Abstract
Acute and subacute ischemia of the lower extremity is still a common reason for amputation. The treatment of this condition includes the well known procedure of local thrombolysis, surgical thrombectomy and, in recent times, percutaneous mechanical thrombectomy procedures such as rotational thrombectomy. However, in randomized studies Fogarty’s procedure of surgical thrombectomy was associated with a high rate of perioperative complications and, in part, low technical success rates. On the other hand, local thrombolysis is associated with hemorrhage as well as high costs because of measures requiring substantial resources, such as intensive care monitoring or repeat angiographies. In several studies, the endovascular therapy options of Straub Rotarex® and Aspirex® systems, both products of technical advancements in the field, were shown to be successful in terms of amputation-free survival. Their use was also associated with low complication rates. The majority of studies were focused on arterial blood flow in the femur. However, in the meantime several registers and studies have shown that the systems can also be effectively used to treat proximal deep vein thrombosis. In the present report we review the current study-based value of rotational thrombectomy in the venous and arterial system.
1
Introduction
Acute and subacute ischemia of the extremity is caused by impaired arterial perfusion to the extremity. The reason, in most cases, is local arterial thrombosis or embolism. Cardiac embolism is the most common cause. An acute arterial perfusion disorder of an extremity may, in addition to involving the risk of irreversible damage to or loss of the extremity, cause life-threatening complications. Due to the anaerobic local and eventually systemic metabolic situation secondary to hypoperfusion, organs such as the heart and kidney are directly involved in the process. The management of patients includes, in addition to general intensive-care measures, the decision to perform an adequate revascularization procedure. An acute embolic arterial occlusion very frequently occurs in a peripheral vascular system with no previous hemodynamic impairment, and with the collateral compensation required for this condition. This results in a much more severe clinical ischemic situation (so-called white ischemia) accompanied by characteristic pain and neurological abnormalities in the affected extremity. On the other hand, the formation of a local arterial thrombus, such as one due to rupture of a plaque in the presence of preexisting peripheral arterial occlusive disease, causes fewer and less severe symptoms because of compensatory collateral circulation . Differentiating between an arterial occlusion of embolic or local thrombotic origin may be aided by the patient’s medical history, such as the presence of heart disease (atrial fibrillation, cardiac valve defect) or a known peripheral arterial occlusive disease treated several times by various interventions. In cases of suspected acute ischemia of the extremity, the location of an acute arterial occlusion must be determined rapidly with the aid of contemporary ultrasound procedures and, if necessary, CT or MR angiography. According to current international guidelines in keeping with the consensus agreement (TASC II guidelines), acute ischemia of the extremity is graded in categories I to III . Especially the vitally threatened extremity of category II calls for immediate diagnostic investigation and therapy ( Table 1 ). According to the current TASC II guidelines, the consensus that applies today is that acute ischemia of the extremity must be treated by an interventional procedure (local thrombolysis, interventional embolectomy) or surgery (embolectomy). Since the TASC II guidelines are entirely based on studies and experience prior to 2007, they do not conform to the current level of study-based development. The intervention of percutaneous mechanical thrombectomy (PMT), employing the principle of rotational thrombectomy, has achieved impressive results in the last few years, as observed in single-center and multicenter studies focusing on various etiologies and locations of acute ischemia of the extremity. This has led to a change of paradigm in favor of less invasive therapy. The general advantage of a PMT device is its rapid use without major preparations (such as preparation for anesthesia, the presence of various specialists), which permits rapid reperfusion of a hypoperfused extremity. The use of any new therapy option should be amenable to, and should demonstrate a significant advantage on, comparison with established measures. In comparative studies concerning local thrombolysis and surgical embolectomy, the following criteria were used for direct comparison of therapeutic measures :
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Technical success rates
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Reintervention measures/re-occlusion
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Preservation rate of the extremity
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Death
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Peripheral embolism as a complication
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Duration of the intervention
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Hemorrhage
| Category | Prognosis | Report | Doppler signal | ||
|---|---|---|---|---|---|
| Loss of sensitivity | Muscle weakness | Arterial | Venous | ||
| I Viable | No immediate threat | None | None | Audible | Audible |
| II Vitality is endangered | |||||
| A | Favorable prognosis in cases of immediate treatment | Minimal | None | Often no evidence | Audible |
| B | Extremity can be preserved when revascularization is performed immediately | Pain at rest | Moderate | No evidence | Audible |
| III Irreversible | Marked tissue necrosis | Anesthesia Paralysis | No evidence | ||
2
Methods
The objective of this article was to give an overview and review of the case selection, technical aspects and procedural outcomes reported after rotational thrombectomy in patients with acute limb ischemia and deep venous thrombosis. An internet based search using Embase, Medline and PubMed databases was performed using free-text search terms “acute and subacute limb ischemia, thrombectomy, thrombosis, deep venous thrombosis, rotational thrombectomy and local lysis therapy”. The reference lists of analyzed articles were also searched to identify further relevant citation.
