Development and content validation of a competency-based assessment tool for penile prosthesis surgery.

The aim of this study was to identify potential hazards for the inflatable penile prosthesis (IPP) surgical procedure and from this develop and content validate an IPP intraoperative competency-based assessment tool. A multi-institutional longitudinal prospective observational study was conducted over a 6-month period. Healthcare Failure Mode and Effects Analysis (HFMEA) methodology was used to prospectively risk assess the IPP procedure using a collaborative multidisciplinary team (MDT) approach. International content validation of the developed tool was then undertaken via face-to-face meetings and WebEx seminars. A total of 22 h of observation led to the construction of a detailed process map consisting of 11 stages and 49 sub-stages. HFMEA identified 50 failure modes and 45 failure mode effects, nine failure modes were excluded after analysis leaving 41 key failure modes included in the checklist. The high-risk steps identified were related to corporal dilatation, incorrect sizing of the prosthesis cylinders and incorrect localisation of the superficial inguinal ring for blind reservoir placement. The final content validated IPP assessment tool (PPAT) consisted of 13 processes and 27 sub-processes. We concluded that HFMEA methodology successfully allowed for the identification of key steps within the IPP procedure from which the PPAT was developed. Formal international content validation confirmed that all key procedural steps were included in the PPAT and that completion of all steps would indicate trainee competency in the procedure. Further validation is required before the tool can be used to assess learning curves for the IPP procedure.

External assessment of the EUROMACS right-sided heart failure risk score.

The EUROMACS Right-Sided Heart Failure Risk Score was developed to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. The predictive ability of the EUROMACS score has not been tested in other cohorts. We performed a single center analysis of a continuous-flow (CF) LVAD cohort (n = 254) where we calculated EUROMACS risk scores and assessed for right ventricular heart failure after LVAD implantation. Thirty-nine percent of patients (100/254) had post-operative RVF, of which 9% (23/254) required prolonged inotropic support and 5% (12/254) required RVAD placement. For patients who developed RVF after LVAD implantation, there was a 45% increase in the hazards of death on LVAD support (HR 1.45, 95% CI 0.98-2.2, p = 0.066). Two variables in the EUROMACS score (Hemoglobin and Right Atrial Pressure to Pulmonary Capillary Wedge Pressure ratio) were not predictive of RVF in our cohort. Overall, the EUROMACS score had poor external discrimination in our cohort with area under the curve of 58% (95% CI 52-66%). Further work is necessary to enhance our ability to predict RVF after LVAD implantation.

Risk-benefit assessment of onlay and retrorectus mesh augmentation for incisional hernia prophylaxis: A secondary analysis from network meta-analysis.

BACKGROUND: Mesh augmentation has proved efficacious for the prevention of incisional hernia (IH). A recent network meta-analysis (NMA) identified onlay and retrorectus mesh (OM and RM) as the most effective therapeutic options, but the risk of surgical site infection (SSI) and other complications require additional consideration. METHODS: The NMA generated pooled risk differences (RD) for the benefits of reducing IH and the risk of SSI and composite seroma/hematoma (CSH) for use in Monte-Carlo data simulations with 1000 replications. Mean incremental risk-benefit ratios (IRBR), i.e., the ratio of incremental risk (or RD) and incremental benefit, and 95% confidence intervals (95% CI) were estimated with a probability of risk-benefits (PRB) across risk-benefit acceptability thresholds from the acceptability curves generated. RESULTS: The RDs of IH were 0.237 and 0.201 lower in OM and RM than primary suture closure, compared to 0.027 and -0.001 for SSI. IRBRs (95% CI) for SSI risk were -0.118 (-0.124, -0.112) and 0.006 (-0.002, 0.013) for OM and RM, respectively. PRBs were much higher in RM than OM, especially at low acceptability thresholds of 0.05 and 0.1. IRBRs (95% CI) for CSH were -0.388 (-0.395, -0.381) and -0.105 (-0.111, -0.100) for OM and RM, respectively. RM yielded a PRB of 0.87 at an acceptability threshold of 0.2, in contrast to OM, which did not. CONCLUSION: Overall, RM offered improved benefit in IH prophylaxis over the risk of complications relative to OM and appeared to be the preferred treatment option for this indication.

