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The Journal of the Swiss Society of
Minimally Invasive Neurological Therapy
The Journal of the Swiss Society of
Minimally Invasive Neurological Therapy
Complications of Endovascular Treatment in Acute Stroke Patients: Results from a Tertiary Referral Centre
EJMINT Original Article, 2014: 1424000143 (10th June 2014)
Abstract
Abbreviations
- CCF
- caroticocavernous fistula
- CT
- computerised tomography
- ECASS II
- Swiss Cooperative Acute Stroke Study II
- IA
- intraarterial
- ICH
- intracranial haemorrhage haemorrhage
- HI
- hemorrhagic infarction
- IV
- intravenous
- MCD
- mechanical clot disruption
- MRI
- magnetic resonance Imaging
- mRS
- the modified Rankin Scale
- NIHSS
- National Institute of Health Stroke Scale
- PH
- parenchymal hematoma
- SAT
- stent assisted thrombectomy
- sICH
- symptomatic intracranial haemorrhage haemorrhage
- TICI
- thrombolysis in cerebral infarction score
- tPA
- tissue plasminogen activator
Introduction
The goal of the acute ischemic stroke treatment is to restore cerebral blood flow rapidly and safely. Today, intravenous (IV) recombinant human tissue plasminogen activator (tPA), formulated as alteplase is the only treatment approved by the Food and Drug Administration. However, the strict inclusion criteria and “last-seen well’’ principle limits its use within 4.5 h after the initiation of stroke [1,2]. Endovascular therapy has emerged and changed the landscape and management of acute ischemic stroke. Additional intraarterial (IA) interventional approach, which is proved to be more effective than IV thrombolysis alone, should be preferred as the main goal of treatment. Advanced treatment choices and techniques have been developed to improve recanalisation efficiency and have shown that endovascular treatment is as safe as IV tPA [3]. Though the time window for endovascular treatment is not standardised, 6 h is generally considered for intra-arterial (IA) thrombolysis and 8 h for mechanical thrombectomy [4,5]. In some studies posterior circulation strokes were treated up to 24 h [6].
Angiography room, angiography staff and conscious sedation are the basic needs for an interventional approach. In addition to the intervention itself, recognising, resolving and follow-up of complications that may arise during and after the process is essential. Complications associated with endovascular intervention may be related to device-related complications, arterial access, medication and contrast media complications, anesthesia-related complications and systemic complications; peri-procedural haemorrhage, the most frequent and feared complication, is usually associated with use of thrombolytic agents [7,8].
Materials and methods
Patients:
The study included consecutive groups of patients with acute ischemic stroke who were admitted to Dr Burhan Nalbatoglu State Hospital and Near East University Hospital within 6 h of symptom onset between September 2011 and May 2013. Upon admission each patient was examined by a neurologist and initial neurological status was graded according to the National Institute of Health Stroke Scale (NIHSS). Past medical history, current medical therapy and contrast allergy were also investigated.
All patients underwent a noncontrast cranial computerised tomography (CT). In most patients, CT was followed by craniocervical multidetector CT angiography or magnetic resonance Imaging (MRI). Patients were treated in accordance with the American Heart Association / American Stroke Association Guidelines [9]. Patients who were admitted to the emergency department within 4.5 h of the clinical presentation without any contraindication received IV tPA treatment. Total thrombolytic drug dose (IV+IA) was calculated as 0.9 mg/kg. The patients were transferred to the angiography unit during IV tPA infusion. The tPA dose of 0.3 mg/kg was selectively infused intraarterially to all parts of the thrombus. Patients with unknown time of symptom onset and patients who exceeded the critical time window of 4.5 h or with any contraindication to tPA, were directly admitted to endovascular approach. The exclusion criteria for endovascular treatment (EVT) were spontaneous NIHSS improvement, recanalisation before endovascular treatment viewed on the first angiographic run and patients older than 80 years. EVT was performed within 6 h for the anterior circulation strokes and 8 h for posterior circulation strokes. According to the TOAST classification, subtypes of acute ischemic stroke were defined at the 3-month follow-up as cardioembolic, large vessel atherosclerosis, other (uncommon etiologies) or undetermined [10].
Angiography:
After explaining the intervention, outcomes and the periprocedural complications that may occur, written consent was obtained from families before the procedure.
