Clinical Neurology and Neurosurgery 138 (2015) 151–156
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Evaluation of a clip-reinforced wrapping technique with collagen-impregnated Dacron for intracranial aneurysms inaccessible to other treatment M. Di Santo a , G. Vaz a , M.-A. Doquier b , C. Raftopoulos a,∗ a b
Department of Neurosurgery, University Hospital St-Luc, Université catholique de Louvain, Avenue Hippocrate 10, 1200 Brussels, Belgium Department of Neuroanesthesia, UCL, University Hospital St-Luc, Université catholique de Louvain, Avenue Hippocrate 10, 1200 Brussels, Belgium
a r t i c l e
i n f o
Article history: Received 19 February 2015 Received in revised form 8 June 2015 Accepted 5 July 2015 Available online 28 August 2015 Keywords: Intracranial aneurysms Treatment Wrapping Clip-reinforced wrapping Collagen-impregnated Dacron fabric Surgical clipping
a b s t r a c t Objective: To describe our clip-reinforced wrapping technique (CRW) with collagen-impregnated Dacron and report our experience in intracranial aneurysms (IA) untreatable by coil embolization (CE) or surgical clipping (SC). Methods: Between July 2003 and November 2010, CRW was performed on 20 IAs in 18 patients using a collagen-impregnated Dacron fabric (Hemashield® , USA) fixed with a clip around the parent vessel and the IA. Results: Two patients (11%) died of complications from their subarachnoid hemorrhage and preexisting conditions. In the remaining 16 patients, after an average follow-up of 45 months (min: 27, max: 77), 16 (89%) out of the 18 treated aneurysms were no longer visible and two were reduced and stable. Conclusion: Our preliminary results suggest that CRW with Hemashield could be an accurate and safe alternative technique for some IA without any other treatment option. Implications: Description of an alternative surgical technique for otherwise untreatable intracranial aneurysms. © 2015 Elsevier B.V. All rights reserved.
1. Introduction Coil embolization (CE) or surgical clipping (SC) are considered to be the most effective treatments for intracranial aneurysms (IAs), However, some IAs do not have the ideal characteristics to permit successful management using one of these two procedures, in particular when the aneurysm’s neck is larger than the sac [1]. There are many procedures that use both SC and wrapping. The clip-reinforced wrapping technique (CRW) and the way in which the clip is placed vary according to the surgical team performing the procedure. Furthermore, various wrapping materials are used, including muscle [2–7], muslin [1–4,8,9], Gore-Tex [1,8], polytetrafluoroethylene (PTFE) [10], silastic sheet [11], cotton [8,12] and, more recently, collagen-impregnated Dacron [13,14] (Hemashield® , Boston Scientific Co, Oakland, NJ, USA). In July 2003, our group implemented a CRW with collagen-impregnated Dacron to treat small aneurysms for which SC alone or CE was
∗ Corresponding author. E-mail addresses:
[email protected] (M. Di Santo),
[email protected] (G. Vaz),
[email protected] (C. Raftopoulos). http://dx.doi.org/10.1016/j.clineuro.2015.07.005 0303-8467/© 2015 Elsevier B.V. All rights reserved.
considered inappropriate. The purpose of this article is to describe our technique and to report our preliminary results. 2. Materials and methods 2.1. Patient population Between July 2003 and November 2010, CRW was performed on 20 IAs in 18 patients (two patients had two aneurysms). The female/male ratio was 2.6 (13 females and 5 males) and the average age was 45 years (range 19–72 yr). Three aneurysms were ruptured (RIA), two out of three were considered by our pluridisciplinary group not suitable for an endovascular procedure; they were, therefore, treated surgically. The other RIA was associated with an acute compressive subdural hematoma that required surgery and the aneurysm was treated during the same operation. The 17 others were unruptured (UIAs). Before management, there is a discussion with the patient (and/or his/her family). The possible strategies, including the one considered most suitable and, when appropriate, the option of observation with an annual 3D computed tomography angiography (CTA), are explained. Two out of the 17 UIAs were considered as needing a surgical approach by our pluridisciplinary group and were treated
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Table 1 Summary of 20 intracranial aneurysms treated by clip-reinforced wrapping technique in eighteen patients. An No.
