Fig. 10.1
Illustration (a) of FAST, forced arterial suction thrombectomy, in a patient with internal carotid artery terminus occlusion. Photograph (b) shows that the 20 or 50 mL syringe is connected to the proximal hub of the reperfusion catheter with forceful suction
10.2.1 FAST: Forced Arterial Suction Thrombectomy
The first cases series on FAST was published in 2011 under the title, “Direct thrombus retrieval using the reperfusion catheter of the Penumbra system: Forced-suction thrombectomy in acute ischemic stroke” [6]. In that case series, 22 consecutive patients with large artery occlusion acute ischemic stroke within the 8 h time window of stroke onset underwent FAST. Any patients that were at high risk of bleeding, or had brain edema, or uncontrolled hypertension, were excluded. The safety of the technique was evaluated according to the incidence of procedural complications, and the efficacy was assessed by the incidence of successful revascularization of the target vessel following the technique, defined as Thrombolysis in Cerebral Ischemia (TICI) grade 2 or 3. The mean interval from the onset of symptoms to arterial puncture was 5.3 h, and the mean baseline NIHSS score was 18.1. The target-vessel locations were 14 middle cerebral artery (MCA) (63.6%), 4 ICA (18.2%), and 4 BA occlusions (18.2%). All the treated target vessels were TICI 0 before the procedure; and all 81.9% of the patients were successfully recanalized as TICI 2b (10/22, 45.5%) or 3 (8/22, 36.4%) after the FAST procedures. The mean procedure time from groin puncture to revascularization was 40.2 min, including diagnostic angiographies. A Penumbra reperfusion catheter 041, the original version of the catheter, was primarily used in every patient and a Penumbra reperfusion catheter 032 was additionally used in two cases of distal embolization to the M2 segment of the MCA. Adjuvant procedures were performed in four patients; balloon angioplasty was undertaken in one patient due to the underlying stenosis of the BA following revascularization of acute BA occlusion, and rescue carotid stenting at proximal ICA was performed in three patients. And there was only one procedural complication, cervical segment ICA dissection occurred while placing the guide catheter in the tortuous vessel, although recovery was confirmed on follow-up MR angiography 5 days after the procedure. Overall intracerebral hemorrhage (ICH) occurred in seven patients (31.8%) and among them, two (9.1%) were symptomatic. The favorable functional outcome (mRS score 0–2) at 3 months was 45.5% (10 of 22 cases).
One year later, the authors of the first FAST paper reported the efficacy of FAST in acute distal ICA occlusions by comparing FAST and MCD and showed greater improvement in functional outcome in the FAST group [8]. In that period-to-period analysis, the rate of successful recanalization, defined as TICI grade 2 or 3, was significantly higher in the FAST group compared to the mechanical clot disruption (MCD) group (85% vs. 32%, P < 0.001). Additionally, favorable outcomes at 3 months, defined as mRS score 0–2, were 45% in the FAST group and 16% in the MCD group. Though this was a comparison between a new technique FAST and an outdated MCD at the time, the authors concluded FAST could be a viable option for acute distal ICA occlusion based on the high rate of successful recanalization and functional recovery.
10.2.2 ADAPT: A Direct Aspiration First Pass Technique
In 2013, another investigation of manual aspiration thrombectomy, with the modification of the standard Penumbra system, took place called ADAPT [7]. In that study, 37 consecutive cases of acute ischemic stroke were treated with the ADAPT technique, 30 of which involved the anterior circulation, seven involving the posterior. The ADAPT, as discussed in that publication, was very similar to the FAST technique (Fig. 10.2). Regarding the specific findings of ADAPT study in 2013, the average time from groin puncture to recanalization was 28 min, and revascularization was successful in all cases. TICI grade 3 recanalization was achieved in 65% of the cases. Patients presented with an admitting NIHSS score of 16.3, and improved to 4.2 by the time of discharge. In that study, there was one procedural complication. And two patients died from parenchymal hematomas.
