Availability of totally implantable venous access devices in cancer patients is high in the long term: a seven-year follow-up study.

PURPOSE: Totally implantable venous access devices (TIVADs) currently have an important place in medical oncology practice; however, their long-term availability deserves further investigation, since they are usually required by patients for prolonged periods. This study aimed to evaluate long-term availability of TIVADs in adult cancer patients, in conjunction with complication/removal rates over time and associated risk factors during 7-year follow-up. METHODS: A total of 204 adult cancer patients who underwent TIVAD placement via subclavian vein using the Seldinger technique were included in this study. Medical data and catheter follow-up records were investigated retrospectively. Complications and port removals due to complications were evaluated over time. RESULTS: During median 21.9 (range, 0.7-82.9) months of follow-up, great majority of the patients did not require catheter removal due to complications (91.7%). During a total follow-up of 183,328 catheter days, 20 (9.8%) patients had complications with an incidence of 0.109 cases per 1000 catheter days and 18 (8.8%) of them required TIVAD removal (0.098 cases per 1000 catheter days). Most device removals due to complications (15/18, 83.3%) occurred within the first 24 months. Multivariate analysis identified left-sided device location as the only significant independent predictor of short device availability (OR, 3.5 [95% CI, 1.1-11.1], p = 0.036). CONCLUSION: TIVADs in cancer patients appear to be safe and their availability appears to be high in the long term. A decision for early removal might be revisited. Opting for the accustomed side (right side in the present study) for implantations seems to be associated with better outcomes.

An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.

In 2017, the European Union (EU) Committee for Risk Assessment (RAC) recommended the classification of metallic cobalt (Co) as Category 1B with respect to its carcinogenic and reproductive hazard potential and Category 2 for mutagenicity but did not evaluate the relevance of these classifications for patients exposed to Co-containing alloys (CoCA) used in medical devices. CoCA are inherently different materials from Co metal from a toxicological perspective and thus require a separate assessment. CoCA are biocompatible materials with a unique combination of properties including strength, durability, and a long history of safe use that make them uniquely suited for use in a wide-range of medical devices. Assessments were performed on relevant preclinical and clinical carcinogenicity and reproductive toxicity data for Co and CoCA to meet the requirements under the EU Medical Device Regulation triggered by the ECHA re-classification (adopted in October 2019 under the 14th Adaptation to Technical Progress to CLP) and to address their relevance to patient safety. The objective of this review is to present an integrated overview of these assessments, a benefit-risk assessment and an examination of potential alternative materials. The data support the conclusion that the exposure to CoCA in medical devices via clinically relevant routes does not represent a hazard for carcinogenicity or reproductive toxicity. Additionally, the risk for the adverse effects that are known to occur with elevated Co concentrations (e.g., cardiomyopathy) are very low for CoCA implant devices (infrequent reports often reflecting a unique catastrophic failure event out of millions of patients) and negligible for CoCA non-implant devices (not measurable/no case reports). In conclusion, the favorable benefit-risk profile also in relation to possible alternatives presented herein strongly support continued use of CoCA in medical devices.

Analytical Problems with Preparation of Paraspinal Tissues from Patients with Spinal Fusion for Analysis of Titanium.

Preparation of paraspinal tissue of patients with implants for elemental analysis is a challenge because it contains titanium in the ionic form, as well as metallic debris. Most literature reports focus on dissolving the tissue, but the impact of digestion conditions on metallic debris of Ti has not been investigated. In our work, various digestion conditions, including systems, compositions of oxidising mixture, and time, were tested aiming (i) to digest the tissue without digestion of metallic titanium to quantify soluble Ti and (ii) to digest metallic titanium debris to asses total Ti content in tissue. The experiments were performed in a closed mode using a microwave-assisted system and a carbon heating block. Our study revealed that total digestion of titanium was impossible in the tested conditions and the maximal level of digested titanium was below 70%. The mineralisation with the use of concentrated nitric acid was optimal to prepare paraspinal samples to analyse the soluble titanium form because metallic titanium passivated and did not migrate to the solution. The elaborated conditions were applied to determine titanium ion in the periimplant tissue of patients with three different titanium-based surgical systems, including traditional growing rod (TGR), guided growth systems (GGS), and vertical expandable prosthesis titanium rib (VEPTR).

