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. 2018 Feb;29(2):375-383.
doi: 10.1007/s00198-017-4281-z. Epub 2017 Oct 24.

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

K L Ong  1 , D P Beall  2 , M Frohbergh  3 , E Lau  4 , J A Hirsch  5
Affiliations

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

K L Ong et al. Osteoporos Int. 2018 Feb.

Abstract

The 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.

Introduction: BKP 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.

Methods: BKP/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.

Results: The 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.

Conclusions: Changes 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.

Keywords: Balloon kyphoplasty; Mortality; Vertebral augmentation; Vertebral compression fracture; Vertebroplasty.

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Conflict of interest statement

Conflicts of interest

KLO, EL, MF: employees of Exponent, Inc., a scientific and engineering consulting firm.

KLO: Exponent has been paid fees by companies and suppliers for my consulting services on behalf of such companies and suppliers (Stryker Orthopaedics, Zimmer Biomet, Ethicon, Ferring Pharmaceuticals, Paradigm Spine, Medtronic, Pacira Pharmaceuticals, DJO, Ossur).

JAH: direct fees consulting (Medtronic; Globus (one-time fee)); Codman Neurovascular Data and Safety Monitoring Board participation.

DPB: Benvenue: paid consultant; paid presenter or speaker; stock or stock options.

Lilly: paid presenter or speaker.

Lilly, Amendia, Medtronic: board or committee member; paid consultant; research support; stock or stock options.

Medtronic: paid presenter or speaker.

SIR: board or committee member.

Vexim: board or committee member; stock or stock options.

EL: Exponent has been paid fees by companies and suppliers for my consulting services onbehalf of such companies and suppliers (Stryker Orthopaedics, Ferring Pharmaceuticals, Medtronic, CeramTec).

Statement of human and animal rights

This study was based on publicly available data sets, did not use private health identifiable information, and did not represent human subject research, and therefore did not require oversight by our institutional review boards.

The manuscript does not contain any studies with human participants or animals performed by any of the authors. For this type of retrospective study, formal consent is not required.

Figures

Fig. 1
Fig. 1
Prevalence of comorbidities in the 12 months prior to VCF diagnosis
Fig. 2
Fig. 2
Overall survival of VCF patients
Fig. 3
Fig. 3
Relative risk of mortality (propensity-adjusted) between NSM, BKP, and VP cohorts (p < 0.001 for all)
Fig. 4
Fig. 4
Relative propensity-adjusted risks of readmission (a), cardiac complications (b), pulmonary embolism (c), pneumonia (d), infection (e), DVT (f), UTI (g), and pulmonary/respiratory complications (h) between NSM, BKP, and VP cohorts (*p < 0.001; **p < 0.01; +p < 0.05)
See this image and copyright information in PMC

Comment in

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