Fig. 10.2
Illustration of ADAPT, a direct aspiration first pass technique, in a patient of middle cerebral artery occlusion. Neuron Max guide catheter is positioned as distally as possible in the parent artery. Penumbra 5 Max reperfusion catheter is advanced over a 0025 in. microcatheter with a 0.016 in. microguidewire through the guide catheter. The microguidewire and the microcatheter are then passed distal to the thrombus to provide support for the Penumbra 5 Max to be advanced to the thrombus. Aspiration is applied until wedging is accomplished between the catheter tip and the thrombus, then the Penumbra 5 Max is removed while maintaining aspiration
The authors of the ADAPT study pointed out some differences between the early FAST technique and ADAPT. For example, they indicated that the FAST series reported more modest results than their ADAPT results likely due to smaller caliber and older technology aspiration catheters. In detail, they indicated that the FAST series involved an older generation aspiration catheter, such as 041 and 032 family of Penumbra reperfusion catheters, as opposed to their more modern devices (Penumbra 5 Max) used 2 years after the FAST study. They mentioned two major advantages of using the new aspiration catheter for ADAPT: (1) the increased internal diameter of the Penumbra 5 Max aspiration catheter allowed for an increased surface area, which provided better contact at the catheter tip-thrombus interface, and (2), additionally, the Penumbra 5 Max was more spacious in its proximal segment, which increased its luminal volume and provided an increased aspiration capacity.
10.2.3 Difference Between FAST and ADAPT Focusing on the Usage of a Balloon Guide Catheter
The techniques of early FAST and ADAPT were very similar in many ways; both techniques were mainly composed of advancement of large-bore catheter to the occlusion site and a forceful aspiration thereafter. From the FAST author’s viewpoint, it was with the additional use of a BGC in subsequent years that set FAST slightly apart from ADAPT. The only possible disadvantage of using a BGC is the time for preparation of a balloon in BGC. But there are several potential advantages here.
The first advantage is that using BGC in the FAST procedure may minimize distal clot migration or embolization. For example, in an in vitro study published in 2013, the incidence of distal embolization was investigated [9]. In that study, the Merci retriever, Solitaire FR (Medtronic Neurovascular, CA, USA), and Trevo devices (Stryker Neurovascular, CA, USA) were compared with and without the use of a BGC to ascertain the number of distal emboli generated during thrombus retrieval. They found that the use of the BGC during thrombus retrieval significantly reduced the formation of large distal emboli with a diameter >1 mm, regardless of the device used (P < 0.01). Additionally, they found that applying aspiration using the BGC in place of a conventional guide catheter resulted in a significant increase of flow reversal (P < 0.0001). The findings related to be reduced embolic events with use of a BGC have also been demonstrated in animal models [10]. In an experimental ischemic stroke model, the number of embolic events was significantly higher with distal thrombectomy device, such as Catch retriever (Balt Extrusion, Montmorency, France), without proximal balloon occlusion compared with use of distal devices with proximal balloon occlusion (42% vs. 9%, OR, 7.1; 95% CI). That brings up the second potential advantage. It may be the case that using a BGC might enhance aspiration efficacy during the FAST or ADAPT procedure by blocking proximal flow. Note that this is a theoretical point; there is no apparently reported evidence to confirm this conjecture yet. However, because the distal part is already blocked by the clot, proximal occlusion with a BGC can make a vacuum there, which then may make the negative pressure more effective. Clearly, this is an area where in vitro confirmation is needed. The third advantage is that it can allow for easy and prompt switching to stent retriever technique in case of failure using the FAST. This may be an important point, especially in light of modern trials, because all the large volume stent retriever trials recommend using the BGC, for example, Solitaire with the intention for thrombectomy (SWIFT) and Solitaire with the intention for thrombectomy as primary endovascular treatment for acute ischemic stroke (SWIFT PRIME) [11, 12]. Regarding the use of the BGC in stent retriever technique, there was a swine model testing the Solitaire device [13], which noted that the clot would be engaged within the struts and would shear off the device during retrieval into the tip of the BGC in many cases. It was possible to aspirate the clot into the guide catheter and prevent distal emboli. Another study published in 2014, which examined the safety and efficacy of the BGC, demonstrated that the use of a BGC with the Solitaire FR device resulted in better revascularization results, faster procedure times, and improved clinical outcomes [14]. In that study, 149 patients (44%) had placement of a BGC. What they found was that procedure time was shorter in patients where the BGC was used (120 vs. 161 min, P = 0.02), and TICI 3 reperfusion scores were higher in patients with the BGC (53.7% vs. 32.5%, P < 0.001). Although rates of distal embolization and emboli in new territory were similar between the two groups, mean discharge NIHSS score (12 vs. 17.5, P = 0.002) and good clinical outcome at 3 months were significantly better in patients where the BGC was used compared with patients without (51.6% vs. 35.8%, P = 0.02). Additionally, it was shown in multivariate analysis that the use of the BGC was an independent predictor of good clinical outcome (OR, 2.5; 95% CI).