Assessment of novel surgical procedures using decellularised muscle and bioactive ceramic: a histological analysis.

Tissue regeneration and neovascularisation in cases of major bone loss is a challenge in maxillofacial surgery. The hypothesis of the present study is that the addition of resorbable bioactive ceramic Silica Calcium Phosphate Cement (SCPC) to Declluraized Muscle Scaffold (DSM) can expedite bone formation and maturation. Two surgical defect models were created in 18 nude transgenic mice. Group 1(n = 6), with a 2-mm decortication calvarial defect, was treated with a DSM/SCPC sheet over the corticated bone as an onlay then seeded with human Mesenchymal Stromal Cells hMSC in situ. In Group 2 (n = 6), a critical size (4 mm) calvarial defect was made and grafted with DSM/SCPC/in situ human bone marrow stromal cells (hMSCs). The control groups included Group 3 (n = 3) animals, with a 2-mm decortication defect treated with an onlay DSM sheet, and Group 4 (n = 3) animals, treated with critical size defect grafted with plain DSM. After 8 weeks, bone regeneration in various groups was evaluated using histology, immunohistochemistry and histomorphometry. New bone formation and maturation was superior in groups treated with DSM/SCPC/hMSC. The DMS/SCPC scaffold has the ability to augment and induce bone regeneration and neovascularisation in cases of major bone resorption and critical size defects.

A short-term comparison of expander prosthesis and DIEP flap in breast reconstructions: A prospective randomized study.

BACKGROUND: There is yet no clear consensus on which method is preferable in secondary breast reconstructions, prosthesis, or autologous tissue. METHODS: In this first prospective randomized study, 29 women underwent reconstruction with expander prosthesis (EP) and 44 with deep inferior epigastric perforator (DIEP) flap. Inclusion started in 2012 and ended in 2018. Demographic data, complications, surgery time, hospital days, and consulting visits were recorded. Patient satisfaction was evaluated pre- and postoperatively using the BREAST-Q questionnaire. Health care costs were calculated based on rates from the financial year 2018. Here, we report the results related to the surgery and the first 30 postoperative days. RESULTS: The two groups were comparable regarding demographics and clinical characteristics. Satisfaction with breasts, measured with BREAST-Q, was significantly higher in patients who had undergone reconstruction with DIEP flap compared with EP. Within 30 days after breast reconstruction, significantly fewer women (n = 2) in the EP group suffered complications compared to the DIEP flap group (n = 16; p < 0.01). The health care cost was also significantly higher in the DIEP flap group relative to the EP group (p < 0.01). DISCUSSION: This patient cohort will be studied systematically over time, and results concerning the need for complementary surgery, costs, esthetics, and the patient-reported outcome (PRO) will be reported in future work. In this short-term report, EP seems to be preferable in regard to cost and complications, and DIEP flap is to choose from the patient's perspective.

Cost of Thoracotomy Approach: An Analysis of the LATERAL Trial.

BACKGROUND: Less invasive techniques for left ventricular assist device implantation have been increasingly prevalent over past years and have been associated with improved clinical outcomes. The procedural economic impact of these techniques remains unknown. We sought to study and report economic outcomes associated with the thoracotomy implantation approach. METHODS: The LATERAL clinical trial evaluated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare centrifugal-flow ventricular assist device system (HVAD). We collected UB-04 forms in parallel to the trial, allowing analysis of index hospitalization costs. All charges were converted to costs using hospital-specific cost-to-charge ratios and were subsequently compared with Medicare cost data for the same period (2015-2016). Because thoracotomy implants were off-label for all left ventricular assist devices during that period, the Medicare cohort was assumed to consist predominately of traditional sternotomy patients. RESULTS: Thoracotomy patients demonstrated decreased costs compared with sternotomy patients during the index hospitalization. Mean total index hospitalization costs for thoracotomy were $204,107 per patient, corresponding to 21.6% reduction (P < .001) and $56,385 savings per procedure compared with sternotomy. Across almost all cost categories, thoracotomy implants were less costly. CONCLUSIONS: In LATERAL, a clinical trial evaluating the safety and efficacy of the thoracotomy approach for HVAD, costs were lower than those reported in Medicare patient claims occurring over the same period. Because Medicare data can be presumed to consist of predominately sternotomy procedures, thoracotomy appears less expensive than traditional sternotomy.

