Cutting Balloon Aids Stenosis Tx In Infrainguinal Bypasses

By Jeff Evans

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WASHINGTON -- New stenotic lesions in infrainguinal bypasses may be treated with cutting balloon angioplasty with relatively good short-term efficacy and safety in patients who are not good candidates for open surgical revision, according to findings from the largest series to date examining the technique for use in treating lower-extremity vein bypass grafts.

Open surgery has been the standard method for repairing lower-extremity vein graft stenosis, but advances in endovascular techniques have created a controversy over what method may now be best, Dr. Robert Garvin said at the annual meeting of the Eastern Vascular Society.

Cutting balloon angioplasty has been used safely and effectively in the coronary circulation for about 10 years, but not much data have been gathered on its use in the peripheral circulation, said Dr. Garvin, of the division of vascular surgery at Western Pennsylvania Hospital, Pittsburgh. Only two small series have been published that were specifically reporting on the use of the cutting balloon to treat lower-extremity vein graft stenosis (J. Vasc. Surg. 2004;39:702-8; Radiology 2002; 223:106-14).

All patients at Western Pennsylvania Hospital who developed significant lower-extremity vein graft stenosis during 2002-2006 were evaluated prospectively with digital subtraction angiography for possible treatment with a percutaneous intervention.

Dr. Garvin and his colleagues Drs. Thomas Reifsnyder, Steven Leers, Gordon McLean, and Richard Foster reviewed 109 cutting balloon angioplasty interventions in 61 patients who had 70 infrainguinal bypasses with stenotic lesions less than 2 cm in length.

The balloon was inflated mechanically for 30 seconds at 6-10 atm, withdrawn, rotated, and then readvanced and reinflated for a total of at least two repetitions for each lesion. Of the 70 bypasses, 60 were femoral-tibial, femoral-distal, or popliteal-distal, while 10 were femoral-popliteal.

The cutting balloon significantly lowered the peak systolic graft velocity from a mean of 360 cm/s before treatment to 158 cm/s immediately afterward, according to duplex ultrasound measurements. Ankle brachial indexes and toe pressures also improved significantly immediately after the procedure.

The cutting balloon achieved an initial technical success rate of 96%. After a median follow-up of 6 months, the bypasses showed a primary patency rate of 48%, an assisted primary patency rate of 72%, and a secondary patency rate of 99%, while the limb salvage rate was found to be 94%. By the end of the study, 7 of the 61 patients had undergone amputation.

The stenotic lesions "really represent the disease process of myointimal hyperplasia, so treating them percutaneously has some caveats associated with it," Dr. Garvin said.

No deaths occurred, but local complications developed in 12 (11%) of the 109 interventions. These included eight graft ruptures, two graft dissections from the cutting balloon, one graft thrombosis, and one late graft aneurysm. This complication rate "is probably a little bit higher than in other series looking at other percutaneous interventions," Dr. Garvin said. "This probably represents our own personal learning curve as we were learning to use the cutting balloon."

But despite the fact that reports consistently have shown that open surgical revision provides better overall patency rates than do percutaneous techniques, some patients may still have better results with percutaneous methods if they do not have any adequate veins left or if getting to their bypass proves to be too difficult due to obesity, Dr.Garvin suggested. Clinicians selected the patients in the series for percutaneous treatment because they knew beforehand that the bypasses would be difficult to revise openly, as most patients required a new bypass.

"What we really need in the future is to conduct a prospective, randomized trial to look specifically at surgical revision, standard balloon angioplasty, or cutting balloon angioplasty," Dr. Garvin concluded.

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