Spiral Flow Prosthetic Grafts In lower extremity bypasses: 1-year results and beyond

Presented at Veith Symposium November 2014, New York Mr N Shaper, Bradford Royal Infirmary, UK

Purpose

The aim of this single centre study was to compare the primary and secondary patency rates at one year of conventional PTFE infrainguinal bypass grafts with a new Spiral Laminar Flow ePTFE graft.

Methods

Prospective data on primary and secondary patency rates and interventions/complications was gathered on 68 infrainguinal bypasses using Spiral Flow Grafts from February 2011 to October 2014. The data on 136 standard grafts was gathered retrospectively on all infrainguinal PFTE grafts over a six year period from Jan 2003 to Dec 2008. Data was obtained from case notes and surveillance scans. There were no changes in case mix or operative/interventional procedures between the two groups/time periods. Data was also obtained on type of operation, mortality and amputation rates. At one year, data for 54 Spiral Flow Grafts and 124 standard grafts was available for review.

Patient Demographics

 Spiral FlowConventional ePTFE
Age69.6 mean (47-92)70.3 (45-93)
Sex78% male48% male
Critical ischaemia53%55%

Level of Implantation

 Spiral FlowConventional ePTFE
Above Knee48%13%
Below Knee / Tibial / Complex52%87%

Vein cuffs were added to all BK/distal anastomoses.

Spiral Flow was seen on post-operative imaging at all distal anastomoses and run-off vessels.

Results

Primary patency (Actuarial %)

 Spiral FlowConventional ePTFE
Overall76%48%
Above Knee77%50%
Below Knee / Tibial / Complex61%48%

Secondary patency (Actuarial %)

Overall87%55%
Above Knee88%71%
Below Knee / Tibial / Complex79%53%
Amputation rate2%10%

Conclusions

Benchmarked against conventional grafts highlights a 30% actuarial improvement in primary and secondary patency. Results out to 3 years, particularly of more complex grafts, would appear to indicate a sustained patency advantage over conventional grafts. Significantly encouraging initial results to warrant continued usage and further long term data acquisition.