球囊扩张支撑架：并发症7-26%
SSYLVIA（Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intercranial Arteries）【1】: (Stroke: 2004) : 裸金属球扩支架多中心非随机对照研究。 N=61例
• 技术成功率: 95%; 30天围手术卒中率 7.2%; 无死亡病例（no death）；治疗一侧年卒中率10.9%。复发性狭窄：35%
意义： 初期结果证明支架安全，围手术中风和死亡率与CEA相似；狭窄度70%~99%的患者，支架后年卒中率＜WASID 实验中的药物治疗的卒中发生率。
SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004 Jun;35(6):1388-92. Epub 2004 Apr 22.
BACKGROUND AND PURPOSE:
Stroke rates in patients with symptomatic intracranial stenosis may be as high as 10% to 24% per year on medical therapy. This multicenter, nonrandomized, prospective feasibility study evaluated the NEUROLINK System for treatment of vertebral or intracranial artery stenosis.
METHODS:
Patients were 18 to 80 years old with symptoms attributed to a single target lesion of > or =50% stenosis. Patients received 5 neurological examinations before and in the year after the procedure, and another angiogram at 6 months.
RESULTS:
In 61 patients enrolled, 43 (70.5%) intracranial arteries (15 internal carotid, 5 middle cerebral, 1 posterior cerebral, 17 basilar, 5 vertebral) and 18 (29.5%) extracranial vertebral arteries (6 ostia, 12 proximal to the posterior inferior cerebellar artery [PICA]) were treated. In the first 30 days, 4 patients (6.6%) had strokes and no deaths occurred. Successful stent placement was achieved in 58/61 cases (95%). At 6 months, stenosis of >50% occurred in 12/37 (32.4%) intracranial arteries and 6/14 (42.9%) extracranial vertebrals, 4 in the vertebral ostia. Seven (39%) recurrent stenoses were symptomatic. Four of 55 patients (7.3%) had strokes later than 30 days, 1 of which was in the only patient not stented.
CONCLUSIONS:
The NEUROLINK System is associated with a high rate of successful stent deployment. Strokes occurred in 6.6% of patients within 30 days and in 7.3% between 30 days and 1 year. Although restenoses occurred in 35% of patients, 61% were asymptomatic. Further trials involving the NEUROLINK System are warranted.
Lylyk (Neurol Res 2005)【2】: N=106. 技术成功率: 98%. 30天围手术中风: 5.7%; 死亡率: 3.7%
Lylyk P, Vila JF, Miranda C, Ferrario A, Musacchio A, Rüfenacht D, Cohen JE.Endovascular reconstruction by means of stent placement in symptomatic intracranial atherosclerotic stenosis.Neurol Res. 2005;27 Suppl 1:S84-8.
OBJECTIVE:
Patients with intracranial atherosclerosis who fail antithrombotic therapy have a poor prognosis. The high rate of recurrent stroke warrants testing alternative treatments such as intracranial angioplasty.
METHODS:
We present our experience in the treatment of 104 patients (age range, 54-82 years; mean age, 67 years) with symptomatic intracranial atherosclerotic stenoses despite medical therapy who underwent stent-assisted angioplasty. Patient records were retrospectively analysed for location and degree of stenosis, regimen of antiplatelet agents, devices used, procedure-related complications and adverse events. Clinical (Modified Rankin Scale) and radiographic outcomes were obtained 24 hours, 1 month and 3-6 months after treatment. Sixty-five lesions (62.5%) were located in the posterior circulation. Mean stenosis was 75.4%.
RESULTS:
In all patients, the angiographic degree of stenosis was reduced to less than 30%. One stent was implanted in 66 patients (63%), and two or more in 38 patients (37%). Modified Rankin Scale (mR) was 1-2 in 67.5% of the cases, 3-4 in 25.9%, 5 in 2.8%, 6 in 3.8%. Procedural morbidity was 5.7% and procedural mortality was 3.8%. Angiographic follow-up was available in 58 patients (55.7%) and the restenosis rate was 12.5%.
DISCUSSION:
In selected patients, endovascular revascularization of intracranial arteries by means of stent-assisted angioplasty is technically feasible, effective and safe.
