Table 28:
Adverse Effects and Complications With Mechanical Thrombectomy Use in Acute and Subacute DVT in Observational Studies
| Results | ||||
|---|---|---|---|---|
| Author, year | Outcome measurement | MT | Comparator | P value |
| PMT (AngioJet) | ||||
| Garcia et al, 201585 | Adverse eventsa | 9 (1 serious—renal failureb) | 0 | NR |
| Huang et al 201596 | Complications (major bleeding, pulmonary embolism, renal failure) | 0 | 0 | P = 1.0 |
| Minor bleeding | 0 | 1 | P = .798 | |
| Huang et al, 202197 | Acute kidney injury | 2 | 0 | P = 1.0 |
| Pulmonary embolism | 4 | 0 | P = 1.0 | |
| Minor bleeding | 9 | 16 | P = .182 | |
| Kuo et al, 201798 | Proportion with adverse effects (gross or micro hemoglobinuria, ecchymosis, or mucosal bleeding) | 46.7% (n = 14) | 22.6% (n = 7) | P = .048 |
| Proportion who received blood transfusion | 36.7% (n = 11) | 29.0% (n = 9) | P = .704 | |
| Lee et al, 202099 | Gross hemoglobinuria, recovered within 24 h | 0 | 85% (17) | NR |
| Major bleeding, renal dysfunction, symptomatic pulmonary embolism | 0 | 0 | NS | |
| Li et al, 2020100 | Minor complications Transient hemoglobinuria | 30 | 0 | P = .0 |
| Fever | 5 | 6 | P = .837 | |
| Gingival bleeding | 1 | 0 | P = .484 | |
| Severe complications Venous damage (bleeding) | 0 | 4.6% (n = 3) | P = .245 | |
| Kidney damage, fatal pulmonary embolism, intracranial hemorrhage | 0 | 0 | P = 1 | |
| Liu et al, 2018101 | Complications (minor bleeding) | 0 | 1 | P = .55 |
| Symptomatic pulmonary embolism, major bleeding | 0 | 0 | P = 1 | |
| Morrow et al, 201773 | Renal dysfunction | 11 patients developed or progressed in their renal dysfunction | no patients progressed to renal dysfunction | NR |
| Pouncey et al, 2020103 | Acute kidney injury, bacteremia, minor bleed, major bleed, cardiac | Range: 0-13 events in each group | P > .05 | |
| Haemoglobinuria | 19% (n = 12) | 4% (n = 3) | P = .006 | |
| Shen et al, 2019104 | Gross hematuria | 100% 0% | NR | |
| Incidence of post operative acute kidney injuryc | 22.8% (n = 18) | 9.2% (n = 11) | P = .013 | |
| Tian et al, 2021105 | Systemic complications | 37.5% (n = 18) | 4% (n = 2) | P = .007 |
| Major complications | 0 | 0 | NS | |
| Minor bleeding | 2 | 6 | P = .157 | |
| Xu et al, 2021107 | Complication rates | 10.2% (n = 19) | 9.6% (n = 23) | P = 0.85 |
| Serious adverse events | 0 | 0 | NS | |
| Xu et al, 2020108 | Complications | A few incidences in both study groups of minor bleeding, puncture site bleeding, hemoglobinuria (recovered after 24 h), acute kidney injury, and infection. No reported major bleeding, gingival bleeding, or symptomatic pulmonary embolism | P > .05 | |
| Zhu et al, 2020109 | Bleeding | 0 | 18% (n = 6) | P = .024 |
| Hemoglobinuria | 19% (n = 6) No other complications (e.g., no pulmonary embolisms) |
0 | P = .011 | |
| Vacuum Aspiration (Indigo) | ||||
| No studies met our inclusion criteria for this MT device | ||||
| Rotational (Rotarex or Cleaner) | ||||
| Ezelsoy et al, 201595 | Major complications | 0 | 0 | NS |
| Ultrasound Assisted (EKOS) | ||||
| Baker et al, 201294 | Major bleeding | 7.8% (n = 5) | 10.5% (n = 2) | P = .709 |
| Minor bleeding | 4.7% (n = 3) | 5.3% (n = 1) | P = .918 | |
| Lu et al, 201775 | Post operative complications (bleeding, intracranial bleeding, hypotension) | 7 | 1 | NS |
| Tichelaar et al, 2016106 | Bleeding, minor or major | 24% (n = 15) | 39% (n = 13) | NS |
Abbreviations: MT, mechanical thrombectomy; NR, not reported; NS, not significant; PMT, pharmacomechanical thrombectomy.
a
A diverse events were not discernible by intervention type.
b
Reported to occur in a patient with MT run-time beyond what was recommended manufacturer.
c
Other metrics of kidney health and function reported, with all findings aligned with this outcome.