Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.

OBJECTIVE: To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage and 3) nurse intervener perspectives. DESIGN: A randomized controlled clinical trial design. SETTING: Urban, community, midwestern United States. SUBJECTS: A total of 254 stroke caregivers (mean ±SD age, 54.4 ±11.8 years), 55 (22.0%) males and 199 (78.4%) females) randomized to the TASK II intervention (n=123) or an Information, Support, and Referral comparison group (n=131). INTERVENTIONS: TASK II participants received the TASK II Resource Guide; Information, Support, and Referral participants received a standard caregiver brochure. At approximately 8 weeks after discharge, both groups received 8 weekly calls from a nurse, with a booster call 4 weeks later. MEASURES: Protocol adherence was evaluated with the TASK II Checklist for Monitoring Adherence. Intervention dosage was measured by the number of minutes caregivers spent reading materials and talking with the nurse. Nurse intervener perspectives were obtained through focus groups. RESULTS: Protocol adherence was 80% for the TASK II and 92% for the Information, Support, and Referral. As expected, intervention dosage differed between TASK II and Information, Support, and Referral with respect to caregiver time spent reading materials (t=-6.49; P<.001) and talking with the nurse (t=-7.38; P<.001). Focus groups with nurses yielded further evidence for treatment fidelity and recommendations for future trials. CONCLUSIONS: These findings substantiate treatment fidelity in both study arms of the TASK II stroke caregiver intervention trial (NIH R01NR010388; ClinicalTrials.govNCT01275495).

Trends over time in the management of 2253 patients with cerebral aneurysms: A single practice experience.

BACKGROUND: To better understand the longitudinal trend in the proportion of techniques employed for cerebral aneurysm treatment, we reviewed our experience with 2253 patients over the last 11 years. METHODS: We reviewed data in our prospective aneurysm database for all consecutive patients treated from January 1998 through December 2009. Data regarding age, sex, aneurysm location, presence or absence of hemorrhage, Fisher grade, clinical grade, treatment methods, length of hospitalization, and mortality rates by the time of discharge were retrieved and retrospectively analyzed. The most common aneurysm types were subsequently classified and analyzed separately. RESULTS: The patient population included 663 males (29%) and 1590 females (71%). A total of 2253 patients presented with 3413 aneurysms; 1523 (63%) of the aneurysms were diagnosed as aneurysmal subarachnoid hemorrhage. A total of 2411 (71%) aneurysms were treated. Overall, 645 (27%) of the 2411 aneurysms underwent endosaccular coiling and 1766 (73%) underwent clip ligation; 69 (3%) of these aneurysms required both treatment modalities. The percentage of all aneurysms treated by endosaccular coiling increased from 8% (21) in 1998 to 28% (87) in 2009. There was no statistical difference between the average length of hospitalization for patients who underwent endosaccular coiling and clip ligation for their ruptured (P = 0.19) and unruptured (P = 0.80) aneurysms during this time period. CONCLUSIONS: In our practice, endovascular treatment has continued to be more frequently employed to treat cerebral aneurysms. This technique has had the greatest proportional increase in the treatment of posterior circulation aneurysms.

Middle cerebral artery aneurysms in children: case series and review.

OBJECT: Pediatric intracranial aneurysms are rare lesions that differ from their adult counterparts. Aneurysms involving the middle cerebral artery (MCA) are particularly challenging to treat in children, as they are often fusiform and cannot undergo direct clipping alone. The authors recently treated a patient with a heavily calcified, dysplastic, left-sided MCA aneurysm. The present study was performed to evaluate the authors' previous operative and follow-up experience with these difficult lesions. METHODS: The authors performed a review of a prospectively maintained database of all aneurysms treated at Methodist Hospital in Indianapolis, Indiana, from January 1990 through November 2010. Relevant operative notes, clinical charts, and radiological reports were reviewed for all patients 18 years of age or younger. RESULTS: A total of 2949 patients with aneurysms were treated over the study period, including 28 children (0.95%). Seven children harbored MCA aneurysms. Five of these 7 aneurysms (71.4%) were fusiform. Two patients were treated with direct clipping, 2 underwent parent vessel occlusion without bypass, and 3 underwent aneurysm trapping with extracranial-intracranial vessel bypass. Long-term follow-up data were available in 6 cases. All 6 patients had a 1-year follow-up Glasgow Outcome Scale score of 5. Long-term radiological follow-up was available in 4 patients. One patient required a reoperation for a recurrent aneurysm 4 years after the initial surgery. CONCLUSIONS: Middle cerebral artery aneurysms in children are often fusiform, giant, and incorporate the origins of proximal artery branches. Direct clipping may not be possible; trapping of the lesion may be required. Children seem to tolerate surgical trapping with or without bypass extremely well. Aggressive therapy of these rare lesions in children is warranted, as even patients presenting with a poor clinical grade may have excellent outcomes. Long-term surveillance imaging is necessary because of the risk of aneurysm recurrence.

Endovascular treatment and radiographic follow-up of proximal traumatic intracranial aneurysms in adolescents: case series and review of the literature.