In Vivo Evaluation of the Biocompatibility of Biomaterial Device.

Biomaterials are widely used to produce devices for regenerative medicine. After its implantation, an interaction between the host immune system and the implanted biomaterial occurs, leading to biomaterial-specific cellular and tissue responses. These responses may include inflammatory, wound healing responses, immunological and foreign-body reactions, and even fibrous encapsulation of the implanted biomaterial device. In fact, the cellular and molecular events that regulate the success of the implant and tissue regeneration are played at the interface between the foreign body and the host inflammation, determined by innate and adaptive immune responses. This chapter focuses on host responses that must be taken into consideration in determining the biocompatibility of biomaterial devices when implanted in vivo of animal models.

In vitro performance of six combinations of adjustable differential pressure valves and fixed anti-siphon devices with and without vertical motion.

OBJECTIVE: Adjustable differential pressure (DP) valves in combination with fixed anti-siphon devices are currently a popular combination in counteracting the effects of cerebrospinal fluid overdrainage following implantation of a ventriculoperitoneal shunt system. The study examined the flow performance of three DP valves in successive combination with an anti-siphon device in an in vitro shunt laboratory with and without vertical motion. METHODS: We analyzed three DP valves (Codman Hakim Medos programmable valve [HM], Codman CertasPlus [CP], and Miethke proGAV [PG], in combination with either Codman SiphonGuard [SG] or Miethke ShuntAssistant [SA]), resulting in the evaluation of six different valve combinations. Defined DP conditions between 4 and 40 cm H2O within a simulated shunt system were generated and the specific flow characteristics were measured. In addition, combinations with SA, which is a gravity-dependent valve, were measured in defined spatial positions (90°, 60°). All device combinations were tested during vertical motion with movement frequencies of 2, 3, and 4 Hz. RESULTS: All valve combinations effectively counteracted the siphon effect in relation to the chosen DP. Angulation-related flow changes were similar in the three combinations of DP valve and SA in the 60° and 90° position. In CP-SA and PG-SA, repeated vertical movement at 2, 3, and 4 Hz led to significant increase in flow, whereas in HM-SA, constant increase was seen at 4 Hz only (flow change at 4Hz, DP 40 cm H2O: PG (opening pressure 4 cm H2O) 90°: 0.95 ml/min, 60°: 0.71 ml/min; HM (opening pressure 4 cm H2O) 90°: 0.66 ml/min, 60°: 0.41 ml/min; CP (PL 2) 90°: 0.94 ml/min, 60°: 0.79 ml/min; p < 0.01); however, HM-SA showed relevant motion-induced flow already at low DPs (0.85 ml/min, DP 4 cm H2O). In combinations of DP valve with SG, increase of flow was far less pronounced and even led to significant reduction of flow in certain constellations. Maximum overall flow increase was 0.46 ± 0.04 ml/min with a HM (opening pressure 12 cm H2O) at 2 Hz and a DP of 10 cm H2O, whereas maximum flow decrease was 1.12 ± 0.08 with a PG (opening pressure 4 cm H2O) at 3 Hz and a DP of 10 cmH2O. CONCLUSION: In an experimental setup, all valve combinations effectively counteracted the siphon effect in the vertical position according to their added resistance. Motion-induced increased flow was consistently demonstrated in combinations of DP valve and SA. The combination of HM and SA especially showed relevant motion-induced flow already at low DPs. In combinations of DP and SG, the pattern of the motion induced flow was more inconsistent and motion even led to significant flow reduction, predominantly at DPs of 10 and 20 cmH2O.