During the endovascular interventions, 6F Mach 1, angled or straight (Stryker Neurovascular California, USA) and 8F balloon guiding catheters (Balt, Montmorency, France) were used to catheterise the posterior and anterior circulation parent arteries, respectively. Simmons 2 catheter or vertebral catheters 100/125cm (Stryker Neurovascular, California, USA) and (Cook, Indiana, USA) were used to engage the supraaortic arteries; Terumo stiff guidewire (Terumo, Tokyo, Japan) were used to place the guiding catheters to the main arteries. Transend floppy microguidewire 300 cm (Stryker Neurovascular, California, USA) and Echelon 18 (Stryker Neurovascular, California, USA) microcatheter were used for the intraarterial thrombolysis and mechanical clot disruption (MCD). Rebar (Covidien, California, USA) microcatheter and Solitaire (Covidien, California, USA) stents were used for the stent-assisted thrombectomy (SAT) referring to the artery diameter. The stent sizes which were used for MCA occlusions were 4-5 mm*30 mm and 6*30 mm for basilar artery or ICA. The intervention was carried out by digital subtraction angiography (Allura Xper FD 20; Philips Healthcare, Best, The Netherlands). Conscious sedation was provided by an anesthesiologist with IV midazolam (1-2, 5 mg and if required, repeated every 3-5 minutes, rarely exceeding 5 mg) or propofol (0.5-1 mg/kg). Standby intubation was performed in severe cases such as basilar and internal carotid artery (ICA) occlusions.
Interventional methods used for the acute stroke treatment were as follows: i) Intraarterial thrombolysis: infusion of thrombolytic agent through the microcatheter into the thrombus; ii) Thrombolysis with MCD: disruption of thrombus by using the microguidewire to and fro through the thrombus under the roadmap guidance to decrease the risk of vascular perforation - MCD was applied if the occlusion did not recanalise successfully after IA thrombolysis; or iii) SAT in the use of detachable Solitaire stent (Covidien, California, USA) to drag the thrombus from the occlusion site.
After deploying the stent to the location of occlusion, we waited for 5 min before applying SAT with negative suction through the guiding catheter until the thrombectomy stent was driven out. A balloon guiding catheter was used for large vessel occlusions to reduce the thrombus migration in SAT. Vascular closure devices were not used unless the patient received tPA.
Patients were monitored in intensive care unit and no patient received antihypertensive therapy if the blood pressure did not exceed 180/100 mmHg. A control CT scan was performed 24 h after treatment unless an intervening complication was suspected. MRI was repeated to exclude probable hemorrhagic complications or recurrent ischemic events after the interventional procedure.
Measures:
In addition to demographic characteristics, we retrospectively obtained data on stroke etiology, admission time to emergency room, anatomical localisation of the occlusion, duration of intervention (from groin puncture to last angiography run) and time to recanalisation.
Recanalisation rates were assessed immediately after the procedure according to thrombolysis in cerebral infarction score (TICI). Successful recanalisation was defined as TICI ≥ 2b and response to treatment was evaluated by NIHSS score at the 24th h and on the 7th day post stroke. The Modified Rankin Scale (mRS) was used as an outcome measure on the 90th day of the stroke. Functional outcomes were defined as good outcome (mRS 0-2), moderate (mRS 3-4), poor outcome (mRS 5) or died (mRS 6).
The major procedural complications were defined as symptomatic intracranial haemorrhage (sICH), subarachnoid haemorrhage, vessel dissection, vessel perforation, caroticocavernous fistula (CCF), air emboli, stent detachment, clot/plaque emboli, reocclusion, symptomatic vasospasm and serious puncture site complications. All peri-procedural complications were collected.
The cerebral haemorrhage was classified according to radiologic criteria of the Swiss Cooperative Acute Stroke Study II (ECASS II) as hemorrhagic infarction (HI) type 1 and type 2 and parenchymal hematoma (PH) type 1 and type 2 [11]. Symptomatic haemorrhage was defined as any intracranial bleeding causing neurological detoriation (increase in NIHSS by ≥ 4) [11,12]. We evaluated the relationship between the incidence of haemorrhage and the time to recanalisation from symptom onset.
Statistical analysis:
Kolmogorov-Smirnov Test of Normality was performed for continuous variables to explore distributions. Depending on results, parametric or nonparametric methods were applied for statistical analysis. The Mann Whitney U test and Wilcoxon test were applied for two group independent and dependent comparisons, respectively. For categorical data, Pearson Chi Square or Fisher's Exact test were performed depending on the expected frequency distributions. For each statistical procedure, level of significance (α) was accepted to be 0.05.
