ARTICLE IN BRIEF
- ✓ The use of tPA increased ten-fold in small hospitals using telemedical facilities, with concomitant improvement among patients in long-term functional outcomes.
Clot-busting tissue plasminogen activator (tPA) can significantly reduce mortality and disability after an acute stroke, but only if given within the first three hours. Unfortunately, most eligible patients are not treated in time because the nearest stroke center is too far away. Physicians at smaller community health centers lack experience with the procedure, which is almost always performed at major stroke centers.
The solution could be just a click of a mouse away, according to German investigators who established a “telethrombosis” network linking stroke centers with smaller community medical facilities in Bavaria. This is not the first study to assess telemedicine for stroke, but it is one of the largest — comparing treatment and outcomes for 300 patients at telemedical facilities and larger stroke centers.
Using online videoconferencing, trained physicians at the stroke centers interviewed patients and walked their inexperienced counterparts at the smaller hospitals through the procedure after reviewing patient information and brain scans over the Internet. The use of tPA increased ten-fold under the program, with concomitant improvement in long-term functional outcomes, according to the latest study from the Telemedical Pilot Project for Integrative Stroke Care (TEMPiS), published in the Aug. 28 Neurology (69:898–903).
Two stroke centers and 12 community hospitals with little or no thrombolysis experience were linked in a network for providing online neurologic examinations and neuroradiologic scans. Smaller facilities using the network quickly had outcomes similar to those at the stroke centers, essentially closing the gap in tPA use, according to TEMPiS investigators.
STUDY PROTOCOLS AND RESULTS
Bijan Vatankhah, MD, and Susanne Schwab, MD, neurologists at the University of Regensburg in Germany, prospectively collected Modified Rankin Scale (mRS) and Barthel Index (BI) scores to measure disability and functional outcomes, as well as mortality data, on patients treated at the smaller hospitals. After two years, they compared outcome measures taken from patients treated at the stroke centers. Rates and scores were assessed at three and six months, with favorable outcomes defined as improvements of 95/100 for the BI and 0/1 for the mRS.
Over the first 22 months of the study, 170 patients were treated with tPA in the telemedicine hospitals and 132 in the stroke center hospitals. After three months, mortality rates were similar for the telemedicine group (11.2 percent) and stroke centers (11.5 percent); at six months, mortality rates for the telemedicine facilities were 14.2 percent and 13 percent (for stroke centers). Good functional outcomes were measured in 39.5 percent of the telemedical hospitals versus 30.9 percent of the stroke centers for the mRS (p=0.10); and the scores were similar for the BI measures — 47.1 percent for the telemedical centers; 44.8 percent for the stroke centers (p=0.44).
About 90 percent of the patients receiving tPA under telemedical supervision survived the first three months after stroke. The cause of death in the telemedical group was almost always due to a large MCA territory infarction resulting from insufficient or late recanalization, not hemorrhage as a complication of treatment.
Several other major trials have assessed telemedicine for thrombolysis, including the European-Australian Randomized Stroke Thrombolysis studies (ECASS) and the National Institute of Neurological Disorders and Stroke (NINDS) tPA Study Group trial (Lancet 2004;363:768–774).
But the mortality rate in the TEMPiS study — 11.8 percent after three months — was lower than in either the ECASS study (22.3 percent) or the NINDS study (17 percent). Mortality at six months was also lower than in either study, the authors reported.
LARGEST TRIAL TO DATE
“This is as many patients treated with tPA as in each of the prior major randomized studies of tPA use,” Dr. Vatankhah told Neurology Today in a telephone interview. “And this is the first large study of long-term mortality and functional outcome in patients treated using a telethrombosis network. Of course the physicians at the smaller facilities first had to be trained in administering tPA by the stroke center doctors, but we think the rates demonstrate that this process works for more rural communities.”
Fully 30 percent of ischemic stroke patients were treated with tPA in the smaller hospitals, Dr. Vatankhah noted. “Most of these patients would otherwise not have been able to reach existing stroke centers in time for effective thrombolysis. Before the study, only 10 patients had ever received tPA thrombolylis at the 12 community hospitals combined. Thus, the safety and effectiveness of systemic thrombolysis performed by less experienced physicians in community hospitals in a telemedical network under guidance by stroke experts seems to be comparable to that achieved in dedicated stroke centers.”
He stressed, however, that the project's success was due to a large extent to the role of the stroke center doctors, who continually trained the physicians in the community hospitals.
Dr. Vatankhah noted that establishing the network requires a dedicated and well-coordinated effort. Specialized multidisciplinary visits by the stroke experts were necessary, standard operation procedures had to be established, and a modern technique allowing fast and high-quality transmission of the patient examination and scans needed to be developed. The study authors noted that these program elements are necessary to assure safe tPA use in a telemedical network.
The authors pointed out, however, that the study was limited by the fact that it was not randomized and interviews were not blinded. Further research is needed to confirm the findings, they wrote.
They also pointed out that although the condition could be determined for almost every patient in the trials, the functional outcome was unknown for 7.6 percent of the subjects in the telemedicine group after six months.
LESS TIME TO OFFER TPA
Last April, at the AAN annual meeting in Boston, Anand Vaishnav, MD, assistant professor of neurology and medical director of the Stroke Unit at the University of Kentucky Medical Center in Lexington, described similar success in what was at that time the largest study of telemedicine as a means of increasing tPA therapy for acute ischemic stroke.
That study evaluated the outcomes of 121 patients who were given tPA at a rural community hospital by a stroke neurologist who was on the telephone guiding the treatment. It took an average of 132 minutes from stroke onset to the beginning of telephone-guided tPA, he reported.
”This is less time than the average 144 minutes from stroke onset to tPA treatment in the NINDS tPA study, which was a large national study published in 1995,” said Dr. Vaishnav. “We also had lower rates of bleeding in the brain and death than the original NINDS study.”
Among findings, 2.5 percent of the patients had symptomatic bleeding in the brain, compared to 6.4 percent in the original NINDS tPA study. In addition, 17 percent of patients in the urban study died, compared to 7.5 percent of the rural patients treated in the Kentucky study. Further, nearly half of the rural patients went home after an average hospital stay of four days.
He noted that unlike the TEMPiS study, these hospitals were not part of a network but rather stand-alone facilities communicating with stroke center experts by telephone.
“The TEMPiS study results are impressive and confirm what we found —this is an effective way to bring thrombosis to the patient instead of the patient having to come to us,” he told Neurology Today in a telephone interview.
“This is the direction where we should be going. Thrombosis with tPA isn't rocket science, but you have to have someone to guide them through it.”
Many doctors are reluctant to administer tPA, he noted, mainly because of concerns about hemorrhage. “But the data do not show that much risk and outcomes were comparable at both experienced and inexperienced centers in the network,” he said. “It's more fear than fact. The final outcome is what matters in these patients, and stroke centers need to reach out.”