Qureshi, Adnan Iqbal

Background: Systolic blood pressure (SBP) fluctuation is linked to increased death or disability in intracerebral hemorrhage (ICH) patients. We analyzed data from the Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 trial to explore whether the association between SBP fluctuation and 90-day outcomes varies with time from randomization. Methods: We calculated hourly SBP fluctuation based on the difference between maximum and minimum SBP during the first 24 hours post-randomization. Logistic regression models assessed the impact of SBP fluctuation on: 1) death or disability (modified Rankin scale [mRS] 4-6 at 90 days); 2) hematoma expansion (>33% increase in volume on 24-hour CT scan); 3) neurological deterioration within 24 hours (defined as ≥2-point decrease on Glasgow Coma Scale or ≥4-point increase on NIH Stroke Scale); and 4) acute kidney injury (AKI) within 72 hours. Adjustments were made for baseline Glasgow Coma Scale score, intraventricular hemorrhage, hematoma volume, and maximum SBP. Results: The hourly SBP fluctuations according to 90-day outcomes (dichotomized into good outcome, mRS 0-3, and poor outcome, mRS 4-6) in 961 patients with ICH are presented in Figure. The SBP fluctuation at 5 hours (p=0.014) and 6 hours (p=0.014) post randomization were significantly associated with death or disability at 90 days, with positive, but not statistically significant associations observed at all other points up to 13 hours after randomization. Risk of neurological deterioration within 24 hours was highly associated with SBP fluctuation, with the largest association observed between 1 (p<0.001) and 5 (p<0.001) hours following randomization, with significant associations observed up to 22 hours following randomization. Risk of hematoma expansion was associated with SBP fluctuation between 3 (p=0.015) and 8 (p=0.002) hours post randomization. Statistically significant associations between SPB fluctuations and risk of AKI were not observed. Conclusions: The first 8 hours following randomization are critical for reducing SBP fluctuations, as this period most strongly influences both short- and long-term outcomes in ICH patients. These findings suggest this time window is crucial for future interventions aimed at controlling SBP in ICH patients.

The proliferation of new endovascular devices and therapeutic strategies calls for a prudent and rational evaluation of their clinical benefit. This evaluation must be done in an effective manner and in collaboration with industry. Such research initiative requires organisational and methodological support to survive and thrive in a competitive environment. We propose the formation of an international consortium, an academic alliance committed to the pursuit of effective neurovascular therapies. Such a consortium would be dedicated to the design and execution of basic science, device development and clinical trials. The Consortium is owned and operated by its members. Members are international leaders in neurointerventional research and clinical practice. The Consortium brings competency, knowledge, and expertise to industry as well as to its membership across a spectrum of research initiatives such as: expedited review of clinical trials, protocol development, surveys and systematic reviews; laboratory expertise and support for research design and grant applications to public agencies. Once objectives and protocols are approved, the Consortium provides a stable network of centers capable of timely realization of clinical trials or preclinical investigations in an optimal environment. The Consortium is a non-profit organization. The potential revenue generated from client-sponsored financial agreements will be re-directed to the academic and research objectives of the organization. The Consortium wishes to work in concert with industry, to support emerging trends in neurovascular therapeutic development. The Consortium is a realistic endeavour optimally structured to promote excellence through scientific appraisal of our treatments, and to accelerate technical progress while maximizing patients' safety and welfare.

Object The utilization of endovascular treatment for ruptured intracranial aneurysms is expected to change since the publication of the International Subarachnoid Aneurysm Trial (ISAT) in 2002. The authors performed this analysis to determine the impact of ISAT results on treatment selection for ruptured intracranial aneurysms and associated in-hospital outcomes using nationally representative data. Methods We determined the national estimates of treatments used for ruptured intracranial aneurysms and associated in-hospital outcomes, length of stay, mortality, and cost incurred using the Nationwide Inpatient Survey (NIS) data. The NIS is the largest all-payer inpatient care database in the US and contains data from 986 hospitals approximating a 20% stratified sample of US hospitals. All the variables pertaining to hospitalization were compared between 2000–2002 and 2004–2006, and in-hospital outcomes were analyzed using multivariate analysis. Results In the 3-year periods prior to and after the ISAT, there were 70,637 and 77,352 admissions for ruptured intracranial aneurysms, respectively. There was a significant increase in endovascular treatment after publication of the ISAT (trend test, p < 0.0001) The in-hospital mortality for ruptured intracranial aneurysm admissions decreased from 27% to 24% (odds ratio [OR] 0.89, 95% CI 0.83–0.96, p = 0.003) after the publication of the ISAT. The cost of hospitalization after adjusting for procedures practices was not significantly higher after the publication of the ISAT ($21,437 vs $22,817, p < 0.89), but cost of hospitalization was higher in the post-ISAT period for patients undergoing endovascular procedure. Conclusions The results of the ISAT have been associated with a prominent change in practice patterns related to the treatment of ruptured aneurysms. The cost of hospitalization has increased and the mortality has decreased, presumably due to a larger proportion of patients receiving any treatment and endovascular treatment.

Object The results of the International Subarachnoid Aneurysm Trial (ISAT) demonstrated lower rates of death and disability with endovascular treatment (coiling) than with open surgery (clipping) to secure the ruptured intracranial aneurysm. However, cost-effectiveness may not be favorable because of the greater need for follow-up cerebral angiograms and additional follow-up treatment with endovascular methods. In this study, the authors' goal was to compare the cost-effectiveness of endovascular and neurosurgical treatments in patients with ruptured intracranial aneurysms who were eligible to undergo either type of treatment. Methods Clinical data (age, sex, frequency of retreatment, and rebleeding) and quality of life values were obtained from the ISAT. Total cost included those associated with disability, hospitalization, retreatment, and rebleeding. Cost estimates were derived from the Premier Perspective Comparative Database, data from long-term care in stroke patients, and relevant literature. Incremental cost-effectiveness ratios (ICERs) were estimated during a 1-year period. Parametric bootstrapping was used to determine the uncertainty of the estimates. Results The median estimated costs of endovascular and neurosurgical treatments (in US dollars) were $45,493 (95th percentile range $44,693–$46,365) and $41,769 (95th percentile range $41,094–$42,518), respectively. The overall quality-adjusted life years (QALY) in the endovascular group was 0.69, and for the neurosurgical group it was 0.64. The cost per QALY in the endovascular group was $65,424 (95th percentile range $64,178–$66,772), and in the neurosurgical group it was $64,824 (95th percentile range $63,679–$66,086). The median estimated ICER at 1 year for endovascular treatment versus neurosurgical treatment was $72,872 (95th percentile range $50,344–$98,335) per QALY gained. Given that most postprocedure angiograms and additional treatments occurred in the 1st year and the 1-year disability status is unlikely to change in the future, ICER for endovascular treatment will progressively decrease over time. Conclusions Using outcome and economic data obtained in the US at 1 year after the procedure, endovascular treatment is more costly but is associated with better outcomes than the neurosurgical alternative among patients with ruptured intracranial aneurysms who are eligible to undergo either procedure. With accrual of additional years with a better outcome status, the ICER for endovascular coiling would be expected to progressively decrease and eventually reverse.