State regulations help increase rate of t-PA treatment for acute ischemic stroke

Measures in Florida and Massachusetts that require paramedics to transport qualifying patients to certified stroke centers helped to increase the number of patients who received tissue plasminogen activator (t-PA) for the treatment of ischemic stroke in both states.

The Florida Stroke Act was signed into law in June 2004 and went into effect on July 1, 2005. It requires emergency medical systems providers to transport suspected stroke patients who might benefit from t-PA to the nearest hospital with a certified stroke center rather than to just the nearest hospital.

In Massachusetts, a similar regulation requires that eligible patients be transported to a licensed Primary Stroke Services (PSS) facility. The licensure program was developed in 2004 by the Massachusetts Department of Public Health. Although hospitals are not required to be licensed, 92% of the state's hospitals achieved PSS status during the first year of the program.

"We found an increase in stroke admissions and an increase in the number of patients treated with t-PA each month (post-implementation vs pre-implementation)," said Scott Silliman, MD, associate professor of neurology at the University of Florida College of Medicine-Jacksonville.

The average stroke admission rate at the 2 hospitals increased from 62.3 patients per month during the 6 months before enactment to 66.2 patients per month during the 6 months after enactment (P=.002). The number of ischemic stroke patients who were treated with t-PA also increased, from 3.8 per month before enactment to 5.2 per month after enactment (P=.002), which corresponded to an increase in the proportion of patients who received treatment, from 8.4% to 10.5%.

"The percentage of individuals receiving t-PA also went up because of the act," said James Meschia, MD, professor of neurology at the Mayo Clinic, Jacksonville, Fla. "The legislation seems to be having a public health impact."

In Massachusetts, t-PA use was compared in 996 stroke patients during the 9 months prior to the mandated transport to licensed stroke centers and in 4,053 stroke patients during the 12 months after the regulation was implemented. The use of t-PA increased from 40% pre-regulation to 63.7% post-regulation among eligible patients who arrived within 2 hours of symptom onset, and from 31.2% to 53.3% among those who arrived within 3 hours. Furthermore, 92% of patients were evaluated for t-PA treatment.

After enforcement of the regulation, the intracerebral hemorrhage rate among t-PA recipients was 3.5%, according to Lee Schwamm, MD, vice chairman of neurology, and director of acute stroke services at Massachusetts General Hospital, Boston. This rate compares with the 6.4% rate of intracerebral hemorrhage observed in the 1996 National Institute of Neurological Disorders and Stroke (NINDS) trial.

"It's reassuring that the rate of intra-cerebral hemorrhage was not increased in the community setting," Dr Schwamm said, attributing the low bleeding rate to strict adherence to t-PA eligibility protocols and subsequent management at certified stroke centers.

"The next phase will be to try to shorten the time from arrival to treatment," Dr Schwamm said. "By far, the main reason that patients are not eligible for t-PA is because they don't show up in time," he said. "Our study has shown that hospitals are capable of urgent evaluation of patients and can safely administer t-PA."

Dr Schwamm said there are additional expenses associated with operating and enabling access to a licensed stroke center, including 24-hour emergency department staffing, enhanced neurosurgeon availability, the ability to quickly perform imaging, and helicopter transports for patients without local access. He said increases in Medicare reimbursement have helped to offset some of these additional costs.