3. Desenvolvimento
3.7. Guidelines da European Stroke Organisation
estudo sugere que poderá ter havido algum grau de selecção dos candidatos a inclusão por parte dos Hospitais referenciadores.
Ainda neste ensaio, apesar de serem produzidas conclusões em relação a doentes submetidos a cirurgia após as 48 horas da instalação dos sintomas (análise de sub-grupo), apenas 11 doentes estavam nestas condições. Este aspecto é relevante na medida em que não se podem retirar conclusões com relevância estatística com base numa amostra de tão reduzida dimensão.
Por fim, estes três ensaios apresentavam algumas diferenças nos seus critérios de inclusão clínicos e, portanto, nas características-base dos doentes incluídos. Este aspecto assume particular relevância na medida em que se efectuou uma pooled analysis com base nos resultados individuais de doentes destes três estudos. Contudo, a sua heterogeneidade não se revelou estatisticamente significativa.
Em contraste, a ausência de uniformidade nos critérios imagiológicos de inclusão (modalidade, tempo de captação de imagens e ausência/presença de efeito de massa) entre os ensaios obrigou à sua exclusão da pooled analysis.
3.7. Guidelines da European Stroke Organisation
Tomando por base os estudos de nível A, a European Stroke Organisation incluiu nas recomendações para o tratamento de AVC isquémico de 2008 a cirurgia descompressiva para doentes até aos 60 anos de idade, com enfartes “malignos” da ACM em evolução, nas primeiras 48 horas após a instalação de sintomas (Recomendação Classe I, Nível A). [34, Anexos 11 e 12]
38 4. CONCLUSÕES/DISCUSSÃO
4.1. Conclusões
Os estudos analisados demonstram que a cirurgia descompressiva, no contexto de enfarte
“maligno” da artéria cerebral média, é um procedimento que reduz a taxa de mortalidade e tem um outcome funcional favorável, aos 6 e aos 12 meses de follow-up, se realizada nas primeiras 48 horas após a instalação de sintomas em doentes com menos de 60 anos.
Nestas condições, o NNT para prevenir um outcome não favorável é de 6, para prevenir incapacidade severa ou morte é de 2 e para prevenir a morte é de 2.
A probabilidade de sobrevivência aumenta de 28 para cerca de 80%. Por seu lado, esta abordagem terapêutica resulta na duplicação do número de doentes com outcome funcional favorável (mRS ≤3), num aumento superior a 10 vezes no número de doentes com mRS de 4 sem incremento no número de doentes severamente incapacitados (mRS=5).
A idade revelou-se uma variável com impacto significativo nos resultados em termos de mortalidade e outcome funcional. Os resultados da pooled analysis e da metanálise actualizada na publicação do estudo HAMLET, demonstram que a cirurgia é benéfica quando realizada em doentes até 60 anos. Neste ensaio, no entanto, foi registada uma tendência para um maior benefício da cirurgia em doentes com idades compreendidas os 51 e os 60 anos.
Outro parâmetro que se revelou determinante nos resultados foi o tempo de intervenção cirúrgico. Foi demonstrado que a abordagem cirúrgica reduz a mortalidade (ARR de 50%) e aumenta o número de doentes com um outcome funcional favorável, quando realizada nas primeiras 48 horas em doentes que apresentam deterioração neurológica. Apesar da redução
39 da mortalidade (ARR de 38%), não há evidência de benefício no outcome funcional quando esta é realizada até 99 horas após o início do AVC.
A lateralidade não se revelou uma variável com impacto significativo na mortalidade ou outcome funcional.
4.2. Questões em aberto
Apesar do grande avanço que representou a realização destes três ensaios, ainda subsistem algumas questões não respondidas.
Mais de metade dos doentes que desenvolvem um enfarte “maligno” da ACM apenas apresentam sinais clínicos de herniação após o segundo dia da instalação dos sintomas [20].
Nesse sentido, julga-se necessário o estabelecimento de preditores clinico-imagiológicos desta entidade clínica. Dessa forma, poder-se-ia submeter o doente a tratamento cirúrgico antes da previsível deterioração neurológica. Em alternativa, justifica-se um estudo multicêntrico e prospectivo com o objectivo de avaliar a eficácia da cirurgia em doentes que apenas apresentem deterioração neurológica mais de 48 horas após o início dos sintomas de AVC.
Apesar do estudo HAMLET apontar no sentido da ausência de benefício funcional quando a cirurgia é realizada entre as 48 e as 96 h após o início do quadro deficitário, são necessários ensaios clínicos com amostras de maior dimensão que comparem os resultados até às 72 e 96 horas.
Os ensaios acima expostos apresentam suficiente evidência clínica do benefício da cirurgia em doentes com idade inferior a 60 anos. No entanto, à luz dos resultados apresentados, não é
40 possível excluir que doentes com idade superior não possam beneficiar deste tipo de abordagem.
