Basic and Translational Research in Cardiac Repair and Regeneration: JACC State-of-the-Art Review.

This paper aims to provide an important update on the recent preclinical and clinical trials using cell therapy strategies and engineered heart tissues for the treatment of postinfarction left ventricular remodeling and heart failure. In addition to the authors' own works and opinions on the roadblocks of the field, they discuss novel approaches for cardiac remuscularization via the activation of proliferative mechanisms in resident cardiomyocytes or direct reprogramming of somatic cells into cardiomyocytes. This paper's main mindset is to present current and future strategies in light of their implications for the design of future patient trials with the ultimate objective of facilitating the translation of discoveries in regenerative myocardial therapies to the clinic.

Multiple pipeline embolization devices improves aneurysm occlusion without increasing morbidity: A single center experience of 140 cases.

INTRODUCTION: Rates of aneurysm occlusion with the pipeline embolization device (PED) has varied widely in the literature from 55.7% to 93.3% at 6 months, which may reflect a difference in technique including sizing and number of devices used. METHODS: 140 cases at our institution were retrospectively reviewed, and aneurysms treated with a single PED vs. multiple were compared. RESULTS: Complete aneurysm occlusion was achieved in 86.9% at 6 months, 91.8% at 1 year, and 97.6% at longest follow-up. Retreatment with an additional device was required in 7 (5.1%). Major and minor complication rate within 30 days was 1.4% and 5.0%, and at greater than 30 days was 0.8% and 3.1%. Patients treated with multiple PEDs had significantly higher rates of aneurysm occlusion at 6 months (92.9% vs. 75.6%, p = 0.017) and 12 months (98.4% vs. 81.1%, p = 0.014), with no difference in complications. The two groups were similar aside from a higher number of ophthalmic and paraophthalmic aneurysms treated with multiple PEDs (23.4% vs. 6.5%, p = 0.004; and 35.1% vs. 17.4%, p = 0.020), and more posterior communicating artery and recurrent aneurysms treated with a single PED (28.3% vs. 3.2%, p = 0.001; 23.9% vs. 8.5%, p = 0.031). The use of multiple PEDs was found to be an independent predictor of aneurysm occlusion in a multivariate analysis (p = 0.015). CONCLUSIONS: The use of multiple PEDs for intracranial aneurysms leads to significantly higher occlusion rates without added morbidity. This benefit is particularly appropriate for ophthalmic segment aneurysms, while more distal segments with eloquent perforating branches should be managed with caution.

Microsurgery of residual or recurrent complex intracranial aneurysms after coil embolization - a quest for the ultimate therapy.

The long-term stability of coil embolization (CE) of complex intracranial aneurysms (CIAs) is fraught with high rates of recanalization. Surgery of precoiled CIAs, however, deviates from a common straightforward procedure, demanding sophisticated strategies. To shed light on the scope and limitations of microsurgical re-treatment, we present our experiences with precoiled CIAs. We retrospectively analysed a consecutive series of 12 patients with precoiled CIAs treated microsurgically over a 5-year period, and provide a critical juxtaposition with the literature. Five aneurysms were located in the posterior circulation, 8 were large-giant sized, 5 were calcified/thrombosed. One presented as a dissecting-fusiform aneurysm, 9 ranked among wide neck aneurysms. Eight lesions were excluded by neck clipping (5 necessitating coil extraction); 1 requiring adjunct CE. The dissecting-fusiform aneurysm was resected with reconstruction of the parent artery using a radial artery graft. Three lesions were treated with flow alteration (parent artery occlusion under bypass protection). Mean interval coiling-surgery was 4.6 years (range 0.5-12 years). Overall, 10 aneurysms were successfully excluded; 2 lesions treated with flow alteration displayed partial thrombosis, progressing over time. Outcome was good in 8 and poor in 4 patients (2 experiencing delayed neurological morbidity), and mean follow-up was 24.3 months. No mortality was encountered. Microsurgery as a last resort for precoiled CIAs can provide-in a majority of cases-a definitive therapy with good outcome. Since repeat coiling increases the complexity of later surgical treatment, we recommend for this subgroup of aneurysms a critical evaluation of CE as an option for re-treatment.

