Reviews of the Teleflex Arrow GPScath Balloon Dilatation Catheter | Which Medical Device

Teleflex Arrow GPScath™ Balloon Dilatation Catheter - A Review

By Dr Kieran McBride, FRCR, FCIRSE, Consultant Interventional Radiologist, Victoria Hospital, Kirkcaldy, NHS Fife, Scotland

 

Device Features

The new Arrow GPScath is a clever two-in-one semi-compliant high pressure balloon dilatation catheter combined with a valved outer sleeve that is easily switched to a flush angiography catheter. It has proven to be safe and reliable in my hands and has several advantages over other angioplasty devices that I will highlight when summarizing my recent experience with more than 20 procedures.

Design and construction

The device was originally produced in a 55cm usable length with a range of diameters of 5 to 8mm. It has an easy to hold handle with a sliding grip that changes the catheter from angioplasty to flush catheter mode and vice-versa, which is clearly labelled. The main central lumen carries a co-axial .035 guidewire and the side arm is connected to the balloon, but is converted to a flush mode by opening  the VisioValve™ located at the proximal end of the balloon. There is now a longer 80cm catheter available which comes in a range of diameters from 3mm to 12mm and rated burst pressures up to 24 atmospheres. At maximum pressure the balloon will over-dilate by 10%. Diameters up to 6mm need a 6Fr sheath, 7mm and 8mm a 7Fr sheath and 9mm and over need a 8Fr sheath.

Device Uses

I have now performed 10 iliac arterial interventions and 5 antegrade femoral arterial procedures in the last year. I have also used it as a high pressure device in 8 native dialysis fistulas and in one each of a distal ureteric and a biliary stricture.

One big advantage is that there is immediate angiographic assessment of dilated lesions using the flush mode without the need to change catheters or adjust guidewires. This applies to retrograde iliac stenoses/occlusions and also to antegrade femoral lesions. In particular over-the-top and down the leg intervention can be performed without the need for a large sheath crossing the bifurcation and angiography is immediate.

Another advantage with placement of covered stents is the ability to pre-dilate an occlusion with the GPScath™ at the diameter required, and following deployment of the covered stent e.g. the Viabahn, it can be post-dilated with the same device under higher pressure giving a higher diameter and “bedding down” of the stent as recommended by the stent manufacturers.

During fistuloplasty I have also been able to pass the whole balloon and valve on it’s shaft across the AV anastomosis to the arterial side to produce excellent post dilatation fistulograms, because the device is so flexible. It is also excellent at conforming to the curve of the cephalic vein arch during high pressure dilatation.

Another feature I discovered is that it is excellent as a pressure gradient measuring device both before and after dilating iliac lesions over the guidewire, without the need for changing catheters.

We have also used carbon dioxide through the flush angiography channel as an alternative to contrast with high quality angiograms. The ureteric and biliary strictures were easy to assess and dilate to maximum pressure with the aid of instant contrast imaging.

 

PowerPoint Presentations:

 

GPScath Fistula case        GPScath Iliac stent       GPScath Popliteal stent

 

Results so far

All 10 of the iliac interventions were successful. Three of these were “kissing stent” procedures and one a covered stent case. One of the 5 antegrade cases suffered a distal embolus that was successfully retrieved and one other ( using a 7Fr sheath ) developed a retroperitoneal haematoma not requiring treatment. All femoral cases had a good clinical outcome.

There were no complications following all 8 fistuloplasties for recurrent venous stenoses. One of these lesions was a tight brachio-cephalic central vein lesion and two were at the cephalic arch. Two had pre-dilatation with a peripheral cutting balloon ( Boston Scientific ) and 6 had maximum pressure dilatation to 25 atmospheres. Because only up to 8mm diameter GPScath™ devices  were available for use, it was necessary to further post-dilate 3 lesions with a 12mm Conquest high pressure balloon ( Bard ).

We have been conducting an audit of the iliac interventions on a prospective basis. We have looked in particular at the duration of the procedure, the radiation dose and the contrast volume. We have also monitored the patients renal function pre- and post-procedure. This is an ongoing project with only 5 cases so far included. It is our ambition to have an electronic version of this audit database rolled out by Teleflex Arrow for the benefit of all new users of the GPScath™ device in a multi-centred fashion to maximize the information. It is hoped that this data can be used to compare the new device for iliac procedures with existing standard devices.

Comparison with other devices

This is a unique device with no other similar dual purpose catheters available currently on the market. It is also a high pressure balloon, but unlike the Conquest (Bard ) and Blue Max ( Boston Scientific ) balloons which are non-compliant, there are some advantages to having a balloon that will dilate by a further 10% diameter at higher rated pressures, e.g pre- and post-covered stent placement. The balloon is also very less rigid than the Conquest in particular and will cross even hair-pin bends like the AV-anastomosis  of a native dialysis fistula. It also does not wing as much as the Blue Max in  particular. One caveat is that I have yet to try out the larger diameters of 10mm and 12mm that I am comparing with the other products.

Again , the relative flexibility and pushability means you can cross the aortic bifurcation with the GPScath™ in an over-the-top technique without the need for a long sheath or guiding catheter. The new 80cm catheter will travel as far as the distal SFA from the other side. I am told there will be an 120cm version of the device in production quite soon too!

Conclusions

This is a new catheter that offers the advantage of being able to perform angioplasty with instant angiographic assessment without the usual steps involving catheter and wire exchange. It is my early impression that it will reduce procedure time and therefore contrast and radiation doses also, with less implied nephrotoxicity. The opportunity to test this hypothesis is there for all operators to take. The manufacturers Teleflex Arrow will be inviting users in all centres to participate in a multi-centre registry to test the potential increased efficiency of the GPScath™.

I have no hesitation in giving this device a FIVE STAR rating.

References:   None available