A prospective histomorphometric and cephalometric comparison of bovine bone substitute and autogenous bone grafting in Le Fort I osteotomies.

PURPOSE: The aim of the present study was the histomorphometric and cephalometric comparison of autogenous bone grafting of the anterior iliac crest and the application of bovine bone substitute concerning new bone formation and postoperative stability in patients undergoing orthognathic Le Fort I osteotomy. PATIENTS AND METHODS: Twenty-five patients requiring orthognathic surgery with Le Fort I osteotomy were included in this study. Patients were randomly divided into three groups receiving either autogenous iliac crest BONE grafting (BONE; n = 8) or xenogenic bovine bone grafting (Bio-Oss®) in INTER (n = 12) or in ONLAY (n = 5) position. Histomorphometric analysis was performed using trephine bone biopsies from the autogenous, respectively xenogenic bone grafting region. Postoperative stability was evaluated using teleradiographies of three different timepoints. RESULTS: All groups showed comparable mineralized fractions in bone biopsies of 50.2% (±13.2%) INTER, 46.48% (±12.3%) ONLAY and 57.1% (±20.6%) BONE as well as comparable percentage of connective tissue. Patients in the INTER-group revealed the lowest relapse rate of 20.5% (INTER) compared to 30.3% (ONLAY) and 33.0% (BONE). All groups underwent comparable maxillary advancement and healing time. CONCLUSIONS: Present results indicate that block shaped bovine bone substitute is a promising alternative to autogenous bone grafting to bridge the Le Fort I osteotomy gap in orthognathic surgery.

Lateral alveolar ridge augmentation procedure using subperiosteal tunneling technique: a pilot study.

BACKGROUND: In this research article, we evaluate the use of sub-periosteal tunneling (tunnel technique) combined with alloplastic in situ hardening biphasic calcium phosphate (BCP, a compound of ß-tricalcium phosphate and hydroxyapatite) bone graft for lateral augmentation of a deficient alveolar ridge. METHODS: A total of 9 patients with deficient mandibular alveolar ridges were included in the present pilot study. Ten lateral ridge augmentation were carried out using the sub-periosteal tunneling technique, including a bilateral procedure in one patient. The increase in ridge width was assessed using CBCT evaluation of the ridge preoperatively and at 4 months postoperatively. Histological assessment of the quality of bone formation was also carried out with bone cores obtained at the implant placement re-entry in one patient. RESULTS: The mean bucco-lingual ridge width increased in average from 4.17 ± 0.99 mm to 8.56 ± 1.93 mm after lateral bone augmentation with easy-graft CRYSTAL using the tunneling technique. The gain in ridge width was statistically highly significant (p = 0.0019). Histomorphometric assessment of two bone cores obtained at the time of implant placement from one patient revealed 27.6% new bone and an overall mineralized fraction of 72.3% in the grafted area 4 months after the bone grafting was carried out. CONCLUSIONS: Within the limits of this pilot study, it can be concluded that sub-periosteal tunneling technique using in situ hardening biphasic calcium phosphate is a valuable option for lateral ridge augmentation to allow implant placement in deficient alveolar ridges. Further prospective randomized clinical trials will be necessary to assess its performance in comparison to conventional ridge augmentation procedures.

Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix.

