Cardiovascular risk assessment for pilots and air traffic controllers

The CAA have published updated guidance for assessing cardiovascular risk assessment for pilots and air traffic controllers. The updated guidance can be found here.

Once again, the CAA Aeromedical department have updated cardiovascular risk assessment guidance without consulting stakeholders and without any justification based on factual data or evidence of proportionality. AOPA have challenged this since the change in guidance was originally made and have recently raised the matter again with the Chairman of the CAA. Perhaps in response to the AOPA challenge, while risk levels remain at >=10% for Class 1 medicals, for Class 2 and 3 medicals this is now >=15% and >=25% for LAPL (which is no longer issued by the UK CAA). Risk is still based on QRISK3, which has been discredited as over calculating risk for older persons and is not the approved cardiovascular risk calculator in Scotland. The NHS recommended risk calculator for Scotland is ASSIGN

While the higher risk levels are welcome, there would appear to be no logical reason why a Class 2 or 3 risk level should be set lower that a LAPL (or eventually a UK NPPL) licence holder.

Additionally, where an elevated cardiovascular risk assessment, based on the discredited QRISK3 calculator, is made the applicant for a medical will be required to take an Exercising ECG every two years – this appears to be in addition to the requirement for a resting ECG of the same periodicity for over 50’s and needs clarification from the CAA.

Where additional national requirements are introduced, they should be supported by clear evidence of safety benefit and assessed for unintended consequences. Currently, data collected by AOPA suggests that the vast majority of pilots undergoing additional testing are subsequently cleared to fly, but only after high extra costs of tests.

Good regulation should target demonstrated risk, not create unnecessary cost, complexity and barriers to participation.

The CAA has adopted an approach that appears to go beyond the baseline intent of ICAO standards by introducing repeated population screening, reliance on QRISK3 thresholds and periodic exercise ECG requirements.

ICAO establishes minimum medical standards but does not prescribe this level of intervention. This is a policy decision on the part of the CAA and potentially damages activity and growth in our sector of aviation and an example of gold plating.

AOPA UK will continue to challenge these new guidelines as they exceed ICAO medical standards and have not been justified on factual data or proportionality and are likely to drive more pilots to PMDs and take them out of any medical examination requirement.

The guidance covers a full range of cardiovascular conditions. The following extracts are likely to be of most interest:

Blood Pressure (BP):

(1) Applicants' blood pressure shall be recorded at each examination.

(2) Applicants whose blood pressure is not within normal limits shall be further assessed with regard to their cardiovascular condition and medication with a view to determining whether they are to be assessed as unfit in accordance with points (3) and (4).

(3) Applicants for a class 1 medical certificate with any of the following medical conditions shall be assessed as unfit:

(i) symptomatic hypotension;

(ii) blood pressure at examination consistently exceeding 160 mmHg systolic or 95 mmHg diastolic, with or without treatment.

(4) Applicants who have commenced the use of medication for the control of blood pressure shall be assessed as unfit until the absence of significant side effects has been established.

Investigation of ECG Abnormalities : Covers the Initial investigations required for abnormal ECG observations Class 1, 2, 3 and LAPL applicants.

Class 1 / 2 / 3 / LAPL certification: Cardiovascular risk assessment : This flow chart sets out the process for investigation following an assessment of cardiovascular risk:

Cardiovascular risk assessment (note 1)

For all classes, a 10-year cardiovascular risk assessment should be undertaken at the first examination after reaching the age of 40 and at regular intervals thereafter, on clinical indication, or upon a new diagnosis or first declaration of a risk factor (for example, hypertension, type 2 diabetes, chronic kidney disease, obstructive sleep apnoea, menopause,

HIV, hyperlipidemia, obesity when BMI is ≥30kg/m2).

As a guide, 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 additional risk factors have been identified.

Use the latest QRISK assessment tool or, for certain conditions, other specialist risk assessment tools may be appropriate, for example, D:A:D for people living with HIV and Steno T1 for people with type 1 diabetes, in consultation with a medical assessor.

