ES2727812A1 - Model to predict large vessel occlusion (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Model to predict large vessel occlusion. Computer program comprising program instructions to make a computer implement a method to determine the occlusion of a large vessel in an individual. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

Model to predict large vessel occlusion.

The present invention belongs to the field of medicine, and more specifically refers to a model for predicting or predicting large vessel occlusion (OGV).

STATE OF THE TECHNIQUE

The stroke is the first cause of death in women and the second in the world population after ischemic heart disease. In addition, it is the first cause of disability and the second cause of dementia with the consequent changes in the family and socioeconomic environment. The current availability of highly effective, although time-dependent, specific treatments for the acute phase, makes it necessary to adapt the systems of care organization.

Stroke is a neurological emergency. The evidence that the results depend on the moment at which the treatment is initiated forces to ensure the minimum response time that allows the evaluation and treatment of the patient in the hospital environment. The delay in treatment leads to the consequent decrease in efficacy and worsening of the short-term and long-term functional prognosis. Likewise, it can increase the costs generated by a longer hospitalization and those derived from morbidity and mortality.

It has been calculated that every five seconds a person suffers a stroke in the world. The National Institute of Statistics (INE) placed the stroke, in 2009, as the second cause of global death in the Spanish population and the first in women. In Spain the prevalence has been estimated at 7% of the urban population over 65 years and the incidence at 128 per 100,000 inhabitants in the general population. According to data from a recent study on the costs of stroke in Spain (CONOCES) (J. Mar, et al, Neurology 2013; 28: 332-9), treating a patient with Stroke has a socio-health cost of 27,711 euros and, taking into account that 120,000 people a year suffer a stroke in our country, the cost of treating them is 3 billion euros.

Due to the spatial dispersion of the population it is necessary to develop a valid tool to reduce the delay of intraarterial revascularization treatment in subsidiary patients, being able to identify them from the outpatient circuit, favoring their referral to a center that has the revascularization technique in a way urgent.

Currently, only a small number of hospitals where they attend patients presenting an ischemic brain event are equipped to perform emergency endovascular procedures.

Therefore, it is essential to develop protocols to ensure that patients with a known or suspected stroke are quickly identified and evaluated through the use of a standardized instrument for screening for strokes.

In this regard, the New Clinical Guidelines for the Treatment of Acute Stroke ( 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association / American Stroke Association), conclude that the use of a Prehospital stroke scale improves the identification of stroke, and that better tools for identifying stroke are needed in the prehospital setting.

Consequently, different tools have been developed, which allow the rapid identification of patients with large vessel occlusion from outpatient care such as the Prehospital Acute Stroke Severity (PASS) (Sidsel et al., 2016. Stroke. 47: 1772-1776) , the Rapid Arterial Occlusion Evaluation Scale (RACE) (Carrera, et al, Journal of Stroke and Cerebrovascular Diseases, 26: 74-77), the Cincinnati Prehospital Stroke Severity Scale (CPSSS) (Kummer, et al. Journal of Stroke and Cerebrovascular Diseases, 25: 1270-1274), The 3-Item Stroke Scale (3ISS) (Oliver, et al. 2005 Stroke.; 36: 773-776), Field Assessment Stroke Triage for Emergency Destination (FAST-ED) (Fabrizio O , et al. Field Assessment Stroke Triage for Emergency Destination.Stroke. 2016; 47: 1997-2002) or the Los Angeles Motor Scale (LAMS) (Joon-Tae Kim, et al. Stroke. 2017; 48: 298-306) .

However, although these scales correlate the etiology of the stroke with occlusion of a large vessel, they all include severity assessments, which depend directly on the observer, so they are not fully reproducible, since they have the observer's bias, which is especially relevant, because generally, these assessments are not carried out by people specialized in neurological examination. It is necessary to develop an unbiased methodology that includes less arbitrary values and non-subjective valuation.

DESCRIPTION OF THE INVENTION

The authors of the present invention have developed a method to solve the problem described above with respect to predicting large vessel occlusion (OGV). For this they have designed a scale, from now on GadSS, of simple and fast application that includes the items that best correlate the etiology of stroke with occlusion of a large vessel. In addition, they have developed a computerized tool of said model that allows estimating said occlusion, and selecting those cases in which the direct transfer of an individual to a specialized unit is necessary, optimizing the management of resources.

There is strong evidence that efficacy and functional prognosis is time-dependent, so it is important to develop tools that allow us to identify subsidiary patients in the shortest possible time regardless of the location from which they come. With the correct application of this scale, it will also be possible to improve the start-door-needle times in both patients candidates for endovascular treatment and those candidates for intravenous fibrinolytic treatment.

