Success, Safety, and Efficacy of the Mynx Femoral Closure Device in a Real-World Cohort: Single-Center Experience

Background. Femoral artery closure device use following percutaneous cannulation allows earlier mobilization, reduced staff burden, and improved comfort for patients compared with manual compression. The Mynx device (Access Closure, Inc), a novel extravascular closure device, uses a water-soluble non-thrombogenic polyethylene glycol plug. Methods. We report retrospective analysis of success, complication rates, and associated factors in 432 consecutive patients undergoing elective outpatient coronary angiography in a single United Kingdom center. Results. Six Fr sheaths were used in 62.1% and 5 Fr sheaths were used in 37.8%, with 100% successful deployment using a Mynx device. A total of 57.5% of patients were male. In 79.4%, this was the first procedure requiring femoral arteriotomy, while 20.6% had a previous procedure. Overall, 3.2% required conversion to manual compression/FemoStop (St. Jude Medical) due to impending hematoma. In all, 99.5% of patients were discharged on the same day. Confirmed hematoma >5 cm was noted in 0.7% patients, with only 2 patients (0.5%) reporting "any discomfort" during deployment and the same requiring overnight hospitalization. Use of a 6 Fr sheath (compared with 5 Fr) was associated with conversion to manual compression and complications (P<.05), as was valvular heart disease as the indication for angiography (P<.05). Hematoma formation was associated with higher diastolic and mean arterial pressure (107.4 mm Hg vs 99.6 mm Hg; P<.01). There was no increase in complications associated with use of antiplatelet/anticoagulants, previous stroke, myocardial infarction/ischemic heart disease, peripheral vascular disease, diabetes, high body mass index, or previous angiographic procedure. Conclusions. Postangiography use of the Mynx closure device is highly successful, safe, and well-tolerated with a low complication rate, allowing safe same-day discharge.