Baseline Characteristics
The 95 aneurysm treatments took place in 87 patients (60 female, 69%) with 1–2 treated aneurysms per patient. Mean age of patients was 58.1 ± 11.7 years, ranging from 29 to 84 years. Of all 95 aneurysms, 61 (64%) were acutely ruptured, 3 (3%) were symptomatic but unruptured, and 31 (33%) were incidental.
Overall, 33 (35%) aneurysms were located at the anterior communicating artery; 27 (28%) at the internal carotid artery; 12 (13%) at the basilar artery (with 8 of these located at the top of the basilar artery); 11 (12%) at the A1 segment of the anterior cerebral artery (with 6 of these located close to the carotid-T); 4 (4%) at the middle cerebral artery; 3 (3%) at the anterior choroidal artery; 2 (2%) at the pericallosal artery; 1 (1%) at the vertebral artery; 1 (1%) at the posterior communicating artery and 1 (1%) at the posterior inferior cerebellar artery.
The average maximum aneurysm diameter was 6.8 ± 3.4 mm, ranging from 1.9 to 19.6 mm. Average neck diameter was 3.6 ± 1.5 mm, ranging from 1.3 to 9.2 mm. Average dome diameter was 5.5 ± 3.5 mm, ranging from 1.3 to 19.6 mm. Average neck-to-dome ratio was 0.7 ± 0.3, ranging from 0.2 to 1.5. Average parent vessel diameters were 2.5 ± 0.8 mm, ranging from 0.9 to 4.5 mm.
Procedural Characteristics
A Solitaire AB stent (Medtronic, Irvine, CA, USA) was used in 87/95 (92%) aneurysms, a Barrel stent (Medtronic) was used in 4 (4%) aneurysms, an Enterprise stent (Codman Neurovascular, Raynham, MA, USA) was used in 3 (3%) aneurysms, and a LEO stent (Balt, Montmorency, France) was used in 1 (1%) aneurysm. A stent was implanted permanently in 7 of 95 (7%) treatments.
In 3 of 95 procedures the stent was expanded over the aneurysm neck first, and the microcatheter for coil embolization was entered into the aneurysm through the mesh of the stent. In 92 of 95 procedures the microcatheter was placed in the aneurysm first before the stent was expanded (jailing technique). In 13 of these 92 procedures the interventionalist later decided to pull the microcatheter back and navigate through the mesh of the stent to a different compartment of the aneurysm for placement of additional coils. This was successful in 12 of 13 cases. In one case this proved difficult and the interventionalist decided against further attempts since acceptable coil embolization had already been achieved.
In 87 of 95 procedures the standard technique of CATS with 2 microcatheters was used. In 8 cases 3 microcatheters were used for double microcatheter embolization (n = 3), additional microcatheter remodeling of a branching vessel (n = 4), or double temporary stent remodeling (n = 1).
Ninety-two of 95 (97%) procedures were performed with platelet inhibition during the procedure, with 88 patients receiving intravenous (IV) tirofiban, 2 patients receiving IV ASA, and 2 patients being pretreated with dual platelet inhibition (ASA and clopidogrel). In 3 cases, the procedure was performed without platelet inhibition.
After the procedure, there was no further platelet inhibition after discharge in 47 cases; in 13 cases, ASA was prescribed for up to 2 weeks; in 27 cases, ASA was prescribed for a period between 4 weeks and 6 months; in 1 case, ASA was prescribed indefinitely; in 10 of the cases with prolonged ASA treatment, there was dual platelet inhibition with additional clopidogrel for a period of 4 weeks to 6 months. In the 7 patients, in whom the stent was implanted permanently, 6 received dual platelet inhibition for at least 3 months and indefinite ASA treatment. The remaining patient died during hospitalization.