PURPOSE: The aim of the present study was to evaluate the healing of post-extraction sockets following alveolar ridge preservation clinically, radiologically, and histologically. METHODS: Overall, 7 extraction sockets in 7 patients were grafted with demineralised bovine bone mineral and covered with a porcine-derived non-crosslinked collagen matrix (CM). Soft tissue healing was clinically evaluated on the basis of a specific healing index. Horizontal and vertical ridge dimensional changes were assessed clinically and radiographically at baseline and 6 months after implant placement. For histological and histomorphometric analysis, bone biopsies were harvested from the augmented sites during implant surgery 6 months after the socket preservation procedure. RESULTS: Clinically, healing proceeded uneventfully in all the sockets. A trend towards reduced horizontal and vertical socket dimensions was observed from baseline to the final examination. The mean width and height of resorption were 1.21 mm (P=0.005) and 0.46 mm (P=0.004), respectively. Histologically, residual xenograft particles (31.97%±3.52%) were surrounded by either newly formed bone (16.02%±7.06%) or connective tissue (50.67%±8.42%) without fibrous encapsulation. The CM underwent a physiological substitution process in favour of well-vascularised collagen-rich connective tissue. CONCLUSIONS: Socket preservation using demineralised bovine bone mineral in combination with CM provided stable dimensional changes of the alveolar ridge associated with good re-epithelialisation of the soft tissues during a 6-month healing period.

Sinus Floor Augmentation Comparing an In Situ Hardening Biphasic Calcium Phosphate (Hydroxyapatite/ß-Tricalcium Phosphate) Bone Graft Substitute with a Particulate Biphasic Calcium Phosphate (Hydroxyapatite/ß-Tricalcium Phosphate) Bone Graft Substitute: An Experimental Study in Sheep.

OBJECTIVE: The aim of the present split-mouth study in sheep was to assess the influence of in situ hardening properties of a biphasic calcium phosphate (BCP) bone graft substitute (BGS) (ratio hydroxyapatite/ß-tricalcium phosphate = 60/40) compared with a particulate BGS with the same biphasic core-granule composition without in situ hardening properties on sinus floor augmentation. MATERIALS AND METHODS: Therefore, bilateral sinus floor augmentation was performed in eight sheep. Poly(lactide-co-glycolide) (PLGA)-coated, in situ hardening biphasic BGS (PLGA-NMP [N-Methyl-2-pyrrolidone]-BCP) was placed at the test site, and a particulate biphasic BGS without PLGA coating (BCP) was used for the contralateral site as a control. Animals were sacrificed after 21 weeks. Sinus augmentation sites were analyzed histologically. The volume was analyzed by computed tomography. Histomorphometric parameters were assessed for the 12 and 21 weeks' time points. Slopes of new bone formation over time were compared with a linear growth regression model. RESULTS: Bone formation after 12 and 21 weeks of healing was 8.94% (±3.74) and 19.82% (±6.29) for PLGA-NMP-BCP and 7.00% (±2.58) and 14.38% (±4.51) for BCP, respectively. The bone growth rate for PLGA-NMP-BCP was higher than the growth rate for BCP (probability 97.5%). The total fraction of calcified hard tissue (% bone fraction + % biomaterial) was around 46% for both tested biomaterials, 21 weeks after sinus floor augmentation. CONCLUSION: The in situ hardening BGS (PLGA-NMP-BCP) performed better than the particulate material (BCP) in terms of bone formation rate. The in situ hardening properties of the PLGA-NMP-BCP material mediated by the PLGA coating and NMP solution as plasticizer had no negative influence on the bone formation.

Ridge preservation using an in situ hardening biphasic calcium phosphate (ß-TCP/HA) bone graft substitute-a clinical, radiological, and histological study.

BACKGROUND: Post-Extraction ridge preservation using bone graft substitutes is a conservative technique to maintain the width of the alveolar ridge. The objective of the present study was to evaluate an in situ hardening biphasic (HA/ß-TCP) bone graft substitutes for ridge preservation without primary wound closure or a dental membrane. METHODS: A total of 15 patients reported for tooth extraction were enrolled in this study. Implants were placed in average 5.2 ± 2 months after socket grafting. At this visit, Cone Beam CT (CBCT) images and core biopsies were taken. Implant stability (ISQ) was assessed at the insertion as well as at the day of final restoration. RESULTS: CBCT data revealed 0.79 ± 0.73 mm ridge width reduction from grafting to implant placement. Histomorphometric analysis of core biopsy samples revealed in average 21.34 ± 9.14% of new bone in the grafted sites. Primary implant stability was high (ISQ levels 70.3 ± 9.6) and further increased until final restoration. CONCLUSIONS: The results of this study show that grafting of intact post-extraction sockets using a biphasic in situ hardening bone graft substitute results in an effective preservation of the ridge contour and sufficient new bone formation in the grafted sites, which is imperative for successful implant placement.

