Table 38:
Summary of Findings of Effect of Ultrasound-assisted 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 | 193 (2 Obs) | OR: 1.51 (0.37-6.12) | 33 more per 1,000 (from 135 fewer to 86 more) | ⊕ Very low |
| Complete thrombus removal | 193 (2 Obs) | OR: 1.70 (0.80-3.61) | 13 fewer per 1,000 (47 fewer to 183 more) | ⊕ Very low |
| Patency | 68 (1 Obs) | OR: 1.75 (0.50-6.17) | 116 more per 1,000 (169 fewer to 275 more) | ⊕ Very low |
| Re-thrombosis (and revision rates) | 102 (1 Obs) | OR: 0.57 (0.23-1.42) | 126 fewer per 1,000 (271 fewer to 87 more) | ⊕ Very low |
| Perioperative mortality | 193 (2 Obs) | OR: 1.05 (0.10-10.62) | 2 more per 1,000 (28 fewer to 224 more) | ⊕ Very low |
| Adverse events | 193 (2 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) | 193 (2 Obs) | People who received MT had no difference in volume of thrombolytic compared to control groups | ⊕ Very low | |
| Time of thrombolytic infusion (hour) | 193 (2 Obs) | — | MD: 0.67 higher (3.04 lower to 4.39 higher) | ⊕ Very low |
| Acute Deep Vein Thrombosis | ||||
| Post-thrombotic syndrome | 120 (1 RCT) | OR: 1.28 (0.42-3.95) | 25 more per 1,000 (57 fewer to 210 more) | ⊕⊕⊕ Moderate |
| 70 (1 Obs) | OR: 0.47 (0.05-4.33) | 50 fewer per 1,000 (94 fewer to 225 more) | ⊕ Very low | |
| Complete thrombus removal | 48 (1 RCT) | RR: 0.93 (0.59-1.48) | 44 fewer per 1,000 (256 fewer to 300 more) | ⊕⊕⊕ Moderate |
| 254 (3 Obs) | RR: 1.03 (0.52-2.05) | 19 more per 1,000 (299 fewer to 654 more) | ⊕ Very low | |
| Patency | 48 (1 RCT) | RR: 1.04 (0.93-1.17) | 38 more per 1,000 (67 fewer to 163 more) | ⊕⊕ Low |
| 144 (2 Obs) | RR: 1.26 (0.86-1.85) | 126 more per 1,000 (68 fewer to 413 more) | ⊕ Very low | |
| Re-thrombosis (and revision rates) | 232 (2 RCTs) | There were no significant findings between study groups for recurrent DVT without stent, in-stent thrombosis, or ulceration reported | ⊕⊕ Low | |
| 159 (2 Obs) | There were no significant findings between study groups for recurrence rates or additional MT procedures | ⊕ Very low | ||
| Quality of life | 232 (2 RCTs) | — | MD: 0.23 higher (2.34 lower to 2.8 higher) | ⊕⊕ Low |
| 95 (1 Obs) | — | MD: 1.00 higher (1.69 lower to 3.69 higher) | ⊕ Very low | |
| Perioperative Mortality | 184 (1 RCT) | OR: 1.02 (0.06-16.59) | 0 fewer per 1,000 (10 fewer to 142 more) | ⊕ Very low |
| 254 (3 Obs) | There were no significant findings between study groups for mortality or time, in months, of event free survival | ⊕ Very low | ||
| Adverse events | 159 (2 RCTs) | There were no significant differences in rates of bleeding, pulmonary embolism, or hematoma between those who received MT and those who did not | ⊕⊕⊕ Moderate | |
| 412 (3 Obs) | There were no statistically significant differences in the rates of bleeding between study groups | ⊕ Very low | ||
| Volume of thrombolytic (mg) | 56 (1 Obs) | — | SMD: 0.51 lower (1.13 lower to 0.1 higher) | ⊕ Very low |
| Time of thrombolytic infusion (hour) | 159 (2 Obs) | — | MD: 1.02 lower (5.81 lower to 3.78 higher) | ⊕ Very low |
| Hospital length of stay, ultrasound assisted | 48 (1 RCT) | — | MD: 0.10 lower (0.86 lower to 0.66 higher) | ⊕⊕⊕ Moderate |
| 95 (1 Obs) | — | MD: 2 lower (3.36 lower to 0.64 lower) | ⊕ Very low | |
Abbreviations: CI, confidence interval; DVT, deep vein thrombosis; GRADE, Grading of Recommendations Assessment, Development, and Evaluation; MD, mean difference; MT, mechanical thrombectomy; OR, odds ratio; Obs, observational study; RR, relative risk; SMD, standardized mean difference.
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.