Morphology characteristics
DSA
GOS
Age
Sex
Group
Mode of discovery
WFNS
Fisher
K
Location, Side
Shape
Greatest diameter
Pre operation
At discharge
At ≥2 months
Last angiographic control Months
Mode
Results
66 39 24 44 44 44 29 49 72 48 62 62 25 72 27 19 26 64 53 51 45 (19–72)
F M F M M M F F F F F F F M F F M F F F
RIA UIA UIA UIA UIA UIA UIA UIA UIA UIA UIA UIA UIA RIA RIA UIA UIA UIA UIA UIA
SAH Mo H/A Mo Perop (3) Mo Fam An FP SAHd Mo H/A Perop (5) H/A SAH SAH H/A Perop (1)h SAHi Diplopia Perop (4)
1 – – – – – – – 4 – – – – 5 1 – – 1 – –
3 – – – – – – – 3 – – – – 3 2 – – 3 – –
80 100 90 90 90 90 100 90 80 90 90 90 90 10 10 90 90 90 90 100
PCoA, R PCoA (Inf), L MCA, R MCA, L MCA, L MCA, R MCA, R Pcl (Opht), R A2, R A1, L PCoA, R MCA, R MCA, R MCA, L ICA–Bi, L MCA, L PCA (P1), R PCoA, L PCoA, R MCA, L
Sa Se Sa Fu Sa RPV Se Sa Sa Se Inf Se RPV Fu Se Se Se Inf Sa Se
3 1.5 3.5 5b 2 2 2 3 1 2 2.5 1 4 5b 2 3 2 3.5 2.5 2 2.6 (1–5)
V V V V NV V V V NV V V NV V V V V NV V V NV
4 5 5 5 5 5 5 5 4 5 5 5 5 1f 1g 5 5 5 5 5
5 5 5 5 5 5 5 5 4 5 5 5 5 – – 5 5 5 5 5
66 77 27 47 47 46 40 49 54 48 35 35 48 – – 38 36 36 31 38 45 (27–77)
CT CT CT CT CT DSA CT MR CT CT CT CT CT – – CT MR CT CT CT
NVR NVR NVR NVR NVR NVR NVR NVR NVR NVR SR NVR NVR – – NVR NVR SR NVR NVR
An no., aneurysm number; DSA, digital subtraction angiography; GOS, Glasgow Outcome Scale; WFNS (score), world federation of neurological surgeons’ score; K, karnofsky (pre-operation); a , same patient with 2 aneurysms; F, female; RIA, ruptured intracranial aneurysm; SAH, subarachnoid hemorrhage; PCoA, posterior communicating artery; R, right; Sa, saccular; V, visible aneurysm; CT, computed tomography angiography; NVR, no visible residue; M, male; UIA, unruptured intracranial aneurysm; Mo, monitoring post operation of another aneurysm; I, incidental; Inf, infundibulum; L, left; Se, sessile; H/A, headache; MCA, middle cerebral artery; b , fusiform aneurysm without neck, and all the artery area is diseased; Perop, UIA discovered during surgery of another aneurysm (multiple aneurysms), Fu, fusiform; c , GOS at discharge = 4 because of SAH; RPV, residue on parent vessel; Fam An, familial aneurysm; FP, facial palsy; Pcl (opht), paraclinoid (ophthalmic artery); MR, magnetic resonance angiography; d , UIA discovered during surgery of a RIA with SAH; A2, Heubner artery; A1, proximal part of A1 (ACA); e , same patient with 2 aneurysms; SR, stable residue; † , death; f , peroperative heart failure, no surgical incident, immediate postoperative: multiple organ failure and patient with acute subdural hematoma; ICA-Bi, internal carotid artery bifurcation; g , immediate postoperative: GCS 15/15, deterioration 36 h later in relation with diffuse severe vasospasm; PCA (P1), posterior cerebral artery; h , Aneurysm discovered during surgery for epilepsy; i , UIA discovered before surgery of another RIA with SAH; Avg, average.
