Performing Transcarotid Artery Revascularization (TCAR) Outside Of Manufacturer's Instructions For Use Is Safe, But Has Higher Reintervention Rates
Stephen Hayes, BS, Christopher Murter, MD, David Dexter, MD, Animesh Rathore, MBBS, Rasesh Shah, MD, Hosam El Sayed, MD, Jean Panneton, MD.
Eastern Virginia Medical School, Norfolk, VA, USA.
OBJECTIVES: We sought to evaluate perioperative and short-term outcomes between TransCarotid Artery Revascularization (TCAR) procedures compliant with manufacturer’s instructions for use (IFU) versus procedures in violation of IFU.
METHODS: We retrospectively evaluated patients undergoing TCAR within a single multispecialty group between December 2015 and February 2020. Patients without adequate pre-operative imaging were excluded. IFU criteria include CCA diameter ≥6 mm, ICA diameter of 4-9 mm, femoral venous access, carotid bifurcation to clavicle length ≥5 cm, and absence of severe CCA disease at the puncture site. Patient selection warnings (PSW) included extensive lesion calcification, intraluminal thrombus, and ICA/CCA tortuosity. Primary endpoints included perioperative (30-day) major adverse events (ipsilateral stroke, transient ischemic attack, death, or myocardial infarction (MI)) and perioperative complications. Secondary endpoints included ipsilateral restenosis, neurologic events, and reinterventions.
RESULTS: 217 procedures (85 symptomatic, 132 asymptomatic) were performed on 209 patients. 198 procedures were IFU compliant, while 19 (8.8%) had IFU violation(s). 69 of 198 within IFU patients (35%) had PSW violation(s). IFU violations included length from clavicle to bifurcation (n=6), distal ICA diameter (n=5), CCA puncture site disease (n=5), and other (n=4). The IFU violation group had higher incidences of urgent or emergent procedures (26% vs 15%, p=.004) and prior ipsilateral CEA (42% vs 16%, p=.006). The perioperative major adverse event rate was 3.2% (n=7), 3.0% within IFU (n=6; 3 strokes, 2 TIAs, 1 death) and 5.3% outside IFU (n=1 death), (p=0.63). There was one conversion to endarterectomy in each group (p<0.05). There were no differences in other perioperative outcomes. Follow up data >30 days was available for 196 of 217 procedures. Average follow-up time was 1.2±1 years. Ipsilateral reintervention rates within 2 years were significantly higher off IFU (log rank p=.04) (Figure 1). Other outcomes (stroke, TIA, MI, and in-stent restenosis) were equivalent. PSW infringement had no differences in early or late outcomes.
CONCLUSIONS: TCAR in patients with anatomy outside of the manufacturer’s IFU can be safely performed, but leads to higher rates of carotid reintervention. Larger sample size and long-term follow-up data is needed to identify risks of specific anatomic violations as well as long-term outcomes.
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