Three-Dimensional Auricular Subunit Models for Cartilage Framework Fabrication: Our Preliminary Experience.

BACKGROUND: Three-dimensional (3D) digital imaging and printing techniques have been popularly applied in microtia reconstruction. However, there is a lack of clinical report of using them to create 3D printed ear subunit models for cartilage framework fabrication. METHODS: A retrospective study of patients who underwent auricle reconstruction with 3D templates was performed. Patients' demography, surgical complications, framework accuracy, and aesthetic outcomes of the reconstructed auricles were analyzed. RESULTS: Twenty cases included in this study. Complications were minor. The average (median) assessing scores for the framework quality and the reconstructed auricle aesthetics were 8.50 (8) and 8.30 (8), respectively. CONCLUSIONS: Our study found that the use of custom-printed tridimensional ear subunit models achieved a relatively high framework precision and gained good outcomes of the reconstructed ears.Level of Evidence: Level IV.

Three-dimensional printing-based personalized limb salvage and reconstruction treatment of pelvic tumors.

BACKGROUND AND OBJECTIVES: The treatment of pelvic tumors is widely recognized to be challenging. The purpose of this study was to evaluate the efficacy of personalized three-dimensional (3D) printing-based limb salvage and reconstruction treatment for pelvic tumors. METHODS: Twenty-eight pelvic tumor patients were enrolled. 3D printing lesion models and osteotomy templates were prepared for surgery planning, prosthesis design, and osteotomy assistance during surgery. 3D printing-based personalized pelvic prostheses were manufactured and used in all 28 patients. Follow-up of postoperative survival, prosthesis survival, imaging examinations, and Musculoskeletal Tumor Society (MSTS) lower limb functional scores were carried out. RESULTS: The mean follow-up period was 32.2 months, during which 16 patients had disease-free survival, 3 survived with the disease, and 9 died. The prostheses were stable, and the mean offset of the center of rotation was 5.48 mm. The prosthesis-bone interface showed good integration. For the 19 surviving patients, the mean MSTS lower limb functional score was 23.2. Postoperative complications included superficial infection in six patients and hip dislocation in three patients. CONCLUSIONS: Personalized 3D printing-based limb salvage and reconstruction was an effective treatment for pelvic tumors. Our patients achieved good early postoperative efficacy and functional recovery.

Ten-Year Outcomes of Total Hip Arthroplasty Using Fit-and-Fill Type Cementless Collared Straight Stem Implants: Relationship between the Initial Contact Status and Stress Shielding.

We investigated the relationship between the initial contact status and stress shielding in total hip arthroplasty (THA) using fit-and-fill type straight-stem implants. In addition we evaluated the clinical and radiographic outcomes. Subjects were 100 hips of 94 patients who underwent THA and were followed-up for ≥10 years. Contact areas with the femoral cortical bone were investigated according to the zonal distribution of Gruen using postoperative CT images. Depending on the number of contact areas, the patients were classified into high contact [HC], medium contact [MC], and low contact [LC] groups. Radiographic and clinical outcomes were evaluated. In the HC group (20 hips), severe stress shielding was observed in 12 hips, which was statistically significant (p=0.008). In the LC group (29 hips), mild stress shielding was observed in 27 hips which was statistically significant (p<0.001). No significant differences were observed among the 3 groups in clinical outcomes, Harris hip score (p=0.719) or Japanese Orthopedic Association (JOA) score (p=0.301). In insertion of cementless collared fit-and-fill type straight-stem implants, severe late stress shielding of the femoral bone may occur if high contact of the femoral component is achieved. However, the degree of stress shielding does not result in adverse clinical outcomes.

Cementless short-stem total hip arthroplasty in the elderly patient - is it a safe option?: a prospective multicentre observational study.