A randomized, controlled, multicentre clinical trial of post-extraction alveolar ridge preservation.

AIM: To compare the effectiveness of two-ridge preservation treatments. MATERIALS AND METHODS: Forty subjects with extraction sockets exhibiting substantial buccal dehiscences were enrolled and randomized across 10 standardized centres. Treatments were demineralized allograft plus reconstituted and cross-linked collagen membrane (DFDBA + RECXC) or deproteinized bovine bone mineral with collagen plus native, bilayer collagen membrane (DBBMC + NBCM). Socket dimensions were recorded at baseline and 6 months. Wound closure and soft tissue inflammation were followed post-operatively, and biopsies were retrieved for histomorphometric analysis at 6 months. RESULTS: Primary endpoint: at 6 months, extraction socket horizontal measures were significantly greater for DBBMC + NBCM (average 1.76 mm greater, p = 0.0256). Secondary and Exploratory endpoints: (1) lingual and buccal vertical bone changes were not significantly different between the two treatment modalities, (2) histomorphometric % new bone and % new bone + graft were not significantly different, but significantly more graft remnants remained for DBBMC; (3) at 1 month, incision line gaps were significantly greater and more incision lines remained open for DFDBA + RECXC; (4) higher inflammation at 1 week tended to correlate with lower ridge preservation results; and (5) deeper socket morphologies with thinner bony walls correlated with better ridge preservation. Thirty-seven of 40 sites had sufficient ridge dimension for implant placement at 6 months; the remainder were DFDBA + RECXC sites. CONCLUSION: DBBMC + NBCM provided better soft tissue healing and ridge preservation for implant placement. Deeper extraction sockets with higher and more intact bony walls responded more favourably to ridge preservation therapy.

Minimally Invasive Alveolar Ridge Preservation Utilizing an In Situ Hardening ß-Tricalcium Phosphate Bone Substitute: A Multicenter Case Series.

Ridge preservation measures, which include the filling of extraction sockets with bone substitutes, have been shown to reduce ridge resorption, while methods that do not require primary soft tissue closure minimize patient morbidity and decrease surgical time and cost. In a case series of 10 patients requiring single extraction, in situ hardening beta-tricalcium phosphate (ß-TCP) granules coated with poly(lactic-co-glycolic acid) (PLGA) were utilized as a grafting material that does not necessitate primary wound closure. After 4 months, clinical observations revealed excellent soft tissue healing without loss of attached gingiva in all cases. At reentry for implant placement, bone core biopsies were obtained and primary implant stability was measured by final seating torque and resonance frequency analysis. Histological and histomorphometrical analysis revealed pronounced bone regeneration (24.4 ± 7.9% new bone) in parallel to the resorption of the grafting material (12.9 ± 7.7% graft material) while high levels of primary implant stability were recorded. Within the limits of this case series, the results suggest that ß-TCP coated with polylactide can support new bone formation at postextraction sockets, while the properties of the material improve the handling and produce a stable and porous bone substitute scaffold in situ, facilitating the application of noninvasive surgical techniques.

Vertical ridge augmentation with titanium-reinforced, dense-PTFE membranes and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 19 patients.

