Suture closure of the femoral arteriotomy following invasive cardiac procedures: A detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases

Abstract

The purpose of this study was to assess the efficacy and safety of using a percutaneous suture device to close femoral arteriotomies following invasive cardiac procedures. All patients presenting for invasive cardiac procedures performed from the femoral artery were considered for suture closure. Patients were carefully assessed for access site complications, oozing, and the impact of suture closure on the safety of early ambulation. Clinical follow-up at 3-6 months was performed to assess for late complications. Femoral artery suture closures were performed in 1,200 consecutive cases in 1,097 patients. In 12.8% of cases, the patients ambulated within 1 hr. The success rate was 91.2% and the complication rate was 3.4%. Complications included the development of a hematoma (2.1%), the need for vascular surgery (0.6%), retroperitoneal hemorrhage (0.3%), blood transfusion (0.7%), local infection (0.5%), and pseudoaneurysm formation (0.1%). Factors found to be independently predictive of procedural failure were an age > 70 years, an ACT > 300 sec, left femoral artery access, and the performance of primary angioplasty. Follow-up at 3-6 months revealed no major hemorrhagic complications. We conclude that percutaneous suture closure effectively achieves femoral artery hemostasis in patients undergoing invasive cardiac procedures. The technique permits early ambulation and is associated with a relatively low incidence of complication.

Percutaneous coronary intervention with bivalirudin anticoagulation, immediate sheath removal, and early ambulation: A feasibility study with implications for day‐stay procedures

“…However, even with closure devices, early ambulation may not be achieved. In a report of 1,200 consecutive cases with percutaneous suture femoral arteriotomy closure, ambulation was in 3 hr in only 40% and only 15% of patients who received a platelet glycoprotein IIb/IIIa inhibiter [6]. In a nonrandomized comparison of transradial and transfemoral PCI with femoral arterial suture closure, same-day ambulation was achieved in 95% of transradial and 56% of transfemoral patients [15].…”

“…There is potential for early ambulation with possible day-stay PCI with use of percutaneous arterial access closure devices [3][4][5][6]. These devices add to the cost of the procedure and are not without complications [5,6]. However, even with closure devices, early ambulation may not be achieved.…”

“…Early sheath removal and ambulation have the added advantage of lessening patient discomfort from enforced bed rest following PCI. Day-stay PCI is feasible in selected patients after transradial intervention [1,2] and if femoral closure devices are used after transfemoral intervention [3][4][5][6]. Outcomes were favorable in selected patients with short-term observation after transfemoral PCI at a tertiay center, then transferred back to the referring hospital [7].…”

Percutaneous management of access site complications

“…If throm- bus persists, the infusion may be continued overnight (12-18 hr). [61][62][63][64]. Device-related complications include bleeding (hematoma, retroperitoneal bleeding, pseudoaneurysm), embolization of collagen plug, late stenosis/ thrombosis and infection [64 -66].…”

Noncoronary complications of coronary intervention

“…In these regards, all currently available devices in the United States have shown favorable results [61][62][63][64][65][66]. However, these devices are prone to specific complications and have not been demonstrated to reduce access site complications compared.…”