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How to make decisions for patients who exceed the time window? Endovascular treatment is a very important treatment for acute ischemic stroke.
Opening the occluded blood vessel as soon as possible, restoring blood flow, and saving the ischemic penumbra is the key to treatment.
So what is the limit of "early"? How to make decisions for patients who have exceeded the time window? At the 24th National Neurology Conference of the Chinese Medical Association, Professor Luo Xiang from the Department of Neurology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology gave a wonderful report on "Progress in the Treatment of Acute Cerebral Infarction Over Time Window Thrombectomy"! The time window has been extended.
Professor Luo Xiang introduced that reviewing the history of ischemic stroke research and extending the treatment time window has always been the direction of neurologists’ efforts
.
For the time window of intravenous thrombolysis, from 3h in the NINDS study, to 4.
5h in the ECASS study, to 4.
5-9h in the EXTEND study, the time window is gradually expanding
.
The time window for mechanical thrombectomy ranges from 6h in the study of MR CLEAN et al.
, to 6-24h in the DAWN study, and then to 6-16h in the DEFUSE 3 study.
The time window for mechanical thrombectomy is also gradually expanding
.
The extension of time comes from the transformation of the treatment concept: from the time window to the organization window, Professor Luo Xiang introduced that the logic behind the time window is that the penumbra gradually decreases with time.
At a certain point in time, most patients have too little penumbra.
It is not suitable for recanalization treatment, this is the law of the group
.
With the development of imaging of acute ischemic stroke, the definition of tissue window is accepted by more and more scholars
.
The logic behind the tissue window is that the penumbra decreases at different speeds between individuals over time.
There are individual differences.
Intravascular recanalization is to save the penumbra.
Multimodal imaging makes the evaluation of the penumbra become Reality, then, it is more reasonable to use the penumbra as the standard
.
Compared with the previously recommended 6h time window, the DAWN study (6-24h) and the DEFUSE 3 study (6-16h) were also "extra-time window" interventional treatment attempts in the same year.
The success of these two studies suggests a multi-modality The importance of imaging and tissue window judgment
.
So, the question is, how to make decisions for patients who have been onset for 24 hours? Figure 1: Comparison of DAWN and DEFUSE 3 studies Q1 Is there still a salvageable penumbra after the onset of more than 24 hours? Theoretically, in patients with good collateral circulation, even if the onset is more than 24h, the penumbra is still present
.
In 2017, a review published by Stroke emphasized that in people with large vessel occlusion, there are people with rapid progression of ischemic foci into infarct foci, as well as people with slow progression.
The speed of progression depends on the collateral circulation
.
In 2021, Stroke published a post-mortem analysis of the DEFUSE 3 study and found that among 182 patients, 144 patients were re-examined for multimodal imaging after 24 hours of grouping.
The article introduced a new concept-persistent ischemic penumbra Persistent Penumbra Index (PPI) is equal to Tmax>6S area volume/DWI infarct area volume
.
The imaging findings of 32 patients 24 hours after grouping showed that PPI>1, that is, the ischemic penumbra still exists
.
Figure 2: PPI classification of Stroke articles in 2021 Figure 3: Left A is PPI>1, right B is PPI≤1 for more than 24 hours, how many still meet the mismatch conditions? In 2019, Stroke published a post-mortem analysis of the DEFUSE 3 study and found that in the drug treatment control group of the DEFUSE 3 study, 18% (10/55) of the patients still met DEFUSE3 at the onset of 38h (quartile 33-39h) Research standard mismatch, that is, there is a penumbra that can be saved
.
Figure 4: How is the safety and effectiveness of interventional therapy with an onset of more than 24 hours in the Stroke article Q2 in 2019 in clinical practice? Professor Luo Xiang introduced that early case reports and case series studies suggest that interventional treatments of more than 24 hours exist in clinical practice, and most of the reported cases are safe and effective
.
A retrospective analysis of the characteristics of these cases showed that most of the NIHSS scores were not high and the collateral circulation was good
.
In 2020, a single-center case-control study published by JAMA Neurology included data from 150 patients with ischemic stroke (anterior circulation great vessel occlusion, NIHSS≥6) with an onset of more than 16 hours, and explored the safety and safety of ultra-window interventional therapy.
Effectiveness, of which 127 patients underwent collateral circulation assessment, 111 patients underwent CT or MRI perfusion imaging, and 24 patients underwent endovascular treatment
.
The results of the study suggest that compared with medical treatment, endovascular treatment has significant clinical benefits.
In the subgroup analysis >24h, endovascular treatment has significant benefits
.
Q3.
What criteria should be included in interventional therapy with an onset of more than 24 hours.
In theory, the imaging standards of the DAWN study and the DEFUSE 3 study do not involve the concept of time, but emphasize the need for small infarct core and large ischemic penumbra.
