Patients with acute
ischemic stroke who are candidates for intravenous thrombolytic therapy benefit
most when thrombolytic therapy can be accomplished in a more timely fashion. Though
the “window” for thrombolytic therapy may be as long as 4.5 hours, those that
do best are those who receive thrombolytic therapy within the first 60 minutes
from onset of symptoms, termed the “golden hour”. A recent meta-analysis
by the Stroke Thrombolysis Trialists' Collaboration
showed that the likelihood ratio of a good stroke outcome (modified Rankin
score of 0 or 1) was 1.85 when tPA
was given within the first hour and decreased to 1.2 when given at 5 hours (Sandercock
2014). Unfortunately, very
few patients are actually treated within the golden hour.
Exciting results of
an ad hoc subgroup analysis were recently published (Ebinger
2015). The PHANTOM-S study (Prehospital
Acute Neurological Treatment and Optimization of Medical Care in Stroke study) was
a prospective controlled study
conducted in Berlin, Germany, within an established infrastructure for stroke
care. A unique aspect of the study was deployment of a specialized ambulance (the
stroke emergency mobile unit or STEMO). This was an ambulance fitted with a
mobile CT scanner and point-of-care lab testing and manned by a neurologist,
paramedic, and radiology technician. The study was randomized not at the
patient level but rather by the weeks according to the availability of the
STEMO.
The substudy analyzed thrombolytic therapy rates and found use
of STEMO increased the percentage of patients receiving thrombolysis within the
golden hour, did not increase the risk to the patients’ safety, and was associated
with better short-term outcomes. Thrombolysis rates in ischemic stroke were
32.6% when STEMO was deployed compared to 22.0% when conventional care was
administered. Among all patients who received thrombolysis, the proportion of
golden hour thrombolysis was 6-fold higher after STEMO deployment (31.0% vs. 4.9%).
They were also more likely to be discharged home and had lower 7-day and 90-day
mortality rates, though the mortality rate differences did not reach
statistical significance. Though the study does not yet have long term outcomes,
it is very likely that those will also be better in the group receiving STEMO
care and “golden hour” thrombolysis.
This is really
exciting work but it will likely be several years before emergency systems and
hospitals in the US might be prepared to institute STEMO’s and associated equipment,
staffing and protocols.
There is one group
of patients who theoretically should be ideal for thrombolytic therapy within
the golden hour: those patients having a stroke while already an inpatient
in the hospital.
But in our March 18,
2014 Patient Safety Tip of the Week “Systems
Approach Improving Stroke Care” we noted a study that mentioned times
to treatment are often paradoxically increased in patients having in-hospital
strokes (Meretoja 2012).
And in our September 23, 2014 Patient
Safety Tip of the Week “Stroke
Thrombolysis: Need to Focus on Imaging-to-Needle Time” we noted a study (Sauser
2014) that had the interesting observation that decisions take longer when the physician has more time
available. Those authors also noted prior studies have demonstrated patients
with shorter onset-to-arrival (OTA) times often have longer door-to-needle
(DTN) times.
A very telling study was recently presented as an abstract at
the Canadian Stroke Congress 2014 (Saltman 2014).
Researchers assessed data from 11 regional stroke centers in Ontario, Canada
and compared 1048 patients who had strokes while already an inpatient to 32,227
patients who had a stroke elsewhere and were brought to the hospital. Time from
symptom recognition to CT scan was 4.5 hours on average for those with
in-hospital strokes compared to 1.3 hours for patients brought to the emergency
department with a stroke. Only 12% of eligible patient with in-hospital strokes
received thrombolytic therapy compared to 19% of those from the community. Moreover,
of those receiving thrombolytic therapy only 29% of those with in-hospital
stroke received thrombolytic therapy within 90 minutes compared to 72% for
those admitted from the community. The in-hospital stroke patients had longer
lengths of stay, were less likely to be discharged home, and more likely to be
discharged to a rehabilitation facility. These held up even after adjustment
for variables such as age, sex, vascular comorbidities, stroke severity and type
of stroke.
The authors note that in some cases the symptoms and signs
of stroke might be masked in patients already admitted (eg.
they might be on a ventilator, be sedated, etc.). But they note that, in
general, physicians and staff caring for inpatients are less likely than those
in the emergency department or prehospital community to be aware of the
protocols for urgent care of stroke patients.
