Spiral laminar flow prosthetic bypass graft: medium-term results from a first-in-man structured registry study.
Ann Vasc Surg
; 26(8): 1093-9, 2012 Nov.
Article
in En
| MEDLINE
| ID: mdl-22682930
ABSTRACT
BACKGROUND:
A number of surgical strategies and graft enhancements have been trialled to improve the performance of prosthetic grafts. Neointimal hyperplasia may, in part, be a normal cellular response to an abnormal (turbulent) flow environment. This first-in-many study assesses the safety and medium-term patency performance of a new graft designed to induce stable laminar flow through the distal anastomosis.METHOD:
Forty patients who required an infrainguinal bypass graft were recruited/registered from a number of centers in Belgium and The Netherlands. Thirty-nine received a Spiral Laminar Flow graft as part of a standard treatment protocol (23 above-the-knee and 16 below-the-knee bypasses). Kaplan-Meier analyses were used to calculate primary and secondary patency rates.RESULTS:
The 12-, 24-, and 30-month primary patency rates were 86%, 81%, and 81% for above-the-knee bypasses and 73%, 57%, and 57% for below-the-knee bypasses, respectively. In the case of secondary patency rates, numbers were unchanged for above-the-knee bypasses and were 86%, 64%, and 64%, respectively, for below-the-knee bypasses. There were no amputations in the study population.CONCLUSION:
This first-in-man series shows potential for the idea of spiral flow-enhanced prosthetic grafts. As always, randomized studies are required to explore the role of different enhanced prosthetic grafts.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Blood Vessel Prosthesis
/
Blood Vessel Prosthesis Implantation
/
Lower Extremity
/
Peripheral Arterial Disease
Type of study:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Observational_studies
Limits:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
Ann Vasc Surg
Journal subject:
ANGIOLOGIA
Year:
2012
Document type:
Article
Affiliation country: