Should we treat unruptured brain aneurysms?



    The CHUM is conducting the first-ever international, multi-centre
    clinical study on the endovascular treatment of unruptured brain
    aneurysms, with funding from the Canadian Institutes of Health Research

    MONTREAL, March 15 /CNW Telbec/ - Centre hospitalier de l'Université de
Montréal (CHUM) is conducting the first, most extensive international
multi-centre study on the treatment of unruptured cerebral aneurysms ever to
be undertaken. The Coordinating Centre for this Trial on Endovascular Aneurysm
Management (or TEAM) is located at Hôpital Notre-Dame du CHUM, and will
receive over 5 million dollars in funding from the Canadian Institutes of
Health Research (CIHR) for the first five-year phase of the study.
    This multi-centre study is being conducted under the direction of Dr.
Jean Raymond, Director of the Interventional Neuroradiology Laboratory at the
CHUM and professor at Université de Montréal. The study will monitor 2002
patients the world over, coordination operations in Montreal, in collaboration
with the Radcliffe Infirmary at Oxford (England), University of California,
San Francisco (US), University of Toronto, University of British Colombia in
Vancouver, and the CHUM Neuropsychology Department. The study is also backed
by the Canadian Stroke Consortium, and Société française de Neuroradiologie.
    TEAM is a randomized study which will work with over 60 international
centres for excellence to recruit 2002 patients (men and women over 18 years
of age) who have been diagnosed with one or more unruptured brain aneurysms.
The primary objective of the study is to assess the safety and efficacy of
endovascular treatment for this condition in the prevention of meningeal
haemorrhages.

    The endovascular treatment of unruptured brain aneurysms: The controversy

    Whether or not to treat patients with unruptured brain aneurysms is one
of the most vexing dilemmas to face the medical community in recent years.
(1),(2) Treatment has existed for this condition for the past decade, and so
the long-term risks and benefits involved are now better known.(3) However,
there is still considerable controversy regarding indications for the
management and prevention of aneurysms. Patients with unruptured brain
aneurysms may suffer an intracranial haemorrhage, but the incidence of this
event is not well documented. Treatment also has its risks. Now that modern
imaging methods are more widely available and our population is aging, more
unruptured aneurysms are being discovered. Should they be treated? "To date,
no scientific study has demonstrated the merit of any kind of treatment for
unruptured aneurysms," says Dr. Jean Raymond. "Therefore, we have not yet been
able to weigh the risks and benefits. A randomized clinical trial is the best
way to demonstrate the potential benefit of endovascular treatment in patient
case management," he added.
    A clinical study of this magnitude requires significant financial support
and the TEAM has come to fruition thanks to the investment of the CIHR. "Given
the wide popularity of endovascular treatment and the millions of patients
treated every year, the world over, it is imperative that we answer these
questions. Determining the merit of endovascular treatment as a preventive
measure in cases of unruptured aneurysms is a question of public health,"
commented Dr. Rémi Quirion, Scientific Director at the Institute of
Neuroscience, Mental Health and Addiction of the CIHR.

    Proposed study

    TEAM is an international, randomized, and controlled comparative study of
morbidity and mortality rates associated with intracranial haemorrhages or the
treatment of patients with at least one unruptured aneurysm. The patients in
this study will either be followed under observation or undergo endovascular
treatment. All patients will be monitored for ten years, or until a formal
indication for treatment is given. The criteria for secondary outcomes
includes the incidence of haemorrhagic events; morbidity/mortality rates of
treatment; morphological results at five and ten years; patient outcomes and
clinical status at five and ten years, and cognitive functions, quality of
life and anxiety or depression levels, as measured in standardized
questionnaires.

    Unruptured brain aneurysms: Unknown prevalence, worried patients

    The exact prevalence of brain aneurysms is still unknown. It is estimated
that 1% to 5% of the adult population has a brain aneurysm.(4) Today, a
constant stream of patients is being diagnosed as having one or several
unruptured brain aneurysms during examinations for symptoms unrelated to their
presence. Most aneurysms remain asymptomatic until they rupture, an event
which strikes an estimated 8 to 10 out of 100,000 individuals every year.(5)
Subarachnoid aneurysm ruptures are associated with high rates of morbidity and
mortality (from 45% to 75%) despite technological advances in recent years.

    Why TEAM?

    There is still no scientific proof to support the necessity of preventive
treatment for unruptured aneurysms, nor are there any clearly established
standards for treatment. The best way to approach this condition therefore
remains unclear.
    The endovascular treatment of aneurysms has existed since 1992. This
approach has allowed us to significantly improve the prognosis of patients
treated after a rupture has taken place, in comparison with conventional
surgery. But the benefits of preventive treatment through endovascular surgery
before any rupture takes place still remain to be demonstrated.
    The time has come to determine whether or not endovascular treatment is
effective in preventing aneurysms from rupturing. If so, does this treatment
benefit most of the patients who are eligible for this intervention? These are
the questions that will be examined during the clinical trial.