10.2.4 Step-by-Step Description of the FAST Technique
10.2.4.1 Step 1: Femoral Arterial Puncture and Sheath Insertion
Same as the beginning of other endovascular procedures, the target for safe femoral puncture is the midportion of the common femoral artery, which is defined as the arterial segment between the inferior epigastric artery and the bifurcation of the superficial and profunda femoral arteries. This is usually located around the central part of the femoral head, so in any difficult cases of puncture, perhaps due to diminished pulse or patients’ obesity, using fluoroscopy to find such bony landmarks can be helpful to confirm a safe puncture site. Then, the puncture needle should enter the artery slightly higher than the skin entry site with an angle about 30° from the horizontal. Incidentally, for large-diameter sheaths or in anticipation of vascular closure devices, a subcutaneous tunnel is helpful for easier device insertion, which permits blood to exit to the surface instead of accumulating in the leg. A single, front wall arterial puncture is the recommended technique, as it reduces the chance of bleeding from an inadvertent puncture leak. Advancement of the needle slowly up the artery is followed by the gentle introduction of a straight or a J-tipped guidewire into the artery. After the guidewire is positioned in the iliac artery, the needle is removed with firm hand pressure applied over the puncture site while the sheath is placed over the wire. Then, the sheath-dilator assembly is advanced, and followed by aspiration and flush of the sheath through the side arm with heparinized saline.
10.2.4.2 Step 2: Balloon Guiding Catheter Placement
The next step begins by advancing the guiding catheter to the proximity of the occluded target vessel. Conventional angiographic techniques are used to achieve a stable guiding catheter position for the thrombectomy procedure. Common selections for a guiding catheter during the FAST technique include either an 8-French or a 9-French BGC. Specifically, the author mostly used a 9-French BGC either an Optimo (Tokai Medical Products, Aichi, Japan) or a Merci (Stryker Neurovascular, CA, USA). A 120 cm diagnostic catheter, one of either a 4-French Headhunter or a Simmons-2 (Cook, IN, USA), is inserted coaxially and is used to select the common carotid artery in the anterior circulation occlusion or the subclavian artery in the posterior circulation occlusion, after which the BGC is advanced coaxially over the diagnostic catheter. Angiographies are then performed to confirm the location of the occlusion and to evaluate for preexisting stenosis at the proximity of the internal carotid or vertebral artery (Fig. 10.3a). If it is safe and available, the BGC is positioned into the internal carotid or vertebral artery using a similar coaxial advancement technique. For the cases of vertebral artery which is not allowed for an 8-French or a 9-French BGC due to small caliber, any general 6-French guide catheter can be used as a substitute. An alternative technique begins with selection of the proximal common carotid or subclavian artery with a diagnostic catheter. Then, the diagnostic catheter is exchanged for a BGC over an exchange wire. With either of these techniques, which can depend on the patient’s vascular anatomy and the practitioner’s preference, the distal tip of a BGC can be advanced to distal cervical segment of ICA or to proximal vertebral artery.
