AcuteCare Telemedicine Blog


The Personal Side of Acute Stroke Intervention

Mr. Rigby was found unresponsive, gazing to the right and unable to move his left side. Just moments ago, his nurse had seen the 91 year old awake in his hospital bed preparing himself for discharge from the hospital. Though the hospital lacked a neurologist, it had invested in telemedicine services. Immediate assessment of his acute neurological deficits would determine whether treatment with tissue plasminogen activator (tPA), a clot-busting medication, or even thrombectomy (direct mechanical extraction of the clot) was appropriate. If performed within a very short time window, tPA or thrombectomy would open arteries and prevent progressive death of brain cells. However, it could also lead to hemorrhage, bleeding into the brain that could be devastating and even life-threatening. Thus, the teleneurologist was charged with not simply recognizing Mr. Rigby’s stroke symptoms, but also those factors which make the risk greater than the benefit.

As the AcuteCare Telemedicine physician on call, I was at the bedside within minutes via remote presence technology. The evidence; left hemiparesis, left visual field loss and inability to speak, made it clear; Mr. Rigby had sustained a large right hemisphere stroke. A large artery, the MCA, was blocked by clot. His nurse knew the exact time of symptom onset. Without treatment he may have survived, but it was likely he would not walk or talk. He met every inclusion criteria for tPA. Unfortunately, Mr. Rigby was not a good candidate. He had undergone a surgical procedure just the day before, his anticoagulation had been restarted that day and his platelets were very low. At the age of 91 years with these risk factors, the likelihood of serious hemorrhage was too great. As I informed the family members that had filled the hospital hallways, a look of desperation filled their eyes. His daughter stated, “This man is worth-saving.” Remembering my Hippocratic Oath, my immediate response in this case was, “I am certain he’s worth saving, but nobody is worth harming.”

Then I remembered this “case” was her father. I asked her to tell me more about Mr. Rigby. A picture of a family patriarch emerged. He was still vigorous, taking walks daily. He was driving. Indeed, he still routinely played 9 holes of golf. But what she told me next illustrated the shortcoming of using population-based inclusion and exclusion criteria as the sole determinant of risk-benefit for an individual. Mr. Rigby was the caretaker of his 89 year old disabled and blind wife. Without the ability to walk and speak not only Mr. Rigby would suffer. I made an immediate call to the Marcus Stroke Center at Grady Memorial Hospital in Atlanta. The Marcus Center stroke physician agreed the criteria for invasive intervention suggested a high risk, but Mr. Rigby would be given a chance because the potential for benefit was irrefutable. Within a few hours the clot was extracted. Mr. Rigby had an opened artery with full reperfusion. His symptoms improved with only residual left arm weakness. Though speaking slowly, his good humor was immediately apparent. A family had their patriarch back.



Two Steps Forward, Two Steps Back

Sometimes, moving healthcare forward is achieved simply by looking back. The following article illustrates the latest example of the type of discoveries that fuel the constant evolution of medicine. Modern techniques, such as those utilized in telemedicine practices, often rely on the latest technical and innovative advances, but stepping back and evaluating standard procedures is a crucial step in ensuring the highest possible standards of care. As in the case of the findings featured here, discarding methods once thought to be best practices can improve both patient outcomes and cost-efficiency.

No Benefit to Patent Foramen Ovale (PFO) Closure in Ischemic Stroke or TIA

S. Andrew Josephson 

M.D., Department of Neurology, University of California San Francisco, San Francisco, USA

 Between 25% and 40% of ischemic strokes have no clear cause despite extensive investigation. These “cryptogenic” strokes may in some instances be due to an embolus traveling through a right-to-left shunt in the heart. A patent foramen ovale (PFO) is present in nearly one-quarter of patients in autopsy studies and is even more prevalent in young patients with cryptogenic stroke. Whether these PFOs should be treated with medical therapy or closure remains a point of much debate; Furlan and colleagues (2012) examined the benefit of a percutaneous closure device for preventing further cerebrovascular events in patients with cryptogenic stroke and transient ischemic attack (TIA).

The authors enrolled patients between the ages of 18 and 60 who had experienced a cryptogenic stroke or TIA within the previous 6 months and who were found to have a PFO documented by transesophageal echocardiography (TEE) with bubble study. These patients were randomly assigned either to percutaneous closure with the STARFlex device plus antiplatelet therapy or to medical therapy alone. Those assigned to closure were treated with clopidogrel for 6 months and aspirin for 2 years, whereas those assigned to medical therapy were treated with warfarin, aspirin, or both at the discretion of the site investigator. The primary outcome examined was a composite 2-year rate of stroke or TIA, death from any cause in the first 30 days, or death from a neurologic cause from 31 days to 2 years.

The authors enrolled 909 patients in the trial, and there were no significant differences in the baseline characteristics of the two groups. At 6 months, effective closure was confirmed by TEE in 86% of the closure group. The primary endpoint was reached in 5.5% of the closure group and 6.8% of the medical group (hazard ratio, 0.78; 95% confidence interval, 0.45–1.35; p = .37). There were no significant differences in stroke or TIA rates between the two groups, although the latter TIA endpoint (a “softer” endpoint, subject to patient reporting) was numerically higher in the medical therapy group. There were no differences in adverse events between the two groups. Atrial fibrillation more frequently developed in the closure group compared with the medical group (5.7% vs 0.7%; p < .001). A variety of subgroups were examined, including sex, the presence of an atrial septal aneurysm, shunt size, entry event (stroke vs TIA), and baseline medication; none was found to significantly favor percutaneous closure.

This well-done negative trial definitively demonstrates no benefit to PFO closure in patients with cryptogenic stroke and argues strongly that these patients should either be treated with medical therapy or be invited to participate in ongoing randomized trials of different devices. The slow recruitment in this trial, which began enrolling in 2003, was likely due in part to the fact that the device was available for use outside of the trial and many patients and their physicians chose to close PFOs rather than enrolling in the study. One limitation of this study may therefore have been a bias toward patients with characteristics thought by their physicians to warrant randomization, perhaps those at perceived at lower risk for stroke. Ideally, the definitive results of this trial will mean that percutaneous PFO closure no longer is practiced outside of these trials.

– Josephson, SA. No Benefit to Patent Foramen Ovale (PFO) Closure in Ischemic Stroke or TIA. Harrison’s Online, April 23, 2012. http://www.accessmedicine.com

Related to Chapter 370 Cerebrovascular Diseases in Harrison’s Principles of Internal Medicine, 18thedition, Dan L. Longo, Dennis L. Kasper, J. Larry Jameson, Anthony S. Fauci, Stephen L. Hauser, Joseph Loscalzo, Eds. McGraw-Hill, New York, 2012.

Reference

Furlan AJ et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med 2012;366:991.

Understanding that even the most accepted methods of diagnosis and treatment are subject to scrutiny is a key tenet of the relentless pursuit of a better standard of care. The partners of AcuteCare Telemedicine agree with Dr. Furlan’s recommendation that device closure of PFOs should now be limited to patients enrolled in one of the ongoing trials.