PURPOSE: This prospective case series evaluated the use of a new titanium-reinforced nonresorbable membrane (high-density polytetrafluoroethylene), in combination with a mixture of anorganic bovine bone-derived mineral (ABBM) and autogenous particulated bone, for vertical augmentation of deficient alveolar ridges. MATERIALS AND METHODS: A mixture of ABBM and autogenous particulated bone was used for vertical ridge augmentation and covered with a new titanium-reinforced nonresorbable membrane. Ridge measurements were obtained before and after the procedure, complications were recorded, and biopsy specimens were taken for histologic examination. RESULTS: Twenty vertical ridge augmentation procedures were carried out in 19 patients. All treated defect sites exhibited excellent bone formation, with an average bone gain of 5.45 mm (standard deviation 1.93 mm). The healing period was uneventful, and no complications were observed. Eight specimens were examined histologically; on average, autogenous or regenerated bone represented 36.6% of the specimens, ABBM 16.6%, and marrow space 46.8%. No inflammatory responses or foreign-body reactions were noted in the specimens. CONCLUSION: The treatment of vertically deficient alveolar ridges with guided bone regeneration using a mixture of autogenous bone and ABBM and a new titanium-reinforced nonresorbable membrane can be considered successful.

Effect of gabapentin-lactam and gamma-aminobutyric acid/lactam analogs on proliferation and phenotype of ovine mesenchymal stem cells.

PURPOSE: Classic tissue engineering consists of three components: scaffold, cells, and growth or differentiation factors. Currently, expensive bone morphogenetic proteins are the most common substance used for hard tissue regeneration. An alternative could be gamma-aminobutyric acid/lactam (GABA-lactam) analogs. MATERIALS AND METHODS: The effects of gabapentin-lactam, cis- and trans-8-tertbutyl-GABA-pentinlactam (trans-TB-GBP-L), and phenyl-GABA-lactam were tested in this study on ovine mesenchymal stem cell (MSC) proliferation. MSCs were selected from bone marrow aspirate concentrate by plastic adherence and amplified. Aliquots of the cells were incubated in medium, with four different concentrations of the GABA-lactam analogs dissolved in dimethyl sulfoxide. Cells in medium with and without dimethyl sulfoxide served as controls. Cell proliferation was tested with a nonradioactive assay. Before and after GABA-lactam analog influence, the MSC character was evaluated by the ability of the cells to differentiate into osteoblasts, chondrocytes, and adipocytes. RESULTS: Proliferation was significantly increased under the influence of the analogs, depending on their concentration. MSCs cultured in 1 nmol/L trans-TB-GBP-L showed the highest proliferation rate. The MSC character was not altered. CONCLUSIONS: GABA-lactam analogs could be suited to stimulate MSC proliferation for tissue engineering applications. Further in vivo studies are necessary to evaluate the possible clinical potential of GABA-lactam analogs for hard tissue regeneration.

Bone marrow aspirate concentrate used with bovine bone mineral to reconstruct vertical and horizontal mandibular defects: report of two techniques.

PURPOSE: Following initial positive reports of the use of bone marrow aspirate concentrate (BMAC) in combination with bovine bone mineral (BBM) in augmentation procedures, the technique was evaluated in patients with mandibular deficiency. MATERIALS AND METHODS: Two adult patients required surgical correction of a deficient alveolar ridge (one patient showed horizontal deficiency only, and the other patient presented with horizontal and vertical deficiency) prior to dental implant placement. In both patients, the reconstruction was performed with BBM in combination with mononuclear cells concentrated by the BMAC method using different techniques. RESULTS: The patients recovered well from all surgical procedures. Histologically, there was uniform bone formation, which allowed placement of dental implants. CONCLUSION: The results suggest that the use of BMAC in combination with BBM, without autogenous bone, has the potential to restore horizontal and vertical mandibular alveolar defects, providing a functional bone structure and allowing dental implant placement for subsequent prosthetic rehabilitation.

Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients.

