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Published online before print March 1, 2002, 10.1148/radiol.2231010793
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(Radiology 2002;223:106-114.)
© RSNA, 2002

Vascular and Interventional Radiology

Cutting Balloon Percutaneous Transluminal Angioplasty for Salvage of Lower Limb Arterial Bypass Grafts: Feasibility1

Christoph Engelke, MD, Robert A. Morgan, FRCR and Anna-Maria Belli, FRCR

1 From the Department of Diagnostic Radiology, St George’s Hospital, London, England. From the 2000 RSNA scientific assembly. Received April 16, 2001; revision requested June 2; revision received August 15; accepted September 7. Address correspondence to C.E., Department of Radiology, Klinikum Rechts der Isar, Ismaninger Strasse 22, D-81675 Munich, Germany (e-mail: cengelke@hotmail.com).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
PURPOSE: To evaluate the feasibility of cutting balloon percutaneous transluminal angioplasty (PTA) for treatment of neointimal hyperplasia in peripheral arterial bypass grafts.

MATERIALS AND METHODS: Fifteen consecutive patients (six women, nine men; age range, 57–89 years; mean age, 71 years) were treated with cutting balloon PTA for 16 anastomotic stenoses after infrainguinal bypass (prosthetic grafts, seven patients; prosthetic-vein composite grafts, two; venous grafts, five; and ileofemoral stent-graft, one). Cutting balloon PTA was followed by conventional PTA to improve anastomotic diameter. Patients with stenotic vein grafts underwent cutting balloon PTA after failed conventional PTA; the other patients were treated primarily with cutting balloon PTA. Criteria for success were a lumen diameter improvement of greater than 50% or residual stenosis of 20% or less. Follow-up was performed with color duplex ultrasonographic surveillance. Patency rates and durations were calculated with Kaplan-Meier survival curves and log-rank statistics.

RESULTS: Attempted conventional PTA (n = 6) prior to cutting balloon PTA was unsuccessful. Cutting balloon PTA was technically successful in 15 (94%) of 16 lesions, without clinical complications. Two local restenoses and one graft occlusion occurred between 5 and 7 months. The cumulative 6-month primary and secondary graft patency rates were 84% and 92%, respectively. At 12 and 18 months, they were 67% (95% CI: 0.34, 0.86) and 83% (95% CI: 0.48, 0.96), respectively; mean follow-up was 10.0 months.

CONCLUSION: Cutting balloon PTA proved feasible for treatment of resistant peripheral arterial bypass graft stenosis, commonly caused by neointimal hyperplasia, with excellent technical success. Short-term patency with this technique appears to be superior to that with conventional PTA, and it compares well with patency of atherectomy for salvage of infrainguinal bypass grafts.

© RSNA, 2002

Index terms: Arteries, restenosis • Arteries, transluminal angioplasty • Grafts, interventional procedures


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Current nonsurgical treatments for anastomotic stenoses of peripheral bypass grafts owing to neointimal hyperplasia are unsatisfactory. Despite a reported initial technical success rate of up to 87% for conventional percutaneous transluminal angioplasty (PTA) (1,2), the 1- and 2-year patency rates are only 44%–53% (3,4). The patency rate after atherectomy is better than that after stand-alone conventional PTA (78%–88% at 1–2 years [5–7]). However, the use of atherectomy devices as an alternative to conventional PTA is limited because of the large caliber and rigidity of these devices.

Cutting balloons (Barath; IVT, San Diego, Calif) are relatively new devices, which were designed for the percutaneous treatment of recurrent stenosis owing to neointimal hyperplasia within coronary artery stents (8,9). With their low profile (4 F) and high flexibility, they confer major handling advantages compared with atherectomy devices. The catheters have three to four microsurgical blades mounted longitudinally on the balloon that cut directly into the stenotic lesion during initial balloon inflation. These blades disrupt the fibroelastic continuity of the ring of neointimal hyperplasia, prevent the elastic recoil, and enable effective dilation of rigid (anastomotic) strictures to a larger diameter than does stand-alone conventional PTA. Thus, lesions that do not respond well to conventional PTA are amenable to cutting balloon PTA (10).

Additionally, microincisions into the neointimal hyperplasia during balloon inflation induce a directed intimal disruption and less wall tension than the diffuse hoop stress produced by conventional PTA and thereby minimize the intimal trauma (9). This is reflected by encouraging clinical results for use in ostial coronary angioplasty (10) and in-stent restenosis (11–13).

