Table 9:
Adverse Effects and Complications With Mechanical Thrombectomy Use in Arterial Acute Limb Ischemia
| Author, year | Outcome measurement | Results | P value | |
|---|---|---|---|---|
| MT | Comparator | |||
| PMT (AngioJet) | ||||
| Byrne et al, 201476 | Systematic bleed | 7.0% (n = 5) | 3.6% (n = 3) | P = .34 |
| Acute renal failure | 4.2% (n = 3) | 0 | P = .06 | |
| Hematoma | 8.4% (n = 6) | 1.2% (n = 1) | P = .03 | |
| Embolization | 14.1% (n = 10) | 6.0% (n = 5) | P = .09 | |
| de Athayde Soares et al, 202077 | Specific complications leading to death | 1 acute renal failure 1 acute myocardial infarction |
2 myocardial infarction 2 pneumonia 2 hemorrhagic stroke |
NR |
| Compartment syndrome | 0 | 2 (1 resulted in infection) | NR | |
| Escobar et al, 201778 | Acute kidney injury | 29% (n = 15) | 8% (n = 4) | P = .007 |
| Fasciotomy | 5 events | 5 events | NR | |
| Bypass/endarterectomy | 3 events | 3 events | NR | |
| Mean blood loss | 12% | 5% | P = .009 | |
| Gandhi et al, 201879 | Any complication | 27.8% (n = 15) | 13.8% (n = 4) | P = .179 |
| Embolism, hematoma, bleeding, respirator distress, dissection or perforation, DVT, pseudoaneurysm, acute renal failure | No difference between groups for any specific type of complication reported | P > .5 | ||
| Gong et al, 20211 Included large bore catheters, AngioJet, and Rotarex |
Minor complications (no therapy, no consequences) | 10.5% (10) | 23.8% (11) | P = .36 |
| Major complications (requires therapy or permanent sequelae) | 5.3% (3) | 4.9% (2) | P = 1.00 | |
| Procedure related distal embolization | 24.6% (14) | 4.9% (2) | P = .009 | |
| Muli Jogi et al, 201882 Included both AngioJet and Rotarex |
Complications, reported using the CIRSE classification system | 28.6% (8) Groin hematoma, pseudoaneurysm, chest wall hematoma, fasciotomy for compartment syndrome |
30.3% (27) Groin hematoma, gastro-intestinal bleed requiring infusion, compartment syndrome requiring fasciotomy, distal embolism |
NR |
| Vacuum Aspiration (Indigo) | ||||
| No studies met our inclusion criteria for this mechanical thrombectomy device | ||||
| Rotational (Rotarex) | ||||
| Gong et al, 2021,1 included large bore catheters, AngioJet, and Rotarex (see findings discussed elsewhere in this assessment)a | ||||
| Hundt et al, 201380 | Complications | Pseudoaneuryma (3), distal embolism (9), local bleeding (2) 0 cases of systemic bleeding, arteriovenous fistula, dissection, or perforation |
Pseudoaneuryma (1), local bleeding (10), systemic bleeding (1) 0 cases of arteriovenous fistula or distal embolism |
NR |
| Kronlage et al, 201781 | Complications in non-critically ill patients (data for critically ill patients are limited): | |||
| Major bleeding | 3.6% (5) | 22.2% (4) | P < .05 | |
| Aneurysma | 2.9% (4) | 0 | NS | |
| AV-fistula | 0.7% (1) | 0 | NS | |
| Compartment syndrome | 0 | 0 | NS | |
| Muli Jogi et al, 2018,82 included both AngioJet and Rotarex (see findings discussed elsewhere in this assessment)b | ||||
| Puangpunngam et al, 202083 | Complications: | |||
| Aneurysm/pseudoaneurysm at the puncture site | 18.2% (2) | 4.8% (1) | NS | |
| Minor bleeding | 18.2% (2) | 31.8% (7) | NS | |
| Major bleeding requiring operation to stop bleeding | 0 | 2 events | NS | |
| Cardiopulmonary complications | 0 | 0 | NR | |
| Ultrasound assisted (EKOS) | ||||
| Chait et al, 201974c | Compartment syndrome | 14% (3) | 10% (7) | P = .65 |
| Significant bleeding requiring more than 4 units of blood | 0 | 4% (3) | P = 1.0 | |
| Other complications | 14% | 14% | P = .92 | |
| Schernthaner et al, 201484 | Proportion of people with bleeding complications | 6.7% (5) | 22.2% (6) | P = .025 |
| Minor complications | 2.7% (2) | 7.4% (1) | P = .276 | |
| Major complications | 4.0% (3) | 14.8% (4) | P = .57 | |
| Distal embolization | 21.7% (15) | 12.0% (3) | P = .289 | |
| Other complications | 18.7% (14) | 22.2% (6) | P = .690 | |
Abbreviations: CDT, catheter directed thrombosis; DVT, deep vein thrombosis; MT, mechanical thrombectomy; NR, not reported; NS, not significant; PMT, pharmacomechanical thrombectomy.
a
Gong et al1 compared treatment groups of large bore catheters versus AngioJet versus Rotarex.
b
Muli Jogi et al, 201882 compared catheter-directed thrombolysis versus AngioJet and Rotarex.
c
While all patients in both groups also received AngioJet, study design was to isolate the effect of EKOS.