Primary Outcome
Initial treatment success: 50 (53%) aneurysms were completely occluded (modified Raymond and Roy class I), 28 (29%) aneurysms had a residual neck (class II), 8 (8%) aneurysms had contrast filling within coil interstices (class IIIa), and 9 (9%) aneurysms showed residual perfusion at the neck and side (dog-ear) (class IIIb). Hence, adequate occlusion including aneurysms with complete occlusion and residual neck (classes I and II) was achieved in 82% (78/95). There was no significant correlation between initial occlusion rate and maximum aneurysm diameter (p = 0.73), aneurysm neck diameter (p = 0.44), dome-to-neck ratio (p = 0.69), and parent artery diameter (p = 0.40).
Follow-up at 6 months: follow-up imaging with magnetic resonance (MR) time-of-flight (TOF) angiography and/or digital subtraction angiography (DSA) after 6 months was available for 67/95 (71%) aneurysms. At 6 months, there was recurrence in 7/67 (10%) aneurysms, whereas the remaining 60 (90%) were stable or improving. In 1 of these 7 cases no need for secondary treatment was seen. In the other 6 cases additional endovascular procedures were performed to treat the aneurysm. There was a significant correlation between aneurysm neck diameter and the risk of recurrence at 6 months (p = 0.01). Risk of recurrence was not associated with initial aneurysm occlusion grade (p = 0.59). There was no significant correlation between recurrence and maximum aneurysm diameter (p = 0.37), neck-to-dome ratio (p = 0.57), and parent artery diameter (p = 0.94).
Follow-up at 12 months: follow-up imaging with MR TOF angiography and/or DSA after 12 months was available for 42/95 (44%) aneurysms. At 12 months, there was recurrence in 7/42 (17%) aneurysms (1 additional compared to after 6 months), whereas the remaining 35 (83%) were stable or improving. In 2 of these 7 cases no need for secondary treatment was seen. In the other 5 cases additional endovascular procedures were performed to treat the aneurysm. There was a significant correlation between aneurysm neck diameter and the risk of recurrence at 12 months (p = 0.04). Risk of recurrence was not associated with initial aneurysm occlusion grade (p = 0.41). There was no significant correlation between recurrence and maximum aneurysm diameter (p = 0.67), neck-to-dome ratio (p = 0.51), and parent artery diameter (p = 0.20).
Secondary Outcome
In 7/95 (7%) aneurysms, it was not possible to safely recover the stent due to impending coil migration into the parent artery. When retrieval of the stent was slowly initiated, the interventionalist observed some degree of outward movement of the coils and decided to fully reopen the stent. Hence, the overall success rate of stent recovery was 93%. These 7 treatments were thus finished as permanent stent-assisted coil embolization.
However, there were no instances of unsuccessful attempted stent retrieval due to a technical inability to retrieve the stent, particularly for those stents that are not electrolytically detached. Thus, the technical success rate of stent recovery was 100%.
There was a significant correlation between success of stent recovery and neck-to-dome ratio (p = 0.03) with larger neck-to-dome ratios favoring successful stent recovery. However, this result was not significant after correction for multiple testing. There was no significant correlation between success of stent-recovery and maximum aneurysm diameter (p = 0.76), aneurysm neck diameter (p = 0.30), and parent artery diameter (p = 0.98).
Periprocedural complications occurred in 12/95 (12.6%) procedures:
Periinterventional bleeding from the aneurysm occurred in 3 cases: In all cases embolization was started under IV tirofiban treatment. Bleeding was caused by perforation of the aneurysm during placement of the first, second, and third coil, respectively. In all cases, the bleeding ceased quickly when coil embolization was continued. Precisely, bleeding ceased when the perforating coil was fully placed, or after placing one or two additional coils, respectively. Notably, all three periinterventional bleedings occurred in acutely ruptured aneurysms. On the other hand, no periinterventional bleedings occurred in elective cases. This corresponds to a periinterventional bleeding rate of 4.9% in acutely ruptured aneurysms and 0% in elective cases. To the best of our knowledge, no additional morbidity was caused by the three periinterventional bleedings.