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1 2 3 4a 5a 6 7 8 9c 10 11e 12e 13 14† 15† 16 17 18 19 20 Avg (min–max)
Clinic characteristics
M. Di Santo et al. / Clinical Neurology and Neurosurgery 138 (2015) 151–156
accordingly. One was a polylobed UIA measuring 8 mm with a neck of 6 mm. During the surgery, the parent vessel wall appeared weak and fragile with a small aneurysm residue between the clip and the parent vessel. Replacement of the clip was deemed too risky and the senior surgeon preferred to perform an additional CRW. Two UIAs (Table 1; patients 3, 16) were initially observed and the aneurysms increased in size. One of these two patients was taking anticoagulant drugs because of a history of ischemic stroke. A surgical procedure was recommended for both. Two other UIAs (Table 1; patients 7, 19) were present in patients with medically refractory anxiety and their quality of life was significantly impaired. One of them had a mother who had died from a ruptured aneurysm. Although we recommended observation with an annual 3D-CTA, they asked for treatment, which was performed with the green light of their family doctors. Five UIAs (Table 1; patients 2, 6, 8, 10, 18) were treated during a surgical procedure initiated for another larger or ruptured IA considered to require a surgical approach by our group. Four UIAs (Table 1; patients No. 5, 9, 12, 20) were not visible on the preoperative DSA and were discovered during surgery for another surgical aneurysm and were treated in the same procedure. And finally, patient 17 suffered from a refractory epilepsy with mental retardation. His UIA (a small bleb on a parent vessel also weak and fragile in parts) was discovered during surgery for his epilepsy and treated in the same procedure. It is important to note that between 2003 and 2010, several advanced endovascular techniques, such as the pipeline embolization devices (PED), were not yet approved by FDA.
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refused to have a new DSA because of the invasiveness of the procedure. 3. Results 3.1. Clinical outcomes Data are summarized in Table 1. The average follow-up period was 45 months (range 27–77 months). Five patients experienced transient postoperative symptoms. One (No. 8) of these patients experienced two complications. It was a patient with a paraclinoid ophthalmic artery UIA, who had a partial third cranial nerve palsy and a mild transient confusional state. For the other patients, one (No. 16) had a sudden headache with blurred vision, one (No. 17) had a cerebrospinal fluid leak. Patient No. 3 had a mild transient confusional state, and the last one (No. 11) with several cardiovascular risks factors and multiple UIA treated during the same surgery, had a mild left hemiparesis. All these five patients recovered their preoperative neurological status during the follow-up period. Postoperatively, two patients (No. 1 and 9) had a GOS of 4 at discharge because of their previous SAH. One out of these two patients (No. 1) fully recovered during the follow-up period. Two patients (No. 14 and 15) died from clinical complications not related to the surgery but to the severity of the SAH: the first died of multiple organ failure postoperatively; the second died from diffuse severe vasospasm associated with a Tako-Tsubo syndrome.
2.2. Size of aneurysms
3.2. Wrapped IAs characteristics and location
Aneurysms were measured using 3D imaging with automatic calibration. The largest diameter of the aneurysm was first measured. Then, a second measurement was taken in the orthogonal axis at 90◦ perpendicularly to the initial diameter. The other aneurysms, discovered during surgery, were measured visually during the operation with the Pentero of Zeiss microscope. A sterile millimetric paper was cut and placed on and beside the aneurysm.
All of clip-wrapped aneurysms (except No. 4 and 14, Table 1) were small and broad-based. The largest diameter measured before surgery was less than 5 mm and the average size was 2.6 mm (range, 1–5 mm). Five categories of IA were observed: fusiform, infundibular, sessile, residue on diseased parent vessel, and small saccular (Table 1). The prevalence of sessile, small saccular and infundibular IAs was 40%, 30% and 10%, respectively. Fusiform IAs (10%) with the largest axis equal to 5 mm (cases No. 4 and 14, Table 1), were located on a diseased arterial segment. In two cases (Table 1, No. 6 and 13), UIAs were at first clipped but because of a residue on a diseased parent vessel (10%), we performed an additional CRW. All IAs were situated on the anterior circulation, with a predominance (50%) of middle cerebral artery aneurysms, except one, which was located on the posterior cerebral artery.