Except for the treatment of hemodialysis shunts and grafts (14,15) or pulmonary artery branch stenosis (16), there has been no published work, to the best of our knowledge, regarding the use of the cutting balloon in the peripheral arterial system. The aim of this study was to evaluate the feasibility of cutting balloon PTA for the treatment of peripheral arterial neointimal hyperplasia.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Study Design
This nonrandomized retrospective study was performed to test the feasibility of cutting balloon PTA for treatment of anastomotic bypass graft stenoses. At our center between late 1999 and 2001, all patients who manifested anastomotic stenosis more than 1 month after arterial bypass grafting were included in the study. These patients would normally undergo atherectomy or surgical procedures at our institution. Each patient provided informed consent prior to treatment. Our institutional review board did not require its approval for this type of study. The study was performed in agreement with the 1990 Declaration of Helsinki principles of human rights regarding physicians in biomedical research involving human subjects.

The technical and clinical outcomes were reviewed. Only discrete anastomotic lesions of a maximum of 2 cm in length were treated with the cutting balloon. No patients who manifested longer graft stenoses were observed during the study period, and no patient was excluded. All lesions were identified at routine graft surveillance color duplex ultrasonography (US), presenting a significant peak systolic flow velocity (PSV) gradient. Concomitant arterial inflow and runoff vessel stenoses were excluded from treatment with cutting balloon PTA and were treated with conventional PTA.

Study Population
Fifteen consecutive patients (six women, nine men; age range, 57–89 years; mean age, 71 years) were treated at our center with cutting balloon PTA for restenosis after lower limb venous or prosthetic bypass graft surgery. The individual risk factors for development of recurrent stenosis and graft thrombosis were insulin-dependent diabetes mellitus in two patients, smoking in four, and hyperlipoproteinemia in one. Six patients manifested concomitant stenoses of the graft inflow or runoff vessels, as discussed later. Indications for graft surgery were severe short-distance (<50 m) claudication, critical leg ischemia, or abdominal aortic aneurysm. Seven patients had polytetrafluoroethylene (PTFE) grafts (five femoropopliteal grafts, one aortobifemoral graft with bilateral anastomosis to the deep femoral arteries, and one femorofemoral crossover graft), three patients had common femoral artery to below-knee composite grafts (PTFE-reversed saphenous vein graft), four had reversed femoropopliteal vein grafts, and one had an external iliac to common femoral artery stent-graft (Table 1).


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  		TABLE 1. Patient Summary for Initial Graft Status

 
Five patients (three with PTFE grafts, one with a reversed long saphenous vein graft, and one with a PTFE–reversed saphenous vein composite graft) were admitted to the hospital with acute bypass occlusion and critical limb ischemia. The remaining 10 patients were asymptomatic but manifested anastomotic stenoses at postoperative routine color duplex US surveillance and required intervention. The PSV gradients ranged from 2.5 to 5.0 (mean, 3.4). The stenosis grade (>50%) of these lesions was confirmed by using digital subtraction angiography (DSA) before cutting balloon PTA.

The five patients with graft occlusion had similarly high velocity gradients (>=2.5) at color duplex US. Graft occlusion occurred before admission for radiologic intervention. All five patients with graft occlusion were treated with local thrombolysis prior to cutting balloon PTA, and a greater than 50% anastomotic stenosis was confirmed at DSA in each case. Sixteen anastomotic lesions were treated with cutting balloon PTA (one patient had two stenoses, one at each end of a femorofemoral crossover graft). Six stenoses were located at graft-vein patch anastomoses. Thirteen stenoses were located at the distal anastomosis, and three lesions were at the proximal graft anastomosis (Table 1). All lesions were short focal stenoses (mean length, 0.8 cm; range, 0.5–2.0 cm).

Stenosis Assessment
A significant stenosis was defined at color duplex US as a PSV gradient, or , which is calculated with the equation = PSVmaximal/PSVproximal, of at least 2.5. A significant stenosis was defined at angiography as the reduction in the vessel diameter of at least 50%, as discussed in the Criteria for Success section. Angiographic assessment of stenosis severity was performed by using the ratio of the minimal intrastenotic to the prestenotic vessel diameter.