BACKGROUND: Due to its bone preserving philosophy, short-stem total hip arthroplasty (THA) has primarily been recommended for young and active patients. However, there may be benefits for elderly patients given a less invasive operative technique due to the short curved implant design. The purpose of this study was to compare the clinical and radiological outcomes as well as perioperative complications of a calcar-guided short stem between a young (< 60 years) and a geriatric (> 75 years) population. METHODS: Data were collected in a total of 5 centers, and 400 short-stems were included as part of a prospective multicentre observational study between 2010 and 2014 with a mean follow-up of 49.2 months. Preoperative femur morphology was analysed using the Dorr classification. Clinical and radiological outcomes were assessed in both groups as well as perioperative complications, rates and reasons for stem revision. RESULTS: No differences were found for the mean visual analogue scale (VAS) values of rest pain, load pain, and satisfaction, whereas Harris Hip Score (HHS) was slightly better in the young group. Comparing both groups, none of the radiological parameters that were assessed (stress-shielding, cortical hypertrophy, radiolucency, osteolysis) reached differences of statistical significance. While in young patients aseptic loosening is the main cause of implant failure, in the elderly group particularly postoperative periprosthetic fractures due to accidental fall have to be considered to be of high risk. The incidence of periprosthetic fractures was found to be 0% in Dorr type A femurs, whereas in Dorr types B and C fractures occurred in 2.1 and 22.2% respectively. CONCLUSIONS: Advanced age alone is not necessarily to be considered as contra-indications for calcar-guided short-stem THA, although further follow-up is needed. However, markedly reduced bone quality with femur morphology of Dorr type C seems to be associated with increased risk for postoperative periprosthetic fractures, thus indication should be limited to Dorr types A and B. TRIAL REGISTRATION: German Clinical Trials Register; DRKS00012634 , 07.07.2017 (retrospectively registered).

Non-contemporaneous bilateral stem fractures occurring after staged bilateral hip revision using extensively porous-coated cylindrical femoral stems: a case report.

BACKGROUND: Distally fixed cylindrical femoral stems extensively coated with porous materials are widely used in revision and total hip arthroplasty surgeries. Stem fracture is an uncommon complication; few case reports have been published. CASE PRESENTATION: We report the case of a 51-year-old male exhibiting extensively porous-coated cylindrical femoral stems fracture after staged bilateral hip revision. His body mass index was 24.22 kg/m2. The major risk factor was poor proximal bony support; and femoral stems with smaller diameter. CONCLUSIONS: Certain patients are at high risk of non-contemporaneous, bilateral femoral stem fractures. It remains unclear whether fracture of the contralateral femoral stem is an inevitable fatigue fracture or reflects the increased weight imposed on the contralateral hip after the first revision. We recommend that a strut bone graft be placed to support the proximal bone, and that non-modular tapered femoral stems be employed in such patients.

Controlling a Lower-Leg Exoskeleton Using Voltage and Current Variation Signals of a DC Motor Mounted at the Knee Joint.

Powered exoskeleton technology helps turns dreams of recovering mobility after paralysis into reality. One of the most common problems encountered in the use of powered exoskeletons is the detection of the motion intentions of the user. Many approaches to conquering this problem have been developed using Electromyography (EMG) sensors, Electroencephalography (EEG) sensors, Center of Pressure (COP), and so forth. When a method, such as the surface EMG, is contaminated with noise during acquisition, it is important to process that raw EMG signal. Doing so usually takes time, and time delays in such a system can lead to a loss in synchronization between the wearer and the exoskeleton. Many algorithms have been developed for data acquisition and the filtering of raw EMG signals as well as accelerometer data. Our approach involves designing an almost sensor-less low limb exoskeleton that is powered by an electric Direct Current (DC) motor, and the same motor is used to detect motion via monitoring the voltage and the current variation. Experimental results are obtained for the actuating knee flexion-to-extension then extension-to-flexion of a sitting person using the National Instrument (NI) MyRIO as a data acquisition system with NI-LabView. The results support the hypothesis that the developed system can detect human motion and drive the motor in the necessary direction without the use of uncomfortable electrodes (sensors) and their connections. Additionally, the system supported the wearer to move his leg up (extension) without having too much effort to do so. In order to identify muscle activation with the change in the angle along the sagittal plane, an accelerometer has been attached to the system. The proposed approach could help open a new pathway along which researchers could develop low-cost and easy-to-wear powered exoskeletons which could emulate precisely the normal gait of a human.

