Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the AngioSeal vascular closure device.
We investigated the prevalence of vascular complications after PCI following hemostasis in 190 patients (67% men and 33% women, mean age 64 years) treated with the AngioSeal vascular closure device (St. Jude Medical, Austin, Texas) versus 238 patients (67% men and 33% women, mean age 64 years) treated with the Mynx vascular closure device (AccessClosure, Mountain View, California).


RESULTS
Death, myocardial infarction or stroke occurred in none of the 190 patients (0%) treated with the AngioSeal versus none of 238 patients (0%) treated with the Mynx. Major vascular complications occurred in 4 of 190 patients (2.1%) treated with the AngioSeal versus 5 of 238 patients (2.1%) treated with the Mynx (p not significant). Major vascular complications in patients treated with the AngioSeal included removal of a malfunctioning device (1.1%), hemorrhage requiring intervention (0.5%) and hemorrhage with a loss of > 3g Hgb (0.5%). The major vascular complications in patients treated with the Mynx included retroperitoneal bleeding requiring surgical intervention (0.8%), pseudoaneurysm with surgical repair (0.8%) and hemorrhage with a loss of > 3g Hgb (0.4%). These complications were not significantly different between the two vascular closure devices (p = 0.77). Minor complications included hematoma > 5 cm (0.5%, n = 1) within the AngioSeal group, as well as procedure failure requiring > 30 minutes of manual compression after device deployment, which occurred in 7 out of 190 patients (3.7%) treated with the AngioSeal versus 22 of 238 patients with the Mynx (9.2%) (p = 0.033).


CONCLUSIONS
Major vascular complications after PCI following hemostasis with vascular closure devices occurred in 2.1% of 190 patients treated with the AngioSeal vascular closure device versus 2.1% of 238 patients treated with the Mynx vascular closure device (p not significant). The Mynx vascular closure device appears to have a higher rate of device failure.
Azmoon
Shah
S
Department Cardiology, New York Medical College, Macy Pavilion, Valhalla, NY 10595, USA.
Pucillo
Anthony L
AL
Aronow
Wilbert S
WS
Ebrahimi
Ramin
R
Vozzolo
Joseph
J
Rajdev
Archana
A
Kalapatapu
Kumar
K
Ro
Jae H
JH
Hjemdahl-Monsen
Craig
C
D000368:Aged; D017541:Aneurysm, False / Q000453:epidemiology* / Q000209:etiology* / Q000601:surgery; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D003430:Cross-Sectional Studies; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006488:Hemostasis, Surgical / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology* / Q000601:surgery; D019106:Postoperative Hemorrhage / Q000453:epidemiology* / Q000209:etiology* / Q000601:surgery; D012086:Reoperation; D012187:Retroperitoneal Space / Q000601:surgery