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Aeromedical Certification Following Mechanical Aortic and Mitral Valve Implants in the United Kingdom.
Aerospace Medicine and Human Performance 2018 October 2
BACKGROUND: For many years, anticoagulant therapy had been deemed unacceptable for civilian pilot medical certification in the United Kingdom under the Joint Aviation Authorities Requirements and, therefore, mechanical valve implants were disqualifying. In 2012, this restriction was removed by implementation of the European Union requirements. This study was undertaken to assess the medical evidence available to develop a certificatory policy following mechanical valve implants in the United Kingdom.
METHODS: A literature review was performed for complication rates following the implantation of mechanical aortic and mitral valves. This study was confined to the three major types of valve commonly used in current clinical practice: the ATS, the Carbomedics, and the St. Jude Medical valves.
RESULTS: We identified 28 papers on aortic valve replacements and 22 papers on mitral valve replacements. Data were extracted for the late complication rates for endocarditis, paravalvular leak, thromboembolism, hemorrhage, and structural valve dysfunction. The total calculated incidence of a late complication was 3.8% per annum for aortic valves over a mean follow-up period of 57 mo and 5.2% per annum for mitral valves over a mean follow-up period of 61 mo. Both of these exceed the maximum 1% per annum medical incapacitation risk considered acceptable for professional multicrew pilot operations.
CONCLUSION: Confounders and sources of error in estimating the risks and methods to mitigate these are considered. A certificatory policy is proposed and the UK experience of mechanical valve replacements is described.Jagathesan T, O'Nunain S, O'Brien M. Aeromedical certification following mechanical aortic and mitral valve implants in the United Kingdom. Aerosp Med Hum Perform. 2018; 89(10):912-917.
METHODS: A literature review was performed for complication rates following the implantation of mechanical aortic and mitral valves. This study was confined to the three major types of valve commonly used in current clinical practice: the ATS, the Carbomedics, and the St. Jude Medical valves.
RESULTS: We identified 28 papers on aortic valve replacements and 22 papers on mitral valve replacements. Data were extracted for the late complication rates for endocarditis, paravalvular leak, thromboembolism, hemorrhage, and structural valve dysfunction. The total calculated incidence of a late complication was 3.8% per annum for aortic valves over a mean follow-up period of 57 mo and 5.2% per annum for mitral valves over a mean follow-up period of 61 mo. Both of these exceed the maximum 1% per annum medical incapacitation risk considered acceptable for professional multicrew pilot operations.
CONCLUSION: Confounders and sources of error in estimating the risks and methods to mitigate these are considered. A certificatory policy is proposed and the UK experience of mechanical valve replacements is described.Jagathesan T, O'Nunain S, O'Brien M. Aeromedical certification following mechanical aortic and mitral valve implants in the United Kingdom. Aerosp Med Hum Perform. 2018; 89(10):912-917.
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