title: The safety and efficacy of "pre-closure" utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) Trial.
abstract: BACKGROUND
  Suture-mediated closure devices have been developed to improve patient comfort and safety following percutaneous coronary interventions (PCI). The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial which we reported previously showed that the Prostar XL appears to be a safe and effective device to achieve hemostasis, improve time-to-ambulation and discharge post-PCI. The diameter of suture capture with the Closer 6 Fr suture-mediated closure device is larger than an 8 Fr hole. This study was performed to assess the pre-closure efficacy using the Closer device in terms of time-to-hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications.
  
  
  METHODS
  Between January and September 2001, 153 consecutive patients were enrolled in this study. In 97 patients, the Closer sutures were introduced prior to insertion of the 8 Fr sheath (pre-closure arm). In 56 patients, the sutures were tied at the conclusion of PCI upon sheath removal (standard arm).
  
  
  RESULTS
  The Closer device was successfully placed on 152 of 153 attempts. The time-to-hemostasis, ambulation and discharge of the pre-closure arm patients seemed to be comparable to those of the standard arm and the PARADISE trial. No major complications were reported.
  
  
  CONCLUSIONS
  The Closer seems to be as safe and effective as the Prostar XL device. The pre-closure technique is a safe means of achieving hemostasis post-PCI using large-sized sheaths without major complications.
authors.affiliation: Department of Cardiology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka-City, Osaka, Japan. yuya0728@m3.kcn.ne.jp
authors.forename: Kenya
authors.initials: K
authors.lastname: Nasu
authors.forename: Etsuo
authors.initials: E
authors.lastname: Tsuchikane
authors.forename: Satoru
authors.initials: S
authors.lastname: Sumitsuji
authors.forename: Takashi
authors.initials: T
authors.lastname: Tsuji
authors.forename: Hideo
authors.initials: H
authors.lastname: Tamai
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D003327:Coronary Disease / Q000503:physiopathology / Q000628:therapy*; D004434:Early Ambulation; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010351:Patient Discharge; D016491:Peripheral Vascular Diseases / Q000209:etiology / Q000503:physiopathology; D012107:Research Design; D013536:Suture Techniques / Q000009:adverse effects / Q000295:instrumentation*; D013997:Time Factors; D016896:Treatment Outcome