Chow (Ajnr 2005)【3】:
In symptomatic VB；insufficiency BES: 23% Cx
Chow MM, Masaryk TJ, Woo HH, Mayberg MR, Rasmussen PA. Stent-assisted angioplasty of intracranial vertebrobasilar atherosclerosis: midterm analysis of clinical and radiologic predictors of neurological morbidity and mortality. AJNR Am J Neuroradiol. 2005 Apr;26(4):869-74.
BACKGROUND AND PURPOSE:
Initial reports of stent-assisted angioplasty for intracranial vertebrobasilar atherosclerosis suggest this is a feasible treatment, but there have been little data regarding predictors of success or failure. We analyzed a series of patients for independent predictors of neurologic morbidity and mortality.
METHODS:
Patient charts and angiograms from 39 patients who underwent intracranial angioplasty and stent placement of vertebrobasilar stenoses were retrospectively reviewed to obtain clinical and detailed angiographic data on potential predictors of neurologic morbidity and mortality. Univariate analyses of these predictors were performed with either Fisher's exact test or simple logistic regression. Multivariate analysis was subsequently performed on the statistically significant predictors.
RESULTS:
Complete clinical data were obtained for 39 patients, and angiographic review was possible for 35 of them. Angiography revealed severe intracranial vertebral (n = 18), basilar (n = 15), or basilar and vertebral (n = 2) stenoses. Two patients (5.1%) died in the periprocedural period, nine patients (23.1%) had neurologic complications, and one patient (2.6%) had transient neurologic symptoms. Univariate analysis revealed female sex, diabetes, and failure of coumadin or heparin therapy were associated with neurologic morbidity, whereas female sex, Mori B lesion, and length-to-stenosis ratio were associated with mortality. The presence of diabetes was the only independent predictor of neurologic morbidity and mortality.
CONCLUSION:
Because of the limited number of patients available for analysis, the only independent predictor of neurologic morbidity and mortality was diabetes, but several other predictors showed trends that deserve further review in future series.
Jiang WJ (Neurology 2006; 66 (12):【4】
N=169 pts 症状性颈内动脉支架 symp ic stenting: perforating br stroke 3% (8.2% in pts w preop infarct vs 0.8% w/o infarct Jiang WJ, Srivastava T, Gao F, Du B, Dong KH, Xu XT. Perforator stroke after elective stenting of symptomatic intracranial stenosis. Neurology. 2006 Jun 27;66(12):1868-72.
OBJECTIVE:
To study the frequency, clinical course, and functional outcome of perforator stroke (PS) resulting from elective stenting of symptomatic intracranial stenosis.
METHODS:
Between September 2001 and November 2004, 169 consecutive patients with 181 symptomatic intracranial stenoses underwent stenting procedure at our institute. The preoperative perforator infarct adjacent to the stenotic segment (PIAS) on MRI was evaluated blindly. Patients who developed PS after stenting were enrolled. Each patient was assessed by an experienced stroke neurologist by neurologic examination and NIH Stroke Scale score every day until discharge and at day 30, and by modified Rankin Scale (mRS) score at the end of the first, third, and sixth month, and then at intervals of 6 months.
RESULTS:
PS frequency was 3.0% (5/169 patients). The patients with preoperative PIAS had a higher frequency of PS and PS exacerbation, resulting from intracranial stenting (8.2%, 4/49), vs patients without preoperative PIAS (0.8%, 1/120; p = 0.031). Four PSs occurred during the procedure and one 10 hours after stenting. Four PSs reached the maximum deficit almost at once, and one after 2 hours from onset. All five patients were functionally independent (mRS <or= 1) within 12 months.
CONCLUSION:
Patients with preoperative perforator infarct adjacent to the stenotic segment have a higher perforator stroke frequency after elective stenting of intracranial stenosis. Most perforator strokes occur during the procedure and reach the maximum deficit almost immediately. Functional outcomes are relatively good.
Fiorella (Neurosurgery 2007): 44 pts 47 lesions in symp.ic VB【5】
技术成功率 success rate: 96%; periproc tech
并发症和死亡 morbidity & mortality: 26%
再狭窄 restenosis: 12.5%
Fiorella D, Chow MM, Anderson M, Woo H, Rasmussen PA, Masaryk TJ. A 7-year experience with balloon-mounted coronary stents for the treatment of symptomatic vertebrobasilar intracranial atheromatous disease.Neurosurgery. 2007 Aug;61(2):236-42; discussion 242-3.
