Sutureless aortic valve replacement for treatment of severe aortic stenosis : a single technology assessment of perceval sutureless aortic valve

BACKGROUND: Aortic stenosis is the most common valvular heart disease in Western countries. A Norwegian study estimates that the prevalence of aortic stenosis is 0.2% in adults aged 50 to 59, 1.3% in adults aged 60 to 69, and up to 9.8% in patients 80 to 89. Aortic stenosis is generally caused by ca...

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Main Authors: Desser, Arna, Arentz-Hansen, Helene (Author), Fagerlund, Beate Charlotte (Author), Harboe, Ingrid (Author)
Corporate Author: Folkehelseinstituttet (Norway)
Format: eBook
Language:English
Published: Oslo Norwegian Institute of Public Health 2017, August 2017
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Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Summary:BACKGROUND: Aortic stenosis is the most common valvular heart disease in Western countries. A Norwegian study estimates that the prevalence of aortic stenosis is 0.2% in adults aged 50 to 59, 1.3% in adults aged 60 to 69, and up to 9.8% in patients 80 to 89. Aortic stenosis is generally caused by calcification of the aortic valve that ultimately can lead to heart failure. The three most important symptoms are chest pains, shortness of breath on exertion, and fainting. The disease may be asymptomatic for long periods of time, but once symptoms appear (severe aortic stenosis), an untreated individual has an average life expectancy of 2 to 3 years. The only effective treatment is aortic valve replacement (AVR) surgery. CONCLUSION: EFFECTIVENESS AND SAFETY: The quality of the available evidence comparing Perceval sutureless AVR to traditional AVR is low to very low. More robust conclusions will be available upon publication of primary data from an ongoing RCT expected in 2019.
Because the data used in the model were not based on the assessed comparative studies, there remains uncertainty about the likelihood and validity of the results. More robust conclusions will be possible on publication of the ongoing RCT.
Based on best available evidence, it is uncertain whether Perceval AVR reduces, increases or has a similar 30-day mortality compared with traditional AVR. Perceval AVR may reduce perioperative cardiac bypass time and cross-clamp time, and may provide little or no difference in hemodynamic function at 30 days compared to traditional AVR. However, no firm conclusions can be made with regard to superiority of either method. HEALTH ECONOMICS: Based on the cost-effectiveness and budget impact analyses performed by the firm Perceval can be cost-saving compared to traditional sutured valves for isolated full sternotomy or minimally invasive valve replacement surgery, and for concomitant surgeries with full sternotomy. Model estimates of clinical effect indicate that there may be small gains connected with Perceval. Estimates from the five-year budget impact analysis show cost savings with expanded use of Perceval.
Item Description:"Report 2017"
Physical Description:1 PDF file (102 pages) illustrations
ISBN:9788280828712