Thromboembolic complications occurred in 3 cases: in two cases, small peripheral thromboembolic vessel occlusions were noted during angiography. In one of these two cases, a small infarction in the parietal region of the middle cerebral artery territory was observed. In the second of these two cases no territorial infarction was found on MR imaging after 24 h. In the remaining third case, peripheral thromboembolic infarctions were observed on follow-up MR imaging. However, this case was inconclusive because the patient suffered from bihemispheric lesions and atrial fibrillation, which may as well have been the source of infarction. All of these three cases were performed with the patient under periinterventional platelet inhibition with IV tirofiban. No specific morbidity could be attributed to the three thromboembolic complications.
Local thrombus formation occurred in 4 cases:
In one case, during embolization of a hemorrhagic giant aneurysm of the internal carotid artery under IV tirofiban treatment an occlusion of the stent was observed. This happened when the aneurysm was already almost completely filled with coils but the interventionalist had decided to reinsert the microcatheter to reach a different part of the aneurysm. Probably, thrombus which had formed between coil loops was pushed back into the parent vessel during this maneuver. The thrombus was successfully removed by partial closure and retrieval of the stent but at this point subarachnoid hemorrhage from the aneurysm neck was noted. The most probable explanation for this was that the microwire, which had been used to reinsert the microcatheter into the aneurysm, had perforated the vessel wall unnoticed. Lastly, it was necessary to occlude the internal carotid artery through coil embolization to stop the hemorrhage. There was cross flow from the contralateral hemisphere but the patient suffered a partial middle cerebral artery infarction resulting in left-sided hemiparesis.
In another case, there was thrombus formation from the aneurysm neck into the parent artery after removal of the microcatheters; the thrombus was dissolved by intra-arterial administration of 45 mg rtPA. No peripheral infarction or resulting morbidity was observed. In another case, there was thrombus formation in the parent artery after removing a stretched coil, which was dissolved by intra-arterial administration of 42 mg of rtPA. No peripheral infarction or resulting morbidity was observed. In the last case, thrombus formation in the parent artery was observed after removal of the microcatheters. Since the thrombus led to occlusion of the artery, thrombectomy was performed successfully using a stent-retriever. During this maneuver one of the coils in the aneurysm became entangled with the stent-retriever but could be removed together with the thrombus without further problems. No peripheral infarction or resulting morbidity was observed. All of these four cases were performed with the patient under periinterventional platelet inhibition with IV tirofiban.
Notably, two of the three thromboembolic complications and all four cases of local thrombus formation occurred in acutely ruptured aneurysms, whereas in elective cases only one thromboembolic complication was observed.
There was displacement of a coil during removal of the stent in one case of an acutely ruptured aneurysm. The coil was removed without complications using the temporary stent (Solitaire AB) for extraction as described previously [
15].
A minor dissection of the cervical part of the internal carotid artery without need for specific treatment and without associated morbidity occurred in 1 case of an acutely ruptured aneurysm.
In total, 11 of the 12 complications occurred in acutely ruptured aneurysms. Only 1 complication occurred in the elective cases. Only 1 of the 12 complications resulted in neurological damage, to the best of our knowledge the other 11 complications were asymptomatic.
Statistical analysis showed that the complication rate was significantly higher in acutely ruptured cases than in elective cases (p = 0.02). However, this result was not significant after correction for multiple testing. There was no significant correlation between the risk of periprocedural complication and aneurysm diameter (p = 0.27), aneurysm neck diameter (p = 0.51), neck-to-dome ratio (p = 0.25), and parent artery diameter (p = 0.51).
Neurological outcome at discharge was as follows: mRS = 0, n = 42; mRS = 1, n = 12; mRS = 2, n = 8; mRS = 3, n = 8; mRS = 4, n = 4; mRS = 5, n = 7; mRS = 6, n = 16. Thus, in our cohort at discharge temporary neurological morbidity (mRS = 3–5) was 19/97 (19.6%), and mortality was 16/97 (16.5%). Neurological outcome at 6 months was as follows: mRS = 0, n = 48; mRS = 1, n = 11; mRS = 2, n = 7; mRS = 3, n = 8; mRS = 4, n = 4; mRS = 5, n = 3; mRS = 6, n = 16. Thus, in our cohort at 6 months neurological morbidity (mRS = 3–5) was 15/97 (15.5%), and mortality was 16/97 (16.5%).