OBJECTIVE:
Balloon-mounted coronary stents (BMCS) have been adapted for use in the intracranial circulation for the treatment of symptomatic intracranial atheromatous disease (ICAD). We performed a retrospective analysis of our 7-year experience with these devices in an attempt to quantify the periprocedural risks and long-term outcomes in patients with symptomatic ICAD of the vertebrobasilar (VB) system treated with BMCS.
METHODS:
A retrospective review of a prospectively maintained database was performed to determine the neurological and non-neurological periprocedural risks of BMCS treatment of ICAD. Patients were followed with serial transcranial Doppler (TCD) and, in some cases, angiographic imaging. The clinical status was determined based on clinic visits and by telephone interviews when possible.
RESULTS:
Over the 6-year period from March 1999 to May 2005, 44 patients (35 men, 9 women; average age, 64.8 yr) with 47 symptomatic atheromatous lesions of the VB system were treated with BMCS.
In two patients, the BMSC could not be delivered across the target lesion. Treatment of the remaining 45 lesions was technically successful (95.7%). The periprocedural neurological morbidity and mortality was 26.1% (10 clinically evident strokes, 2 deaths). One additional patient experienced a periprocedural transient ischemic attack (TIA). Two patients died of non-neurological causes within 6 months (4.3%, myocardial infarction and cholecystitis). The average stenosis measured 82.5%, declining to 10.0% stenosis after BMCS. TCD examinations showed a preprocedural velocity of 127.7 cm/second (n = 43; standard deviation, 63.7 cm/s), which declined to 54.0 cm/s immediately after the procedure (n = 42; standard deviation, 22.7 cm/s). In patients with serial TCD evaluations, velocities were typically constant over years of follow-up (six patients with >5 yr of follow-up; average velocity, 52.2 cm/s). Angiographic follow-up was available for 11 patients. Three patients had stent occlusion (all symptomatic with TIAs), one patient had greater than 50% in-stent restenosis (ISR) (symptomatic with TIA) and seven had no significant (<50%) stenosis. The overall ISR/occlusion rate was 12.5% (4 out of 32 lesions with angiographic and/or TCD follow-up > 6 mo). Of the 42 patients who successfully underwent BMCS, clinical follow-up was available for 33 (78.6%, average follow-up period, 43.5 mo), three patients died before any follow-up could be performed, and seven were lost to follow-up. Of the patients with follow-up, five had recurrent vertebrobasilar ischemic symptoms (15%; four TIA, one stroke). Four out of five patients with recurrent symptoms had ISR or occlusion verified on conventional angiography. At the time of the last follow-up examination, seven patients of 44 patients who underwent attempted treatment were dead (modified Rankin Scale [mRS] score, 6); four had an mRS score of 3 to 5, 16 had an mRS score of 1 or 2, and 10 had an mRS score of 0.
CONCLUSION:
Percutaneous transluminal angioplasty and stenting using BMCS for the treatment of symptomatic VB ICAD can be carried out with high rates of technical success and excellent immediate angiographic results. However, the procedure carries with it a very high rate of periprocedural morbidity and mortality. Greater than 50% ISR or stent occlusion occurred in 12.5% of the patients and was associated with recurrent TIAs. In the absence of ISR/occlusion, patients who tolerated the initial procedure did well neurologically and did not typically experience recurrent ischemic symptoms.
Suh (AJNR 2008【6】: N=100 pts (%70+ stenosis);
技术成功率 success rate: 99%
并发症 Adverse event: 10%，包括3%的死亡率 (incl.3% mortality)
稳定病人 Stable pts: 4.1% vs 不稳定病人 unstable pts: 26%
结果好 Good outcome: 97% in stable and 67% in unstable pts
无再狭窄 No restenosis
AJNR Am J Neuroradiol. 2008 Apr;29(4):781-5.
Intracranial stenting of severe symptomatic intracranial stenosis: results of 100 consecutive patients.
Suh DC1, Kim JK, Choi JW, Choi BS, Pyun HW, Choi YJ, Kim MH, Yang HR, Ha HI, Kim SJ, Lee DH, Choi CG, Hahm KD, Kim JS.
