Annals of vascular surgery · 2026
Outcome of a Prospective Registry to Evaluate the Performance of the MANTA Vascular Closure Device in EVAR Patients.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Goeteyn Jens, Jongen Audrey, Loos Maarten, Yazar Ozan, Zwetsloot Jenny, van Sambeek Marc R H M, Bode Aron, Cuypers Philippe
Аннотация
BACKGROUND: Percutaneous endovascular aortic repair (pEVAR) has become the gold standard in the treatment of aortic aneurysms. Vascular puncture site complications can have severe implications on morbidity and mortality of patients, underlining the necessity for safe and effective closure devices. The MANTA vascular closure device (VCD) has shown to be safe and effective in patients undergoing endovascular aortic repair (EVAR) and transcatheter aortic valve replacement (TAVR). However, most of these trials were conducted in TAVR patients, involved highly selected populations, and had a retrospective design. This study aims to address the limited real-world data on the performance of the MANTA device in EVAR patients.
METHODS: We performed a multicenter, prospective, observational, non-∖randomized study on the performance of the MANTA VCD (Teleflex Inc., Pennsylvania, USA) in patients receiving percutaneous EVAR. We selected patients within instructions for use of MANTA VCD. Time to hemostasis was measured. All patients had a clinical evaluation before discharge and at 30 days. A computed tomography angiography was performed at 30 days of index procedure. Primary outcome was technical success defined as successful vessel closure within 5 minutes after MANTA VCD deployment, without rebleeding and without the need of any additional procedures. Secondary outcome was technical failure defined as closure device failure, infection, bleeding, perforation, lower leg ischemia, hematoma >5 cm, seroma, pseudoaneurysm, arteriovenous fistula, distal embolization, femoral artery thrombosis, and arterial dissection within 30 days after the index procedure.
RESULTS: Patient inclusion took place between January 2019 and November 2023. A total of 279 groins were treated with the MANTA VCD, and every patient received EVAR through femoral access. Technical success was seen in 263 groins (94.3%). Adverse events were seen in 16 groins (5.7%). The median time to hemostasis was 1 minute 0 seconds in both the right and left common femoral artery (interquartile range right: 11min10sec, left: 1m40sec). Immediate suture of the femoral artery during index procedure due to bleeding of the femoral artery was seen in 10 groins (3.6%). Postprocedural complications were seen in another 6 groins (2.2%) of which 2 patients (0.7%) received adjunctive surgical procedures.
CONCLUSION: The MANTA VCD was found to be a safe and effective closure device in patient receiving pEVAR repair with a high technical success rate.
METHODS: We performed a multicenter, prospective, observational, non-∖randomized study on the performance of the MANTA VCD (Teleflex Inc., Pennsylvania, USA) in patients receiving percutaneous EVAR. We selected patients within instructions for use of MANTA VCD. Time to hemostasis was measured. All patients had a clinical evaluation before discharge and at 30 days. A computed tomography angiography was performed at 30 days of index procedure. Primary outcome was technical success defined as successful vessel closure within 5 minutes after MANTA VCD deployment, without rebleeding and without the need of any additional procedures. Secondary outcome was technical failure defined as closure device failure, infection, bleeding, perforation, lower leg ischemia, hematoma >5 cm, seroma, pseudoaneurysm, arteriovenous fistula, distal embolization, femoral artery thrombosis, and arterial dissection within 30 days after the index procedure.
RESULTS: Patient inclusion took place between January 2019 and November 2023. A total of 279 groins were treated with the MANTA VCD, and every patient received EVAR through femoral access. Technical success was seen in 263 groins (94.3%). Adverse events were seen in 16 groins (5.7%). The median time to hemostasis was 1 minute 0 seconds in both the right and left common femoral artery (interquartile range right: 11min10sec, left: 1m40sec). Immediate suture of the femoral artery during index procedure due to bleeding of the femoral artery was seen in 10 groins (3.6%). Postprocedural complications were seen in another 6 groins (2.2%) of which 2 patients (0.7%) received adjunctive surgical procedures.
CONCLUSION: The MANTA VCD was found to be a safe and effective closure device in patient receiving pEVAR repair with a high technical success rate.