2.3. Operative technique All patients were operated on under mild hypothermia (33 ◦ C) and burst suppression for brain protection. The wrapping of all IA of our group (Fig. 1, A) was performed with a strip of collagenimpregnated Dacron (Hemashield Finesse® ) placed around the parent vessel and the aneurysm (Fig. 1B and C) and held in place (Fig. 1D and E) with a clip (Peter Lazic GMBH Aneurysm-Clip Systems® ). The aim was to apply enough pressure to occlude the aneurysm without stenosing the parent vessel (Fig. 1E). 2.4. Neurological status and follow-up Neurological status was evaluated in the pre-operative period and at regular intervals in the post-operative period (immediate post-operative period, at discharge, at three, 12 months after surgery, and regularly thereafter), using the Glasgow Outcome Scale (GOS).
3.3. Aneurysm occlusion results with CRW At the time of the last control, 16 (89%) out of 18 IAs were no longer visible and 2 (11%), which were infundibular type, were reduced and stable (No. 11 and 18, Table 1). The two infundibular residues were already visible at the postoperative control at 1 month, and showed no further change in size or shape in the last control, performed respectively at 35 and 36 months after surgery. None of the clip-wrapped aneurysms increased in size and there were no new hemorrhages after the treatment. 4. Discussion
2.5. Radiological follow-up of treated aneurysms The follow-up control of treated aneurysms was performed in 13 patients with 3D-CTA. A 3D magnetic resonance angiography (MRA) was used on two patients with iodine allergy. Only one patient agreed to control with digital substraction angiography (DSA) because the control was performed during the endovascular management of another aneurysm (Fig. 2). The other patients
Despite advances in microsurgical techniques and endovascular treatments, a small number of IAs remain in which SC and CE cannot be used safely. In order to treat IAs that are not amenable to only clipping, neurosurgeons have tried to reinforce the aneurysm walls with various materials. This approach uses these materials either for simple wrapping or with a clip to reinforce the wrapping around the aneurysm and the parent vessel.
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Fig. 1. Anatomic dissection of the left MCA in the last patient of our series showing the CRW technique on an M1 early temporal branch aneurysm. (A) Small aneurysm located on the M1 segment of the MCA. Another early temporal branch aneurysm treated by clipping is visible more distally on the M1 segment. (B) First part of the CRW technique: a strip of collagen-impregnated Dacron (Hemashield® ) is carefully placed around the M1 segment at the level of the small ICA. (C) Second part of surgery: the wrapping material squeezes the aneurysm and is held in place by an anatomical forceps before clipping. (D) ICA wrapped with Hemashield® and reinforced by a clip. (E) A schematic drawing illustrates the result of the CRW technique. MCA, middle cerebral artery; CRW, Clipped reinforced wrapping; M1, M1 segment of MCA; *, early temporal branch MCA aneurysm clipped; ETB, early temporal branch; SA, small aneurysm, Bif., MCA bifurcation; M2, M2 segment of MCA; ICA, intracranial aneurysm; Hem., Hemashield® ; Asp., aspirator; f., anatomical forceps; Diss., dissector.
M. Di Santo et al. / Clinical Neurology and Neurosurgery 138 (2015) 151–156
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Fig. 2. Digital subtraction angiographies (DSA, patient of Fig. 1) of a left internal carotid artery. (A) Presurgical image showing an unruptured saccular aneurysm located on a distal early temporal branch of the left MCA. (B) Postoperative image demonstrating two clips, one for the distal ETB aneurysm (preoperatively identified) and the other more proximal for maintaining the wrapping applied on a intraoperatively identified more proximal 2 mm aneurysm. ACA, Anterior cerebral artery; M1, proximal segment of MCA; Bif., MCA bifurcation; *, preoperatively identified saccular aneurysm treated by clipping; ETB, early temporal branch (distal) of MCA; ICA, internal carotid artery; CRW, clip-reinforced wrapping.
