Citations

Background and Purpose— We report the primary outcome of the Cerecyte Coil Trial, a randomized trial to determine whether polymer-loaded Cerecyte coils compared with Micrus bare platinum coils improved the proportion of patients with angiographic occlusion of the aneurysm at 6 months when assessed by a core laboratory. The secondary objectives were to compare the clinical outcomes and retreatment rates in the 2 groups. Methods— Five hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm were randomized to be treated with either Cerecyte or bare platinum coils in 23 centers worldwide. Two hundred forty-nine patients were assigned to Cerecyte coils and 251 to bare platinum coils. Analysis was by intention to treat. Results— Four hundred ninety-four patients were eligible for analysis. Four hundred eighty-one patients underwent coil treatment of their aneurysm, 227 patients with recently ruptured aneurysms and 254 with unruptured aneurysms. Four hundred thirty-three follow-up angiograms were assessed by the core laboratory; 127 of 215 (59%) and 118 of 218 (54%) in the Cerecyte and bare platinum groups, respectively, fulfilled the trial prespecified definition of success, namely that the treated aneurysm showed complete angiographic occlusion, had stable neck remnant, or improved in angiographic appearance compared with the end-of-treatment angiogram ( P =0.17). Late retreatment was performed in 25 of 452 (5.5%) patients, 17 (7.7%) Cerecyte versus 8 (3.5%) bare platinum ( P =0.064; range, 4–34 months). The clinical outcomes did not differ between the groups. Conclusion— There was no significant difference at 6 months in the angiographic outcomes between Cerecyte coils and bare platinum coils when assessed by the core laboratory. Clinical Trial Registration Information— URL: www.controlled-trials.com . Unique Identifier: ISRCTN82461286.

Background Reported incidence of extravertebral cement leakage after vertebroplasty varies widely across studies. Purpose To retrospectively compare the relative detection rates of extravertebral leakage noted under intra-procedural fluoroscopic surveillance, postprocedure plain radiographs, and postprocedure computed tomography (CT) in a cohort of patients undergoing vertebroplasty. Material and Methods With IRB approval, we retrospectively identified 181 patients with 277 levels treated with percutaneous vertebroplasty among a total of 1255 patients undergoing vertebroplasty between 1999 and 2010 who had subsequently undergone a CT examination that included the treated level(s). Categories of leakage were paravertebral, end plate, epidural, and prevertebral venous leakage. CT-detected leak rates were then compared to those noted on the vertebroplasty procedure reports and the archived fluoroscopic images for this same cohort using Pearson's χ 2 test. Results One hundred and forty-nine (82%, 95% CI 76–87%) of 181 patients demonstrated evidence of some type of leakage on CT at one or more treated levels. Sixty-two (34%, 95% CI 28–42%) and seventy-seven (50%, 95% CI 43–57%) of 149 CT-detected leaks were reported in the procedural dictation or detected on plain radiography ( P = 0.01 and 0.006, respectively). The most common type of leakage noted on CT was end plate ( n = 81, 45%, 95% CI 38–52%), followed by paravertebral ( n = 64, 35%, 95% CI 29–43%), epidural ( n = 36, 20%, 95% CI 15–26%), and prevertebral venous ( n = 32, 18%, 95% CI 13–24%). Conclusion Cement leakage after vertebroplasty is common and is often not reported by operators in procedural dictations. CT detects substantially more leaks than plain radiography.

Object Familial predisposition is a recognized nonmodifiable risk factor for the formation and rupture of intracranial aneurysms (IAs). However, data regarding the characteristics of familial IAs are limited. The authors sought to describe familial IAs more fully, and to compare their characteristics with a large cohort of nonfamilial IAs. Methods The Familial Intracranial Aneurysm (FIA) study is a multicenter international study with the goal of identifying genetic and other risk factors for formation and rupture of IAs in a highly enriched population. The authors compared the FIA study cohort with the International Study of Unruptured Intracranial Aneurysms (ISUIA) cohort with regard to patient demographic data, IA location, and IA multiplicity. To improve comparability, all patients in the ISUIA who had a family history of IAs or subarachnoid hemorrhage were excluded, as well as all patients in both cohorts who had a ruptured IA prior to study entry. Results Of 983 patients enrolled in the FIA study with definite or probable IAs, 511 met the inclusion criteria for this analysis. Of the 4059 patients in the ISUIA study, 983 had a previous IA rupture and 657 of the remainder had a positive family history, leaving 2419 individuals in the analysis. Multiplicity was more common in the FIA patients (35.6% vs 27.9%, p < 0.001). The FIA patients had a higher proportion of IAs located in the middle cerebral artery (28.6% vs 24.9%), whereas ISUIA patients had a higher proportion of posterior communicating artery IAs (13.7% vs 8.2%, p = 0.016). Conclusions Heritable structural vulnerability may account for differences in IA multiplicity and location. Important investigations into the underlying genetic mechanisms of IA formation are ongoing.