In a sense, borrowing should be promoted
.
Research suggests that the DAWN research standards may be feasible
.
In 2018, J Neurolntervent Surg published a case series report that retrospectively analyzed the data of interventional treatment of ischemic stroke over 24 hours in 3 stroke centers, and included 21 patients based on DAWM standards
.
The study found that the rate of vascular recanalization—modified Thrombolysis in Cerebral Infarction Score (mTICI) ≥ 2b was 81%, the 90-day functional independence (mRS-0-2) rate was 43%, and symptomatic bleeding occurred.
The rate was 5%, which was not statistically different from the interventional treatment group in the DAWN study
.
The study suggests that ischemic stroke can follow the DAWM research standards, and interventional therapy is safe and effective even if it exceeds 24 hours
.
Q4 The onset is 16-24h, and the DAWN research standard is not met.
Can I borrow the DEFUSE 3 research standard? There are two situations that do not meet the DAWN study: 1.
The infarct core is too large (>50/30/20ml); 2.
The NIHSS score is too small (<10)
.
The DEFUSE 3 study set a larger infarct range, up to 70ml, and only required ≥6 points for the NIHSS score
.
In theory, patients with an infarct range of <70ml or NIHSS scores of 6-9 can learn from the standard of the DEFUSE 3 study
.
Summary: Multimodal imaging can obtain information on multiple levels of brain parenchymal structure changes, cerebrovascular, cerebral perfusion, and collateral circulation.
It is our main basis for selecting patients for super-window treatment
.
Interventional therapy studies that exceed the 6-16h or 6-24h time window recommended by the current guidelines, although most of them are retrospective studies and the sample size is small, but these studies suggest to a certain extent that the ultra-window is carried out under the guidance of multimodal imaging Interventional therapy may be safe and effective
.
After the onset of more than 24 hours, studies have proved that there is still a salvageable ischemic penumbra.
You can refer to the DAWN study and the DEFUSE 3 study for patient screening
.
For patients whose onset is 16h-24h and do not meet the DAWN study criteria, it may be feasible to use the DEFUSE 3 study criteria for patient screening
.
The content of this article is compiled from the lecture of Professor Luo Xiang at the 24th National Conference on Neurology of the Chinese Medical Association-"Progress in the Treatment of Thrombus Removal for Acute Cerebral Infarction over Time Window"
.
How to make decisions for patients who exceed the time window? Endovascular treatment is a very important treatment for acute ischemic stroke.
Opening the occluded blood vessel as soon as possible, restoring blood flow, and saving the ischemic penumbra is the key to treatment.
So what is the limit of "early"? How to make decisions for patients who have exceeded the time window? At the 24th National Neurology Conference of the Chinese Medical Association, Professor Luo Xiang from the Department of Neurology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology gave a wonderful report on "Progress in the Treatment of Acute Cerebral Infarction Over Time Window Thrombectomy"! The time window has been extended.
Professor Luo Xiang introduced that reviewing the history of ischemic stroke research and extending the treatment time window has always been the direction of neurologists’ efforts
.
For the time window of intravenous thrombolysis, from 3h in the NINDS study, to 4.
5h in the ECASS study, to 4.
5-9h in the EXTEND study, the time window is gradually expanding
.
The time window for mechanical thrombectomy ranges from 6h in the study of MR CLEAN et al.
, to 6-24h in the DAWN study, and then to 6-16h in the DEFUSE 3 study.
The time window for mechanical thrombectomy is also gradually expanding
.
The extension of time comes from the transformation of the treatment concept: from the time window to the organization window, Professor Luo Xiang introduced that the logic behind the time window is that the penumbra gradually decreases with time.
At a certain point in time, most patients have too little penumbra.
It is not suitable for recanalization treatment, this is the law of the group
.
With the development of imaging of acute ischemic stroke, the definition of tissue window is accepted by more and more scholars
.
The logic behind the tissue window is that the penumbra decreases at different speeds between individuals over time.
There are individual differences.
Intravascular recanalization is to save the penumbra.
Multimodal imaging makes the evaluation of the penumbra become Reality, then, it is more reasonable to use the penumbra as the standard
.
Compared with the previously recommended 6h time window, the DAWN study (6-24h) and the DEFUSE 3 study (6-16h) were also "extra-time window" interventional treatment attempts in the same year.
The success of these two studies suggests a multi-modality The importance of imaging and tissue window judgment
.
So, the question is, how to make decisions for patients who have been onset for 24 hours? Figure 1: Comparison of DAWN and DEFUSE 3 studies Q1 Is there still a salvageable penumbra after the onset of more than 24 hours? Theoretically, in patients with good collateral circulation, even if the onset is more than 24h, the penumbra is still present
.