Collagen-impregnated Dacron fabric [13,14] (Hemashield® ) was used for the first time in the 1980s, for cardiovascular surgery [15,16]. Nakano et al. [13] introduced its use in neurosurgery to treat aneurysms with a CRW in 2000. These authors described interesting features of this material: stable for years in a highpressure circulatory system, pliable enough for wrapping, and leak-proof [15,16]. Moreover, its porosity allows tissue penetration into the graft while the collagen impregnation renders the graft impervious to blood. In their study, as in ours, no significant problems associated with the use of this material were reported. Kubo et al. [10] also noted that Dacron was flexible enough to allow insertion between the small arteries around the aneurysm and is easily tailored with scissors, observations that we also made in our series. This material seems to be safe without apparent contraindications. The CRW technique was first described by Kempe [17]. Bederson et al. [1] and Fujitsu et al. [11] and presented a modification of the traditional wrapping technique. These authors reported satisfactory results in all patients after 1 and 3 years follow-up. The Fujitsu et al. [11] technique is quite similar to ours, except that they clip the dome of the aneurysm instead of squeezing it. In 2000, Nakano et al. [13] published the first series of patients treated with CRW and Hemashield. In their study, out of seven patients, only three patients were treated with a similar CRW to ours. The other aneurysms were wrapped and clipped at their base between the two ends of the Hemashield® sheet. There were no deaths and no complications. The follow-up period ranged between 6 months and 2 years. Out of the three patients, the postoperative angiography of one patient saw that the dome of the aneurysm was well compressed. The authors stressed the importance of the wrapping material. The major characteristics that they suggested were that the wrapping material should be strong enough to ensure reinforcement; should be safe, resistant, and durable; and that it must prevent slippage of the clip. Our study is the largest series in literature of patients treated with CRW using collagen-impregnated Dacron (Hemashield® ). A majority of patients had saccular or sessile aneurysms that were too small or fragile for CE or direct SC. Some fusiform and infundibular IAs were also treated. In our series, there was no atherosclerotic IAs, another IAs type, potentially suitable for CRW, according to some authors [1,3,6,11]. This technique allows a uniform distribution of forces around the IA and, in our series, was never associated, after a
follow-up ranging from 27 to 77 months, with aneurysm regrowth, inflammatory reaction (granuloma, . . .) or development of stenosis. However, according to our point of view, one limitation is that its efficiency could depend on the neurosurgeon’s experience to obtain wrapping that is just tight enough to avoid stenosing the parent vessel. 5. Conclusions Our preliminary results suggest that CRW technique with collagen-impregnated Dacron could be an accurate and safe alternative for some aneurysms without any other treatment option. Our study has however some limitations: it is a retrospective study (with the risk of selection bias), the duration of follow up is relatively short (mean, 45 months), search for small residual aneurysm was performed using 3D CTA and not DSA (the gold standard technique). The risk/benefice ratio of CRW technique with collagen-impregnated Dacron seems favorable but has to be further evaluated and compared to conservative treatment by prospective studies with a long period of follow up. Conflict of interest None. References [1] J.B. Bederson, J.M. Zabramski, R.F. Spetzler, Treatment of fusiform intracranial aneurysms by circumferential wrapping with clip reinforcement, J. Neurosurg. 77 (1992) 478–480. [2] N.M. Dott, Intracranial aneurysms: cerebral arterio-radiography: surgical treatment, Edinb. Med. J. 40 (1933) 219–234. [3] C.G. Drake, R.G. Vanderlinden, The late consequences of incomplete surgical treatment of cerebral aneurysms, J. Neurosurg. 27 (1967) 226–238. [4] L.A. Mount, J.L. Antunes, Results of treatment of intracranial aneurysms by wrapping and coating, J. Neurosurg. 42 (1975) 189–193. [5] K. Sato, S. Fujiwara, M. Kameyama, A. Ogawa, T. Yoshimoto, J. Suzuki, Follow-up study on ruptured aneurysms treated by wrapping, Neurol. Med. Chir. (Tokyo) 30 (1990) 734–737. [6] H.S. Shin, T.H. Kim, Y.S. Hwang, S.K. Park, Circumferential wrapping and clipping with temporalis fascia for treatment of unclippable intracranial aneurysms, Yonsei Med J. 44 (2) (2003) 210–214. [7] S.J. Suh, S.C. Kim, D.G. Kang, K.Y. Ryu, H.G. Lee, J.H. Cho, Clinical and angiographic results after treatment with combined clipping and wrapping technique for intracranial aneurysm, J. Korean Neurosurg. Soc. 44 (4) (2008) 190–195.
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