Results
Clinical and procedural characteristics:
28 patients (17 females and 11 males) with acute ischemic stroke were treated. Among 28 patients, the number of arterial occlusions were 31. The anatomic localisations of the occlusions were middle cerebral artery (MCA) in 18, basilar artery in 6, ICA in 6 and brachiocephalic trunk in one patient. Intervention was not carried out for the occlusion of brachiocephalic trunk. The characteristics of patients, location of occlusions, treatment modalities and ethiologies are demonstrated in Table 1. The stroke etiology was cardioembolism in most patients (78.5 %) and the most frequent cause of the cardioembolic event was atrial fibrillation. Treatment protocols according to the occluded arteries are shown in Table 2.
The recanalisation rate (≥ TICI 2b) was 23 out of 30 intervened arteries (76.6 %). Out of 30 arteries, TICI 3 in 18 (60 %), TICI 2b in 5 (16.6 %), TICI 2a in 4 (13.3 %), TICI 1 in 2 (6.6 %) and TICI 0 in 1 (3.3 %). Even though the total dose of tPA calculated was used in the patients during thrombolytic therapy, none recanalised unless MCD or SAT was applied. The angiographic results and the neurological status after treatment are summarised in Table 3.
The difference between median of initial and 24th h NIHSS scores were 10 points, whereas the difference between initial and 7th day was 15.5 points in living patients. The alterations were statistically significant (p=0.000, p=0.000). Five patients: 2 with basilar artery occlusion, one with MCA occlusion, one with ICA occlusion and one with multiple vessel occlusions, died in the first week of the stroke (17.8 %). At 90th day, 14 patients (50 %) had good, 5 had moderate (17.8 %), 4 (14.2 %) had poor outcome. 59 % (13/22) of patients with successful recanalisation had good 90-day neurological outcome.
The characteristics and results of the thrombolysis with MCD and SAT groups are shown in Table 4. Statistical analysis showed no difference in, mortality and outcome at 3 months (p=1, p=0.44 respectively).
Complications
Intracranial haemorrhage (ICH) was reported in 7 patients (25 %). Six patients had cerebral and 1 patient had posterior fossa haemorrhage. The cerebral haemorrhage types were ECASS HI-2 in 2 cases, PH-1 in 2 cases and PH-2 in 2 cases. Also, 1 basilar reperfusion bleeding was detected (Figure 1). No symptomatic haemorrhage was observed. Six patients were treated with thrombolysis with MCD while one of them was treated with SAT alone. The relationship between the haemorrhage incidence and time to recanalisation from symptom onset statistically did not reach significance (p=0.072).
Figure 1Cerebellar and brainstem infarction with brainstem hemorrhage, Noncontrast CT scan.
Stent detachment was observed in 1 patient (3.5 %). Arterial dissection was grouped as intracranial dissection, which was noted in 2 patients (7 %) and extracranial dissection, stated as a puncture side complication, was seen in 1 patient (3.5 %). CCF was noted in a single case (3.5 %). Ischemic complications / arterial occlusions in other locations were detected in 4 patients (14 %). In 1 patient distal embolisation of occluded plaque was the cause of ischemic complication. Reocclusion was observed in 2 patients (7 %). In stent thrombosis was the cause of reocclusion in 1 case (3.5 %). Major complications according to the occluded arteries and stroke treatment protocols are shown in Table 5.
Discussion
As the number of acute ischemic stroke patients treated with endovascular interventions increase, peri-procedural complications following this therapy become more common. However, there are not many reports in the literature about the peri-procedural complications. In clinical practice, these complications are not always life-threatening; however, they can be serious and often lead to prolonged stays in intensive care units, delay rehabilitation and increase morbidity.