BACKGROUND AND PURPOSE:
There are a few reports regarding the outcome evaluation of balloon-expandable intracranial stent placement (BEICS). The purpose of our study was to evaluate the outcome and factors related to the adverse events (AEs) of BEICS.
MATERIALS AND METHODS:
We evaluated 100 consecutive patients who underwent BEICS. We assessed the procedural success (residual stenosis < 50%), AEs (minor strokes, major strokes, and death), clinical outcome, and restenosis (> 50%) at 6 months. We also analyzed 18 factors including symptom patterns related to AE rate. Symptom patterns revealed 1) stable patients (n = 73) with improving, stationary, or resolved symptoms; and 2) unstable patients (n = 27) with gradual worsening or fluctuating symptoms (National Institutes of Health Stroke Scale [NIHSS] > or = 4) within 2 days before stent placement.
RESULTS:
The procedural success rate was 99%. Overall, there were 10 (10%) AEs within the 6 months: 4 (4%) minor strokes, 3 (3%) major strokes, and 3 (3%) deaths including a death from myocardial infarction. AE rate was 4.1% in stable and 25.9% in unstable patients. Restenosis at 6 months revealed 0% (0/59). Good outcome (modified Rankin Scale < or = 2) at 6 months was 97% (71/73) in stable and 67% (18/27) in unstable patients. Stepwise logistic regression model revealed that symptom pattern (unstable versus stable) was the only significant risk factor (OR, 8.167; 95% CI, 1.933-34.500; P = .004).
CONCLUSION:
BEICS revealed a low AE and good outcome rate at 6 months, especially in the stable patients. Midterm outcome was also favorable in the unstable patient group.
Fiorella et al: Stroke 2007; 38:881【7】
操作和早期术后结果 Procedural and early postopeartive results:
N=78 pts w 病变数82 lesions
技术成功率 Procedural success: 98.8%
治疗前平均狭窄 Average stenosis before tx: 74.6 %±13.9
治疗后狭窄 Stenosis after Tx : 27.2% ± 16.7
严重围手术并发症 6.1% major periprocedural Cx
死亡率 5% mortality
Levy et al: Neurosurgery 2007; 61:644【8】
In stent restenosis and thrombosis: ISR= vessel diameter>50% or postop diameter >20% stenosis N=78 pts 病变数=84 lesions (total 129 pts/ 137 lesions)
平均随访 Average F/U: 5.9 month
支架内狭窄 Instent restenosis: 29.7% (25 lesions)
支架内血栓 4 stent thrombosis (4.8%)
完全血栓 Complete thrombosis:
2=1+stent; 1 early plavix discontd; 1
ant cerebral art (<1.5mm)
most asymp. (24%: symp);15/29 retx (4 CX);
ANT: 42%; post: 13%
OBJECTIVE:
Wingspan (Boston Scientific, Fremont, CA) is a self-expanding stent designed specifically for the treatment of symptomatic intracranial atheromatous disease. The current series reports the observed incidence of in-stent restenosis (ISR) and thrombosis on angiographic follow-up.
METHODS:
A prospective, intent-to-treat registry of patients in whom the Wingspan stent system was used to treat symptomatic intracranial atheromatous disease was maintained at five participating institutions. Clinical and angiographic follow-up results were recorded. ISR was defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20%.
RESULTS:
To date, follow-up imaging (average duration, 5.9 mo; range, 1.5-15.5 mo) is available for 84 lesions treated with the Wingspan stent (78 patients). Follow-up examinations consisted of 65 conventional angiograms, 17 computed tomographic angiograms, and two magnetic resonance angiograms. Of these lesions with follow-up, ISR was documented in 25 and complete thrombosis in four. Two of the 4 patients with stent thrombosis had lengthy lesions requiring more than one stent to bridge the diseased segment. ISR was more frequent (odds ratio, 4.7; 95% confidence intervals, 1.4-15.5) within the anterior circulation (42%) than the posterior circulation (13%). Of the 29 patients with ISR or thrombosis, eight were symptomatic (four with stroke, four with transient ischemic attack) and 15 were retreated. Of the retreatments, four were complicated by clinically silent in-stent dissections, two of which required the placement of a second stent. One was complicated by a postprocedural reperfusion hemorrhage.
