[Endovascular abdominal aortic aneurysm repair with a new stent graft:early results from a multicenter study].
Zhonghua Wai Ke Za Zhi
; 60(12): 1049-1056, 2022 Dec 01.
Article
em Zh
| MEDLINE
| ID: mdl-36480871
ABSTRACT
Objective:
To examine the safety and effectiveness of a new stent graft system for endovascular repair of abdominal aortic aneurysm(AAA).Methods:
This is a prospective,multi-center,single-arm clinical trial. The patients with AAA treated with a new stent graft system were enrolled at 21 centers from September 2018 to September 2019 in China. Follow-up was performed before discharge, and at 30, 180, 360 days after operation, respectively. The primary safety endpoint was the incidence of major adverse events(MAE) within 30 days. The primary efficacy endpoint was the success rate of AAA treatment at 360 days. Secondary safety endpoints were the incidence of perioperative access complications and acute lower limb ischemia,all-cause mortality, AAA related mortality and incidence of serious adverse events (SAE) at 180 and 360 days. Secondary efficacy endpoints were the incidence of type â or â ¢ endoleak,stent displacement,and conversion to open surgery or re-intervention at 180 and 360 days.Results:
One hundred and fifty-six patients were enrolled,including 137 males and 19 females. The age was (68.9±6.9) years (range48.2 to 84.6 years).Maximum aneurysm diameter was (50.8±11.2) mm (range25.0 to 85.0 mm),diameter of proximal landing zone was (21.2±2.5) mm (range17.0 to 29.5 mm),and length of proximal landing zone was (31.4±13.0) mm (range11.0 to 75.0 mm).The incidence of MAE was 1.3% (2/156) at 30 days,both were all-cause death cases. The success rate of AAA treatment was 88.5% (138/156) at 360 days. No perioperative access complication and acute lower limb ischemia occurred. All-cause mortality was 2.0% (3/154) at 180 days and 2.6% (4/153) at 360 days,and there was no AAA related death. The incidence of SAE was 23.0%(35/152) at 180 days and 30.5%(46/151) at 360 days, and no device-related SAE occurred. The incidence of type â or â ¢ endoleak was 3.4% (5/147) at 180 days and 3.5% (5/144) at 360 days.Conclusion:
The new stent graft system is easy to operate,and early-term safety and effectiveness results are expected.
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Aneurisma da Aorta Abdominal
/
Isquemia
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limite:
Aged
/
Aged80
/
Humans
/
Middle aged
País/Região como assunto:
Asia
Idioma:
Zh
Revista:
Zhonghua Wai Ke Za Zhi
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
China