This prospective case series evaluated the use of a resorbable natural collagen membrane with a mixture of autogenous bone and anorganic bovine bone-derived mineral (ABBM) for lateral ridge augmentation and subsequent implant placement. A mixture (1:1) of particulated autogenous bone and ABBM was used for lateral ridge augmentation and covered with a resorbable, natural collagen bilayer membrane to treat knife-edge ridges and prepare them for implant placement. Ridge measurements were obtained pre- and postsurgery, complications recorded, and biopsy specimens examined histologically. Seventy-six implants were placed in 25 patients with 31 knife-edge ridge surgical sites. One defect had a bone graft complication (3.2%; exact 95% confidence interval: 0.1%, 16.7%). Clinical measurements revealed an average of 5.68 mm (standard deviation [SD] = 1.42 mm) of lateral ridge augmentation after a mean 8.9-month (SD = 2.1 months) graft healing period. Clinically, all treated ridges were sufficient in width for subsequent implant placement. All implants survived with an average follow-up of 20.88 months (SD = 9.49 months). Histologic analysis of nine surgical sites showed that ABBM was connected with a dense network of newly formed bone with varying degrees of maturation. Histomorphometric analysis demonstrated that autogenous bone represented a mean of 31.0% of the specimens, ABBM 25.8%, and marrow space 43.2%. The treatment of horizontally deficient alveolar ridges with the guided bone regeneration technique using autogenous bone mixed with ABBM and a natural collagen resorbable barrier membrane can be regarded as successful. Implant success and survival need to be confirmed with long-term follow-up examinations.

Incidence, diagnosis, and treatment of sinus graft infection after sinus floor elevation: a clinical study.

PURPOSE: The aims of this clinical study were to evaluate the occurrence of sinus graft infection and the results of a planned surgical and pharmacologic treatment regimen to eliminate infections and preserve the graft. MATERIALS AND METHODS: Patients were consecutively treated with sinus floor elevations using the lateral window technique. If a clinical diagnosis of sinus graft infection was made for a patient, a postoperative computed tomographic scan was performed to diagnose involvement of the sinus cavity. RESULTS: Of 198 patients treated with 274 sinus grafts, 8 (2.3%) developed a sinus graft infection. These patients were treated with the same surgical and pharmacologic regimen. Symptoms of infection were recognized, the infected graft was removed, and the remaining graft material was cleansed. The remaining defect was not filled with new graft material; instead, it was left to heal for an extended healing period (average of 10.6 months), and residual bone defects were corrected during implant placement. Acute symptoms of infection disappeared within 48 hours of treatment and all patients healed uneventfully thereafter. All 24 implants placed have survived to date (with implant loading times ranging from 1 to 9 years), resulting in a 100% implant survival rate for these sites with postoperative infection. CONCLUSIONS: The overall clinical outcome, including patient satisfaction, achievement of optimal graft volume without subsequent sinus elevation, and long-term implant survival, confirmed the success of this treatment protocol.

Bone marrow concentrate and bovine bone mineral for sinus floor augmentation: a controlled, randomized, single-blinded clinical and histological trial--per-protocol analysis.

PURPOSE: The purpose of this work was to evaluate the potential of substituting autogenous bone (AB) by bone marrow aspirate concentrate (BMAC). Both AB and BMAC were tested in combination with a bovine bone mineral (BBM) for their ability of new bone formation (NBF) in a multicentric, randomized, controlled, clinical and histological noninferiority trial. MATERIALS AND METHODS: Forty-five severely atrophied maxillary sinus from 26 patients were evaluated in a partial cross-over design. As test arm, 34 sinus of 25 patients were augmented with BBM and BMAC containing mesenchymal stem cells. Eleven control sinus from 11 patients were augmented with a mixture of 70% BBM and 30% AB. Biopsies were obtained after a 3-4-month healing period at time of implant placement and histomorphometrically analyzed for NBF. RESULTS: NBF was 14.3%±1.8% for the control and nonsignificantly lower (12.6%±1.7%) for the test (90% confidence interval: -4.6 to 1.2). Values for BBM (31.3%±2.7%) were significantly higher for the test compared with control (19.3%±2.5%) (p<0.0001). Nonmineralized tissue was lower by 3.3% in the test compared with control (57.6%; p=0.137). CONCLUSIONS: NBF after 3-4 months is equivalent in sinus, augmented with BMAC and BBM or a mixture of AB and BBM. This technique could be an alternative for using autografts to stimulate bone formation.

