COMPARE EARLY MORTALITY AFTER AORTIC VALVE REPLACEMENT WITH MECHANICAL PROSTHETIC VS BIOPROSTHETIC VALVES AMONG MEDICARE BENEFICIARIES
Author(s)
Du D1, McKean S2, Kelman JA3, Laschinger J1, Johnson C2, Warnock R2, Worrall CM4, Sedrakyan A5, Encinosa W6, MaCurdy TE2, Izurieta HS1
1Food and Drug Administration, Silver Spring, MD, USA, 2Acumen LLC, Burlingame, CA, USA, 3CMS, Washington DC, DC, USA, 4CMS, Baltimore, MD, USA, 5Weill Cornell Medical College, New York City, NY, USA, 6Agency for Healthcare Research and Quality, Rockville, MD, USA
OBJECTIVES: To compare early mortality after aortic valve replacement (AVR) between the recipients of mechanical and bioprosthetic aortic valves. METHODS: A retrospective analysis of patients 65 years or older in the 2006-2011 Medicare databases who underwent AVR. In the mixed effects models adjusting for physician and hospital random effects, we estimated odds ratios (OR) of early mortality, comparing mechanical versus bioprosthetic valves. Early mortality was measured as death on the surgery date, death within 1-30 and 31-365 days after the surgery date, death within 30 days after the hospital discharge date and operative mortality (death within 30 days following surgery, or at discharge, whichever is longer). RESULTS: Of the 66,453 Medicare beneficiaries included in the study, 19,190 (28.88%) received a mechanical valve and 47,263 (71.12%) received a bioprosthetic valve. The risk of death on the surgery date was 60% higher for mechanical valves than for bioprosthetic valves (OR, 1.61; 95% CI, 1.27-2.04; P<0.0001). The risk difference decreased to 16% during 30 days after the surgery date (OR, 1.18; 95% CI, 1.09-1.28; P<0.0001). There were no differences within 31 to 365 days after the surgery date and within the 30 days post-discharge. Risk of operative mortality was 19% higher for mechanical valves than for bioprosthetic valves (OR, 1.21; 95% CI, 1.13-1.30; P<0.0001). The number needed to treat with mechanical valves to observe one additional death on the surgery date was 290. Consistent findings were observed in subgroup analyses of patients who underwent concurrent AVR and Coronary Artery Bypass Graft (CABG), but not in isolated AVR subgroup. CONCLUSIONS: In this cohort analysis of Medicare beneficiaries, mechanical aortic valves were associated with a higher risk of death on the surgery date and within the 30 days following surgery when compared with bioprosthetic aortic valves among patients who underwent concurrent AVR and CABG, but not isolated AVR.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PCV22
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Comparative Effectiveness or Efficacy, Safety & Pharmacoepidemiology
Disease
Cardiovascular Disorders