Fig. 10.3
Baseline angiography (a) shows total occlusion of the M1 segment of the left middle cerebral artery. Angiogram and illustration (b) of the FAST procedure show the occlusion site and surrounding angioarchitecture. The balloon of the guiding catheter is inflated during forceful aspiration (c). Examples of retrieved clot are shown: fragmented type (d) and whole type (e). Final angiography (f) shows complete revascularization
10.2.4.3 Step 3: Advancement of Large-Bore Aspiration Catheter
Once the BGC is optimally positioned, it is attached to a rotating hemostatic valve, through which a set of microsystems can be introduced coaxially while simultaneously allowing for continuous saline flushing and preventing air entry into the system. Then, the microcatheter and microguidewire can be advanced through the system up to the occlusion (Fig. 10.3b). For the FAST technique, it is recommended that a 2.0-French (Excelsior 1018; Stryker Neurovascular, CA, USA) or a 2.3-French microcatheter (Prowler Select Plus; Cordis Neurovascular, FL, USA) with a 0.014 in. (Synchro, Stryker Neurovascular) or a 0.016 in. microguidewire (GT; Terumo, Tokyo, Japan) inside it is introduced into a large-bore aspiration catheter (Penumbra 4/5 Max or 5 Max Ace; Penumbra). This set of construct is introduced into the BGC as a unit and is advanced to the occlusion site.
In this stage, it is recommended to avoid distal passage of the thrombus by a microcatheter or a microguidewire, because distal passage itself can theoretically elevate the chance of clot disruption and distal migration. Therefore, in cases where the patient’s vascular anatomy allows easy passage, the Penumbra catheter is directly advanced to the thrombus without any distal passage of the clot by an inner microcatheter or a microguidewire. However, in the cases where a patient’s arterial anatomy is tortuous, an inner microcatheter is necessarily advanced past the thrombus over a microguidewire. Then, the large-bore aspiration catheter is advanced over it up to the thrombus to make a wedge between the tip of the catheter and the thrombus. If required, local angiography can be performed before aspiration is done to predict the original path of the occluded segment and to outline the occlusion, including the extent of thrombus. Once the large-bore aspiration catheter is located optimally, the inner microcatheter and microguidewire are then removed. Thereafter, the proximal hub of the Penumbra catheter directly is connected to a 20 mL or 50 mL syringe.
10.2.4.4 Step 4: Balloon Inflation and Manual Aspiration with a Syringe, Then Catheter Retrieval Maintaining Aspiration Force
After connecting the proximal hub of Penumbra catheter directly to a 20 mL or 50 mL syringe, slight negative pressure is attempted by partial pulling of the plunger to confirm direct wedging and a vacuum state between the tip of Penumbra catheter and the clot. At this point, absence of backflow mostly indicates the thrombus is trapped in the catheter. There are a few notable points to make. First, try to use the largest possible reperfusion catheter to maximize suction power. Second, try to keep the direction of the tip of Penumbra reperfusion catheter parallel to the presumptive path of the occluded vessel for prevention of direct contact between the tip and the endothelium. Just before applying the negative pressure, the balloon of the BGC is inflated to block proximal flow (Fig. 10.3c). Then negative pressure applied by forceful pulling of the plunger of the syringe for a period of 60–90 s. After that, the large-bore aspiration catheter is slightly advanced further into the thrombus and then slowly withdrawn under continuous aspiration. The procedure can result in one of either type of the following conditions. First, the vacuum state is unexpectedly lifted, followed by entry of free blood flow into the catheter, suggesting that the wedged clot is disrupted and sucked into the catheter (Fig. 10.3d). Then, the catheter is manually aspirated with a syringe to remove any residual thrombus fragments within the Penumbra catheter. Second, if the wedging or vacuum state persists, so no free blood flow in the syringe tubing is restored upon withdrawing the large-bore aspiration catheter into the BGC, the aspiration catheter is slowly and carefully removed from the patient under continuous aspiration from the Penumbra catheter and syringe (Fig. 10.3e). And the BGC is manually aspirated with a syringe to remove any residual thrombus fragments. Finally, the balloon of the BGC is slowly deflated to restore proximal blood flow. This process can be repeated until successful reperfusion is achieved (Fig. 10.3f). However, if three FAST passes fail to achieve incremental reperfusion, then stent retriever thrombectomy may be employed as a rescue procedure.