    CHUM

    The Centre hospitalier de l'Université de Montréal (CHUM) provides
specialised and ultraspecialised services to its regional and supraregional
clienteles. Within its more immediate coverage area, it also offers general
and specialised hospital care and services. CHUM has a five-part mandate,
comprising research, teaching, the assessment of technologies, the evaluation
of health care methodologies, and the promotion an integrated-networks
approach to health care. Hôtel-Dieu, Hôpital Notre-Dame, and Hôpital Saint-Luc
form the CHUM, whose 10,000 employees, 900 physicians, 270 researchers, 5,000
students and trainees, and 800 volunteers provide services to over 500,000
patients every year. www.chummontreal.qc.ca

    Université de Montréal

    Deeply rooted in Montreal and dedicated to its international mission,
Université de Montréal is one of the top universities in the French-speaking
world. Founded in 1878, U de M has grown to include 13 faculties and two
affiliated schools (Ecole Polytechnique and HEC Montréal). It is now the
largest centre for university studies and research in Quebec, the second
largest in Canada, and among the largest in North America. Université de
Montréal comprises some 55,000 students, 2,400 professors and researchers, and
over 650 programs at all levels of post-secondary education. Approximately
3,000 master's and doctoral are conferred by U de M every year.
www.umontreal.ca

    Canadian Institutes of Health Research

    Canadian Institutes of Health Research (CIHR) is the major federal agency
responsible for funding health research in Canada. It aims to excel in the
creation of new scientific knowledge, and to translate that knowledge from the
research setting into real world applications. The results are improved health
for Canadians, more effective health services and products, and a strengthened
Canadian health care system. The CIHR has 13 Institutes, which provide
leadership and support to more than 10,000 researchers and
researchers-in-training across Canada.
    www.irsc-cihr.gc.ca.

    --------------------------
    (1) Weir B. Unruptured intracranial aneurysms: A review. J Neurosurg.
    2002;96:3-42

    (2) Kassell N, Lanzino G. Unruptured intracranial aneurysms: In search of
    the best management strategy. Editorial comment. Stroke. 2001;32:603-605

    (3) Raymond J, Guilbert F, Georganos S, Juravsky L, Lambert A, Lamoureux
    J, Chagnon M, Weill A, Roy D. Long-term angiographic recurrences after
    selective endovascular treatment of aneurysms with detachable coils.
    Stroke. 2003;34:421-427

    (4) Deruty R, Pelissou-Guyotat I, Mottolese C, Amat D. Management of
    unruptured cerebral aneurysms. Neurol. Res. 1996;18:39-44

    (5) Menghini VV, Brown RD, Jr., Sicks JD, O'Fallon WM, Wiebers DO.
    Incidence and prevalence of intracranial aneurysms and hemorrhage in
    Olmsted County, Minnesota, 1965 to 1995. Neurology. 1998; 51:405-411.

    Raymond J, Meder JF, Molyneux A, Fox, A J, Johnston S C, Collet JPl,
    Rouleau I and the Trial on Endovascular Aneurysm Management (TEAM)
    collaborative group. Trial on endovascular treatment of unruptured
    aneurysms (TEAM): Study Monitoring and Rationale for Trial Interruption
    or Continuation. In press in Journal of Neuroradiology. Journal de
    Neuroradiologie, 2007.

    Raymond J, Guilbert F, Weill A, Roy D. Unruptured intracranial aneurysms:
    A call for a randomized clinical trial. American Journal of
    Neuroradiology. Vol. 27(2)(pp 242-243), 2006

    Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP.
    Rouleau I. Unruptured intracranial aneurysms: The unreliability of
    clinical judgment, the necessity for evidence, and reasons to participate
    in a randomized trial. (Journal: Review) Journal of Neuroradiology.
    Journal de Neuroradiologie. Vol. 33(4)(pp 211-219), 2006.

    Raymond J, Chagnon M, Collet J, Guilbert F, Weill A. Efficacité du
    traitement endovasculaire des anévrismes non rompus: Une étude randomisée
    est nécessaire. XXXIe Congrès annuel de la Société Française de
    Neuroradiologie. 2004;31:89

    Raymond J, Roy D, Guilbert F, Weill A. Endovascular treatment of
    intracranial aneurysms. Part 1: Current status and indications.
    Cardiovascular reviews and Reports, 2004;25:196-199. (by invitation)

    Raymond J, Roy D, Guilbert F, Weill A. Endovascular treatment of
    intracranial aneurysms. Part 2: Recent advances. Cardiovascular reviews
    and Reports, 2004;25:265-267. (by invitation)

    Raymond J, Roy D, Guilbert F, Weill A. A randomized trial on safety and
    efficacy of endovascular treatment of unruptured intracranial aneurysms
    is feasible.  Interventional Neuroradiology, June 2004;10(2):103-112.




For further information:

For further information: Nathalie Forgue, M.A., Communications Advisor,
Centre hospitalier de l'Université de Montréal, (514) 890-8000, ext. 15380,
Pager: (514) 860-7110; Sophie Langlois, Director of Media Relations,
Université de Montréal, (514) 343-7704; David Coulombe, Media Specialist,
Canadian Institutes of Health Research, (613) 941-4563, Cell: (613) 808-7526;
Source: Jean Raymond, M.D., Neuroradiologist, Director of the Interventional
Neuroradiology Laboratory, Hôpital Notre-Dame du CHUM;  www.TEAMstudy.org
(French and English)

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Centre hospitalier de l'Université de Montréal (CHUM)

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