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Hemodialysis-related Venous Stenosis: Treatment with Ultrahigh-Pressure Angioplasty Balloons¹

¹ From the Department of Radiology, Division of Interventional Radiology and Medicine (S.O.T., S.W.S., R.S.G., C.M.T.) and Division of Nephrology (S.K., M.R.R.), University of Pennsylvania Medical Center, 1 Silverstein, 3400 Spruce St, Philadelphia, PA 19104. Received June 17, 2003; revision requested August 29; revision received September 2; accepted September 4. Address correspondence to S.O.T. (e-mail: streroto@uphs.upenn.edu).

	ABSTRACT

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The authors retrospectively reviewed the use of ultrahigh-pressure angioplasty balloons at atmospheric pressures at or above the manufacturer recommended burst pressure (30 atm) for the treatment of resistant hemodialysis-related venous stenosis at their institution. In seven of 87 procedures, high-pressure angioplasty (up to 27 atm) was unsuccessful. By coupling new balloon technology with aggressive inflation pressures, 100% technical success was achieved in the treatment of stenoses that were resistant to high-pressure angioplasty in these seven procedures. This approach could potentially offer cost savings compared with the costs of other previously described treatment methods for resistant lesions, such as atherectomy devices and cutting balloons.

© RSNA, 2004

Index terms: Dialysis, 81.42, 9_*.457², 9_*.458 • Veins, transluminal angioplasty, 9_*.454, 9_*.458

	INTRODUCTION

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Percutaneous balloon angioplasty of hemodialysis-related venous stenoses is a cost-effective method for prolonging hemodialysis access and reducing thrombosis rates (1) and is supported in published national guidelines (2). It has been known for nearly 20 years that hemodialysis-related stenoses can be resistant to balloon angioplasty and often necessitate use of high-pressure angioplasty balloons for successful treatment (3). Even with high-pressure angioplasty balloons at atmospheric pressures well above the manufacturer rated burst pressure, however, there is a subset of patients in whom balloon angioplasty fails because of resistant stenoses (ie, those in which the waist on the balloon cannot be effaced) (4). With such stenoses, interventional radiologists have resorted to alternative means of treating these lesions, including atherectomy devices (5,6) and cutting balloons (7). The purpose of the present study was to present a retrospective review of our experience with ultrahigh-pressure angioplasty balloons at pressures equal to or exceeding manufacturer recommendations in the treatment of hemodialysis-related venous stenosis.

	Materials and Methods

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Patients
From August through November 2002, we performed 87 hemodialysis access revascularization procedures in all 75 patients who were treated during the reporting period. Indications included thrombosis (n = 39), arm swelling (n = 8), high venous pressures (n = 17), low flow (n = 11), clinical problems (bleeding, difficult puncture, pulling clots, abnormal physical examination, aneurysm) (n = 10), and failure of a native fistula to mature (n = 2). Seventeen procedures were in native fistulae, and 70 were in grafts. Twenty access sites were in the left forearm, eight in the right forearm, 41 in the left upper arm, 17 in the right upper arm, and one in the left thigh.

Among the 75 patients, angioplasty failed in seven as a result of failure to efface the waist on the balloon at maximum pressure. The seven patients were treated with ultrahigh-pressure angioplasty, and they are the primary subjects in this study. These seven patients were treated with off-label use of the inflation device solely for medical reasons and not as part of any research project or protocol. We obtained institutional review board exemption for the retrospective analysis; patient informed consent was not required. Our institutional review board was aware of the off-label use. All demographic and procedural data were obtained from a quality assurance database maintained by the first author. These data included access type and location, technical details of the procedure, complications, and procedure outcome.

Procedures
All procedures were performed on an outpatient basis with local anesthesia according to the Dialysis Outcomes Quality Initiative guidelines (2), with conscious sedation (midazolam, Versed, Hoffman-LaRoche, Nutley, NJ; and fentanyl, Elkins-Sim, Cherry Hill, NJ) titrated to effect. Anticoagulants (heparin [3,000 U intravenously]) and antibiotics (cefazolin, Kefzol; Lilly, Indianapolis, Ind [1 g intravenously]) were administered routinely for mechanical thrombectomy procedures and were prescribed at the discretion of the attending interventional radiologist for prophylactic angioplasty procedures. Initial balloon size was determined on the basis of the diameter of the graft (7-mm-diameter balloon for a 6-mm graft, 8 mm for a 7-mm graft) or the adjacent normal vessel in a fistula, with the aim of 10%–20% oversizing. Inflation time was 60–90 seconds, with prolonged inflation for 5 minutes as needed for elastic stenoses (those lesions in which the waist of the balloon could be effaced, but the lesion recoiled). The end point for angioplasty (technical success) was complete effacement of the balloon waist and restoration of a thrill in the access; the end point was determined by the interventional radiologist.

