2 The procedure
2.1.1 Femoropopliteal arterial lesions are common in patients with symptomatic peripheral arterial disease (PAD) of the lower limbs, usually presenting with intermittent claudication.
2.1.2 Cardiovascular risk factor modification is fundamental to management. For patients with severely impaired walking distance or with critical limb ischaemia, revascularisation procedures such as balloon angioplasty, stenting or bypass grafting can be used.
2.2.1 Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices aims to improve arterial flow by removing atheromatous plaque that is restricting blood flow.
2.2.2 With the patient under local anaesthesia, a guidewire is inserted percutaneously into the femoral artery, and the atherectomy catheter is introduced. Catheters of various diameters are available to suit the arterial diameter at the site of the lesion. After appropriately positioning the device, a high-speed rotating cutting blade excises the plaque. Plaque debris is usually collected in a distal nosecone and removed on device withdrawal. Alternatively, depending on the catheter design, the sheathed cutting blade may be advanced over the guidewire beyond the lesion and then exposed so that excision can be undertaken while the device is being withdrawn. Several passes of the catheter may be required. A distal embolic protection device is sometimes used. Adjunctive balloon angioplasty or stenting of the atherectomised segment may be done before removal of the sheath.
2.2.3 Various devices can be used for this procedure.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 A case series of 601 patients reported that procedural success (≤ 50% residual stenosis with no death, myocardial infarction, amputation, revascularisation, or major bleeding) was achieved in 95% (778/822) of lesions at 30-day follow-up.
2.3.2 A case series of 275 patients reported that limb amputation was avoided in 93% of patients at 12-month follow-up and 92% of patients at 18-month follow-up (absolute figures not stated). A case series of 60 patients reported that amputation was required in 7% (4/60) of patients at a mean 5-month follow-up. Of these patients, 2 had a patent atherectomy site but continuing ischaemia.
2.3.3 The case series of 601 patients reported that no further target lesion revascularisation was required in 90% of patients at 6-month follow-up (n = 248), and in 80% of patients at 12-month follow-up (n = 87) (absolute figures not stated).
2.3.4 A case series of 34 patients reported clinical PAD improvement of 1 or more grades (on the Trans-Atlantic Inter‑Society Consensus [TASC] II grading system) in 75% (27/36) of procedures at 1-month follow-up and 55% (12/22) of procedures at 12-month follow-up. A case series of 16 patients (17 limbs) with TASC grade C lesions reported that 71% (12/17) had improved symptoms at 1-month follow-up, and 41% (7/17) of limbs remained symptom-free at 6-month follow-up.
2.3.5 The case series of 275 patients reported that for all primary percutaneous atherectomy procedures (without adjunctive balloon angioplasty) the primary patency rate (arterial duplex ratio between proximal adjacent artery and the arterial lesion in question greater than 5.0) was 53% at 18-month follow-up (absolute figures not stated).
2.3.6 The Specialist Advisers listed key efficacy outcomes as adequate luminal channel and long-term patency, limb salvage, improvement in claudication, quality of life and ulcer healing.
2.4.1 Periprocedural embolism was reported in 1 out of 1258 procedures in the case series of 601 patients (clinical sequelae were not described) and in 7% (5/70) of procedures in the case series of 60 patients (treated with suction embolectomy or tissue plasminogen activator). Embolism (treated by atherectomy) was reported in 5% (1/18) of procedures in a case series of 16 patients.
2.4.2 Intraoperative arterial wall perforation occurred in 1% (10/1258) of procedures in the case series of 601 patients (clinical sequelae not described). No arterial wall perforation was reported in case series of 60 and 131 procedures.
2.4.3 Graft thrombosis (requiring surgery) following atherectomy at the inflow end of a femorofemoral crossover graft was reported in 1 patient in the case series of 34 patients. Pseudoaneurysm formation (requiring surgery) was reported in 1 patient in the same case series.
2.4.4 The Specialist Advisers considered theoretical adverse events to include distal embolisation, limb loss, puncture site bleeding/haematoma and device-related complications.