Complications:
Hemorrhagic complications
ICH is the most feared complication of endovascular therapy as it increases patient morbidity and mortality [13]. Our rate of symptomatic haemorrhage (0 %) was lower than most previous studies [5, 14-21]. Tuilier et al. also did not detect any case with symptomatic haemorrhage [22]. The ECASS II study demonstrated that only PH2 independently causes clinical deterioration and impairs prognosis [23]. Two cases had PH2 in our series. Since the first patient with right MCA occlusion had successful recanalisation, the NIHSS score dropped 3 points despite ICH. The second patient had multiple arterial occlusions. As the successful recanalisation was not achieved in both MCA and basilar arteries, the initial severe neurological status (NIHSS 40) remained the same. The case with basilar occlusion recanalised in the 8th h of stroke had massive bleeding in the posterior fossa (Figure 1), which resulted from reperfusion in already infarcted vulnerable tissue. Despite this devastating complication, the initial NIHSS score was 38 and the bleeding caused only a 2 point rise; thus, the haemorrhage could not be classified as a symptomatic haemorrhage. The severity of the initial NIHSS score of these two patients affected the rate of symptomatic ICH. The relationship between the haemorrhage incidence and time of recanalisation from symptom onset has approached but did not reach significance (p=0.072). It could be argued that the small sample size of our study affected the result and studies with larger sample sizes may demonstrate significance.
Device related complications
Device related complications reported in the literature include retrieval system and interventional instruments related (stent, wire, etc.) complications.
Stent detachment
In our patient group, inadvertent stent detachment occurred in the patient with proximal basilar occlusion due to arterial dissection. The thrombectomy stent detached from the proximal sealing of the wire at the second pass of the stent (Figure 2). While applying SAT, the stent detached and as a result of prolonged maneuvers to withdraw the stent, the dissection progressed proximal to the vertebral artery. In this patient, the stent was left in place and angioplasty was applied. Although the detached stent did not cause any occlusion, the patient died because of brainstem infarction. Gascauet et al. reported fracture and spontaneous release of the stent retriever in 2 patients (1.3 %) while many studies did not report any occurences [14,19,21,24].
Figure 2Detached thrombectomy stent at the vertebral artery and vertebrobasilar dissection, Digital Subtraction Angiography (DSA) image.
Arterial Dissection
Endovascular intervention can cause iatrogenic intracranial and extracranial dissections. Intracranial dissection was noticed in 2 patients. The first patient had ICA-T occlusion whereas focal dissection was observed in the distal cervical segment of ICA while launching the guiding catheter with stiff hydrophilic wire. This was accepted as an iatrogenic complication that was related to manipulations of the stiff guidewire. As there was no progression of the localised dissection, the patient was followed medically without any clinical problem. The second patient had basilar artery occlusion due to dissection. During the prolonged maneuvers to withdraw the stent, the dissection progressed from the proximal to the vertebral artery. In this patient, another wallstent was deployed in the proximally dissected vertebral artery. The third patient had an extracranial, aortoiliac arterial dissection, discussed below in puncture site complications. The incidence of dissection varies between 0.4 % and 4.5 % in different series [7,14,17,23,24]. Although usually benign and followed medically, dissection can also result in significant neurological deficits.
Caroticocavernous fistula
CCF usually results from a direct wire perforation during a revascularisation manipulation or rarely from angioplasty [25]. In our case with MCA occlusion, right distal ICA occlusion was detected in DSA scan. While SAT was performed, CCF occurred at the cavernous segment which was noticed at the control runs (Figure 3). As the ICA was not recanalised, the patient died in a few days. This kind of fistula is usually treated with different methods, which is prompted due to flow rate [7].
Figure 3Caroticocavernous fistula filling from right, DSA image.
Arterial occlusions / ischemic complications in other locations
The causes include distal embolisation of occluded plaque, new emboli in another location and vasospasm. Arterial occlusions can result in ischemia if they are not treated successfully in time. Distal embolisation of the occlusive plaque was observed in a case with truncal MCA occlusion (3.5 %). Distal embolic migration of the calcified plaque was detected in the CT scan at the superior division after the MCA trunk was totally recanalised by IV+IA thrombolysis with MCD (Figure 4). In the second case with cardioembolic stroke, the left MCA occlusion was restored by IV+ IA thrombolysis with MCD, the left PCA infarction was detected at the 24th hour, although control CT scan in the 6th hour was normal. The third case presented with left distal MCA occlusion and the distal branches recanalised after IV tPA. Control runs showed occlusion at the cervical segment of the right ICA (Figure 5). The complete recanalisation of this site was provided by using SAT without causing infarction. This was accepted as a cardioembolic event and not as a device related complication. Although anticoagulant therapy in the first 24 h after thrombolytic treatment is contraindicated according to the guidelines, it has to be considered, as any peri-procedural or late onset new stroke attacks may be missed especially for patients who receive SAT treatment alone [26]. The fourth patient had right MCA occlusion. During the MSD a clot particle occluded right anterior cerebral artery (ACA). Recanalisation was achieved in the right MCA while right ACA A1 segment remained occluded. Because of the good flow from anterior communicating artery, the patient did not have infarction in ACA territory.