Radiographic parameter-driven decision tree reliably predicts aseptic mechanical failure of compressive osseointegration fixation.

Background and purpose - Compressive osseointegration fixation is an alternative to intramedullary fixation for endoprosthetic reconstruction. Mechanical failure of compressive osseointegration presents differently on radiographs than stemmed implants, therefore we aimed to develop a reliable radiographic method to determine stable integration.Patients and methods - 8 reviewers evaluated 11 radiographic parameters from 29 patients twice, 2 months apart. Interclass correlation coefficients (ICCs) were used to assess test-retest and inter-rater reliability. We constructed a fast and frugal decision tree using radiographic parameters with substantial test-retest agreement, and then tested using radiographs from a new cohort of 49 patients. The model's predictions were compared with clinical outcomes and a confusion matrix was generated.Results - 6 of 8 reviewers had non-significant intra-rater ICCs for ≥ one parameter; all inter-rater ICCs were highly reliable (p < 0.001). Change in length between the top of the spindle sleeve and bottom of the anchor plug (ICC 0.98), bone cortex hypertrophy (ICC 0.86), and bone pin hypertrophy (ICC 0.81) were used to create the decision tree. The sensitivity and specificity of the training cohort were 100% (95% CI 52-100) and 87% (CI 74-94) respectively. The decision tree demonstrated 100% (CI 40-100) sensitivity and 89% (CI 75-96) specificity with the test cohort.Interpretation - A stable spindle length and at least 3 cortices with bone hypertrophy at the implant interface predicts stable osseointegration; failure is predicted in the absence of bone hypertrophy at the implant interface if the pin sites show hypertrophy. Thus, our decision tree can guide clinicians as they follow patients with compressive osseo-integration implants.

Consumer Prices for Surgical Management of End-Stage Hallux Rigidus.

Background. Hallux rigidus is the most prevalent arthritic condition of the foot. Treatment of end-stage disease traditionally consists of a first metatarsophalangeal joint (MTPJ) arthrodesis; however, the use of a synthetic cartilage implant is becoming more common. With the high prevalence of disease and implementation of new treatment modalities, health care consumers should be aware of the costs associated with management. The purpose of this study was to determine access to the cost and variability in price of first MTPJ arthrodesis and synthetic cartilage implantation. Methods. Forty academic centers were contacted using a standardized patient script. The patient was a 59-year-old female who had failed conservative treatment of hallux rigidus. Each institution was contacted up to 3 times in an attempt to obtain a full bundled operative quote for a first MTPJ arthrodesis and synthetic cartilage implantation. Results. Twenty centers (50%) provided a quote for first MTPJ arthrodesis and 15 centers (38%) provided a quote for synthetic cartilage implantation. Only 14 centers (35%) were able to provide a quote for both procedures. The mean bundled price for MTPJ arthrodesis was $21 767 (range $8417 to $39 265). The mean bundled price for synthetic cartilage implantation was $21 546 (range $4903 to $74 145). There was no statistically significant difference between the bundled price for first MTPJ arthrodesis and synthetic cartilage implantation. Conclusions. There was limited availability of consumer prices for first MTPJ arthrodesis and synthetic implantation, thus impeding health care consumers' decision making. There was a wide range of quotes for both procedures, indicating potential cost savings.Levels of Evidence: IV, basic science.

Pre- and intraoperative acoustic and functional assessment of the novel APrevent® VOIS implant during routine medialization thyroplasty.

