Journal of Invasive Cardiology

The sizes of introducer sheaths and guiding catheters for percutaneous therapeutic interventions have decreased, which should reduce access-site complications.1–6 However, the use of novel antiplatelet drugs like glycoprotein IIb/IIIa inhibitors7,8 tends to increase access-site complications. The search for simple, safe and cost-effective devices for percutaneous puncture site closure is ongoing. Collagen plug devices were initial steps in this direction. They have been only moderately successful in reducing groin complications, especially in patients with aggressive anticoagulation.9–11 The only suture-based system currently available is quite cumbersome and inferior in terms of efficacy.12 In this study, we prospectively evaluated our initial experience with a new suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) and determined whether patients could be ambulated safely at 1 hour after both diagnostic and therapeutic interventions.

METHODS

The X-PRESS system consists of the X-PRESS device (6 French size), a guidewire, a suture pack containing a single strand of suture attached to two needles and a knot pusher (Figure 1). The X-PRESS device is composed of a sheath that is mounted to the distal end of a molded hub, which can be threaded over the guidewire (Figure 2). The hub incorporates a slit that allows two needles attached to a single strand of suture to be individually advanced across a tissue capture region and then back into the device (Figures 3 and 4). The device is withdrawn, leaving a suture loop across the arteriotomy site (Figure 5). A knot is prepared and then advanced using the knot pusher, thus tightening and securing the suture loop across the arteriotomy site. Hemostasis is thus achieved through a percutaneous surgical closure (Figure 6).

Device deployment was performed after initial training on the use of the device provided by the manufacturer over a one-week period in the catheterization laboratory. All patients provided written informed consent. Patients received 5,000 U of heparin or less. Patients with > 6 French sheaths, on more than 5,000 U heparin, or on glycoprotein IIb/IIIa inhibitors were excluded.
All patients were observed for groin complications during the hospital stay. No patient was discharged the same day in spite of the possibility to do so because the admission procedure of the hospital requires an overnight stay. Vascular ultrasound was performed in the first five patients and revealed no pseudoaneurysms.

RESULTS

The baseline characteristics of this study are summarized in Table 1. All patients had 6 French access sheaths. Procedures performed included 36 diagnostic interventions (73%) and 15 therapeutic interventions (27%).

The devices were deployed immediately following the procedure. Once the sutures were secured, no additional manual pressure was used unless bleeding persisted. Following the procedure, a simple dressing was applied. Patients were ambulated after a period of 1.3 ± 0.4 hours of bedrest except for patients with failure to deploy and one with a minor hematoma. The device was successfully deployed in 48 patients (94%). Failure to deploy was observed in 3 patients (6%), of which 2 patients were among the initial patients treated. Failures were due to missing the tissue lip with the needle. All of these patients received manual compression without untoward sequelae.
The average time to complete arterial hemostasis (TTH) was 5.5 ± 3.5 minutes (range, 3–26 minutes). Of the 48 successful device closures, a total of 44 patients (92%) attained immediate total hemostasis without the need for additional manual compression and had uneventful courses. Four patients (8%) needed additional manual compression for an average period of 10 minutes. Three patients had trivial oozing needing no further intervention. One patient developed a hematoma (< 6 cm), which was treated with manual compression and had no further sequelae. No patient experienced a major complication and no patient needed a blood transfusion. The average time to ambulation was 1.3 ± 0.4 hours (range, 0.8–3.5 hours). Time to potential dischargeability was 4.2 ± 3.4 hours (range, 0.9–12.5 hours).

Telephone follow-up after 2 weeks to patients and referring physicians revealed no subjective or objective sequelae.

DISCUSSION

After femoral arterial access, bleeding complications range from a trivial ooze to serious adverse events such as large hematomas, pseudoaneurysms, arteriovenous fistulas, the need for vascular surgery and even death.13,14 These complications lead to increased duration of hospital stay and cost.
The time to hemostasis in our study was 5.5 ± 3.5 minutes, which compares favorably with other studies15,16 and is superior to times to achieve hemostasis reported with compression devices (19.6 ± 13.2 minutes).
After device deployment, mobilization was possible after 1.3 ± 0.4 hours of bedrest, which also compares favorably with other studies.15 The main advantage of this type of device, therefore, is increased patient comfort without the need for prolonged rest and immobilization.
Complication rates were in agreement with the average stated in several studies on puncture-site closure techniques.3,14,17–20 Failure to deploy the device in 3 patients reflects an initial learning curve germane to most new devices.

Many devices, such as Femostop21 or collagen plugs like Vasoseal or Angioseal,16 have been employed to minimize groin complications. Only the Angioseal device has achieved this goal in a randomized study.12
The results of our study with a novel, suture-mediated device, not excluding patients with peripheral vascular disease or uncontrolled hypertension, suggest that it has a certain potential to further reduce femoral access-site complications. The study also highlighted the fact that the patients could be mobilized within an average of one hour of device insertion irrespective of the procedure performed. This could save time for the staff and allow earlier hospital discharge, which benefits the healthcare system. An advantage of this device is the possibility to close a puncture site percutaneously without foreign material save a single suture thread. If the posterior lip of the arterial wall is missed, the needles can be redeployed, which is in contrast to the other suture-mediated device in use.20 Reinterventions should be safe at any time through that same site. The device is relatively easy to produce and should be available at low cost.

Study limitations. The sample size of this initial feasibility trial is small. Randomized studies for comparisons with other hemostatic techniques and devices need to be carried out. Patients received minimal or no anticoagulation. The safety of the device in conjunction with such anticoagulation and antithrombotic therapy (including glycoprotein IIb/IIIa antagonists) needs to be tested in further studies.

CONCLUSION

Our initial experience with a novel suture-mediated device was promising. This device is an effective, safe and relatively cost-efficient tool for arterial hemostasis after percutaneous interventions. It affords early ambulation, short time to discharge, and little patient morbidity, which could have long-term cost implications. This device is a good alternative to the existing closure devices in the management of arterial access sites.