Comfort level discussion for prosthetic sockets with different fabricating processing conditions.

BACKGROUND: In the past, manufacture of prosthetic socket by using traditional handmade method not only consumed research time but also required a special assembly approach. Recently, reverse engineering and rapid prototype technology have grown up explosively, and thus, provide a choice to fabricate prosthetic socket. METHODS: Application 3D computer aided design and manufacturing (computer-aided design/computer-aided engineering) tools approach the surface shape stump data is digitized and can be easily modified and reused. Collocation investigates gait parameters of prosthetic socket, and interface stress between stump and socket with different processing conditions. Meanwhile, questionnaire was utilized to survey satisfaction rating scale, comfort level, of subjects using this kind of artificial device. RESULTS: The main outcome of current research including gait parameters, stress interface and satisfaction rating scale those would be an informative reference for further studies in design and manufacture as well as clinical applications of prosthetic sockets. CONCLUSIONS: This study found that, regardless of the method used for socket fabrication, most stress was concentrated in tibia end pressure-relief area. This caused discomfort in the area of tibia end to the participant wearing prosthesis. This discomfort was most evident in case when the prosthetic socket was fabricated using RE and RP.

Uncemented three-dimensional-printed prosthetic reconstruction for massive bone defects of the proximal tibia.

BACKGROUND: Currently, it is challenging to treat massive bone defects of proximal tibia. Although numerous methods are available for reconstruction with epiphysis preservation, limitations in knee function and complications are noted with these methods. Our paper describes our attempt to reconstruct a marked defect in the proximal tibia with an uncemented three-dimensional (3D)-printed prosthesis and to evaluate the prosthesis design and short-term outcomes. CASE PRESENTATION: A 15-year-old boy with metaphyseal osteosarcoma of the tibia underwent intercalary allograft reconstruction following wide tumour resection with epiphysis preservation. However, chronic allograft rejection and/or infection occurred after the surgery and a sinus tract was formed. The rejection and/or infection process was successfully stopped by the removal of the graft and implantation of an antibiotic-loaded cement spacer; however, the limb function was poor. Because of the irregular shape of the defect and the excessively short length of the residual proximal tibia, we used the 3D printing technology to design and fabricate a personalised prosthesis to reconstruct the defect, with the preservation of the knee joint. At the last follow-up at 26 months, the patient had satisfactory limb function. CONCLUSIONS: The 3D-printed prosthesis may be a feasible option in the reconstruction of tibial metaphyseal defects with the preservation of the knee joint. Moreover, it can result in good postoperative function and low complication rates. However, a long-term follow-up is required to clarify its long-term outcomes.

Radiological changes do not influence clinical mid-term outcome in stemless humeral head replacements with hollow screw fixation: a prospective radiological and clinical evaluation.

BACKGROUND: Stemless shoulder arthroplasty is a fairly new concept. Clinical and radiological follow-up is essential to prove implant safety and concept. This prospective single-centre study was performed to evaluate the influence of radiological changes on clinical mid-term outcome following stemless humeral head replacement with hollow screw fixation. METHODS: Short- and mid-term radiological and clinical evaluations were performed in 73 consecutive shoulders treated mainly for idiopathic and posttraumatic osteoarthritis with stemless humeral head arthroplasty including 40 hemi- (HSA) and 33 total shoulder arthroplasties (TSA). Operating times of stemless implantations were compared to 110 stemmed anatomical shoulder prostheses. Appearances of humeral radiolucencies or radiological signs of osteolysis or stress shielding were assessed on standardized radiographs. Patients' clinical outcome was evaluated using the Constant score and patients' satisfaction was documented. RESULTS: Radiological changes, detected in 37.0%, did not affect clinical outcome. Constant scores significantly improved from baseline to short and mid-term follow-up (p < 0.001). The majority of patients (96.2%) were satisfied with the procedure. No loosening of the humeral head component was detected during a mean follow-up of 58 months. Operating times were significantly shorter with stemless compared to stemmed implants (p < 0.001). CONCLUSIONS: Clinical mid-term outcome after stemless humeral head replacement was not affected by radiological changes. TRIAL REGISTRATION: The institutional review board (St. Vincent Hospital Vienna; 201212_EK01; date of issue: 11.12.2012) approved the study. The trial was registered at ClinicalTrials.gov ( NCT02754024 ). Retrospective registration.