Object The authors conducted a study to review their experience with tentorial dural arteriovenous fistulas (DAVFs) treated with transarterial endovascular embolization in which Onyx was used. Methods The authors reviewed prospectively collected data in 9 patients with tentorial DAVFs treated with Onyx embolization between 2008 and 2011. Information reviewed included clinical presentation, angiographic features, treatment, and clinical and radiologically documented outcome. Clinical follow-up was available in every patient. Radiological follow-up studies were available in 8 of 9 patients (mean follow-up 4.6 months). Results Six of 9 patients had complete angiographic obliteration (in 5 this was confirmed by a follow-up angiogram obtained 3–6 months later), and 2 patients had near-complete obliteration (faint filling of the venous drainage in the late venous phase). One patient had partial obliteration and required surgical disconnection. In all patients with complete obliteration, transarterial embolization was performed through the posterior branch of the middle meningeal artery. There were no procedural complications, and no morbidity or mortality resulted from Onyx embolization. Conclusions Transarterial Onyx embolization is a valid, effective, and safe alternative to surgical disconnection in many patients with tentorial DAVFs. The presence of an adequate posterior branch of the middle meningeal artery is critical to achieve a microcatheter position distal enough to increase the likelihood of complete obliteration.

Object In this study the authors determined the patency rate of the ophthalmic artery (OphA) after placement of 1 or more flow diversion devices across the arterial inlet for treatment of proximal internal carotid artery (ICA) aneurysms, and correlated possible risk factors for OphA occlusion. Methods Nineteen consecutive patients were identified (mean age 53.9 years, range 23–74 years, all female) who were treated for 20 ICA aneurysms. In all patients a Pipeline Embolization Device (PED) was placed across the ostium of the OphA while treating the target aneurysm. Flow through the OphA after PED placement was determined by immediate angiography as well as follow-up angiograms (mean 8.7 months), compared with the baseline study. Potential risk factors for OphA occlusion, including age, immediate angiographic flow through the ophthalmic branch, status of flow within the aneurysm after placement of PEDs, whether the ophthalmic branch originated from the aneurysm dome, and number of PEDs placed across the ophthalmic branch inlet were correlated with patency rate. Results Patients were treated with 1–3 PEDs (3 aneurysms treated with placement of 1 PED, 12 with 2 PEDs, and 5 with 3 PEDs). In 17 (85%) of 20 treated aneurysms, no changes in the OphA flow were noted immediately after placement of the device. Two (10%) of 20 patients had delayed antegrade filling immediately following PED placement and 1 patient (5%) had retrograde flow from collaterals to the OphA immediately after placement of the device. One patient (5%) experienced delayed asymptomatic ICA occlusion; this patient was excluded from analysis at follow-up. At follow-up the OphA remained patent with normal antegrade flow in 13 (68%) of 19 patients, patent but with slow antegrade flow in 2 patients (11%), and was occluded in 4 patients (21%). No visual changes or clinical symptoms developed in patients with OphA flow compromise. The mean number of PEDs in the patients with occluded OphAs or change in flow at angiographic follow-up was 2.4 (SEM 0.2) compared with 1.9 (SEM 0.18) in the patients with no change in OphA flow (p = 0.09). There was no significant difference between the patients with occluded OphAs compared with nonoccluded branches based on patient age, immediate angiographic flow through the ophthalmic branch, status of flow through the aneurysm after placement of PEDs, whether the ophthalmic branch originated from the aneurysm dome, or number of PEDs placed across the ophthalmic branch inlet. Conclusions Approximately one-quarter of OphAs will undergo proximal thrombosis when covered with flow diversion devices. Even though these events were well-tolerated clinically, our findings suggest that coverage of branch arteries that have adequate collateral circulation may lead to spontaneous occlusion of those branches.

