Initial experience using Prostar: a new device for percutaneous suture-mediated closure of arterial puncture sites.

A new device that enables closure of the femoral artery puncture site by percutaneous placement of two nonabsorbable sutures (Prostar) was evaluated. Our initial experience included 32 insertion attempts at 29 femoral arterial puncture sites and one femoral venous puncture site. The device was applied at arterial puncture sites that had been used to carry out 12 balloon angioplasties (41%), seven intracoronary stent placements (24%), five intraaortic balloon pump insertions (17%), four diagnostic angiographies (14%), and one rotational ablation (3%). The venous access site closed was in a patient who had undergone balloon angioplasty and intracoronary thrombolysis. Most patients were anticoagulated with an average activated clotting time (ACT) of 306 +/- 123 sec (12 patients) or an average PTT of 68 +/- 29 sec (14 patients). There were four failures to achieve hemostasis using the device due to: inability to place the device because of peripheral vascular disease, entrapment of cutaneous tissue in the suture, a suture break that prevented hemostasis from being achieved, and avulsion of the sutures from the needles. Although three other suture breaks occurred, these did not prevent hemostasis from being achieved. Thus, 88% (28/32) of attempted uses were successful, and by using a second device in two of the failed attempts, 94% (30/32) of the puncture sites were successfully closed using the device. There was one late rebleed that required 1 hr of groin clamp pressure in an angioplasty patient who had received intracoronary urokinase. An ooze of blood occurred in 4 patients, but in only 2 was this more than trivial, resulting in discontinuation of heparin in one patient and a small hematoma in the other. We conclude that this device can be used safely and effectively, even in fully anticoagulated patients who have undergone complex procedures. The ultimate role of the device will require further experience and appropriate randomized studies.