CONCLUSION:
The ISR rate with the Wingspan stent is higher in our series than previously reported, occurring in 29.7% of patients. ISR was more frequent within the anterior circulation than the posterior circulation. Although typically asymptomatic (76% of patients in our series), ISR can cause neurological symptoms and may require target vessel revascularization.
Young age: ISR 45.2% vs 24.2% （55 y threshold）【9】
• Ant: 50% > Post: 20%
supraclinoid ICA & more symptomatic
Angioplasty Alone:
Technical success rate: 80%+
CX: 4-40%;
Disadvantages:
• Immediate elastic recoil
• Dissection
• acute vessel occlusion
• Residual stenosis 50%+
• High restenosis rate
Intracranial stenting in atherosclerosis : Results of Hacettepe (1999-2012)
• 156 patients; 158 lesions,
• 112 men, 44 women
• Age: 41-83
• 67 lesion ant circulation; 91 patients post circulation
• S670-BX Sonic-Cordis/ROrybus/Wingspan/Enterprise/Solitarie (74 SE, 84 BE)
• 132 patients had control angiography or CTA (6 monthto 2-5 yrs).
• 14 lesions restenosis necessitating re-PTA restenosis: 10.6%
• 7 mortality (4.5%): 4 due to reperfusion hemorrhage (postop 2., 4. 6. and 12th hrs) and 3 distal wire rupture (in 2) and stroke
• 5 patients major stroke (3.2%) all due to perforating br compromise following midbasilar stenting or M1 stenting; one recovered totally, the others mRS>2 (2.5%)
• Permanent morbidity/ mortality: 7%
• 1 pt had basilar artery rupture but managed with covered stent; no neurologic deficit at the 6 mo control
1. SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results.Stroke. 2004 Jun;35(6):1388-92. Epub 2004 Apr 22.
2. Lylyk P, Vila JF, Miranda C, Ferrario A, Musacchio A, Rüfenacht D, Cohen JE. Endovascular reconstruction by means of stent placement in symptomatic intracranial atherosclerotic stenosis. Neurol Res. 2005;27 Suppl 1:S84-8.
3. Chow MM, Masaryk TJ, Woo HH, Mayberg MR, Rasmussen PA. Stent-assisted angioplasty of intracranial vertebrobasilar atherosclerosis: midterm analysis of clinical and radiologic predictors of neurological morbidity and mortality. AJNR Am J Neuroradiol. 2005 Apr;26(4):869-74.
4. Jiang WJ, Srivastava T, Gao F, Du B, Dong KH, Xu XT. Perforator stroke after elective stenting of symptomatic intracranial stenosis. Neurology. 2006 Jun 27;66(12):1868-72.
5. Fiorella D1, Chow MM, Anderson M, Woo H, Rasmussen PA, Masaryk TJ. A 7-year experience with balloon-mounted coronary stents for the treatment of symptomatic vertebrobasilar intracranial atheromatous disease. Neurosurgery. 2007 Aug;61(2):236-42; discussion 242-3.
6. Suh DC, Kim JK, Choi JW, Choi BS, Pyun HW, Choi YJ, Kim MH, Yang HR, Ha HI, Kim SJ, Lee DH, Choi CG, Hahm KD, Kim JS. Intracranial stenting of severe symptomatic intracranial stenosis: results of 100 consecutive patients. AJNR Am J Neuroradiol. 2008 Apr;29(4):781-5. doi: 10.3174/ajnr.A0922. Epub 2008 Feb 29.
7. Fiorella D, Woo HH. Stroke. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. 2007 Aug;38(8):2391-6. Epub 2007 Jun 21. 8. Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Pride L, Purdy P, Welch B, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG, Fiorella DJ. Wingspan in-stent restenosis and thrombosis: incidence, clinical presentation, and management. Neurosurgery. 2007 Sep;61(3):644-50; discussion 650-1. 9. Turk AS, Levy EI, Albuquerque FC, Pride GL Jr, Woo H, Welch BG, Niemann DB, Purdy PD, Aagaard-Kienitz B, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG, Fiorella D. Influence of patient age and stenosis location on wingspan in-stent restenosis. AJNR Am J Neuroradiol. 2008 Jan;29(1):23-7. Epub 2007 Nov 7. 10. 11. 12. |