Midterm Results of Intravascular Lithotripsy for Severely Calcified Common Femoral Artery Occlusive Disease: A
Elda Chiara Colacchio1, Matteo Salcuni2, Angelo Gasparre3
1Vascular and Endovascular Surgery Section, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, Padova, Italy.
Insights
Intravascular lithotripsy (IVL) offers a safe and effective endovascular option for treating severe common femoral artery (CFA) calcifications. This technique, combined with drug-coated balloon angioplasty, shows promising results for peripheral arterial disease (PAD).
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Endovascular Therapy
Background:
- Traditional open surgery for common femoral artery (CFA) occlusive disease poses risks for frail patients.
- Endovascular revascularization techniques are increasingly sought for peripheral arterial disease (PAD).
- Intravascular lithotripsy (IVL) has demonstrated potential in treating lower limb arterial disease.
Purpose of the Study:
- To evaluate the safety and efficacy of intravascular lithotripsy (IVL) for severely calcified common femoral artery (CFA) disease.
- To report the experience with IVL as an endovascular treatment for complex PAD in the CFA.
Main Methods:
- Prospective enrollment of 10 consecutive patients (12 limbs) with severe CFA PAD and calcification.
- Treatment involved intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty.
- Primary outcomes included technical success, procedural success, clinical success, and target lesion revascularization (TLR).
Main Results:
- 100% technical and procedural success was achieved with IVL and DCB angioplasty.
- A median stenosis reduction of 55.5% was observed, with a significant improvement in Rutherford class.
- Low rates of target lesion revascularization (8.3%) and no access site or distal embolization complications were reported.
Conclusions:
- Intravascular lithotripsy (IVL) combined with drug-coated balloon (DCB) angioplasty appears safe and effective for selected cases of severe CFA calcified disease.
- Further long-term follow-up and larger patient cohorts are necessary to validate these promising findings.
Purpose:
Common femoral artery (CFA)-occlusive disease has traditionally been treated with open surgery, yet nowadays the frailty of patients has induced to find new techniques of revascularisation by endovascular means. So far, intravascular lithotripsy (IVL) has shown promising results in several lower limbs arterial districts. The purpose of this article is to report our experience with IVL for severely calcified peripheral arterial disease (PAD) of the CFA.
Methods:
From November 2018 and October 2020, 10 consecutive patients (12 limbs) treated with IVL were prospectively enrolled in a dedicated database. Inclusion criteria were CFA localization of PAD, with a severe degree of calcification, a lesion length ≥10 mm, and a degree of stenosis ≥70% (severe). The only admitted adjunctive treatment was drug-coated balloon (DCB) angioplasty. Primary outcomes were technical and procedural success, clinical success, and target lesion revascularisation (TLR). Secondary outcomes were target extremity revascularisation (TER) and major adverse events (MAEs).
Results:
All patients underwent IVL with associated DCB angioplasty. The median percentage of achieved stenosis reduction was 55.5% (interquartile range [IQR] 50-60.75), with a technical and procedural success of 100%. Over the study period, TLR only occurred in one limb (8.3%), with a mean upgrade in Rutherford class of 2.7 ± 0.77. No target vessel and access site complications were reported, as well as no distal embolization. One death and one major amputation occurred over the follow-up period, both in the same patient.
Conclusions:
Based on our experience, IVL for selected cases of severely calcified CFA disease, associated with DCB angioplasty, may be considered a safe and effective technique. Of course, a long-term follow-up and a larger series of patients are needed to validate our results.
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