AOPA Note: QRISK is not the recommended risk calculator for NHS Scotland. The NHS recommended risk calculator for Scotland is ASSIGN

Criteria for screening (note 2)

The following limits are considered an elevated 10-year cardiovascular risk for the purpose of assessing whether further investigation is required:

• Class 1: ≥10%
• Class 2: ≥15%
• Class 3: ≥15%
• LAPL: ≥25%

Where an applicant meets any of the exception criteria listed below, screening should be undertaken regardless of the 10-year cardiovascular risk assessment:

• treatment resistant hypertension (typified by ≥3 medications with an uncontrolled blood pressure, or ≥4 medications with a controlled blood pressure), or evidence of target-end organ damage (for example, presence of microalbuminuria, renal impairment, retinopathy, left ventricular hypertrophy)

• diabetes with presence of microalbuminuria, or other target-end organ damage (renal impairment, left ventricular hypertrophy, retinopathy), or in the presence of three or more major risk factors (hypertension, dyslipidemia, smoking, obesity), or type 1 diabetes upon reaching age 40 where age of onset was between ages 0-10 years

• chronic kidney disease with eGFR 30-44mL/min/1.73m2 (stage G3b) plus albumin:creatinine ratio >30mg/mmol

• transplant recipient

This list is not exhaustive. Where it is felt that the clinical risk is markedly elevated, despite the applicant having an acceptable 10-year cardiovascular risk assessment and / or no exception condition, screening should be undertaken.

Screening modalities (note 3)

Any one of the listed modalities may be utilised, with no hierarchy, recognising that some of these investigations are more definitive for the detection of coronary disease than others. Please note that coronary artery calcium scoring (CACS) is unlikely to be accepted without a CTCA.

Exercise ECG (note 4)

Symptom limited according to the Bruce protocol in the cardiovascular system guidance.

CTCA (note 5)

The CTCA should be reported according to the CAA specification for CTCA reports in the cardiovascular system guidance. It is strongly recommended that these guidelines are highlighted in advance to the doctor reporting the CTCA, in order to ensure that the required information is available to allow a fitness decision to be made. If not included in the CTCA report, there may be a delay while this information is obtained.

Follow-up: normal result (note 6)

If an individual is found to have an elevated 10-year cardiovascular risk and undergoes one of the specified screening tests with a satisfactory result, no further screening for coronary artery disease would usually be required until the end of the relevant interval (listed below), provided their risk profile remains stable. A new diagnosis or other significant change in cardiovascular risk should prompt earlier reassessment.

• exercise ECG – two years
• MPS/MRI perfusion scan, stress echocardiogram – three years
• CTCA – six years

It is acceptable if an applicant has undergone any of the above screening tests in preceding year(s), provided the test falls within the specified timeframes. Should an applicant develop a change in their risk factors, a new assessment should be undertaken.

Follow-up: abnormal result (note 7)

Depending on the modality used, further action is required as follows:

• any reversible ischemia on stress imaging requires an unfit assessment, with further management guided by the applicant’s treating clinician
• an abnormal CTCA should be assessed as per the CTCA stenosis flow chart in the cardiovascular system guidance
• an abnormal exercise ECG should be assessed as per the investigation of suspected coronary artery disease flow chart in the cardiovascular system guidance

Pilot Medical Declaration (PMD)

AOPA supports the option for Pilots to make a PMD where they meet the medical conditions set and any restrictions on licence privileges. For the current CAA Review of the PMD Consultation, we support the current system, but with consideration of the following variations:

• Currently the only student pilots who may fly solo using a PMD are NPPL students flying non-Part 21 aircraft if they meet the ‘up to 5700kg’ criteria. We strongly recommend that this should be extended to all NPPL / LAPL students flying non-Part 21 or Part 21 aircraft who meet the ‘up to 2000kg’ criteria.
• There needs to be a note on the PMD declaration form stating that if the applicant has been declared unfit for a Part-MED medical then the CAA may require further information from the applicant before the declaration is accepted. We understand that this has been happening, so it shoud be made clear to anyone making a declaration.
  

We do not believe it to be fair that there is no independent process to appeal medical decisions made by the CAA and will press for a solution for this.

NOTE: If you are 70 or over your PMD must be renewed every 3 years to remain valid. It is recommended that you print out a copy of your current PMD, from CELLMA, and keep it with your pilot licence.