Cutting Balloon Technology
The cutting balloon is a balloon catheter with cardiologic specifications (maximum balloon diameter, 4.0 mm) that has three to four microsurgical blades mounted longitudinally on the balloon. These blades are exposed only during the balloon inflation (Fig 1). The catheter has a central guide wire channel ("monorail" system) only in the distal part that allows rapid exchange with the use of a dedicated 0.014-inch flexible-tip stiff guide wire (Trackwire; IVT). In the peripheral vascular system, cutting balloon PTA is performed technically analogous to conventional PTA.



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  		Figure 1. Cutting balloon function. Left: Microsurgical blades are covered inside balloon folds in the deflated state (profile view). Right: During inflation, the microtomes are exposed and pressed into adjacent structures. (Image courtesy of IVT Europe, Lisnenan, Letterkenny, County Donegal, Ireland.)

 
Technique
Each patient received 150 mg of aspirin the day before intervention was performed. The procedures were conducted by three interventionalists (C.E., R.A.M., A.M.B.). The arterial access site was chosen to guarantee the best accessibility of the lesion. The access vessel was then assessed for special puncture requirements (high or low puncture or the use of an introducer sheath smaller than 6 F, eg, owing to previous surgical venous patch plasty) or for the requirement for surgical cutdown. Intraarterial administration of a 5,000-IU bolus of heparin was routinely performed after insertion of the introducer sheath. To prevent arterial spasm, intraarterial glyceryl trinitrate in 150-µg aliquots was injected at the discretion of the operator. The patients with occluded grafts were treated with regional thrombolysis with recombinant tissue plasminogen activator immediately prior to cutting balloon PTA.

To define the anatomy, diagnostic arteriography was routinely performed before intervention. The lesion was crossed by using a hydrophilic guide wire (Terumo Europe, Leuven, Belgium) and a 4–5-F cobra catheter (Cordis; Johnson & Johnson Europe, the Netherlands). In six patients with vein grafts, conventional PTA was attempted prior to cutting balloon PTA by using a standard over-the-wire technique with an 0.018-inch guide wire (V18; Boston Scientific, Natick, Mass) and 3.0–6.0-mm-diameter angioplasty balloons (Smash or Bijou; Boston Scientific), but in all cases the stenosis could not be dilated. Therefore, conventional PTA was immediately followed by cutting balloon PTA. The 0.018-inch guide wire was exchanged for a dedicated 0.014-inch guide wire for the cutting balloon.

Cutting balloon PTA was performed with cutting balloons that were 4.0 mm in diameter (the largest diameter available) by 10 mm long in 13 stenoses or with 2.5-mm-diameter devices in two stenoses below the knee. In one case, the largest balloon diameter of 4.0 mm was not available, and a 3.5-mm cutting balloon was used. For use in femoral or popliteal anastomotic stenoses, generally the largest cutting balloon diameter was chosen. For use in stenoses below the popliteal artery, the cutting balloon was sized according to the diameter of a normal runoff vessel segment distal to the anastomosis. Cutting balloon PTA was performed with one to three overlapping inflations (maximum pressure of 8 atm) and included the entire length of each stenotic lesion. In all patients, cutting balloon PTA was followed by conventional PTA to restore a normal anastomotic diameter. Control DSA was performed after each cutting balloon PTA and conventional PTA procedure and included the cutting balloon PTA site and runoff vessels for documentation of the diameter improvement and assessment of potential complications, such as vasospasm, dissection, thrombosis, or embolism. All control DSA studies were conducted by and the findings thereof interpreted by the same examiners (C.E., R.A.M., A.M.B.).

In four patients with graft stenosis of the common femoral, the superficial femoral, or the deep femoral artery anastomosis, crossover cutting balloon PTA was performed with (n = 3) or without (n = 1) guiding support with a Balkin sheath (Cook Europe, Bjaeverskov, Denmark). One patient underwent cutting balloon PTA of both distal anastomoses of the femorofemoral crossover graft. At the time of cutting balloon PTA, six patients underwent conventional PTA of an associated iliac inflow (n = 3) or infrapopliteal runoff stenosis (n = 3) in the same limb outside the graft.

Criteria for Success
Technical success was defined as improvement in luminal diameter of more than 50% or less than 20% residual stenosis (in keeping with the PTA guidelines of the Society of Cardiovascular and Interventional Radiology). Restenosis was defined as a greater than 50% stenosis at angiography or a two and a half times or greater PSV gradient at duplex US examination. A two and a half times PSV gradient is used in our department rather than the more conventional two times the PSV gradient because previous audit of our graft surveillance showed better correlation of this parameter with a substantial angiographic abnormality that required intervention. Clinical success was defined as the complete relief of or substantial improvement of symptoms in patients who had graft occlusion at presentation. No other patient had any symptoms prior to or at the time of intervention.

