ABSTRACT
BACKGROUND: The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). METHODS: The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium. RESULTS: A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement). CONCLUSIONS: Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.
Subject(s)
Endovascular Procedures/instrumentation , Femoral Artery , Peripheral Arterial Disease/therapy , Popliteal Artery , Self Expandable Metallic Stents , Vascular Calcification/therapy , Aged , Aged, 80 and over , Alloys , Belgium , Endovascular Procedures/adverse effects , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prospective Studies , Prosthesis Design , Registries , Time Factors , Treatment Outcome , Vascular Calcification/diagnostic imaging , Vascular Calcification/physiopathology , Vascular PatencyABSTRACT
BACKGROUND: Carotid endarterectomy (CEA) is the gold standard for treatment of carotid artery stenosis. CEA can be challenging, even technically impossible. Prosthetic carotid bypass grafting is a proven and safe alternative when CEA is hazardous. An alternative technique that is prosthetic carotid bifurcation resection and interposition of a polytetrafluorethylene graft (BRIG) is described in this article. METHODS: In our Department of Vascular Surgery, between January 2007 and October 2014, 103 BRIG procedures were performed. The outcome of conventional CEA and patients treated by the BRIG procedure were compared. Within the same period of time 50 CEA procedures (32.7%) were performed. Morbidity, mortality, and postoperative restenosis were compared. RESULTS: The 30-day mortality was 1% for the BRIG group and 0% in the CEA group (P value, 0.4839). The 30-day stroke rate was 1.9% for the BRIG group and 0% in the CEA group (P value, 0.3222). One patient died in the early postoperative period from acute myocardial infarction. A total of 13 (8.5%) patients died during follow-up, none of which were surgery related. Median follow-up was 29.1 months. There was a statistically higher restenosis rate in the CEA group compared with the BRIG group (16.0% vs. 1.9%, P value, 0.0053). Other complications were comparable. Mean operating and clamping time were significantly shorter in the BRIG group. CONCLUSIONS: BRIG appears to be a safe and feasible surgical alternative to CEA. The technique allows for shorter operating time, shorter clamping time, and appears to result in lower restenosis rates. Complication rates seem to be comparable to CEA. Prospective, randomized controlled trials on this topic are needed. To perform bilateral procedures, a bifurcation graft should be created to revascularize both the internal and external carotid artery.
