Table 37:
Summary of Findings of Effect of Rotational Mechanical Thrombectomy Device in Acute Lower Limb Ischemia (Arterial or Venous)
| Outcome | No. of participants (studies) | Effect | GRADEa | |
|---|---|---|---|---|
| Relative (95% CI) | Absolute (95% CI) | |||
| Arterial Acute Limb Ischemia | ||||
| Limb salvage | 109 (2 Obs) | OR: 0.88 (0.17-4.57) | 10 fewer per 1,000 (from 260 fewer to 62 more) | ⊕ Very low |
| Complete thrombus removal | 34 (1 Obs) | OR: 3.46 (0.61-19.72) | 242 more per 1,000 (123 fewer to 375 more) | ⊕ Very low |
| Re-thrombosis (and revision rates) | 109 (2 Obs) | OR: 0.92 (0.39-2.18) | 20 fewer per 1,000 (204 fewer to 192 more) | ⊕ Very low |
| Perioperative mortality | 75 (1 Obs) | Not estimable | 0 fewer per 1,000 (0 fewer to 0 fewer) | ⊕ Very low |
| Adverse events | 311 (3 Obs) | Fewer bleeding events among those who received MT. Otherwise no significant difference reported between study groups for any other adverse outcome | ⊕ Very low | |
| Volume of thrombolytic (mg; Rotational) | 34 (1 Obs) | People who received MT had lower volumes of thrombolytic compared to control groups | ⊕ Very low | |
| Hospital length of stay (days after PMT) | 202 (1 Obs) | — | MD: 0.2 lower (1.34 lower to 0.94 higher) | ⊕ Very low |
| Acute Deep Vein Thrombosis | ||||
| Post thrombotic syndrome | 50 (1 Obs) | OR: 0.31 (0.09-0.99) | 277 fewer per 1,000 (457 fewer to 2 fewer) | ⊕ Very low |
| Perioperative mortality | 50 (1 Obs) | There were no significant differences in mortality reported, with 0 in both study arms | ⊕ Very low | |
| Adverse events | 50 (1 Obs) | There were no cases of adverse events reported in either study group | ⊕ Very low | |
Abbreviations: CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; MD, mean difference; MT, mechanical thrombectomy; OR, odds ratio; Obs, observational study; PMT, pharmacomechanical thrombectomy.
Note: summary of findings table developed using GRADEpro GDT. GRADEpro Guideline Development Tool [Software]. McMaster University and Evidence Prime, 2022. Available from gradepro.org
We evaluated the quality of the body of evidence for each outcome according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Handbook.70 See Appendix 2 for further details.