Feasibility, Safety and Cement Leakage in Vertebroplasty of Osteoporotic and Malignant Compression Fractures Using Ultra-Viscous Cement and Hydraulic Delivery System

Abstract

Background: The major complications arising from vertebroplasty or kyphoplasty are related to leakage of cement beyond the confines of the collapsed vertebral body. Traditionally, a liquid (low viscosity) cement is used in most vertebroplasty systems available on the market, coupled with mechanical injection devices or one mL syringes. Objectives: The purpose of this study is to evaluate the feasibility and safety, as well as study cement leakage patterns, in vertebroplasty performed for both osteoporotic and malignant vertebral compression fractures using ultraviscous cement injected by the hydraulic CONFIDENCE Vertebral Augmentation System. Study Design: Retrospective evaluation of postoperative images. Setting: Single center inpatient and outpatient population. Methods: A retrospective evaluation of clinical charts and postoperative X-ray imaging was performed in 122 cases; a total of 214 levels were treated. The study group comprised a total of 163 levels of benign osteoporotic fractures and 51 levels of various malignant lesions. The degree of leakage, seen in postoperative films, was assessed at each treated level using a strict 4-point scale (none, mild, moderate, severe). Results: For benign lesions, there was no leakage in 82 levels (50%), mild venous leakage in 38 levels (23%), moderate venous leakage in 4 levels (2%), mild disc leakage in 28 levels (17%), moderate disc leakage in 7 levels (4%), mild paravertebral leakage in 2 levels (1%), and moderate paravertebral leakage in 2 levels (1%). No severe leakage or epidural leakage were seen. For malignant lesions, there was no leakage in 25 levels (49%), mild venous leakage in 12 levels (24%), moderate venous leakage in 4 levels (8%), mild disc leakage in 7 levels (14%), moderate disc leakage in one level (2%), mild paravertebral leakage in one level (2%), and one level showed a mild epidural leakage (2%). Limitations: Retrospective study, single center. Conclusion: Percutaneous cement augmentation in osteoporotic and malignant compression fractures using a highly viscous cement that can be safely controlled and injected via a hydraulic system can be performed safely without significant complications. The leakage rate and patterns were similar in both benign and malignant compression fractures. The use of highly viscous cement may decrease the complication rate in malignant lesions that has been traditionally described to exhibit more cement leakage with low viscosity cement. Institutional Review: This study was approved by the Institutional Review Board Key words: Vertebroplasty, high viscosity cement, CONFIDENCE system, hydraulic injection.