Faculty Opinions recommendation of Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial.

Author(s):  
Jack Kron
Circulation ◽  
2012 ◽  
Vol 125 (21) ◽  
pp. 2566-2571 ◽  
Author(s):  
Michele Brignole ◽  
Carlo Menozzi ◽  
Angel Moya ◽  
Dietrich Andresen ◽  
Jean Jacques Blanc ◽  
...  

2007 ◽  
Vol 13 (3) ◽  
pp. 225-237 ◽  
Author(s):  
J. Raymond ◽  
T. Nguyen ◽  
M. Chagnon ◽  
G. Gevry ◽  

In the absence of level one evidence, the treatment of unruptured intracranial aneurysms is grounded on opinions. Results of the largest registry available, ISUIA (the International Study on Unruptured Intraacranial Aneurysms) suggest that surgical or endovascular treatments are rarely justified. Yet the unruptured aneurysm is the most frequent indication for treatment in many endovascular centres. In preparation for the initiation of a randomized trial, we aimed at a better knowledge of endovascular expert opinions on unruptured aneurysms. We administered a standard questionnaire to 175 endovascular experts gathered at the WFITN meeting in Val d'Isère in 2007. Four paradigm unruptured aneurysms were used to poll opinions on risks of treatment or observation, as well as on their willingness to treat, observe or propose to the patient participation in a randomized trial, using six questions for each aneurysm. Opinions varied widely among lesions and among participants. Most participants (92.5%) were consistent, as they would offer treatment only if their estimate of the ten-year risk of spontaneous hemorrhage would exceed risks of treatment. Estimates of the natural history were consistently higher than that reported by ISUIA. Conversely, treatment risks were underestimated compared to those reported in ISUIA, but within the range reported in a recent French registry (ATENA). Participants were more confident in their evaluation of treatment risks and in their skills at treating aneurysms than in their estimates of risks of rupture entailed by the presence of the lesion, the latter being anchored at or close to 1% /year. The gulf between expert opinions, clinical practices and available data from registries persist. Expert opinions are compatible with the primary hypothesis of a recently initiated randomized trial on unruptured aneurysms (TEAM), which is a benefit of endovascular treatment of 4% compared to observation over ten years. Only data from a randomized trial could provide convincing objective evidence in favour or against preventive treatment of unruptured intracranial aneurysms.


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