Simultaneous Versus Sequential Side-by-Side Bilateral Metal Stent Placement for Malignant Hilar Biliary Obstructions.

BACKGROUND: Endoscopic bilateral self-expandable metallic stent (SEMS) placement for malignant hilar biliary obstructions (MHBOs) is technically demanding, and a second SEMS insertion is particularly challenging. A simultaneous side-by-side (SBS) placement technique using a thinner delivery system may mitigate these issues. AIMS: We aimed to examine the feasibility and efficacy of simultaneous SBS SEMS placement for treating MHBOs using a novel SEMS that has a 5.7-Fr ultra-thin delivery system. METHODS: Thirty-four patients with MHBOs underwent SBS SEMS placement between 2010 and 2016. We divided the patient cohort into those who underwent sequential (conventional) SBS placement between 2010 and 2014 (sequential group) and those who underwent simultaneous SBS placement between 2015 and 2016 (simultaneous group), and compared the groups with respect to the clinical outcomes. RESULTS: The technical success rates were 71% (12/17) and 100% (17/17) in the sequential and simultaneous groups, respectively, a difference that was significant (P = .045). The median procedure time was significantly shorter in the simultaneous group (22 min) than in the sequential group (52 min) (P = .017). There were no significant group differences in the time to recurrent biliary obstruction (sequential group: 113 days; simultaneous group: 140 days) or other adverse event rates (sequential group: 12%; simultaneous group: 12%). CONCLUSIONS: Simultaneous SBS placement using the novel 5.7-Fr SEMS delivery system may be more straightforward and have a higher success rate compared to that with sequential SBS placement. This new method may be useful for bilateral stenting to treat MHBOs.

Customized Knee Prosthesis in Treatment of Giant Cell Tumors of the Proximal Tibia: Application of 3-Dimensional Printing Technology in Surgical Design.

BACKGROUND We explored the application of 3-dimensional (3D) printing technology in treating giant cell tumors (GCT) of the proximal tibia. A tibia block was designed and produced through 3D printing technology. We expected that this 3D-printed block would fill the bone defect after en-bloc resection. Importantly, the block, combined with a standard knee joint prosthesis, provided attachments for collateral ligaments of the knee, which can maintain knee stability. MATERIAL AND METHODS A computed tomography (CT) scan was taken of both knee joints in 4 patients with GCT of the proximal tibia. We developed a novel technique - the real-size 3D-printed proximal tibia model - to design preoperative treatment plans. Hence, with the application of 3D printing technology, a customized proximal tibia block could be designed for each patient individually, which fixed the bone defect, combined with standard knee prosthesis. RESULTS In all 4 cases, the 3D-printed block fitted the bone defect precisely. The motion range of the affected knee was 90 degrees on average, and the soft tissue balance and stability of the knee were good. After an average 7-month follow-up, the MSTS score was 19 on average. No sign of prosthesis fracture, loosening, or other relevant complications were detected. CONCLUSIONS This technique can be used to treat GCT of the proximal tibia when it is hard to achieve soft tissue balance after tumor resection. 3D printing technology simplified the design and manufacturing progress of custom-made orthopedic medical instruments. This new surgical technique could be much more widely applied because of 3D printing technology.

Risk factors for failure of revision total hip arthroplasty using a Kerboull-type acetabular reinforcement device.

