Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty \u201csham\u201d trials?

K L Ong,E Lau,D P Beall,M Frohbergh,J A Hirsch

doi:10.1007/s00198-017-4281-z

Abstract

SummaryThe 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients.IntroductionBKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients.MethodsBKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005–2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors.ResultsThe cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007–2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3–4%; p < 0.001) greater in 2010–2014 versus 2005–2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19–19%; p < 0.001) and 7% (95% CI, 7–8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12–13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort.ConclusionsChanges in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

Highlights

Osteoporosis affects up to 12 million older adults in the USA, with an additional 47 million affected by low bone mass [1]
The balloon kyphoplasty (BKP) cohort had a 13% lower propensity-adjusted 10-year mortality risk than the VP cohort
With questions raised about the effectiveness of VP and the corresponding reductions in number of patients treated, this study addressed the following research questions: (1) What is the utilization of BKP/VP in the US elderly patient population? (2) Did the mortality risk for vertebral compression fracture (VCF) patients differ between 2010 and 2014 and 2005–2009? (3) Are there differences in mortality and morbidity risks between BKP/VP and non-surgical management (NSM) patients?

Summary

Introduction

Osteoporosis affects up to 12 million older adults in the USA, with an additional 47 million affected by low bone mass [1]. The number of older adults with osteoporosis or low bone mass is expected to increase in the USA by about 17 million (32%) from 2010 to 2030 [2]. Spine fracture prevalence is approximately 5.4% in adults aged 40 years and older, increasing to 18% in those 80 years and older [3]. There are associated mortality risks, with up to 72% mortality rate at 5 years [5] and 90% at 7 years [6]. Back braces, and immobilization are common non-surgical means for VCF treatment, but may be poorly tolerated in elderly patients with side effects, such as constipation and increased risk of falls [7, 8].

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Conclusion