PURPOSE: Traumatic intracranial aneurysms are rare lesions that are relatively more common in the pediatric population. Proximal traumatic aneurysms occur near the skull base. Direct surgical repair of these lesions is difficult due to the anatomically confined area, clinical status of a head injury patient, and the transmural nature of the injury. These lesions often lack a definable neck or wall suitable for clipping. While the indications and capabilities of endovascular treatment continue to expand, there are unanswered questions about the durability of treatment, especially in young patients. There are few reports examining the radiographic outcomes of endovascular treatment specifically for traumatic intracranial aneurysms. Therefore, we examined our experience treating these rare proximal lesions in an adolescent population. METHODS: A retrospective review of prospectively collected data from 2000-2008 in a large, multidisciplinary neurovascular and trauma center was performed. RESULTS: Three pediatric patients received endovascular treatment for traumatic intracranial aneurysms near the skull base. All patients had successful obliteration of their lesion without vessel sacrifice; however, two patients required multiple procedures for coil compaction or refilling of the aneurysm. There were no complications or ischemic events related to treatment. Follow-up imaging ranged from 6 months to 3.5 years. CONCLUSIONS: Traumatic intracranial aneurysms at the skull base can be successfully treated with endovascular methods; however, close follow-up is necessary.

Endovascular retrograde suction decompression as an adjunct to surgical treatment of ophthalmic aneurysms: analysis of risks and clinical outcomes.

OBJECTIVE: Endovascular retrograde suction decompression with balloon occlusion of the internal carotid artery is a useful adjunct in the surgical treatment of ophthalmic aneurysms. This technique helps establish proximal control, facilitates intraoperative angiography, and may aid dissection by evacuating blood and softening the aneurysm. Although the technical aspects of this procedure have been described, the published data on its safety are scant. This study analyzed 2 groups of patients who underwent craniotomies for treatment of ophthalmic aneurysms, comparing a group who received suction decompression with a group who did not. METHODS: A retrospective analysis of prospectively collected data on 118 craniotomies for ophthalmic aneurysms performed from 1990 to 2005 is presented. A group of 63 patients treated with endovascular suction decompression during surgery is compared with 55 patients who did not undergo this technique. RESULTS: In our overall analysis of ophthalmic aneurysms, the clinical outcome was statistically related to aneurysm size (P = 0.046). The endovascular suction decompression group in this study had overall larger aneurysms (P < 0.0001) compared with the other group. There was no statistical difference between the 2 groups in rates of complications, stroke, new visual deficit, or death. The clinical outcomes were statistically similar at discharge and at 1 year. CONCLUSION: Endovascular balloon occlusion and suction decompression did not increase the complication rate in a large cohort of craniotomy patients with ophthalmic aneurysms. This technique may be used to augment surgical capabilities without significantly increasing the operative risk.

Results, outcomes, and follow-up of remnants in the treatment of ophthalmic aneurysms: a 16-year experience of a combined neurosurgical and endovascular team.

OBJECTIVE: Ophthalmic aneurysms present unique challenges to a vascular team. This study reviews the 16-year experience of a multidisciplinary neurovascular service in the treatment, complications, outcomes, and follow-up of patients with ophthalmic aneurysms from 1990 to 2005. METHODS: A retrospective analysis of prospectively collected data of 134 patients with 157 ophthalmic aneurysms is presented. Subgroup analysis is performed based on treatment and clinical presentation of the patients. RESULTS: Clinical outcomes are reported using the Glasgow Outcome Scale. A "good" outcome is defined as a Glasgow Outcome Scale score of 4 or 5, and a "poor" outcome is defined as a Glasgow Outcome Scale score of 1 to 3. Outcome was related to patient age (P = 0.0002) and aneurysm size (P = 0.046). Outcomes for patients with ruptured aneurysms were related to hypertension (P < 0.0001) and clinical admission grade (P = 0.001). In patients with unruptured aneurysms, a good clinical outcome was noted in 103 (92.7%) of 111 patients at discharge and 83 (94.3%) of 88 patients at the time of the 1-year follow-up evaluation. Complete clipping was attained in 89 (79.5%) of 112 patients with angiographic follow-up. Patients with aneurysm remnants from both coiling and clipping had a low risk of regrowth, and there were no rehemorrhages. One of 25 patients with angiographic follow-up (average, 4.3 +/- 4.1 years) after "complete" clipping showed recurrence of the aneurysm. CONCLUSION: Despite the difficulties presented by ophthalmic aneurysms, these lesions can be successfully managed by a multidisciplinary team. Imaging follow-up of patients is important, as there is a risk of aneurysm regrowth after either coiling or clipping.

Analysis of intraoperative rupture in the surgical treatment of 1694 saccular aneurysms.

OBJECTIVE: Intraoperative rupture (IOR) of an aneurysm is a known risk in the surgical management of intracranial aneurysms. The purpose of this study was to determine the incidence of IOR in a modern surgical series and to assess which factors bear upon it. METHODS: This study retrospectively examined 1269 patients with saccular aneurysms treated surgically between 1986 and 1998. Three vascular neurosurgeons performed 1435 operations on 1694 aneurysms. Multiple factors, including the magnitude and time of occurrence of IOR, aneurysm location, subarachnoid hemorrhage, timing of surgery, and use of temporary occlusion, were analyzed. RESULTS: There were 113 instances of IOR (7.9% per surgery; 6.7% per aneurysm; 8.9% per patient). If the 59 "minor leaks" are excluded (as in previously published reports), the incidence becomes 3.8% per surgery, 3.2% per aneurysm, and 4.3% per patient. Posteroinferior cerebellar artery and anterior and posterior communicating artery aneurysms were more liable to rupture intraoperatively. The IOR rate was greater in ruptured than unruptured aneurysms (10.7 versus 1.2%, P < 0.0001). There was a lower rate of IOR in operations using temporary arterial occlusion (3.1 versus 8.6%, P < 0.0001). The occurrence of IOR for early surgery was not significantly higher than for surgery performed more than 3 days after subarachnoid hemorrhage (11.1 versus 10.0%, P = 0.6234). CONCLUSION: The rate of significant IOR can be kept low. Aneurysm location, subarachnoid hemorrhage, and temporary arterial occlusion seem to be important factors affecting the incidence of IOR.