Clinical experience of StarClose vascular closure device in patients with first and recurrent femoral punctures.
OBJECTIVE
We present our clinical experience of StarClose in patients undergoing coronary interventions, including its use in patients after repeated puncture of the same femoral access site.


BACKGROUND
The StarClose is a novel vascular closure device that deploys a small, flexible, circumferential nitinol clip onto the femoral artery surface.


METHODS
In this study, 103 consecutive patients (24% with repeated punctures) who underwent percutaneous coronary intervention and received a StarClose were followed up prospectively. The patients were assessed for vascular complications prior to hospital discharge. Device success, based on time-to-hemostasis, was divided into (1) immediate success: hemostasis achieved immediately after StarClose deployment without the need for adjunctive manual compression, (2) partial success: occurrence of minor oozing after StarClose deployment and hemostasis achieved after <3 minutes of manual compression, and (3) device failure: need for adjunctive manual compression for >3 minutes.


RESULTS
Immediate success, partial success, and device failure rates were 74% (n = 68), 16% (n = 15), and 10% (n = 9), respectively. There were no major complications attributable to the StarClose device. There were 10 (9.7%) cases of minor complications; all were recurrent wound bleeding requiring manual compression in the wards. Among these 10 cases of recurrent bleeding, 5 (50%) had initial device success (immediate success, n = 2, partial success, n = 3) in the catheterization laboratory. The risk for recurrent bleeding was 2.9% after immediate device success and 20.0% after partial device success.


CONCLUSIONS
Our study found no major complications but a 10% failure rate and a 9.7% rate of minor complications. Close surveillance is important as there is a risk for recurrent bleeding, especially in patients with partial device success as defined in this report.
Tay
Edgar Lik-Wui
EL
Cardiac Department, National University Hospital, Singapore.
Co
Melissa
M
Tai
Bee-Choo
BC
Lee
Yian Ping
YP
Low
Adrian
A
Lim
Yean-Teng
YT
Tan
Huay-Cheem
HC
Lee
Chi-Hang
CH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D002408:Catheters, Indwelling; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011677:Punctures; D012008:Recurrence; D012307:Risk Factors; D013525:Surgical Instruments; D013536:Suture Techniques / Q000295:instrumentation*; D013997:Time Factors