Histomorphometric evaluation of anorganic bovine bone coverage to reduce autogenous grafts resorption: preliminary results.

Physiologic resorption due to remodeling processes affects autogenous corticocancellous grafts in the treatment of atrophic jawbone alveolar ridges. Such a situation in the past made overgrafting of the recipient site mandatory to get enough bone support to dental implants in order to perform a prosthetic rehabilitation. Anorganic bovine bone, conventionally used to treat alveolar bone deficiencies in implant surgery, showed a high osteoconductive property thanks to its micro and macrostructure very similar to that of human hydroxyapatite. An original technique provides for the application of a thin layer of anorganic bovine bone granules and a collagen membrane on the top of the corticocancellous onlay bone grafts to reduce in a remarkable way the graft resorption due to remodeling. The results of a clinical prospective study and a histomorphometric analysis done on autogenous grafts harvested from the iliac crest showed that the proposed technique is able to maintain the original bone volume of the corticocancellous blocks.

Horizontal ridge augmentation with a resorbable membrane and particulated autogenous bone with or without anorganic bovine bone-derived mineral: a prospective case series in 22 patients.

PURPOSE: This prospective case series evaluated the use of a new synthetic resorbable membrane with autogenous bone, either alone or in combination with anorganic bovine bone-derived mineral, for horizontal ridge augmentation and subsequent implant placement. MATERIALS AND METHODS: Particulated autogenous bone, either alone or in combination with anorganic bovine bone-derived mineral, was used for lateral ridge augmentation and covered with a new synthetic resorbable membrane (glycolide and trimethylene carbonate) to treat knife-edged ridges and prepare them for implant placement. Ridge measurements were obtained before and after augmentation, complications were recorded, and biopsy specimens were examined histologically. RESULTS: Fifty-eight implants were placed in 22 patients with 25 surgical sites in knife-edged ridges. No complications were associated with this treatment. Clinical measurements revealed an average of 5.56 mm (± 1.45 mm) of lateral ridge augmentation after an average of 8.12 months (± 2.32 months) of graft healing. Clinically, all treated ridges were sufficient in width for subsequent implant placement. All implants have survived, with an average follow-up period of 45.88 months (± 12.43 months). Histologic analysis of the selected augmentation sites showed new bone formation and good incorporation of the bovine bone mineral particles. CONCLUSION: The high implant survival rate and the low complication rate show the potential of this technique for the treatment of horizontal augmentation of lateral ridges and the efficacy of the new resorbable synthetic membrane.

Making bone II: maxillary sinus augmentation with mononuclear cells--case report with a new clinical method.

We report a simplified method of using bone marrow aspirate concentrate (BMAC™) to regenerate hard tissue. The results suggest that BMAC™ combined with a suitable biomaterial can form sufficient bone within 3 months for further implants to be inserted, and at the same time minimise morbidity at the donor site.

Onset and maintenance of angiogenesis in biomaterials: in vivo assessment by dynamic contrast-enhanced MRI.

OBJECTIVE: To describe dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) as a practical tool for longitudinal assessment of angiogenesis in biomaterials. BACKGROUND: There is a lack of suitable methods for in vivo evaluation of the integration of biomaterials in a clinical setting. In oncology, DCE-MRI is used for the longitudinal monitoring of altered tumor angiogenesis during therapy. Thus, we investigated whether DCE-MRI enables to assess the integration of biomaterials over time. METHODS: The tested material was bovine bone matrix applied in a bilateral sinus lift procedure in combination with concentrated mononuclear cells, including mesenchymal stem cells and autologous thrombin. To assess the development of new blood vessels inside the biomaterial, DCE-MRI was carried out before and 11, 25, 53, and 104 days after surgery. Perfusionparameters were calculated according to the model of Tofts. RESULTS: Analysis of the data revealed increasing parameters for perfusion and blood supply within the transplant over time. It was possible to determine the values for each transplantation site and each point of time separately. CONCLUSION: DCE-MRI is appropriate to repetitively survey angiogenesis and integration of biomaterials in patients. It seems appropriate as a valuable indicator of treatment response or failure, with consecutive adaption of the therapy regime.

