a population of a certain region to provide a crude risk estimate. A risk calculator to be used for screening of CAT pilots should be relevant for the ethnicity of the pilots being screened and should predict the 5–10-year risk for non-fatal events such as acute coronary syndromes or stroke, as well as fatal cardiac events, as both may lead to total in-flight incapacitation. It is recommended to use a risk estimation tool that is based on populations similar to your most common target population. No risk calculator is perfect, and an assessment of advantages and disadvantages should be made when deciding on which tools should be used. For example, the most common tools that are based on European population are: SCORE 2, PROCAM, AGLA and QRISK 3. In the risk assessment AMEs should give proper consideration to the latest published guidance of the European Society of Cardiology. At the time of the drafting, the most recent guidelines are ‘2021 ESC Guidelines on cardiovascular disease prevention in clinical practice’.

(b)Cardiovascular assessment It is recommended that for applicants involved in single-pilot HEMS operations who have reached the age of 60, the cardiovascular assessment considers the risk level when deciding on enhanced screening investigations. In this regard the following flow chart algorithm adapted by Simons et al. (2019) from Gray et al.(2019) is aimed at supporting AMEs and medical assessors. The classification of low, intermediate or high risk is given by the cardiovascular score being used. The enhanced screening investigations are in the realm of the consultant cardiologist. Abbreviations used in the flowchart: CACS=Coronary Artery Calcium Score; CTCA=Computed Tomography Coronary Angiography; SPECT=Single-Positron Emission Tomography; PET=Positron Emission Tomography; CMR=Cardiac Magnetic Resonance; ICA= Invasive Coronary Angiography. [Simons et al. (2019] [Figure or form omitted from this preview — available in the Avioverse workspace library.]