There are two available methods to make negative pressure; manual syringe aspiration and the Penumbra aspiration pump. FAST is performed under manual aspiration only. A 50 mL syringe is usually used for ICA occlusions and the M1 segment of MCA occlusions. And, a 20 mL syringe is usually used for the M2 segment of MCA occlusions and BA occlusions. However, if the 20 mL syringe fails, it can be switched to the 50 mL syringe to intensify suction power. Based upon the experiences, one certain benefit of manual syringe aspiration is its technical simplicity and cheap price. However, each method can have its own benefit. And there has been no proven evidence yet for which is better regarding clot retrieval efficacy and safety. Therefore, the practitioners can choose their preferential aspiration method using either a syringe or the aspiration tubing and Penumbra aspiration pump.
10.2.5 Technical Tips to Overcome Tortuous Segment During the FAST
Despite recent huge advances in the large-bore aspiration catheter’s tracking facility, crossing the curved segment of cerebral arteries, such as the carotid siphon, is still not always easy. Tortuosity itself is one big barrier for passage, and the anatomic condition where a small artery is arising from the tortuous segment, such as an ophthalmic artery origin from the carotid siphon, can be another challenging situation during advancement (Fig. 10.4a). Moreover, underlying atherosclerotic stenosis is another potential barrier for catheter passage by making the endothelial surface uneven and rough. In this section, a few technical tips to overcome such obstacles will be introduced.
Fig. 10.4
Illustration (a) shows how the navigation difficulty originates from the large-caliber of the aspiration catheter and vascular anatomy, such as high curvature or origin of ophthalmic artery. Steam shaping of the tip of Penumbra catheter (b) can be a solution. The examples of steam shaping are shown as the following: 45° curved (c, d), 90° curved (e, f), and J shape (g, h)
10.2.5.1 Use the Softest Aspiration Catheter on the Practitioner’s Hand and Maximize Guiding Catheter Support
This tip is intuitive and simple to convey. First, the softer the aspiration catheter is (relative to similarly sized large-bore catheters), the better the tracking ability will be. All of the FAST cases are based on the experiences using the Penumbra reperfusion catheter from the first generation of the 041 and 032 family to the 5 Max Ace. However recently, several new large-bore catheters for clot aspiration have been continuously launched in this field, such as ACE 64 (Penumbra), Sofia (MicroVention, CA, USA), Arc (Medtronic Neurovascular), and Catalyst (Stryker Neurovascular), so the practitioner can use any of these catheters for the FAST technique. Again, the most important point in selecting an aspiration catheter is to choose the largest and simultaneously softest aspiration catheter available to the practitioner’s hand. Second, likewise, maximizing the guiding catheter support intuitively allows for more stable behavior of the aspiration catheter. This naturally means better control of aspiration catheter by practitioner. These intuitive points are easy to state and understand and are left to the discretion of the practitioner. However, they should be emphasized as noteworthy, nevertheless. The next two technical tips will require more explanation.
10.2.5.2 Steam Shaping of the Tip of Penumbra Aspiration Catheter: 45°, 90°, and J-Shape
As an aspiration catheter becomes larger in diameter, passing the curved segment can be technically more unlikely in some tortuous cases with its original straight shape of the tip of the aspiration catheter. This can be achieved through steam shaping (Fig. 10.4b). There are various shapes available for the tip of microcatheter, such as straight, simple-curved (45°, 90°, and J), preshaped-C, pigtail, and preshaped-S [15, 16]. Among the various shapes, there are three grades of “simple-curved” steam shaping that are recommended for navigating tortuous segments with the Penumbra aspiration catheter. This steaming usually takes 30–60 s, and steamed microcatheters are then soaked in normal saline for 30 s or more. In most of the cases, a 45° curved shape is the recommended choice. By steam shaping the tip of Penumbra aspiration catheter with a 45° curved shape prior to its application, advancement through tortuous segments is more easily achieved. However, in some proportion of the cases with extreme tortuosity or severe stenosis due to underlying atherosclerosis, which is determined by the practitioner (but accounts for less than 20% of cases in the author’s experience), a 90° curved or J-shape can be used (Fig. 10.4).