Nuisance bleeding complications in patients with cerebral aneurysm treated with Pipeline embolization device.

BACKGROUND: Patients with cerebral aneurysms treated with the Pipeline embolization device (PED) are maintained on dual antiplatelet therapy (DAPT) to prevent thromboembolic complications. Rates of minor, "nuisance" bleeding in these patients remain unknown. We sought to evaluate the frequency and factors associated with this bleeding and its effect on DAPT compliance. METHODS: We performed a multicenter retrospective cohort study on consecutive cases of intracranial aneurysms treated with PED. Patient characteristics, aneurysm characteristics, and bleeding complications were analyzed. Severity of bleeding was defined according to a previously published classification defining nuisance bleeding as easy bruising, bleeding from small cuts, petechia, and ecchymosis. RESULTS: 245 PED aneurysm procedures on 243 patients were retrospectively collected from three academic centers over a 4.25-year period. Sixty-seven patients (27%) had nuisance bleeds. Patients with a higher risk of nuisance bleeding were older (59.1±3.4 vs . 54.7±2.2, P=0.032). Patients with nuisance bleeds were more likely to have their DAPT regimen changed or dose lowered (29% vs 8.3%, P<0.001), were on DAPT for less time (10.0 months±2.60 vs. 14.6 months±1.95, P=0.005) and were more likely to have aneurysm occlusion at 6 months (P<0.001). Stepwise logistic regression found age predictive of a nuisance bleed (OR=1.033) CONCLUSIONS: Nuisance bleeding was a common complaint of PED-treated aneurysm patients maintained on DAPT. Increasing age and aneurysmal occlusion at 6 months were the only factors predictive of nuisance bleeds. Clinicians were more likely to adjust antiplatelet regimens or stop DAPT early given a nuisance bleed.

Fabricating Organized Elastin in Vascular Grafts.

Surgically bypassing or replacing a severely damaged artery using a biodegradable synthetic vascular graft is a promising treatment that allows for the remodeling and regeneration of the graft to form a neoartery. Elastin-based structures, such as elastic fibers, elastic lamellae, and laminae, are key functional components in the arterial extracellular matrix. In this review, we identify the lack of elastin in vascular grafts as a key factor that prevents their long-term success. We further summarize advances in vascular tissue engineering that are focused on either de novo production of organized elastin or incorporation of elastin-based biomaterials within vascular grafts to mitigate failure and enhance enduring in vivo performance.

Anatomic Suitability for Branched Thoracic Endovascular Repair in Patients with Aortic Arch Pathological Features.

Background Endovascular repair has become a viable alternative for aortic pathological features, including those located within the aortic arch. We investigated the anatomic suitability for branched thoracic endovascular repair in patients previously treated with conventional open surgery for aortic arch pathological features. Methods and Results Patients who underwent open surgery for aortic arch pathological features at our institution between 2000 and 2018 were included. Anatomic suitability was determined by strict compliance with the anatomic criteria within manufacturers' instructions for use for each of the following branched thoracic stent grafts: Relay Plus Double-Branched (Terumo-Aortic), TAG Thoracic Branch Endoprosthesis (W.L. Gore & Associates), Zenith Arch Branched Device (Cook-Medical), and Nexus Stent Graft System (Endospan Ltd/Jotec GmbH). Computed tomography angiography images were analyzed with outer luminal line measurements. A total of 377 patients (mean age, 64±14 years; 64% men) were identified, 153 of whom had suitable computed tomography angiography images for measurements. In total, 59 patients (15.6% of the total cohort and 38.6% of the measured cohort) were eligible for endovascular repair using at least one of the devices. Device suitability was 30.9% for thoracic aneurysms, 4.6% for type A dissections, 62.5% for type B dissections, and 28.6% for other pathological features. Conclusions The anatomic suitability for endovascular repair of all aortic arch pathological features was modest. The highest suitability rates were observed for thoracic aneurysms and for type B dissections, of which repair included part of the aortic arch. We suggest endovascular repair of arch pathological features should be reserved for high-volume centers with experience in endovascular arch repair.