Num período em que muitos dos doentes com enfartes da ACM são submetidos a tratamento fibrinolítico, permanece por estabelecer se estes doentes são candidatos a cirurgia; em caso afirmativo, qual o timing da intervenção pós-trombólise e qual o outcome em comparação com aqueles não tratados com este fármaco.
4.3. Propostas de estudos clínicos
Em função do que foi exposto na secção 4.2, sugere-se a realização dos seguintes ensaios clínicos:
- Estudo multicêntrico, randomizado e controlado comparando a descompressão cirúrgica em enfartes “malignos” da ACM em doentes com idades 60-65 vs 66-70 anos;
- Estudo multicêntrico, randomizado e controlado comparando a descompressão cirúrgica em enfartes “malignos” da ACM em doentes com deterioração neurológica >48 e ≤72h e >72 e
≤96h;
- Estudo multicêntrico, randomizado e controlado comparando a descompressão cirúrgica em enfartes “malignos” da ACM em doentes submetidos a fibrinólise há mais de 12 horas vs não submetidos a fibrinólise.
.
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48
ANEXOS
49 ANEXO 1 – modified Rankin Scale [14]
Descrição do Score 0 Sem sintomas
1 Nenhuma incapacidade significativa apesar dos sintomas; capacidade para realizar todas as actividades da vida diária
2 Incapacidade ligeira; incapacidade de realizar algumas actividades prévias mas com capacidade de fazer a sua vida sem assistência
3 Incapacidade moderada; requer alguma ajuda, mas com capacidade de se movimentar sem assistência
4 Incapacidade moderadamente severa; incapacidade de se movimentar e de atender às necessidades fisiológicas sem assistência
5 Incapacidade severa; acamado, incontinente e requerendo cuidados de enfermagem e atenção constantes
6 Morte
50 ANEXO 2 – NIHSS
51 ANEXO 3 - Barthel Index [14]
Score de Actividades da Vida Diária Alimentação
5 = independente (ou no chuveiro) Higiene pessoal
0 = necessita de assistência nos cuidados de higiene pessoal
5 = independente lavagem da face/pentear/lavagem dos dentes/barbear (com ajuda de instrumentos)
Vestir e despir 0 = dependente
5 = necessita de assistência mas faz cerca de metade sozinho 10 = independente (incluindo butões, fechos, laços, etc.) Controlo esfincteriano intestinal
0 = incontinente (ou precisa de clisteres) 5 = perdas ocasionais
10 = continente Continência vesical
0 = incontinente, ou sonda urinária e incapaz de a tratar sozinho
52 5 = perdas ocasionais
10 = continente Idas ao WC 0 = dependente
5 = necessita de assistência, mas faz parte sozinho 10 = independente (vestir, lavagem)
Transferências (da cama para a cadeira e vice-versa) 0 = incapaz, sem equilíbrio sentado
5 = necessitando de muita ajuda (ajuda física por uma ou duas pessoas), consegue ficar sentado
10 = necessita de pouca ajuda (verbal ou física) 15 = independente
Deambulação (em superfícies niveladas) 0 = imóvel ou menos de 35 metros
5 = em cadeira de rodas mas independente, incluindo nas curvas, > 35 metros 10 = caminha com a assistência de uma pessoa (verbal ou física) > 35 metros
15 = independente (mas pode usar ajuda; como por exemplo uma bengala) > 35 metros Subir e descer escadas
0 = incapaz
5 = necessita de ajuda (verbal, física, bengala) 10 = independente
TOTAL 0–100
53 0 – completa dependência em todas as AVD‟s
<60 – dependência funcional / incapacidade severa
60-85 – independência para cuidados pessoais essenciais / incapacidade ligeira a moderada
>85 – independência necessitando de assistência mínima 100 – completa independência
54 ANEXO 4 – Montgomery and Asberg depression rating scale
The rating should be based on a clinical interview moving from broadly phrased questions about symptoms to more detailed ones which allow a precise rating of severity. The rater must decide whether the rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5) and then report the appropriate number. The items should be rated with regards to how the patient has done over the past week.
1 - APPARENT SADNESS - Representing despondency, gloom and despair, (more than just ordinary transient low spirits) reflected in speech, facial expression, and posture. Rate by depth and inability to brighten up.
0 No sadness 1
2 Looks dispirited but does brighten up without difficulty 3
4 Appears sad and unhappy most of the time 5
6 Looks miserable all the time. Extremely despondent.
2 - REPORTED SADNESS - Representing reports of depressed mood, regardless of whether it is reflected in appearance or not. Includes low spirits, despondency or the feeling of being beyond help and without hope. Rate according to intensity, duration and the extent to which the mood is reported to be influenced by events.
0 Occasional sadness in keeping with the circumstances.
55 1
2 Sad or low but brightens up without difficulty.
3
4 Pervasive feelings of sadness or gloominess. The mood is still influenced by external circumstances.
5
6 Continuous or unvarying sadness, misery or despondency.
3 - INNER TENSION - Representing feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish. Rate according to intensity, frequency, duration and the extent of reassurance called for.