Two Different Methods to Measure the Stability of Acetabular Implants: A Comparison Using Artificial Acetabular Models.

The total number of total hip arthroplasties is increasing every year, and approximately 10% of these surgeries are revisions. New implant design and surgical techniques are evolving quickly and demand accurate preclinical evaluation. The initial stability of cementless implants is one of the main concerns of these preclinical evaluations. A broad range of initial stability test methods is currently used, which can be categorized into two main groups: Load-to-failure tests and relative micromotion measurements. Measuring relative micromotion between implant and bone is recognized as the golden standard for implant stability testing as this micromotion is directly linked to the long-term fixation of cementless implants. However, specific custom-made set-ups are required to measure this micromotion, with the result that numerous studies opt to perform more straightforward load-to-failure tests. A custom-made micromotion test set-up for artificial acetabular bone models was developed and used to compare load-to-failure (implant push-out test) with micromotion and to assess the influence of bone material properties and press-fit on the implant stability. The results showed a high degree of correlation between micromotion and load-to-failure stability metrics, which indicates that load-to-failure stability tests can be an appropriate estimator of the primary stability of acetabular implants. Nevertheless, micromotions still apply as the golden standard and are preferred when high accuracy is necessary. Higher bone density resulted in an increase in implant stability. An increase of press-fit from 0.7 mm to 1.2 mm did not significantly increase implant stability.

Nurses' Perceptions of Implant Barcode Scanning in Surgical Services.

The US Food and Drug Administration's 2013 Unique Device Identification System Rule requires manufacturers to label devices with unique identifiers. Implantable devices are now shipped with unique identifiers, and many electronic health records have fields to incorporate them. Health policy changes have prompted hospital systems to assess implementation of implant barcode scanning systems to capture unique device identifiers. Project aims were to assess predictors of operating room nurses' acceptance of a new implant barcode scanning system, describe operating room nurses' perceptions of the system value, and identify operating room nurses' perceived gaps in system implementation. An online survey was disseminated to operating room nurses, and focus groups were conducted with orthopedic operating room nurses in an academic medical center that had recently implemented an implant barcode scanning system in surgical services. Predictors of barcode scanning acceptance included perceived usefulness for patient care, perceived ease of use, and perceived usefulness (self). Nurses perceived the system to be more accurate and valuable for patient safety. Perceived gaps in system implementation related to communication, completeness of the system, consistency in process, and training. Understanding nurse perceptions of new barcode scanning systems and engaging them in the implementation process are key areas for success and optimization of these systems.

Relationship between Implant Length and Implant Stability of Single-Implant Restorations: A 12-Month Follow-Up Clinical Study.

Background and Objectives: Implant stability in vivo is contingent on multiple factors, such as bone structure, instrument positioning and implant surface modifications, implant diameter, and implant length. Resonance-frequency analysis is considered a non-invasive, reliable, predictable, and objective method by which to evaluate implant stability, due to its correlation with bone-to-implant contact. The purpose of this study was to evaluate the effect of implant length on the primary and secondary stability of single-implant crown rehabilitations, as measured by resonance-frequency analysis at different times. Materials and Methods: Implants of 10 and 11.5 mm were placed, and the resonance frequency was measured at the time of surgery (T0), as well as at 3 (T1), 6 (T2), and 12 (T3) months post-surgery. Results: A total of 559 implants were placed in 195 patients. Significant differences were observed when comparing the implant stability quotient (ISQ) values at T1, with values for 10-mm implants being greater than those for 11.5-mm implants (p = 0.035). These differences were also observed when comparing ISQ values for buccal and lingual areas. At T0, T2, and T3, no significant differences in ISQ values were observed. The use of 10-mm implants in the anterior maxilla yielded significantly greater values at T0 (p = 0.018) and T1 (p = 0.031) when compared with 11.5-mm implants. Significant differences in measurements were observed only for buccal areas (p = 0.005; p = 0.018). When comparing the sample lengths and sex, women with 11.5-mm implants showed significantly lower results than those with 10-mm implants (p < 0.001). Conclusions: There is a direct relationship between implants of a smaller length and greater ISQ values, with this relationship being most evident in the maxilla and in women.

