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Technical Innovation |
1 All authors: Department of Radiology, Division of Vascular–Interventional Radiology, Duke University Medical Center, Box 3808, Erwin Rd., Durham, NC 27710.
Received July 12, 2002;
accepted after revision September 4, 2002.
Address correspondence to J. M. Ryan.
Introduction
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Sedation was not performed at the patient's request. A local analgesic was administered to the proposed puncture site. The venous limb of the graft was punctured in the direction of the venous anastomosis because hemodynamic monitoring suggested that a venous anastomotic lesion was likely.
A fistulogram and a central venogram were obtained that showed a high-grade stenosis (>90%) at the venous anastomosis (Fig. 1A). The central veins were normal. On the basis of the abnormal finding and its likely role in the reduced function of the graft, a decision was made to proceed with angioplasty of the venous anastomosis. A 7-French angiography sheath (Pinnacle; Boston Scientific/Medi-Tech, Natick, MA) was placed, and through the sheath a hydrophilic guidewire was manipulated through the area of stenosis. Two thousand units of heparin was administered. A 7 x 40 mm high-pressure angioplasty balloon (Blue Max 20; Boston Scientific/Medi-Tech) was inserted over the guidewire to the area of abnormality, and multiple balloon inflations of 1-min duration to 24 atm of pressure were performed (Fig. 1B). (The Blue Max 20 angioplasty balloon has a burst pressure rating of 20 atm and a 5.8-French shaft size.) A resistant stenosis of greater than 70% remained (Fig. 1C). A decision was made to attempt treatment with the Cutting balloon. The experimental nature of this proposed treatment was explained in full to the patient. A 4 x 10 mm Cutting balloon (rated burst pressure, 10 atm; shaft size, 3.6-French), the largest balloon currently commercially available in the United States, was obtained.
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A guidewire exchange was performed, and a 0.014-inch guidewire (Spartacore 14; Guidant, Temecula, CA) was placed. Preparation of the balloon involves a wet negative preparation procedure that must be followed precisely [5]. The Cutting balloon was then placed over the guidewire and across the resistant stenosis. Inflation was performed initially to 6 atm and then to 10 atm (Figs. 1D and 1E). Two further overlapping inflations were performed. Angioplasty balloon exchange was performed, and a second conventional angioplasty with the same 7 x 40 mm high-pressure balloon was performed. A postdilatation fistulogram revealed marked improvement in the appearance of the stenosis, with less than 30% residual stenosis remaining. The patient was discharged to dialysis, where he showed a marked improvement in hemodynamic parameters. The patient was scheduled to return for reexamination 12 weeks after the procedure.
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The Cutting balloon device is approved by the United States Food and Drug Administration for dilatation of stenoses (atherotomy) in coronary arteries in which a lesion has proven resistant to a high-pressure balloon. The manufacturer (Interventional Technologies) recommends that the coronary artery lesion be discrete (<15 mm in length) or tubular (10–20 mm in length), have a vessel diameter ranging from 2.0 to 4.0 mm, be readily accessible to the device, have a smooth angiographic contour, and lack an angiographically visible thrombus or calcification.
The Cutting balloon catheter consists of a noncompliant balloon with either three or four blades (atherotomes) arranged longitudinally about the balloon. When the balloon is inflated, it unfolds in a manner that exposes the blades to the intima of the vessel, creating controlled intimal disruption, which allows the vessel to be dilated to the desired diameter.
There have been reports in the literature on the use of the Cutting balloon for treatment of resistant stenoses of the coronary arteries [5]. Popma et al. [6] reviewed the angiographic and clinical outcomes of 160 consecutive patients with 173 lesions who underwent Cutting balloon coronary angioplasty. Angiographic success was obtained in 145 lesions (97%), and no major in-hospital complications occurred in patients after the operator used the Cutting balloon. In the coronary arteries, atherotomy poses a greater risk of perforation than that observed with conventional balloon angioplasty, and oversizing further increases the risk of perforation. To reduce the potential for vessel perforation, the operator should approximate the inflated diameter of the Cutting balloon device to the diameter of the vessel just proximal and distal to the stenosis. The procedure of ballon size selection differs from conventional angioplasty, especially in the peripheral vessels, which we often oversize by as much as 15–20%. When the catheter is introduced into the vessel, it must be observed under high-quality imaging, and care must be taken not to advance or retract the catheter unless the balloon is fully deflated under a vacuum.
The Cutting balloon has been available outside the United States for about 6 years, and, to our knowledge, few reports have appeared in the literature on the use of the Cutting balloon for indications other than coronary stenoses. Engelke et al. [7] reported excellent clinical success with Cutting balloon angioplasty for the treatment of resistant peripheral arterial bypass graft stenosis caused by neointimal hyperplasia. In this study, short-term patency with the Cutting balloon technique was superior to that of conventional angioplasty and compared well with patency after atherectomy for salvage of infrainguinal bypass grafts. Vorwerk et al. [8, 9] reported the use of the Cutting balloon in the treatment of venous stenoses in 15 Brescia-Cimino fistula lesions and four dialysis graft lesions in a single case and a small patient series. In these studies, the researchers had the benefit of having a 6-mm Cutting balloon available, which more closely approximated the actual fistula or graft size. With the use of a larger 6-mm Cutting balloon, they were able to decrease the average stenosis from a mean of 65% before the procedure to 14% after the procedure. Until recently, radiologists in the United States have not had the opportunity of using the Cutting balloon.
In our patient, the polytetrafluoroethylene graft was 6 mm in diameter. As a default, we usually use a 7-mm high-pressure balloon for angioplasty of dialysis graft stenoses, in anticipation that venous anastomotic lesions can be difficult to treat. Although the Blue Max 20 balloon is burst-rated to 20 atm of pressure, our experience is that this balloon will tolerate higher pressures because of a built-in safety margin by the manufacturer. The residual lesion was extremely tight. Although the graft was 6 mm in diameter, we believed that the 4-mm-diameter Cutting balloon, which is currently the largest diameter that is commercially available in the United States, might cause enough of a controlled incision to the intima to allow further successful angioplasty with a high-pressure balloon. This, in fact, proved to be the case, although there was still residual stenosis seen at the end of the study. We believe that the residual stenosis was a result of having to use a smaller diameter Cutting balloon than the actual vessel size, and the use of a larger balloon would have achieved a better angiographic result [8]. However, the desired clinical result was achieved in our patient in that a resumption of efficient dialysis was accomplished, and surgery or abandonment of the graft was avoided. Currently, clinical trials that are investigating the use of Cutting balloons in a dialysis population are getting under way in the United States.
Stenting of resistant venous anastomotic strictures has been shown to have patency rates similar to those of angioplasty; however, early thrombosis rates of 10% have been reported [10]. Currently, stenting is reserved for treating lesions that are resistant to angioplasty alone. It will be necessary to evaluate patency rates of a Cutting balloon versus stenting to decide how best to treat resistant venous strictures in dialysis patients in the future.
In summary, this case illustrates that the coronary-size Cutting balloon can be effective in treating resistant highly stenotic lesions in dialysis grafts. Consideration should be given to using this balloon for such lesions until the proposed larger diameter Cutting balloons become commercially available.
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