Follow-up
All patients were followed up in a postinterventional surveillance program, which included clinical evaluation by a consultant vascular surgeon, recording of Doppler-based ankle-brachial pressure indices, and color duplex US scanning at 6 weeks postintervention followed by evaluations at 3-month intervals up to 1 year and at 6- and 12-month intervals thereafter performed by a consultant radiologist and a vascular ultrasonographer. Each duplex US assessment included the inflow and runoff vessels. If significant anastomotic stenosis recurred, the patient was scheduled for repeat cutting balloon PTA. If associated inflow or runoff vessel stenosis was detected during follow-up, the patient was scheduled for conventional PTA.

Statistical Analysis
Our institutional statistician was consulted to ensure the use of the appropriate statistical tests. All calculations were performed with a spreadsheet-based statistical software package (StatsDirect release 1.9.4; CamCode, Herts, England). Cumulative primary and secondary (assisted by using reintervention) patency rates were calculated by using Kaplan-Meier survival curves. The 95% CIs, the statistical differences between the survival groups (primary and secondary patency rates), the estimated median patency, and the overall hazard ratios were computed with the log-rank (Cox-Mantel) test.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 
Cutting balloon PTA was technically successful in 15 of the 16 (94%) lesions in which it was attempted, including the six lesions that were resistant to conventional PTA (Figs 2–4). In 10 lesions (nine patients), cutting balloon PTA was performed as the primary procedure (Figs 2, 5). In six lesions, cutting balloon PTA was performed only after unsuccessful conventional PTA (Figs 3, 4). The handling of cutting balloons was straightforward in all 16 lesions (15 patients). There were no special requirements for the arterial access regarding the vascular anatomy or the low-profile (4-F) flexible cutting balloon catheters, and 6-F standard introducer sheaths were used in all patients. No surgical cutdown was required in any patient. All lesions were easily accessible over the 0.014-inch guide wire, and crossover use of the cutting balloon catheter from the contralateral side was performed without difficulty when required (Fig 5).



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  		Figure 2. Posteroanterior digital subtraction angiograms of a common femoral to above-knee popliteal artery PTFE bypass graft (*). Left: Image shows a distal bypass graft stenosis (arrowhead). Middle: Image shows the result after cutting balloon PTA with a 4.0-mm-diameter balloon with partial dilation of the stenosis (arrowhead). Right: Subsequent image shows the final result after subsequent conventional PTA with a 6.0-mm-diameter balloon that was 20 mm long (arrowhead). Lesion was successfully treated, and restenosis did not occur during a 9-month follow-up.

 


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  		Figure 3. Posteroanterior unsubtracted angiograms show a femoropopliteal vein bypass graft (*) with distal anastomosis below the knee. Far left: Image shows a distal anastomotic stenosis (arrowhead). Left middle: Image shows the result of initial conventional PTA with 6-mm-diameter balloon that failed to dilate the rigid stenosis (arrowhead) of neointimal hyperplasia. Right middle: Image shows the result after subsequent cutting balloon PTA with 4.0-mm-diameter balloon that achieved partial dilatation of the resistant stenosis (arrowhead). Far right: Image shows the final result after subsequent conventional PTA that achieved normal vessel diameter (arrowhead), which was maintained during a follow-up of 4 months.

 


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  		Figure 4. Posteroanterior digital subtraction angiograms show a femorodistal PTFE vein composite bypass graft (*) with venous graft anastomosis to the posterior tibial artery. Far left: Image shows an anastomotic (arrow) and postanastomotic (arrowheads) stenosis (image composed from two data acquisitions). Left middle: Image shows the result after conventional PTA of combined anastomotic and postanastomotic stenosis with a 3.0-mm-diameter balloon that was 20 mm long. The anastomotic stenosis (arrow) did not respond (magnified image). Right middle: Image shows the result after subsequent anastomotic cutting balloon PTA with a 2.5-mm-diameter device and final subsequent conventional PTA and subsequent conventional PTA with a 3.0-mm-diameter balloon that was 20 mm long, with satisfactory anastomotic (arrow) and distal (arrowheads) results, which were maintained to date (3 months follow-up). Far right: Magnification of image at right middle.