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study.

BACKGROUND: The first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs. METHODS: The SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death. RESULTS: Of 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death. CONCLUSIONS: The findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT02719522.

Endosaccular Flow Disruption: A New Frontier in Endovascular Aneurysm Management.

Flow modification has caused a paradigm shift in the management of intracranial aneurysms. Since the FDA approval of the Pipeline Embolization Device (Medtronic, Dublin, Ireland) in 2011, it has grown to become the modality of choice for a range of carefully selected lesions, previously not amenable to conventional endovascular techniques. While the vast majority of flow-diverting stents operate from within the parent artery (ie, endoluminal stents), providing a scaffold for endothelial cells growth at the aneurysmal neck while inducing intra-aneurysmal thrombosis, a smaller subset of endosaccular flow disruptors act from within the lesions themselves. To date, these devices have been used mostly in Europe, while only utilized on a trial basis in North America. To the best of our knowledge, there has been no dedicated review of these devices. We therefore sought to present a comprehensive review of currently available endosaccular flow disruptors along with high-resolution schematics, presented with up-to-date available literature discussing their technical indications, procedural safety, and reported outcomes.

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.

BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION: NCT02186561.

Diffusion weighted image documented cerebral ischemia in the postprocedural period following pipeline embolization device with shield technology treatment of unruptured intracranial aneurysms: a prospective, single center study.

OBJECTIVE: Acute ischemic stroke and silent cerebral infarctions following pipeline embolization device (PED) treatment of intracranial aneurysms have been estimated to occur in 3-6% and in 50.9-90% of patients respectively. The PED with Shield technology (PED-Shield) incorporates a surface phosphorylcholine polymer to reduce the thrombogenicity of the implant. We sought to determine the incidence of diffusion weighted image (DWI) documented cerebral ischemia after PED-Shield treatment of unruptured intracranial aneurysms. METHODS: This prospective study involved a single center series of consecutive patients treated for an unruptured intracranial aneurysm with the PED-Shield. All participants underwent clinical evaluation on admission, after the procedure, at discharge, and 30 days following treatment. Brain MRI was obtained within 72 hours of the procedure. Ischemic lesions identified on DWI sequences where examined as to their number, size, and location in relation to the procedure. RESULTS: Over 12 months, 33 patients harboring 38 intracranial aneurysms were treated with the PED-Shield in 36 procedures. Neither mortality nor clinically evident ischemic events were noted in the 30 day postprocedural period. DWI documented, silent cerebral ischemia occurred in six patients (18.18%) after six procedures (16.66%). No statistically significant risk factors for postprocedural silent cerebral ischemia were identified. CONCLUSION: We demonstrated a reduced rate of silent cerebral infarcts following PED-Shield treatment of intracranial aneurysms than previously reported with other endovascular treatment modalities and with the previous device generations. Further research is necessary to evaluate our results and to identify methods to reduce the incidence of postprocedural cerebral ischemic events.

Future Directions of Flow Diverter Therapy.

The treatment of intracranial aneurysms has undergone a few very significant paradigm shifts in its history. Needless to say, microsurgery and surgical clipping served as the initial basis for successful treatment of these lesions. The pursuit of endovascular therapy subsequently arose from the desire to reduce the invasiveness of therapy. While the first breakthrough arose with Guido Guglielmi's invention of the detachable platinum coil, commercialized flow diverter therapy represents a disruptive therapy with a completely different paradigm for aneurysmal obliteration. This has not only altered the distribution of aneurysmal management strategies, but also opened the gateway to the treatment of previously inoperable lesions. With the basic flow diverter stent technology now considered an integral part of the neurointerventional armamentarium, we now consider what may lay in the future - including potential directions for research with regards to case selection; the location and type of aneurysms which may become routinely treatable; and modifications to the flow diverter, which may increase its utility and safety in terms of size, structural design, and surface modifications.