BACKGROUND: The present study aimed to identify the risk factors associated with revision total hip arthroplasty (THA) failure using a Kerboull-type (KT) plate. METHODS: We analyzed 77 revision THAs using cemented acetabular components with a KT plate for aseptic loosening between May 2000 and March 2012. We examined the association of bone graft type, acetabular bone defects, age at the time of surgery, preoperative Japanese Orthopaedic Association (JOA) score, postoperative JOA hip score, and body mass index, with radiographic failure as the outcome. RESULTS: The 7.4-year radiographic failure survival rate was 81.6%. The survival rate was significantly different between the beta-tricalcium phosphate (ß-TCP) group and the bulk allograft group (p = 0.019). The survival curves were also significantly different between the ß-TCP group and bulk allograft group (p = 0.036). American Academy of Orthopaedic Surgeons type IV was significantly associated with radiographic failure (odds ratio [OR]: 15.5, 95% confidence interval [CI]: 1.4-175.4; p = 0.032). CONCLUSIONS: The midterm outcomes of revision THA indicate that type of bone graft and bone defect size may affect radiographic survival rate when using a KT plate.

Computer-aided design/computer-aided manufacturing skull base drill.

The authors have developed a simple device for computer-aided design/computer-aided manufacturing (CAD-CAM) that uses an image-guided system to define a cutting tool path that is shared with a surgical machining system for drilling bone. Information from 2D images (obtained via CT and MRI) is transmitted to a processor that produces a 3D image. The processor generates code defining an optimized cutting tool path, which is sent to a surgical machining system that can drill the desired portion of bone. This tool has applications for bone removal in both cranial and spine neurosurgical approaches. Such applications have the potential to reduce surgical time and associated complications such as infection or blood loss. The device enables rapid removal of bone within 1 mm of vital structures. The validity of such a machining tool is exemplified in the rapid (< 3 minutes machining time) and accurate removal of bone for transtemporal (for example, translabyrinthine) approaches.

Restoration of motor control and proprioceptive and cutaneous sensation in humans with prior upper-limb amputation via multiple Utah Slanted Electrode Arrays (USEAs) implanted in residual peripheral arm nerves.

BACKGROUND: Despite advances in sophisticated robotic hands, intuitive control of and sensory feedback from these prostheses has been limited to only 3-degrees-of-freedom (DOF) with 2 sensory percepts in closed-loop control. A Utah Slanted Electrode Array (USEA) has been used in the past to provide up to 81 sensory percepts for human amputees. Here, we report on the advanced capabilities of multiple USEAs implanted in the residual peripheral arm nerves of human amputees for restoring control of 5 DOF and sensation of up to 131 proprioceptive and cutaneous hand sensory percepts. We also demonstrate that USEA-restored sensory percepts provide a useful source of feedback during closed-loop virtual prosthetic hand control. METHODS: Two 100-channel USEAs were implanted for 4-5 weeks, one each in the median and ulnar arm nerves of two human subjects with prior long-duration upper-arm amputations. Intended finger and wrist positions were decoded from neuronal firing patterns via a modified Kalman filter, allowing subjects to control many movements of a virtual prosthetic hand. Additionally, USEA microstimulation was used to evoke numerous sensory percepts spanning the phantom hand. Closed-loop control was achieved by stimulating via an electrode of the ulnar-nerve USEA while recording and decoding movement via the median-nerve USEA. RESULTS: Subjects controlled up to 12 degrees-of-freedom during informal, 'freeform' online movement decode sessions, and experienced up to 131 USEA-evoked proprioceptive and cutaneous sensations spanning the phantom hand. Independent control was achieved for a 5-DOF real-time decode that included flexion/extension of the thumb, index, middle, and ring fingers, and the wrist. Proportional control was achieved for a 4-DOF real-time decode. One subject used a USEA-evoked hand sensation as feedback to complete a 1-DOF closed-loop virtual-hand movement task. There were no observed long-term functional deficits due to the USEA implants. CONCLUSIONS: Implantation of high-channel-count USEAs enables multi-degree-of-freedom control of virtual prosthetic hand movement and restoration of a rich selection of both proprioceptive and cutaneous sensory percepts spanning the hand during the short 4-5 week post-implant period. Future USEA use in longer-term implants and in closed-loop may enable restoration of many of the capabilities of an intact hand while contributing to a meaningful embodiment of the prosthesis.

