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LAS VEGAS -- The data to support the use of endovascular grafting of thoracic aortic aneurysm have come quickly, given that the procedure is only about 10 years old, Michael D. Dake, M.D., said at a meeting on vascular interventions sponsored by Medical Media Communications.

All the current data from clinical trials and patient registries indicate that success rates are as good as open surgery, if not better, said Dr. Dake, chairman of the department of radiology at the University of Virginia, Charlottesville.

The first grafting device for thoracic aneurysm, the GORE TAG Thoracic Endoprosthesis, was approved by the Food and Drug Administration in March of this year.

Patient registry data suggest that even in 2000, results were at least as good as open surgery, said Dr. Dake.

The registry includes data on 1,180 patients. The data indicate that 30-day mortality was 2.8% and that the 2.5%, rate of paraplegia--the most common specific complication after stroke (also 2.8%)--was less than the mortality rate.

The rate of type II endoleaks was 24%.

The mortality and stroke rates point up the fact that there is a substantial risk of embolism with the procedure, one that might be solved in the future by smaller, more compact devices, he noted.

The data also show that paraplegia frequently can be delayed following this procedure, Dr. Dake said. In 43% of cases, it occurred later, sometimes by as much as a week.

"The rule, more than the exception, is that when paraplegia does occur, it is not immediate," Dr. Dake said.

Prior to this experience, many would have predicted that the paraplegia rate would be higher than the mortality rate, so this is welcome news, he said.

Still, it indicates that proceduralists need to be vigilant about keeping the patient's blood pressure up and spinal collateral channels perfused, and that the ICU staff needs to be aware that the paraplegia can be delayed.

The trial of the Gore TAG device used by the FDA in its approval process showed results for the device that were significantly better than those for open surgery, Dr. Dake said.

Although the all-cause mortality rate at 2 years has not differed significantly in the group treated endovascularly, compared with the group treated with open surgery, this probably reflects the fact that the patients were selected, not randomized.

Many of those patients treated endovascularly also were not good surgical candidates.

In other measures, there were dramatic differences. In aneurysm-related mortality, the rate was 97% in the endovascular group at 1 year, compared with 90% in the surgery group, and that difference has continued out to 2 years.

The paraplegia rate was 3% in the endovascular group versus 14% in the surgery patients. The stroke rate was 5% versus 10%, and enlargement occurred in 3% versus 10%. Moreover, both the overall time spent in the hospital and in the ICU were reduced by days.

One important way in which treating thoracic aneurysms differs from treating abdominal aneurysms is that often it is not possible to completely address the thoracic aneurysm, and as a result, the aneurysm progresses over time, Dr. Dake also said.

"If the patient lives long enough, there is going to be progression. That is the natural history," he said.

PATIENT REGISTRY DATA SUGGEST THAT EVEN IN 2000, ENDOVASCULAR GRAFTING RESULTS WERE AT LEAST AS GOOD AS OPEN SURGERY.