Τhe AFX unibody bifurcated unibody aortic endograft for the treatment of abdominal aortic aneurysms: current evidence and future perspectives.

Introduction: AFX is a bifurcated unibody aortic endograft for the treatment of Abdominal Aortic aneurysms. It consists of an inner metallic endoskeleton with multiple metallic struts covered by a polytetrafluoroethylene graft fabric. The endoskeleton is sutured to the outer fabric only at the proximal and distal ends. The unique design of AFX aims at fixation onto the aortic bifurcation while a proximal cuff ensures sealing at the infrarenal level.Areas covered: Since this endograft design by Endologix has undergone significant changes over the last years, the aim of this article is to present its unique structure and deployment method and discuss the relevant clinical results as well as reported complications and associated concerns.Expert commentary: the AFX stent-graft exhibits very satisfactory clinical mid-term results in abdominal aortic aneurysms treated within the instructions-for-use. Its 'active-seal' concept of infrarenal fixation stemming from the loose conjugation of the fabric material to the endoskeleton can accommodate efficiently to challenging necks with thrombus or morphological irregularities, thereby extending the anatomical sealing zone without exerting significant radial outward force. Long-term results are needed to validate the promising performance of AFX.

Gender-Based Utilization and Outcomes of Autogenous Fistulas and Prosthetic Grafts for Hemodialysis Access.

BACKGROUND: To evaluate gender-based patterns of utilization and outcomes of arteriovenous fistulas (AVFs) and grafts (AVGs) in a population-based cohort of hemodialysis (HD) patients. METHODS: A retrospective analysis of all patients in the United States Renal Data System who had an AVF or AVG placed for HD access (January 2007 to December 2014). Outcomes were access maturation, conduit patency, infection, and mortality. Chi-square, Student's t, Kaplan-Meier, and multivariable Cox regression analyses were employed accordingly. RESULTS: There were 456,693 (57%) males and 341,571 (43%) females who initiated HD via AVF (16%), AVG (4%) and HD catheter (80%). There was a 30% decrease in odds of initiating HD with AVF in females compared with males (adjusted odds ratio [aOR]: 0.70; 95% confidence interval [CI]: 0.69-0.71, P < 0.001). The use of HD catheter as a bridge to AVF was 36% higher in females compared with males (aOR: 1.36; 95% CI: 1.33-1.39, P < 0.001). Preemptive AVF maturation was 78% for males and 76% for females (P < 0.001). The risk-adjusted analyses showed a 7% decrease in AVF maturation comparing females with males (adjusted hazard ratio [aHR]: 0.93; 95% CI: 0.92-0.95, P < 0.001) but no difference in AVG maturation (aHR: 0.99; 95% CI: 0.97-1.01, P = 0.46) After risk adjustment, primary (AVF: aHR-0.87; AVG: aHR-0.96), primary-assisted (AVF: aHR-0.84; AVG: aHR-0.97), and secondary (AVF: aHR-0.85; AVG: aHR-0.98) patency were lower for females compared with males (all P < 0.05). Initiation of HD with a catheter and conversion to AVF was associated with lower patency in males (aHR: 0.29; 95% CI: 0.28-0.29; P < 0.001) and females (aHR: 0.31; 95% CI: 0.30-0.31; P < 0.001) compared with AVF initiates. Patient survival was higher for females compared with males who received AVF (aHR: 1.08; 95% CI: 1.07-1.09; P < 0.001) and AVG (aHR: 1.13; 95% CI: 1.11-1.15; P < 0.001). Initiation with HD catheter and subsequent conversion to AVF was associated with an increase in mortality for males (aHR: 1.45; 95% CI: 1.43-1.47; P < 0.001) and females (aHR: 1.44; 95% CI: 1.44-1.52; P < 0.001) compared with initiation via AVF. There was no significant difference in severe AVG infection comparing females with males (aHR: 1.05; 95% CI: 0.98-1.13; P = 0.16). CONCLUSIONS: Female gender is associated with a lower prevalence of preemptive AVF's, higher utilization of catheters as a bridge to AVF, and lower patency compared with males. There was no difference in access maturation but patient survival was higher for females compared with males.

