Safety and efficacy of a 6 French perclose arterial suturing device following percutaneous coronary interventions: a pilot evaluation.
BACKGROUND
Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort.


METHODS
The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62   13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64   12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis.


RESULTS
Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3 4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8   2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site.


CONCLUSIONS
The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.
Kornowski
Ran
R
Cardiac Catheterization Laboratory, Cardiology Department, Rabin Medical Center, Petach Tikva, and Sackler Faculty of Medicine, Tel Aviv University, Israel. rkornowski@clalit.org.il
Brandes
Simcha
S
Teplitsky
Igal
I
Rechavia
Eldad
E
Shor
Nurit
N
Battler
Alexander
A
Assali
Abid
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011336:Probability; D011379:Prognosis; D011677:Punctures; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D013536:Suture Techniques / Q000295:instrumentation*; D016896:Treatment Outcome