0 Placid. Only fleeting inner tension.
1
2 Occasional feelings of edginess and ill-defined discomfort 3
4 Continuous feelings of inner tension or intermittent panic which the patient can only master with some difficulty.
5
6 Unrelenting dread or anguish. Overwhelming panic.
4 - REDUCED SLEEP - Representing the experience of reduced duration or depth of sleep compared to the subject's own normal pattern when well.
0 Sleeps as usual.
1
2 Slight difficulty dropping off to sleep or slightly reduced, light or fitful
56 sleep
3
4 Sleep reduced or broken by at least two hours.
5
6 Less than two or three hours sleep.
5 - REDUCED APPETITE
Representing the feeling of a loss of appetite compared with when well. Rate by loss of desire for food or the need to force oneself to eat.
0 Normal or increased appetite.
1
2 Slightly reduced appetite 3
4 No appetite. Food is tasteless.
5
6 Needs persuasion to eat at all.
6 - CONCENTRATION DIFFICULTIES - Representing difficulties in collecting one's thoughts mounting to incapacitating lack of concentration. Rate according to intensity, frequency, and degree of incapacity produced.
0 No difficulties in concentrating.
1
2 Occasional difficulties in collecting one's thoughts.
3
4 Difficulties in concentrating and sustaining thought which reduces
57 ability to read or hold a conversation.
5
6 Unable to read or converse without great difficulty.
7 - LASSITUDE - Representing a difficulty getting started or slowness initiating and performing everyday activities.
0 Hardly any difficulties in getting started. No sluggishness.
1
2 Difficulties in starting activities.
3
4 Difficulties in starting simple routine activities, which are carried out with effort.
5
6 Complete lassitude. Unable to do anything without help.
8 - INABILITY TO FEEL - Representing the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure.The ability to react with adequate emotion to circumstances or people is reduced.
0 Normal interest in the surroundings and in other people.
1
2 Reduced ability to enjoy usual interests.
3
4 Loss of interest in the surroundings. Loss of feelings for friends and acquaintances.
5
58
6 The experience of being emotionally paralyzed, inability to feel anger, grief or pleasure and a complete or even painful failure to feel for close relatives and friends.
9 - PESSIMISTIC THOUGHTS - Representing thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.
0 No pessimistic thoughts.
1
2 Fluctuating ideas of failure, self-reproach or self-depreciation.
3
4 Persistent self-accusations, or definite but still rational ideas of guilt or sin.
Increasingly pessimistic about the future.
5
6 Delusions of ruin, remorse and unredeemable sin. Self-accusations which are absurd and unshakable.
10 - SUICIDAL THOUGHTS - Representing the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide. Suicidal attempts should not in themselves influence the rating.
0 Enjoys life or takes it as it comes.
1
59 2 Weary of life. Only fleeting suicidal thoughts.
3
4 Probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention.
5
6 Explicit plans for suicide when there is an opportunity. Active preparations for suicide.
The scale ranges form 0 to 60.
0-6: no symptoms of depression 7-18: mild symptoms of depression 19-60: symptoms of severe depression
60 ANEXO 5 – SF-36 (Medical Outcomes Study 36-item short-form health survey)
1. In general, would you say your health is:
Excellent 1
Very good 2
Good 3
Fair 4
Poor 5
2. Compared to one year ago, how would your rate your health in general now?
Much better now than one year ago 1
Somewhat better now than one year ago 2
About the same 3
Somewhat worse now than one year ago 4
Much worse now than one year ago 5
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? (Circle One Number on Each Line)
Yes, 3. Vigorous activities, such as running,
lifting heavy objects, participating in strenuous sports
[1] [2] [3]
4. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf
[1] [2] [3]
5. Lifting or carrying groceries [1] [2] [3]
6. Climbing several flights of stairs [1] [2] [3]
7. Climbing one flight of stairs [1] [2] [3]
61
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health?
(Circle One Number on Each Line)
Yes No 13. Cut down the amount of time you spent on work or other activities 1 2
14. Accomplished less than you would like 1 2
15. Were limited in the kind of work or other activities 1 2 16. Had difficulty performing the work or other activities (for example, it took
extra effort)
1 2
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? (Circle One Number on Each Line)
Yes No 17. Cut down the amount of time you spent on work or other activities 1 2
18. Accomplished less than you would like 1 2
19. Didn't do work or other activities as carefully as usual 1 2 20. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups?
(Circle One Number)
62
21. How much bodily pain have you had during the past 4 weeks? (Circle One Number) None 1
22. During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)? (Circle One Number)
Not at all 1 A little bit 2 Moderately 3 Quite a bit 4
Not at all 1 A little bit 2 Moderately 3 Quite a bit 4