2.1
Technique of rotational thrombectomy
The Rotarex® thrombectomy system (Straub Medical, Wangs, Switzerland, Figs. 1 ) functions on the basis of the Archimedes screw principle. This consists of a spiral rotating at a speed of about 40,000 rotations per minute. The system consists of three individual components which can be assembled in a few minutes by a practiced team. It is driven by a motor which also serves as an electronic control unit and displays information about the functionality of the rotating helix. The conveyor helix connected to the motor through a magnetic coupling operates within the catheter. Rapid rotation of the helix creates a persistent vacuum inside the catheter, which causes thrombotic material in the target lesion to be suctioned and conveyed into a collection bag at the end of the catheter. The difference between the Aspirex catheter system used in the venous system and the Rotarex system mainly used in the arterial system is the configuration of the catheter head. The Rotarex system used in arteries allows occlusive (thrombotic and organized) material to become detached and be removed. In contrast, the Aspirex catheter indicated for the thin-walled venous system serves to aspirate and remove thrombotic material. Depending on the size of the system used (Rotarex® 6–8 F, Aspirex® 6–10 F), aspiration rates of 1.5 ml/s can be achieved with the 8-F Rotarex system. Larger systems are used in the pelvic and femoral flow region. In cases of thrombotic occlusions at these locations, a larger quantity of thrombotic material has to be removed because of the large vessel diameter. Depending on the size of the target vessel, the 6-F system permits thrombectomy well into the lower leg. After performing a diagnostic angiography one should use a 6-F or 8-F Rotarex system, depending on the diameter of the vessel. It may be necessary to switch to an 8-F catheter. When using the roadmap or overlay technique, a 0.018-in. guidewire is introduced into the target lesion and guided in distal direction. Through this guidewire, the respective Rotarex system is inserted to a point a few centimeters above the occlusion and then activated. Passage of the occlusion should be performed slowly. Especially in cases of subacute occlusions with partly organized material, one should proceed slowly in order to avoid peripheral embolism. Depending on morphological conditions after the achievement of re-flow, one should perform an angioplasty with or without stent implantation according to current recommendations. In our experience, a stent is required in the large majority of treated lesions because dissection or relevant hemodynamic stenoses are quite common in the region of intervention. This may have to be followed by guideline-based antithrombocytic combination therapy consisting of acetylsalicylic acid and clopidogrel. A summary of advantages and disadvantages of the rotational thrombectomy devices can be found in Table 3 .
| Study | Success rate for endovascular technique | Amputation-free survival after 12 months | Restenosis and Reintervention rate | Complications |
|---|---|---|---|---|
| Zeller et al. Rotarex® (n = 98 patients) | 96% primary success rate | 95% | 33% restenosis in native vessels, 74% for instent restenosis recanalisation, 86% for bypass-graft occlusions. Follow-up: 13 +/− 4 months | Two amputations after unsuccessful recanalization 16 minor complications including bleeding complications |
| Wissgott et al. Rotarex® (n = 265 patients) | 94.7% with complete thrombus removal | 100% | 49% restenosis (acute occlusion group) 51% restenosis (subacute occlusion group) Follow up: 12 +/− 3 months | Distal embolization: 16/265 Vessel perforation: 3/265 Retroperitoneal bleeding: 1/265 |
| TOPAS Thrombolysis versus surgery (n = 544 patients) | Recanalisation: 79.7% Thrombus dissolution: 67.9% | 65% thrombolysis patients (native artery and bypass-graft occlusions) 69.9% surgery patients (native artery and bypass-graft occlusions) | Open surgical reprocedure (thrombolysis group): 40% after 6 months, 39.3% after 12 months. Open surgical reprocedure (surgical group): 69% after 6 months, 65% after 12 months. Endovascular reprocedure (thrombolysis group): 16.9% after 6 months, 15.4% after 12 months. Endovascular reprocedure (surgical group): 2.1% after 6 months, 1.7 after 12 months. | Major Bleeding complication: 32/272 (urokinase group) 14/272 (surgery group) Distal embolization: 41/272 (urokinase group) Vessel perforation: 3/272 False aneurysm: 7/272 |
| Advantages of rotational thrombectomy | Disadvantages of rotational thrombectomy |
|---|---|
| Quick set up < 3 min. Easy access to culprit lesion even in cross over with catheter length up to 135 cm | Still kinking problems with ineffective thrombectomy in angled and sclerotic aortic bifurcations |
| Effective study based thrombectomy of fresh thrombus formation | Potential danger of vessel wall dissection and perforation in highly calcified vessels |
| Short hospital stay after effective thrombectomy, no ICU stay affordable | High costs for Rotarex and Aspirex catheter system |
| Multicenter studies published comparing different thrombectomy therapies/devices with rotational thrombectomy in arterial vessels | So far only case reports and monocentric evaluation for use in deep venous thrombosis |
| Reduced use of additive lytic agent because of effective thrombectomy | Distal embolization still possible with indication for thrombectomy or lysis therapy |
| Available catheter size 6–10 French to use in aortic and infraaortic vessels. Case reports for use in upper extremities and visceral arteries available. | No catheter device available for below the knee thrombectomy. Minimal lumen vessel 4 mm |
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