Safety and Efficacy of Bilateral Flow Diversion for Treatment of Anterior Circulation Cerebral Aneurysms.

BACKGROUND: Nearly 20% of individuals with an aneurysm will have multiple aneurysms-these individuals are at increased risk of subarachnoid hemorrhage. Treatment of bilateral aneurysms with flow diverters (FDs), or Pipeline embolization device, has not yet been established as an effective therapy. We evaluated the safety and efficacy of a 2-stage treatment of bilateral aneurysms with Pipeline embolization devices placed 6 months apart. METHODS: We performed a retrospective review to analyze the clinical and angiographic outcomes of 16 individuals with bilateral aneurysms treated with 2-stage flow diversion at a tertiary referral center from January 2010 to July 2018. RESULTS: Of the 16 patients with 33 aneurysms treated with bilateral flow diversion, 1 had 2 aneurysms treated with a single FD on the contralateral side. The aneurysms treated were ophthalmic, superior hypophyseal, posterior communicating, or cavernous segment aneurysms, with an average size of 6.5 mm. No major complications, such as in-stent stenosis, thromboembolic events, distal intraparenchymal hemorrhage, rerupture, stent migration, or neurological death, were recorded. All the patients had good functional outcomes. At the 24-month follow-up examination, 81% of aneurysms showed complete occlusion. No aneurysm required repeat treatment. CONCLUSIONS: The results from the present study have demonstrated that 2-stage treatment of bilateral aneurysms with FDs is both safe and efficacious. The timing of contralateral FD stent placement is critical. We found that 6 months allows for adequate neurological recovery and stent endothelialization.

Predictors of Clinical Outcome After Treatment of Intracranial Aneurysms with the Pipeline Embolization Device.

BACKGROUND: Flow-diverting stents have revolutionized the endovascular treatment of intracranial aneurysms. The purpose of this study is to identify predictors of adverse outcomes associated with the pipeline embolization device (PED). METHODS: A retrospective analysis of all patients treated with PED at a single high-volume center from January 2014 to September 2018. Patient outcomes, neurologic morbidity/mortality, and other clinical variables were analyzed. RESULTS: We treated 204 aneurysms in 170 patients with PED. Mean length of follow-up was 11 months. Most (181) aneurysms (89%) were located in the anterior circulation, and 23 (11%) were found in the posterior circulation. Most aneurysms were saccular (82%), followed by fusiform (11%), blister (4%), and dissecting pseudoaneurysms (3%). Mean aneurysm size was 8.2 + 5.7 mm with 145 (71%) small aneurysms (≤10 mm), 53 (26%) large aneurysms (between 10 and 25 mm), and 6 (3%) giant aneurysms (≥25 mm). Ninety-two percent of aneurysms were unruptured, and 8% were ruptured. The overall major neurologic morbidity/mortality was 4.7% and 1.8%, respectively. The all-cause mortality was 2.9%. Predictors of neurologic morbidity/mortality included the baseline modified Rankin Scale (P = 0.001), aneurysm neck size (P = 0.003), aneurysm size (P = 0.006), anterior versus posterior location (P = 0.02), and rupture at presentation (0.006). The P2Y12 Reactivity Unit, parent vessel diameter, and patient age did not correlate with adverse events. CONCLUSIONS: The PED has a satisfactory safety profile in both on- and off-label indications. A poor clinical patient baseline, wider aneurysm neck or larger size, and rupture predict an increased risk of an unfavorable outcome.

