Treatment of Thoracolumbar Type A3 Fractures Using a Percutaneous Intravertebral Expandable Titanium Implant: Long-term Follow-up Results of a Pilot Single Center Study.

BACKGROUND: There are controversies about the optimal management of AO subtype A3 burst fractures. The most common surgical treatment consists of posterior fixation with pedicle screw and rod augmentation. Nevertheless, a loss of correction in height restoration and kyphotic reduction has been observed. OBJECTIVES: The aim of this study was to assess long-term outcomes of a minimally invasive technique using a percutaneous intravertebral expandable titanium implant (PIETI). STUDY DESIGN: This prospective, single center, pilot study was carried out on a consecutive case series of 44 patients with acute (< 2 weeks) traumatic thoracolumbar fractures AO type A3. The average follow-up was 5.6 years. SETTING: A single center in Castilla y Leon, SpainMETHODS: Clinical outcomes (pain intensity on visual analog scale [VAS], Oswestry Disability Index [ODI], analgesic consumption) and radiographic outcomes (anterior/mid/posterior vertebral body height, vertebral area, local kyphosis angle, traumatic regional angulation) were analyzed before surgery, at one month after surgery, and at the end of the follow-up period. RESULTS: At one-month postsurgery, significant improvements in VAS score and ODI score were observed. PIETI achieved significant vertebral body height restoration with median height increases of 2.9 mm/4.3 mm/2.3 mm for anterior/middle/posterior parts, respectively. Significant correction of the local kyphotic angle and improvement of the traumatic regional angulation were accomplished. All these improvements were maintained throughout the follow-up period. The only complication reported was a case of cement leakage. LIMITATIONS: In our opinion, the main limitation of the study is the small number of patients. However, the sample is superior to that shown in other papers. CONCLUSIONS: This study showed that using a PIETI in the treatment of fractures type A3 is a safe and effective method that allows marked clinical improvement, as well as anatomical vertebral body restoration. Unlike with other treatments, results were maintained over time, allowing a better long-term clinical and functional improvement. The rate of cement leakage was lower than other reports.

Fixed Dose IV rt-PA and Clinical Outcome in Ischemic Stroke Patients With Body Weight >100 kg: Pooled Data From 3 Randomized Clinical Trials.

BACKGROUND AND PURPOSE: The ASA/AHA guidelines recommend a fixed dose of 90 mg of intravenous (IV) recombinant tissue plasminogen activator (rt-PA) for acute stroke patients weighing more than 100 kg. We aimed to determine if body weight >100 kg (and receiving <0.9 mg/kg dose) independently influence patient clinical outcomes following IV rt-PA treatment. METHODS: We pooled data from IV rt-PA treatment arms from 3 randomized controlled clinical trials; NINDS IV rt-PA study, Interventional Management of Stroke 3 and ALIAS (part 1 and 2). Baseline characteristic, hospital course and 90-day mRS were compared between patients >100 kg and those ≤100 kg body weight. Multivariate logistic regression model was used to identify the independent effect of >100 kg body weight on favorable 90-day outcome (defined as mRS 0-2), the rate of symptomatic intracranial hemorrhage, and poor 90-day outcome (mRS 4-6). RESULTS: Among 873 patients treated with IV rt-PA, a total of 105 (12%) subjects had body weight >100 kg. Compared with patients having ≤100 kg body weight, the rate of favorable outcome at 90 days was not significantly different among patients with >100 kg body weight (OR: 0.99; 95% CI: 0.91-1.01; p=0.91) , after adjusting for potential confounders. The ordinal analysis did not show any significant shift in the distribution of 90-day mRS score in patients with >100 kg body weight (OR, 0.93; 95% CI, 0.64-1.37; P = 0.74) CONCLUSIONS: There was no reduction in the rate of favorable outcome in patients with acute ischemic stroke with body weight >100 kg who received <0.9 mg/kg dose of IV rt-PA. Our results support the current recommendations in the ASA/AHA guidelines.

Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data.

BACKGROUND: Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed. OBJECTIVE: To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK. SETTING: A representative US hospital. STUDY DESIGN: Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs. METHODS: The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis. RESULTS: With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva System was attributable to 19 reduced adjacent-level fractures with the Kiva System. LIMITATIONS: This study does not compare the Kiva System with VP or any other non-surgical procedures for the treatment of VCF. CONCLUSION: This first-ever economic analysis of the KAST data showed that the Kiva System for vertebral augmentation is hospital resource and cost saving over BK in a hospital setting over 2 years. These savings are attributable to reduced risk of developing adjacent-level fractures with the Kiva System compared to BK.

Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.

OBJECTIVE: Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. DESIGN: Prospective, nonrandomized Food and Drug Administration approved pilot study. SETTING: Three centers in the United States. SUBJECTS: Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography. INTERVENTIONS: Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s). OUTCOME MEASURES: Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ). RESULTS: Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product. EFFICACY: Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively. CONCLUSION: Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.

Spinal cord stimulation: a basic approach.

Chronic back pain and other refractory pain syndromes are a documented burden on our society. They also are a huge cost in quality of life and dollars spent on health care. Neuromodulation and specifically dorsal column stimulation of the spinal cord has been shown to decrease pain with minimal risk to the patient. We describe in this article the basic techniques and methods of both the stimulation trial and the permanent implantation of the leads and generator. With advanced imaging and the minimally invasive approach we further explain how to minimize any risk associated with this percutaneous procedure.

Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative prospective evaluation of long-term outcomes.

PURPOSE: Osteoporotic vertebral compression fractures may cause debilitating pain that lasts for weeks or months, and which is often neither quickly nor completely relieved by conventional conservative therapy. Previous retrospective studies have suggested significant and nearly immediate pain relief, as well as rapid and sustained functional recovery, after percutaneous polymethylmethacrylate vertebroplasty (PPV). This prospective, quantitative study with long-term follow-up was designed to evaluate the safety and efficacy of PPV as a new treatment for patients with osteoporotic vertebral body compression fractures of the lumbar and thoracic spine. MATERIALS AND METHODS: PPV was performed in 30 patients with 54 symptomatic osteoporotic vertebral compression fractures who had a less-than-satisfactory response to conventional therapy. All procedures were performed by a single operator with significant experience in performing PPV. The Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) spinal intervention questionnaire, which includes the SF-36, was administered to all patients before intervention and exactly 2 weeks after the final PPV procedure. Pain and disability, treatment expectations and satisfaction, mental function, and quality of life were evaluated by four specialized modules, and responses to questionnaires preceding treatment were compared to those obtained at follow-up. Results of a long-term follow-up questionnaire were collected 15-18 months after the final vertebroplasty treatment. RESULTS: Our population consisted of three men and 27 women, with a mean age of 79 years. Fifty-four PPV procedures were performed for compression fractures in these 30 patients. Significant postprocedural improvement in all four MODEMS modules was demonstrated at 2 weeks (treatment score, P <.0001; pain and disability, P <.0001; physical function, P =.0004; and mental function, P =.0009). A small epidural leak of polymethylmethacrylate in one patient was asymptomatic and did not require intervention. At long-term follow-up (15-18 mo), 22 of 23 patients responding remained satisfied with the outcome of therapy and believed that the procedure had provided durable pain relief. Verbal pain scores documented significantly diminished back pain at 2 weeks (P <.0001) and again at long-term follow-up when compared to baseline (P <.0001). CONCLUSIONS: PPV is a safe and efficacious procedure for the relief of pain and disability after osteoporotic vertebral compression fractures. Patient satisfaction is high and persists when compared to preprocedural expectations; durable pain relief is provided.