PURPOSE: Persistent unilateral vocal fold paralysis (UFVP) with glottal insufficiency often requires type I medialization thyroplasty (MT). Previous implants cannot be adjusted postoperatively if necessary. The newly developed APrevent® VOIS implant (VOIS) can provide postoperative re-adjustment to avoid revision MT. The objective of this pilot study is to evaluate the VOIS intraoperatively concerning voice improvement, surgical feasibility and device handling. METHODS: During routine MT, VOIS was applied short time in eight patients before the regular implantation of the Titanium Vocal Fold Medialization Implant (TVFMI™). In all patients, perceptual voice sound analysis using R(oughness)-B(reathiness)-H(oarseness)-scale, measurement of M(aximum)-P(honation)-T(ime) and glottal closure in videolaryngoscopy were performed before and after implanting VOIS/TVFMI™. Acoustic analyses of voice recordings were performed using freeware praat. Surgical feasibility, operative handling and device fitting of VOIS and TVFMI™ were assessed by the surgeon using V(isual)-A(nalog)-S(cale). Data were statistically analyzed with paired t test. RESULT: All patients showed significant improvement of voice sound parameters after VOIS/TVFMI™ implantation. The mean RBH-scale improved from preoperative R = 2.1, B = 2.3, H = 2.5 to R = 0.6, B = 0.3, H = 0.8 after VOIS and R = 0.5, B = 0.3, H = 0.8 after TVFMI™ implantation. The mean MPT increased from preoperative 7.9 to 14.6 s after VOIS and 13.8 s after TVFMI™ implantation. VOIS/TVFMI™ achieved complete glottal closure in 7/8 patients. The satisfaction with intraoperative device fitting and device handling of VOIS was as good as that of TVFMI™. CONCLUSION: The novel APrevent® VOIS implant showed similar intraoperative voice improvement compared to routinely used TVFMI™ without adverse device events and with safe device fitting.

Assessment of Physical Performance and Early Treatment Outcomes after Implantation of Modular Prostheses of Femoral and Tibial Shaft.

BACKGROUND: Tumours of bone diaphyses often require resection followed by bone reconstruction. The use of modular pro-sthe-ses permits early limb loading and rapid improvement in physical performance. The aim of this study was to evaluate the func-tioning of patients and early treatment outcomes after the implantation of modular prostheses. The analysis covered the correlation between the extent of resection, physical performance and the number of perioperative complications. MATERIAL AND METHODS: 10 patients (5 women and 5 men) with diaphyseal tumours who had modular prostheses implanted were treated at the Orthopaedic Oncology Department in Brzozów between 2014 and 2018. The mean age of the patients was 51.1 years (range: 26-63 years). Functional outcomes were assessed using the MSTS and the Karnofsky scoring system. A VAS was used to evaluate pain intensity. the extent of resection was also analysed, considering bone length and tumour weight. RESULTS: The mean tumour weight was 374g (150-700g). The length of the implants varied from 10 to 25 cm. The mean dura-tion of hospitalisation was 16 days (14-19 days). At 3 months following the surgery, the intensity of pain had decreased from a mean of 6.8 points to 4.2 points (a decrease of 26% from the pre-operative baseline). The MSTS showed improvement of functional performance from a mean of 10.8 points (36%) to 22.9 points (76%). The Karnofsky scores demonstrated an increase in physical performance from 47 to 67 points (20 points on average). Superficial infection of the wound developed in 1 patient. CONCLUSIONS: 1. The treatment of diaphyseal tumours with modular prostheses produces good functional outcomes. 2. The extent of the resection and the size of the implant have an effect on the post-operative physical performance of the patients. 3. Pre-operative evaluation of the weight of the tumour may be helpful in predicting the patient's post-operative functional status. 4. Phy-sical perfor-mance is better after the resection of femoral vs tibial tumours.

Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial).

In patients with heart failure and preserved or mildly reduced ejection fractions (EF ≥40%), implantation of an interatrial shunt device (IASD) resulted in heterogenous changes of the left atrial (LA) volume. Baseline characteristics that correlate with a favorable decrease in LA volume are unknown. We hypothesized that a larger ratio of left to right atrial volume at baseline would correlate strongly with LA volume decongestion following IASD implantation. Reduce Elevated LA Pressure in Patients With Heart Failure was a multicenter study of the safety and feasibility of IASD implantation. Sixty-four patients with EF ≥40% underwent device implantation along with baseline conventional echocardiograms, speckle tracking echocardiography, and resting and exercise hemodynamics. Higher LA compliance (-4.2%, p = 0.048) and right atrial reservoir strain (-0.8%, p = 0.005) were independently associated with a percent decrease in the systolic LA volume index from baseline to 6-months. In conclusion, greater LA volume reduction following IASD implantation is associated with higher baseline compliance of the left atrium and higher reservoir strain of the right atrium.