 


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  		Figure 5. Posteroanterior digital subtraction angiograms of an aortobifemoral PTFE bypass graft (*). Left: Image shows a stenosis at the left distal deep femoral artery anastomosis (arrowhead). Right: Magnified image shows the result after cutting balloon PTA and subsequent conventional PTA (arrowhead). The procedure was performed from a right distal graft limb access (6-F introducer sheath) without aid of a crossover sheath. This lesion developed restenosis after 5 months, and the restenosis was successfully treated with repeat cutting balloon PTA.

 
The balloon expanded completely in all patients, and no balloon waist remained. All lesions were dilated with a good angiographic result (substantial improvement of the vessel diameter to less than 30% residual stenosis in all cases) and without any clinical complications of occlusion, significant vasospasm, dissection, thrombosis, or embolization. Cutting balloon PTA and conventional PTA successfully decreased the percentage of anastomotic stenosis: Before intervention, the mean stenosis was 75.5% (range, 55%–95%); after cutting balloon PTA and conventional PTA, the mean stenosis was 8.3% (range, 0%–30%; 95% CI: 0.60, 0.75; P < .001). On the other hand, initial conventional PTA in patients with venous grafts resulted in minimal improvement of 0%–20% (mean improvement, <10%). In one patient, the cutting balloon ruptured during inflation. The device was retrieved without difficulty, and the procedure was completed by using PTA with a conventional balloon, with a good angiographic result and no significant remaining duplex US velocity gradient. At initial duplex US follow-up, all systolic peak velocity gradients were less than 2. The clinical success after thrombolysis and cutting balloon PTA was 100% (all five patients with acute graft occlusion).

The mean follow-up was 10.0 months (range, 3–19 months). To date, two local restenoses have occurred at cutting balloon sites after 5 and 7 months follow-up. One of them was treated successfully with repeat cutting balloon PTA. The second restenosis after previous cutting balloon rupture, as discussed before, was treated surgically with anastomotic vein patch plasty after vascular interventional therapy failed twice (conventional PTA 14 months earlier and cutting balloon PTA 7 months earlier) (Table 2).


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  		TABLE 2. Patient Summary for Treatment and Follow-up Data

 
There was one intragraft stenosis 2 cm above the original site of cutting balloon PTA at 7 months, and this lesion was treated successfully with cutting balloon PTA. In all cases, subsequent interventional treatment of recurrent stenosis was performed on the basis of duplex US and DSA findings. One patient with severe runoff vessel disease had a graft occlusion at 6 months after cutting balloon PTA and required below-knee amputation. This patient was included in the restenosis category when Kaplan-Meier and Cox-Mantel statistics for local patency rates and duration were calculated. The limb salvage rate was 14 (93%) of 15 limbs. No other patient had recurrent critical limb ischemia (Table 2).

The estimated cumulative local (cutting balloon PTA site–related) primary and secondary patency rates determined by using Kaplan-Meier survival curves for a 6-month observation were 84% (95% CI: 0.49, 0.96) and 92% (95% CI: 0.54, 0.99), respectively. For 12- and 18-month observations, the primary and secondary patency rates were 76% (95% CI: 0.42, 0.91) and 83% (95% CI: 0.48, 0.96), respectively (Fig 6).



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  		Figure 6. (a) Cumulative primary and secondary local patency (Kaplan-Meier) rates (in percentages) at the cutting balloon PTA sites. (b) Cumulative primary and secondary graft patency (Kaplan-Meier) rates (in percentages) after cutting balloon PTA. Dotted lines = primary patency rates, solid lines = secondary patency rates.

 
The cumulative primary and secondary graft patency rates for a 6-month observation were 84% (95% CI: 0.49, 0.95) and 92% (95% CI: 0.54, 0.99), respectively. For 12- and 18-month observations, the primary and secondary graft patency rates were 67% (95% CI: 0.34, 0.86) and 83% (95% CI: 0.48, 0.96), respectively (Fig 6, B). The hazard ratios for local and graft-related (primary vs secondary) patency rates were 1.61 (95% CI: 0.28, 9.32) and 2.16 (95% CI: 0.45, 10.71), respectively. The estimated median duration of primary and secondary local patency was 15.8 and 16.9 months, respectively, and the median duration of primary and secondary graft patency was 14.8 and 16.9 months, respectively (Table 3).


