Object: Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice. Methods: In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index). Results: All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1–5.3; LP-VAS, 2.1–4.7; ODI, 11–22.9; and EQ-5D, 0.15–0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor. Conclusions: The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.

Background and purpose BRANCH (wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques) is a multicentre, retrospective study comparing core lab evaluation of angiographic outcomes with self-reported outcomes. Materials and methods Consecutive patients were enrolled from 10 US centres, aged between 18 and 85 with unruptured wide-neck middle cerebral artery (MCA) or basilar apex aneurysms treated endovascularly. Patient demographics, aneurysm morphology, procedural information, mortality and morbidity data and core lab and self-reported modified Raymond Roy (RR) outcomes were obtained. Results 115 patients met inclusion criteria. Intervention-related mortality and significant morbidity rates were 1.7% (2/115) and 5.8% (6/103) respectively. Core lab adjudicated RR1 and 2 occlusion rates at follow-up were 30.6% and 32.4% respectively. The retreatment rate within the follow-up window was 10/115 (8.7%) and in stent stenosis at follow-up was 5/63 (7.9%). Self-reporting shows a statistically significant direction to angiographic RR one outcomes at follow-up compared with core lab evaluation, with OR 1.75 (95% CI 1.08 to 2.83). Conclusion Endovascular treatment of wide-neck MCA and basilar apex aneurysms resulted in a core lab adjudicated RR1 occlusion rate of 30.6%. Self-reported results at follow-up favour better angiographic outcomes, with OR 1.75 (95% CI 1.08 to 2.83). These data demonstrate the need for novel endovascular devices specifically designed to treat complex intracranial aneurysms, as well as the importance of core lab adjudication in assessing outcomes in such a trial.

BACKGROUND:. The Pipeline embolization device (PED) is a new endovascular option for wide-necked or fusiform anterior circulation aneurysms that were c

Background and objective Flow diverters are an exciting new class of endovascular devices that treat aneurysms by curative reconstruction of the parent artery. The Pipeline embolization device (PED) is the first FDA-approved intracranial flow diverting device available in the USA. This paper presents periprocedural results with the device in a series of 35 consecutive cases. Methods All patients who underwent PED treatment of an intracranial aneurysm at our institution following FDA approval of the device in April 2011 were included in the series. Patient demographics, aneurysm characteristics, procedural details and technical and clinical outcomes were analyzed. Results Thirty-four patients (age range 23–78 years, mean 56.4 years) with 41 unruptured aneurysms (37 anterior circulation, four posterior circulation, mean size 11.4 mm, 20/21 large or giant) were treated with the PED in 35 cases (one patient had bilateral aneurysms treated on 2 separate occasions). Thirty-four of 35 cases (97%) were successfully completed. A total of 64 PEDs were implanted, with a mean number of 1.2 PEDs implanted per anterior circulation cases and 6.5 per posterior circulation cases. A single PED was implanted in 73% of cases. Immediate flow disruption occurred in 97% of the cases. The overall rate of major stroke or mortality was 3% (1/35 patients). Minor stroke, cranial nerve palsy, transient neurological deficit and groin complication occurred in one patient each (3% each, 12% total). Conclusion Treatment of cerebral aneurysms with the PED carries an acceptable risk profile when a rigorous and uniform technique is used. Although the long-term results will need to be analyzed, the immediate procedural outcomes in the study series using this technique appear quite promising.

Introduction Aneurysm recurrence is a principle limitation of endovascular coiling procedures, with recurrence rates reported of >30%. The adjunct use of self-expandable stents has revolutionized the treatment of intracranial aneurysms, especially for complex morphologies, wide necks or unfavorable dome to neck ratios. However, further investigation into the durability and outcomes of stent assisted coiling procedures is required. Methods The records of a prospective single center aneurysm database were retrospectively reviewed, and 90 consecutive patients with paraophthalmic aneurysms who underwent coil embolization were identified, 30 of which included stent placement. Patient demographics, aneurysm characteristics, coil packing density, angiographic results (initial and follow-up) and complications were analyzed. Results Complete aneurysm occlusion was obtained on initial angiography in 13/30 (43.3%) stented and 19/60 (31.7%) non-stented patients. At ≤24 months (mean follow-up 12.8±6.2 months for stented and 12.8±6.6 months for non-stented group), aneurysm recurrence occurred in 3/26 (11.5%) stented and 14/39 (35.9%) non-stented patients (p<0.05). At the longest follow-up (mean 14.5±12.5 months for stented and 37.6±35.3 months for non-stented), aneurysm recurrence occurred in 4/26 (15.4%) stented and 17/41 (41.5%) non-stented patients (p<0.03). There was no statistically significant correlation between recurrence and aneurysm size or coiling packing. Conclusions Following endovascular coil embolization of paraophthalmic region aneurysms, recurrence rates at 2 years were significantly lower in patients who had stent assisted coiling (11.5%) compared with patients who had coiling procedures without the use of a stent (35.9%). Aneurysm size and coiling packing density did not significantly affect recurrence in our study population.

Non-accidental trauma in pediatric patients: a review of epidemiology, pathophysiology, diagnosis and treatment