Assessment of a Vacuum-Based Intra-Colonic Diverting Device: A Preclinical Study.

Purpose. Anastomotic leak is the main complication after low colorectal anastomosis. Defunctioning ileostomy is therefore recommended, which carries its own morbidity. The aim of this study was to assess the technical feasibility, safety, and preliminary efficacy of a vacuum-based intra-colonic diverting device (Colovac) to reduce the impact of anastomotic leak. Methods. This prospective preclinical study was conducted on living swine. The device was surgically inserted transanally, proximal to a colorectal anastomosis, and removed endoscopically at day 14. Then, open surgery was performed to look for deep sepsis and/or anastomotic leak, and the remaining colorectal anastomosis was resected for histopathological analysis. The endpoints were successful insertion and delivery of the device, postoperative morbidity, successful maintaining of the device, and absence of feces spillage and/or abscess in the abdominal cavity. Results. The Colovac was inserted in 22 swine. Stent migration occurred in 7 of the first 8 specimens, leading to natural expulsion of the device. After diet adaptation, a subsequent group of 14 swine was undertaken, of which 13 did not show any sign of migration post-implantation. Disconnection of the suction drain occurred in 1 case, leading to device expulsion on day 10. Colovac retrieval was achieved successfully in 13 cases. The endoscopic assessment of the anchorage site showed limited mucosal injury, whereas histopathological findings revealed mild hyperplasia. One swine died prematurely of postoperative colonic ischemia. Conclusion. This new device appears to be safe in the swine model and may prevent peritonitis or abscess due to colorectal anastomotic leak.

Contemporary Approaches to Preventing and Treating Infections of Novel Intrathecal Neurostimulation Devices.

INTRODUCTION: Contemporary approaches to surgical site infections have evolved significantly over the last several decades in response to the economic pressures of soaring health care costs and increasing patient expectations of safety. Neurosurgeons face multiple unique challenges when striving to avoid as well as manage surgical implant infections. The tissue compartment, organ system, or joint is characterized by biological factors and physical forces that may not be universally relevant. Such implants, once rare, are now routine. Although the prevention, diagnosis, and treatment of surgical site infections involving neural implants has advanced, guidelines are ever changing, and the incidence still exceeds acceptable levels. We assess the impact of these factors on a new class of implantable neuromodulation devices. METHODS: The available evidence along with practice patterns were examined and organized to establish relevant groupings for continuing evaluation and to propose justifiable recommendations for the treatment of infections that might arise in the case of intradural spinal cord stimulators. RESULTS: Few studies in the modern era have systematically evaluated preventive behaviors that were applied to intradural neural implants alone. We anticipate that future efforts will focus even more on the investigation of modifiable factors along a continuum from bacterially repellant implants to weight management. Early diagnosis could offer the best hope for device salvage but to date has been largely understudied. CONCLUSIONS: Historically, prevention is the cornerstone to infection mitigation. However, immediate diagnosis and hardware salvage have not received the attention deserved, and that approach may be especially important for intradural devices.

Radiographic assessment of overlengthening of the MoPyC radial head prosthesis: a cadaveric study.

INTRODUCTION: The aim of this study was to evaluate a radiographic measurement method for assessment of overlengthening of the MoPyC radial head prosthesis. MATERIALS AND METHODS: Seven cadaver specimens were studied in ten stages: native specimen (1), radial head resection (2), and implantation of the MoPyC radial head prostheses (Bioprofile, Tornier, Montbonnot-Saint-Martin, France) in four increasing length (correct length, overlengthening of 1.5 mm, 3 mm, and 5 mm) with an intact medial collateral ligament (MCL 3-6) and following transection of the MCL (7-10). The radiographic measurement method according to Athwal et al. was evaluated to detect overlengthening. Statistical analysis included calculation of the diagnostic accuracy of the radiographic method. RESULTS: The radiographic measurement method correctly determined the size of the radial head prosthesis within ± 1 mm in 224 of 336 scenarios (67%) and within ± 2 mm in 320 of 336 scenarios (95%). With a threshold value of ≥ 1 mm, the overall diagnostic sensitivity for detecting overlengthening when it was present and was 90% and the specificity was 79%. The sensitivity was higher with increasing size of the prosthesis: in cases with overlengthening of 1.5 mm, the sensitivity was 76%, with an overlengthening of 3 mm, the sensitivity was 95%, and with an overlengthening of 5 mm, the sensitivity was 100%. CONCLUSION: The radiographic measurement method of Athwal et al. can be used to estimate and to diagnose the magnitude overlengthening of the MoPyC radial head prosthesis. However, the sensitivity is limited (76%) in cases with a small amount of overlengthening of 1.5 mm.