Orofacial rehabilitation with zygomatic implants: CAD-CAM bar and magnets for patients with nasal cancer after rhinectomy and partial maxillectomy.

Nasal carcinoma extending into the premaxilla requires radical surgical excision including rhinectomy and partial maxillectomy. Rehabilitation is complex and involves the use of removable prostheses. Three patients treated with zygomatic implants and custom-milled bars to retain an obturator and nasal prosthesis are presented.

["Surgeon-modified" Stent Grafts in Emergency Cases as Addition to Off-the-shelf Stent Grafts for Complex Abdominal and Thoracoabdominal Aortic Pathologies]. / "Surgeon-modified" Stentgrafts für den Notfall ­ Ergänzung zu "off-the-shelf" Prothesen für die Versorgung von komplexen abdominellen und thorakoabdominellen Aortenpathologien.

Background Endovascular techniques have revolutionised the therapy of abdominal and thoracoabdominal aortic disease. For infrarenal abdominal aortic aneurysm, the endovascular aortic repair has become a standard for elective and emergent cases. In complex abdominal or thoracoabdominal aortic pathologies, involving reno-visceral vessels, there are technical challenges for open and endovascular surgery. Due to high mortality and morbidity of open surgery of complex aortic lesions, especially in emergent cases, endovascular techniques have developed as well. Results Endovascular treatment options for complex aortic pathologies are fenestrated and branched stent grafts and the chimney graft technique. In elective cases, fenestrated and branched stent grafts are ordered as "custom-made" devices but planning, production and delivery takes up to approximately 12 weeks. For urgent cases, there recently only exists one 4-vessel branched "off-the-shelf" stent graft, that fits only about 60% of patients' anatomy in complex abdominal or thoracoabdominal aneurysm cases. As an alternative for these patients, "surgeon-modified" stent grafts are a treatment option. Here, a commercially available stent graft is modified with the needed fenestrations and branches for the visceral vessel prior to the operation. Compared to off-the-shelf stent grafts, the surgeon-modified stent grafts have similar results for mortality and morbidity. Conclusion As long as off-the-shelf devices for a larger variety of abdominal and thoracoabdominal anatomy are available, surgeon-modified stent grafts are a good treatment alternative for urgent complex abdominal and thoracoabdominal aortic pathologies in high-risk patients.

Intermanual Transfer Effects in Below-Elbow Myoelectric Prosthesis Users.

OBJECTIVES: To determine intermanual transfer effects in patients with a below-elbow amputation using a myoelectric prosthesis and to establish whether laterality affects these effects. DESIGN: Case-control. SETTING: A standardized setting in a rehabilitation clinic. PARTICIPANTS: A convenience sample (N=44) of experienced myoelectric prosthesis users (n=22) and matched controls (n=22). Controls were matched on sex, age (±5y), and hand dominance. INTERVENTIONS: Both the experienced group and the control group performed several tasks using a prosthesis simulator attached to their nonaffected arm. MAIN OUTCOME MEASURES: Movement time, force control, Box and Block test (BBT) scores, and duration of hand opening. RESULTS: Movement times of myoelectric prosthesis users were shorter, and these users had significantly higher BBT scores and shorter hand opening durations than those of controls. No intermanual transfer effects on force control and no laterality effects were found. CONCLUSIONS: Intermanual transfer effects were present in experienced myoelectric prosthesis users with a below-elbow amputation, independent of laterality. These findings support the clinical relevance of intermanual transfer training, which may facilitate persons with an upper limb amputation to start training directly after the amputation.

Computationally Optimizing the Compliance of a Biopolymer Based Tissue Engineered Vascular Graft.

