To our knowledge, this is the first report of a Canadian experience with PEVAR. Our procedural success of 93% and EVAR success of 100% may encourage other centres to pursue this technique.
The technique failed in only 1 patient, occurring early in our experience. We believe the failure was caused by the suture loop and knots not being tightened sufficiently during the initial deployment. Suture knots may sometimes be caught in the sheath tract. Since the knots for both devices are preformed, they have the potential to entangle within the tract. We advocate careful attention when tightening the sutures. The knots should be pushed using the knot pusher sequentially and firmly on both suture loops to make sure they seat properly on to the artery. Another factor that may have contributed to bleeding in this patient was the fact that anticoagulation was not reversed after the procedure.
The Perclose ProGlide system is the only device approved in Canada that allows the PEVAR technique to be performed. According to the instruction manual, the Perclose device is intended for closure of defects made by sheaths 8-Fr or smaller. The technique of using 2 devices at off-centred and opposite angles has been described for closure of larger defects. Lee and colleagues15
reported a technical success rate of 94% in 292 patients, which is comparable with our reported procedural success. Failures in their study were related to coagulopathy, high puncture sites, dissection, pseudoaneurysm or sutures pulling through the artery. They also reported a shorter mean procedural time, which has also been seen by other authors.12
At a medium-term follow-up of 12 months, Lee and colleagues reported 3 long-term complications in 292 patients: 1 femoral dissection and 2 pseudoaneurysms.15
The same group proposed the following contra-indications for PEVAR: obesity, severely scarred groin, high femoral bifurcation, the need for frequent introducer sheath removals and insertion, proximal iliac occlusive disease, small iliofemoral arteries and anterior or near circumferential calcific disease.5
We believe that obesity may actually become an indication to perform PEVAR as one becomes familiar with this technique since these patients are usually at higher risk for groin complications with a cut-down approach.
Failure of the Perclose device to achieve hemostasis may occur if the sutures did not provide for adequate seal or if they cut out from the arterial wall. It is crucial for the surgeon to be prepared in the event of device failure and bleeding. It is of paramount importance that the guidewire be kept in the artery until one is confident that hemostasis is achieved. The puncture site should be completely hemostatic when the sutures are tightened. If ongoing bleeding is present after both sutures were tightened, a third device can be deployed over the guidewire. If bleeding persists, hemostasis can be assured be replacing the large sheath back into the femoral artery to plug the entry site. Open arterial repair can be done leisurely by cutting down on the femoral artery following the guidewire and dilator. On the other hand, if bleeding is to occur after the guidewire is removed, the situation will be more difficult. Standard vascular principles should apply with firm digital pressure on the bleeding site and rapid control of proximal and distal artery followed by open arterial repair.
This report documents our initial experience with PEVAR. The technique was brought to our institution by a surgeon (J.C.C.) who went on sabbatical to a centre that used this technique. The surgeon proctored 4 others (including J.G. and Y.N.H.) in our institution. The 4 learners rated the difficulty of this technique and its learning curve as 3 out of 5, with 5 corresponding to the most difficult rating. On average, the learners felt they needed 4 proctored cases before they were totally comfortable with the procedure.
Nonsheath–based endograft devices such as the Anaconda (Vascutek, a Terumo Company) and Talent (World Medical/Medtronic) are less amenable to PEVAR, as introduction and removal of these devices without sheaths can result in increased risk of bleeding and groin hematoma. We believe it is still possible to perform PEVAR with these devices if a large sheath (from a different manufacturer) is used for the femoral artery and facilitate hemostasis after the endograft device is deployed and removed.
The cost of EVAR is a major issue in most hospitals owing to resource constraints. Perclose ProGlide is a commonly used closure device that is priced competitively. The cost of 4 devices (4 are needed for each PEVAR case) is about one-quarter the cost of one piece of leg extension stent-graft or about two-thirds of the cost of a 1-day stay in our hospital. We have demonstrated that length of stay is shortened for patients who undergo PEVAR compared with those who undergo open cut-down EVAR. We believe PEVAR is a potentially a cost-saving measure. Further detailed randomized studies are needed to verify this impression. In terms of time in the operating room, we did not find PEVAR to be much faster than open cut-down EVAR.
Regarding length of stay in hospital (2.2 d), we feel that there is room for improvement. Our study documents our initial experience with PEVAR, and we were quite conservative in keeping patients in hospital at first. We kept some patients for extra days owing to postimplant fever, confusion and urinary retention. We believe with more experience, most of these patients’ stays can be reduced to 1 day, which will translate into further savings.