Intra-Scleral Ciliary Sulcus Suprachoroidal Microtube: Making Supraciliary Glaucoma Surgery Affordable.

PURPOSE: The suprachoroidal space (SCS) has been a successful target to lower intraocular pressure (IOP) in glaucoma patients. We present the results of 4 patients who underwent a novel glaucoma surgical procedure to lower IOP: Intrascleral Ciliary Sulcus-Suprachoroidal Microtube. METHODS: A sterile medical grade silicone microtube (Tube extender, New World Medical) was surgically placed to drain aqueous from the posterior chamber ciliary sulcus of the eye to the SCS. The internal diameter of the tube was 300 um and the length varied from 8-10mm. After informed consent was obtained and witnessed, this procedure was performed in glaucoma patients with pseudophakia. The tube was placed intrasclerally beneath an inferotemporal sclera flap (50% thickness approximately 4mm x 4mm). The anterior end of the tube was inserted into the ciliary sulcus approximately 2mm from the limbus and the posterior end was placed into the SCS approximately 4mm from the limbus. The microtube was sutured to the sclera with a 10-0 nylon suture. 8-0 vicryl sutures were used to close the sclera flap and the conjunctiva inferotemporally. RESULTS: All 4 patients had lower IOP. The average reduction of IOP was 36% at 3 months. The amount of glaucoma medications per patient at 3 months dropped from an average of 3 to 0.25. The risks are similar to traditional glaucoma incisional surgery. CONCLUSION: This new technique of Intrascleral Ciliary Sulcus-Suprachoroidal Microtube in all four patients with mild, moderate, and advanced glaucoma demonstrated a significant lowering of IOP and a decrease in the number of medications. Further research is required to assess long term efficacy and safety.

Early cost-utility estimation of the surgical correction of pectus excavatum with the Nuss bar.

OBJECTIVES: The surgical correction of pectus excavatum (PE) with a Nuss bar provides satisfactory outcomes, but its cost-effectiveness is yet unproven. We prospectively analysed early outcomes and costs for Nuss bar placement. METHODS: Fifty-four patients aged 16 years or older (6 females and 48 males; mean age, 17.9 years; range 16.0-29.4 years) with a PE filled out a Short Form-36 Health Survey (SF-6D) preoperatively and 1 year after a Nuss procedure. Costs included professional fees and fees for the operating room, materials and hospital care. Changes in the responses to the SF-36 or its domains were compared using the Wilcoxon signed rank test and the utility test results were calculated preoperatively and postoperatively from the SF-6D. The quality-adjusted life years (QALYs) were calculated from the results of these tests. RESULTS: Significant improvements in physical functioning, social functioning, mental health and health transition (all P < 0.05) were noted. The other SF-36 subgroups showed improvement; however, the improvement was not significant. The SF-6D utility showed improvement from 0.76 preoperatively to 0.79 at the 1-year follow-up (P = 0.096). The mean direct costs were €8805. The 1-year discounted QALY gain was 0.03. The estimated cost-utility ratio was €293 500 per QALY gained. CONCLUSIONS: Despite a significant improvement in many domains of the SF-36, the results of the SF-6D cost-utility analysis showed only a small improvement in cost-effectiveness (> €80 000/QALY) for patients with PE 1 year after Nuss bar placement. Based on this discrepancy, general health outcome measurements as the basis for cost-utility analysis in patients with PE may not be the best way forward.

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database.