Therefore, a first aspect of the invention relates to the use of seven neurological symptoms:

1. level of consciousness,

2. oculocephalic deviation,

3. facial paresis,

4. upper limb paralysis,

5. lower limb paralysis,

6. Aphasia and

7. heminegligence,

to determine large vessel occlusion in an individual.

The inventors have developed the GadSS scale, with the seven previous items, for this purpose they have monitored, from January 2016 to November 2017, 187 patients who attended the Emergency Department of the Puerta del Mar de Cádiz University Hospital after activating stroke code and those who underwent a simple cranial computed tomography (CT) and CT angiography of supraaortic trunks. Of the total patients, 117 were male (62%) and 70 female (38%). The average age was 68 years.

The average NIHSS score of the total patients was 10.87 points. Of the 117 patients, in 93 occlusion of large OGV vessel was identified, named in the positive angioTC study. And 94 patients without large vessel occlusion, called negative angioTC. The GADSS scale was applied by extrapolating the data from the on-call neurologist examination upon arrival at the Emergency Department and found 70 cases with positive CT angiography (initial score equal to or greater than four), that is, a sensitivity of 78%.

In an analysis of the sample, based on the result of CT angiography, in those with a positive CT angiography, an average score on the GadSS scale of 4.73 and 14.5 on the scale was obtained. NIHSS, being 2.94 and 7.2 respectively in those with a negative Angio-CT for OGV large vessel occlusion (Table 1 and 2).

Table 1. Contingency table

Table 2 Sample characteristics

In the 94 patients with a negative CT angiography, 74 patients scored less than 4 on the GadSS scale, resulting in a specificity of 76%. The positive predictive value (PPV) of the scale reached 75% and the negative predictive value (NPV) 79%.

The results obtained were confronted with the RACE > 5 scale, obtaining a sensitivity of 55%, specificity of 87% and a positive predictive value of 68% and negative of 79%.

The RACE scale, is one of the most used, is a simple and rapid neurological scale created to assess patients with acute stroke at the prehospital level and detect cases with a high probability of having a large vessel arterial occlusion, candidates therefore to be treated with endovascular techniques in tertiary stroke centers.

The RACE scale is a simplification of the NIHSS scale, it values 5 items:

1. facial paresis,

2. brachial paresis,

3. crural paresis,

4. oculocephalic deviation and

5. aphasia / agnosia,

With a total score of 0 to 9, a score> 4 makes it possible to suspect the presence of occlusion of large OGV vessel.

In turn, they have compared the results with other scales of international use, finding that GadSS has a greater sensitivity than the scales that had better statistical data than they had so far, such as FAST-ED with 60% sensitivity or PASS with 64% excluding the rest of the scales that obtained results of lower statistical power (Table 3).

Table 3. Comparison with other scales

The GadSS scale is based on the NIHSS National Institutes Health Stroke Scale or NIH Stroke Scale scale , which is a tool used to objectively quantify the damage caused by a stroke. The NIHSS is composed of 11 elements:

1. Level of consciousness

2. Conjugate look

3. Visual fields

4. Facial paresis

5. Superior limb paresis

6. paresis of lower limbs

7. Limb ataxia

8. Sensitivity

9. Language

10. Dysarthria

11. Extinction, neglect, inattention

Each item qualifies a skill between 0 to 4. For each item, a rating of 0 indicates a normal function, the higher the score indicates some level of damage. (0: No symptoms. 1-4: Slight cerebrovascular accident (CVA). 5-15: Moderate LCA. 16-20: moderate to severe. 21-42: Severe. The individual score of each element is added to calculate the score. Total NIHSS, where the maximum grade is 42, and the lowest is 0.

METHODS OF DETERMINATION OF OCLUSION OF A LARGE GLASS.

A second aspect of the invention relates to a method for determining large vessel occlusion, hereafter referred to as the method of the invention, comprising:

to. Decide:

1. level of consciousness,

2. oculocephalic deviation,

3. facial paresis,

4. upper limb paralysis,

5. lower limb paralysis,

6. Aphasia and

7. heminegligence an individual and

b. assess the presence or absence of each item listed in the previous paragraph, and c relate the values obtained in the previous step with the occlusion of the great vessel ( OGV), when they present at least 4 points in the assessment

In the GadSS scale, all items of the scale are evaluated with the presence or absence, granting a maximum of 1 point for all of them, with the exception of the oculocephalic deviation, in which their presence will contribute 2 points to the final score, since It is the neurological alteration that best correlates with the occlusion of a large vessel in the anterior circulation. (Table 4).

Table 4. GadSS scale items

For the correct application of the scale, the patient's previous neurological deficits must be ignored, so only those newly established will be taken into account. On the other hand, the motor balance of the 4 members should also be evaluated, granting a point in each of them in which it is altered, again providing greater sensitivity for patients with stroke of the posterior territory. It includes the alteration of the level of consciousness as a parameter that identifies patients with an occlusion of the posterior territory.