10.2.5.3 Coaxial Advancement Technique of the Penumbra Catheter
If a microguidewire is just used for advancing the large-bore aspiration catheter, the gap between the two devices will be large. This can result in difficulty steering and controlling the catheter, because the angle vectors of the two devices may be at different directions during the passage of curved segment. Specifically, this means that the Penumbra aspiration catheter will have too much freedom of motion during advancement when only guided by the microguidewire. And, advancement through a highly curved segment is technically unlikely due to all this freedom of movement for the Penumbra catheter. To overcome such problem, the coaxial advancement technique is recommended here, which means introducing another microcatheter of intermediate size between the Penumbra catheter and microguidewire to reduce the gap between them (Fig. 10.5a). This serves to restrict the freedom of movement of the Penumbra reperfusion catheter to a necessary extent, which will allow greater ability to steer and control the large-bore catheter during advancement through the curved segment.
Fig. 10.5
Coaxial advancement technique with an inner, intermediate-sized microcatheter (a) can be another solution to overcome navigation difficulty. The examples of coaxial assembly are shown, Penumbra 5 Max or 5 Max Ace is nicely assembled with a 2.3-French inner microcatheter and a 0.016 in. microguidewire (b, c), and Penumbra 4 Max is assembled with a 2.0-French inner microcatheter and a 0.014 inch microguidewire (d, e)
The author’s technical “recipe for coaxial assembly” is as follows (Fig. 10.5). In each case, an appropriate size for the inner microcatheter is necessary. For the ICA and the proximal M1 segment of MCA, it is recommended to use the Penumbra 5 Max or 5 Max Ace with a 2.3-French inner microcatheter, with which the author preferred a Prowler Select Plus preshaped 45 or 90 (Cordis Neurovascular) and a 0.016 in. microguidewire (GT; Terumo). For the distal M1 segment or the M2 segment of MCA, it is recommended to use the Penumbra 4 Max with a 2.0-French inner microcatheter, with which the author preferred an Excelsior 1018 preshaped 45 or 90 (Stryker Neurovascular) and a 0.014 in. microguidewire (Synchro; Stryker Neurovascular).
10.2.6 Additional Case Examples of the FAST
10.2.6.1 Acute ICA Terminus Occlusion
Here a case is presented where FAST was used for an ICA terminus occlusion. In this case, a 72-year-old man presented with sudden onset left hemiparesis. CT findings were normal, and carotid angiography demonstrated near-complete occlusion of the terminal segment of the right ICA. Cardioembolic stroke was diagnosed, and immediate recanalization was performed using the FAST technique 3 h after symptom onset (Fig. 10.6). A 9-French Optimo BGC (Tokai Medical Product) was placed on the cervical segment of the ICA and was followed by advancing the Penumbra 5 Max Ace to the proximal part of the clot coaxially with a 2.3-French Prowler Select Plus microcatheter (Cordis Neurovascular) and a 0.016 inch GT microguidewire (Terumo). The first forceful aspiration with a 50 mL syringe was attempted at MCA M1 segment, some clot fragments were then retrieved, but the following angiography showed still occluded anterior cerebral artery. Thereafter, the second forceful suction at proximal anterior cerebral artery enabled retrieval of the larger sized clot, which resulted in TICI 3 recanalization. The interval from arterial puncture to revascularization was 20 min. No procedure-related complications or ICH occurred, and the patient improved in NIHSS score from 14 at baseline to 5 at 24 h after the procedure. Functional recovery was mRS 1 at 3 months after the procedure.