Importance: The iStent Trabecular Micro-Bypass (Glaukos Corporation) is a minimally invasive glaucoma implant used in conjunction with cataract surgery to lower intraocular pressure. Objective: To determine whether implantation of the iStent concurrent with cataract surgery is associated with reduced use of ocular antihypertensive medications in a US health care claims database. Design, Setting, and Participants: Retrospective, observational longitudinal cohort study of individuals enrolled in a US managed care network who underwent iStent implantation with cataract surgery (iStent/CEIOL) from 2012 to 2016 (n = 1509 bilateral and n = 1462 unilateral surgery). A control group of individuals who underwent bilateral cataract surgery only (CEIOL) were matched 1:1 to patients undergoing bilateral iStent/CEIOL on baseline demographic and clinical factors. Data were analyzed between November 1, 2017, and January 31, 2018. Main Outcomes and Measures: The number of topical ocular antihypertensive agents used postoperatively by patients undergoing iStent/CEIOL compared with baseline and with matched CEIOL control individuals, and hazard ratios with 95% confidence intervals for sustained reduced use of at least 1 topical ocular antihypertensive agent postoperatively. Results: Of the 2971 eligible enrollees, mean age at first surgery was 74.3 years, and 1659 (55.8%) were women. Patients undergoing iStent/CEIOL had diagnoses that included primary open-angle glaucoma (n = 2329; 78.4%), narrow angles (n = 381; 12.8%), and secondary glaucomas (n = 261; 8.8%). At baseline, 1223 (41.2%) were receiving no topical glaucoma agents; 876 (29.5%), 437 (14.7%), and 435 (14.6%) were receiving 1, 2, or at least 3 agents, respectively. Although only 678 persons (22.8%) completed at least 2 years of postoperative follow-up, the proportion of patients receiving no drops increased postoperatively (64.7%, 20-24 months, P < .001, χ2). Patients receiving at least 1 topical agent at baseline had mean reduction of 1.01 and 0.61 medications used at 20 to 24 months with bilateral or unilateral surgery, respectively (both P < .001, paired t). Sustained reduction in glaucoma medication use was more likely in patients receiving at least 3 vs 1 medication at baseline (hazard ratio, 1.68; 95% CI, 1.36-2.09). Compared with matched control individuals undergoing CEIOL, patients undergoing bilateral iStent/CEIOL had a greater mean reduction in drops used (0.99 vs 0.49; postoperative month 20-24; P < .001; paired t) and a higher proportion receiving no drops postoperatively (73.5% vs 55.3%, postoperative month 20-24; P < .001; χ2). Conclusions and Relevance: Implantation of the iStent trabecular micro-bypass stent concurrent with cataract surgery was associated with moderately reduced use of topical ocular antihypertensive medication. Reduction in the use of glaucoma medications may lessen the burden of medication adverse effects and promote better adherence.

Assessment of Fissure Integrity in Patients With Intrabronchial Valves for Treatment of Prolonged Air Leak.

BACKGROUND: Intrabronchial valves (IBVs) are a treatment alternative for persistent air leak (PAL). However, there is a paucity of evidence regarding whether the absence of collateral ventilation (CV) can predict successful treatment of PAL with IBV placement. We assessed whether absence of CV measured by fissure integrity could predict successful resolution of PAL with IBV placement. METHODS: A multicenter, retrospective study was performed. Patients who underwent IBV placement for PAL were identified. Chest computed tomography analysis via VIDA Diagnostics was used to assess CV. CV was present if the treated lobe was adjacent to a fissure that was <90% complete. RESULTS: A total of 81 valves were placed in 26 patients (median, 3 per patient). A total of 16 patients without CV underwent IBV placement: 14 patients had complete resolution of PAL with a median time from IBV placement to air leak resolution of 4.5 days and 2 patients required subsequent procedures to manage the PAL. In a subset of patients without CV who underwent complete lobar occlusion with IBV (n = 8), median time to PAL resolution was 3 days, whereas in patients without CV who underwent incomplete lobar occlusion with IBV (n = 6), median time PAL resolution was 6.5 days (p = 0.045). All 10 patients with CV underwent IBV placement and complete lobar occlusion: 4 patients had complete PAL resolution with a median time from IBV placement to PAL resolution of 17.5 days and 6 patients required subsequent procedures to manage their PAL. CONCLUSIONS: PAL treatment with IBV is more successful in patients without CV, especially when complete lobar occlusion with IBV is achieved.

Osseointegrated Prosthetic Implants for People With Lower-Limb Amputation: A Health Technology Assessment.