Unlike other scales, GadSS includes parameters that are easy to assess, scoring only when the deficit is present in the patient, without graduating the severity, since we consider that the latter is not a predictor of occlusion of a large vessel. In this way, reproducibility will be high, reducing interobserver bias and can be executed by doctors not specialized in neurological examination.

In this report, "specialized unit" is understood as any Center, Endovascular Center, Tertiary stroke centers, Reference centers, Units, Provincial reference center, which refers to the center that has neurointerventional radiology techniques to perform cerebral vascular techniques You must have an interventional radiology room, equipped with equipment and specific devices, qualified medical and nursing staff trained for these techniques and available 24 hours a day every day.

The term "individual" in this report is synonymous with "patient", and is not intended to be limiting in any way, and may be of any age, sex and physical condition.

KIT OR DEVICE OF THE INVENTION

A third aspect relates to a kit or device, hereafter kit or device of the invention, which comprises the elements necessary to assess the items and, additionally, comprises instructions for carrying out the method of the invention. These instructions include the GadSS scale, or the information necessary to carry out the calculations described in this document that allow the direct transfer of an individual to a specialized unit.

AUTOMATION OF THE METHOD OF THE INVENTION IMPLEMENTING IT IN A COMPUTER PROGRAM

Another aspect of the invention relates to a computer program comprising program instructions to make a computer carry out the method according to the method of the invention.

In particular, the invention encompasses computer programs arranged on or within a carrier. The carrier can be any entity or device capable of supporting the program. When the program is incorporated into a signal that can be directly transported by a cable or other device or medium, the carrier may be constituted by said cable or other device or means. As a variant, the carrier could be an integrated circuit in which the program is included, the integrated circuit being adapted to execute, or to be used in the execution of, the corresponding processes.

For example, the programs could be incorporated into a storage medium, such as a ROM, a CD ROM or a semiconductor ROM, a USB memory, or a magnetic recording medium, for example, a floppy disk or a disk Lasted. Alternatively, the programs could be supported on a transmissible carrier signal. For example, it could be an electrical or optical signal that could be transported through an electrical or optical cable, by radio or by any other means.

The invention also extends to computer programs adapted so that any processing means can implement the methods of the invention. Such programs may have the form of source code, object code, an intermediate source of code and object code, for example, as in partially compiled form, or in any other form suitable for use in the implementation of the processes according to the invention . Computer programs also cover cloud applications based on that procedure.

Another aspect of the invention relates to a computer-readable storage medium comprising program instructions capable of causing a computer to carry out the steps of the method of the invention.

Another aspect of the invention relates to a transmissible signal comprising program instructions capable of causing a computer to carry out the steps of the method of the invention.

Throughout the description and the claims the word "comprises" and its variants are not intended to exclude other technical characteristics, additives, components or steps. For those skilled in the art, other objects, advantages and features of the invention will be derived partly from the description and partly from the practice of the invention. The following examples and drawings are provided by way of illustration, and are not intended to be limiting of the present invention.

EXAMPLES OF THE INVENTION

Example 1.

A 60-year-old patient whose family warns from home to present a sudden picture of the impossibility of issuing words and mobilizing the right arm and legs with a deviation from the oral commissure about 30 minutes of evolution. Upon arrival of the outpatient health care service, they confirm the start time and perform a Gadss scale with a result of 5 points (high probability of OGV) so it is referred to the reference hospital to check the suitability of the patient to undergo revascularization treatment urgent in the shortest possible time. Thus avoiding the delay of time that would be treated in the first instance in the hospital of your health area, if it does not have adequate resources. Example 2

A 70-year-old patient who is treated by out-of-hospital services with symptoms of difficulty speaking the words and deviation from the oral commissure for 2 hours. On the GadSS scale, it has a score of 2, so the probability that it is an OGV is low. The patient will be referred to his hospital of sanitary area where the pertinent radiological and analytical studies will be practiced.

Claims (7)

1. A computer program comprising program instructions for having a computer implement a method for determining large vessel occlusion in an individual, comprising: to. determine the items: 1. level of consciousness, 2. oculocephalic deviation, 3. facial paresis, 4. upper limb paralysis, 5. lower limb paralysis, 6. Aphasia and 7. heminegligence an individual and b. assess the presence or absence of each item listed in stage (a) above, and c relate the values obtained in the previous step to the occlusion of the great vessel ( OGV), when the individual has at least 4 points in the assessment, where the assessment of each item is carried out as indicated in Table 4, and when the assessment is> 4, the individual is included in the group of individuals with suspected occlusion of a large vessel. 2. A computer-readable storage medium comprising program instructions capable of having a computer carry out the steps of the method according to claim 1. 3. A transmissible signal comprising program instructions capable of having a computer carry out the steps of the method according to claim 1.