Histology Strategies for Medical Implants and Interventional Device Studies.

Histology of medical devices poses a variety of unique challenges. Comprehensive histologic assessment of medical devices often requires spatial context and high-quality retention of the device-tissue interface. However, the composition of many medical devices is often not amenable to traditional paraffin embedding and thus alternative specialized methodologies such as hard resin embedding must be used. Hard resin embedding requires specialized laboratory technical expertise and equipment, and the fixation techniques and resin composition used markedly impact the feasibility of immunohistochemistry. For the continuity of spatial context during histologic evaluation, additional imaging methods such as macrophotography, radiography, micro-Computerized Tomography (microCT), or magnetic resonance imaging (MRI) can be used to guide sectioning and to complement histologic findings. Although standardized approaches are scarce for medical devices, important considerations specific to medical device histology are discussed, including general specimen preparation, special considerations for devices by organ system, and the challenges of immunohistochemistry. Histologic preparation of medical devices must be thoughtful, thorough, and tailored to achieve optimal histologic outcomes for complex, valuable, and often limited implant specimens.

Evaluation of Magnesium-based Medical Devices in Preclinical Studies: Challenges and Points to Consider.

Absorbable metallic implants have been under investigation for more than a century. Animal and human studies have shown that magnesium (Mg) alloys can be safely used in bioresorbable scaffolds. Several cardiovascular and orthopedic biodegradable metallic devices have recently been approved for use in humans. Bioresorbable Mg implants present many advantages when compared to bioabsorbable polymer or nonabsorbable metallic implants, including similar strength and mechanical properties as existing implant-grade metals without the drawbacks of permanence or need for implant removal. Imaging visibility is also improved compared to polymeric devices. Additionally, with Mg-based cardiovascular stents, the risk of late stent thrombosis and need for long-term anti-platelet therapy may be reduced as the host tissue absorbs the Mg degradation products and the morphology of the vessel returns to a near-normal state. Absorbable Mg implants present challenges in the conduct of preclinical animal studies and interpretation of pathology data due to their particular degradation process associated with gas production and release of by-products. This article will review the different uses of Mg implants, the Mg alloys, the distinctive degradation features of Mg, and the challenges confronting pathologists at tissue collection, fixation, imaging, slide preparation, evaluation, and interpretation of Mg implants.

Medical three-dimensional printing opens up new opportunities in cardiology and cardiac surgery.

Advanced percutaneous and surgical procedures in structural and congenital heart disease require precise pre-procedural planning and continuous quality control. Although current imaging modalities and post-processing software assists with peri-procedural guidance, their capabilities for spatial conceptualization remain limited in two- and three-dimensional representations. In contrast, 3D printing offers not only improved visualization for procedural planning, but provides substantial information on the accuracy of surgical reconstruction and device implantations. Peri-procedural 3D printing has the potential to set standards of quality assurance and individualized healthcare in cardiovascular medicine and surgery. Nowadays, a variety of clinical applications are available showing how accurate 3D computer reformatting and physical 3D printouts of native anatomy, embedded pathology, and implants are and how they may assist in the development of innovative therapies. Accurate imaging of pathology including target region for intervention, its anatomic features and spatial relation to the surrounding structures is critical for selecting optimal approach and evaluation of procedural results. This review describes clinical applications of 3D printing, outlines current limitations, and highlights future implications for quality control, advanced medical education and training.

Percutaneous Interspinous Spacer in Spinal-Canal-Stenosis Treatment: Pros and Cons.