Figure 4Distal embolic migration of calcified plaque during thrombolysis with mechanical clot disruption (MCD), early postprocedure CT scan.
Figure 5Embolic occlusion of right ICA at control runs after the left MCA recanalization, DSA image.
The risk of distal migration of clot is a concern during manipulation to retrieve a clot; this can be solved by using balloon guiding catheters. Catheter and wire manipulation can result in arterial vasospasms and rarely could be symptomatic [24]. Since we didn’t have a case with symptomatic vasospasm, we didn’t count it as a complication.
Reocclusion
Reocclusion was observed in 2 patients (7 %).
In the first patient, complete recanalisation of the proximal high grade stenotic ICA was restored with SAT. However, MCA occlusion was noted in the control runs considered as tandem occlusion due to unstable plaques in the bifurcation of stenotic ICA. Recanalisation was achieved using SAT in MCA and stent was placed at the stenotic ICA after thrombectomy. The patient was loaded with clopidogrel and aspirin. Three hours after procedure, the symptoms recurred and in-stent thrombosis was detected in control CTA. The patient underwent another thrombectomy session where she completely recanalised. The incidence of in-stent thrombosis is rare. The frequency was 0.6 % in Gasgaou et al. patients, while Gratz et al. noted 3 % and Lefevre et al. noted 6.4 % [14,16,28]. The second patient with right MCA occlusion was treated by IA thrombolysis with MCD but recanalisation was limited and reocclusion occurred at control CT scan. Although thrombectomy stents can be used for such patients and patients with distally migrated thrombus, Solitaire was not available in our centre at the time. In addition to this, SAT can also be used as an alternative in the treatment of thromboembolic complications during endovascular management of cerebral vascular aneurysms [29].
Puncture site complication
One of the cases with right truncal MCA stenosis developed coolness, numbness and pain on her right lower extremity and arterial embolism was confirmed by doppler ultrasonography. Dissection extending from distal abdominal aorta to iliac artery was observed in the DSA as the source of embolism which was repaired by stent application. The reason in this case was the introducer sheath which was withdrawn 2 days after the procedure. Later, this patient was diagnosed with Systemic Lupus Erythematosus.
Limitations
Our study was a retrospective, single endovascular centre study. The major limitations of our study include the heterogeneity of treatment modalities at different vascular occlusion sites and small patient group. All angiographic and imaging results were interpreted by a single neuroradiologist who performed the endovascular stroke intervention.
Conclusion
In our retrospective study, haemorrhage was the most frequent complication (25 %). We noted 1 stent detachment (3.5 %), 2 intracranial (7 %) and 1 extracracranial dissection (as a puncture site complication) (3.5 %), one CCF (3.5 %), 4 arterial occlusions / ischemic complications in other locations and 2 reocclusions in our patients.
As the number of interventions for stroke increases overtime, planning for complications should be revised. Therefore, we think it is important to adequately report the peri-procedural complications of EVT as their recognition is crucial and affects outcome.
Conflict of interest
We declare that we have no conflict of interest.
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- intracranial aneurysms
- endovascular treatment
- flow diverter
- clopidogrel resistance
- training
- UEMS
- charter
- neuroradiology
- Interventional
- INR
- pharmacogenetics
- aneurysm
- pipeline embolisation device
- silk flow diversion device
- stents
- intracranial
- stroke
- interventional neuroradiology
- thrombectomy
- thrombolysis
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- stroke treatment
- mechanical thrombectomy
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- magnetic resonance angiography
- intracranial aneurysm
- subarachnoid haemorrhage
- computed tomography
- angiography
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- delayed rupture
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- anterior circulation aneurysm
- acute ischemic stroke
- randomised clinical trials
- carotid artery stenting
- high-risk
- complications
- flow disruption
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- tPA
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- balloon-assisted
- stability
- sedation
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- coils
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- ischaemic stroke
- MRI
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- brain infarction – anterior circulation
- predictors
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