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

Abstract

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.

Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method

“…Four of five patients who have sustained a fragility fracture are not treated for the underlying osteoporosis that predisposed the patient to the fracture, and the treatment rates have been getting lower over the last two decades [18,19]. A similar phenomenon is seen for the rates of VA in patients with VFF, declining 32% in the fee-for-service Medicare population between 2004 and 2014 [8,20]. A portion of the decreased VA treatment rates has been attributed to the publication of two studies on vertebroplasty versus sham treatment in 2009 [21,22].…”

“…These include pneumonia, loss of bone, muscle and body mass, incidental falls, deep venous thrombosis, and depression and social isolation [4À6]. These morbidities may have a strong negative impact on the patient's quality of life and may even contribute to a reduced life expectancy [7,8].…”

“…A portion of the decreased VA treatment rates has been attributed to the publication of two studies on vertebroplasty versus sham treatment in 2009 [21,22]. Although these articles were equivocal and found no advantage to either treatment, and despite two additional sham trials showing statistically significant advantage to vertebroplasty [23,24], the negative impressions appear to have caused a downward trend in operative treatment of patients with VFF [8]. In the same period, an increase of the mortality risk in patients with VFF was seen [8].…”

The evidentiary basis of vertebral augmentation: a 2019 update

“…The excess mortality risk from VCF has been estimated to range between 2% and 42% at 12 months 46. Numerous national registry and insurance datasets from various countries have been analyzed in an attempt to clarify the short- and long-term morbidity and mortality risk in patients with VCFs who have undergone either NSM or VA 47–52. One analysis of 858 978 patients with new VCF from the US Medicare dataset collected between 2005 and 2008 found a significant adjusted survival benefit at up to 4 years follow-up for patients who underwent VA compared with those who received NSM (60.8% vs 50.0%; p<0.001) 47.…”

Long Term Survival of Pathological Thoracolumbar Fractures Treated with Vertebroplasty: Analysis Using a Nationwide Insurance Claim Database

“…Kyphoplasty, another cement augmentation technique, which uses a balloon or other instrument to reduce the collapsed vertebrae and then injects the cement into the created cavity, was developed to minimize the complication of cement leakage [19]. Some researchers have explored the long-term mortality and survival for the osteoporotic vertebral compression fractures treated with vertebroplasty or kyphoplasty compared with conservative treatment, and most found kyphoplasty had better survival than vertebroplasty, and both kyphoplasty and vertebroplasty seemed to have better survival than conservative treatment [20][21][22][23][24][25]. However, there is still limited research [9] comparing the long-term survival of pathological thoracolumbar fractures treated with vertebroplasty, conventional open surgery, and conservative treatment, as well as their related complications including: pulmonary embolism [26]; leakage of cement causing neurological deficits [27], shock [28] or death [29]; vertebral infection or osteomyelitis [30,31]; adjacent vertebral fractures [32]; and loosening of PMMA cement [33].…”