A comprehensive description of the literature regarding interspinous process devices (IPD) mainly focused on comparison with conservative treatment and surgical decompression for the treatment of degenerative lumbar spinal stenosis. Recent meta-analysis and articles are listed in the present article in order to establish IPD pros and cons.

Innovative Spine Implants for Improved Augmentation and Stability in Neoplastic Vertebral Compression Fracture.

Background and objectives: Tumor-related vertebral compression fractures often result in severe back pain as well as progressive neurologic impairment and additional morbidities. The fixation of these fractures is essential to obtain good pain relief and to improve the patients' quality of life. Thus far, several spine implants have been developed and studied. The aims of this review were to describe the implants and the techniques proposed to treat cancer-related vertebral compression fractures and to compile their safety and efficacy results. Materials and Methods: A systematic MEDLINE/PubMed literature search was performed, time period included articles published between January 2000 and March 2019. Original articles were selected based on their clinical relevance. Results: Four studies of interest and other cited references were analyzed. These studies reported significant pain and function improvement as well as kyphotic angle and vertebral height restoration and maintain for every implant and technique investigated. Conclusions: Although good clinical performance is reported on these devices, the small numbers of studies and patients investigated draw the need for further larger evaluation before drawing a definitive treatment decision tree to guide physicians managing patients presenting with neoplastic vertebral compression fracture.

Development of esthetic prosthesis for a patient with severe stigmatizing facial lesions due to cancer: a pilot study.

PURPOSE: Severe physical facial deformities due to surgical interventions can have significant psychosocial consequences to patient's relationships with friends and family and thus, has a considerable impact on their quality of life. We have developed a 3D prosthesis for a 56-year-old woman diagnosed with epidermoid carcinoma at the right hemiface, to improve her quality of life. METHODS: The patient started radiotherapy with modulated intensity. To deal with the advance of the process, a maxilectomy of supra structure with modified radical cervical emptying on the right hemiface was performed. Reconstruction of areas surgically affected by the displacement of islands of skin and muscle (flaps) from healthy regions was initiated. Although the procedure occurred without intercurrences, the patient developed necrosis and loss of the myocutaneous flap. After the removal of the flap, the esthetic result of the treatment was evident causing exposure of subcutaneous and granulation tissues. RESULTS: A computational model was used to develop a 3D structure of the affected area and then used to construct the prosthesis. The prosthesis was applied over the affected area, and the patient was able see her face on the mirror for the first time in years. The patient was grateful and hopeful. CONCLUSION: We have found that the application of this new technology greatly improves the social interaction of patients with deformities due to surgical interventions.

Comparison among perfect-C®, zero-P®, and plates with a cage in single-level cervical degenerative disc disease.

BACKGROUND: We intended to analyze the efficacy of a new integrated cage and plate device called Perfect-C for anterior cervical discectomy and fusion (ACDF) to cure single-level cervical degenerative disc disease. METHODS: We enrolled 148 patients who were subjected to single-level ACDF with one of the following three surgical devices: a Perfect-C implant (41 patients), a Zero-P implant (36 patients), or a titanium plate with a polyetheretherketone (PEEK) cage (71 patients). We conducted a retrospective study to compare the clinical and radiological results among the three groups. RESULTS: The length of the operation, intraoperative blood loss, and duration of hospitalization were significantly lower in the Perfect-C group than in the Zero-P and plate-with-cage groups (P < 0.05). At the last follow-up visit, heterotopic ossification (HO) was not observed in any cases (0%) in the Perfect-C and Zero-P groups but was noted in 21 cases (30%) in the plate-with-cage group. The cephalad and caudal plate-to-disc distance (PDD) and the cephalad and caudal PDD/anterior body height (ABH) were significantly greater in the Perfect-C and Zero-P groups than in the plate-with-cage group (P < 0.05). Subsidence occurred in five cases (14%) in the Perfect-C group, in nine cases (25%) in the Zero-P group, and in 15 cases (21%) in the plate-with-cage group. Fusion occurred in 37 cases (90%) in the Perfect-C group, in 31 cases (86%) in the Zero-P group, and in 68 cases (95%) in the plate-with-cage group. CONCLUSIONS: The Perfect-C, Zero-P, and plate-with-cage devices are effective for treating single-level cervical degenerative disc disease. However, the Perfect-C implant has many advantages over both the Zero-P implant and conventional plate-cage treatments. The Perfect-C implant was associated with shorter operation times and hospitalization durations, less blood loss, and lower subsidence rates compared with the Zero-P implant or the titanium plate with a PEEK cage.