The December 2014 AHRQ Web M&M also had a case study of
a patient who suffered a stroke 2 days into a hospital admission (Barrett 2014). It has a
good discussion on the protocols we use for managing acute ischemic stroke
patients. It mentions several of the barriers to timely assessment and
management that we’ve previously discussed in our Patient Safety Tips of the Week for November 6, 2012 “Using
LEAN to Improve Stroke Care” and March 18, 2014 “Systems
Approach Improving Stroke Care” and September 23, 2014 “Stroke
Thrombolysis: Need to Focus on Imaging-to-Needle Time”. These include
getting timely imaging studies, drawing and getting lab results in an expedited
manner, image interpretation, decision making, ordering and preparing tPA, discussion and informed
consent with the patient and family, and administering the tPA.
In addition, personnel on inpatient services may be more likely to require
neurological consultation than emergency physicians well-trained to handle
acute strokes. Or the stroke neurologist on-call may be immediately notified by
a stroke alert when a patient is coming to the ED but inpatient staff may not
know how to trigger that stroke alert.
In an article about integrating quality improvement into CME
activities, Eiser and colleagues noted how discussion
at an M&M rounds about a stroke occurring in an inpatient led to recognition
that not all clinicians were as familiar with the “stroke alert” process as
were emergency physicians (Eiser 2013).
This led to dissemination of information about the concept of stroke alert and
the protocol procedure to all medical staff, with additional communications to
resident physicians via residency program directors.
So few eligible patients are in a position to receive
thrombolytic therapy for their acute ischemic stroke within the “golden hour”.
It is a shame that those who could most likely be managed in that therapeutic time
window are slipping through the cracks in our complex medical system. Does your
organization have protocols in place to alert the appropriate stroke team and
manage patients expediently when they have a stroke while in the hospital? And
are your staff (medical, nursing, residents, etc.) aware of those protocols and
the need to intervene immediately?
Some of our previous columns on improving stroke care:
November 6, 2012 “Using
LEAN to Improve Stroke Care”
March 18, 2014 “Systems
Approach Improving Stroke Care”
Septembrer 23, 2014
“Stroke
Thrombolysis: Need to Focus on Imaging-to-Needle Time”
References:
Sandercock P, on behalf of the
Stroke Thrombolysis Trialists' Collaboration. 9th
World Stroke Congress (WSC). Session FC01 (no abstract number). Presented
October 23, 2014
As reported in Medscape. Keller DM. Early Thrombolysis
Reduces Post-stroke Disability. Medscape November 11, 2014
http://www.medscape.com/viewarticle/834731
Ebinger M, Kunz A, Wendt M, et al.
Effects of Golden Hour Thrombolysis. A Prehospital Acute Neurological Treatment
and Optimization of Medical Care in Stroke (PHANTOM-S) Substudy.
JAMA Neurol 2015; 72(1): 25-30
http://archneur.jamanetwork.com/article.aspx?articleid=1934717
Sauser K, Levine DA, Nickles AV, Reeve MJ. Hospital Variation in Thrombolysis
Times Among Patients With Acute Ischemic StrokeThe
Contributions of Door-to-Imaging Time and Imaging-to-Needle Time. JAMA Neurol. 2014;
71(9): 1155-1161
http://archneur.jamanetwork.com/article.aspx?articleid=1886777
Meretoja A, Strbian
D, Mustanoja S, et al. Reducing in-hospital delay to
20 minutes in stroke thrombolysis. Neurology 2012; 79: 306–313
http://www.neurology.org/content/79/4/306.abstract
Saltman A, et al. Canadian Stroke
Congress. Presented October 6, 2014. Abstract 8094
In-Hospital Stroke Patients Wait Longer for Care. as reported in Medscape Oct 09, 2014.
http://www.medscape.com/viewarticle/833003
Also reported in Canadian Stroke Congress. Code Stroke on
the Ward. Press Release October 6, 2014
Barrett KM. A Stroke of Error. AHRQ Web M&M.
December 2014
http://webmm.ahrq.gov/case.aspx?caseID=335
Eiser AR, McNamee WB, Miller JY. Integrating
Quality Improvement Into Continuing Medical Education
Activities Within a Community Hospital System. American Journal of Medical Quality 2013; 28(3): 238-242, first
published on September 13, 2012
http://ajm.sagepub.com/content/28/3/238.abstract
Print “PDF
version”
http://www.patientsafetysolutions.com/