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Percutaneous vertebral augmentation assisted by PEEK implant in painful osteolytic vertebral metastasis involving the vertebral wall: experience on 40 patients. Pain Physician 2013 Jul-Aug;16(4):E397-404

Date

07/24/2013

Pubmed ID

23877463

Scopus ID

2-s2.0-84880608645   24 Citations

Abstract

BACKGROUND: Vertebral metastases are associated with significant pain, disability, and morbidity. Open surgery for fracture stabilization is often inappropriate in this cancer population due to a poor risk-benefit profile, particularly if life expectancy is short. Vertebroplasty and kyphoplasty are appealing adjunctive procedures in patients with malignancy for alleviation of intractable pain. However, these patients have a higher risk of serious complications, notably cement extravasation.

STUDY DESIGN: We prospectively evaluated clinical results of polyetheretherketone (PEEK) implant (Kiva) assisted vertebroplasty performed in malignant painful osteolytic lesions at risk for cement extravasation due to vertebral wall involvement.

SETTING: Department of Interventional Radiology, Institute for Cancer Research and Treatment, Candiolo, Turin, Italy

METHODS: Forty patients (22 women; mean age 66.8 ± 12.4), suffering from a painful spine malignancy with vertebral wall involvement not responding to conventional therapies and without surgical indications, underwent vertebral augmentation with Kiva intravertebral implant for pain palliation. The procedure was performed with moderate sedation and local anesthesia under combined digital fluoroscopy and computed tomography guidance. After the coil-shaped PEEK implant was deployed within the vertebral lesion, bone cement was injected under continuous digital fluoroscopic control. Patients were discharged from the hospital the next procedural day. The Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), analgesic requirement, and use of external brace support were evaluated to determine efficacy. The primary end-point was safety and efficacy at one month after the procedure. However, all the patients were scheduled to be followed-up at month 3, 6, and every 6 months thereafter. Follow-up was prospectively evaluated in all patients after Kiva with clinical interviews. The Institution's Internal Review Board approved this study.

RESULTS: Median pre-treatment VAS of 10 (range 6 - 10) significantly (P < 0.001) dropped to one (range 0 - 3), with all patients achieving a clinically relevant benefit on pain at one month. Differences in pre- and post-treatment analgesic therapy were significant (P < 0.001). All patients no longer use an external brace after Kiva. In 7 out of 43 (16.3%) treated vertebrae a bone cement leakage was detected.

LIMITATIONS: This is a not randomized study. Participants were limited to 40 patients.

CONCLUSION: The Kiva System potentially represents a novel and effective minimally invasive treatment option for patients suffering from severe pain due to osteolytic vertebral metastases.

Author List

Anselmetti GC, Manca A, Tutton S, Chiara G, Kelekis A, Facchini FR, Russo F, Regge D, Montemurro F

Author

Sean Tutton MD Vice Chair, Professor in the Radiology department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Bone Cements
Bone Neoplasms
Female
Fractures, Compression
Humans
Ketones
Male
Middle Aged
Pain
Pain Measurement
Polyethylene Glycols
Prospective Studies
Spinal Fractures
Vertebroplasty
jenkins-FCD Prod-480 9a4deaf152b0b06dd18151814fff2e18f6c05280