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Home > Vascular Annual Meeting > deutsch_clinical_in_vitro

Clinical In-vitro Endothelialization of Infrainguinal Eptfe Grafts: Long-term Experience in 310 Consecutive Patients

Manfred Deutsch¹, Johann G. Meinhart¹, Norbert Howanietz¹, Michael Gorlitzer¹, Alexander Froeschl¹, Andreas Stuempflen¹, Martin Grabenwoeger¹, Peter Zilla.^2
1Hietzing Hospital, Vienna, Austria;²Christiaan Barnard Department of Cardiothoracic Surgery, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.

OBJECTIVES: Based on a randomized study that showed a significantly superior patency rate of in-vitro endothelialized ePTFE grafts, we investigated whether it was feasible to provide autologous in-vitro endothelialization as a routine procedure at a non-tertiary institution to all patients needing an infra-inguinal bypass who had no suitable saphenous vein available.

METHODS: Over a period of 15 years 310 consecutive patients (age 64.7±8.6) received 341 endothelialized ePTFE grafts (308 femoro-popliteal: 153 above knee [AK] and 155 below knee [BK] and 33 femoro-distal). Autologous endothelial cells were harvested from short segments (3.9±1.1cm) of subcutaneous veins (80.0% cephalic; 11.0% basilic; 1.8% external jugular and 7.2% saphenous) grown to mass cultures within 20.3±7.2 days and confluently lined onto fibrin glue-coated ePTFE grafts. The graft diameter was 6mm [73.6%] or 7mm [34.4%]. The procedure-related delay for graft implantation was 28.1+7.7 days. Growth failure prevented 2.6% of patients from receiving an endothelialized graft. Mean observation period was 9.6 years. Primary patencies were obtained from Kaplan-Meier survivorship functions. Explants for morphological investigation were obtained from 7 patients.

RESULTS: The overall primary patency rate of femoro-popliteal grafts was 68.8% at 5 years (68.0% [AK] vs. 70.5% [BK]) and 60.5% at 10 years (59% [AK] vs. 64% [BK]) [Figure 1]. Primary patency of 7mm vs. 6mm grafts was 78%/62% at 5 years and 71%/55% at 10 years. The difference between the two groups was statistically significant (log rank test p=0.023; Breslow test p=0.017). Stage I vs. II/III patients showed 5 year patencies of 67% vs. 73% (N.S.) and 10 year patencies of 61% vs. 53% (N.S.) [Figure 2]. The primary patency of femoro-distal grafts was 52.2% at 5 years and 35.9% at 10 years. The limb salvage rate was 94% (fem-pop) vs. 86% (fem-distal) at 5 years and 89% vs. 71% at 10 years. All retrieved samples showed the presence of an endothelium after 38.9±17.8 months.

CONCLUSIONS: Autologous in-vitro endothelialization was shown to be a feasible routine procedure at a non-tertiary hospital. Explants confirmed the presence of an endothelium years after implantation while the primary patency in the particularly challenging subgroup of patients without a suitable saphenous vein resembles that of vein grafts.

AUTHOR DISCLOSURES: M. Deutsch, None; J.G. Meinhart, None; N. Howanietz, None; M. Gorlitzer, None; A. Froeschl, None; A. Stuempflen, None; M. Grabenwoeger, None; P. Zilla, None.