Vessel Preparation in Infrapopliteal Arterial Disease: A Systematic Review and Meta-Analysis
Michael J Nugteren1,2, Rutger H A Welling3, Olaf J Bakker3
1Department of Vascular Surgery, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.
Insights
Vessel preparation before angioplasty for infrapopliteal arterial disease showed similar outcomes, except for improved limb salvage with scoring balloons and mechanical atherectomy. Standard use of these devices offers no additional value over angioplasty alone.
Area of Science:
- Endovascular therapy
- Peripheral artery disease
- Vascular access
Background:
- Infrapopliteal arterial disease presents complex challenges due to small vessel size, long lesions, and calcification.
- Effective treatment is crucial for limb salvage in patients with chronic limb-threatening ischemia.
- Vessel preparation devices aim to improve outcomes of angioplasty in these challenging cases.
Approach:
- Systematic review of Medline, EMBASE, and Cochrane databases (2000-2022).
- Comparison of vessel preparation techniques versus plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty alone.
- Primary outcomes: 12-month primary patency and limb salvage.
Key Points:
- 1685 patients (1913 lesions) included; POBA studies (n=11) had poor to moderate quality.
- DCB studies (n=2) showed no benefit of adjunctive atherectomy.
- Scoring balloons and mechanical atherectomy (MA) showed improved 12-month limb salvage versus POBA.
Conclusions:
- Adjunctive vessel preparation showed similar 12-month outcomes to POBA/DCB alone, except for improved limb salvage with scoring balloons and MA.
- Study heterogeneity and methodological quality raise concerns about selection bias.
- No additional value found for the standard use of vessel preparation devices.
Purpose:
Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease.
Methods:
Medline, EMBASE, and Cochrane databases were searched for studies published between 2000 and 2022 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The primary outcomes were 12-month primary patency and limb salvage.
Results:
A total of 1685 patients with 1913 lesions were included in 11 POBA studies. Methodological quality was assessed as poor to moderate in these studies. Only 2 studies with 144 patients assessed vessel preparation in conjunction with DCB angioplasty. These randomized trials were assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency and limb salvage in the POBA studies were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA), and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons and MA demonstrated significantly improved 12-month limb salvage compared to POBA.
Conclusions:
Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.
Clinical Impact:
Infrapopliteal arterial disease is associated with chronic limb-threatening ischemia (CLTI) and generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification. A wide range of vessel preparation devices have been developed to contribute to improved peri- and postprocedural outcomes in these complex lesions. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB angioplasty alone in infrapopliteal arterial disease. Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and mechanical atherectomy (MA). However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.
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