In 2017, a review published by Stroke emphasized that in people with large vessel occlusion, there are people with rapid progression of ischemic foci into infarct foci, as well as people with slow progression.
The speed of progression depends on the collateral circulation
.
In 2021, Stroke published a post-mortem analysis of the DEFUSE 3 study and found that among 182 patients, 144 patients were re-examined for multimodal imaging after 24 hours of grouping.
The article introduced a new concept-persistent ischemic penumbra Persistent Penumbra Index (PPI) is equal to Tmax>6S area volume/DWI infarct area volume
.
The imaging findings of 32 patients 24 hours after grouping showed that PPI>1, that is, the ischemic penumbra still exists
.
Figure 2: PPI classification of Stroke articles in 2021 Figure 3: Left A is PPI>1, right B is PPI≤1 for more than 24 hours, how many still meet the mismatch conditions? In 2019, Stroke published a post-mortem analysis of the DEFUSE 3 study and found that in the drug treatment control group of the DEFUSE 3 study, 18% (10/55) of the patients still met DEFUSE3 at the onset of 38h (quartile 33-39h) Research standard mismatch, that is, there is a penumbra that can be saved
.
Figure 4: How is the safety and effectiveness of interventional therapy with an onset of more than 24 hours in the Stroke article Q2 in 2019 in clinical practice? Professor Luo Xiang introduced that early case reports and case series studies suggest that interventional treatments of more than 24 hours exist in clinical practice, and most of the reported cases are safe and effective
.
A retrospective analysis of the characteristics of these cases showed that most of the NIHSS scores were not high and the collateral circulation was good
.
In 2020, a single-center case-control study published by JAMA Neurology included data from 150 patients with ischemic stroke (anterior circulation great vessel occlusion, NIHSS≥6) with an onset of more than 16 hours, and explored the safety and safety of ultra-window interventional therapy.
Effectiveness, of which 127 patients underwent collateral circulation assessment, 111 patients underwent CT or MRI perfusion imaging, and 24 patients underwent endovascular treatment
.
The results of the study suggest that compared with medical treatment, endovascular treatment has significant clinical benefits.
In the subgroup analysis >24h, endovascular treatment has significant benefits
.
Q3.
What criteria should be included in interventional therapy with an onset of more than 24 hours.
In theory, the imaging standards of the DAWN study and the DEFUSE 3 study do not involve the concept of time, but emphasize the need for small infarct core and large ischemic penumbra.
In a sense, borrowing should be promoted
.
Research suggests that the DAWN research standards may be feasible
.
In 2018, J Neurolntervent Surg published a case series report that retrospectively analyzed the data of interventional treatment of ischemic stroke over 24 hours in 3 stroke centers, and included 21 patients based on DAWM standards
.
The study found that the rate of vascular recanalization—modified Thrombolysis in Cerebral Infarction Score (mTICI) ≥ 2b was 81%, the 90-day functional independence (mRS-0-2) rate was 43%, and symptomatic bleeding occurred.
The rate was 5%, which was not statistically different from the interventional treatment group in the DAWN study
.
The study suggests that ischemic stroke can follow the DAWM research standards, and interventional therapy is safe and effective even if it exceeds 24 hours
.
Q4 The onset is 16-24h, and the DAWN research standard is not met.
Can I borrow the DEFUSE 3 research standard? There are two situations that do not meet the DAWN study: 1.
The infarct core is too large (>50/30/20ml); 2.
The NIHSS score is too small (<10)
.
The DEFUSE 3 study set a larger infarct range, up to 70ml, and only required ≥6 points for the NIHSS score
.
In theory, patients with an infarct range of <70ml or NIHSS scores of 6-9 can learn from the standard of the DEFUSE 3 study
.
Summary: Multimodal imaging can obtain information on multiple levels of brain parenchymal structure changes, cerebrovascular, cerebral perfusion, and collateral circulation.
It is our main basis for selecting patients for super-window treatment
.
Interventional therapy studies that exceed the 6-16h or 6-24h time window recommended by the current guidelines, although most of them are retrospective studies and the sample size is small, but these studies suggest to a certain extent that the ultra-window is carried out under the guidance of multimodal imaging Interventional therapy may be safe and effective
.
After the onset of more than 24 hours, studies have proved that there is still a salvageable ischemic penumbra.
You can refer to the DAWN study and the DEFUSE 3 study for patient screening
.
For patients whose onset is 16h-24h and do not meet the DAWN study criteria, it may be feasible to use the DEFUSE 3 study criteria for patient screening
.
The content of this article is compiled from the lecture of Professor Luo Xiang at the 24th National Conference on Neurology of the Chinese Medical Association-"Progress in the Treatment of Thrombus Removal for Acute Cerebral Infarction over Time Window"
.