In-vivo study of osseointegration in Prestige LP cervical disc prosthesis.

BACKGROUND: A study was designed to quantify the extent of porous osseointegration at the prosthesis-bone interface in the Prestige LP prosthesis containing a plasma-sprayed titanium coating. METHODS: Using an anterior surgical approach, cervical disc arthroplasty was performed in 8 mature male goats at the C3-C4 segment, followed by implantation of the Prestige LP prosthesis. The vertebral specimens were examined using microcomputed tomograph for histomorphometric quantification, and proceeded by routine paraffin processing for histological observation. Hence, the porous osseointegration at the prosthesis-bone interface was evaluated based on histologic and histomorphometric analyses. RESULTS: At 6 months after surgery, there was no evidence of prosthesis migration, loosening, subsidence, or neurologic or vascular complications. Based on gross histologic analysis, there was excellent porous ingrowth at the prosthesis-bone interface, without significant histopathologic changes. Histomorphometric analysis at the prosthesis-bone interface indicated the mean porous ingrowth of 48.5% ± 10.4% and the total ingrowth range of 36.6 to 59.8%. CONCLUSIONS: As the first comprehensive in vivo investigation into the Prestige LP prosthesis, this project established a successful animal model in the evaluation of cervical disc arthroplasty. Moreover, histomorphometric analysis of porous ingrowth at the prosthesis-bone interface was more favorable for cervical disc arthroplasty with the Prestige LP prosthesis compared to historical reports of appendicular total joint arthroplasty.

Clinical Evaluation of a Novel Intrarectal Device for Management of Fecal Incontinence in Bedridden Patients.

PURPOSE: The primary objective of the study was to evaluate the safety and efficacy of a stool management kit (SMK) for containment of fecal incontinence in hospitalized bedridden patients. DESIGN: A single-group quasi-experimental study. SUBJECTS AND SETTING: Twenty bedridden adults who had at least 1 episode of fecal incontinence in the prior 24 hours participated in the study. The study setting was the neurological unit of the All India Institute of Medical Sciences in New Delhi, India. METHODS: The study was carried out in 2 phases. The device was placed in situ for up to 24 hours in 10 patients during phase I of the study and up to 120 hours in an additional 10 patients during phase II. Participants were assessed for anorectal injury and peripheral device leakage on a 4- to 6-hourly basis. Sigmoidoscopy was performed to evaluate for any mucosal trauma or alteration of anorectal pathology after retrieval of the device. RESULTS: The device was successfully placed in all patients following the first attempt to place the device; 80% of patients retained the device until planned removal. The SMK diverted fecal matter without anal leakage in 174 (93.5%) out of 186 assessment points in a group of 20 patients. The devices remained in situ for 21 ± 0.2 and 84.5 ± 38.9 hours during phase I and phase II, respectively. None experienced anorectal bleeding, sphincter injury, or mucosal ulceration with device usage. Post-device sigmoidoscopy revealed erythema at the site of diverter placement in 2 participants. CONCLUSION: Study findings suggest that the SMK successfully diverted liquid to semiformed fecal exudate without peripheral device leakage in 93.5% of bedridden patients. No serious adverse events occurred. Additional research is needed to compare its effectiveness with that of currently available intrarectal balloon devices.

Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey.

