Abstract
Despite increasing experience and improved material, endovascular treatment of cerebral aneurysms still has risks linked to the technique itself and to the specificity of the pathology treated. The purpose of this report is to examine procedural technical and clinical negative events, even minimal ones, occurring in this type of treatment. We considered 557 procedures carried out from January 1994 to December 2005 in 533 patients harboring 550 aneurysms. Of the patients, 448 presented with SAH and 85 with unruptured aneurysms. All procedures were performed under general anesthesia. The GDC-10 system was routinely used. Additional devices like the balloon remodeling technique, Trispan and stents were also occasionally used. Every procedural complication occurring during or soon after treatment was registered. Endovascular treatment was completed in 539 out of 557 procedures. There were 18 failures (3.3%). Occlusion of the aneurysm was judged complete in 343 (64%), near complete in 184 (34%) and incomplete in 12 (2%). Procedural complications occurred in 72 (13%) of the cases. The most frequent negative events were thromboembolisms (6.6%) and ruptures (3.9%). Other types (coil migration, transient occlusions of the parent vessel, dissections and early rebleeding) were rarer (2.5%). In the majority of cases there were no clinical consequences. Procedural morbidity and mortality were 1.1 and 1.8%, respectively. Considering the 449 procedures performed in ruptured and the 90 in the unruptured aneurysms separately, morbidity and mortality were 1.1 and 2.2% in the former group and 1.1 and 0% in the latter. Many factors influence the risk of complications. Being progressively aware of this and with increasing experience, the frequency can be limited. Negative events linked to the procedure have more significant serious clinical consequences in patients admitted in a critical clinical condition after SAH, because of the already present changes involving the brain parenchyma and cerebral circulation.
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Juergen Reul, Siegen, Germany
At first glance this is a very promising paper dealing with endovascular management of cerebral aneurysms, demonstrating 12 years of experience and more than favorable results. However, at second glance, some points induce a critical analysis with questions arising that make the results and conclusions to some degree debatable.
The endovascular treatment of aneurysms by controlled detachment of platinum coils has a history of more than 15 years now. The breakthrough came with the results of the ISAT trial, leading to a shift from microsurgical clipping to endovascular “coiling” in a large number of patients.
Analyzing the ISAT study critically, the results of the endovascular therapy were not far different from the surgical results. In the endovascular group, the immediate and the 1-year outcome were superior, but the rebleeding rate was slightly higher. However, the ISAT results changed the therapeutic management, and in many countries and centers worldwide the endovascular treatment is now the first choice.
As we know from other randomized studies comparing different treatment modalities for vascular diseases (as, for example, the NASCET or ECASS studies for carotid surgery or the CAVATAS and SPACE study comparing stenting to surgery), the results under study conditions may differ from the daily clinical experience because a study produces to some degree an artificial situation. The included centers are often those of excellence with greater experience and high procedure numbers, and the patient selection is sometimes different from the patient population in normal life due to several factors such as exclusion and other selection criteria and the number of included centers. Therefore, the clinical and operative results can be different between study results and clinical routine findings. Because of the study design of ISAT, such selction artifacts were excluded as far as possible; nevertheless, there may be some slight differences.
All this, which can be discussed long and critically, led to the conclusion that a single-center experience over a long period can give very valuable clinical information on the value of a method, the learning curve, technical and personal aspects and other facts that cannot always be analyzed in a prospective randomized trial.
The authors present their results from 557 procedures over a period of 12 years performed by two neuroradiologists. The number of procedures was low in the first 7 years and increased markedly in the last 5 years as a result of ISAT and the further development of the technique with better coils and microcatheters. Four hundred forty-eight patients suffered from an SAH; 90 were incidental/unruptured. This means that more than 80% of all patients had an SAH. In this group about 50% were graded Hunt and Hess 3–5.
The distribution, size and location of the aneurysms did not differ from surgical series. The early complications (13%) were classified into transient and permanent and include mostly thromboembolism (6.6%) and rupture (3.9%). All other problems (such as coil migration, dissection, early rebleeding, etc.) were rare. The permanent complication rate was 1.1 and 1.8% for morbidity and mortality, respectively. However, this can only be regarded as the periprocedural negative events and not as the overall clinical morbidity and mortality of the patients related to the SAH.
For thromboembolic complications the authors analyzed the relationship between the vascular territory involved and the localization of the aneurysm. Risk factors for thromboembolism were a prolongated work and the use of additional devices or techniques (remodeling; stents). This is an interesting point and supports the clinical experience, “simple is often more safe.” The more technically difficult the procedure, the more complications may occur.
The four cases of early rebleeding were discussed as well as the treatment of patients of higher age and of those with unruptured aneurysms, all with favorable results.
It would have been interesting to see if and how there was a learning curve over the years influencing the rate of periprocedural complications.
Compared to surgical series, the nature and course of the disease and the complications differ in this endovascular series as well as the management of the complications. Thromboembolism was the most frequent adverse event and was responsible for the majority of complications in the early phase; however, many of them were described as clinically asymptomatic or reversible. Even the perforation of the aneurysm during the procedure occurring in 21 cases was not associated with a high morbidity or mortality.
Overall, with regard to the clinical state (SAH and HH grade), the authors present a series with extremely low morbidity and mortality.
However, the results should be discussed critically because the authors present and discuss the periprocedural complications and not the clinical outcome.
The majority of the patients suffered from an SAH, and 278 were Hunt and Hess Grade 3–5. Analyzing the current literature, the outcome of these patients includes a much higher morbidity and mortality than the authors have described for their series. Data from the neurosurgical literature demonstrate that patients HH grade 3–5 have morbidity and mortality rates up to 50% (especially in HH grade 5) due to vasospasm and all known problems of an SAH.
To my experience, in a comatose patient HH grade 5, a thromboembolic complication cannot always be regarded as asymptomatic. Thus, it may be debatable to classify an adverse event as asymptomatic if the patient cannot be examined for the possible defect. Keeping this in mind, the complication rate might be higher than the authors have calculated. Therefore, the true complication rate may be higher than the given numbers and lower than the early rate of 13%.
To conclude, the paper demonstrates that the nature of negative events due to endovascular management differs significantly from those of surgical procedures and gives a good overview of the development of the method in a single center.
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Bradac, G.B., Bergui, M., Stura, G. et al. Periprocedural morbidity and mortality by endovascular treatment of cerebral aneurysms with GDC: a retrospective 12-year experience of a single center. Neurosurg Rev 30, 117–126 (2007). https://doi.org/10.1007/s10143-006-0059-z
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DOI: https://doi.org/10.1007/s10143-006-0059-z