Patient sex and success of peripheral percutaneous transluminal arterial angioplasty.

HYPOTHESIS: Female sex negatively affects the durability of percutaneous angioplasty of native arteries supplying the lower extremity. DESIGN: Outcome analysis of the results of percutaneous angioplasty of lower extremity arteries in a single vascular surgery practice. SETTING: University-affiliated community hospital. PATIENTS: All patients undergoing percutaneous intervention on lower extremity arteries during 10 years. INTERVENTIONS: Indication for intervention, anatomic site of intervention, placement of percutaneous stents, and length of lesion undergoing angioplasty were noted. Patient demographics and risk factors were identified. MAIN OUTCOME MEASURES: Results were analyzed by sex. Kaplan-Meier life tables were plotted and differences between groups tested by the log-rank method. A Cox proportional hazards regression model was used to perform the multivariate analysis. RESULTS: During 10 years, 351 angioplasties were performed in 248 patients, 173 in women and 178 in men. There was no difference between men and women in indication for intervention, length and type of lesion treated, or quality of distal runoff. Univariate survival analysis identified a difference in duration of patency between men and women (P = .047). However, multivariate analysis demonstrated no significant difference in duration of patency between men and women (P = .18). Iliac angioplasty and adequate distal runoff were positive predictors of long-term patency (P<.001 for both). CONCLUSIONS: There appears to be no significant difference in the durability of angioplasty between men and women. However, location of angioplasty and adequacy of distal runoff may be useful in determining when to use angioplasty.

The use of closure devices.

The use of arterial closure devices offers significant benefits over manual compression in achieving groin hemostasis following catheter-based procedures. Several currently available devices provide rapid puncture site closure with complication rates similar to that of manual compression. Closure devices allow for early times to ambulation and hospital discharge, and have a high degree of patient satisfaction. Their use may be of particular benefit inpatients that are anticoagulated. We believe that their use should be strongly considered in all patients following femoral artery catheterization.

The use of the Angioseal device for femoral artery closure.

BACKGROUND: As vascular surgeons perform increasing numbers of percutaneous catheter-based procedures, they will need to become familiar with varying methods of femoral artery closure. Few studies on closure devices have included significant numbers of patients with peripheral arterial disease. It is the purpose of this study to determine whether the Angioseal device (St. Jude Medical) is a satisfactory method of achieving femoral artery puncture site hemostasis in these patients. METHODS: The records of all patients undergoing Angioseal closure of femoral artery puncture by a single vascular surgeon were reviewed. Indication, type of intervention, and size of the vascular sheath employed were recorded. Times to mobilization and discharge were determined. Patients were seen before discharge and 1, 4, and 12 weeks after the procedure, and at 3- month intervals thereafter. Complications including hemorrhage, pseudoaneurysm, infection, and vessel occlusion were noted. RESULTS: Between February 1, 2002, and August 31, 2003, 220 Angioseal collagen plugs were deployed in 188 patients. Attempts were made to deploy Angioseal devices in 92% of patients undergoing percutaneous procedures during this time period. One hundred forty-four procedures were diagnostic and 74 procedures included 76 therapeutic interventions. One hundred forty-four 5F sheaths, 47 6F sheaths, and 29 7F sheaths were employed during the procedures. Time to mobilization and discharge was 58 +/- 19 minutes and 102 +/- 31 minutes in patients undergoing diagnostic studies, 68 +/- 22 minutes and 146 +/- 42 minutes following interventions using 6F sheaths, and 127 +/- 18 minutes and 219 +/- 37 minutes when interventions were performed using 7F sheaths. No patient developed a major hematoma or infection following the use of an Angioseal. There were 2 complications related to device deployment. One patient developed a 1.4-cm false aneurysm at the femoral artery puncture site that resolved spontaneously. A second patient required operation for vessel occlusion when an Angioseal was deployed in a markedly diseased femoral artery. These adverse events occurred early in our experience. CONCLUSIONS: The Angioseal provides a secure method of achieving hemostasis following femoral artery puncture. It is easy to deploy, has a high level of patient satisfaction, and allows for early ambulation and hospital discharge. When simple guidelines are observed, the device can be safely used in the great majority of patients with peripheral vascular disease. It offers considerable advantages over the traditional method of manual compression.