We present a case of a 63-year-old male undergoing attempted basilar artery embolization using a right transradial artery approach in which continuous pulse oximetry of the ipsilateral thumb uncovered unanticipated hand ischemia during the procedure. A preprocedural evaluation using pulse oximetry of the right thumb demonstrated normal waveform and maintenance of normal oxygen saturation during manual compression of the right radial artery. This normal waveform and oxygen saturation was maintained after insertion of a 6Fr sheath into the radial artery. After insertion of a 6Fr guiding catheter into the right vertebral artery, near-complete dampening of the pulse oximetry waveform and precipitous decline in oxygen saturation were noted. Examination of the right hand demonstrated poor tissue perfusion. Immediate removal of the guiding catheter led to return of a normal waveform, oxygen saturation, and tissue perfusion. This case demonstrates the importance of continuous, intraprocedural monitoring of oxygenation of the ipsilateral hand during transradial angiography in order to avoid unanticipated perfusion abnormalities.

Objective A study was undertaken to estimate the fraction of intracranial aneurysms that might be amenable to treatment with the pipeline embolization device (PED), a current flow diverter device, and to determine the types of aneurysms that are probably not amenable to treatment with this device. Methods A retrospective analysis of 200 consecutive intracranial aneurysms as seen on three-dimensional rotational angiography images was conducted. Based on aneurysm and parent artery morphology, four independent observers experienced in the use of the PED judged the likelihood that a given aneurysm could theoretically be treated with one or more PED using a 5-point scale: grades 1 and 2 indicated amenability to treatment with multiple devices; grade 3 indicated amenability to treatment with one device; and grades 4 and 5 indicated the aneurysm would not be amenable to treatment with the PED. Aneurysms were analyzed on the basis of anatomical factors only. Rupture status was not considered. Interobserver agreement was determined. Results 94 of 200 aneurysms (47%) were judged to be likely to be amenable to treatment with the PED; 50 cases (25%) were judged to be amenable to the use of multiple overlapping devices while, in 44 cases (22%), coverage with a single device was preferred. There was a significant relationship between the location of the aneurysm and the grade of the aneurysm (p<0.0001). Conclusion On the basis of anatomical configuration, nearly half of the aneurysms in this study were likely to be amenable to treatment with the PED.

Object The management of incidental small unruptured intracranial aneurysms (UIAs) is controversial and many factors need to be considered in the decision-making process. The authors describe a large consecutive series of patients harboring small incidental intracranial aneurysms. Treatment strategy, natural history, complications, and short-term outcomes are presented. Methods Between January 2008 and May 2011, the authors prospectively evaluated 212 patients with 272 small (< 10-mm) incidental aneurysms. Treatment recommendations (observation, endovascular treatment, or surgery), complications of treatment, and short-term outcomes were assessed. Results Recommended treatment consisted of observation in 125 patients, endovascular embolization in 64, and surgery in 18. Six patients were excluded from further analysis because they underwent treatment elsewhere. In the observation group, at a mean follow-up of 16.7 months, only 1 patient was moved to the embolization group. Seven (6%) of the 125 patients in the observation group died of causes unrelated to aneurysm. Sixty-five patients underwent 69 embolization procedures. The periprocedural permanent morbidity and mortality rates in patients undergoing endovascular treatment were 1.5% and 1.5%, respectively (overall morbidity and mortality rate 3.0%). In the surgery group no periprocedural complications were observed, although 1 patient did not return to her previous occupation. No aneurysmal rupture was documented in any of the 3 treatment groups during the follow-up period. Conclusions A cautious and individualized approach to incidental UIAs is of utmost importance for formulation of a safe and effective treatment algorithm. Invasive treatment (either endovascular or surgery) can be considered in selected younger patients, certain “higher-risk” locations, expanding aneurysms, patients with a family history of aneurysmal hemorrhage, and in those who cannot live their lives knowing that they harbor the UIA. Although the complication rate of invasive treatment is very low, it is not negligible. The study confirms that small incidental UIAs deemed to be not in need of treatment have a very benign short-term natural history, which makes observation a reasonable approach in selected patients.

Background and Purpose— It is important to know the costs of hospitalization for patients undergoing endovascular embolectomy so that comparisons can be made with payments to hospitals. Methods— Using the National Inpatient Sample, we evaluated the costs of hospitalization for patients treated with endovascular embolectomy in the United States from 2006 to 2008. The primary end point examined in this study was total hospital costs, and these were correlated with clinical outcome. Results— A total of 3864 patients received endovascular embolectomy. A total of 1649 patients were <65 years old and 2205 patients were ≥65 years old. Median hospital costs in 2008 dollars were $36 999 (interquartile range, $26 662–$56 405) for patients with good outcome, $50 628 (interquartile range, $33 135–$76 063) for patients with severe disability, and $35 109 (interquartile range, $25 053–$62 621) for patients with mortality. Conclusions— Hospitalization costs for patients treated with endovascular embolectomy are rather high, probably due to the serious nature of their illness. Medicare payments have not been adequate reimbursement for these hospitalizations.