ABSTRACT
OBJECTIVE: Based on a previous randomized study showing significantly superior patency rates for in vitro endothelialized expanded polytetrafluoroethylene (ePTFE) grafts we investigated whether it was feasible for a nontertiary institution to offer autologous in vitro endothelialization to all elective infrainguinal bypass patients who had no suitable saphenous vein available. METHODS: Over a period of 15 years, 310 out of 318 consecutive nonacute patients (age 64.7 +/- 8.6) received 341 endothelialized ePTFE grafts (308 femoropopliteal: 153 above knee [AK] and 155 below knee [BK] and 33 femorodistal). Autologous endothelial cells were harvested from short segments (3.9 +/- 1.1 cm) of subcutaneous veins (80% cephalic, 11% basilic, 2% external jugular, and 7% saphenous) and grown to mass cultures within 18.9 +/- 4.5 days before being confluently lined onto fibrin glue-coated ePTFE grafts. The graft diameter was 6 mm (64%) or 7 mm (36%). The overall procedure-related delay for graft implantation was 27.6 + 7.8 days. Growth failure prevented 2.5% of patients from receiving an endothelialized graft. The mean observation period was 9.6 years. Primary patencies were obtained from Kaplan-Meier survivorship functions. Explants for morphological analysis were obtained from eight patients. RESULTS: The overall primary patency rate of femoropopliteal grafts was 69% at 5 years (68% [AK] vs 71% [BK]) and 61% at 10 years (59% [AK] vs 64% [BK]). Primary patency of 7 mm vs 6 mm 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 = .023; Breslow test P = .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.). The primary patency of femorodistal grafts was 52% at 5 years and 36% at 10 years. The limb salvage rate was 94% (fempop) vs 86% (femdistal) 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. CONCLUSION: Autologous in vitro endothelialization was shown to be a feasible routine procedure at a nontertiary 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.
Subject(s)
Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endothelial Cells/transplantation , Lower Extremity/blood supply , Peripheral Arterial Disease/surgery , Tissue Scaffolds , Aged , Blood Vessel Prosthesis Implantation/adverse effects , Cell Culture Techniques , Cell Proliferation , Feasibility Studies , Female , Fibrin Tissue Adhesive/therapeutic use , Graft Occlusion, Vascular/etiology , Humans , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/pathology , Peripheral Arterial Disease/physiopathology , Polytetrafluoroethylene , Prospective Studies , Prosthesis Design , Risk Assessment , Time Factors , Tissue Adhesives/therapeutic use , Transplantation, Autologous , Treatment Outcome , Ultrasonography, Doppler, Duplex , Vascular PatencyABSTRACT
OBJECTIVE: To eradicate treatment-resistant lower back pain caused by painful degeneration of the intervertebral disks. To avoid the disadvantages of alternative fusion surgery, especially degenerative wear and tear on adjacent segments, by maintaining the mobility of the affected motion segments. INDICATIONS: Treatment-resistant lower back pain due to painful degeneration of the intervertebral disks ("degenerative disk disease"). CONTRAINDICATIONS: Spondylolisthesis, scoliosis, osteoporosis, infection, spinal stenosis, degeneration of the vertebral articulations. SURGICAL TECHNIQUE: The intervertebral disk is excised through an anterior approach. It is essential to retain good mobility of the motion segment, if necessary, by resection of the posterior longitudinal ligament. After revitalization of the vertebral base and cover plates and chiseling of a groove for the keel of the prosthesis, the upper and lower prosthetic plates are inserted and the polyethylene inlay is locked into place. RESULTS: From April 2002 to May 2004, 36 ProDisc (Synthes Spine, West Chester, PA, USA) modular intervertebral disk prostheses were implanted in 34 patients (26 women, eight men, average age 44.3 years). Clinical evaluation was based on the visual analog scale (VAS), the Oswestry Disability Index (ODI), and the SF-36 Questionnaire. Follow-up assessment also included radiographic views of the lumbar spine in two planes in flexion and extension and standing. The follow-up interval for all patients was at least 1 year and 2 years for 14 patients. 26 patients were very satisfied with the operation, five patients were satisfied, and three patients were less satisfied. The clinical parameters recorded on the VAS, ODI and SF-36 improved from 7.4 to 2.8 (VAS), 48.0 to 13.1 (ODI) and 31.3 to 44.2 (SF-36, Physical Component Summary Score) from the time of the preoperative assessment to the 1-year follow-up. The range of motion at the segment with the implanted prosthesis was 10 degrees on average at L4/5 and 7 degrees on average at L5/S1 1 year postoperatively.