Evaluation of the HiFocus electrode array with positioner in human temporal bones.

The aim of the study presented was to assess the insertion mode and possible intracochlear trauma after implantation of the HiFocus electrode with positioner in human temporal bones. The study was performed in five freshly frozen temporal bones. The position of electrodes was evaluated using conventional X-ray analysis, rotational tomography and histomorphological analysis. Insertion of the HiFocus electrode with positioner resulted in considerable trauma to fine cochlear structures including fracture of the osseous spiral lamina, dislocation of the electrode array from the scala tympani into the scala vestibuli and fracture of the modiolus close to the cochleostomy. The implication of the results regarding clinical outcome will be discussed.

Clarion 1.2 standard electrode array with partial space-filling positioner: radiological and histological evaluation in human temporal bones.

The purpose of this study was to evaluate whether use of a positioner for situating the Clarion 1.29 standard electrode array in close proximity to the modiolus, causes damage to fine intra-cochlear structures, and to provide a comparison with results obtained for insertions of the array performed without a positioner. The study was performed in seven freshly frozen human temporal bones. Electrode location and intra-cochlear trauma was analysed using cross-sectional imaging and histological analysis. Insertion of the Clarion array did not reveal major trauma. The devices inserted with the positioner showed a consistently closer location of the electron array towards the modiolus, however, insertion resulted in significant displacement of both the electrode array and the positioner resulting in severe destruction of the basilar membrane and osseous spiral lamina along the length of the basal and middle turns. The devices inserted with the positioner resulted in major trauma to the basilar membrane and osseous spiral lamina. Therefore, systematic safety studies in larger samples of human temporal bones should be performed and the results carefully evaluated before implantation can be recommended unreservedly.

Liquid 2-poly-hydroxyethyl-methacrylate embolization of experimental arteriovenous malformations: feasibility study.

BACKGROUND AND PURPOSE: We investigated the use of 2-poly-hydroxyethyl-methacrylate (2-P-HEMA) as an embolic agent in swine arteriovenous malformations (AVMs). METHODS: In seven mini swine, experimental AVMs were created surgically. The aim of treatment was complete embolization of the nidus compartment filled by the feeding artery, without brain embolization. Six animals received pure liquid 2-P-HEMA, and one, 50% 2-P-HEMA. For radiopacity, liquid 2-P-HEMA was mixed with tungsten powder. Six animals underwent angiographic follow-up within 5-8 mo (mean, 6.5 mo). Evaluation criteria were controllability, procedural reproducibility, and duration of the nidus occlusion. To detect complications, brain MR imaging and CT were performed. Histopathologic studies were performed to prove occlusion and assess histopathologic responses. RESULTS: 2-P-HEMA was easily injected through microcatheters, with a reproducible technique. Because of the radiopacity of the mixture, deep nidus penetration was controlled with fluoroscopy and confirmed with CT and histopathologic examination. In five AVMs embolized with pure 2-P-HEMA, feeder obliteration was long term. One animal had vasospasm during embolization, and complete obliteration of the main feeder was maintained for 3 mo, but partial recanalization developed 2 mo later. One animal receiving pure 2-P-HEMA had an infarction. In the animal embolized with 50% 2-P-HEMA, angiography and CT revealed embolic material in the circle of Willis; the animal died after embolization. No marked inflammatory reaction in the vessel wall or perivascular tissue was observed in the embolized AVMs. CONCLUSION: Experimental AVM embolization with pure 2-P-HEMA, made radiopaque with tungsten, is technically feasible in swine. Because of its properties, 2-P-HEMA has great potential as a therapeutic embolic agent.