Our longstanding practice has been to treat hemodialysis-related venous stenosis in an escalating fashion, beginning with moderately high-pressure angioplasty balloons (Ultra-thin; Boston Scientific, Natick, Mass [rated burst pressure, 12 atm], which was succeeded by the Ultrathin SDS; Boston Scientific [rated burst pressure, 12 atm]) inflated to atmospheric pressures above the manufacturer recommendation (off-label use, 18 atm for the Ultra-thin balloon, 21 atm for the Ultrathin SDS balloon). When a resistant stenosis is encountered at these pressures, we use another high-pressure angioplasty balloon (Blue Max; Boston Scientific [rated burst pressure, 20 atm]) inflated to pressures above the manufacturer recommendation (off-label use, 27 atm) (4). A standard pressure inflation device (model 622510; B Braun Medical, Bethlehem, Pa) is always used with high-pressure balloons.

Even with this approach, there is a subset of patients with stenoses that are resistant to this high-pressure angioplasty balloon. Recently, a high-pressure angioplasty balloon has been introduced (Conquest; Bard, Covington, Georgia) that has a rated burst pressure of 30 atm. As with the other balloons, we inflated this balloon well above the manufacturer rated burst pressure, although, to our knowledge, there is no pressure inflation device currently available that can measure pressures above 30 atm. We estimated pressures with the standard pressure inflation device, which has its highest mark at 30 atm. We assumed linearity above the 30-atm mark and extrapolated to the 0-atm mark on the inflation device, estimated at 40 atm.

Initially, patients in whom angioplasty failed at 27 atm with the Blue Max balloon were treated with the Conquest balloon. As our experience grew, the Conquest balloon was used when standard angioplasty (Ultrathin SDS) balloons failed. We always noted when the pressure reached 27 atm. Only those seven patients with lesions that necessitated use of pressures above 27 atm (ie, beyond the capacity of the Blue Max balloon) are the subject of this study. The procedures were performed by fellowship-trained radiologists with certificates of added qualification for interventional radiology (S.O.T., C.M.T., S.W.S., R.S.G.) with 4–15 years of experience in the treatment of failing hemodialysis access circuits.

Inflation Device Testing
To test our assumptions about the inflation device gauge above 30 atm (at approximately the 5-o’clock position on the dial), we performed the following in vitro experiment. A digital pressure gauge (DCT Instruments, model JKW750GZ; Sensotec, Columbus, Ohio) was used. A high-pressure catheter was connected to the digital gauge by using quick connectors and Teflon tape. The standard pressure inflation device was filled with water. The digital pressure gauge was turned on and set to 0 atm. The inflation device was connected to the high-pressure catheter that was attached to the digital gauge. The handle on the inflation device was turned until the gauge on the device read 30 atm. The pressure was recorded from the digital gauge. The handle of the inflation device was then turned until the needle on the gauge was in the 6-o’clock position. The pressure was recorded from the digital gauge. The pressure in the inflation device was increased until the needle on the gauge would not move anymore (this was considered maximum pressure, at approximately the 7-o’clock position). The pressure was recorded from the digital gauge. This process was repeated with a second inflation device.

Follow-up
Follow-up findings were determined during the quality assurance process (S.O.T.) by means of communication at our regular access meetings and/or with staff in the dialysis units. Follow-up data included time to next access intervention, type of intervention, and technical details of the next intervention (from the quality assurance database). Primary patency was defined as uninterrupted patency without any intervention.

	Results

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In seven procedures (in one native fistula and six grafts), mechanical thrombolysis (two procedures) and prophylactic percutaneous transluminal angioplasty (five procedures) (in four men and three women [age range, 41–88 years; mean age, 67 years]), pressures above 27 atm were necessary with ultrahigh-pressure angioplasty to efface the balloon waist and thus achieve technical success. In three of these seven patients, a Blue Max balloon failed at 27 atm, and thereafter a Conquest balloon was used. In the remaining four patients, a Conquest balloon was used when standard (Ultrathin SDS) balloons failed. In these seven procedures, the waist of the balloon was effaced at a mean pressure of 34 atm (estimated range, 30–40 atm) in all patients. No venous rupture or other complication occurred when the ultrahigh-pressure balloons were used. No angioplasty balloons ruptured. No significant (>30%) residual stenosis remained in any access site, as defined by published standards (2). All patients had thrill restored in the access, and all were able to resume dialysis. Thus, the technical success rate of 92% (80 of 87 procedures) was achieved without ultrahigh-pressure angioplasty and was improved to 100% with the high-pressure angioplasty technique used in this study.

Follow-up
Four patients underwent repeat intervention (with primary patency rates of 15, 58, 120, and 145 days), and the remaining three patients had primary patency rates of 200, 231, and 228 days at the time of this writing. The repeat interventional procedures were similar in scope to the original procedures; however, ultrahigh-pressure angioplasty was not required at the repeat procedure. There was no evidence to suggest that ultrahigh-pressure percutaneous transluminal angioplasty increased the level of difficulty of subsequent interventional procedures.