The influence of purification of carp collagen used in a novel composite graft with sandwich construction of the wall on its biological properties and graft patency rates.

We compared graft outcome between two types of a novel composite three-layer carp-collagen-coated vascular graft in low-flow conditions in a sheep model. Collagen in group A underwent more cycles of purification than in group B in order to increase the ratio between collagen and residual fat. The grafts were implanted end-to-side in both carotid arteries in sheep (14 grafts in 7 sheep in group A, 18 grafts in 9 sheep in group B) and artificially stenosed on the right side. The flow in the grafts in group A decreased from 297±118 ml/min to 158±159 ml/min (p=0.041) after placement of the artificial stenosis in group A, and from 330±164ml/min to 97±29 ml/min (p=0.0052) in group B (p=0.27 between the groups). From the five surviving animals in group A, both grafts occluded in one animal 3 and 14 days after implantation. In group B, from the six surviving animals, only one graft on the left side remained patent (p=0.0017). Histology showed degradation of the intimal layer in the center with endothelization from the periphery in group A and formation of thick fibrous intimal layer in group B. We conclude that the ratio between collagen and lipid content in the novel three-layer graft plays a critical role in its patency and structural changes in vivo.

Thoracoabdominal Aortic Aneurysm Repair: From an Era of Revolution to an Era of Evolution.

Thoracoabdominal aortic aneurysm (TAAA) repair has a rich and storied tradition that began in Houston, Texas with great pioneer surgeons such as Drs Michael E. DeBakey, Denton A. Cooley, and E. Stanley Crawford. Their early attempts to repair TAAA were complicated by the persistent threats of renal and spinal cord ischemia and difficulty in reattaching the branching vessels of the thoracoabdominal aorta. Today, under the tutelage of Dr Joseph S. Coselli, the Texas Medical Center remains at the forefront of TAAA repair. In this place where great surgeons once walked the halls, their legacy continues.

Prosthesis Used in Microvascular Decompressions: A Multicenter Survey in Japan Focusing on Adverse Events.

OBJECTIVE: To investigate the characteristics of materials used as prostheses for microvascular decompression surgery (MVDs) in Japan and their possible adverse events (AEs) to determine preferable materials for MVDs. METHODS: A questionnaire was sent to all members of the Japanese Society for MVDs, and answers were obtained from 59 institutions. RESULTS: Among a total of 2789 MVDs, 1088 operations for trigeminal neuralgia, 1670 for hemifacial spasm, and 31 others, including 117 reoperations, were performed between April 2011 and March 2014. Nonabsorbable material was used in 96.5% of MVDs, including polytetrafluoroethylene (PTFE) (80.5%), polyurethane (11.9%), expanded PTFE (2.1%), and silk thread (1.47%). The use of absorbable materials, including fibrin glue (87.5%), cellulose (13.5%), gelatin (4,77%), and collagen (1.76%), was reported. The major combinations were PTFE with fibrin glue (58.7%) followed by PTFE alone (7.60%). Eighty-eight AEs in 85 (3.2%) cases were reported among 2672 first operations. AEs included 51 central nervous system dysfunctions, 15 wound infections/dehiscence, and 10 others, which were presumed to be related to the intraoperative procedure. Among relatively high-, moderate-, and low-volume centers, there were no significant differences in the frequency of AEs (P = 0.077). Tissue-prosthesis adhesion and/or granuloma formation were reported in 13 cases of 117 reoperations. The incidence of adhesion-related recurrence was 11.1% of all reoperations. CONCLUSIONS: The number of AEs was quite low in this survey, and intradural use of any prosthesis reported in this paper might be justified; however, further development of easily handled and less-adhesive prosthesis materials is awaited.