Effect of Prophylactic Transluminal Balloon Angioplasty on Cerebral Vasospasm and Outcome in Patients With Fisher Grade III Subarachnoid Hemorrhage

Abstract

Background and Purpose-Cerebral vasospasm continues to be a major cause of poor outcome in patients with ruptured aneurysms. Prophylactic Transluminal Balloon Angioplasty (pTBA) appeared to prevent delayed ischemic neurological deficit in a pilot study. A phase II multicenter randomized clinical trial was subsequently designed. Methods-One hundred and seventy patients with Fisher Grade III subarachnoid hemorrhage were enrolled in the study.Of these, 85 patients were randomized to the treatment group and underwent pTBA within 96 hours after subarachnoid hemorrhage. Main end points of the study included the 3-month dichotomized Glasgow Outcome Score (GOS), development of delayed ischemic neurological deficit (DIND), occurrence of Transcranial Doppler (TCD) vasospasm, and length of stay in the ICU and hospital. Results-The incidence of DIND was lower in the pTBA group (Pϭ0.30) and fewer patients required therapeutic angioplasty to treat DIND (Pϭ0.03). Overall pTBA resulted in an absolute risk reduction of 5.9% and a relative risk reduction of 10.4% unfavorable outcome (Pϭ0.54). Good grade patients had absolute and relative risk reductions of respectively 9.5 and 29.4% (Pϭ0.73). Length of stay in ICU and hospital was similar in both groups. Four patients had a procedure-related vessel perforation, of which three patients died. Conclusions-While the trial is unsuccessful as defined by the primary end point (GOS), proof of concept is confirmed by these results. Fewer patients tend to develop vasospasm after treatment with pTBA and there is a statistically significantly decreased need for therapeutic angioplasty. pTBA does not improve the poor outcome of patients with Fisher grade III subarachnoid hemorrhage. (Stroke. 2008;39:1759-1765.)

Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies

“…Because of its delayed onset, this complication is often called delayed cerebral ischemia (DCI). 2,4 Besides the term "DCI," many other terms are used in the literature to describe this clinical phenomenon, such as delayed ischemic neurological deficit, [5][6][7] delayed ischemic deficit, 8,9 delayed neurological deficit, 10,11 secondary cerebral ischemia, 12,13 vasospasm, 14,15 clinical vasospasm, 16,17 symptomatic vasospasm, 18,19 symptomatic ischemia, 20 and cerebral infarction. 21 The use of so many different terms is problematic, not only because many studies provide incomplete definitions of the terms used, if at all, 22,23 but also because a variety of definitions are used for the same term.…”

Management of cerebral vasospasm following aneurysmal subarachnoid hemorrhage

“…Therefore, prophylactic angioplasty is not indicated in patients following aneurysmal SAH. 44 balloon angioplasty is reserved for patients with angiographic or clinical vasospasm. Endovascular treatment is repeated as needed, and there is no guideline about the appropriate time to discontinue endovascular management.…”

Treatment Options for Cerebral Vasospasm in Aneurysmal Subarachnoid Hemorrhage

“…Prophylactic PTA (in the absence of arterial narrowing) reduces the incidence of DCI, but is associated with significant complications, resulting in no net benefit [63]. Complications of PTA include vessel occlusion, dissection, and rupture, dislodging of aneurysm clips, and thrombus formation [64][65][66][67].…”