Fig. 10.6
Baseline angiography (a) shows an ICA terminus occlusion on the right. Penumbra 5 Max Ace is advanced to the clot coaxially with a 2.3-French microcatheter and a 0.016 in. microguidewire (b, c). Clot fragments (d) are retrieved via FAST technique; final angiography (e) shows complete revascularization
10.2.6.2 Acute MCA Occlusion at M2 Segment
Another case example is presented where FAST was used for an M2 segment occlusion. In this case, a 60-year-old woman presented with acute onset right hemiparesis and global aphasia within a 2.5 h time window. Left carotid angiography demonstrated complete occlusion of the M2 segment of the MCA. FAST was attempted to recanalize the vessel (Fig. 10.7). A 9-French Optimo BGC (Tokai Medical Product) was placed on the cervical segment of the ICA and was followed by advancing the Penumbra 4 Max to the proximal part of the clot coaxially with a 2.0-French Excelsior 1018 microcatheter (Stryker Neurovascular) and a 0.014 inch Synchro microguidewire (Stryker Neurovascular). After wedging the reperfusion catheter to the proximal part of the clot, a single forceful suction with a 20 mL syringe enabled retrieval of the whole clot and resulted in TICI 3 recanalization. The interval from arterial puncture to revascularization was 15 min. No procedure-related complications or ICH occurred, and the patient improved in NIHSS score from 18 at baseline to 10 at 24 h after the procedure. Good functional recovery was achieved as mRS 1 at 3 months after the procedure.
Fig. 10.7
Baseline angiographies (a, b) show an M2 segment occlusion on the left MCA. Penumbra 4 Max is advanced to the proximity of the clot coaxially with a 2.0-French microcatheter and a 0.014 inch microguidewire (c, d). Whole clot is retrieved via FAST technique, and final angiographies (e, f) show complete revascularization
10.3 Combined Usage of Direct Clot Aspiration and Stent Retriever Thrombectomy: Switching Strategy and Solumbra Technique
There are two major mechanical thrombectomy techniques that have emerged as the dominant strategies in the present era of endovascular stroke therapy. The primary involves the use of a stent retriever, such as the Solitaire FR (Medtronic Neurovascular) or the Trevo device (Stryker Neurovascular). The second type of technique is the use of direct clot aspiration, using either the FAST or the ADAPT techniques with a large-bore aspiration catheter, such as the Penumbra 5 Max or 5 Max Ace (Penumbra). In addition, there have been a few attempts to enhance the rate of successful recanalization through a combination of the two major techniques, stent retriever and direct clot aspiration. The background of such attempts is straightforward. Despite advancement of the devices and techniques, 100% successful recanalization cannot be guaranteed solely using a primary mechanical thrombectomy, whether the stent retriever or clot aspiration is adopted as the primary technique. In the cases of a stent retriever being used as the primary device, the rate of successful recanalization was 83% in the SWIFT trial (TIMI 2–3: 45/54) and 85% in the TREVO 2 trial (TICI 2–3: 73/86) [11, 17]. Even in the more recent randomized controlled trials of 2015, which were mostly based on stent retriever thrombectomy, the rate of successful recanalization defined as TICI 2b or 3 was 59% in Multicenter Randomized CLinical trial of Endovascular treatment for Acute ischemic stroke in the Netherlands (MR CLEAN; 82% of the device used was stent retriever), 86% in EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA; only Solitaire FR is used), 72% in Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times (ESCAPE; 79% of the device used was stent retriever and 61% was Solitaire FR), 88% in SWIFT PRIME (only Solitaire FR used), and 66% in Revascularization with Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 h (REVASCAT; only Solitaire FR used) [12, 18–21]. Although the detail of the interventional strategy was slightly different in each trial, these findings apparently demonstrate that practitioners were required to prepare adjuvant rescue procedures for the patients without successful recanalization through the primary devices. Similar findings were reported regarding the use of clot aspiration as the primary technique. The rate of successful recanalization defined as TICI 2b or 3 was 82% in the first FAST trial, 65% in the next FAST trial for acute ICA occlusions, and 75% in the ADAPT trial [6–8]. Likewise with stent retriever thrombectomy methodology, if clot aspiration with a large-bore catheter is adopted as the first-line technique, the practitioner may need to employ potential salvage with a stent retriever or another treatment, if several passes fail to achieve successful recanalization or if advancement of the large-bore aspiration catheter to the occlusion site fails by the vascular tortuosity.