Inflation Device Testing
Results from inflation device tests are shown in the Table. The results confirmed our assumptions regarding the linearity of inflation-device pressure from 30 to 0 atm.

	Discussion

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Various methods to treat resistant stenoses include atherectomy devices (5,6); cutting balloons (7); laser angioplasty (9); "parallel-wire" technique (10); and "infiltrate and perforate" technique, in which needles are used to pierce the stenosis to weaken it before subsequent angioplasty (11). As we have shown, application of very high pressures with high-pressure balloons can accomplish the same results. When the cost of a high-pressure angioplasty balloon (list price, $255) is compared with that of other alternative methods for the treatment of resistant stenoses—including a cutting balloon (list price, $950 [appropriate diameters are not currently available in the United States]) and an atherectomy device (list price, approximately $1,000 [none are currently available in the United States])—it would appear that the use of high-pressure balloons may be a cost-effective alternative. However, a more formal study of cost-effectiveness would be needed to confirm this. Furthermore, it is tempting to consider a cost analysis of the cost of the high-pressure angioplasty balloons that we describe in comparison to that of newer and more expensive angioplasty balloons from the start in every hemodialysis access interventional procedure. However, there may be too many variables to address this question without further data collection. The prices of the three angioplasty balloons used in this study change frequently, and this fluctuation would render any calculation incorrect.

There is no question, however, that this approach yields improved technical patency rates over those with previously available balloon technology. In this small series, the technical success rate was improved from 92% (80 of 87 procedures) to 100%. Another unknown factor that remains to be explored is whether ultrahigh-pressure angioplasty results in more vessel injury or different patency rates than does the controlled injury of balloon angioplasty with previously available devices used at lower atmospheric pressures. It remains to be seen whether the approach used in this study yields patency rates that are the same as, better than, or worse than those achieved with the other techniques. Findings in previous studies of high-pressure balloon angioplasty do not suggest any decrement in patency (3), however, and our follow-up findings to date appear to confirm this.

Furthermore, again with limited data, our approach does not appear to have increased the complexity of subsequent interventional procedures; indeed, the subsequent percutaneous transluminal angioplasty procedure did not require use of ultrahigh-pressure balloons. Follow-up findings to the end of primary patency in all patients will be needed to ensure that we achieve the 50% 6-month primary patency rate suggested in the Dialysis Outcomes Quality Initiative guidelines (2).

The ability to extend the high-pressure balloons beyond the 30-atm limit of present inflation devices calls for the development of devices capable of delivering and recording pressures higher than 30 atm. When such devices are available, as with previous devices, further evaluation of the balloon with in vitro experiments will be necessary to explore its mode of failure and the outer limits of this working pressure. Fortunately, as shown by results of our inflation-device tests, our assumptions regarding the linearity of pressure measurements above 30 atm proved to be correct; thus, until such an inflation device becomes available, we can maintain a working knowledge of the pressures that we deliver to the balloon. Such factors as patient acceptance should be factored in when cutting-balloon technology is compared with ultrahigh-pressure balloon inflation because it has been suggested that patients experience less pain with cutting balloons (12).

The off-label practice of inflating angioplasty balloons to pressures beyond the manufacturer recommendation is well established in interventional radiology, particularly with venous angioplasty (4). We have found, through years of experience, that most angioplasty balloons can be inflated to approximately 150% of the manufacturer rated burst pressure. Our absolute maximum inflation pressures of 18 atm for the Ultra-thin balloon, 21 atm for the Ultrathin SDS balloon, and 27 atm for the Blue Max balloon were derived from this experience. Notably, the ultrahigh-pressure balloon used in this study is the first that we have not been able to rupture with commercially available inflation devices, which is reflected in the positive clinical results we describe herein.

In summary, we described ultrahigh-pressure balloon angioplasty in the treatment of hemodialysis access–related stenoses with excellent results. This approach may obviate more costly and/or commercially unavailable technology, such as cutting balloons and laser or atherectomy devices. Further evaluation of this inflation device in hemodialysis access and other settings seems warranted.

	ACKNOWLEDGMENTS

 
Costs associated with manuscript preparation were supported by an unrestricted grant from Medcomp, Harleysville, Pa. We thank Corey Stapleton and Robert Righi of Bard Peripheral Vascular, Tempe, Ariz, for performing the inflation-device tests.

	FOOTNOTES

 
²9_*. Vascular system, location unspecified

Author contributions: Guarantor of integrity of entire study, S.O.T.; study concepts and design, S.O.T.; literature research, S.O.T.; clinical studies, C.M.T., S.O.T., R.S.G., S.W.S.; data acquisition and analysis/interpretation, S.O.T.; manuscript preparation, S.O.T.; manuscript definition of intellectual content, editing, revision/review, and final version approval, all authors

	REFERENCES

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