Decisions to adopt medical devices at the hospital level have consequences for health technology assessment (HTA) on system level and are therefore important to decision makers. Our aim was to investigate the characteristics of organizations and individuals that are more inclined to adopt and utilize cardiovascular devices based on a comprehensive analysis of environmental, organizational, individual, and technological factors and to identify corresponding implications for HTA. Seven random intercept hurdle models were estimated using the data obtained from 1249 surveys completed by members of the European Society of Cardiology. The major findings were that better manufacturer support increased the adoption probability of 'new' devices (i.e. in terms of CE mark approval dates), and that budget pressure increased the adoption probability of 'old' devices. Based on our findings, we suggest investigating the role of manufacturer support in more detail to identify diffusion patterns relevant to HTA on system level, to verify whether it functions as a substitute for medical evidence of new devices, and to receive new insights about its relationship with clinical effectiveness and cost-effectiveness. © 2017 The Authors. Health Economics published by John Wiley & Sons, Ltd.

New implantable cardiac monitor with three-lead ECG and active noise detection.

BACKGROUND: A new implantable cardiac monitor (BioMonitor, Biotronik) with a continuous remote monitoring option was prospectively implanted in patients with suspected arrhythmias or for therapy control after atrial fibrillation (AF) ablation. A three-lead ECG detection was intended to make the implantation more independent of the implantation site and the electrical heart axis. Because noise is a frequent problem in implantable cardiac monitors, an active noise detection algorithm was implemented. The aim of the trial was to evaluate the clinical performance of the device. METHODS: The device performance was evaluated in a prospective nonrandomized multicenter study with a follow-up of 12 months. Study endpoints were device-related serious adverse events at 3 months, appropriate QRS detection in direct comparison with synchronized Holter ECG recordings, sensitivity and positive predictive value of arrhythmia detection in comparison with Holter ECG and independent of it, and noise burden during the entire follow-up period. RESULTS: The implantation was successful in all 152 patients. Two device-related serious adverse events (pocket infections) occurred by 3 months. The mean QRS amplitude of 0.3 ± 0.2 mV at implantation remained stable over 12 months. QRS sensing performance indicated little over- and undersensing in most patients. More than 80 % of the patients had more than 22 h of noise-free monitoring per day. CONCLUSION: BioMonitor effectively detects patients with bradycardia, tachycardia, AF, or asystole. Active noise detection seems to reduce the transmission of meaningless data without diminishing the positive predictive value of the device.

Comparison of artificial graft versus autograft in anterior cruciate ligament reconstruction: a meta-analysis.

BACKGROUND: Critically evaluation and summarization for the outcomes between autografts and artificial grafts using in anterior cruciate ligament (ACL) reconstruction have not been performed currently. The purpose of this study is to compare the clinical outcomes between artificial ligaments and autografts at a short- to mid-term follow-up. METHODS: A computerized search of the databases was conducted including Medline, Embase, and the Cochrane library. Only prospective or retrospective comparative studies with a minimum 2-year follow-up and a minimum sample size of 15 for each group were considered for inclusion. Two independent reviewers performed data extraction and methodological quality assessment. A Mantel-Haenszel analysis was used for pooling of results. Sensitivity analysis was performed in order to maintain the stability of results. RESULTS: Seven studies were included in this study. The total sample size was 403 (autograft group: 206 patients; synthetic graft group: 197 patients). Four studies were randomized controlled trials. Two studies were retrospective comparative studies and one study was non-randomized prospective comparative study. In terms of instrumented laxity, patient-oriented outcomes and complications, no significant difference was occurred between new artificial ligaments and autografts. But the results of IKDC grades and instrumented laxity were worsen in early artificial ligaments compared to autografts. CONCLUSIONS: The outcomes of new generation of artificial ligaments are similar to autografts at a short- to mid-term follow-up. However, the early artificial ligaments are not suggested for ACL reconstruction compared to autografts.