title: Vascular complications after percutaneous coronary intervention following hemostasis with the Mynx vascular closure device versus the AngioSeal vascular closure device.
abstract: 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.
authors.affiliation: Department Cardiology, New York Medical College, Macy Pavilion, Valhalla, NY 10595, USA.
authors.forename: Shah
authors.initials: S
authors.lastname: Azmoon
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Pucillo
authors.forename: Wilbert S
authors.initials: WS
authors.lastname: Aronow
authors.forename: Ramin
authors.initials: R
authors.lastname: Ebrahimi
authors.forename: Joseph
authors.initials: J
authors.lastname: Vozzolo
authors.forename: Archana
authors.initials: A
authors.lastname: Rajdev
authors.forename: Kumar
authors.initials: K
authors.lastname: Kalapatapu
authors.forename: Jae H
authors.initials: JH
authors.lastname: Ro
authors.forename: Craig
authors.initials: C
authors.lastname: Hjemdahl-Monsen
mesh_terms: 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