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  		TABLE 3. Cumulative Patency

 
There was no change in cumulative local or graft patency more than 7 months after initial treatment. So far, neither of the two patients who underwent repeat cutting balloon PTA has manifested recurrent restenosis at duplex US follow-up 5 and 9 months after the procedure.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
REFERENCES
 
The concept of using cutting balloon PTA with surgical microtomes mounted on the balloon to enhance standard PTA was introduced in cardiology by Barath et al (8) and Barath (9). Since 1996, cutting balloon PTA has been used for overcoming the high rigidity of calcified plaques in coronary artery stenoses (17) and for treating ostial or nonostial coronary artery stenosis (10,18,19) and coronary in-stent restenosis (20,21). Findings in initial studies indicated that lesions that did not respond well to conventional PTA could be treated with this new technique (17,18,20,22) to facilitate stent placement (23) or the treatment of neointimal hyperplasia (21,24).

In a prospective study in which cutting balloon PTA was compared with conventional PTA for treatment of ostial coronary artery stenosis, Muramatsu and co-workers (10) found that cutting balloon PTA had excellent technical success rates in the group treated with this technique (94% vs 84.6% in the conventional PTA group) and a lower short-term restenosis rate than conventional PTA (43% for cutting balloon PTA vs 53% for conventional PTA at 5.3 months of follow-up). A similar short-term advantage of cutting balloon PTA compared with conventional PTA was described by Kondo et al (19) in a matched comparison of cutting balloon PTA and conventional PTA for the treatment of nonostial coronary stenosis (23% restenosis with cutting balloon PTA vs 42% restenosis with conventional PTA at 4 months of follow-up). In addition, Adamian et al (21) in a retrospective analysis of in-stent restenosis in which cutting balloon PTA was compared with conventional PTA and atherectomy observed restenosis rates of 25%, 43%, and 34% at 6 months. Findings in these two studies suggest that cutting balloon PTA could offer a reasonable alternative to coronary PTA and atherectomy in the treatment of complex coronary artery lesions, including neointimal hyperplasia.

Articles concerning experience with the use of the cutting balloon in the noncoronary circulation are limited to the treatment of resistant stenoses in hemodialysis shunts and grafts (14,15) and in pulmonary artery branch stenosis (16). To the best of our knowledge, there are no articles about the use of this device in the treatment of lower extremity peripheral vascular disease. By using postsurgical restenosis at infra- and transinguinal bypass graft anastomoses as a model for neointimal hyperplasia in the peripheral arterial system, we evaluated the feasibility and safety of cutting balloon PTA with respect to immediate success and long-term graft patency.

The patency of peripheral arterial bypass grafts relies on various factors, including demographics, previous tissue loss of the foot, graft material, anastomotic site, vessel diameter, and status of inflow and runoff vessels (25). Five-year patency rates of infrainguinal vein grafts can approach 80% (26–28). The durability of prosthetic infrainguinal grafts is less with 3–5-year patency rates of 42%–60% for above-knee femoropopliteal grafts (29–31), and it is even less for below-knee femoropopliteal or femorodistal bypass grafts with prosthetic graft material (25,32).

After technical surgical errors, anastomotic stenosis is the most frequent cause of lower limb bypass graft failure (33,34). Anastomotic stenoses that occur more than 1 month after surgery are usually induced by neointimal hyperplasia and require treatment to prevent graft occlusion (35). Standard techniques for percutaneous treatment of neointimal restenosis in peripheral arterial bypass grafts include conventional PTA and atherectomy. They are complemented by surgical procedures that include vein patch revision and jump grafting.

Unfortunately, the results of conventional PTA in the treatment of infrainguinal bypass graft stenoses are not as favorable as they are for treatment of native artery stenoses. Technical success is diminished as a result of elastic recoil, and primary 1-year patency rates are relatively poor and range from 44% to 53% (3,4). In addition, some anastomotic lesions are resistant to dilation, with failure to overcome the waist on the balloon despite the use of higher inflation pressures. This was observed in all six patients who did not respond to conventional PTA in this series.

The results of atherectomy are better than those of conventional PTA in the treatment of anastomotic strictures, with a technical success rate of 92% and patency rates of 78%–88% at 14 months (5–7). These data compare well with our current results with cutting balloon PTA. However, atherectomy devices are inflexible, have a large diameter (8–10 F), and are relatively complex to handle, and therefore require substantially more technical expertise than is required for use of balloon catheters with conventional PTA or cutting balloon PTA. Generally, they require large introducer sheaths, sometimes with surgical access to the vessel, and they cannot be used across the aortic bifurcation. Conventional PTA is frequently required prior to atherectomy to enable the device to pass into the anastomotic stenosis. In the study of Porter et al (5), infrainguinal atherectomy was associated with higher complication rates (6%–11%) than conventional PTA (2). Complications included distal embolization, graft occlusion, and pseudoaneurysm formation. Surgery as a more invasive procedure often is reserved for cases after failed endovascular therapy (36).

