SIR: Percutaneous Vertebroplasty Gets High Grades for Safety and Efficacy

By Michael Smith
WASHINGTON, March 19 -- Percutaneous vertebroplasty is a safe procedure that offers marked relief of pain, according to a large case series reported here by Italian researchers. The data "suggest that vertebroplasty should always be proposed to patients when conservative medical treatment fails," said Giovanni Anselmetti, M.D., of the Institute for Cancer Research and Treatment in Turin. In a study of 844 patients, who had 3,954 vertebrae treated altogether, the procedure significantly relieved pain and improved quality of life, with remarkably few adverse events, Dr. Anselmetti told the Society of Interventional Radiology meeting.
The minimally invasive procedure -- which gained notice in 2004 when actress Elizabeth Taylor had two collapsed vertebrae repaired -- is widely performed in the U.S., with about 100,000 per year.
Interventional radiologists use imaging guidance to inject medical-grade bone cement into the spine to stabilize collapsed vertebrae, Dr. Anselmetti said.
In the prospective Turin series, Dr. Anselmetti and colleagues collected data on pain using an 11-point visual analog scale and measured quality of life on the Oswestry Disability Questionnaire.
The also recorded how many patients required a back brace before and after vertebroplasty. The study found:
On average, patients said their pain level was 7.9 on the 11-point scale (0 to 10) before the procedure and 1.3 afterward. The change was significant at P<0.0001.
694 patients needed a brace before the vertebroplasty, compared with 102 afterward -- a difference that was significant at P<0.0001.
Before the procedure 69.3% of patients reported poor quality of life on the Oswestry questionnaire, and that dropped to 18.8% afterward, a change that was also significant at P<0.0001.
"About 95.6% of the 884 patients treated for osteoporosis-caused vertebrae fractures reported that their pain was ameliorated by vertebroplasty," Dr. Anselmetti said.
An issue in vertebroplasty is whether repairing one vertebra is likely to cause another to fail. Dr. Anselmetti said the new fracture rate in his cohort was 12%, occurring on average 9.4 months after the original procedure.
That rate, he said, is not significantly different than a 2004 study comparing two doses of the recombinant parathyroid hormone teriparatide (Forteo) with placebo.
In that study, the new fracture rate among placebo patients was 18.9%, while the rate among teriparatide patients was 11.2% and 10.4%, depending on which dose was used.
Dr. Anselmetti said all of the patients who suffered a new fracture were successfully retreated with vertebroplasty.
The complication rate among the 884 patients was remarkably low, he said, with 12 asymptomatic pulmonary embolisms, caused by migrating bits of bone cement, and six cases of nerve root irritation successfully treated with steroid injections.
The findings are "very relevant as a public health concern to our elderly," commented Joshua Hirsch, M.D., of Massachusetts General Hospital, who moderated a press briefing at which the study was discussed.
"This is a study that affects people we know, people we see every day," he said. It is "remarkably important because (Dr. Anselmetti) has prospectively taken this data out over the course of five years and it's a very, very powerful case series."
Dr. Hirsch noted that in Europe, physicians are allowed to treat adjacent vertebrae to prevent future collapse -- something that is not yet permitted in the U.S.
"I think prophylactic treatment has a great future," he said. "Unfortunately, that future is in Europe."
The researchers reported no external funding. Dr. Anselmetti said he had no conflicts.
Primary source: Journal of Vascular and Interventional RadiologySource reference:Anselmetti GC, et al "Percutaneous vertebroplasty in the osteoporotic patients: 5 years prospective follow-up in 884 consecutive patients" J Vasc Interv Radiol 2008; 19(2) Supplement S: Abstract 182.