Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial.

Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.

BACKGROUND CONTEXT: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. PURPOSE: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. STUDY DESIGN/SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. PATIENT SAMPLE: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. OUTCOME MEASURES: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. METHODS: Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. RESULTS: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. CONCLUSIONS: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery.

Right ventricular dysfunction and pulmonary obstruction index at helical CT: prediction of clinical outcome during 3-month follow-up in patients with acute pulmonary embolism.

PURPOSE: To retrospectively quantify right ventricular dysfunction (RVD) and the pulmonary artery obstruction index at helical computed tomography (CT) on the basis of various criteria proposed in the literature and to assess the predictive value of these CT parameters for mortality within 3 months after the initial diagnosis of pulmonary embolism (PE). MATERIALS AND METHODS: Institutional review board approval was obtained, and informed consent was not required for retrospective study. In 120 consecutive patients (55 men, 65 women; mean age +/- standard deviation, 59 years +/- 18) with proved PE, two readers assessed the extent of RVD by quantifying the ratio of the right ventricle to left ventricle short-axis diameters (RV/LV) and the pulmonary artery to ascending aorta diameters, the shape of the interventricular septum, and the extent of obstruction to the pulmonary artery circulation on helical CT images, which were blinded for clinical outcome in consensus reading. Regression analysis was used to correlate these parameters with patient outcome. RESULTS: CT signs of RVD (RV/LV ratio, >1.0) were seen in 69 patients (57.5%). During follow-up, seven patients died of PE. Both the RV/LV ratio and the obstruction index were shown to be significant risk factors for mortality within 3 months (P = .04 and .01, respectively). No such relationship was found for the ratio of the pulmonary artery to ascending aorta diameters (P = .66) or for the shape of the interventricular septum (P = .20). The positive predictive value for PE-related mortality with an RV/LV ratio greater than 1.0 was 10.1% (95% confidence interval [CI]: 2.9%, 17.4%). The negative predictive value for an uneventful outcome with an RV/LV ratio of 1.0 or less was 100% (95% CI: 94.3%, 100%). There was a 11.2-fold increased risk of dying of PE for patients with an obstruction index of 40% or higher (95% CI: 1.3, 93.6). CONCLUSION: Markers of RVD and pulmonary vascular obstruction, assessed with helical CT at baseline, help predict mortality during follow-up.