In our study, cutting balloon PTA proved feasible, safe, and efficient in the treatment of peripheral arterial bypass graft restenosis, with primary technical success rates similar to those in studies on the use of cutting balloon PTA in treatment of coronary disease (10) or in the treatment of anastomotic bypass graft stenosis with infrainguinal atherectomy (7). The observation that none of the six attempts to perform conventional PTA prior to cutting balloon PTA was successful supports the idea that anastomotic restenosis more than 1 month after surgery is associated with a high resistance to conventional PTA (eg, caused by neointimal hyperplasia, which requires cutting balloon PTA for adequate immediate results). Although our patient group was small, the short-term results suggest a role for cutting balloon PTA in the treatment of peripheral neointimal hyperplasia lesions that do not respond well to conventional PTA. In addition, the cumulative patency rates at 6, 12, and 18 months in this series compare favorably with those in studies in which conventional PTA (3,4) was used, and the results are similar to those in studies with the use of atherectomy for salvage of peripheral arterial grafts (6,7).

These findings are supported by the favorable estimated median patency rates that rather represent underestimates, because most of the lesions still remain without restenosis. The hazard ratio for restenosis appeared to be 1.6 to two times as high in patients without reintervention. However, this estimate, which suggests a substantial reintervention benefit, is based on a small number of patients and should be supported by a larger trial to evaluate whether cutting balloon PTA could replace conventional PTA and atherectomy as the optimal nonsurgical treatment for neointimal hyperplasia–induced stenoses of lower limb bypass grafts.

The current technical limitation of the cutting balloon in peripheral arterial use is its cardiologic device specification with a maximum balloon diameter of 4.0 mm. The combination with conventional PTA enables application of cutting balloon PTA in vessels as large as 6 mm in diameter. Other potential target vessels with comparable size are the renal arteries and dialysis fistulas or grafts (14,15). However, for treatment of iliac in-stent restenosis, anastomotic stenosis of aortoiliac surgical grafts, or subclavian artery in-stent restenosis, larger devices are required.

Complications of cutting balloon PTA are few. To our knowledge, only one coronary artery aneurysm following PTA of the coronary artery has been reported (37), and focal coronary artery dissection, which occurs less frequently in comparison with conventional PTA of the coronary artery (38), does not appear to be clinically important (39). In our patients, the use of the cutting balloon in graft anastomosis was reliably safe. This finding may have implications for bypass graft salvage in different vascular territories, such as the coronary arteries.

A limitation of this study is that it was observational and involved a small number of patients. Although our early data show a trend similar to that in studies with different endovascular techniques, with the restenosis peak at about 6 months and stable patency thereafter, more work is required to determine the long-term effectiveness of cutting balloon PTA for the treatment of late peripheral bypass graft anastomotic stenosis in comparison with that of competing endovascular techniques.

In conclusion, currently, cutting balloon PTA appears to be a valuable tool in the endovascular arsenal for the treatment of neointimal hyperplasia, and it could replace atherectomy and conventional PTA for endovascular salvage of peripheral arterial bypass grafts.


   ACKNOWLEDGMENTS
 
The ongoing meticulous noninvasive follow-up of our patients by Kok Tee Khaw, FRCR, and Jane Danaher, ultrasonographer, was invaluable for this study and greatly appreciated. We also thank Professor J. Martin Bland from our Department of Medical Statistics for his invaluable advice and help.


   FOOTNOTES
 
Abbreviations: DSA = digital subtraction angiography, PSV = peak systolic flow velocity, PTA = percutaneous transluminal angioplasty, PTFE = polytetrafluoroethylene

Author contributions: Guarantor of integrity of entire study, C.E.; study concepts and design, C.E., A.M.B.; literature research, C.E.; clinical studies, C.E.; data acquisition, C.E.; data analysis/interpretation, C.E., R.A.M.; statistical analysis, C.E.; manuscript preparation, C.E.; manuscript definition of intellectual content, editing, revision/review, and final version approval, C.E., R.A.M., A.M.B.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 

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