Coronary heart disease is a leading cause of death among Americans for which coronary artery bypass graft (CABG) surgery is a standard surgical treatment. The success of CABG surgery is impaired by a compliance mismatch between vascular grafts and native vessels. Tissue engineered vascular grafts (TEVGs) have the potential to be compliance matched and thereby reduce the risk of graft failure. Glutaraldehyde (GLUT) vapor-crosslinked gelatin/fibrinogen constructs were fabricated and mechanically tested in a previous study by our research group at 2, 8, and 24 hrs of GLUT vapor exposure. The current study details a computational method that was developed to predict the material properties of our constructs for crosslinking times between 2 and 24 hrs by interpolating the 2, 8, and 24 hrs crosslinking time data. matlab and abaqus were used to determine the optimal combination of fabrication parameters to produce a compliance matched construct. The validity of the method was tested by creating a 16-hr crosslinked construct of 130 µm thickness and comparing its compliance to that predicted by the optimization algorithm. The predicted compliance of the 16-hr construct was 0.00059 mm Hg-1 while the experimentally determined compliance was 0.00065 mm Hg-1, a relative difference of 9.2%. Prior data in our laboratory has shown the compliance of the left anterior descending porcine coronary (LADC) artery to be 0.00071 ± 0.0003 mm Hg-1. Our optimization algorithm predicts that a 258-µm-thick construct that is GLUT vapor crosslinked for 8.1 hrs would match LADC compliance. This result is consistent with our previous work demonstrating that an 8-hr GLUT vapor crosslinked construct produces a compliance that is not significantly different from a porcine coronary LADC.

Technological Improvements in Three-Piece Inflatable Penile Prosthesis Design over the Past 40 Years.

INTRODUCTION: The advent of the penile prosthesis revolutionized the treatment of erectile dysfunction (ED), resulting in near-complete treatment efficacy and high patient satisfaction rates. While several types of penile prosthesis are available, the inflatable penile prosthesis (IPP) is the most commonly used device in the United States. AIMS: To describe the key modifications to IPPs from the two major manufacturers-American Medical Systems (AMS) and Coloplast-since the invention of the IPP, and to relate these changes to improvements in prosthesis function and patient outcomes based on available literature. METHODS: Review and evaluation of the literature between 1973 and present describing modifications in IPP design and the influence of these modifications on IPP durability and patient-related factors. MAIN OUTCOME MEASURES: Data describing the impact of iterative improvements in three-piece IPP design on device function, durability, and patient outcomes. RESULTS: There were progressive improvements in IPP technology from both major manufacturers not only on the durability of the prosthesis but also on patient outcomes, with fewer device failures and lower infection rates. Notable improvements include incorporation of kink-resistant tubing, changes in the weave or addition of shear- and infection-resistant coatings to cylinder layers, pump and tubing connection modifications, the addition of rear tip extenders, and the incorporation of lockout valves to prevent autoinflation. CONCLUSIONS: Numerous incremental modifications to the IPP from both major manufacturers since its invention have increased its durability and improved patient outcomes.

Comparison of the Occlutech ® Figulla ® septal occluder and Amplatzer ® septal occluder for atrial septal defect device closure.

The Occlutech(®) Figulla(®) septal occluder (OFSO) is a later-generation double-disk device with few reports of its success rates and complications compared with the Amplatzer(®) septal occluder (ASO), which is the worldwide standard device in percutaneous atrial septal defect (ASD) closure. We recruited and compared the results in 149 patients (76.5 % female) who underwent ASD device closure in our center between January 2003 and June 2012. The patients ranged in age from 2.3 to 77.2 years. There were no statistically significant differences between the two groups regarding patient baseline characteristics and procedure variables. The success rate using either device was excellent (ASO 94.4 % and OFSO 97.4 %; p = 0.43). Although the diameter of the ASD and the pulmonary arterial pressure in the OFSO group were slightly higher than in the ASO group, the median fluoroscopic time in the OFSO group was significantly shorter (ASO 13.7 min; OFSO 9.0 min; p < 0.001). The overall median follow-up time was 3.6 years (interquartile range 2.1-9.0 years). There were no significant differences between the major and minor complications when comparing the two devices. Both devices were safe and effective for percutaneous ASD closures. The OFSO had the benefit of a shorter fluoroscopic time.