BACKGROUND: Osseointegrated prosthetic implants are biocompatible metal devices that are inserted into the residual bone to integrate with the bone and attach to the external prosthesis, eliminating the need for socket prostheses and the problems that may accompany their use. We conducted a health technology assessment of osseointegrated prosthetic implants, compared with conventional socket prostheses, for people with lower-limb amputation who experience chronic problems with their prosthetic socket, leading to prosthesis intolerance and reduced mobility. Our analysis included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding osseointegrated prosthetic implants, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence on the safety and effectiveness of the latest iterations of three implant systems: the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the Endo-Exo-Femur-Prosthesis, and the Osseointegration Group of Australia-Osseointegration Prosthetic Limb (OGAP-OPL). We assessed the risk of bias of individual studies and determined the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective. We also analyzed the net budget impact of publicly funding osseointegrated prosthetic implants in Ontario. To contextualize the potential value of osseointegrated prosthetic implants, we spoke with people with lower-limb amputations. RESULTS: We included nine studies in the clinical evidence review. All studies included patients with above-the-knee amputation who underwent two-stage surgery and mostly had short-term follow-up. With osseointegrated prosthetic implants, scores for functional outcomes improved significantly as measured by 6-Minute Walk Test (6MWT), Timed Up and Go (TUG) test, and Questionnaire for Persons with a Transfemoral Amputation (Q-TFA). The scores for quality of life measured by SF-36 showed significant improvement in the physical component summary but a nonsignificant decline for the mental component summary. The most frequently seen adverse event was superficial infection, occurring in about half of patients in some studies. Deep or bone infection was a serious adverse event, with variable rates among the studies depending on the length of follow-up. The treatment of deep or bone infection required long-term antibiotic use, surgical debridement, revision surgery, and implant extraction in some cases. Other adverse events included femoral bone fracture, implant breakage, issues with extramedullary parts that required replacement, and implant removal. Our assessment of the quality of the clinical evidence according to the GRADE criteria found low certainty in terms of improvement in functional outcomes, low certainty for quality of life, and high certainty of an increase in adverse events; all findings compared receiving an osseointegrated prosthetic implant with not receiving an osseointegrated prosthetic implant.In our economic model, osseointegrated prosthetic implants were found to be more effective and more expensive than having people remain users of an uncomfortable socket prosthesis. Our best estimate of the incremental cost-effectiveness ratio (ICER) for osseointegration, compared with an uncomfortable socket, was $94,987 per quality-adjusted life-year (QALY) gained. The probability of osseointegration being cost-effective was 54.2% at a willingness-to-pay value of $100,000 per QALY gained. The annual net budget impact of publicly funding osseointegrated prosthetic implants in Ontario over the next 5 years, for a small population of eligible candidates, would range from $1.5 million in year 1 to $0.6 million in year 5, for a 5-year total of $5.3 million.We interviewed 13 people with a lower-limb amputation; nine had experience with both a conventional socket prosthesis and an osseointegrated prosthetic implant, three had experience with a conventional socket prosthesis only, and one had only recently undergone amputation and had not yet chosen a prosthesis. People who had received an osseointegrated prosthetic implant said they had better mobility and quality of life than before receiving this implant but had concerns about the ongoing risk of infection and potential for problems with implant maintenance. People using a conventional socket prosthesis said cost was the only factor preventing them from undergoing an osseointegration procedure. CONCLUSIONS: In the studies included in the clinical evidence review, most people who received osseointegrated prosthetic implants were followed for only a few years. Studies showed that functional outcomes and physical ability improved with osseointegrated prosthetic implants (GRADE: Low), but there was uncertainty about the impact of these implants on people's emotional health (GRADE: Low). Osseointegrated prosthetic implants can lead to serious adverse events such as bone infection and bone fracture in some patients, which may require additional surgeries (GRADE: High). The reference case of the primary economic evaluation represented a conservative estimate of cost-effectiveness and found osseointegration may be cost-effective, but there is a large degree of uncertainty given parameter uncertainty and the need to use proxy costs. Scenario analyses explored potential variations in approaches to modelling and parameter selection. Qualitative interviews with people with a lower-limb amputation and caregivers underscored the challenges of conventional socket prostheses, but cost remains an important barrier to pursuing osseointegrated prosthetic implantation.