Based on the aforementioned background, there have been a few attempts to improve recanalization by using the stent retriever and clot aspiration together. The first was called the “switching strategy,” which involved switching from FAST to Solitaire stent thrombectomy and the second is the “Solumbra technique,” which uses the two devices simultaneously [22–26]. Although both attempts bear similarities in terms of the concept of combined usage of two major techniques, the detail is very different. Some of the difference lies in the regulatory rules and laws prevailing in the originating countries. For example, the switching strategy of mechanical thrombectomy actually originated as a result of a limitation in the health insurance system in South Korea. Specifically, the public health insurance system supported by government in South Korea pays for about 90% of the price of the first device, either a stent retriever or a large-bore aspiration catheter during the mechanical thrombectomy for a major stroke patient. This means that if the practitioner used a second device for rescue, the patient’s family pays fully for the second device. Therefore, the practitioners under such health insurance system naturally try their best to achieve successful recanalization by using only one device and then “switch” to a second device as a rescue procedure. On the other hand, in some other countries such as the USA, practitioners are allowed to simultaneously use both the stent retriever and the large-bore aspiration catheter at once under the practitioner’s discretion during the procedure, so some practitioners routinely use both devices to enhance the rate of successful recanalization. The most common combination is to use the Solitaire FR stent (Medtronic Neurovascular) and the Penumbra reperfusion catheter (Penumbra), so this has come to be known as the “Solumbra technique.” The details of both the switching strategy and the Solumbra technique will be discussed in the following.
10.3.1 What Is the Switching Strategy for Mechanical Thrombectomy?
The origins of the switching strategy came from a desire to improve recanalization rates following thrombectomy procedures. A period-to-period comparison analysis for introducing the switching strategy was published in the year of 2013 [22]. In the former period (period 1, from April 2009 to October 2010), the investigators used FAST only for a mechanical thrombectomy procedure. Then they applied switching strategy from FAST to stent retriever thrombectomy in difficult cases in a subsequent one and half year period (period 2, from October 2010 to January 2012). In the paper, “difficult case” was defined as three or more failed attempts by the FAST for recanalization. During period 1, they inevitably kept using only FAST in the difficult cases because that was the only approved thrombectomy technique in South Korea at the time. From the time when Solitaire stent was available, at the beginning of period 2, they began to apply switching strategy of mechanical thrombectomy in the difficult cases with FAST, under the hypothesis that additional attempts with a different mechanism (Solitaire stent) could improve recanalization (Fig. 10.8). One hundred and 35 consecutive patients who presented with acute large vessel occlusion in the anterior circulation and treated with mechanical thrombectomy, enrolled to this analysis; 61 in period 1 and 74 in period 2. Although puncture-to-recanalization time was not significantly different between the two periods, the patients in period 2 showed a trend for better angiographic outcome (TICI 2b-3: 73.8% in period 1 vs. 85.1% in period 2, P = 0.10). And notably, period 2 showed a significantly better 3-month functional outcome (mRS 0–2: 49.2% vs. 67.6%, P = 0.030). The subgroup analysis of the “difficult cases” showed that the difference of successful recanalization was more pronounced in between non-switching and switching cases (TICI 2b-3: 52.7% vs. 82.9%, P = 0.030), which suggested the switching of mechanical thrombectomy techniques in difficult cases played a major role to improve the recanalization and outcome. But the differences in symptomatic ICH and procedure-related complications were not statistically significant between the two subgroups.